Dataset Information

Publication language and the estimate of treatment effects of physical therapy on balance and postural control after stroke in meta-analyses of randomised controlled trials.

ABSTRACT: BACKGROUND:Findings regarding the impact of language bias on treatment effect estimates (TEE) are conflicting, and very few studies have assessed these impacts in rehabilitation. The purpose was to compare TEE between studies published in non-English language (SPNEL) and those published in English language (SPEL) included in a previously published meta-analysis assessing the effects of physical therapy on balance and postural control after stroke. METHODS:Six databases were searched until January 2019. Two independent reviewers selected randomised trials, extracted data, and assessed risk of bias. We conducted subgroup meta-analyses according to the language of study publication, then compared TEE between SPEL and SPNEL subgroups by using a random-effects meta-regression model. RESULTS:From 13,123 records, 132 SPEL (n = 5219) and 13 SPNEL (n = 693) were included. SPNEL had a weight in the pooled estimate (8.2%) significantly lower than SPEL (91.8%; p<0.001). Compared to SPEL, SPNEL had both significantly worse methodological quality (p = 0.002) and quality of reporting for blinding of outcome assessment (p<0.001); and a significantly worse quality of reporting for incomplete outcome data (p<0.001). SPNEL had a significantly worse precision (i.e. inverse of variance) of TEE than SPEL (p = 0.005). Overall, the TEE was not significantly different between SPNEL and SPEL (standardised mean difference -0.16, 95% confidence interval [-0.53; 0.22], heterogeneity I2 = 78%). However, when PT was compared to sham treatment or usual care, SPNEL significantly over-estimated treatment effects (SMD -0.68, 95%CI [-1.03; -0.33], I2 = 39%) compared to SPEL. Restriction of the search to SPEL only did not change the direction of TEE for 8 out of 9 comparisons. CONCLUSIONS:SPNEL had a worse methodological quality than SPEL and were likely to over-estimate treatment effect. If inclusion of SPNEL in a systematic review is considered to be relevant, the impact of such studies on TEE should be explored by sensitivity analyses to ensure the findings validity.

SUBMITTER: Hugues A

PROVIDER: S-EPMC7062257 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Publication language and the estimate of treatment effects of physical therapy on balance and postural control after stroke in meta-analyses of randomised controlled trials.

Hugues Aurélien A Di Marco Julie J Bonan Isabelle I Rode Gilles G Cucherat Michel M Gueyffier François F

PloS one 20200309 3

<h4>Background</h4>Findings regarding the impact of language bias on treatment effect estimates (TEE) are conflicting, and very few studies have assessed these impacts in rehabilitation. The purpose was to compare TEE between studies published in non-English language (SPNEL) and those published in English language (SPEL) included in a previously published meta-analysis assessing the effects of physical therapy on balance and postural control after stroke.<h4>Methods</h4>Six databases were search ...[more]

