Patient and lay carer education for preventing pressure ulceration in at‐risk populations

Abstract

Background

Pressure ulcers (PUs) are injuries to the skin and underlying tissues that occur most commonly over bony prominences, such as the hips and heels as a result of pressure and shear forces. PUs cause pain, discomfort, longer hospital stays, and decreased quality of life. They are also very costly to treat and consume substantial parts of healthcare budgets. PUs are largely preventable, and education targeted at patients and their carers is considered important.

Objectives

To assess the effects of patient and/or lay carer education on preventing pressure ulceration in at‐risk people, in any care setting.

Search methods

In June 2019 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In‐Process & Other Non‐Indexed Citations); Ovid Embase; Ovid PsycINFO and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies.  There were no restrictions with respect to language, date of publication or study setting.

Selection criteria

We included randomised controlled trials (RCTs) that recruited people of any age at risk of pressure ulceration, and RCTs that recruited people who informally care for someone at risk of pressure ulceration.

Data collection and analysis

Two review authors independently performed study selection, data extraction, 'Risk of bias' assessment, and GRADE assessment of the certainty of the evidence.

Main results

We included 10 studies with 11 publications (2261 participants analysed). Seven targeted their intervention at people at risk of ulceration and measured outcomes on these at risk people; two targeted those at risk and their family carers and measured outcomes on the at risk people cared for by their families; and one targeted lay carers only and measured outcomes on the at risk people they cared for. There were two main types of interventions: the provision of information on prevention of pressure ulcers, and the use of different types of education programmes.

Provision of information on the prevention of pressure ulcers

Three studies (237 participants) reported data for this comparison: two provided information directly to those at risk and their carers, and the third provided information to lay carers. As data could not be pooled we present individual study data. The evidence for primary outcomes is of very low certainty (downgraded twice for study limitations and twice for imprecision).

We are uncertain whether the combined use of a self‐instruction manual and one‐to‐one patient training and counselling versus a self‐instruction manual alone reduces the proportion of at risk people developing a new PU (risk ratio (RR) 0.40, 95% confidence interval (CI) 0.14 to 1.18), or whether carer self‐instruction and one‐to‐one counselling versus self‐instruction alone reduces the proportion of at risk people developing a new PU (RR 2.05, 95% CI 0.19 to 21.70).

We are uncertain whether the use of home‐based training, compared with routine ward‐based training, reduces the proportion of at risk people developing a new PU (RR 0.53, 95% CI 0.27 to 1.02).

One study explored the secondary outcome patient knowledge of pressure ulcer prevention; however, as usable data were not provided, we were unable to carry out further analysis, and no effect estimate could be calculated.

Educational programmes on the prevention of pressure ulcers

Seven studies (2024 participants analysed) provided data for this comparison. In all studies the intervention was aimed at people at risk of ulceration.

Risk of pressure ulceration

One secondary report of an included study reported the primary outcome as time to PU development or occurrence and three studies and one secondary report of an included study reported this as the proportion of at risk people developing a new PU. One study reported the secondary outcome grade of PU and five studies and one secondary report of an included study reported on patient knowledge.

There is low certainty evidence of there being no clear difference in the proportion of participants developing a new PU between use of a pressure ulcer prevention care bundle (PUPCB) and standard care: HR 0.58, 95% CI 0.25 to 1.33 (downgraded twice for imprecision).

One secondary report of an included study explored whether individualised PU education and monthly structured telephone follow‐up changes the mean time to PU occurrence. Not all participants in this study developed a pressure ulcer, therefore the mean time to pressure ulcer occurrence could not be calculated from the data.

We are uncertain whether the following three interventions reduce the proportion of at risk people developing a new PU as we assessed the certainty of evidence as very low: individualised PU education and monthly structured telephone follow‐up (RR 0.55, 95% CI 0.23 to 1.30), education delivery (RR 3.57, 95% CI 0.78 to 16.38), (downgraded twice for risk of bias and twice for imprecision); and computerised feedback and one‐to‐one consultations (no clear data provided), (downgraded twice for risk of bias and once for indirectness).

Grade of pressure ulcer

There is low certainty evidence that use of a PU prevention care bundle may make no difference to the severity of new PU development when compared with standard care.

Patient knowledge

We are uncertain whether the following interventions improve patient knowledge: enhanced educational intervention and structured follow‐up (mean difference (MD) 9.86, 95% CI 1.55 to 18.17); multi component motivational interviewing/self‐management with a multi component education intervention (no clear data provided); Spinal Cord Injury Navigator programme (no clear data provided); individualised PU education and monthly structured telephone follow‐up (no clear data provided); computerised feedback (no clear data provided), structured, patient‐centric PU prevention education event (MD 30.15, 95% CI 23.56 to 36.74). We assessed the certainty of the evidence for this outcome as low or very low (downgraded for risk of bias, imprecision, or indirectness).

Authors' conclusions

We are uncertain whether educational interventions make any difference to the number of new PUs that develop, or to patient knowledge based on evidence from the 10 included studies, which we assessed as of low or very low certainty due to problems with risk of bias, serious imprecision and indirectness. The low certainty of evidence means that additional research is required to confirm these results.

Plain language summary

Patient and lay carer education for preventing pressure ulceration in at‐risk populations

What is the aim of this review?

The aim of this review was to find out whether education programmes aimed at people at risk of developing pressure ulcers (also known as bedsores or decubitus ulcers) and their carers are effective in the prevention of pressure ulcers. We collected and analysed all relevant studies (randomised controlled trials) to answer this question, and found 10 studies with 11 publications for inclusion. Randomised controlled trials are medical studies where the treatment or care that people receive is chosen at random. This type of trial provides the most reliable health evidence.

Key messages

In all studies, it is uncertain whether educational interventions make any difference to the proportion of at risk people developing a new ulcer, or to patient or lay carer knowledge.

What was studied in the review?

Pressure ulcers are wounds that occur on the skin or underlying tissues. People who cannot move and change position (such as those using wheelchairs, or in long‐term nursing and hospital care) are at most risk of developing pressure ulcers. These wounds can cause pain, discomfort, and distress and have a negative effect on quality of life. Preventing pressure ulcers is therefore very important. Educating people about the risks of pressure ulcers and how to prevent them is considered to be an important part of preventative care.

What are the main results of the review?

We found 10 relevant studies, with 11 publications, (2261 participants analysed) dating from 2002 to 2018 comparing interventions aimed at educating people at risk of developing pressure ulcers or their carers. Four studies (five publications) included people with spinal cord injuries, mainly males, with a mean age of less than 60 years. The remaining studies included both males and females of varying ages, some who had disorders of the central nervous system, and others who were other types of at risk people cared for in hospital or in the community. Seven studies focused on people at risk of pressure ulcers; two focused on at risk people and carers; and one focused on lay carers. The interventions tested aimed to prevent pressure ulcers either by providing people with written information or by involving them in a variety of educational programmes. The studies explored the impact of the interventions on at risk people, either 1) the number of new pressure ulcers developed, 2) the severity of pressure ulcers developed, or 3) patient knowledge. None of the studies explored patient or lay carer satisfaction with the interventions.

Two studies (three publications) were funded by the Department of Veterans Affairs (USA). Two studies were funded by the National Institute for Disability and Rehabilitation Research (USA). One study was funded by the Department of Health Policy Research Programme (UK); one study by the Post Graduate Institute of Medical Education and Research (Chandigarh, India); one study by the Indian Council of Medical Research (New Delhi, India); and one study by the National Health and Medical Research Council (Australia). Two studies did not outline any source of funding.

The results of the trials do not allow us to draw any firm conclusions regarding the effectiveness of educational interventions in preventing pressure ulcers, or in increasing patient knowledge about pressure ulcer prevention. The certainty of the evidence in these trials is low or very low.

How up‐to‐date is this review?

We searched for studies that had been published up to June 2019.

Summary of findings

Summary of findings 1. Self‐instruction and one‐to‐one counselling versus self‐instruction for preventing pressure ulceration in at‐risk populations.

Self‐instruction and one‐to‐one counselling versus self‐instruction for preventing pressure ulceration in at‐risk populations
Patient or population: general patients and carers Settings: orthopaedic setting Intervention: self‐instruction and one‐to‐one counselling Comparison: self‐instruction
Outcomes	Illustrative comparative risks* (95% CI)		Relative effect (95% CI)	No. of participants (studies)	Certainty of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Self‐instruction	Self‐instruction and one‐to‐one counselling
Time to occurrence of new ulcer	Not reported
Proportion of participants developing a new ulcer (3 months)	Study population		RR 0.40 (0.14 to 1.18)	92 (1 study)	⊕⊝⊝⊝ Very low1	It is uncertain whether the use of a self‐instruction manual and one‐to‐one patient training and counselling reduces the proportion of participants developing a new ulcer.
	217 per 1000	87 per 1000 (30 to 257)
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; RR: risk ratio
GRADE Working Group grades of evidence High certainty: further research is very unlikely to change our confidence in the estimate of effect. Moderate certainty: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low certainty: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low certainty: we are very uncertain about the estimate.

¹Downgraded twice for risk of bias due to high risk of selection, detection, and performance bias, and twice for imprecision due to the very small number of events and wide confidence interval.

Summary of findings 2. Carer self‐instruction and one‐to‐one counselling versus self‐instruction for preventing pressure ulceration in at‐risk populations.

Carer self‐instruction and one‐to‐one counselling versus self‐instruction for preventing pressure ulceration in at‐risk populations
Patient or population: carers caring for patients at risk of pressure ulcers Settings: community (patient's home) Intervention: carer self‐instruction and one‐to‐one counselling Comparison: self‐instruction alone
Outcomes	Illustrative comparative risks* (95% CI)		Relative effect (95% CI)	No. of participants (studies)	Certainty of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Self‐instruction	Carer self‐instruction and one‐to‐one counselling
Time to occurrence of a new ulcer	Not reported
Proportion of participants developing a new ulcer (12 months)	Study population		RR 2.05 (0.19 to 21.70)	75 (1 study)	⊕⊝⊝⊝ Very low1	It is uncertain whether the use of carer self‐instruction and one‐to‐one counselling reduces the proportion of participants developing a new ulcer.
	26 per 1000	54 per 1000 (5 to 571)
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; RR: risk ratio
GRADE Working Group grades of evidence High certainty: further research is very unlikely to change our confidence in the estimate of effect. Moderate certainty: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low certainty: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low certainty: we are very uncertain about the estimate.

¹Downgraded twice for unclear risk of attrition bias, selection, detection, and performance bias, and twice for imprecision due to wide confidence interval, small sample and event size.

Summary of findings 3. Home‐based training versus usual care for preventing pressure ulceration in at‐risk populations.

Home‐based training versus usual care for preventing pressure ulceration in at‐risk populations
Patient or population: patients at risk of pressure ulcers and their family caregivers Settings: community (patient's home) Intervention: home‐based training Comparison: usual care
Outcomes	Illustrative comparative risks* (95% CI)		Relative effect (95% CI)	No. of participants (studies)	Certainty of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Usual care	Home‐based training
Time to occurrence of new ulcer	Not reported
Proportion of participants developing a new ulcer (3 months)	Study population		RR 0.53 (0.27 to 1.02)	70 (1 study)	⊕⊝⊝⊝ Very low1	It is uncertain whether the use of home‐based training reduces the proportion of participants developing a new ulcer.
	486 per 1000	259 per 1000 (109 to 486)
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; RR: risk ratio
GRADE Working Group grades of evidence High certainty: further research is very unlikely to change our confidence in the estimate of effect. Moderate certainty: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low certainty: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low certainty: we are very uncertain about the estimate.

¹Downgraded twice for risk of bias due to high risk of selection, performance, and detection bias, and twice for imprecision due to small sample size and wide confidence interval.

Summary of findings 4. Enhanced educational intervention and structured follow‐up versus standard education alone for preventing pressure ulceration in at‐risk populations.

Enhanced educational intervention and structured follow‐up versus standard education alone for pressure ulcer prevention in at‐risk populations
Patient or population: individuals with spinal cord injury Settings: hospital Intervention: enhanced educational intervention and structured follow‐up Comparison: standard education alone
Outcomes	Illustrative comparative risks* (95% CI)		Relative effect (95% CI)	No. of participants (studies)	Certainty of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Standard education alone	Enhanced educational intervention and structured follow‐up
Time to occurrence of new ulcer	Not reported
Proportion of participants developing a new ulcer	Not reported
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval
GRADE Working Group grades of evidence High certainty: further research is very unlikely to change our confidence in the estimate of effect. Moderate certainty: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low certainty: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low certainty: we are very uncertain about the estimate.

Summary of findings 5. Education versus standard printed material for preventing pressure ulceration in at‐risk populations.

Education versus standard printed material for preventing pressure ulceration in at‐risk populations
Patient or population: individuals with neurological disorders Settings: patient's home Intervention: education Comparison: standard printed material
Outcomes	Illustrative comparative risks* (95% CI)		Relative effect (95% CI)	No. of participants (studies)	Certainty of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Standard printed material	Education
Time to occurrence of new ulcer	Not reported
Proportion of participants developing a new pressure (12 months)	Study population		RR 3.57 (0.78 to 16.38)	105 (1 study)	⊕⊝⊝⊝ Very low1	It is uncertain whether education delivery reduces the proportion of participants developing a new ulcer.
	38 per 1000	135 per 1000 (29 to 618)
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; RR: risk ratio
GRADE Working Group grades of evidence High certainty: further research is very unlikely to change our confidence in the estimate of effect. Moderate certainty: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low certainty: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low certainty: we are very uncertain about the estimate.

¹Downgraded twice for risk of bias due to high risk of performance and detection bias and unclear risk of attrition bias and selection bias, and twice for imprecision due to the very small number of events and very wide confidence interval.

Summary of findings 6. Computerised feedback and one‐on‐one consultations versus no feedback for preventing pressure ulceration in at‐risk populations.

Computerised feedback and one‐on‐one consultations versus no feedback for pressure ulcer prevention
Patient or population: individuals with spinal cord injury Settings: hospital Intervention: computerised feedback and one‐on‐one consultations Comparison: no feedback
Outcomes	Illustrative comparative risks* (95% CI)		Relative effect (95% CI)	No. of participants (studies)	Certainty of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	No feedback	Computerised feedback and one‐on‐one consultations
Time to occurrence of new ulcer	Not reported
Proportion of participants developing a new ulcer	Not reported
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval
GRADE Working Group grades of evidence High certainty: further research is very unlikely to change our confidence in the estimate of effect. Moderate certainty: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low certainty: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low certainty: we are very uncertain about the estimate.

Summary of findings 7. Individualised pressure ulcer education and monthly structured telephone follow‐up versus standard pressure ulcer education and monthly mail or telephone follow‐up.

Individualised pressure ulcer education and monthly structured telephone follow‐up versus standard pressure ulcer education and monthly mail or telephone follow‐up, for preventing pressure ulceration in at‐risk populations
Patient or population: individuals with spinal cord injury Settings: veterans medical centre Intervention: individualised pressure ulcer education and monthly structured telephone follow‐up Comparison: standard pressure ulcer education and monthly mail or telephone follow‐up
Outcomes	Illustrative comparative risks* (95% CI)		Relative effect (95% CI)	No. of participants (studies)	Certainty of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Standard pressure ulcer education and monthly mail or telephone follow‐up	Individualised pressure ulcer education and monthly structured telephone follow‐up
Time to occurrence of new ulcer	Data insufficiently reported to enable analysis.
Proportion of participants developing a new ulcer (24 months)	Study population		RR 0.55 (0.23 to 1.30)	31 (1 study)	⊕⊝⊝⊝ Very low 1	It is uncertain whether individualised pressure ulcer education and monthly structured telephone follow‐up reduces the proportion of participants developing a new ulcer.
	545 per 1000	300 per 1000 (125 to 709)
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; RR: risk ratio
GRADE Working Group grades of evidence High certainty: further research is very unlikely to change our confidence in the estimate of effect. Moderate certainty: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low certainty: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low certainty: we are very uncertain about the estimate.

¹Downgraded twice for risk of bias due to high risk of performance and reporting bias and unclear risk of attrition, selection, and detection bias, and twice for imprecision due to the very small sample size and very wide confidence interval.

Summary of findings 8. Standard pressure ulcer education and monthly mail or telephone follow‐up, versus standard pressure ulcer education and quarterly mail or telephone follow‐up, for preventing pressure ulceration in at‐risk populations.

Standard pressure ulcer education and monthly mail or telephone follow‐up, versus standard pressure ulcer education and quarterly mail or telephone follow‐up, for preventing pressure ulceration in at‐risk populations
Patient or population: individuals with spinal cord injury Settings: veterans medical centre Intervention: standard pressure ulcer education and monthly mail or telephone follow‐up Comparison: standard pressure ulcer education and quarterly mail or telephone follow‐up
Outcomes	Illustrative comparative risks* (95% CI)		Relative effect (95% CI)	No. of participants (studies)	Certainty of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Standard pressure ulcer education and quarterly mail or telephone follow‐up	Standard pressure ulcer education and monthly mail or telephone follow‐up
Time to occurrence of new ulcer	Data insufficiently reported to enable analysis.
Proportion of participants developing a new ulcer (24 months)	Study population		RR 0.61 (0.34 to 1.08)	21 (1 study)	⊕⊝⊝⊝ Very low1	It is uncertain whether standard pressure ulcer education and monthly mail or telephone follow‐up, reduces the proportion of participants developing a new ulcer.
	900 per 1000	603 per 1000 (351 to 1000)
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; RR: risk ratio
GRADE Working Group grades of evidence High certainty: further research is very unlikely to change our confidence in the estimate of effect. Moderate certainty: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low certainty: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low certainty: we are very uncertain about the estimate.

¹Downgraded twice for risk of bias due to high risk of performance and reporting bias and unclear risk of attrition, selection, and detection bias, and twice for imprecision due to the very small sample size and very wide confidence interval.

Summary of findings 9. Individualised pressure ulcer education and monthly structured telephone follow‐up versus standard pressure ulcer education and quarterly mail or telephone follow‐up, for preventing pressure ulceration in at‐risk populations.

Individualised pressure ulcer education and monthly structured telephone follow‐up versus standard pressure ulcer education and quarterly mail or telephone follow‐up, for preventing pressure ulceration in at‐risk populations
Patient or population: individuals with spinal cord injury Settings: veterans medical centre Intervention: individualised pressure ulcer education and monthly structured telephone follow‐up Comparison: standard pressure ulcer education and quarterly mail or telephone follow‐up
Outcomes	Illustrative comparative risks* (95% CI)		Relative effect (95% CI)	No. of participants (studies)	Certainty of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Standard pressure ulcer education and quarterly mail or telephone follow‐up	Individualised pressure ulcer education and monthly structured telephone follow‐up
Time to occurrence of new ulcer	Data insufficiently reported to enable analysis.
Proportion of participants developing a new ulcer (24 months)	Study population		RR 0.33 (95% CI 0.17 to 0.67)	31 (1 study)	⊕⊝⊝⊝ Very low1	It is uncertain whether individualised pressure ulcer education and monthly structured telephone follow‐up reduces the proportion of participants developing a new ulcer.
	900 per 1000	297 per 1000 (153 to 603)
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; RR: risk ratio
GRADE Working Group grades of evidence High certainty: further research is very unlikely to change our confidence in the estimate of effect. Moderate certainty: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low certainty: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low certainty: we are very uncertain about the estimate.

¹Downgraded twice for risk of bias due to high risk of performance and reporting bias and unclear risk of attrition, selection, and detection bias, and twice for imprecision due to the very small sample size and very wide confidence interval.

Summary of findings 10. Spinal Cord Injury Navigator programme versus usual rehabilitation care/education for preventing pressure ulceration in at‐risk populations.

