Silvia Gianola

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.

Efficacy of Muscle Exercise in Patients with Muscular Dystrophy: A Systematic Review Showing a Missed Opportunity to Improve Outcomes

Background Although muscular dystrophy causes muscle weakness and muscle loss, the role of exercise in the management of this disease remains controversial. Objective The purpose of this systematic review is to evaluate the role of exercise interventions on muscle strength in patients with muscular dystrophy. Methods We performed systematic electronic searches in Medline, Embase, Web of Science, Scopus and Pedro as well as a list of reference literature. We included trials assessing muscle exercise in patients with muscular dystrophy. Two reviewers independently abstracted data and appraised risk of bias. Results We identified five small (two controlled and three randomized clinical) trials comprising 242 patients and two ongoing randomized controlled trials. We were able to perform two meta-analyses. We found an absence of evidence for a difference in muscle strength (MD 4.18, 95% CIs - 2.03 to 10.39; p = 0.91) and in endurance (MD −0.53, 95% CIs –1.11 to 0.05; p = 0.26). In both, the direction of effects favored muscle exercise. Conclusions The first included trial about the efficacy of muscular exercise was published in 1978. Even though some benefits of muscle exercise were consistently reported across studies, the benefits might be due to the small size of studies and other biases. Detrimental effects are still possible. After several decades of research, doctors cannot give advice and patients are, thus, denied basic information. A multi-center randomized trial investigating the strength of muscles, fatigue, and functional limitations is needed.

Epidemiologic evidence of slow growing, nonprogressive or regressive breast cancer: A systematic review

The general aim of this systematic review is to mitigate breast cancer (BC) overdiagnosis and overtreatment. The specific aim is to summarize available data on the occurrence and features of indolent invasive or in situ (DCIS) BC, and precisely survival of untreated cases, prevalence of occult cancers found in autopsies, frequency of regressive BC. PubMed, Embase and Cochrane Library were systematically searched up to 3/31/2014. Eligibility criteria were: cohort studies, case‐control studies, uncontrolled case series assessing survival in women with a diagnosis of BC who did not receive treatment compared to treated women; case series of autopsies estimating the prevalence of undiagnosed BC; cohort studies, case‐control studies, uncontrolled case series, case reports assessing the occurrence of spontaneous regression of BC in women with a confirmed histology diagnosis. Untreated BC: 8 cohort studies and 12 case series (3593 BC) were included. In three controlled cohort studies (diagnoses 1978–2006), the 5‐years overall survival was 19–43%. Occult BC: 8 case series (2279 autopsies) were included. The prevalence of invasive BC undiagnosed during lifetime range was 0–1.5%, while for DCIS the range was 0.2–14.7%. Spontaneous regression: 2 cohort studies, 3 case reports, 1 case series included. In the cohort studies the relative risk of regression for screen detected compared with nonscreened BC was estimated as 1.2 and 1.1. It seems plausible that around 10% of invasive BC are not symptomatic during life, and that one fith of BC patients if untreated would be alive after 5 years. Around 1 of 10 screen‐detected BC may regress according two studies.

Cognitive-behavioral Treatment for Subacute and Chronic Neck Pain: A Cochrane Review

Study Design. Systematic review of randomized-controlled trials (RCTs). Objective. To assess the effects of cognitive-behavioral therapy (CBT) on neck pain (NP). Summary of Background Data. Although research on nonpharmacological and nonsurgical treatments for NP is progressing, there remains uncertainty about the efficacy of CBT. Methods. We searched electronic databases for RCTs. We included RCTs assessing the use of CBT on adults with subacute and chronic NP. 2 independent reviewers extracted data on pain (primary outcome), disability, psychological indicator, and quality of life. We calculated standardized mean differences and 95% confidence intervals. We used the Cochrane Collaborations tool to assess risk of bias and the GRADE approach to evaluate the quality of evidence and summarize conclusions. Results. We included 10 studies (836 participants), 4 at low risk of bias. With regard to chronic NP, there was low quality evidence that CBT was better than no treatment for improving pain, disability, and quality of life, whereas no effect was found on kinesiophobia. The clinical importance of these benefits is uncertain. When comparing both CBT to other interventions and CBT in addition to another intervention to the other intervention alone, no difference was found for pain and disability, whereas a positive effect was achieved for kinesiophobia only when comparing CBT with other interventions. On subacute NP, CBT was found to be better than other interventions for pain, whereas no difference was found for secondary outcomes. Conclusion. CBT was shown to induce changes on pain and disability for chronic NP only when compared with no treatment. On subacute NP, benefit was found on pain relief but not on disability when comparing CBT with other interventions. However, none of these effects were clinically meaningful. Due to the low quality of the evidence, our conclusions might change over time whereas new data are available. Level of Evidence: 1

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.