PMID: 32150596

Similar Datasets

Project description:BackgroundPostural balance is an important rehabilitation outcome, and screening stroke patients for confidence in postural balance during rehabilitation and before hospital discharge is recommended. Early supported discharge could improve postural balance self-confidence. This study aimed to investigate associations between patient self-confidence in postural balance and observer-assessed postural balance and anxiety during the first year after stroke. Whether very early supported discharge (VESD) affects self-confidence in postural balance compared with standard discharge was also evaluated.MethodsA longitudinal trial for with data extracted from a randomized controlled study of 140 adults with confirmed stroke was conducted. The experimental group received VESD. The control group was discharged according to the standard routine. Postural balance was assessed with Berg Balance Scale (BBS), Timed Up and Go (TUG) test, and Falls Efficacy Scale. Anxiety was assessed with the Hospital Anxiety and Depression Scale. Spearman's rank correlation coefficient (rho) was used to test associations between independent variables. The Wilcoxon signed-rank test was used to examine differences over time. A single test, according to Eid, Gollwitzer, and Schmidt, was used to test temporal differences in correlation.ResultsThe correlation between self-confidence in postural balance and observer-assessed postural balance was 0.62-0.78 in the first year after stroke. The correlation between self-confidence and anxiety was 0.22-0.41 in the first year after stroke. Correlations did not differ by group affiliation at any time point when the postural balance was assessed with BBS. The intervention group had a significantly higher correlation (r = - 0.709) than the control group (r = - 0.416) when postural balance was assessed with the TUG test 1 month after discharge. There were no significant differences in correlations between confidence in postural balance and anxiety between the two groups at any time point.ConclusionsPatients with mild stroke can accurately assess their confidence in performing daily activities without falling. VESD does not substantially affect the correlation between self-confidence in postural balance and observer assessed postural balance and is safe to use as an alternative to standard discharge. Assessment of self-confidence can provide important information for rehabilitation planning and supporting the physical activity of patients after discharge.Trial registrationClinical Trials.gov: NCT01622205 . Registered 19 June 2012 (retrospectively registered).

Project description:OBJECTIVE:Randomised controlled trials (RCT) are the gold standard to provide unbiased data. However, when patients have a treatment preference, randomisation may influence participation and outcomes (eg, external and internal validity). The aim of this study was to assess the influence of patients' preference in RCTs by analysing partially randomised patient preference trials (RPPT); an RCT and preference cohort combined. DESIGN:Systematic review and meta-analyses. DATA SOURCES:MEDLINE, Embase, PsycINFO and the Cochrane Library. ELIGIBILITY CRITERIA FOR SELECTING STUDIES:RPPTs published between January 2005 and October 2018 reporting on allocation of patients to randomised and preference cohorts were included. DATA EXTRACTION AND SYNTHESIS:Two independent reviewers extracted data. The main outcomes were the difference in external validity (participation and baseline characteristics) and internal validity (lost to follow-up, crossover and the primary outcome) between the randomised and the preference cohort within each RPPT, compared in a meta-regression using a Wald test. Risk of bias was not assessed, as no quality assessment for RPPTs has yet been developed. RESULTS:In total, 117 of 3734 identified articles met screening criteria and 44 were eligible (24 873 patients). The participation rate in RPPTs was >95% in 14 trials (range: 48%-100%) and the randomisation refusal rate was >50% in 26 trials (range: 19%-99%). Higher education, female, older age, race and prior experience with one treatment arm were characteristics of patients declining randomisation. The lost to follow-up and cross-over rate were significantly higher in the randomised cohort compared with the preference cohort. Following the meta-analysis, the reported primary outcomes were comparable between both cohorts of the RPPTs, mean difference 0.093 (95% CI -0.178 to 0.364, p=0.502). CONCLUSIONS:Patients' preference led to a substantial proportion of a specific patient group refusing randomisation, while it did not influence the primary outcome within an RPPT. Therefore, RPPTs could increase external validity without compromising the internal validity compared with RCTs. PROSPERO REGISTRATION NUMBER:CRD42019094438.