Spinal Cord Injury Navigator programme versus usual rehabilitation care/education for preventing pressure ulceration in at‐risk populations
Patient or population: individuals with spinal cord injury Settings: rehabilitation hospital Intervention: Spinal Cord Injury Navigator programme Comparison: usual rehabilitation care/education
Outcomes	Illustrative comparative risks* (95% CI)		Relative effect (95% CI)	No. of participants (studies)	Certainty of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Usual rehabilitation care/education	Spinal Cord Injury Navigator programme
Time to occurrence of new ulcer	Not reported
Proportion of participants developing a new ulcer	Not reported
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval
GRADE Working Group grades of evidence High certainty: further research is very unlikely to change our confidence in the estimate of effect. Moderate certainty: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low certainty: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low certainty: we are very uncertain about the estimate.

Summary of findings 11. Multicomponent motivational interviewing/self‐management intervention with a multi component education intervention versus telephone‐based individual educational counselling plus group education for preventing pressure ulceration in at‐risk populations.

Multicomponent motivational interviewing/self‐management intervention with a multi component education intervention versus telephone‐based individual educational counselling plus group education for preventing pressure ulceration in at‐risk populations
Patient or population: individuals with spinal cord injury Settings: veterans hospitals Intervention: multi component motivational interviewing/self‐management intervention with a multi component education intervention Comparison: telephone‐based individual educational counselling plus group education
Outcomes	Illustrative comparative risks* (95% CI)		Relative effect (95% CI)	No. of participants (studies)	Certainty of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Telephone‐based individual educational counselling plus group education	Multicomponent motivational interviewing/self‐management intervention with a multi component education intervention
Time to occurrence of new ulcer	Not reported
Proportion of participants developing a new ulcer	Not reported
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval
GRADE Working Group grades of evidence High certainty: further research is very unlikely to change our confidence in the estimate of effect. Moderate certainty: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low certainty: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low certainty: we are very uncertain about the estimate.

Summary of findings 12. Pressure ulcer prevention care bundle versus standard care for preventing pressure ulceration in at‐risk populations.

Pressure ulcer prevention care bundle versus standard care for preventing pressure ulceration in at‐risk populations
Patient or population: hospitalised patients Settings: tertiary hospital Intervention: pressure ulcer prevention care bundle Comparison: standard care
Outcomes	Illustrative comparative risks* (95% CI)		Relative effect (95% CI)	No. of participants (studies)	Certainty of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Standard care	Pressure ulcer prevention care bundle
Time to occurrence of new ulcer	Not reported
Proportion of participants developing a new ulcer (28 days)	Study population		HR 0.58 (0.25 to 1.33)	1598 (1 study)	⊕⊕⊝⊝ Low1	There is no clear difference in the proportion of participants developing a new ulcer over the follow‐up time between use of a pressure ulcer prevention care bundle (PUPCB) and standard care.
	105 per 1000	62 per 1000 (27 to 137)
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; HR: hazard ratio
GRADE Working Group grades of evidence High certainty: further research is very unlikely to change our confidence in the estimate of effect. Moderate certainty: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low certainty: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low certainty: we are very uncertain about the estimate.

¹Downgraded twice for imprecision due to the wide confidence interval.

Summary of findings 13. Structured, patient‐centric pressure ulcer prevention education event versus standard unit education for preventing pressure ulceration in at‐risk populations.

Structured, patient‐centric pressure ulcer prevention education event versus standard unit education for preventing pressure ulceration in at‐risk populations
Patient or population: hospitalised patients Settings: family care medical surgical unit Intervention: structured, patient‐centric pressure ulcer prevention education event Comparison: standard unit education
Outcomes	Illustrative comparative risks* (95% CI)		Relative effect (95% CI)	No. of participants (studies)	Certainty of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Standard unit education	Structured, patient‐centric pressure ulcer prevention education event
Time to occurrence of new ulcer	Not reported
Proportion of participants developing a new ulcer	Not reported
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval
GRADE Working Group grades of evidence High certainty: further research is very unlikely to change our confidence in the estimate of effect. Moderate certainty: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low certainty: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low certainty: we are very uncertain about the estimate.

Background

Description of the condition

A pressure ulcer is defined as "localized injury to the skin and/or underlying tissue usually over a bony prominence, as a result of pressure, or pressure in combination with shear" (EPUAP 2019). Pressure is the amount of force acting on a unit of area (O'Callaghan 2007), whereas shear forces occur in soft tissue when these tissues are stretched, as happens when the bony structures move but the skin remains stationary (Sanders 2005). Pressure ulcers commonly occur in people with limited functional mobility or capacity for activity and as such are exposed to prolonged periods of exposure to sustained pressure/shear forces from lying or sitting in one position for a long time (Gefen 2008). Whereas it is acknowledged that there are numerous potential risk factors, it has been postulated that some specific factors play a key role in the development of pressure ulcers, such as impaired activity and mobility (Moore 2011; Moore 2014). Healthy people regularly change their position while seated or recumbent. There are normally a number of stimulators, during sleep and whilst awake, that motivate the person to move (Defloor 2005; Krapfl 2008). However, this innate movement is affected by the person's ability to feel sensation and the person's actual physical ability to move or reposition themselves (Defloor 2005). Mino 2001 found a four‐fold greater risk ratio (RR) for the development of pressure ulcers in people who have an inability to turn over in bed (RR 4.09). Papanikolaou 2003 compared the odds of pressure ulcer occurrence amongst people with varying levels of mobility and found that pressure ulcer development was five times more likely amongst people with limited mobility (odds ratio 5.41, 95% confidence interval 2.00 to 14.63; P = 0.001). Furthermore, a systematic review by Coleman 2013 noted that risk factors emerging most frequently as independent predictors of pressure ulcer development were mobility/activity, perfusion, and skin/pressure ulcer status.

Pressure ulcers vary in severity. One of the most widely recognised systems for categorising pressure ulcers is that of the National Pressure Ulcer Advisory Panel (NPUAP), which is summarised below (EPUAP 2019).

Category/Stage I ‐ non‐blanchable erythema: "Intact skin with non‐blanchable redness of a localized area usually over a bony prominence. Darkly pigmented skin may not have visible blanching; its colour may differ from the surrounding area. The area may be painful, firm, soft, warmer or cooler as compared to adjacent tissue. Category I may be difficult to detect in people with dark skin tones. May indicate 'at risk' persons."

Category/Stage II ‐ partial thickness: "Partial thickness loss of dermis presenting as a shallow open ulcer with a red pink wound bed, without slough [dead tissue]. May also present as an intact or open/ruptured serum‐filled or sero‐sanguinous filled blister. Presents as a shiny or dry shallow ulcer without slough or bruising (bruising indicates deep tissue injury). This category should not be used to describe skin tears, tape burns, incontinence associated dermatitis, maceration [damage through the skin being wet] or excoriation [damage through scratching/abrasion or burns]."

Category/Stage III ‐ full thickness skin loss: "Full thickness tissue loss. Subcutaneous fat may be visible but bone, tendon or muscle are not exposed. Slough may be present but does not obscure the depth of tissue loss. May include undermining and tunnelling. The depth of a Category/Stage III pressure ulcer varies by anatomical location. The bridge of the nose, ear, occiput [back of the head] and malleolus [ankle] do not have (adipose) subcutaneous tissue and Category/Stage III ulcers can be shallow. In contrast, areas of significant adiposity can develop extremely deep Category/Stage III pressure ulcers. Bone/tendon is not visible or directly palpable."

Category/Stage IV ‐ full thickness tissue loss: "Full thickness tissue loss with exposed bone, tendon or muscle. Slough or eschar [scabbing] may be present. Often includes undermining and tunnelling. The depth of a Category/Stage IV pressure ulcer varies by anatomical location. The bridge of the nose, ear, occiput (the back of the head) and malleolus (the projection on either side of the ankle) do not have (adipose) subcutaneous tissue and these ulcers can be shallow. Category/Stage IV ulcers can extend into muscle and/or supporting structures (e.g. fascia, tendon or joint capsule) making osteomyelitis [bone infection] or osteitis [inflammation of bone] likely to occur. Exposed bone/muscle is visible or directly palpable."

The presence of pressure ulcers amongst people in the care of health professionals is often used as an indicator of the quality of health care provided (NICE 2014). Consequently, in order to place the problem of pressure ulcers into context, the number of pressure ulcers within a given clinical care setting is measured and reported as prevalence or incidence figures (Moore 2013).

Prevalence is a determination of the number of people with an existing pressure ulcer at a given point in time, whereas incidence is the number of people that develop a new pressure ulcer over a given time (Beaglehole 1993). Prevalence and incidence estimates vary according to the population being assessed, the data collection methods used, and decisions about whether or not Stage I pressure ulcers should be included (since there is no open wound at this stage but evidence of possible tissue damage) (EPUAP 2019). One review noted mean pressure ulcer prevalence rates in various settings of 8.9% in Iceland (one study), 17% in Norway (three studies), 16% in Ireland (six studies), 15% in Denmark (five studies), and 25% in Sweden (17 studies) (Moore 2013). These studies were conducted in acute care (23 studies); long stay (five studies); hospice (one study); community care (two studies); and a centre for rare diseases (one study). Not all studies clearly delineated between categories of pressure ulcer. Furthermore, different classification systems were used, including self‐developed classification systems, the European Pressure Ulcer Advisory Panel (EPUAP) pressure ulcer classification system, the EPUAP/NPUAP guidelines, and sometimes none at all (Moore 2013). In one study from Jordan, across two care settings, a prevalence of 12% (Stage I and above) (EPUAP) was noted (Tubaishat 2011). Conversely, mean pressure ulcer prevalence across 198 nursing homes in Japan was 9.6% (Stage I and above) (Igarashi 2013). The lowest figure was reported in China, where data were gathered from one university hospital and 11 general hospitals, and there was a prevalence of 1.58% (Stage I and above, including "unstageable" and "suspected deep tissue injury") (Jiang 2014). From a Canadian perspective, a detailed literature review identified a prevalence of 26% (staging not described) amongst 14,102 people residing in 18 acute‐care facilities, 23 non‐acute care facilities, 19 mixed healthcare settings, and five community‐care agencies (Woodbury 2004). Results from the Victorian statewide prevalence in Australia noted a prevalence of 17.6% (Stage I and above) (Quality and Safety Branch 2006). Conversely, a USA estimate for pressure ulcer prevalence (Stage II and above) across acute‐care, long‐term care, and rehabilitation settings was 9%, with prevalence highest in long‐term acute‐care settings (26%) (VanGilder 2009).

Pressure ulcer incidence figures also vary across countries and healthcare settings. For example, a single incidence study from Norway noted a figure of 16.4%, whereas mean incidence in Denmark was 1.8% (two studies), 11% in Ireland (four studies), and 20% in Sweden (12 studies) (Moore 2013). In one study from Australia, incidence was 4.6% (Stage I and above) (Graves 2005). A further study from the USA collected data from 242,745 hospital discharges from 15 general and tertiary‐care hospitals, identifying a pressure ulcer incidence of 2.68% (Gardiner 2014). One study from Australia noted an incidence of 16.6% within the acute‐care setting (Jolley 2004), whereas in long‐term care in Canada this figure was 11.7% (Stage I and above) (Davis 2001). Prevalence and incidence figures from healthcare institutions are consistently highest in acute‐care and hospice settings, and lowest in the care of the older person setting (Moore 2013); however, it is notable that a prevalence of between 4% and 27% has been identified in acutely ill paediatric populations (McLane 2004; Schlüer 2009), reflecting the figures found across other clinical care settings.

The point prevalence of pressure ulceration in the total adult population of Leeds, UK, was estimated using a cross‐sectional survey in 2011. Of the total adult population of 751,485, the point prevalence of pressure ulceration was 0.31 per 1000 (Hall 2014). UK pressure ulcer prevalence estimates specifically for community settings have reported rates of 0.77 per 1000 adults in a UK urban area (Stevenson 2013).

Pressure ulcers have a large impact on those affected: the ulcers can be painful, and may become seriously infected or malodorous. A number of studies conducted in the USA, Langemo 2000, the UK, Fox 2002; Spilsbury 2007; Essex 2009; Gorecki 2009, and the UK and Belgium, Hopkins 2006, have explored the impact of pressure ulcers on people's lives. After adjustment for age, sex, and co morbidities, people with pressure ulcers had a lower health‐related quality of life than people without pressure ulcers (Essex 2009). Pressure ulcers impacted on four health‐related quality of life domains, namely symptoms, physical functioning, psychological well‐being, and social functioning (Gorecki 2009). Participants report a preoccupation with their pressure ulcer, with pain regarded as one of the most overwhelming aspects of their experience (Langemo 2000; Fox 2002; Hopkins 2006). Worryingly, treatments, repositioning, and equipment often served to worsen the patient's experience rather than improving it (Hopkins 2006). Furthermore, pain can increase with movement, therefore individuals may be inclined to keep as still as possible. However, this is not always possible, and repositioning regimens initiated by staff, or spontaneous movements during sleep, may bring on the pain cycle (Hopkins 2006). The use of pressure redistribution devices, particularly alternating surfaces, can also be problematic, as when the cells inflated, they appear to 'stick into' the pressure ulcer, exacerbating the pain experience (Hopkins 2006). One systematic review exploring the impact of pressure ulcers on quality of life in older people also identified that people feel that they are a burden to others and generally have a lack of knowledge about pressure ulcers (Gorecki 2009).

Pressure ulcers not only affect the patient, but also have a wider effect on families and lay carers (Hopkins 2006; Gorecki 2009). In a systematic review of the impact of pressure ulcer on quality of life, Gorecki 2009 found that pressure ulcers imposed additional care burdens on families and lay carers (such as skin inspections and help with activities of daily living), whilst also causing emotional distress.

In an economically constrained health service, revenue spent on pressure ulcers is a concern, as it is suggested that many pressure ulcers can be avoided with appropriate risk assessment and use of interventions targeted at combating this risk (Moore 2014). However, despite this premise, it is estimated that approximately 4% of the annual healthcare budget is spent on pressure ulcers, with nursing time accounting for 41% of these costs (Posnett 2009). Pressure ulcers increase length of hospital stay, readmission, and mortality rates (Lyder 2012), and add considerably to the cost of an episode of hospital care (Chan 2013). Figures from the USA suggest that 'pressure ulcer' was noted as a diagnosis for half a million hospital stays in 2006; the total hospital costs of these stays for adults was USD 11,000 million (Russo 2008). Costs to the Australian healthcare system for treating pressure ulceration have been estimated at AUD 285 million per annum (Graves 2005).

Description of the intervention

The World Health Organization (WHO) considers that health education is not limited to the dissemination of health‐related information but also "fostering the motivation, skills and confidence (self‐efficacy) necessary to take action to improve health" (WHO 2012a). Patient involvement in health care and the rights of patients to have a central part in the healthcare process have for some time been seen as important aspects of healthcare provision (McCormack 2006; Nilsen 2006; Coulter 2008; European Commission 2012). The benefits of patient involvement are thought to include increased motivation and knowledge about health and illness amongst patients, resulting in patients having increased capacity to monitor and look after themselves, increased patient safety, and ultimately patients having better health outcomes (Elwyn 2000; Davis 2011; European Commission 2012).

However patient involvement is a vague concept and can include a number of different factors and a range of activities or interventions (Aharony 1993). In one qualitative investigation into the concept, the European Commission identified differences between health practitioners and patients with regard to what patient involvement means. Practitioners were reported to consider patient involvement to be about compliance, patients taking more interest in their health care, or taking steps to inform themselves about their health status. Furthermore, practitioners considered involvement to be about them providing information or education to patients, and the patient feeding back relevant information to their practitioner regarding their health status. Patients also emphasised being compliant as an element of their involvement, but equated involvement with taking responsibility for their health and health information needs. In this report, such constructs of involvement were often considered to be passive (i.e. following health practitioner orders), but patients with chronic diseases highlighted their more active involvement, which they considered to be necessary, as they were most familiar with their own disease processes (European Commission 2012). There is also the increased potential for patients to be knowledgeable and involved in their disease processes when they have accessibility of information via the Internet, fraught as that is with problems of misinformation and misinterpretation (Anderson 2008).

Whilst there may be many facets to patient involvement, it is clear that the central tenets are the provision of information and education in order to prompt patients to either take action themselves or to engage with health practitioners with regard to their health needs. Such responses are aimed at preventing disease, preventing further exacerbation of disease, or alleviating existing disease (Smith 2009). The provision of education and information is standard practice in many healthcare situations, ranging from the single supply of medicine information leaflets to extensive and repeated education programmes for people with chronic illness such as diabetes, Radhakrishnan 2012, and cardiovascular disease (Holland 2014).

The prevention of pressure ulcers has traditionally been largely practitioner led (Asimus 2011). The increased move towards community‐based care, coupled with the increasing need for patient control over their health processes, points to a requirement for people who are at risk of pressure ulcers to be more involved in their care (WHO 2013). Involvement in pressure ulcer risk assessment necessitates certain knowledge and skills on behalf of the patients requiring information provision or educational interventions.

For the purposes of this review, patient, family, and lay carer involvement concentrated on lay people becoming more knowledgeable and active in the prevention of pressure ulcers. We therefore included any intervention that involved:

• the provision of information to patients, family, and lay carers regarding the prevention of pressure ulcers;

• educational programmes aimed at increasing patient, family, lay carer, or a combination of these, involvement in the prevention of pressure ulcers;

• strategies that encourage patients, their family, lay carers, or a combination of these, to become more knowledgeable about pressure ulcer prevention;

• the use of sensors or pressure monitoring devices aimed at encouraging patients to move to relieve pressure or be helped to move by family or lay carers.

How the intervention might work

This intervention falls within the broader domain of knowledge concerning health literacy and its benefits for health. Health literacy concerns patients' capacities to access, process, and understand information so that they can actively and knowledgeably participate in decisions and actions relating to their health (Ratzan 2000; Nielsen‐Bohlman 2004; Martensson 2012). A significant body of research has demonstrated the link between lower levels of health literacy and poorer health outcomes (Gazmararian 2003; Berkman 2011; Bostock 2012). Evidence to support the benefits of introducing strategies to increase health literacy for better health outcomes is also beginning to emerge (Pignone 2005; Lee 2016; Palumbo 2016). Interventions aimed at increasing health literacy are thus likely to lead to better health outcomes. The health literacy intervention in this context is aimed at making patients more knowledgeable and active in the prevention of pressure ulcers. This is likely to lead to:

• an increased capacity to self‐manage;

• an increased level of awareness of risk factors in pressure ulcer development;

• an increased ability to act on risk;

• a decrease in pressure ulcers development.

Why it is important to do this review

Patient safety is at the heart of healthcare delivery, and as such, avoidance of unnecessary complications associated with clinical care is considered to be a fundamental patient right (WHO 2012b). As pressure ulcers remain an important issue, adopting strategies aimed at reducing their occurrence makes both human and economic sense (Moore 2014). Patients, their families, and lay carers are central to the success of any interventions adopted, as the majority of people with pressure ulcers are not nursed within a care setting where there is ready access to trained health professionals (CDC 2017). WHO stresses the importance of enhancing the contribution of the patient and their wider personal network to their own health and well‐being (WHO 2012c). In this way, the patient may be empowered to make more informed decisions pertaining to the type of healthcare delivery most suited to their clinical needs (WHO 2012c). As pressure ulcers are a key concern for the patient, their family, and lay carers, their involvement in pressure ulcer prevention is important and recommended in guidelines for prevention (NICE 2014). However, the precise impact of patient, family, and lay carer education on clinical outcomes has not been systematically reviewed; this is the rationale for the current review.

Objectives

To assess the effects of patient and/or lay carer education on the prevention of pressure ulceration in at‐risk people, in any care setting.

Methods

Criteria for considering studies for this review

Types of studies

We included published and unpublished randomised controlled trials (RCTs), including cluster‐RCTs, irrespective of language of report. We excluded cross‐over trials and studies using quasi‐randomisation.

