"Spin" in wound care research

NewsBot · Nov 8, 2013

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"Spin" in wound care research: the reporting and interpretation of randomized controlled trials with statistically non-significant primary outcome results or unspecified primary outcomes.
Lockyer S, Hodgson R, Dumville JC, Cullum N.
Trials. 2013 Nov 6;14(1):371.

BACKGROUND:
Spin in the reporting of randomized controlled trials, where authors report research in a way that potentially misrepresents results and mislead readers, has been demonstrated in the broader medical literature. We investigated spin in wound care trials with (a) no statistically significant result for the primary outcome and (b) no clearly specified primary outcome.
METHODS:
We searched the Cochrane Wounds Group Specialised Register of Trials for randomized controlled trials (RCTs). Eligible studies were: Parallel-group RCTs of interventions for foot, leg or pressure ulcers published in 2004 to 2009 (inclusive) with either a clearly identified primary outcome for which there was a statistically non-significant result (Cohort A) or studies that had no clear primary outcome (Cohort B).We extracted general study details. For both Cohorts A and B we then assessed for the presence of spin. For Cohort A we used a pre-defined process to assess reports for spin. For Cohort B we aimed to assess spin by recording the number of positive treatment effect claims made. We also compared the number of statistically significant and non-significant results reported in the main text and the abstract looking specifically for spin in the form of selective outcome reporting.
RESULTS:
Of the 71 eligible studies, 28 were eligible for Cohort A; of these, 71% (20/28) contained spin. Cohort B contained 43 studies; of these, 86% (37/43) had abstracts that claimed a favorable treatment claim. Whilst 74% (32/43) of main text results in Cohort B included at least one statistically non-significant result, this was not reflected in the abstract where only 28% contained (12/43) at least one statistically non-significant result.
CONCLUSIONS:
Spin is a frequent phenomenon in reports of RCTs of wound treatments. Studies without statistically significant results for the primary outcome used spin in 71% of cases. Furthermore, 33% (43/132) of reports of wound RCTs did not specify a primary outcome and there was evidence of spin and selective outcome reporting in the abstracts of these. Readers should be wary of only reading the abstracts of reports of RCTs of wound treatments since they are frequently misleading regarding treatment effects.
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Admin2 · Nov 8, 2013

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Why is it so hard to do the right thing in wound care?

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Identification and Content Validation of Wound Therapy Clinical Endpoints Relevant to Clinical Practice and Patient Values for FDA Approval. Part 1. Survey of the Wound Care Community.
Driver VR et al
Wound Repair Regen. 2017 Apr 3. doi: 10.1111/wrr.12533

Wounds that exhibit delayed healing add extraordinary clinical, economic, and personal burdens to patients, as well as to increasing financial costs to health systems. New interventions designed to ease such burdens for patients with cancer, renal, or ophthalmologic conditions are often cleared for approval by the US Food and Drug Administration (FDA) using multiple endpoints but the requirement of complete healing as a primary endpoint for wound products impedes FDA clearance of interventions that can provide other clinical or patient-centered benefits for persons with wounds. A multidisciplinary group of wound experts undertook an initiative, in collaboration with the FDA, to identify and content validate supporting FDA criteria for qualifying wound endpoints relevant to clinical practice (CP) and patient-centered outcomes (PCO) as primary outcomes in clinical trials. As part of the initiative, a research study was conducted involving 628 multidisciplinary expert wound clinicians and researchers from 4 different groups: the interdisciplinary core advisory team; attendees of the Spring 2015 Symposium on Advanced Wound Care (SAWC); clinicians employed by a national network of specialty clinics focused on comprehensive wound care; and Association for the Advancement of Wound Care (AAWC) and Wound Healing Society (WHS) members who had not previously completed the survey. The on-line survey assessed 28 literature-based wound care endpoints for their relevance and importance to clinical practice and clinical research. Fifteen of the endpoints were evaluated for their relevance to improving quality of life. Twenty-two endpoints had content validity indexes (CVI) ≥ 0.75, and 15 were selected as meriting potential inclusion as additional endpoints for FDA approval of future wound care interventions. This study represents an important first step in identifying and validating new measurable wound care endpoints for clinical research and practice and for regulatory evaluation
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