Completeness of Outcomes Description Reported in Low Back Pain Rehabilitation Interventions: A Survey of 185 Randomized Trials

Abstract

Purpose: To assess reporting completeness of the most frequent outcome measures used in randomized controlled trials (RCTs) of rehabilitation interventions for mechanical low back pain. Methods: We performed a cross-sectional study of RCTs included in all Cochrane systematic reviews (SRs) published up to May 2013. Two authors independently evaluated the type and frequency of each outcome measure reported, the methods used to measure outcomes, the completeness of outcome reporting using a eight-item checklist, and the proportion of outcomes fully replicable by an independent assessor. Results: Our literature search identified 11 SRs, including 185 RCTs. Thirty-six different outcomes were investigated across all RCTs. The 2 most commonly reported outcomes were pain (n=165 RCTs; 89.2%) and disability (n=118 RCTs; 63.8%), which were assessed by 66 and 44 measurement tools, respectively. Pain and disability outcomes were found replicable in only 10.3% (n=17) and 10.2% (n=12) of the RCTs, respectively. Only 40 RCTs (21.6%) distinguished between primary and secondary outcomes. Conclusions: A large number of outcome measures and a myriad of measurement instruments were used across all RCTs. The reporting was largely incomplete, suggesting an opportunity for a standardized approach to reporting in rehabilitation science.

Estimates of the mean difference in orthopaedic randomized trials: obligatory yet obscure

“…The true nature of many of the continuous outcomes, such as physical ability to function, cannot have clear ceiling values, even if the PROMs can. Other methods exist, and are outside the scope of this article, that are needed to enhance the validity and reporting of the PROM results are in example [ 29 ]; blinded outcome assessment when feasible, focus on what were the comparisons and circumstances in the validation studies of the PROMs and evaluate how the trial population fits to it, reporting outcome assessment methods and reference validation studies appropriately.…”

Core outcome measurement instruments for clinical trials in nonspecific low back pain

“…A consensus procedure is recommended to find an agreement on core outcome measurement instruments. 7 , 92 An online modified Delphi survey was chosen as it is a widely used method to establish a consensus on various health- and research-related issues 47 , 63 , 74 , 85 , 105 ; allows participation of a broad, international, and multistakeholder panel of ‘experts’; enables reconsideration of participants' views based on responses from others; and preserves anonymity among respondents. 51 , 98 Authors of at least 2 publications comprising psychometric or clinimetric studies, randomized clinical trials, or systematic reviews of clinical trials in patients with nsLBP were selected to participate.…”

Effectiveness of treatments for acute and sub-acute mechanical non-specific low back pain: protocol for a systematic review and network meta-analysis

“…This is a common problem of complex non-pharmacological interventions [55, 56]. Potential issues of the proposed review include high clinical heterogeneity, poor quality of reporting of the included trials, and difficulty in interpreting measures of effect when the pooled estimates come from trials that measured the outcome using different measurement tools [35, 57]. Another plausible limitation, solely concerning the network meta-analysis, might be the lack of available treatment comparisons to build robust nodes.…”