Types of participants

We included RCTs that recruited people of any age at risk of pressure ulceration and RCTs that recruited people who informally cared for someone at risk of pressure ulceration.

Types of interventions

We included studies where the only systematic difference between study groups was the specific use of an intervention aiming to educate at risk people, lay carers (carers and family members), or both, in pressure ulcer prevention. We included the following interventions: the provision of information on the prevention of pressure ulcers, or educational programmes aimed at increasing at risk peoples' or family/lay carer knowledge of the prevention of pressure ulcers, or strategies that encouraged people to become more knowledgeable about pressure ulcer prevention, such as pressure monitoring systems or technology that prompted action to prevent pressure ulcers for at risk people or lay person use. We included interventions that were based on the provision of education via written (e.g. information leaflets), verbal (e.g. teaching sessions), multimedia (e.g. web‐based programmes or audiovisual aids), or skill‐based (e.g. practical demonstrations) methods. We considered educational interventions that were singular, one‐off interventions or that were delivered multiple times. The comparators of interest for this review were usual care, no educational intervention, or an attention control (e.g. an educational intervention on a different topic).

Types of outcome measures

Studies were included regardless of outcomes and outcomes were not used to assess eligibility. We analysed outcomes at the latest time point available (assumed to be length of follow‐up if not specified) and the time point specified in the methods as being of primary interest (if that differed from the latest time point available). We categorised assessment of outcomes as:

• short term: less than one week to eight weeks;

• medium term: greater than eight weeks to 26 weeks;

• long term: greater than 26 weeks.

Primary outcomes

• Risk of pressure ulceration, defined as a new ulcer of any grade developing during the study period. We regarded the following as adequate measures of this outcome:

• • time to occurrence of a new ulcer;

  • proportion of people developing a new ulcer.

We accepted study authors' assessment/measurement processes when classifying a new ulcer.

Secondary outcomes

• Grade/category of pressure ulcer, as reported by the study author.

• Patient/lay carer knowledge of pressure ulcer risk and prevention.

• Measures of acceptability of interventions to users where this was systematically recorded.

Search methods for identification of studies

Electronic searches

We searched the following electronic databases to identify reports of relevant clinical trials:

• the Cochrane Wounds Specialised Register (searched 12 June 2019);

• the Cochrane Central Register of Controlled Trials (CENTRAL; 2019, Issue 5) in the Cochrane Library (searched 12 June 2019);

• Ovid MEDLINE including In‐Process & Other Non‐Indexed Citations (1946 to 12 June 2019);

• Ovid Embase (1974 to 12 June 2019);

• Ovid PsycINFO (1806 to 12 June 2019);

• EBSCO CINAHL Plus (Cumulative Index to Nursing and Allied Health Literature; 1937 to 12 June 2019).

The search strategies for the Cochrane Wounds Specialised Register, CENTRAL, Ovid MEDLINE, Ovid Embase and EBSCO CINAHL Plus are shown in Appendix 1. We combined the Ovid MEDLINE search with the Cochrane Highly Sensitive Search Strategy for identifying randomised trials in MEDLINE: sensitivity‐ and precision‐maximising version (2008 revision) (Lefebvre 2011). We combined the Embase search with the Ovid Embase filter developed by the UK Cochrane Centre (Lefebvre 2011). We combined the CINAHL Plus searches with the trial filters developed by the Scottish Intercollegiate Guidelines Network (SIGN 2019). There were no restrictions with respect to language, date of publication, or study setting.

We also searched the following clinical trials registries:

• US National Institutes of Health Ongoing Trials Register ClinicalTrials.gov (www.clinicaltrials.gov) (searched 30 June 2019);

• World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (apps.who.int/trialsearch/Default.aspx) (searched 30 June 2019);

• EU Clinical Trials Register (www.clinicaltrialsregister.eu/) (searched 30 June 2019).

Search strategies for clinical trial registries are shown in Appendix 1.

Searching other resources

We attempted to identify other potential eligible trials or ancillary publications by searching the reference lists of retrieved trials, as well as relevant systematic reviews, meta‐analyses and Health Technology Assessment reports.

Data collection and analysis

We carried out data collection and analysis according to the methods stated in the published protocol (O'Connor 2015), which were based on the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011a).

Selection of studies

Two review authors (TO'C and ZM) independently assessed the titles and abstracts of the citations retrieved by the searches for relevance. We then obtained full‐text copies of all studies considered to be potentially relevant. Two review authors (TO'C and ZM) independently checked the full‐text papers for eligibility, resolving any disagreements by discussion or with the input of a third review author (DP) where required. We contacted study authors where the eligibility of a study was unclear. We recorded all reasons for exclusion of studies for which we had obtained full copies (see Characteristics of excluded studies). We completed a PRISMA flowchart (Figure 1) to summarise the selection process (Liberati 2009).

1.

Study flow diagram.

If studies were reported in multiple publications/reports, we obtained all publications. Whilst we included the study only once in the review, we extracted data from all reports to ensure that maximal relevant data were obtained. Where data from a secondary publication were the only source for an outcome we made this clear.

Data extraction and management

We extracted and summarised details of the eligible studies using Covidence software (Covidence 2013) (see Characteristics of included studies). Two review authors (TO'C and ZM) independently extracted the data, resolving any disagreements by discussion or by consulting a third review author (DP) where required. In the case of missing data, we attempted to contact the study authors to obtain this information. Where a study with more than two intervention arms was included, only data from intervention and control groups that met the eligibility criteria were extracted. Where a study with more than two eligible intervention arms was included, we used separate comparisons (with different forest plots). This avoided the double‐counting of participants.

We extracted the following data by treatment group for the interventions and outcomes prespecified in this review. We collected outcome data for relevant time points as described in the Types of outcome measures section as follows.

• Country of origin

• Unit of randomisation

• Unit of analysis

• Trial design (e.g. parallel, cluster)

• Care setting

• Number of participants randomised to each trial arm

• Eligibility criteria and key baseline participant data

• Details of intervention regimen received by each group

• Duration of intervention

• Details of any co‐interventions

• Primary and secondary outcome(s) (with definitions)

• Outcome data for primary and secondary outcomes (by group)

• Duration of follow‐up

• Number of withdrawals (by group)

• Publication status of study

• Source of funding for trial

Assessment of risk of bias in included studies

Two review authors (TO'C and ZM) independently assessed risk of bias in the included studies using the Cochrane 'Risk of bias' tool (Higgins 2011b), which addresses six specific domains: sequence generation, allocation concealment, blinding, incomplete data, selective outcome reporting, and other issues. We recorded issues related to unit of analysis, for example where a cluster trial had been undertaken but analysed at the individual level in the study report (Appendix 2). We assessed blinding and completeness of outcome data for each of the review outcomes separately.

For trials using cluster randomisation, we also considered risk of bias in terms of recruitment bias, baseline imbalance, loss of clusters, incorrect analysis and comparability with individually randomised trials (Appendix 3) (Higgins 2011c).

Measures of treatment effect

For dichotomous outcomes (e.g. pressure ulcer present, yes or no), we calculated the risk ratio (RR) with 95% confidence intervals (CI). The RR is the ratio of the risk of an event in the two groups. An RR of 1 means there is no difference in risk between the two groups, whereas an RR of less than 1 means the event is less likely to occur in the experimental group than in the control group, and an RR of greater than 1 means the event is more likely to occur in the experimental group than in the control group (Deeks 2011).

For continuous outcomes (e.g. health‐related knowledge), we used the mean difference (MD) with 95% CIs if all trials used the same or a similar assessment scale. The MD is a standard statistic that measures the absolute difference between the mean value in two groups in a clinical trial. It estimates the amount by which the experimental intervention changes the outcome on average compared with the control. Interpretation of the results is the same as RR, except the point of no effect is 0 rather than 1 (Deeks 2011). If trials had used different assessment scales, we would have used the standardised mean difference (SMD) with 95% CIs. The SMD expresses the size of the intervention effect in each study relative to the variability observed in that study; an SMD of 0 means that the intervention and the control have equivalent effects (Deeks 2011). We did not use the SMD as we did not identify trials using different assessment scales.

We report time‐to‐event data (e.g. time to occurrence of a new ulcer) as hazard ratios (HR) where possible, in accordance with the methods described in the Cochrane Handbookfor Systematic Reviews of Interventions (Deeks 2011). If studies reporting time‐to‐event data (e.g. time to occurrence of a new ulcer ) did not report an HR, then, where feasible, we would have estimated this using other reported outcomes, such as the numbers of events, through the application of available statistical methods (Parmar 1998). We planned to only consider mean, or median time to occurrence of a new ulcer without survival analysis as a valid outcome in the unlikely event that a report specified that all participants had developed a wound (i.e. if the trial authors regarded time to occurrence of a new ulcer as a continuous measure as there is no censoring).

Unit of analysis issues

We planned that where studies performed randomisation at the participant level and measured outcomes at the wound level (e.g. number of pressure ulcers), we would have treated the participant as the unit of analysis when the number of pressure ulcers assessed appeared to be equal to the number of participants (e.g. one pressure ulcer per person). We did not do this as we did not identify studies randomised at the participant level where outcomes were measured at the wound level.

Particular unit of analysis issues in wound care trials can occur when 1) studies perform randomisation at the participant level, use the allocated treatment on multiple wounds per participant, and then analyse outcomes per wound; or 2) studies undertake multiple assessments of an outcome over time per participant. We planned to treat these approaches as cluster trials, alongside more standard cluster designs (such as delivery of interventions at the organisational level). We did not do this as we did not identify studies using these approaches.

We planned that where a cluster trial had been conducted and correctly analysed (i.e. using methods that adjust for clustering), we would meta‐analyse effect estimates and their standard errors using the generic inverse variance method in Review Manager 5 (Review Manager 2014). We were unable to undertake meta‐analysis due to the heterogeneity of the interventions included in this review.

We planned to record where a cluster‐randomised trial had been conducted but incorrectly analysed, as part of the 'Risk of bias' assessment. We did not do this as the cluster trial included in this review had been conducted and analysed correctly.

We planned to approximate the correct analyses based on the guidance in Chapter 8 of the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011b), as follows:

• the number of clusters (or groups) randomised to each intervention group, or the mean size of each cluster;

• the outcome data ignoring the cluster design for the total number of participants (e.g. number or proportion of participants with events, or means and standard deviations);

• an estimate of the intracluster (or intraclass) correlation coefficient (ICC).

We planned that if we were unable to analyse the study data correctly, we would extract and present outcome data. We did not do this as the cluster trial included in this review had been conducted and analysed correctly.

We also planned to note when randomisation had used a split‐site, or split‐body design. We planned to assess whether the correct paired analysis had been undertaken in the study. Again, we planned to record issues in the 'Risk of bias' section. We did not do this because randomisation in the included studies was not undertaken using a split‐site, or split‐body design.

We planned that if an incorrect analysis had been undertaken, we would approximate a correct analysis if the required data were available from the study report or the study authors. If this was not possible, we would have extracted and presented the relevant outcome data, but would not have analysed them further. We did not do this as the cluster trial included in this review had been conducted and analysed correctly.

Dealing with missing data

Data are commonly missing from trial reports. Excluding participants post randomisation from the analysis, or ignoring those participants who are lost to follow‐up, compromises the randomisation, and potentially introduces bias into the trial. We planned that if potentially relevant missing data were noted, we would contact the study authors to request whether these data were available. We did not do this as we did not judge there to be potentially relevant missing data in the included trials.

Where data remained missing for the outcome 'risk of pressure ulceration', we would have compared the effects of assuming both a best‐ and worst‐case scenario for participants with a missing outcome. We did not do this as we did not judge there to be potentially relevant missing data in the included trials.

For continuous variables (e.g. health‐related quality of life measures) and for all secondary outcomes, we have presented available data from the study reports/study authors and did not impute missing data. Where measures of variance were missing, we would have calculated these wherever possible. If this was not possible, we would have contacted the study authors. Where these measures of variance were not available, we would have excluded the study from any relevant meta‐analyses. We did not do this as we were unable to undertake meta‐analysis due to the heterogeneity of the interventions included in this review.

Assessment of heterogeneity

We planned to assess heterogeneity comprising an initial assessment of clinical and methodological heterogeneity, that is the degree to which the included studies varied in terms of participant, intervention, outcome, and characteristics such as length of follow‐up. We planned to supplement this assessment of clinical and methodological heterogeneity using information regarding statistical heterogeneity, which is assessed by the Chi² test (a significance level of P < 0.10 indicating statistically significant heterogeneity) in conjunction with the I² statistic (Higgins 2003). The I² statistic examines the percentage of total variation across RCTs that is due to heterogeneity rather than chance (Higgins 2003). In general, I² values of 25% or less may mean a low level of heterogeneity (Higgins 2003), whilst values of more than 75% indicate very high heterogeneity (Deeks 2011). Where we found evidence of high heterogeneity, we would have explored this further (see Data synthesis). We did not do this as we were unable to undertake meta‐analysis due to the heterogeneity of the interventions included in this review.

Assessment of reporting biases

Reporting biases arise when the dissemination of research findings is influenced by the nature and direction of results. Publication bias is one of a number of possible causes of small‐study effects, that is a tendency for estimates of the intervention effect to be more beneficial in smaller RCTs. Funnel plots allow a visual assessment of whether small‐study effects could be present in a meta‐analysis. A funnel plot is a simple scatter plot of the intervention effect estimates from individual RCTs against some measure of each trial's size or precision (Sterne 2001). We planned to present funnel plots for meta‐analyses comprising 10 or more RCTs using Review Manager 5 (Review Manager 2014). We did not do this as we were unable to undertake meta‐analysis due to the heterogeneity of the interventions included in this review.

Data synthesis

We combined details of included studies in a narrative review according to type of comparator, by location/type of wound, and then by outcomes by time period. We considered clinical and methodological heterogeneity, and planned to undertake pooling when studies appeared appropriately similar in terms of wound type, intervention type, duration of follow‐up, and outcome type.

In terms of meta‐analytical approach, in the presence of clinical heterogeneity (review author's judgement) or evidence of statistical heterogeneity (or both), we would have used the random‐effects model. We planned to use a fixed‐effect approach if we considered clinical heterogeneity minimal and estimated statistical heterogeneity as non‐statistically significant for the Chi² value and 0% for the I² assessment (Kontopantelis 2012). We planned to adopt this approach because it is recognised that statistical assessments can miss potentially important between‐study heterogeneity in small samples, hence the preference for the more conservative random‐effects model (Kontopantelis 2013). Had we considered clinical heterogeneity acceptable, or of interest, we would have meta‐analysed even when statistical heterogeneity was high, but attempted to interpret the causes of this heterogeneity and considered using meta‐regression for that purpose, had this been possible (Thompson 1999). We did not do this as we were unable to undertake meta‐analysis due to the heterogeneity of the interventions included in this review.

We have presented data using forest plots where this was possible. For dichotomous outcomes, we have presented the summary estimate as an RR with 95% CI. We planned that if continuous outcomes were measured in the same way across studies, we would present a pooled MD with 95% CI; where studies measured the same outcome using different methods, we would pool SMD estimates. For time‐to‐event data, we planned to plot (and if appropriate pool) estimates of HRs and 95% CIs as presented in the study reports, using the generic inverse variance method in Review Manager 5 (Review Manager 2014). Where time to occurrence of a new ulcer was analysed as a continuous measure, but it was not clear if all wounds had healed, we would not have used the outcome in the studies where we summarised data, or we would not have used them in any meta‐analysis. We did not need to take this approach as we were unable to undertake meta‐analysis due to the heterogeneity of the interventions included in this review.

We planned to obtain pooled estimates of treatment effect using Review Manager 5 software (Review Manager 2014). We did not do this as we were unable to undertake meta‐analysis due to the heterogeneity of the interventions included in this review.

Subgroup analysis and investigation of heterogeneity

Had there been evidence of between‐trial heterogeneity, we would have conducted the following subgroup analyses where feasible:

• type of interventions being evaluated (e.g. the provision of information to patients, families, lay carers, or a combination of these, regarding the prevention of pressure ulcers; educational programmes aimed at increasing involvement in the prevention of pressure ulcers; strategies that encourage patients, families, lay carers, or a combination of these to become more knowledgeable about pressure ulcer prevention);

• provision of information to patients versus provision to lay carers;

• studies at low risk of selection bias versus studies at unclear or high risk of bias.

We did not perform these analyses as whilst there was heterogeneity due to interventions, there were not enough data for each intervention type to allow subgroup analyses.

Sensitivity analysis

We planned to perform a sensitivity analysis by excluding studies assessed as having a high risk of bias in the key domains of generating the randomisation sequence, allocation concealment, and blinding of outcome assessment. We planned to explore the effect of unpublished studies, small studies (fewer than 100 participants), and cluster trials, where the analysis was not at the same level as the allocation (i.e. allocation by cluster and analysis by participant). These analyses were not implemented due to a lack of available data.

Summary of findings and assessment of the certainty of the evidence

We have presented the main results of the review in 'Summary of findings' tables. These tables present key information concerning the certainty of the evidence, the magnitude of the effects of the interventions examined, and the sum of the available data for the main outcomes (Schünemann 2011a). The 'Summary of findings' tables also include an overall grading of the evidence related to each of the main outcomes using the GRADE approach (Schünemann 2011a), which defines the certainty of a body of evidence as the extent to which one can be confident that an estimate of effect or association is close to the true quantity of specific interest. The GRADE approach involves consideration of within‐trial risk of bias (methodological quality), directness of evidence, heterogeneity, precision of effect estimates, and risk of publication bias (Schünemann 2011b). We have presented the following outcomes in the 'Summary of findings' tables:

• time to occurrence of a new ulcer;

• proportion of participants developing a new ulcer.

Results

Description of studies

See Characteristics of included studies; Characteristics of excluded studies.

Results of the search

The search strategy yielded 666 citations, of which 15 were considered potentially relevant and the full text of these citations obtained. Following review of the full texts, and application of the inclusion and exclusion criteria, we excluded three studies with reasons (see Characteristics of excluded studies). We identified one ongoing trial on the clinical trials registry for which data collection and analyses have not been completed (NCT02969343); we will include this trial, if relevant, in future updates of the review. We included 10 studies. Garber 2002 and the secondary publication Rintala 2008 are reporting results from the same study participants, but each publication reports different outcomes. The secondary reference Rintala 2008 was used as a basis for some comparisons, and data from Rintala 2008 is being used in these, this is noted where this is the case. Thus, we report on 10 studies with 11 publications in the review (see Figure 1).

Included studies

The included studies had a total of 2261 analysed participants (mean 209; minimum 30, maximum 1598) (Guihan 2014; Garber 2002; Ward 2004; Rowland 2006; Ljungberg 2010; Kathirvel 2013; Chaboyer 2016; Sahingoz 2017; Karimi 2018; Kaur 2018).

Participants

Seven studies targeted their intervention at people at risk of ulceration and measured outcomes on these at risk people; two targeted those at risk and their family carers and measured outcomes on the at risk people cared for by their families (Kathirvel 2013; Karimi 2018); and one targeted lay carers only and measured outcomes on the at risk individuals they cared for (Kaur 2018).

The mean age of the participants in five studies where these data were reported was 53 years (minimum 35 years, Rowland 2006, maximum 59 years, Guihan 2014) (Guihan 2014; Garber 2002; Rowland 2006; Karimi 2018; Kaur 2018). The median age of patient participants in Chaboyer 2016 was 70 years for the intervention group and 74 years for the control group, and the median age of the patient participants in Ward 2004 was 64 years. No information pertaining to patient participant age was provided in Ljungberg 2010, Kathirvel 2013, and Sahingoz 2017.

Five studies were conducted in the USA (Garber 2002; Rowland 2006; Ljungberg 2010; Guihan 2014; Sahingoz 2017). Two studies were conducted in India (Kathirvel 2013; Kaur 2018), one in the UK (Ward 2004), one in Australia (Chaboyer 2016), and one in Iran (Karimi 2018).