Project description:IntroductionPatients with right stroke lesion have postural and balance disorders, including weight-bearing asymmetry, more pronounced than patients with left stroke lesion. Spatial cognition disorders post-stroke, such as misperceptions of subjective straight-ahead and subjective longitudinal body axis, are suspected to be involved in these postural and balance disorders. Prismatic adaptation has showed beneficial effects to reduce visuomotor disorders but also an expansion of effects on cognitive functions, including spatial cognition. Preliminary studies with a low level of evidence have suggested positive effects of prismatic adaptation on weight-bearing asymmetry and balance after stroke. The objective is to investigate the effects of this intervention on balance but also on postural disorders, subjective straight-ahead, longitudinal body axis and autonomy in patients with chronic right stroke lesion.Methods and analysisIn this multicentre randomised double-blind sham-controlled trial, we will include 28 patients aged from 18 to 80 years, with a first right supratentorial stroke lesion at chronic stage (≥12 months) and having a bearing ≥60% of body weight on the right lower limb. Participants will be randomly assigned to the experimental group (performing pointing tasks while wearing glasses shifting optical axis of 10 degrees towards the right side) or to the control group (performing the same procedure while wearing neutral glasses without optical deviation). All participants will receive a 20 min daily session for 2 weeks in addition to conventional rehabilitation. The primary outcome will be the balance measured using the Berg Balance Scale. Secondary outcomes will include weight-bearing asymmetry and parameters of body sway during static posturographic assessments, as well as lateropulsion (measured using the Scale for Contraversive Pushing), subjective straight-ahead, longitudinal body axis and autonomy (measured using the Barthel Index).Ethics and disseminationThe study has been approved by the ethical review board in France. Findings will be submitted to peer-reviewed journals relative to rehabilitation or stroke.Trial registration numberNCT03154138.

Project description:BackgroundIt is still unclear, which physiotherapeutic approaches are most effective in stroke recovery. Vojta therapy is a type of physiotherapy that was originally developed for children and adolescents with cerebral palsy. Vojta therapy has been reported to improve automatic control of body posture. Because acute stroke patients are characterised by a disturbance in the ability to adapt to changes in body position, requiring automatic postural adjustment, we decided to investigate Vojta therapy in the early rehabilitation of stroke patients. Aim of the trial was to test the hypothesis that Vojta therapy - as a new physiotherapeutic approach in early stroke recovery - improves postural control and motor function in patients with acute ischaemic stroke (AIS) or intracerebral haemorrhage (ICH).MethodsThis prospective, randomised controlled trial included patients with imaging-confirmed AIS or ICH, severe hemiparesis and randomly assigned them to Vojta therapy or standard physiotherapy within 72 h after stroke onset. Main exclusion criterion was restricted ability to communicate. Primary endpoint was the improvement of postural control measured by the Trunk Control Test (TCT) on day 9 after admission. Secondary endpoint among others was improvement of arm function (measured with Motor Evaluation Scale for Upper Extremity in Stroke Patients [MESUPES]).ResultsForty patients (20 per group) were randomised into the trial. Median age was 75 (66-80) years, 50% were women. The median improvement in TCT within 9 days was 25.5 points (=25.5%) (interquartile range [IQR] 12.5-42.5) in the Vojta group and 0 (IQR 0-13) in the control group (p = 0.001). Patients treated with Vojta therapy achieved a greater improvement in the MESUPES than patients in the control group (20% vs 10%, p = 0.006).ConclusionThis first randomised controlled trial of Vojta therapy in acute stroke patients demonstrates improvement of postural control through Vojta therapy compared to standard physiotherapy. Although this trial has some methodical weaknesses, Vojta therapy might be a promising approach in early stroke rehabilitation and should be studied in larger trials.Trial registrationClinicalTrials.gov; Unique identifier: NCT03035968. Registered 30 January 2017 - Retrospectively registered; http://www.clinicaltrials.gov.

