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.

Constraint-induced movement therapy for upper extremities in people with stroke.

BACKGROUND: In people who have had a stroke, upper limb paresis affects many activities of daily life. Reducing disability is therefore a major aim of rehabilitative interventions. Despite preserving or recovering movement ability after stroke, sometimes people do not fully realise this ability in their everyday activities. Constraint-induced movement therapy (CIMT) is an approach to stroke rehabilitation that involves the forced use and massed practice of the affected arm by restraining the unaffected arm. This has been proposed as a useful tool for recovering abilities in everyday activities. OBJECTIVES: To assess the efficacy of CIMT, modified CIMT (mCIMT), or forced use (FU) for arm management in people with hemiparesis after stroke. SEARCH METHODS: We searched the Cochrane Stroke Group trials register (last searched June 2015), the Cochrane Central Register of Controlled Trials (CENTRAL; The Cochrane Library Issue 1, 2015), MEDLINE (1966 to January 2015), EMBASE (1980 to January 2015), CINAHL (1982 to January 2015), and the Physiotherapy Evidence Database (PEDro; January 2015). SELECTION CRITERIA: Randomised control trials (RCTs) and quasi-RCTs comparing CIMT, mCIMT or FU with other rehabilitative techniques, or none. DATA COLLECTION AND ANALYSIS: One author identified trials from the results of the electronic searches according to the inclusion and exclusion criteria, three review authors independently assessed methodological quality and risk of bias, and extracted data. The primary outcome was disability. MAIN RESULTS: We included 42 studies involving 1453 participants. The trials included participants who had some residual motor power of the paretic arm, the potential for further motor recovery and with limited pain or spasticity, but tended to use the limb little, if at all. The majority of studies were underpowered (median number of included participants was 29) and we cannot rule out small-trial bias. Eleven trials (344 participants) assessed disability immediately after the intervention, indicating a non-significant standard mean difference (SMD) 0.24 (95% confidence interval (CI) -0.05 to 0.52) favouring CIMT compared with conventional treatment. For the most frequently reported outcome, arm motor function (28 studies involving 858 participants), the SMD was 0.34 (95% CI 0.12 to 0.55) showing a significant effect (P value 0.004) in favour of CIMT. Three studies involving 125 participants explored disability after a few months of follow-up and found no significant difference, SMD -0.20 (95% CI -0.57 to 0.16) in favour of conventional treatment. AUTHORS' CONCLUSIONS: CIMT is a multi-faceted intervention where restriction of the less affected limb is accompanied by increased exercise tailored to the person's capacity. We found that CIMT was associated with limited improvements in motor impairment and motor function, but that these benefits did not convincingly reduce disability. This differs from the result of our previous meta-analysis where there was a suggestion that CIMT might be superior to traditional rehabilitation. Information about the long-term effects of CIMT is scarce. Further trials studying the relationship between participant characteristics and improved outcomes are required.

Constraint-induced movement therapy: trial sequential analysis applied to Cochrane collaboration systematic review results.

BACKGROUND: Trial sequential analysis (TSA) may establish when firm evidence about the efficacy of interventions is reached in a cumulative meta-analysis, combining a required information size with adjusted thresholds for conservative statistical significance. Our aim was to demonstrate TSA results on randomized controlled trials (RCTs) included in a Cochrane systematic review on the effectiveness of constraint-induced movement therapy (CIMT) for stroke patients. METHODS: We extracted data on the functional independence measure (FIM) and the action research arm test (ARAT) from RCTs that compared CIMT versus other rehabilitative techniques. Mean differences (MD) were analyzed using a random-effects model. We calculated the information size and the cumulative Z-statistic, applying the O'Brien-Fleming monitoring boundaries. RESULTS: We included data from 14 RCTs. In the conventional meta-analysis (seven trials, 233 patients), the effect of CIMT on FIM was reported as significant (MD 2.88, 95% CI 0.08 to 5.68; P = 0.04). The diversity-adjusted required information size was 142 patients, and the cumulative Z-score did not cross the trial sequential monitoring boundary for benefit (adjusted 95% CI -0.02 to 5.78). The effect of CIMT on ARAT (nine trials, 199 patients) was reported as significant (MD 7.78, 95% CI 1.19 to 14.37; P = 0.02). However, the diversity-adjusted required information size was 252 patients, and the Z-score did not cross the trial sequential monitoring boundary for benefit (adjusted 95% CI -0.06 to 15.62). CONCLUSIONS: Although conventional meta-analyses of CIMT reached statistical significance, their overall results remain inconclusive and might be spurious. Researchers should not be overconfident on CIMT efficacy based on the results of meta-analyses and derived recommendations.