The patients in four of the studies were individuals with spinal cord injury (Garber 2002; Rowland 2006; Ljungberg 2010; Guihan 2014).

In Ward 2004, participants were patients aged over 15 years of age with progressive neurological conditions. In Chaboyer 2016, participants were inpatients with one of eight tertiary hospitals, aged 18 years and over, who had an expected hospital length of stay of 48 hours and were at risk of PU as measured by limited mobility. In Sahingoz 2017, participants had been admitted to an inpatient family care surgical unit.

Participants in Kathirvel 2013 and Karimi 2018 included both patients and their caregivers. Patients in Kathirvel 2013 were individuals with Stage I pressure ulcers, a Braden score ≤ 12, and admitted during study period in emergency and general orthopaedic wards of the hospital. In Karimi 2018, the intervention was initially delivered to participants who were stroke patients who were moderately or severely at risk of pressure ulcers, in addition to their family caregivers. Follow‐up education sessions were delivered only to the family caregivers. Finally, in Kaur 2018, the intervention was delivered to informal caregivers of bedridden patients above 12 years of age who had been confined to bed for 15 days or more, for 90% of the time during the day and who were unable to get out of the bed without assistance, or were unable to change position in bed without assistance.

Interventions and comparators

All interventions were delivered by healthcare professionals, except for Guihan 2014, where the intervention was delivered by both healthcare professionals and lay leaders.

There were two main types of interventions (a full outline of these interventions and comparators is available in Table 14):

1. Interventions and comparators.

Study	Intervention	Target (patients or carers or both)	Comparator
Chaboyer 2016	Patient‐centred pressure ulcer prevention care bundle. This was an education programme in pressure ulcer prevention for patients that included a 5‐minute DVD, an information brochure, and a poster on pressure ulcer prevention. The programme was designed around three key messages: keep moving, adequate nutrition, and good skin care.	Patients	Standard care
Garber 2002	Enhanced educational intervention on the prevention and management of pressure ulcers and structured follow‐up	Patients	Standard education and no structured follow‐up
Guihan 2014	Multicomponent motivational interviewing/self‐management intervention with a multi component education intervention	Patients	Telephone‐based individual educational counselling plus group education
Karimi 2018	A 2‐hour group lecture delivered at the hospital before discharge for the patient and their family caregiver, then a 2‐hour educational session delivered two and three weeks after discharge for the family caregiver; an educational pamphlet was also provided	Patients and carers	Usual care
Kathirvel 2013	Self‐instruction manual on the prevention of pressure ulcer in bedridden patients with one‐to‐one training and counselling	Patients and carers	Self‐instruction manual on the prevention of pressure ulcer in bedridden patients, without any training and counselling
Kaur 2018	Self‐instruction manual, training, and counselling	Carers	Self‐instruction manual alone
Ljungberg 2010	The Spinal Cord Injury Navigator programme, including nursing education and provision of general spinal cord injury materials	Patients	Usual rehabilitation care/education, including nursing education and provision of general spinal cord injury materials
Rowland 2006	Provision of computerised feedback and one‐on‐one consultations, based on patient's risk of developing a complication following spinal cord injury	Patients	No feedback provided.
Sahingoz 2017	Structured, patient‐centric pressure ulcer prevention education event	Patients	Standard education
Ward 2004	Participants received an education visit and a tailored version of the standard information package, as well as a specially constructed leaflet offering information about the participant's condition and about self‐help organisations.	Patients	Standard printed material

• the provision of information on the prevention of pressure ulcers (this type of intervention focused on whether education in itself makes any difference to the prevention of pressure ulcers, regardless of the mode of delivery of the education);

• use of different types of education programmes (this type of intervention focused on different types of education delivery, e.g. use of DVD and patient leaflets).

Provision of information on the prevention of pressure ulcers

Three studies explored the impact of information provision (Kathirvel 2013; Karimi 2018; Kaur 2018):

• Kathirvel 2013: a self‐instruction manual on the prevention of pressure ulcers, with one‐to‐one training and counselling. The comparator was the same self‐instruction manual on the prevention of pressure ulcer in bedridden patients, without any training and counselling;

• Kaur 2018: a pressure ulcer prevention package, which included a self‐instruction manual, training, and counselling. The comparator was use of the same self‐instruction manual alone;

• Karimi 2018: home‐based training: a 2‐hour group lecture for the patient and their family caregiver delivered at the hospital before discharge, then a 2‐hour educational session for the family caregiver delivered two and three weeks after discharge; an educational pamphlet was also provided. The comparator was routine care, described as routine training on the ward.

Use of different types of education programmes

In seven studies the intervention was an education programme (Garber 2002; Ward 2004; Rowland 2006; Ljungberg 2010; Guihan 2014; Chaboyer 2016; Sahingoz 2017).

• Garber 2002: an enhanced educational intervention consisting of four hours of individualised, structured education on the prevention and management of pressure ulcers, and structured follow‐up. The intervention was delivered to patients at risk of pressure ulcer development. The comparator was standard education and no structured follow‐up.

• Ward 2004: baseline visit and assessment. Within six weeks of the baseline visit, participants received an education visit from the research occupational therapist, who provided personalised advice and information based on an expert panel discussion, a tailored version of the standard information package, and a specially constructed leaflet offering information about the participant's condition and about self‐help organisations. The intervention was delivered to patients at risk of pressure ulcer development. The comparator was standard printed material.

• Rowland 2006: computerised feedback and one‐on‐one consultations, based on the risk of developing a complication following spinal cord injury. The intervention was delivered to patients at risk of pressure ulcer development. The comparator was no feedback.

• Ljungberg 2010: Spinal Cord Injury Navigator programme, in addition to usual rehabilitation care and education, including nursing education and general spinal cord injury materials, interaction with the spinal cord injury navigator either in person or over the phone using the pressure ulcer guideline as the primary education tool. The intervention was delivered to patients at risk of pressure ulcer development. The comparator was usual rehabilitation care/education, including nursing education and provision of general spinal cord injury materials.

• Guihan 2014: a multi component motivational interviewing/self‐management intervention with a multi component education intervention. Self‐management group content was tailored for the study with modules on (1) guideline‐based skin care education; (2) training in problem‐solving and self‐monitoring skills; (3) community resource utilisation; (4) relaxation, stress, and mood management skills; (5) improving provider relationships; and (6) development of action plans. The intervention was delivered to patients at risk of pressure ulcer development. The comparator was telephone‐based individual educational counselling plus group education.

• Chaboyer 2016: standard care in line with regional guidelines, and education of patients pertaining to a Pressure Ulcer Prevention Care Bundle. The bundles consisted of a 5‐minute DVD, an information brochure, and poster on pressure ulcer prevention with three messages: 1) keep moving; 2) look after your skin; and 3) eat a healthy diet. The DVD and brochure focused on these same three messages and used the same photographs but provided detailed information about each message; face‐to‐face patient education was provided once to patients at risk of pressure ulcer development, at their bedsides within 24 hours of their being enrolled in the study. The education was delivered by intervention research assistants who were nurses or dietitians with over five years of acute care experience. The comparator was usual care.

• Sahingoz 2017: a structured, patient‐centric pressure ulcer prevention education event (PUPET). The intervention was delivered to patients at risk of pressure ulcer development. The comparator was unit (clinical care setting) education.

Outcomes

One secondary report of an included study reported the primary outcome pressure ulcer risk as the time to occurrence of a new ulcer (Rintala 2008). Six studies and one additional secondary report of an included study (Rintala 2008 linked to Garber 2002) reported the primary outcome as the proportion of people developing a new ulcer (Ward 2004; Rowland 2006; Kathirvel 2013; Chaboyer 2016; Karimi 2018; Kaur 2018).

One study reported the secondary outcome grade/category of pressure ulcer (Chaboyer 2016). Six studies and one secondary report of an included study reported the secondary outcome patient knowledge of pressure ulcer risk and prevention (Garber 2002; Rowland 2006; Ljungberg 2010; Kathirvel 2013; Guihan 2014; Sahingoz 2017).

None of the included studies measured the secondary outcome lay carer knowledge or acceptability of interventions to users.

Excluded studies

We excluded a total of three studies with reasons provided. Figueiredo 2010 was not an interventional study, but rather a cross‐sectional descriptive survey of patients' and caregivers' existing knowledge. Houlihan 2013 related to the healing of pressure ulcers, as measured by the pressure ulcer scale for healing tool. Bhatia 2015 did not meet our inclusion criteria as participants were not lay carers.

Risk of bias in included studies

See Figure 2 and Figure 3 for summaries of the risk of bias of the included studies.

2.

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

3.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Allocation

Random sequence generation

Eight trials provided the methods used for generating the allocation sequence and were therefore assessed as at low risk of bias for this domain (Garber 2002; Ward 2004; Rowland 2006; Kathirvel 2013; Guihan 2014; Chaboyer 2016; Sahingoz 2017; Karimi 2018). Two studies did not describe the method of randomisation and were deemed as at unclear risk of bias (Ljungberg 2010; Kaur 2018).

Allocation concealment

Two studies described allocation concealment and were deemed as at low risk of bias for this domain (Guihan 2014; Chaboyer 2016). We assessed two studies as at high risk of bias for this domain, as Kathirvel 2013 suggested that allocation concealment was not applicable, and Karimi 2018 did not use a method of allocation concealment. The remaining six studies did not describe allocation concealment and were therefore deemed as at unclear risk of bias (Garber 2002; Ward 2004; Rowland 2006; Ljungberg 2010; Sahingoz 2017; Kaur 2018).

Blinding

Performance bias

One study described blinding of participants and was deemed as at low risk of bias for this domain (Chaboyer 2016). Four studies were deemed as at high risk of bias as they stated that blinding was not possible (Ward 2004; Rowland 2006), not applicable (Kathirvel 2013); or not carried out (Guihan 2014). The remaining five studies did not describe participant blinding and were therefore deemed as at unclear risk of bias (Garber 2002; Ljungberg 2010; Sahingoz 2017; Karimi 2018; Kaur 2018).

Detection bias

Two studies described blinding of outcome assessment and were therefore deemed as at low risk of bias for this domain (Guihan 2014; Chaboyer 2016). Two studies were deemed as at high risk for this domain as they stated that blinding of outcome assessment was either not applicable (Kathirvel 2013), or that participants knew to which study group they had been assigned and self‐reported outcomes (Ward 2004). The remaining six studies did not describe blinding of outcome assessment and were therefore deemed as at unclear risk of bias for this domain (Garber 2002; Rowland 2006; Ljungberg 2010; Sahingoz 2017; Karimi 2018; Kaur 2018).

Incomplete outcome data

Six studies included all of those randomised in the final analysis and were deemed as at low risk of bias for this domain (Guihan 2014; Garber 2002; Ljungberg 2010; Kathirvel 2013; Chaboyer 2016; Karimi 2018). Three studies lost participants to follow‐up: Ward 2004 (8% loss of participants); Rowland 2006 (6% loss of participants); Kaur 2018 (4% loss of participants). Given that the numbers were relatively small and that they were evenly distributed amongst the study groups, we assessed these studies as at unclear risk of bias. In Sahingoz 2017, it was unclear if any participants were lost to follow‐up, therefore this study was also deemed as at unclear risk of bias for this domain.

Selective reporting

Seven studies reported on all prespecified outcomes and were deemed as at low risk of bias for this domain (Garber 2002; Ward 2004; Rowland 2006; Ljungberg 2010; Kathirvel 2013; Chaboyer 2016; Kaur 2018). One study did not report the prespecified outcome of patient knowledge and were therefore deemed as at high risk of bias for this domain (Guihan 2014). In Sahingoz 2017 and Karimi 2018 it was unclear if there were any reporting biases.

Other potential sources of bias

For two studies (Ljungberg 2010; Kathirvel 2013), we obtained data from abstracts and not from full publications, thus it is possible that there were other aspects of bias that were not identified, for example we were unable to determine baseline comparability of the study groups from the information provided in the abstracts. We assessed the remaining eight studies as at low risk of other potential sources of bias (Garber 2002; Ward 2004; Rowland 2006; Guihan 2014; Chaboyer 2016; Sahingoz 2017; Karimi 2018; Kaur 2018).

Recruitment Bias (cluster trials only)

In Chaboyer 2016, as recommended by Hahn 2005, the participants were identified before random allocation of the clusters, therefore, we judged the study to be at low risk of bias in this domain.

Baseline imbalance (cluster trials only)

In Chaboyer 2016, there were differences between the PUCB clusters and the usual care clusters at baselines, however, analysis was undertaken to adjust for clustering. Thus, we assessed the study as being of low risk of bias in this domain.

Loss of Clusters (cluster trials only)

In Chaboyer 2016, there were no losses of clusters, thus, we assessed the study as being of low risk of bias in this domain.

Incorrect Analysis (cluster trials only)

In Chaboyer 2016, analysis was undertaken to adjust for clustering, thus, we assessed the study as being of low risk of bias in this domain.

Comparability with individually randomised trials (cluster trials only)

We did not identify similar trials, and were unable to undertake meta‐analysis, thus were unable to assess comparability with individually randomised trials. Therefore, we judged Chaboyer 2016 as being of unclear risk of bias in this domain.

Effects of interventions

See: Table 1; Table 2; Table 3; Table 4; Table 5; Table 6; Table 7; Table 8; Table 9; Table 10; Table 11; Table 12; Table 13

See Table 1; Table 2; Table 3; Table 4; Table 5; Table 6; Table 7; Table 8; Table 9; Table 10; Table 11; Table 12; Table 13.

Comparison 1: Provision of information on the prevention of pressure ulcers (3 trials, 237 participants)

In three studies the intervention was information provision (Kathirvel 2013; Karimi 2018; Kaur 2018). These interventions were too dissimilar to permit meta‐analysis, therefore we have provided a narrative summary.

Self‐instruction manual on prevention of pressure ulcers, with one‐to‐one training and counselling, versus self‐instruction alone delivered to patients and their caregivers (1 trial, 92 participants)

Primary outcome: risk of pressure ulceration

Proportion of at risk people developing a new ulcer

In Kathirvel 2013 we are uncertain whether the use of a self‐instruction manual and one‐to‐one patient training and counselling reduces the proportion of at risk people developing a new ulcer, compared with the use of a self‐instruction manual only. In the study, 9% (4/46) developed a pressure ulcer in the self‐instruction manual and one‐to‐one patient training and counselling group; 22% (10/46) developed a pressure ulcer in the self‐instruction group (risk ratio (RR) 0.40, 95% confidence interval (CI) 0.14 to 1.18). The certainty of the evidence is very low (downgraded twice due to high risk of selection, detection, and performance bias and twice for imprecision due to the very small number of events and wide confidence interval) (Table 1; Analysis 1.1).

1.1. Analysis.

Comparison 1: Patient self‐instruction and one‐to‐one counselling versus self‐instruction, Outcome 1: Proportion of people developing a new ulcer

Secondary outcomes

Grade of pressure ulcer

Not reported.

Patient knowledge of pressure ulcer prevention

Kathirvel 2013 did not outline the instrument used to assess knowledge. However, the study authors reported that patients in the self‐instruction manual with one‐to‐one training and counselling group had better knowledge of pressure ulcer prevention than those in the self‐instruction manual‐alone group. The author does not provide precise figures for this outcome. The certainty of the evidence is very low (downgraded twice for risk of bias due to high risk of selection, detection, and performance bias and once for imprecision).

Lay carer knowledge of pressure ulcer prevention

Not reported.

Measures of acceptability of interventions to users

Not reported.

Self‐instruction and one‐to‐one counselling versus self‐instruction delivered to carers (1 trial, 75 participants)

Primary outcome: risk of pressure ulceration

Proportion of at risk people developing a new ulcer

In Kaur 2018, we are uncertain whether the use of carer self‐instruction and one‐to‐one counselling reduces the proportion of at risk people developing a new ulcer (at one month) compared with carer self‐instruction alone. In the study, 5% (2/37) people developed a pressure ulcer in the carer self‐instruction and one‐to‐one counselling group, whilst 2% (1/38) of people developed a pressure ulcer in the carer self‐instruction group (RR 2.05, 95% CI 0.19 to 21.70). The certainty of the evidence is very low (downgraded twice due to unclear risk of attrition, selection, detection, and performance bias and twice for imprecision due to the very small number of events and wide confidence interval) (Table 2; Analysis 2.1).

2.1. Analysis.

Comparison 2: Carer self‐instruction and one‐to‐one counselling versus self‐instruction, Outcome 1: Proportion of people developing a new ulcer

Secondary outcomes

Grade of pressure ulcer

Not reported.

Patient or lay carer knowledge of pressure ulcer prevention

Not reported.

Measures of acceptability of interventions to users

Not reported.

Home‐based training versus usual care delivered to patients and their family caregivers (1 trial, 70 participants)

Primary outcome: risk of pressure ulceration

Proportion of at risk people developing a new ulcer

In Karimi 2018, we are uncertain whether the use of home‐based training reduces the proportion of at risk people developing a new ulcer compared with usual care. In the study, 26% (9/35) developed a pressure ulcer in the home‐based training group, whilst 49% (17/35) developed a pressure ulcer in the usual care group (RR 0.53, 95% CI 0.27 to 1.02). The certainty of the evidence is very low (downgraded twice due to high risk of selection, detection, and performance bias and twice for imprecision due to the very small number of events and wide confidence interval) (Table 3; Analysis 3.1).

3.1. Analysis.

Comparison 3: Home‐based training versus usual care, Outcome 1: Proportion of people developing a new ulcer

Secondary outcomes

Grade of pressure ulcer

Not reported.

Patient or lay carer knowledge of pressure ulcer prevention

Not reported.

Measures of acceptability of interventions to users

Not reported.

Comparison 2: Educational programmes on the prevention of pressure ulcers (7 trials, 2024 participants)

In seven studies and one secondary report of an included study (Garber 2002 (also reported in Rintala 2008); Ward 2004; Rowland 2006; Ljungberg 2010; Guihan 2014; Chaboyer 2016; Sahingoz 2017), the intervention was an education programme. These interventions were too dissimilar to permit meta‐analysis, therefore we have provided a narrative summary. In all seven studies, the intervention was aimed at people at risk of ulceration.

Enhanced educational intervention and structured follow‐up versus standard education alone (1 trial, 41 participants)

Primary outcome: risk of pressure ulceration

Not reported.

Secondary outcomes

Grade of pressure ulcer

Not reported.

Patient knowledge of pressure ulcer prevention

Garber 2002 measured patient knowledge of pressure ulcer prevention using a pressure ulcer prevention knowledge test developed by the study author, where scores are measured out of 100, with a higher score indicating better knowledge. We are uncertain whether enhanced educational intervention and structured follow‐up improves patient knowledge. Mean knowledge score was 73.86 (standard deviation (SD) 12.35) for the enhanced education and structured follow‐up group versus 64 (SD 14.74) for the standard education alone group (mean difference (MD) 9.86, 95% CI 1.55 to 18.17). The certainty of the evidence is very low (downgraded twice for risk of bias due to unclear risk of selection, performance, and detection bias and twice for imprecision due to the very small sample size and very wide confidence interval) (Table 4; Analysis 4.1).

4.1. Analysis.

Comparison 4: Enhanced educational intervention and structured follow‐up versus standard education and no structured follow‐up, Outcome 1: Pressure ulcer prevention knowledge

Lay carer knowledge of pressure ulcer prevention

Not reported

Measures of acceptability of interventions to users

Not reported.