Project description:BackgroundValid assessment of drug efficacy and safety requires an evidence base free of reporting bias. Using trial reports in Food and Drug Administration (FDA) drug approval packages as a gold standard, we previously found that the published literature inflated the apparent efficacy of antidepressant drugs. The objective of the current study was to determine whether this has improved with recently approved drugs.Methods and findingsUsing medical and statistical reviews in FDA drug approval packages, we identified 30 Phase II/III double-blind placebo-controlled acute monotherapy trials, involving 13,747 patients, of desvenlafaxine, vilazodone, levomilnacipran, and vortioxetine; we then identified corresponding published reports. We compared the data from this newer cohort of antidepressants (approved February 2008 to September 2013) with the previously published dataset on 74 trials of 12 older antidepressants (approved December 1987 to August 2002). Using logistic regression, we examined the effects of trial outcome and trial cohort (newer versus older) on transparent reporting (whether published and FDA conclusions agreed). Among newer antidepressants, transparent publication occurred more with positive (15/15 = 100%) than negative (7/15 = 47%) trials (OR 35.1, CI95% 1.8 to 693). Controlling for trial outcome, transparent publication occurred more with newer than older trials (OR 6.6, CI95% 1.6 to 26.4). Within negative trials, transparent reporting increased from 11% to 47%. We also conducted and contrasted FDA- and journal-based meta-analyses. For newer antidepressants, FDA-based effect size (ESFDA) was 0.24 (CI95% 0.18 to 0.30), while journal-based effect size (ESJournals) was 0.29 (CI95% 0.23 to 0.36). Thus, effect size inflation, presumably due to reporting bias, was 0.05, less than for older antidepressants (0.10). Limitations of this study include a small number of trials and drugs-belonging to a single class-and a focus on efficacy (versus safety).ConclusionsReporting bias persists but appears to have diminished for newer, compared to older, antidepressants. Continued efforts are needed to further improve transparency in the scientific literature.

Project description:BackgroundImpaired balance regulation after stroke puts patients and therapists at risk of injury during rehabilitation. Body weight support systems (BWSSs) minimize this risk and allow patients to safely practice balance activities during therapy. Treadmill-based balance perturbation systems with BWSSs are known to improve balance in patients with age- or disease-related impairments. However, these stationary systems are unable to accommodate complex exercises that require more freedom of movement.ObjectiveThis study aims to evaluate the effect of a new balance perturbation module, which is directly integrated into a track-mounted BWSS, on balance impairments secondary to acute stroke.MethodsThis unblinded quasi-randomized controlled preliminary study was conducted in a rehabilitation-focused long-term acute care hospital. Participants were recruited from stroke rehabilitation inpatients with an admission Berg Balance Scale (BBS) score of 21 (out of 56) or greater. Over a 2-week period, consented participants completed 8 BWSS or BWSS with perturbation (BWSS-P) treatment sessions; study activities were incorporated into regular treatment to avoid disruption of their normal care. Although both groups conducted the same balance and gait activities during their treatment sessions, the BWSS-P sessions included lateral, anterior, and posterior balance perturbations. Pre- and postintervention BBS and Activities-Specific Balance Confidence (ABC) assessments were the primary outcome measures collected. Institutional BBS data from the year before installation of the track-mounted BWSS were retrospectively included as a post hoc historical standard of care comparison.ResultsThe improved postintervention BBS and ABC assessment scores showed that all participants benefited from therapy (P<.001 for all pre- and postintervention comparisons). The average BBS percent change for the BWSS-P sample (n=14) was 66.95% (SD 43.78%) and that for the BWSS control sample (n=15) was 53.29% (SD 24.13%). These values were greater than those for the standard of care group (n=30; mean 28.31%, SD 17.25%; P=.02 and P=.005 respectively), with no difference among the BWSS groups (P=.67). ABC score changes were also similar among the preintervention and postintervention BWSS groups (P=.94 and P=.92, respectively).ConclusionsBoth BWSS groups demonstrated similar BBS and ABC score improvements, indicating that balance perturbations were not detrimental to postacute stroke rehabilitation and were safe to use. These data provide strong rationale and baseline data for conducting a larger follow-up study to further assess if this new perturbation system provides additional benefit to the rehabilitation of gait and balance impairments following stroke.Trial registrationClinicalTrials.gov NCT04919161; https://clinicaltrials.gov/ct2/show/NCT04919161.

Dataset Information

Publication language and the estimate of treatment effects of physical therapy on balance and postural control after stroke in meta-analyses of randomised controlled trials.

Publications

Publication language and the estimate of treatment effects of physical therapy on balance and postural control after stroke in meta-analyses of randomised controlled trials.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets