PASSReviewer 1· 90% conf
A well-designed human RCT with centralised web-based randomisation (stratified, variable block sizes), a pre-specified power calculation, detailed eligibility criteria, an ITT analysis population with defined imputation, and masked outcome assessment despite open-label treatment.
Evidence
paraphrase[Methods, Randomisation and masking]
“Randomisation to NPWT or usual care (1:1) was stratified by wound location ..., using variable block sizes (two, four, six, and eight). The allocation sequence was generated independently by the trial statistician and was implemented using a bespoke, centralised, secure online randomisation service”paraphrase[Methods, Statistical analysis]
“To detect a 25% reduction in median time to healing ... with 90% power, two-sided type I error rate of 5%, a 12-month follow-up period, and allowing for 20% attrition, ... 696 participants were required (348 per group).”direct quote[Abstract / Methods, Randomisation and masking]
“Participants and the clinical and research teams were unmasked to treatment allocation. However, to minimise bias, masked assessment of wound healing photographs was completed by clinically experienced independent observers”PASSReviewer 2· 95% conf
Well-designed and well-reported RCT with central web-based randomisation, stratification, variable block sizes, a pre-specified power calculation, detailed eligibility criteria, and ITT analysis with appropriate censoring and imputation.
Evidence
direct quote[Methods, Randomisation and masking]
“Randomisation to NPWT or usual care (1:1) was stratified by wound location (foot and ankle, leg, abdomen, or other), wound area (<28 cm 2 or ≥28 cm 2 , calculated as the measurement arising from the longest part of the wound multiplied by the measurement for the widest part of the wound), and study centre, using variable block sizes (two, four, six, and eight).”paraphrase[Methods, Statistical analysis]
“To detect a 25% reduction in median time to healing (from 86 days with usual care to 65 days with NPWT equating to a hazard ratio [HR] of 1·32 and a control group event proportion of 0·95), with 90% power, two-sided type I error rate of 5%, a 12-month follow-up period, and allowing for 20% attrition, , , , 696 participants were required (348 per group).”direct quote[Methods, Randomisation and masking]
“Participants and the clinical and research teams were unmasked to treatment allocation. However, to minimise bias, masked assessment of wound healing photographs was completed by clinically experienced independent observers and analysis of this was included as a secondary outcome.”PASSReviewer 3· 95% conf
The study design is rigorous, with clear randomization, stratification, blinding of outcome assessment, a priori power analysis, and pre-specified inclusion/exclusion criteria.
Evidence
paraphrase[Methods, Randomisation and masking]
“Randomisation to NPWT or usual care (1:1) was stratified by wound location, wound area, and study centre, using variable block sizes (two, four, six, and eight). The allocation sequence was generated independently by the trial statistician and was implemented using a bespoke, centralised, secure online randomisation service”direct quote[Methods, Randomisation and masking]
“Participants and the clinical and research teams were unmasked to treatment allocation. However, to minimise bias, masked assessment of wound healing photographs was completed by clinically experienced independent observers”paraphrase[Methods, Statistical analysis]
“To detect a 25% reduction in median time to healing (from 86 days with usual care to 65 days with NPWT equating to a hazard ratio [HR] of 1·32 and a control group event proportion of 0·95), with 90% power, two-sided type I error rate of 5%, a 12-month follow-up period, and allowing for 20% attrition, 696 participants were required (348 per group).”