Education versus standard printed material (1 trial, 105 participants)

Primary outcome: risk of pressure ulceration

Proportion of at risk people developing a new ulcer

We are uncertain whether education delivery versus standard printed material reduces the proportion of at risk people developing a new ulcer. In Ward 2004, 13% (7/52) of patients in the education group developed a pressure ulcer versus 4% (2/53) in the standard printed material group (RR 3.57, 95% CI 0.78 to 16.38). The certainty of the evidence is very low (downgraded twice for risk of bias due to high risk of performance and detection bias and unclear risk of attrition bias and selection bias, and twice for imprecision due to the very small number of events and very wide confidence interval) (Table 5; Analysis 5.1).

5.1. Analysis.

Comparison 5: Education versus standard printed material, Outcome 1: Proportion of people developing a new ulcer

Secondary outcomes

Grade of pressure ulcer

Not reported.

Patient or lay carer knowledge of pressure ulcer prevention

Not reported.

Measures of acceptability of interventions to users

Not reported.

Computerised feedback and one‐on‐one consultations versus no feedback (1 trial, 67 participants)

Primary outcome: risk of pressure ulceration

Proportion of at risk people developing a new ulcer

Rowland 2006 reports the proportion of at risk people in each of the study groups that developed a pressure ulcer (23.7% in the computerised feedback group, and 27.6% in the no‐feedback group). Because the actual number of at risk people in each group is not provided by the author, we have not re‐analysed these data, and the values are from the study author analysis. The certainty of the evidence is very low (downgraded twice for risk of bias due to high risk of performance bias and unclear risk of attrition, selection, and detection bias and once for indirectness) (Table 6).

Secondary outcomes

Grade of pressure ulcer

Not reported.

Patient knowledge of pressure ulcer prevention

Rowland 2006 used a questionnaire designed by the study authors to assess patient knowledge of pressure ulcer prevention, where scores indicate greater knowledge. The mean score for the computerised feedback group was 86.9%, whilst the mean score for the no‐feedback group was 84.2%. Because the actual number of patients in each group is not provided by the author, we have not re‐analysed these data, and the values are from the study author analysis. The certainty of the evidence is very low (downgraded twice for risk of bias due to high risk of performance bias and unclear risk of attrition, selection, and detection bias and once for indirectness) (Table 6).

Lay carer knowledge of pressure ulcer prevention

Not reported.

Measures of acceptability of interventions to users

Not reported.

Individualised pressure ulcer education and monthly structured telephone follow‐up versus standard pressure ulcer education and monthly mail or telephone follow‐up (1 trial, 31 participants)

Rintala 2008 is a secondary publication of Garber 2002 and the data from Rintala 2008 are being used for this comparison.

Primary outcome: risk of pressure ulceration

Time to pressure ulcer occurrence

Rintala 2008 (related to Garber 2002) reported mean time to pressure ulcer occurrence or patient reaching the end of study follow‐up period; however, given that not all patients developed a pressure ulcer, the mean time to pressure ulcer occurrence cannot be calculated from the data. We are uncertain whether individualised pressure ulcer education and monthly structured telephone follow‐up changes the time to pressure ulcer occurrence, as the certainty of the evidence is very low (downgraded twice for risk of bias due to high risk of performance and reporting bias and unclear risk of attrition, selection, and detection bias; twice for imprecision due to the very small sample size; and once for indirectness) (Table 7).

Proportion of at risk people developing a new ulcer

We are uncertain whether individualised pressure ulcer education and monthly structured telephone follow‐up reduces the proportion of at risk people developing a new ulcer. In Rintala 2008 (related to Garber 2002), 30% (6/20) developed a pressure ulcer in the individualised pressure ulcer education and monthly structured telephone follow‐up group, and 55% (6/11) developed a pressure ulcer in the group receiving standard pressure ulcer education and monthly mail or telephone follow‐up (RR 0.55, 95% CI 0.23 to 1.30). The certainty of the evidence is very low (downgraded twice for risk of bias due to high risk of performance and reporting bias and unclear risk of attrition, selection, and detection bias, and twice for imprecision due to the very small sample size and very wide confidence interval) (Table 7; Analysis 6.1).

6.1. Analysis.

Comparison 6: Individualised pressure ulcer education and monthly structured telephone follow‐up versus standard pressure ulcer education and monthly or quarterly mail or telephone follow‐up, Outcome 1: Proportion of people developing a new ulcer

Secondary outcomes

Grade of pressure ulcer

Not reported.

Patient knowledge of pressure ulcer prevention

We are uncertain whether individualised pressure ulcer education and monthly structured telephone follow‐up improves patient knowledge of pressure ulcer prevention. Garber 2002 used the pressure ulcer knowledge test to assess patients' knowledge of pressure ulcer prevention, with higher scores indicating better knowledge. The study authors provided knowledge scores at baseline (individualised pressure ulcer education group: mean 54.17, SD 19.18; standard pressure ulcer education group: mean 55.00, SD 12.45). Rintala 2008 provided no follow‐up knowledge scores; the author instead reports that the knowledge scores are reported in the publication by Garber 2002 (mean knowledge score was 73.86 (SD 12.35) for the enhanced educational intervention and structured follow‐up group versus 64 (SD 14.74) for the standard education and monthly mail or telephone follow‐up group (MD 9.86, 95% CI 1.55 to 18.17). The certainty of the evidence is very low (downgraded twice for risk of bias due to high risk of performance and reporting bias and unclear risk of attrition, selection, and detection bias, and twice for imprecision due to the very small sample size) (Table 7).

Lay carer knowledge of pressure ulcer prevention

Not reported.

Measures of acceptability of interventions to users

Not reported.

Standard pressure ulcer education and monthly mail or telephone follow‐up, versus standard pressure ulcer education and quarterly mail or telephone follow‐up (1 trial, 21 participants)

Primary outcome: risk of pressure ulceration

Time to pressure ulcer occurrence

Rintala 2008 (secondary publication of Garber 2002, as above) reported mean time to pressure ulcer occurrence or patient reaching the end of study follow‐up period; however, given that not all patients developed a pressure ulcer, the mean time to pressure ulcer occurrence cannot be calculated from the data. We are uncertain whether standard patient education and monthly follow‐up changes the time to pressure ulcer occurrence, as the certainty of the evidence is very low (downgraded twice for risk of bias due to high risk of performance and reporting bias and unclear risk of attrition, selection, and detection bias; twice for imprecision due to the very small sample size; and once for indirectness) (Table 8).

Proportion of at risk people developing a new ulcer

We are uncertain whether standard patient education and monthly follow‐up reduces the proportion of at risk people developing a new ulcer. In Rintala 2008, 6/11 (55%) in the monthly follow‐up group and 9/10 (90%) in the quarterly follow‐up group developed a pressure ulcer (RR 0.61, 95% CI 0.34 to 1.08). The certainty of the evidence is very low (downgraded twice for risk of bias due to high risk of performance and reporting bias and unclear risk of attrition, selection, and detection bias, and twice for imprecision due to the very small sample size and very wide confidence interval) (Table 8; Analysis 6.2).

6.2. Analysis.

Comparison 6: Individualised pressure ulcer education and monthly structured telephone follow‐up versus standard pressure ulcer education and monthly or quarterly mail or telephone follow‐up, Outcome 2: Proportion of people developing a new ulcer

Secondary outcomes

Grade of pressure ulcer

Not reported.

Patient knowledge of pressure ulcer prevention

We are uncertain whether standard patient education and monthly follow‐up improves patient knowledge of pressure ulcer prevention. The publication by Rintala 2008 used the pressure ulcer knowledge test to assess patients' knowledge of pressure ulcer prevention, with higher scores indicating better knowledge. The study authors provided knowledge scores at baseline (monthly follow‐up group: mean 55.00, SD 12.45; quarterly follow‐up group: 54.50, SD 12.00); however, precise scores for the follow‐up period are not provided, rather the author reports that the knowledge scores are reported in the earlier publication Garber 2002. The certainty of the evidence is very low (downgraded twice for risk of bias due to high risk of performance and reporting bias and unclear risk of attrition, selection, and detection bias, and twice for imprecision due to the very small sample size) (Table 8).

Lay carer knowledge of pressure ulcer prevention

Not reported.

Measures of acceptability of interventions to users

Not reported.

Individualised pressure ulcer education and monthly structured telephone follow‐up versus standard pressure ulcer education and quarterly mail or telephone follow‐up (1 trial, 31 participants)

Primary outcome: risk of pressure ulceration

Time to pressure ulcer occurrence

Rintala 2008 (secondary publication of Garber 2002) reported mean time to pressure ulcer occurrence or patient reaching the end of study follow‐up period; however, given that not all patients developed a pressure ulcer, the mean time to pressure ulcer occurrence cannot be calculated from the data. We are uncertain whether individualised pressure ulcer education and monthly structured telephone follow‐up changes the time to pressure ulcer occurrence, as the certainty of the evidence is very low (downgraded twice for risk of bias due to high risk of performance and reporting bias and unclear risk of attrition, selection, and detection bias, and twice for imprecision due to the very small sample size and indirectness) (Table 9).

Proportion of at risk people developing a new ulcer

We are uncertain whether individualised pressure ulcer education and monthly structured telephone follow‐up reduces the proportion of at risk people developing a new ulcer, as in the publication Rintala 2008, 30% (6/20) developed a pressure ulcer in the individualized pressure ulcer education and monthly structured telephone follow‐up group, and 90% (9/10) developed a pressure ulcer in the group receiving standard pressure ulcer education and quarterly mail or telephone follow‐up (RR 0.33, 95% CI 0.17 to 0.67). The certainty of the evidence is very low (downgraded twice for risk of bias due to high risk of performance and reporting bias and unclear risk of attrition, selection, and detection bias, and twice for imprecision due to the very small sample size and very wide confidence interval) (Table 9; Analysis 6.3).

6.3. Analysis.

Comparison 6: Individualised pressure ulcer education and monthly structured telephone follow‐up versus standard pressure ulcer education and monthly or quarterly mail or telephone follow‐up, Outcome 3: Proportion of people developing a new ulcer

Secondary outcomes

Grade of pressure ulcer

Not reported.

Patient knowledge of pressure ulcer prevention

We are uncertain whether individualised pressure ulcer education and monthly structured telephone follow‐up improves patient knowledge of pressure ulcer prevention. The secondary publication Rintala 2008 used the pressure ulcer knowledge test to assess patients' knowledge of pressure ulcer prevention, with higher scores indicating better knowledge. The study authors provide knowledge scores at baseline (individualised pressure ulcer education group: mean 54.17, SD 19.18; standard pressure ulcer education group: 54.50, SD 12.00); however, precise scores for the follow‐up period are not provided; rather, the author reports that the knowledge scores are reported in the earlier publication by Garber 2002. The certainty of the evidence is very low (downgraded twice for risk of bias due to high risk of performance and reporting bias and unclear risk of attrition, selection, and detection bias, and twice for imprecision due to the very small sample size and very wide confidence interval).

Lay carer knowledge of pressure ulcer prevention

Not reported.

Measures of acceptability of interventions to users

Not reported.

Spinal Cord Injury Navigator programme versus usual rehabilitation care/education (1 trial, 30 participants)

Primary outcome: risk of pressure ulceration

Not reported.

Secondary outcomes

Grade of pressure ulcer

Not reported.

Patient knowledge of pressure ulcer prevention

Ljungberg 2010 used the pressure ulcer knowledge scale (PRESS) to assess patients' knowledge of pressure ulcer prevention; no reference is provided for the instrument. Ljungberg 2010 reports that the PRESS score changed from 18.3 to 19.9 for the Navigator group and from 17.9 to 20.6 for the control group. We have not re‐analysed these data. The certainty of the evidence is low (downgraded once for risk of bias due to unclear risk of selection and performance bias) (Table 10).

Lay carer knowledge of pressure ulcer prevention

Not reported.

Measures of acceptability of interventions to users

Not reported.

Multicomponent motivational interviewing/self‐management intervention with a multi component education intervention versus telephone‐based individual educational counselling plus group education (1 trial, 144 participants)

Primary outcome: risk of pressure ulceration

Not reported.

Secondary outcomes

Grade of pressure ulcer

Not reported.

Patient knowledge of pressure ulcer prevention

Guihan 2014 used the pressure ulcer prevention knowledge test developed by Garber 2002 to assess patients’ knowledge of pressure ulcer prevention. Scores for this test are measured out of 100, with a higher score indicating better knowledge. Results for this outcome are not presented in the paper (Table 11).

Lay carer knowledge of pressure ulcer prevention

Not reported.

Measures of acceptability of interventions to users

Not reported.

Pressure ulcer prevention care bundle versus standard care (1 trial, 1598 participants)

Primary outcome: risk of pressure ulceration

Proportion of people at risk people developing a new ulcer

Chaboyer 2016 undertook a cluster RCT and presented findings from an adjusted analysis on the incidence of hospital acquired pressure ulcers per 1000 participant days of follow‐up. There is low certainty evidence of there being no clear difference in the proportion of participants developing a new PU over the follow‐up time between use of a pressure ulcer prevention care bundle (PUPCB) and standard care: HR 0.58, 95% CI 0.25 to 1.33. Evidence was downgraded twice for imprecision as the 95% CIs were wide suggesting benefits and harm as well as potentially no effect (Table 12).

Secondary outcomes

Grade of pressure ulcer

In Chaboyer 2016 there is low certainty evidence that use of a PU prevention care bundle may make no difference to the severity of new PU development when compared with standard care.

Patient or lay carer knowledge of pressure ulcer prevention

Not reported.

Measures of acceptability of interventions to users

Not reported.

Structured, patient‐centric pressure ulcer prevention education event versus standard unit education (1 trial, 39 participants)

Primary outcome: risk of pressure ulceration

Not reported.

Secondary outcomes

Grade of pressure ulcer

Not reported.

Patient knowledge of pressure ulcer prevention

In Sahingoz 2017, it is unclear whether structured, patient‐centric pressure ulcer prevention education event (PUPET) improves patient knowledge. In the study, the mean scores post‐test for the intervention group (n = 18) were 94.44% (SD 7.84%), whilst the mean post‐test scores for the control group (n = 21) were 64.29% (SD 12.97%) and (MD 30.15, 95% CI 23.56 to 36.74). The certainty of the evidence is very low (downgraded twice for risk of bias due to high risk of performance, detection, and attrition bias and unclear risk of selection bias, and twice for imprecision due to the very small sample size and wide confidence interval) (Table 13; Analysis 7.1).

7.1. Analysis.

Comparison 7: Structured, patient‐centric pressure ulcer prevention education event versus standard unit education, Outcome 1: Patient knowledge

Lay carer knowledge of pressure ulcer prevention

Not reported.

Measures of acceptability of interventions to users

Not reported.

Discussion

Summary of main results

The search strategy yielded 666 citations, of which 10 studies with 11 publications, were deemed relevant and were included in the review. Two main types of interventions were included: provision of information on the prevention of pressure ulcers (this type of intervention focused on whether education in itself makes any difference to the prevention of pressure ulcers, regardless of the mode of delivery of the education), and use of different types of education programmes (this type of intervention focused on different types of education delivery, e.g. the use of DVD and patient leaflets). Seven studies were aimed at patients; two included both patients and carers; and one included carers; all outcomes were measured on at risk people. None of the included studies reported on our secondary outcome of lay carer knowledge of pressure ulcer prevention, or measures of acceptability of interventions to users.

Provision of information on the prevention of pressure ulcers

We are uncertain whether the use of a self‐instruction manual with one‐to‐one training and counselling, or provision of information on the prevention of pressure ulcers, or home‐based training reduces the risk of pressure ulcer development due to very low‐certainty evidence.

Educational programmes on the prevention of pressure ulcers

Risk of pressure ulceration

In seven studies (eight publications), the certainty of the evidence is very low or low, therefore we are uncertain whether any of the interventions reduce the proportion of at risk people developing a new ulcer.

Grade of pressure ulcer

In one study, use of a pressure ulcer prevention care bundle (PUPCB) may make no difference to the severity of new PU developed, when compared with standard care, with low‐certainty evidence.

Patient knowledge

In the comparisons that explored patient knowledge, we are uncertain whether any of the interventions improve patient knowledge due to low‐ or very low‐certainty evidence.

In summary, we are uncertain whether educational interventions make any difference to the proportion of at risk people developing a new ulcer or patient knowledge due to very low‐ or low‐certainty evidence. This uncertainty is due to risk of bias and serious imprecision within the studies. Further, use of a PUPCB, may make no difference to the severity of new PU developed.

Overall completeness and applicability of evidence

There are significant weaknesses in the completeness and applicability of the evidence overall. There was a high degree of heterogeneity amongst studies with regard to the description and measurement of interventions, which precluded meta‐analysis. Lack of detail in the findings in Guihan 2014 and Rowland 2006 prevented statistical analysis. All studies explored a different intervention making it very difficult to draw conclusions with any certainty. Despite the majority of studies reporting on the proportion of at risk people developing a new ulcer following the intervention, only one study reported on the grade/category of pressure ulcers (Chaboyer 2016). Knowledge of pressure ulcer risk and prevention was measured in six of the included studies, with only two studies using the same instrument to measure this outcome (Garber 2002; Guihan 2014). This makes it very difficult to assess overall impact on knowledge. None of the included studies reported on lay carer knowledge of pressure ulcer prevention or patient or lay carer acceptability of the education strategies. This information is clearly useful and should be included in future studies.

Quality of the evidence

Limitations in study design and implementation

All studies included in this review except Chaboyer 2016 had small sample sizes, and it is not clear that they are adequately powered to detect an effect of education on pressure ulcer prevention, should one exist. While the follow‐up time in these studies was sufficient (ranging between 3 and 24 months), the underpowered samples sizes remain problematic.

Most of the included studies present with high or unclear risks of bias for other domains. This is most notable with regard to allocation concealment and blinding of both participants and outcomes. Chaboyer 2016 is the one exception, which had a low risk of bias overall.

In general, information provided in the included studies with regard to bias was limited, pointing to a lack of conformity with good reporting standards.

Indirectness of the evidence

The lack of standardised scales to measure pressure ulcer risk knowledge and the absence of validation of the measures used is particularly notable. This makes it difficult to draw comparisons across studies, and the validation of such scales should be considered in future studies. Although most of the included studies reported on the prespecified outcomes, information within the studies pertaining to these outcomes was commonly poorly presented, thereby limiting interpretation of the data. For example, Kathirvel 2013 explored the secondary outcome patient knowledge, but did not provide precise figures for this outcome. Similarily, Rowland 2006 did not provide precise outcome data for the proportion of at risk people developing a new ulcer. For these reasons we downgraded the certainty of the evidence for indirectness within the relevant comparisons.

Imprecision of results

We downgraded all of the studies results for imprecision. This arose due to the relatively small sample sizes and few events, which generated wide confidence intervals in the data analysis. Wide confidence intervals represent a high level of uncertainty around the effect size, consequently further research is very likely to have an important impact on the confidence of the estimate of effect for education interventions for patients. Furthermore, in Guihan 2014, Ljungberg 2010 and Rowland 2006, insufficient data were provided pertaining to patient knowledge to permit analysis of the data using Review Manager 5.

Publication bias

We feel confident that our comprehensive electronic searches identified all existing, published RCTs addressing the review question. Whilst unlikely, it is theoretically possible that we did not locate potentially eligible, published studies. There is always the risk that unpublished studies exist that we failed to locate. In line with Cochrane policy, we will update this review again in the future, and any further studies identified that meet the inclusion criteria will be included at that stage.

Potential biases in the review process

We followed clearly described procedures to prevent potential bias in the review process. This included a careful literature search using methods that were transparent and reproducible. We also attempted to contact all authors where additional information was required. None of the review authors has any conflict of interest. It is possible that trials published in journals that were outside our search strategy may have been missed.

Agreements and disagreements with other studies or reviews

We are not aware of any other published systematic reviews on patient and lay carer education for preventing pressure ulceration.

Authors' conclusions

Implications for practice.