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: trial sequential analysis applied to Cochrane collaboration systematic review results

BackgroundTrial 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.MethodsWe 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.ResultsWe 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).ConclusionsAlthough 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.

Improving Power and Sample Size Calculation in Rehabilitation Trial Reports: A Methodological Assessment

OBJECTIVE To systematically assess the reporting of sample size calculation in randomized controlled trials (RCTs) on rehabilitation interventions for mechanical low back pain. DATA SOURCES The Cochrane Database of Systematic Reviews was searched through February 2015. STUDY SELECTION We conducted an electronic database search for RCTs published from January 1, 1968 to February 28, 2015 and included in the Cochrane Systematic Reviews. DATA EXTRACTION Two investigators independently used an ad hoc 6-item checklist derived from the Consolidated Standards of Reporting Trials (CONSORT) 2010 statement recommendations to extract data on sample size calculation. The primary outcome was the proportion of RCTs that reported sample size calculation; the secondary outcome was the completeness of sample size analysis reporting. We also evaluated improvement in reporting of sample size calculation over time. DATA SYNTHESIS Sample size calculation was reported in 80 (36.0%) of the 222 eligible RCTs included in 14 Cochrane Systematic Reviews. Only 13 (16.3%) of these RCT reports gave a complete description, and about half reported ≥4 of the 6 elements of sample size calculation (median, 4; interquartile range, 3-5). Completeness of reporting of sample size calculation improved from 1968 to 2013; since 2005, the number of RCTs reporting sample size calculation has increased compared with the number of RCTs not reporting it. CONCLUSIONS Despite improvement, reporting of sample size calculation and power analysis remains inadequate, limiting the readers ability to assess the quality and accuracy of rehabilitation studies.

Mechanical Low Back Pain: Secular Trend and Intervention Topics of Randomized Controlled Trials

PURPOSE To evaluate the number of published randomized controlled trials (RCTs) focusing on mechanical low back pain (MLBP) rehabilitation, the secular (i.e., long-term) trend, and the distribution of interventions studied. METHODS All included RCTs were extracted from all Cochrane systematic reviews focusing on rehabilitation therapies for MLBP, and two independent reviewers screened and analyzed the information on interventions. RESULTS After removal of duplicates, the data set consisted of 196 RCTs published between 1961 and 2010. The number of RCTs published increased consistently over time: 2 trials (1% of the total) were published in 1961-1970, 10 (5%) in 1971-1980, 41 (21%) in 1981-1990, 68 (35%) in 1991-2000, and 75 (38%) in 2001-2010. The intervention of interest in the majority of RCTs was exercise therapy (115/399; 29%), followed by spinal manipulation therapies (60/399; 15%). CONCLUSION The number of RCTs focusing on MLBP has risen over time; of all interventions studied, exercise therapy has attracted the most research interest.

Effectiveness of Trigger Point Manual Treatment on the Frequency, Intensity, and Duration of Attacks in Primary Headaches: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Background A variety of interventions has been proposed for symptomatology relief in primary headaches. Among these, manual trigger points (TrPs) treatment gains popularity, but its effects have not been investigated yet. Objective The aim was to establish the effectiveness of manual TrP compared to minimal active or no active interventions in terms of frequency, intensity, and duration of attacks in adult people with primary headaches. Methods We searched MEDLINE, COCHRANE, Web Of Science, and PEDro databases up to November 2017 for randomized controlled trials (RCTs). Two independent reviewers appraised the risk-of-bias (RoB) and the grading of recommendations, assessment, development, and evaluation (GRADE) to evaluate the overall quality of evidence. Results Seven RCTs that compared manual treatment vs minimal active intervention were included: 5 focused on tension-type headache (TTH) and 2 on Migraine (MH); 3 out of 7 RCTs had high RoB. Combined TTH and MH results show statistically significant reduction for all outcomes after treatment compared to controls, but the level of evidence was very low. Subgroup analysis showed a statistically significant reduction in attack frequency (no. of attacks per month) after treatment in TTH (MD −3.50; 95% CI from −4.91 to −2.09; 4 RCTs) and in MH (MD −1.92; 95% CI from −3.03 to −0.80; 2 RCTs). Pain intensity (0–100 scale) was reduced in TTH (MD −12.83; 95% CI from −19.49 to −6.17; 4 RCTs) and in MH (MD −13.60; 95% CI from −19.54 to −7.66; 2RCTs). Duration of attacks (hours) was reduced in TTH (MD −0.51; 95% CI from −0.97 to −0.04; 2 RCTs) and in MH (MD −10.68; 95% CI from −14.41 to −6.95; 1 RCT). Conclusion Manual TrPs treatment of head and neck muscles may reduce frequency, intensity, and duration of attacks in TTH and MH, but the quality of evidence according to GRADE approach was very low for the presence of few studies, high RoB, and imprecision of results.