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. 2021 May 10;2021(5):CD013620. doi: 10.1002/14651858.CD013620.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‐site: unspecified
Study start date and end date: not described
Setting: 3 medical‐surgical units.
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 has serious decubiti on admission, 1 in each of the groups)
Group difference:
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 three‐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 development
  • Reporting: not reported


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


All reported adverse events 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 the 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 performed this study.
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.