A patient’s right to have a central role in the healthcare process is an important aspect of healthcare provision, with benefits including enhanced motivation and knowledge about health and illness, and increased capacity for patients to monitor and look after themselves (Shanley 2019). The World Health Organization (WHO) stresses the importance of enhancing the contribution of the patient and their wider personal network to their own health and well‐being (WHO 2012c). In this way, the patient may be empowered to make more informed decisions pertaining to the type of healthcare delivery most suited to their clinical needs (WHO 2012c). Pressure ulcers have a significant impact on the lives of patients as they are common, costly, and impact negatively on health‐related quality of life. Prevention of pressure ulcers is a key issue for enhancing health, and education is a means to empower people to take an active role in their own health promotion (Shanley 2019). However, patient involvement in pressure ulcer prevention tends to be limited, as this aspect of care has been largely viewed as being in the domain of the trained healthcare professional (Shanley 2019).

All of the included studies presented uncertain evidence on the value of educational interventions for decreasing the risk of pressure ulceration. From a practice perspective, it remains unclear whether the interventions explored will make any difference to pressure ulcer incidence, thus the time and resources needed to implement these interventions should be considered in light of the uncertainty of the evidence.

Implications for research.

The low and very low certainty of the evidence presented in the studies included in this review points to a need for more robust studies with larger sample sizes and standardised measurement methods. Further trials also need to be adequately powered. The lack of agreed‐upon standards for education programmes and methods being employed with regard to pressure ulcer prevention should be addressed in further research. Thus, future trials need to include carefully developed interventions, methodological features to reduce bias, and cluster trials should be conducted and analysed correctly.

What's new

Date	Event	Description
5 March 2021	Amended	Minor amendments to wording in Abstract and Results

History

Protocol first published: Issue 12, 2015
Review first published: Issue 2, 2021

Appendices

Appendix 1. Search strategies

Cochrane Wounds Specialised Register

1 MESH DESCRIPTOR Education EXPLODE ALL AND INREGISTER

2 MESH DESCRIPTOR Pamphlets EXPLODE ALL AND INREGISTER

3 ((educat* or train* or learn* or teach*) near3 (self* or patient* or carer* or caregiver* or famil* or partner* or friend*)) AND INREGISTER

4 ((educat* or train* or learn* or teach*) near3 (program* or model* or system* or intervention*)) AND INREGISTER

5 ((educat* or train* or learn* or teach*) near3 (technol* or multimedia or web or audiovisual or online or internet or app* or e‐learning or elearning or written or printed or oral or face‐to‐face or "face to face")) AND INREGISTER

6 ((patient or health) near3 (information or literacy)) AND INREGISTER

7 (leaflet* or booklet* or pamphlet* or poster* or brochure*) AND INREGISTER

8 ((written or printed or oral or online or audiovisual or audio‐visual or Internet or web or online or telephon*) near3 information) AND INREGISTER

9 (academic detailing) AND INREGISTER

10 (algorithm* or decision tree*) AND INREGISTER

11 #1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7 OR #8 OR #9 OR #10 AND INREGISTER

12 MESH DESCRIPTOR Pressure Ulcer EXPLODE ALL AND INREGISTER

13 (pressure next (ulcer* or sore* or injur*)) AND INREGISTER

14 (decubitus next (ulcer* or sore*)) AND INREGISTER

15 (bedsore* or bed sore*) AND INREGISTER

16 #12 OR #13 OR #14 OR #15 AND INREGISTER

17 #11 AND #16 AND INREGISTER

The Cochrane Central Register of Controlled Clinical Trials (CENTRAL)

#1 MeSH descriptor: [Education] explode all trees

#2 MeSH descriptor: [Pamphlets] explode all trees

#3 ((educat* or train* or learn* or teach*) near/3 (self* or patient* or carer* or caregiver* or famil* or partner* or friend*)):ti,ab,kw (Word variations have been searched)

#4 ((educat* or train* or learn* or teach*) near/3 (program* or model* or system* or intervention*)):ti,ab,kw (Word variations have been searched)

#5 ((educat* or train* or learn* or teach*) near/3 (technol* or multimedia or web or audiovisual or audio‐visual or online or internet or app* or e‐learning or elearning or written or printed or oral or face‐to‐face or "face to face")):ti,ab,kw (Word variations have been searched)

#6 ((patient or health) near/3 (information or literacy)):ti,ab,kw (Word variations have been searched)

#7 (leaflet* or booklet* or pamphlet* or poster* or brochure*):ti,ab,kw

#8 ((written or printed or oral or online or audiovisual or audio‐visual or Internet or web or online or telephon*) near/3 information):ti,ab,kw (Word variations have been searched)

#9 (academic detailing):ti,ab,kw (Word variations have been searched)

#10 (algorithm* or decision tree*):ti,ab,kw (Word variations have been searched)

#11 {or #1‐#10}

#12 MeSH descriptor: [Pressure Ulcer] explode all trees

#13 (pressure near (ulcer* or sore* or injur*)):ti,ab,kw (Word variations have been searched)

#14 (decubitus near (ulcer* or sore*)):ti,ab,kw (Word variations have been searched)

#15 (bedsore* or bed sore*):ti,ab,kw (Word variations have been searched)

#16 {or #12‐#15}

#17 {and #11, #16} in Trials

Ovid MEDLINE

1 exp Education/

2 Pamphlets/

3 ((educat* or train* or learn* or teach*) adj3 (self* or patient* or carer* or caregiver* or famil* or partner* or friend*)).ti,ab,kw.

4 ((educat* or train* or learn* or teach*) adj3 (program* or model* or system* or intervention*)).ti,ab,kw.

5 ((educat* or train* or learn* or teach*) adj3 (technol* or multimedia or web or audiovisual or audio‐visual or online or internet or app* or e‐learning or elearning or written or printed or oral or face‐to‐face or "face to face")).ti,ab,kw.

6 ((patient or health) adj3 (information or literacy)).ti,ab.

7 (leaflet* or booklet* or pamphlet* or poster* or brochure*).ti,ab.

8 ((written or printed or oral or online or audiovisual or audio‐visual or Internet or web or online or telephon*) adj3 information).ti,ab.

9 academic detailing.ti,ab.

10 (algorithm* or decision tree*).ti,ab.

11 or/1‐10

12 exp Pressure Ulcer/

13 (pressure adj (ulcer* or sore* or injur*)).tw.

14 (decubitus adj (ulcer* or sore*)).tw.

15 (bedsore* or bed sore*).tw.

16 or/12‐15

17 and/11,16

18 randomized controlled trial.pt.

19 controlled clinical trial.pt.

20 randomi?ed.ab.

21 placebo.ab.

22 clinical trials as topic.sh.

23 randomly.ab.

24 trial.ti.

25 or/18‐24

26 exp animals/ not humans.sh.

27 25 not 26

28 17 and 27

Ovid Embase

1 exp education/

2 ((educat* or train* or learn* or teach*) adj3 (self* or patient* or carer* or caregiver* or famil* or partner* or friend*)).ti,ab,kw.

3 ((educat* or train* or learn* or teach*) adj3 (program* or model* or system* or intervention*)).ti,ab,kw.

4 ((educat* or train* or learn* or teach*) adj3 (technol* or multimedia or web or audiovisual or audio‐visual or online or internet or app* or e‐learning or elearning or written or printed or oral or face‐to‐face or "face to face")).ti,ab,kw.

5 ((patient or health) adj3 (information or literacy)).ti,ab.

6 (leaflet* or booklet* or pamphlet* or poster* or brochure*).ti,ab.

7 ((written or printed or oral or online or audiovisual or audio‐visual or Internet or web or online or telephon*) adj3 information).ti,ab.

8 academic detailing.ti,ab.

9 (algorithm* or decision tree*).ti,ab.

10 or/1‐9

11 exp decubitus/

12 (pressure adj (ulcer* or sore* or injur*)).tw.

13 (decubitus adj (ulcer* or sore*)).tw.

14 (bedsore* or bed sore*).tw.

15 or/11‐14

16 and/10,15

17 Randomized controlled trials/

18 Single‐Blind Method/

19 Double‐Blind Method/

20 Crossover Procedure/

21 (random* or factorial* or crossover* or cross over* or cross‐over* or placebo* or assign* or allocat* or volunteer*).ti,ab.

22 (doubl* adj blind*).ti,ab.

23 (singl* adj blind*).ti,ab.

24 or/17‐23

25 exp animals/ or exp invertebrate/ or animal experiment/ or animal model/ or animal tissue/ or animal cell/ or nonhuman/

26 human/ or human cell/

27 and/25‐26

28 25 not 27

29 24 not 28

30 16 and 29

Ovid PsycINFO

1 exp Health Promotion/

2 exp Health Knowledge/

3 exp Health Literacy/

4 exp Health Education/

5 exp Education/

6 ((educat* or train* or learn* or teach*) adj3 (self* or patient* or carer* or caregiver* or famil* or partner* or friend*)).ti,ab,kw.

7 ((educat* or train* or learn* or teach*) adj3 (program* or model* or system* or intervention*)).ti,ab,kw.

8 ((educat* or train* or learn* or teach*) adj3 (technol* or multimedia or web or audiovisual or audio‐visual or online or internet or app* or e‐learning or elearning or written or printed or oral or face‐to‐face or "face to face")).ti,ab,kw.

9 ((patient or health) adj3 (information or literacy)).ti,ab.

10 (leaflet* or booklet* or pamphlet* or poster* or brochure*).ti,ab.

11 ((written or printed or oral or online or audiovisual or audio‐visual or Internet or web or online or telephon*) adj3 information).ti,ab.

12 academic detailing.ti,ab.

13 (algorithm* or decision tree*).ti,ab.

14 or/1‐13

15 (pressure adj (ulcer* or sore* or injur*)).tw.

16 (decubitus adj (ulcer* or sore*)).tw.

17 (bedsore* or bed sore*).tw.

18 or/15‐17

19 and/14,18

20 clinical trials/

21 (clin$ adj25 trial$).ti,ab.

22 random$.ti,ab.

23 ((randomised adj controlled adj trial$) or (randomized adj controlled adj trial$)).mp.

24 (controlled adj clinical adj trial$).mp.

25 (random adj allocat$).mp.

26 ((singl$ or doubl$ or trebl$ or tripl$) adj25 (blind$ or mask$)).ti,ab.

27 (control$ adj4 trial$).mp.

28 or/20‐27

29 (ANIMALS not HUMANS).sh.

30 28 not 29

31 and/19,30

EBSCO CINAHL Plus

S31 S17 AND S30

S30 S18 OR S19 OR S20 OR S21 OR S22 OR S23 OR S24 OR S25 OR S26 OR S27 OR S28 OR S29

S29 TI allocat* random* or AB allocat* random*

S28 MH "Quantitative Studies"

S27 TI placebo* or AB placebo*

S26 MH "Placebos"

S25 TI random* allocat* or AB random* allocat*

S24 MH "Random Assignment"

S23 TI randomi?ed control* trial* or AB randomi?ed control* trial*

S22 AB ( singl* or doubl* or trebl* or tripl* ) and AB ( blind* or mask* )

S21 TI ( singl* or doubl* or trebl* or tripl* ) and TI ( blind* or mask* )

S20 TI clinic* N1 trial* or AB clinic* N1 trial*

S19 PT Clinical trial

S18 MH "Clinical Trials+"

S17 S11 AND S16

S16 S12 OR S13 OR S14 OR S15

S15 TI decubitus OR AB decubitus

S14 TI ( ( bed sore* or bedsore* ) ) OR AB ( ( bed sore* or bedsore* ) )

S13 TI ( ( pressure ulcer* or pressure sore* or pressure injur* ) ) OR AB ( ( pressure ulcer* or pressure sore* or pressure injur*) )

S12 (MH "Pressure Ulcer+")

S11 S1 OR S2 OR S3 OR S4 OR S5 OR S6 OR S7 OR S8 OR S9 OR S10

S10 TX (algorithm* or decision tree*)

S9 TX academic detailing

S8 TX ((written or printed or oral or online or audiovisual or audio‐visual or Internet or web or online or telephon*) N3 information)

S7 TX (leaflet* or booklet* or pamphlet* or poster* or brochure*)

S6 TX ((patient or health) N3 (information or literacy))

S5 TX ((educat* or train* or learn* or teach*) N3 (technol* or multimedia or web or audiovisual or audio‐visual or online or internet or app* or e‐learning or elearning or written or printed or oral or face‐to‐face or "face to face"))

S4 TX ((educat* or train* or learn* or teach*) N3 (program* or model* or system* or intervention*))

S3 TX ((educat* or train* or learn* or teach*) N3 (self* or patient* or carer* or caregiver* or famil* or partner* or friend*))

S2 (MH "Pamphlets")

S1 (MH "Education+")

We also searched the following clinical trials registries for ongoing studies:

 ClinicalTrials.gov (www.clinicaltrials.gov);

 WHO International Clinical Trials Registry (ICTRP;apps.who.int/trialsearch/Default.aspx);

 The EU Clinical Trials Register (www.clinicaltrialsregister.eu).

The keywords used in the search included:

#1 MeSH descriptor: [Education] explode all trees

#2 MeSH descriptor: [Pamphlets] explode all trees

#3 ((educat* or train* or learn* or teach*) near/3 (self* or patient* or carer* or cargiver* or famil* or partner* or friend*)):ti,ab,kw

#4 ((educat* or train* or learn* or teach*) near/3 (program* or model* or system* or intervention*)):ti,ab,kw

#5 ((educat* or train* or learn* or teach*) near/3 (technol* or multimedia or web or audiovisual or audio‐visual or online or internet or app* or e‐learning or elearning or written or printed or oral or face‐to‐face or “face to face”)):ti,ab,kw

#6 ((patient or health) near/3 (information or literacy)):ti,ab,kw

#7 (leaflet* or booklet* or pamphlet* or poster* or brochure*) .ti,ab,kw

#8 ((written or printed or oral or online or audiovisual or audiovisual or Internet or web or online or telephon*) near/3 information): ti,ab,kw

#9 academic detailing:ti,ab,kw

#10 (algorithm* or decision tree*):ti,ab,kw

#11 {or #1‐#10}

#12 MeSH descriptor: [Pressure Ulcer] explode all trees

#13 (pressure near (ulcer* or sore* or injur*)):ti,ab,kw

#14 (decubitus near (ulcer* or sore*)):ti,ab,kw

#15 (bedsore* or bed sore*):ti,ab,kw

#16 {or #12‐#15}

#17 {and #11, #16} in Trial

ClinicalTrials.gov (www.clinicaltrials.gov): No studies found.

WHO International Clinical Trials Registry (ICTRP; apps.who.int/trialsearch/Default.aspx): No studies found.

The EU Clinical Trials Register (www.clinicaltrialsregister.eu): No studies found.

Appendix 2. 'Risk of bias' assessment (individually randomised controlled trials)

1. Was the allocation sequence randomly generated?

Low risk of bias

The investigators describe a random component in the sequence generation process such as: referring to a random number table; using a computer random number generator; coin tossing; shuffling cards or envelopes; throwing dice; drawing of lots.

High risk of bias

The investigators describe a non‐random component in the sequence generation process. Usually, the description would involve some systematic, non‐random approach, for example: sequence generated by odd or even date of birth; sequence generated by some rule based on date (or day) of admission; sequence generated by some rule based on hospital or clinic record number.

Unclear

Insufficient information about the sequence generation process provided to permit a judgement of low or high risk of bias.

2. Was the treatment allocation adequately concealed?

Low risk of bias

Participants and investigators enrolling participants could not foresee assignment because one of the following, or an equivalent method, was used to conceal allocation: central allocation (including telephone, web‐based, and pharmacy‐controlled randomisation); sequentially numbered drug containers of identical appearance; sequentially numbered, opaque, sealed envelopes.

High risk of bias

Participants or investigators enrolling participants could possibly foresee assignments and thus introduce selection bias, such as allocation based on: use of an open random allocation schedule (e.g. a list of random numbers); assignment envelopes without appropriate safeguards (e.g. envelopes were unsealed, non‐opaque, or not sequentially numbered); alternation or rotation; date of birth; case record number; any other explicitly unconcealed procedure.

Unclear

Insufficient information provided to permit a judgement of low or high risk of bias. This is usually the case if the method of concealment is not described, or not described in sufficient detail to allow a definitive judgement, for example if the use of assignment envelopes is described, but it remains unclear whether envelopes were sequentially numbered, opaque, and sealed.

3. Blinding ‐ was knowledge of the allocated interventions adequately prevented during the study?

Low risk of bias

Any one of the following:

• No blinding, but the review authors judge that the outcome and the outcome measurement are not likely to be influenced by lack of blinding.

• Blinding of participants and key study personnel ensured, and it is unlikely that the blinding could have been broken.

• Either participants or some key study personnel were not blinded, but outcome assessment was blinded, and the non‐blinding of others is unlikely to have introduced bias.

High risk of bias

Any one of the following:

• No blinding or incomplete blinding, and the outcome or outcome measurement is likely to be influenced by lack of blinding.

• Blinding of key study participants and personnel attempted, but it is likely that the blinding could have been broken.

• Either participants or some key study personnel were not blinded, and the non‐blinding of others is likely to have introduced bias.

Unclear

Either of the following:

• Insufficient information to permit a judgement of low or high risk of bias.

• The study did not address this outcome.

4. Were incomplete outcome data adequately addressed?

Low risk of bias

Any one of the following:

• No missing outcome data.

• Reasons for missing outcome data are unlikely to be related to true outcome (for survival data, censoring is unlikely to introduce bias).

• Missing outcome data are balanced in numbers across intervention groups, with similar reasons for missing data across groups.

• For dichotomous outcome data, the proportion of missing outcomes compared with the observed event risk is not enough to have a clinically relevant impact on the intervention effect estimate.

• For continuous outcome data, a plausible effect size (difference in means or standardised difference in means) amongst missing outcomes is not enough to have a clinically relevant impact on the observed effect size.

• Missing data have been imputed using appropriate methods.

High risk of bias

Any one of the following:

• Reasons for missing outcome data are likely to be related to the true outcome, with either an imbalance in numbers or reasons for missing data across intervention groups.

• For dichotomous outcome data, the proportion of missing outcomes compared with the observed event risk is enough to induce clinically relevant bias in the intervention effect estimate.

• For continuous outcome data, a plausible effect size (difference in means or standardised difference in means) amongst missing outcomes is enough to induce a clinically relevant bias in the observed effect size.

• 'As‐treated' analysis done with a substantial departure of the intervention received from that assigned at randomisation.

• Potentially inappropriate application of simple imputation.

Unclear

Either of the following:

• Insufficient reporting of attrition/exclusions to permit a judgement of low or high risk of bias (e.g. number randomised not stated, no reasons for missing data provided).

• The study did not address this outcome.

5. Are reports of the study free of the suggestion of selective outcome reporting?

Low risk of bias

Either of the following:

• The study protocol is available, and all of the study’s prespecified (primary and secondary) outcomes that are of interest in the review have been reported in the prespecified way.

• The study protocol is not available, but it is clear that the published reports include all expected outcomes, including those that were prespecified (convincing text of this nature may be uncommon).

High risk of bias

Any one of the following:

• Not all of the study’s prespecified primary outcomes have been reported.

• One or more primary outcomes is/are reported using measurements, analysis methods, or subsets of the data (e.g. subscales) that were not prespecified.

• One or more reported primary outcomes was/were not prespecified (unless clear justification for their reporting is provided, such as an unexpected adverse effect).

• One or more outcomes of interest in the review is/are reported incompletely so that they cannot be entered in a meta‐analysis.

• The study report fails to include results for a key outcome that would be expected to have been reported in such a study.

Unclear

Insufficient information provided to permit a judgement of low or high risk of bias. It is likely that the majority of studies will fall into this category.

6. Other sources of potential bias

Low risk of bias

The study appears to be free of other sources of bias.

High risk of bias

There is at least one important risk of bias. For example, the study:

• had a potential source of bias related to the specific study design used;

• has been claimed to have been fraudulent; or

• had some other problem.

