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. 2021 May 6;2021(5):CD013621. doi: 10.1002/14651858.CD013621.pub2

Whitney 1984.

Study characteristics
Methods Study objective: to provide data that will assist nurses in determining which mattress is the best choice for pressure sore prevention, and under which circumstances
Study design: randomised controlled trial
Study grouping: parallel group
Duration of follow‐up: the average length of study 8.9 days in alternating pressure mattress; 7.6 in foam mattress
Number of arms: 2
Single centre or multi‐sites: single centre
Study start date and end date: not described
Setting: medical‐surgical unit
Participants Baseline characteristics
Inclusion criteria: patients on 3 medical‐surgical units who were in bed for 20 out of 24 hours daily
Exclusion criteria: not described
Sex (M:F): not described
Age (years): mean 63.2 (range 19 to 91)
Baseline skin status: people with ulcers included (2 had serious decubiti on admission, 1 in each of the groups)
Group difference: not reported
Total number of participants: n = 51
Unit of analysis: individuals
Unit of randomisation (per patient): individuals
Interventions Intervention characteristics
Alternating pressure mattress
  • Description of interventions: an alternating pressure mattress consisting of 134 3‐inch diameter air cells with a 2.5‐inch lift, and micro air vents for air circulation. Adjacent air cells inflated and deflated alternately every 3 minutes.

  • NPIAP S3I classification: powered, alternating pressure (active) air surface

  • Co‐interventions: routine nursing care received including turning every 2 hours

  • Number of participants randomised: n = 25

  • Number of participants analysed: n = 25


Foam mattress
  • Description of interventions: a 4‐inch polyurethane convoluted foam pad

  • NPIAP S3I classification: non‐powered, reactive foam surface; polyurethane convoluted foam

  • Co‐interventions: routine nursing care received including turning every 2 hours

  • Number of participants randomised: n = 26

  • Number of participants analysed: n = 26

Outcomes Proportion of participants developing a new pressure ulcer
  • Outcome type: binary

  • Time points: not described

  • Reporting: partially reported

  • Measurement method (e.g. scale, self‐reporting): not described

  • Definition (including ulcer stage): changes in skin condition; the definition of pressure ulcers not given

  • Dropouts: not described

  • Notes (e.g. other results reported): 20% of 25 with worse skin condition, 20% with better condition, and 60% with the same condition in alternating pressure mattress; 23.1% with worse skin condition, 19.2% with better condition, and 57.7% with the same condition in foam mattress


Time to pressure ulcer incidence
  • Reporting: not reported


Support‐surface‐associated patient comfort
  • Reporting: not reported


All reported adverse events of using allocated support surfaces
  • Reporting: not reported


Health‐related quality of life (HRQOL)
  • Reporting: not reported


Cost‐effectiveness
  • Reporting: not reported

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "26 were selected at random and placed in the foam mattress group, 25 in the AP mattress group"
Comment: unclear risk of bias because it is unclear how random sequence was generated.
Allocation concealment (selection bias) Unclear risk Comment: no information provided.
Blinding of participants and personnel (performance bias)
All outcomes High risk Outcome group: primary outcome
Quote: "... the investigators, who assessed the patient and placed him/her in one of the two mattress groups"
Comment: high risk of bias because it is likely the investigators, i.e. key study personnel who operated the study, were not blinded.
Blinding of outcome assessment (detection bias)
All outcomes High risk Outcome group: primary outcome
Quote: "In most cases patients were assessed by two investigators as a team, and occasionally by only one of the investigators"
Quote: "The investigators who rated patient risk and evaluated skin condition knew the mattress assignment of each patient, making investigator bias possible"
Comment: high risk of bias because non‐blinding of outcome assessment is clearly stated.
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Comment: no information provided.
Selective reporting (reporting bias) Unclear risk Comment: no information provided.
Other bias Unclear risk Comment: no information provided.