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

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.

Objectif : évaluer l'exhaustivité des déclarations en ce qui concerne les mesures de résultats utilisées le plus fréquemment dans les essais cliniques randomisés (ECR) portant sur les interventions en réadaptation pour les douleurs chroniques au bas du dos. Méthodes : nous avons mené une étude transversale des ECR inclus dans toutes les revues systématiques Cochrane publiées jusqu'en mai 2013. Deux auteurs ont indépendamment évalué : la nature et la fréquence de chacune des mesures de résultats rapportées, les méthodes utilisées pour effectuer ces mesures, l'exhaustivité des déclarations de résultats (à l'aide d'une liste de contrôle en 8 points) et la proportion des résultats qui peuvent être complètement reproduits par un évaluateur indépendant. Résultats : notre recension de la littérature a identifié 11 revues systématiques comprenant un total de 185 ECR. Trente-six résultats différents ont été étudiés dans l'ensemble des essais cliniques. Les deux résultats les plus fréquemment rapportés étaient la douleur (n=164 ECR; 89,2%) et l'incapacité (n=118; 63,8%), qui ont été évalués respectivement par 66 et 44 instruments de mesure. Les résultats relatifs à la douleur et à l'incapacité se sont avérés reproductibles dans seulement 10,3% (n=17) et 10,2% (n=12), respectivement, des essais cliniques. Seuls 40 (21,6%) des ECR ont fait la distinction entre le résultat principal et les résultats secondaires. Conclusion : un grand nombre de mesures de résultats et d'instruments de mesure ont été utilisés dans l'ensemble des ECR. Les déclarations sont pour la plupart incomplètes; il pourrait y avoir là une occasion de mettre au point une approche standardisée pour la communication des résultats en science de la réadaptation.

Reporting of Rehabilitation Intervention for Low Back Pain in Randomized Controlled Trials: Is the Treatment Fully Replicable?

STUDY DESIGN: Methodological review of randomized controlled trials (RCTs). OBJECTIVE: To assess the quality of reporting of rehabilitation interventions for mechanical low back pain (LBP) in published RCTs. SUMMARY OF BACKGROUND DATA: Reporting of interventions in RCTs often focused on the outcome value and failed to describe interventions adequately. METHODS: We systematically searched for all RCTs in Cochrane systematic reviews on LBP published in the Cochrane Database of Systematic Reviews until December 2013. The description of rehabilitation interventions of each RCT was evaluated independently by 2 of the investigators, using an ad hoc checklist of 7 items. The primary outcome was the number of items reported in sufficient details to be replicable in a new RCT or in everyday practice. RESULTS: We found 11 systematic reviews, including 220 eligible RCTs, on LBP. Of those, 185 RCTs were included. The median publication year was 1998 (I-III quartiles, 1990 to 2004). The most reported items were the characteristics of participants (91.3%; 95% confidence interval [CI], 87.3-95.4), the intervention providers (81.1%; 95% CI, 75.4-86.7), and the intervention schedule (69.7%; 95% CI, 63-76). Based on the description of the intervention, less than one fifth would be replicable clinically. The proportion of trials providing all essential information about the participants and interventions increased from 14% (n = 7) in 1971 to 1980 to 20% (n = 75) in 2001 to 2010. CONCLUSION: Despite the remarkable amount of energy spent producing RCTs in LBP rehabilitation, the majority of RCTs failed to report sufficient information that would allow the intervention to be replicated in clinical practice. Improving the quality of intervention description is urgently needed to better transfer research into rehabilitation practices. LEVEL OF EVIDENCE: 1.