Unclear

There may be a risk of bias, but there is either:

• insufficient information to assess whether an important risk of bias exists; or

• insufficient rationale or evidence that an identified problem will introduce bias.

Appendix 3. 'Risk of bias' assessment (cluster‐randomised controlled trials)

In cluster‐randomised trials, particular biases to consider include: recruitment bias; baseline imbalance; loss of clusters; incorrect analysis; and comparability with individually randomised trials.

• Recruitment bias:

  • can occur when participants are recruited to the trial after the clusters have been randomised, as the knowledge of whether each cluster is an 'intervention' or 'control' cluster could affect the types of participants recruited.

• Baseline imbalance:

  • cluster‐randomised trials often randomise all clusters at once, so lack of concealment of an allocation sequence should not usually be an issue. However, because small numbers of clusters are randomised, there is a possibility of chance baseline imbalance between the randomised groups, in terms of either the clusters or the participants. Although not a form of bias as such, the risk of baseline differences can be reduced by using stratified or pair‐matched randomisation of clusters. Reporting of the baseline comparability of clusters, or statistical adjustment for baseline characteristics, can help reduce concern about the effects of baseline imbalance.

• Loss of clusters:

  • complete clusters are occasionally lost from a trial and have to be omitted from the analysis. Just as for missing outcome data in individually randomised trials, this may lead to bias. In addition, missing outcomes for participants within clusters may also lead to a risk of bias in cluster‐randomised trials.

• Incorrect analysis:

  • many cluster‐randomised trials are analysed by incorrect statistical methods that do not take the clustering into account. Such analyses create a 'unit of analysis error' and produce overprecise results (the standard error of the estimated intervention effect is too small) and P values that are too small. Whilst they do not lead to biased estimates of effect, they will receive too much weight in a meta‐analysis if uncorrected.

• Comparability with individually randomised trials:

  • in a meta‐analysis including both cluster‐ and individually randomised trials, or including cluster‐randomised trials with different types of clusters, possible differences between the intervention effects being estimated need to be considered. For example, in a vaccine trial of infectious diseases, a vaccine applied to everyone in a community would be expected to be more effective than if the vaccine was applied to only half of the people. Another example is provided by a Cochrane Review of hip protectors (Hahn 2005). The cluster trials showed large positive effects, whereas individually randomised trials did not show any clear benefit. One possibility is that there was a 'herd effect' in the cluster‐randomised trials (which were often performed in nursing homes, where compliance with using the protectors may have been enhanced). In general, such 'contamination' would lead to underestimates of effect. Thus, if an intervention effect is still demonstrated despite contamination in those trials that were not cluster‐randomised, a confident conclusion about the presence of an effect can be drawn. However, the size of the effect is likely to be underestimated. Contamination and herd effects may be different for different types of clusters.

Data and analyses

Comparison 1. Patient self‐instruction and one‐to‐one counselling versus self‐instruction.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1.1 Proportion of people developing a new ulcer	1	92	Risk Ratio (M‐H, Fixed, 95% CI)	0.40 [0.14, 1.18]

Comparison 2. Carer self‐instruction and one‐to‐one counselling versus self‐instruction.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
2.1 Proportion of people developing a new ulcer	1	75	Risk Ratio (M‐H, Fixed, 95% CI)	2.05 [0.19, 21.70]

Comparison 3. Home‐based training versus usual care.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
3.1 Proportion of people developing a new ulcer	1	70	Risk Ratio (M‐H, Fixed, 95% CI)	0.53 [0.27, 1.02]

Comparison 4. Enhanced educational intervention and structured follow‐up versus standard education and no structured follow‐up.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
4.1 Pressure ulcer prevention knowledge	1	41	Mean Difference (IV, Fixed, 95% CI)	9.86 [1.55, 18.17]

Comparison 5. Education versus standard printed material.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
5.1 Proportion of people developing a new ulcer	1	105	Risk Ratio (M‐H, Fixed, 95% CI)	3.57 [0.78, 16.38]

Comparison 6. Individualised pressure ulcer education and monthly structured telephone follow‐up versus standard pressure ulcer education and monthly or quarterly mail or telephone follow‐up.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
6.1 Proportion of people developing a new ulcer	1	31	Risk Ratio (M‐H, Fixed, 95% CI)	0.55 [0.23, 1.30]
6.2 Proportion of people developing a new ulcer	1	21	Risk Ratio (M‐H, Fixed, 95% CI)	0.61 [0.34, 1.08]
6.3 Proportion of people developing a new ulcer	1	30	Risk Ratio (M‐H, Fixed, 95% CI)	0.33 [0.17, 0.67]

Comparison 7. Structured, patient‐centric pressure ulcer prevention education event versus standard unit education.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
7.1 Patient knowledge	1	39	Mean Difference (IV, Random, 95% CI)	30.15 [23.56, 36.74]

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Chaboyer 2016.

Study characteristics
Methods	Study design: cluster‐randomised controlled trial Study grouping: parallel groups Country: Australia Setting: tertiary hospital Ethics and informed consent: yes Follow‐up period: 28 days Sample size estimate: yes (8 clusters of 169 patients each) ITT analysis: yes; number randomised: 1598; number analysed: 1598 Funding: National Health and Medical Research Council (NHMRC) project grant number 1058963
Participants	Inclusion criteria: inpatients with 1 of 8 tertiary hospitals; aged 18 years and over; had an expected hospital length of stay of 48 hours; at risk of PU as measured by limited mobility (i.e. requiring physical or mechanical assistance to reposition or ambulate); able to read English and provide informed consent. Exclusion criteria: admitted to the hospital for > 36 hours prior to recruitment; admitted to day surgery, critical care, emergency, maternity, paediatrics, mental health, or dialysis; previous trial participants; palliative, or receiving end‐of‐life care. Pretreatment: age, median: years, intervention 70.0, control 74.0 sex: female: intervention 393 (49.2%), control 434 (54.3%) admission type: surgical: intervention: 232 (29.0%), control: 316 (39.5%); medical: intervention: 558 (69.8%), control: 463 (57.9%); cancer, intervention: 9 (1.1%), control: 20 (2.5%)
Interventions	Intervention (n = 799): intervention group received standard care, in line with regional guidelines, and the PUPCB 5‐minute DVD, information brochure, and poster on PUP were the resources used to educate patients and promote their participation in PUP. Poster had photographs and 3 messages: 1) keep moving; 2) look after your skin; and 3) eat a healthy diet. DVD and brochure focused on these same 3 messages and used the same photographs but provided detailed information about each message. Face‐to‐face patient education was provided once to patients at their bedsides within 24 hours of being enrolled in the study (i.e. within 50 hours of hospital admission). Each patient received the intervention from 1 intervention RA, and there was no follow‐up or reinforcement of the training. Control (n = 799); standard care, in line with regional guidelines
Outcomes	The primary outcome was incidence of new HAPU. Outcome type: dichotomous outcome Reporting: fully reported Unit of measure: the number of new PU of any stage per 1000 patient follow‐up days Direction: lower is better Data value: endpoint Secondary outcome: severity of HAPU Outcome type: dichotomous outcome Reporting: fully reported Unit of measure: European Pressure Ulcer Advisory Panel et al, 2014 Direction: lower is better Data value: endpoint
Identification	Author's name: Wendy Chaboyer Institution: NHMRC Centre for Research Excellence in Nursing, Griffith University, Gold Coast Campus, QLD 4222, Australia & Menzies Health Institute Queensland, Griffith University, Australia Email: w.chaboyer@griffith.edu.au
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "random number generating software was used to randomise hospitals (clusters) within strata, with random 1:1 block allocation of hospitals to intervention or control group." Quote: "to further limit the possibility of selection bias, a statistician not associated with recruitment generated a random number list, which was used to determine the order in which recruiters approached the wards to recruit participants. Initial recruitment targeted four medical/ surgical wards at each hospital, but if weekly recruitment targets of 10 patients/week were not being met, further wards were included in the trial"
Allocation concealment (selection bias)	Low risk	Quote: "allocation was concealed until all sites had confirmed participation. Hospital staff were not informed about the comparator intervention nor the group allocation"
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "patients and staff were blinded to group allocation"
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "recruitment and outcome assessment research assistants (RAs) were masked to the trial design and group allocation"
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "intention‐to‐treat analyses were undertaken by a statistician (LT) blinded to group allocation. All patients who were randomised were analysed in the groups to which they were randomised. Patients who withdrew or were lost to follow‐up were analysed based on their last skin inspection"
Selective reporting (reporting bias)	Low risk	Trial was registered: ACTRN12613001343796. This was checked, and all outcomes listed were reported in the publication.
Other bias	Low risk	None identified
Recruitment bias	Low risk	Participants were identified before random allocation of the clusters
Baseline imbalance	Low risk	There were differences between the PUCB clusters and the usual care clusters at baselines, however, analysis was undertaken to adjust for clustering
Loss of clusters	Low risk	There were no losses of clusters
Incorrect analysis	Low risk	Analysis was undertaken to adjust for clustering
Comparability with individually randomised trials	Unclear risk	We did not identify similar trials, and were unable to undertake meta‐analysis, thus we were unable to assess comparability with individually randomised trials.

Garber 2002.

Study characteristics
Methods	Study design: randomised controlled trial Study grouping: parallel groups Country: USA Setting: ICU Ethics and informed consent: not stated Follow‐up period: 3, 6, and 12 months Sample size estimate: no ITT analysis: yes; number randomised: 41; number analysed: 41 Funding: supported by the Rehabilitation Research and Development Service, Department of Veterans Affairs, Washington, DC Additional/alternative information from Rintala 2008 which reports data on the same participants Setting: Veterans Affairs Medical Center Ethics and informed consent: yes; approved by the Baylor College of Medicine Institutional Review Board for Human Subjects’ Research and the MEDVAMC Research and Development Committee Follow‐up period: 24 months Sample size estimate: yes; to attain a power of.80 (.05) in comparing group 1 with group 2 and group 2 with group 3, 62 participants in group 1, 36 in group 2, and 36 in group 3 would be needed, for a total of 134 participants ITT analysis: no; number randomised: 41; number analysed: 38 Funding: supported by the Department of Veterans Affairs, Veterans Health Administration, Rehabilitation Research and Development Service (grant no. B1343‐R)
Participants	Inclusion criteria: men with SCI who were admitted to the Houston Veterans Affairs Medical Center (VAMC) for surgery to repair a Stage III or IV pelvic pressure ulcer (sacrum/coccyx, ischium, or trochanter) veterans were included regardless of level and completeness of SCI, age, ethnicity, educational level, or functional independence Exclusion criteria: veterans were excluded if they were cognitively impaired to the extent that they were unable to understand either the consent form or the educational material Pretreatment: Age, mean: 53 years Sex: males Time since onset of SCI, mean: 36 years Educational status: less than high school graduate: 3 high school graduate or GED: 15 college: 16 bachelor’s degree: 7 graduate school: 0 In Rintala 2008 Inclusion criteria veterans with SCI who have had surgical repair of a pressure ulcer. Pretreatment: Age (28 to 78 years); age at onset of spinal cord injury or dysfunction (19 to 69 years) Time since onset of spinal cord injury or dysfunction (1 to 44 years) Educational status: all but 3 participants had graduated from high school or received their General Educational Development (GED) diploma, and 56% had at least some college education.
Interventions	Intervention characteristics (n = 20): Enhanced educational intervention and structured follow‐up 4 hours of individualised, structured education on the prevention and management of pressure ulcers near the end of their hospital stay presented in four 1‐hour sessions consisting of specific information followed by discussion topics included pressure ulcer aetiology, prevention strategies (e.g. weight shifts, skin inspection), nutrition, and pressure‐reducing support surfaces for the bed and wheelchair investigator also provided printed materials that the veteran could take home, including monographs on skin care, prevention, and treatment of pressure ulcers. All these materials were developed specifically for individuals at risk of pressure ulcers. participants were contacted by telephone monthly after discharge until 2 years after discharge or the occurrence of a pressure ulcer in the pelvic area, whichever came first during the telephone contacts, participants responded to questions about the status of their skin and pressure ulcer prevention behaviours participants were reminded of any behaviours that they should have been doing but were not (e.g. eating a balanced diet) Control (n = 21): Standard education and no structured follow‐up contacted periodically only to determine skin status no information was sought or given regarding preventive practices during these contacts until the final contact at 24 months postdischarge or when discontinued because of pressure ulcer occurrence In Rintala 2008 The control group were considered as two groups as follows: Group 2 (n = 11) standard pressure ulcer education: monthly mail or telephone follow‐up Group 3 (n = 10) standard pressure ulcer education: quarterly mail or telephone follow‐up
Outcomes	Pressure ulcer knowledge Outcome type: continuous outcome Reporting: fully reported Unit of measure: percentage Direction: higher is better Data value: endpoint Outcomes reported in the publication Rintala 2008: Pressure ulcer incidence Outcome type: dichotomous outcome Reporting: fully reported Unit of measure: numbers Direction: lower is better Data value: endpoint Knowledge Outcome type: continuous outcome Reporting: not reported Unit of measure: numbers Direction: higher is better Data value: endpoint
Identification	Author's name: Susan L Garber Institution: Houston Veterans Affairs Medical Center Email: sgarber@bcm.tmc.edu For the Rintala 2008 publication: Author's name: Diana H Rintala Institution: Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX Email: drintala@bcm.tmc.edu
Notes	A secondary publication (Rintala 2008) reported a second set of outcomes on the same participants and additional information. These are clearly noted.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "they were randomised to one of two groups by selecting a numbered paper from a container" In Rintala 2008 this states "they were randomised to one of the 3 groups by selecting a numbered paper out of a container"
Allocation concealment (selection bias)	Unclear risk	Not stated
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not stated
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not stated
Incomplete outcome data (attrition bias) All outcomes	Low risk	All those randomised were analysed. In Rintala 2008 3 participants were lost to follow up
Selective reporting (reporting bias)	Low risk	All outcomes reported. In Rintala 2008 education outcomes were not reported so this domain is considered to be high risk
Other bias	Low risk	None noted.

Guihan 2014.

Study characteristics
Methods	Study design: randomised controlled trial Study grouping: parallel groups Country: USA Setting: 6 Veterans Affairs (VA) SCI centres Ethics and informed consent: study oversight was provided by the VA Health Services Research and Development Service National Data Safety and Monitoring Board. The study protocol was approved by the institutional review boards at all the participating VA medical centres and affiliated universities. Follow‐up period: 3 and 6 months Sample size estimate: yes, the study was designed to randomly assign a minimum of 300 participants, with 80% power to detect a 30% difference between treatment and control groups in number of skin care behaviours already followed (alpha = .05, 2‐sided) ITT analysis: yes; number randomised: 144; number analysed: 144 Funding: Department of Veterans Affairs, Office of Research and Development, Health Services Research and Development Service (grant no. IIR 06‐203)
Participants	Inclusion criteria: admission for treatment of a severe (Stage III or IV) pelvic ulcer 18 years of age 6 months post‐SCI Exclusion criteria: terminal diagnosis or severe psychiatric comorbidities (e.g. current psychosis) cognitive impairments that limited their ability to consent or participate severe hearing loss wounds not expected to heal people discharged to nursing homes unable to direct their own care were also excluded Pretreatment: Age: mean (SD) years: intervention: 59.4 (10.1); control: 59.0 (12.8) Sex (M/F): intervention 69/2; control: 2/70 Education n (%): high school graduate or lower: intervention: 23 (32.4); control: 22 (30.5) college: intervention: 35 (49.3); control: 38 (52.8) college graduate: intervention: 10 (14.1); control: 9 (12.5) graduate school: intervention: 3 (4.2); control: 3 (4.2)
Interventions	Intervention characteristics (n = 72) Multicomponent motivational interviewing (MI)/self‐management (SM) intervention with a multicomponent education intervention SM groups included 8 to 10 participants who were discharged about the same time. SM group content was tailored for the study with modules on: guideline‐based skin care education; training in problem‐solving and self‐monitoring skills; community resource utilisation; relaxation, stress, and mood management skills; improving provider relationships; and development of action plans. Participants received an initial welcome call from group leaders and reminder calls before each session. Participants received SM study materials by mail before the first group call. MI‐based individual telephone counselling calls: site co‐ordinators called participants at 8 scheduled times over 24 weeks. Standard MI strategies (open questions, affirmations, reflections, summaries) used to elicit change talk and commitment language relating to improving skin care behaviour. Control (n = 72) Telephone‐based individual educational counselling plus group education Equivalent to the SM/MI intervention in terms of number and timing of sessions and who delivered the intervention. Education control intervention emphasised teaching and advice giving whilst barring the presumed active ingredients of skills training and MI. Education control arm participants received copies of SCI educational guide.
Outcomes	Pressure ulcer knowledge Outcome type: continuous outcome Reporting: not reported Unit of measure: percentage Direction: higher is better Data value: endpoint
Identification	Author's name: Marylou Guihan Institution: Center for Healthcare Studies, Feinberg School of Medicine, Northwestern University Email: Marylou.guihan@va.gov
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "participants were randomly assigned at discharge from the hospital by the Hines Data Coordinating Center. Randomization was 1:1, blocked (using random block sizes of 2, 4, 6, and 8),23 and stratified by hospital, previous Pr Us (0, 1, 2þ), and skin status at discharge (open vs closed)."
Allocation concealment (selection bias)	Low risk	Quote: "participants were randomly assigned at discharge from the hospital by the Hines Data Coordinating Center. Randomization was 1:1, blocked (using random block sizes of 2, 4, 6, and 8),23 and stratified by hospital, previous Pr Us (0, 1, 2þ), and skin status at discharge (open vs closed)."
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote: "single blind" Individuals and staff would have known which group they were in.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "single blind"
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "ITT analysis"
Selective reporting (reporting bias)	High risk	Patient knowledge not reported.
Other bias	Low risk	None noted.

Karimi 2018.

Study characteristics
Methods	Study design: randomised controlled trial Study grouping: parallel groups Country: Iran Setting: residents' home Ethics and informed consent: yes Follow‐up period: 3 months Sample size estimate: the sample size with confidence of 95% and test power of 85% was determined as 35 for each group and 70 participants overall, according to the formula of estimating the prevalence in both groups and based on the results obtained from the study by Benedict and colleagues. ITT analysis: yes; number randomised: 70; number analysed: 70 Funding: research plan approved by Zahedan University of Medical Sciences
Participants	Inclusion criteria: Inclusion criteria for patients included: stroke patients; absence of any signs suggesting bedsore or skin disorders in the patient at the beginning of the study; being a resident of Zahedan; aged 45 to 75 years old; bedsore risk score of less than or equal to 14 (being moderately or severely at risk of bedsore, according to Braden scale). Inclusion criteria for family caregivers included: age above 18 years; having a caregiver that provided care for a longer time compared to other caregivers; being literate (able to read and write). Exclusion criteria: Exclusion criteria for patients included: rehospitalisation of the patient during the study; death of the patient during the study; having suspicious ulcers or any skin disease. Exclusion criteria for family caregivers included: absent from more than 1 educational session. Pretreatment: Patients: age: control: 62.46 ± 10.34; intervention: 61.49 ± 10.71 gender: male: control: 19 (54.3%); intervention: 14 (40%); female control: 16 (45.7%); intervention: 21 (60%) marital status: single: control: 1 (2.9%); intervention: 0 (0%); married: control: 34 (97.1%); intervention: 35 (100%) Family caregivers: age: control: 40.23 ± 11.20; intervention: 36.06 ± 10.87 gender: male: control: 12 (34.3); intervention: 12 (34.3); female: control: 13 (65.7); intervention: 13 (65.7) marital status: single: control: 9 (25.7%); intervention: 11 (31.4%); married: control: 26 (74.3%); intervention: 24 (68.6%) educational status: under diploma: control: 18 (51.4%); intervention: 21 (60%); upper diploma: control: 17 (48.6%); intervention: 14 (40%) occupation status: unemployed: control: 17 (48.6%); intervention: 15 (42.9%); employed: control: 18 (51.4%); intervention: 20 (57.1%)
Interventions	Intervention characteristics (n = 35) Before discharge of the patient from hospital, a 2‐hour group lecture educational session was held for at the hospital for the patient and their family members and specifically for the main caregiver of the patient about stroke, risk factors, and problems caused by stroke. Next, the address and telephone number of the patient’s caregiver were obtained, and another 2‐hour educational session was held in the second week after discharge about the ways that bedsore develops, as well as in the third week after discharge about recognising different types of bedsore and methods for preventing bedsore for the main caregiver of the patient, administered face‐to‐face. Furthermore, an educational pamphlet addressing the points that were discussed was provided to the main caregiver of the patient. Control (n = 35) Patients in the control group only received routine care.
Outcomes	Frequency of PU development Outcome type: dichotomous outcome Reporting: fully reported Unit of measure: the number of new PU of any stage Direction: lower is better Data value: endpoint
Identification	Author's name: Fateme Karimi Institution: Nursing and Midwifery School, Zahedan University of Medical Sciences, Zahedan, Iran Email: askarihas77@yahoo.com
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "subjects were randomly assigned to 35‐subject intervention and control groups."
Allocation concealment (selection bias)	High risk	Quote: "Specifically, colored cards, including red (intervention) and blue (control), including 70 in total (35 of each card) were randomly placed inside a box and given to the family caregivers. Then, everyone picked a colored card randomly from inside the box. Eventually, this procedure was continued without substituting the card until completion of the colored cards."
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not mentioned
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not mentioned
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "no attrition occurred in the samples either from patients or caregivers"
Selective reporting (reporting bias)	Unclear risk	Protocol not registered.
Other bias	Low risk	None detected.

