scholarly journals Recruitment and retention rates in randomised controlled trials of exercise therapy in people with multimorbidity: a systematic review and meta-analysis

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Lasse K. Harris ◽  
Søren T. Skou ◽  
Carsten B. Juhl ◽  
Madalina Jäger ◽  
Alessio Bricca

Abstract Aim To quantify recruitment, retention and differential retention rates and associated trial, participant and intervention characteristics in randomised controlled trials (RCTs) evaluating the effect of exercise therapy in people with multimorbidity. Data sources MEDLINE, EMBASE, CINAHL and CENTRAL from 1990 to April 20, 2020. Study selection RCTs including people with multimorbidity comparing exercise therapy with a non-exposed comparator group reporting at least one of the following outcomes: physical function, health-related quality of life, depression symptoms, or anxiety symptoms. Data extraction and synthesis Recruitment rates (proportion of people randomised/proportion of people eligible), retention rates (proportion of people providing the outcomes of interest/proportion randomised) and differential retention rates (difference in proportion of people providing the outcomes in the intervention group and comparator group) were calculated. Meta-analysis using a random-effects model was used to estimate pooled proportions. Methodological quality was assessed using Cochrane ´Risk of Bias tool 2.0´ for individual studies, and the GRADE approach was used to assess the overall quality of the evidence. Results Twenty-three RCTs with 3363 people were included. The pooled prevalence for recruitment rate was 75% (95%CI 66 to 84%). The pooled prevalence for retention rate was 90% (95%CI 86 to 94%) at the end of the intervention (12 weeks; interquartile range (IQR) (12 to 12)). Meta-regression analyses showed that increasing age and including a higher proportion of people with hypertension was associated with lower retention rates. Retention rates did not differ between the intervention and comparator groups. The overall quality of the evidence was deemed very low. Conclusion Three in four eligible people with multimorbidity were randomised to RCTs using exercise therapy, of which nine out of 10 provided end of treatment outcomes with no difference seen between the intervention and comparison groups. However, the results must be interpreted with caution due to large differences between the included studies. Trial registration ClinicalTrials.govCRD42020161329. Registered on 28 April 2020.

2016 ◽  
Vol 34 (5) ◽  
pp. 342-348 ◽  
Author(s):  
Min Deng ◽  
Xu-Feng Wang

Objective Mild cognitive impairment (MCI) is a pre-dementia state; 5–10% of cases per year will evolve into dementia. MCI can be amnestic (AMCI) or non-amnestic. AMCI is associated with a higher risk of progression. In recent years, interest in acupuncture as a potential treatment for AMCI has grown. The aim of this meta-analysis was to estimate the clinical effectiveness and safety of acupuncture for AMCI. Methods Randomised controlled trials (RCTs) of acupuncture versus medical treatment for AMCI were identified using the following databases from inception to July 2015: PubMed; Medline; CENTRAL; Chinese Scientific Journal Database; The Chinese Acupuncture Trials Register; China National Knowledge Infrastructure (CNKI); and Wanfang database. Data were extracted from RCTs meeting the inclusive criteria according to Cochrane methods. Meta-analyses were conducted using Rev Man V.5.3 software. Results Five trials involving 568 subjects were included. Meta-analysis showed that participants receiving acupuncture had better outcomes than those receiving nimodipine with greater clinical efficacy rates (odds ratio (OR) 1.78, 95% CI 1.19 to 2.65; p<0.01), mini-mental state examination (MMSE) scores (mean difference (MD) 0.99, 95% CI 0.71 to 1.28; p<0.01), and picture recognition score (MD 2.12, 95% CI 1.48 to 2.75; p<0.01). Meta-analysis also showed acupuncture in conjunction with nimodipine significantly improved MMSE scores (MD 1.09, 95% CI 0.29 to 1.89; p<0.01) compared to nimodipine alone. Three trials reported adverse events. Methodological quality of the included studies was judged to be generally poor. Conclusions Acupuncture appears effective for AMCI when used as an alternative or adjunctive treatment; however, caution must be exercised given the low methodological quality of included trials. Further, more rigorously designed studies are needed.


2019 ◽  
Vol 54 (18) ◽  
pp. 1073-1080 ◽  
Author(s):  
Andre Niemeijer ◽  
Hans Lund ◽  
Signe Nilssen Stafne ◽  
Thomas Ipsen ◽  
Cathrine Luhaäär Goldschmidt ◽  
...  

ObjectiveTo evaluate the relative risk (RR) of serious and non-serious adverse events in patients treated with exercise therapy compared with those in a non-exercising control group.DesignSystematic review and meta-analysis.Data sourcesPrimary studies were identified based on The Cochrane Database of Systematic Reviews investigating the effect of exercise therapy.Eligibility criteriaAt least two of the authors independently evaluated all identified reviews and primary studies. Randomised controlled trials were included if they compared any exercise therapy intervention with a non-exercising control. Two authors independently extracted data. The RR of serious and non-serious adverse events was estimated separately.Results180 Cochrane reviews were included and from these, 773 primary studies were identified. Of these, 378 studies (n=38 368 participants) reported serious adverse events and 375 studies (n=38 517 participants) reported non-serious adverse events. We found no increase in risk of serious adverse events (RR=0.96 (95%CI 0.90 to 1.02, I2: 0.0%) due to exercise therapy. There was, however, an increase in non-serious adverse events (RR=1.19 (95%CI 1.09 to 1.30, I2: 0.0%). The number needed to treat for an additional harmful outcome for non-serious adverse events was 6 [95%CI 4 to 11).ConclusionParticipating in an exercise intervention increased the relative risk of non-serious adverse events, but not of serious adverse events. Exercise therapy may therefore be recommended as a relatively safe intervention.PROSPERO registration numberCRD42014014819.