Survey of the reporting characteristics of systematic reviews in rehabilitation.

BACKGROUND: Systematic reviews (SRs) have become increasingly important for informing clinical practice; however, little is known about the reporting characteristics and the quality of the SRs relevant to the practice of rehabilitation health professionals. OBJECTIVE: The purpose of this study was to examine the reporting quality of a representative sample of published SRs on rehabilitation, focusing on the descriptive, reporting, and bias-related characteristics. METHODS: A cross-sectional study was conducted by searching MEDLINE for aggregative and configurative SRs indexed in 2011 that focused on rehabilitation as restorative of functional limitations. Two reviewers independently screened and selected the SRs and extracted data using a 38-item data collection form derived from Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). The data were analyzed descriptively. RESULTS: Eighty-eight SRs published in 59 journals were sampled. The median compliance with the PRISMA items was 17 (63%) out of 27 items (interquartile ratio=13-22 [48%-82%]). Two thirds of the SRs (n=66) focused on interventions for which efficacy is best addressed through a randomized controlled trial (RCT) design, and almost all of these SRs included RCTs (63/66 [95%]). More than two thirds of the SRs assessed the quality of primary studies (74/88 [84%]). Twenty-eight reviews (28/88 [32%]) meta-analyzed the results for at least one outcome. One half of the SRs reported positive statistically significant findings (46%), whereas a detrimental result was present only in one review. CONCLUSIONS: This sample of SRs in the rehabilitation field showed heterogeneous characteristics and a moderate quality of reporting. Poor control of potential source of bias might be improved if more widely agreed-upon evidence-based reporting guidelines will be actively endorsed and adhered to by authors and journals.

Constraint-induced movement therapy for upper extremities in stroke patients.

BACKGROUND: In stroke patients, upper limb paresis affects many activities of daily life. Reducing disability is therefore a major aim of rehabilitation programmes for hemiparetic patients. Constraint-induced movement therapy (CIMT) is a current approach to stroke rehabilitation that implies the forced use and the massed practice of the affected arm by restraining the unaffected arm. OBJECTIVES: To assess the efficacy of CIMT, modified CIMT (mCIMT), or forced use (FU) for arm management in hemiparetic patients. SEARCH STRATEGY: We searched the Cochrane Stroke Group trials register (last searched June 2008), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 1, 2008), MEDLINE (1966 to June 2008), EMBASE (1980 to June 2008), CINAHL (1982 to June 2008), and the Physiotherapy Evidence Database (PEDro) (June 2008). SELECTION CRITERIA: Randomised control trials (RCTs) and quasi-RCTs (qRCTs) comparing CIMT, mCIMT or FU with other rehabilitative techniques, or none. DATA COLLECTION AND ANALYSIS: Two review authors independently classified the identified trials according to the inclusion and exclusion criteria, assessed methodological quality and extracted data. The primary outcome was disability. MAIN RESULTS: We included 19 studies involving 619 participants. The trials included participants who had some residual motor power of the paretic arm, the potential for further motor recovery and with limited pain or spasticity, but tended to use the limb little if at all. Only five studies had adequate allocation concealment. The majority of studies were underpowered (median number of included patients was 15) and we cannot rule out small-trial bias. Six trials (184 patients) assessed disability immediately after the intervention, indicating a significant standard mean difference (SMD) of 0.36, 95% confidence interval (CI) 0.06 to 0.65. For the most frequently reported outcome, arm motor function (11 studies involving 373 patients), the SMD was 0.72 (95% CI 0.32 to 1.12). There were only two studies that explored disability improvement after a few months of follow up and found no significant difference, SMD -0.07 (95% CI -0.53 to 0.40). AUTHORS' CONCLUSIONS: CIMT is a multifaceted intervention: the restriction to the normal limb is accompanied by a certain amount of exercise of the appropriate quality. It is associated with a moderate reduction in disability assessed at the end of the treatment period. However, for disability measured some months after the end of treatment, there was no evidence of persisting benefit. Further randomised trials, with larger sample sizes and longer follow up, are justified.