Kathirvel 2013.

Study characteristics
Methods	Study design: randomised controlled trial Study grouping: parallel groups Country: India Setting: orthopaedic Ethics and informed consent: yes Follow‐up period: 3 months Sample size estimate: no ITT analysis: yes; number randomised: 92; number analysed: 92 Funding: Post Graduate Institute of Medical Education and Research (PGIMER) Chandigarh
Participants	Inclusion criteria: all patients (18 years of age or older) Braden score ≤ 12 Stage I PU resident of Chandigarh Tricity (Chandigarh Mohali & Panchkula) admitted during study period in emergency and general orthopaedic wards of PGIMER Exclusion criteria: ambulatory cases who could get out of bed without assistance or who could walk without assistance patients with Stage II, ΙΙΙ, ΙV pressure ulcer under NPUAP 2007 patients and caregivers who did not give consent for the study eligible patients not residents of Chandigarh Tricity (Chandigarh Mohali & Panchkula) Pretreatment: not stated
Interventions	Intervention characteristics (n = 46) self‐instruction manual on prevention of pressure ulcer in bedridden patients with one‐to‐one training and counselling of orthopaedically bedridden patients and their caregivers on prevention of pressure ulcer development followed up daily from day one of admission till hospital discharge, then weekly for 2 weeks and fortnightly for 2 months in patient's home to monitor any development of pressure ulcer Control (n = 46) self‐instruction manual on the prevention of pressure ulcer in bedridden patients without any training and counselling of orthopaedically bedridden patients and their caregivers on prevention of pressure ulcer development given only self‐instruction manual without any training followed up daily from day one of admission till hospital discharge, then weekly for 2 weeks and fortnightly for 2 months in patient's home to monitor any development of pressure ulcer
Outcomes	Pressure ulcer incidence Outcome type: dichotomous outcome Reporting: fully reported Unit of measure: numbers Direction: lower is better Data value: endpoint Knowledge Outcome type: continuous outcome Reporting: not reported Unit of measure: numbers Direction: higher is better Data value: endpoint
Identification	Author's name: Soundappan Kathirvel Institution: Post Graduate Institute of Medical Education and Research (Chandigarh, India) Email: selvkathir@gmail.com
Notes	Data obtained from a conference abstract and from the trial registration: CTRI/2011/07/001862.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "permuted block randomization, fixed"
Allocation concealment (selection bias)	High risk	Quote: "not applicable"
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote: "not applicable"
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quote: "not applicable"
Incomplete outcome data (attrition bias) All outcomes	Low risk	Data provided for all participants.
Selective reporting (reporting bias)	Low risk	Pressure ulcer incidence reported.
Other bias	Unclear risk	Incomplete study report, so it is difficult to rule out further bias.

Kaur 2018.

Study characteristics
Methods	Study design: randomised controlled trial Study grouping: parallel groups Country: India Setting: community (patients' homes) Ethics and informed consent: yes Follow‐up period: 12 months Sample size estimate: yes: calculated sample size as per α = 0.05; β = 0.20; P = 0.80 was 30 patients in each group. Taking into consideration the dropouts, it was planned to enrol 50 patients in each group. ITT analysis: yes; number randomised: 92; number analysed: 75 Funding: Indian Council of Medical Research, New Delhi
Participants	Inclusion criteria bedridden patient, defined as a patient above 12 years of age who had been confined to bed for 15 days or more, for 90% of the time during the day and who was unable to get out of bed or change position in bed without assistance Exclusion criteria none stated Pretreatment mean age: Group A: 51.7 ± 21.7 years (range 19 to 95); Group B: 54.2 ± 24.4 years (range 13 to 97) more male patients in both groups educational status: around one‐third were high school graduates
Interventions	Intervention: (n = 46) Group A received Prevention Package I, i.e. self‐instruction manual, training, and counselling. Comparison (n = 46) Group B received Prevention Package 2, i.e. only self‐instruction manual.
Outcomes	Pressure ulcer incidence Outcome type: dichotomous outcome Reporting: fully reported Unit of measure: numbers Direction: lower is better Data value: endpoint
Identification	Author's name: Dr Sukhpal Kaur Institution: National Institute of Nursing Education, PGIMER, Chandigarh, India Email: sukhpal.trehan@yahoo.in
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "randomly allocated by a faculty into two groups"
Allocation concealment (selection bias)	Unclear risk	Not stated
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not stated
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not stated
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	23 participants not followed up at 3 months.
Selective reporting (reporting bias)	Low risk	The trial was registered with the WHO ICTRP (CTRI/2011/09/002002); outcome reported as per trial registration.
Other bias	Low risk	None noted.

Ljungberg 2010.

Study characteristics
Methods	Study design: randomised controlled trial Study grouping: parallel groups Country: USA Setting: SCI rehabilitation Ethics and informed consent: not stated Follow‐up period: 3 months Sample size estimate: not stated ITT analysis: yes number randomised: 30; number analysed: 30 Funding: funded by NIDRR grant #H133N060028, the National Capital Spinal Cord Injury Model System
Participants	Inclusion criteria: individuals with newly acquired SCI admitted to the National Rehabilitation Hospital for inpatient rehabilitation Exclusion criteria: not stated Pretreatment: not stated
Interventions	Intervention characteristics (n = 19) SCI Navigator programme usual rehabilitation care and education including nursing education and general SCI materials interaction with the SCI navigator either in person or over the phone using the PVA PU guideline as the primary PU education tool Control (n = 11) usual rehabilitation care/education including nursing education and general SCI materials
Outcomes	Knowledge Outcome type: dichotomous outcome Reporting: fully reported Unit of measure: numbers Direction: higher is better Data value: endpoint
Identification	Author's name: Inger Ljungberg Institution: National Rehabilitation Hospital, Washington, DC Email: Inger.h.ljungberg@medstar.net
Notes	Data obtained from a conference abstract and poster.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "were randomised"
Allocation concealment (selection bias)	Unclear risk	Not stated
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not stated, however blinding would not be possible due to the nature of the interventions.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not stated
Incomplete outcome data (attrition bias) All outcomes	Low risk	All patients reported on.
Selective reporting (reporting bias)	Low risk	Outcome reported.
Other bias	Unclear risk	Incomplete study report, so it is difficult to rule out further bias.

Rowland 2006.

Study characteristics
Methods	Study design: randomised controlled trial Study grouping: parallel groups Country: USA Setting: SCI Center Ethics and informed consent: yes; approved by Internal Review Boards at the University of Kansas and at each Model System site Follow‐up period: 12 months Sample size estimate: no ITT analysis: no; number randomised: 71; number analysed: 67 Funding: RISC project was funded by grant #H133B980016 from the National Institute for Disability and Rehabilitation Research (NIDRR) in collaboration with Spain Rehabilitation at the University of Alabama, Birmingham.
Participants	Inclusion criteria: traumatic SCI diagnosis within 6 to 18 months of entering the study receiving treatment at a participating Model SCI Center returning for first annual post injury medical visit at the Model SCI Center ability to read and understand the informed consent no Grade IV pressure sores upon entering the study between the ages of 18 and 65 upon entering the study medical reading score of 6th grade or higher, as measured by REALMb Exclusion criteria: not stated Pretreatment: age: mean = 35.43 years (SD 13.53) sex: males: 73%; females: 27% race: white: 73%; black: 24%; Hispanic: 3% injury: cervical: 61%; thoracic and lumbar: 39% severity: complete: 70%; incomplete: 30% aetiology: MVA: 36%; work‐related: 24%; other: 40% education: high school: 63%; college courses: 30%; vocational: 6%; other: 1%
Interventions	Intervention (n = not provided): computerised feedback and one‐on‐one consultations, based on their risk of developing a complication following spinal cord injury Control (n = not provided): no feedback
Outcomes	Pressure ulcer incidence Outcome type: continuous outcome Reporting: fully reported (for the whole study group, but not by treatment arm) Unit of measure: numbers Direction: lower is better Data value: endpoint
Identification	Author's name: Jennifer L Rowland Institution: Department of Disability and Human Development, University of Illinois at Chicago (M/C 626) Email: jenrow@uic.edu
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "the RISC computer program randomly assigned participants"
Allocation concealment (selection bias)	Unclear risk	Not stated
Blinding of participants and personnel (performance bias) All outcomes	High risk	Unable to blind due to the nature of the interventions
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not stated
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	4 patients lost to follow‐up
Selective reporting (reporting bias)	Low risk	All outcomes reported.
Other bias	Low risk	None noted.

Sahingoz 2017.

Study characteristics
Methods	Study design: randomised controlled trial Study grouping: parallel groups Country: USA Setting: Family Care Medical Surgical Unit Ethics and informed consent: yes Follow‐up period: 3 days Sample size estimate: proposed sample size of 70 for the 2 groups would have resulted in the study having a power of 83.6% to yield a statistically significant result ITT analysis: yes; number randomised: 39; number analysed: 39 Funding: not stated
Participants	Inclusion criteria: male and female adult patients aged 45 to 65 years admitted on the inpatient family care surgical unit Exclusion criteria: patients younger than 45 and older than 65, who were confused, or who had diminished mental capacity Pretreatment: intervention group self‐identified ethnicity as Caucasian (understood to be white) in 94.4% (n = 17) and African‐American in 5.6% (n = 1) of the participants. The intervention group was comprised of 7 females (38.9%) and 11 males (61.1%). The majority of the participants (n = 11) indicated that they had graduated high school. control group self‐identified ethnicity as Caucasian (understood to be white) in 90.5% (n = 19) and African‐American in 9.6% (n = 2) of the participants. The control group was comprised of 6 females (28.6%) and 15 males (71.4%). The majority of the participants (n = 15) indicated that they had graduated high school. average age in the intervention group (n = 18) was 57.39 years. The average age in the control group (n = 21) was 58.81 years. average Braden score was 19.44 for the intervention group (n = 18) and 20.14 for the control group (n = 21). intervention and control groups were comparable in terms of age, gender, education, ethnicity, and pretest Braden scale scores.
Interventions	Intervention (n = 18): structured, patient‐centric pressure ulcer prevention education event (PUPET) Control (n = 21): standard unit education
Outcomes	Pressure ulcer knowledge Outcome type: continuous outcome Reporting: fully reported Unit of measure: numbers Direction: higher is better Data value: endpoint
Identification	Author's name: Anne Marie Sahingoz Institution: Walden University, Minneapolis, Minnesota, USA Email: not provided
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "assigned the subjects into control and intervention groups using a computer generated randomisation ‐ Random.org"
Allocation concealment (selection bias)	Unclear risk	Allocation concealment not clearly described.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not stated
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not stated
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Not stated
Selective reporting (reporting bias)	Unclear risk	Protocol not registered in a trial register, so unable to determine if proposed outcomes were reported.
Other bias	Low risk	None noted.

Ward 2004.

Study characteristics
Methods	Study design: randomised controlled trial Study grouping: parallel groups Country: UK Setting: patients' homes Ethics and informed consent: yes; approved by the research ethics committee of Queen's Medical Centre (Nottingham, UK) Follow‐up period: 12 months Sample size estimate: no ITT analysis: no; number randomised: 114; number analysed: 105 Funding: Department of Health Policy Research Programme
Participants	Inclusion criteria: adults aged over 15 years with 1 of the following possible recorded diagnoses: multiple sclerosis, Parkinson's disease and other causes of progressive parkinsonism, motor neurone disease, Huntington's disease, and other degenerative disorders affecting the central nervous system, muscles, or peripheral nerves Excluded criteria: individuals with dementing disorders such as Alzheimer's disease individuals whose clinical features appeared incompatible with the recorded diagnosis were excluded, as were those with neurological complications of primarily non‐neurological conditions such as diabetes mellitus, or additional causes of severe disability Pretreatment age, median years (range): control: 65 (22 to 86); intervention: 63 (29 to 89) diagnosis: n (%): Parkinson's disease: control: 26 (45.6); intervention: 27 (47.4); multiple sclerosis: control: 23 (40.4); intervention: 22 (38.6); other: control: 8 (14.0); intervention: 8 (14.0) sex: n (%): control: male: 31 (54.4); female: 26 (45.6); intervention: male: 32 (56.1); female: 25 (43.9) ethnic group: n (%): control: white: 53 (93.0); other: 4 (7.0); intervention: white: 54 (94.7); other: 3 (5.3)
Interventions	Intervention (n = 52): baseline visit and assessment within six weeks of the baseline visit, participants received an education visit from the research OT, who provided personalized advice and information based on the expert panel discussion, a tailored version of the standard information package, and a specially constructed leaflet offering information about the participant's condition and about self‐help organizations. action plan was then proposed, and relevant phone numbers supplied. approximately two weeks later, EG participants received a single follow‐through phone call from the research OT to confirm and reinforce the educational content of the visit, after which EG patients had no subsequent contact with the OT 12 month assessment Control (n = 53): baseline visit and assessment six weeks later an information package on generic services and condition‐specific self‐help organizations was delivered to the home by the research OT. participants raising any specific queries during the information visit were advised to consult routine sources of advice such as their GP, so as to avoid providing a personalized educational intervention 12 month assessment
Outcomes	Pressure ulcers developed Outcome type: dichotomous outcome Reporting: fully reported Unit of measure: numbers Direction: lower is better Data value: endpoint
Identification	Author's name: Professor CD Ward Institution: University of Nottingham Rehabilitation Research Unit, Email: c.d.ward@nottingham.ac.uk
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "each participant was allocated consecutively to a group by consulting a computer‐generated random number series"
Allocation concealment (selection bias)	Unclear risk	Not stated
Blinding of participants and personnel (performance bias) All outcomes	High risk	Not possible to blind because the interventions are obviously different
Blinding of outcome assessment (detection bias) All outcomes	High risk	Self reported by the participants
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	5 lost to follow‐up in the experimental group and 4 lost to follow‐up in the control group
Selective reporting (reporting bias)	Low risk	All outcome measures reported
Other bias	Low risk	None noted

GED: general educational development test
HAPU: hospital‐acquired pressure ulcer
ICU: intensive care unit
ITT: intention‐to‐treat
MVA: motor vehicle accident
NPUAP: National Pressure Ulcer Advisory Panel
PU: pressure ulcer
PUP: pressure ulcer prevention
PUPCB: pressure ulcer prevention care bundle
PVA: paralysed veterans affairs
RA: research assistant
SCD: spinal cord damage
SCI: spinal cord injury
SD: standard deviation
WHO ICTRP: World Health Organization International Clinical Trials Registry Platform

Characteristics of excluded studies [ordered by study ID]

Study	Reason for exclusion
Bhatia 2015	Wrong participants, not lay carers
Figueiredo 2010	No intervention, cross‐sectional descriptive survey of patients' and caregivers' existing knowledge
Houlihan 2013	Author contacted but unable to provide information; study relates to the healing of pressure ulcers as measured by the pressure ulcer scale for healing tool

Characteristics of ongoing studies [ordered by study ID]

NCT02969343.

Study name	Patient safety learning laboratory: making acute care more patient‐centered (PSLL)
Methods	Study design: randomised controlled trial Study grouping: parallel groups
Participants	Patients in acute hospital 18 to 99 years of age
Interventions	PSLL patient safety health information technology tool
Outcomes	Pressure ulcers: proportion of hospitalisations with hospital‐acquired pressure ulcer (time frame: up to 21 months); safety outcomes: proportion of hospitalisations with hospital‐acquired pressure ulcer Pressure ulcers: proportion of hospitalisations with pressure ulcer worsening in stage from admission to discharge (time frame: up to 21 months); safety outcomes: proportion of hospitalisations with hospital‐acquired pressure ulcer worsening in stage from admission to discharge
Starting date	April 2015
Contact information	David W Bates, MD, MSc, Brigham and Women's Hospital
Notes

Differences between protocol and review

None.

Contributions of authors

Tom O'Connor: conceived the review; designed the review; co‐ordinated the review; extracted data; checked quality of data extraction; analysed or interpreted data; undertook quality assessment; checked quality assessment; performed statistical analysis; checked quality of statistical analysis; produced the first draft of the review; contributed to writing or editing the review; advised on the review; wrote to study authors/experts/companies; approved the final review prior to publication; is guarantor of the review.
Zena Moore: conceived the review; designed the review; co‐ordinated the review; extracted data; checked quality of data extraction; analysed or interpreted data; undertook quality assessment; checked quality assessment; performed statistical analysis; checked quality of statistical analysis; produced the first draft of the review; contributed to writing or editing the review; advised on the review; approved the final review prior to publication.
Declan Patton: conceived the review; designed the review; co‐ordinated the review; extracted data; checked quality of data extraction; analysed or interpreted data; undertook quality assessment; checked quality assessment; performed statistical analysis; checked quality of statistical analysis; produced the first draft of the review; contributed to writing or editing the review; advised on the review; approved the final review prior to publication.

Contributions of the editorial base

Nicky Cullum (Joint Co‐ordinating Editor): edited the protocol; advised on methodology, interpretation and content; approved the final protocol prior to publication.

Jo Dumville (Joint Co‐ordinating Editor): edited the review; advised on methodology, interpretation, and content; approved the final review prior to publication.

Gill Rizzello (Managing Editor): co‐ordinated the editorial process; advised on interpretation and content; edited the protocol and the review.

Naomi Shaw and Sophie Bishop (Information Specialists): designed the search strategy, ran the search and edited the search methods section.

Tom Patterson (Editorial Assistant): edited the reference sections.

Sources of support

Internal sources

• Royal College of Surgeons in Ireland, Ireland

External sources

• National Institute for Health Research (NIHR), UK

  This project was supported by the National Institute for Health Research (NIHR), via Cochrane Infrastructure and Cochrane Programme Grant funding (NIHR Cochrane Programme Grant 13/89/08 High Priority Cochrane Reviews in Wound Prevention and Treatment) to Cochrane Wounds. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care.

Declarations of interest

Tom O'Connor: none known.

Zena EH Moore: has received a speakers' honorarium from Smith & Nephew and 3M.

Declan Patton: none known.

Edited (no change to conclusions)