2017 ◽  
Vol 48 (7) ◽  
pp. 1068-1083 ◽  
Author(s):  
A. P. Bailey ◽  
S. E. Hetrick ◽  
S. Rosenbaum ◽  
R. Purcell ◽  
A. G. Parker

AbstractWe aimed to establish the treatment effect of physical activity for depression in young people through meta-analysis. Four databases were searched to September 2016 for randomised controlled trials of physical activity interventions for adolescents and young adults, 12–25 years, experiencing a diagnosis or threshold symptoms of depression. Random-effects meta-analysis was used to estimate the standardised mean difference (SMD) between physical activity and control conditions. Subgroup analysis and meta-regression investigated potential treatment effect modifiers. Acceptability was estimated using dropout. Trials were assessed against risk of bias domains and overall quality of evidence was assessed using GRADE criteria. Seventeen trials were eligible and 16 provided data from 771 participants showing a large effect of physical activity on depression symptoms compared to controls (SMD = −0.82, 95% CI = −1.02 to −0.61, p < 0.05, I2 = 38%). The effect remained robust in trials with clinical samples (k = 5, SMD = −0.72, 95% CI = −1.15 to −0.30), and in trials using attention/activity placebo controls (k = 7, SMD = −0.82, 95% CI = −1.05 to −0.59). Dropout was 11% across physical activity arms and equivalent in controls (k = 12, RD = −0.01, 95% CI = −0.04 to 0.03, p = 0.70). However, the quality of RCT-level evidence contributing to the primary analysis was downgraded two levels to LOW (trial-level risk of bias, suspected publication bias), suggesting uncertainty in the size of effect and caution in its interpretation. While physical activity appears to be a promising and acceptable intervention for adolescents and young adults experiencing depression, robust clinical effectiveness trials that minimise risk of bias are required to increase confidence in the current finding. The specific intervention characteristics required to improve depression remain unclear, however best candidates given current evidence may include, but are not limited to, supervised, aerobic-based activity of moderate-to-vigorous intensity, engaged in multiple times per week over eight or more weeks. Further research is needed. (Registration: PROSPERO-CRD 42015024388).


2021 ◽  
pp. bmjspcare-2021-003135
Author(s):  
Chao-Ming Hung ◽  
Bing-Yan Zeng ◽  
Bing-Syuan Zeng ◽  
Cheuk-Kwan Sun ◽  
Yu-Shian Cheng ◽  
...  

BackgroundModerate-to-severe cancer-related fatigue occurs in 45% of patients with cancer and interferes with many aspects of quality of life. Although physical exercise has level 1 evidence for improvement of cancer-related fatigue, it has a relatively high behavioural demand compared with other non-pharmacological interventions. The aim of this updated meta-analysis was to address the efficacy of light therapy in improving cancer-related fatigue in patients with cancer.MethodsWe included randomised controlled trials investigating the efficacy of bright white light (BWL) therapy in ameliorating cancer-related fatigue in patients with cancer. This meta-analysis was conducted using a random-effects model. The target outcomes were changes in cancer-related fatigue associated with BWL or dim red light (DRL).ResultsThere were 9 articles with 231 participants included. The main results revealed that daily morning BWL for 30 min was associated with significantly better improvement in fatigue severity compared with DRL (k=5, Hedges’ g=−0.414, 95% CI −0.740 to −0.087, p=0.013). The subgroup without psychiatric comorbidities (k=4, Hedges’ g=−0.479, 95% CI −0.801 to −0.156, p=0.004) was associated with significantly better improvement in fatigue severity with BWL than with DRL. In contrary, BWL was not associated with significantly different changes in depression severity or quality of life compared with DRL. Finally, BWL was associated with similar acceptability (ie, dropout rate) and safety profile (ie, any discomfort) as those of DRL.ConclusionsThis meta-analysis provides an updated evidence on the rationale for application of BWL in ameliorating cancer-related fatigue in patients with different types of cancer.Trial registration numberINPLASY202140090.


2013 ◽  
Vol 31 (4) ◽  
pp. 368-374 ◽  
Author(s):  
Huijuan Cao ◽  
Yuyi Wang ◽  
Dennis Chang ◽  
Li Zhou ◽  
Jianping Liu

Background Vascular mild cognitive impairment (VMCI) is the most common type of vascular cognitive impairment induced by cerebrovascular disease. No effective medicines are currently available for VMCI. Objective To assess the effectiveness and safety of acupuncture for VMCI. Methods Seven electronic databases were searched for randomised controlled trials which investigated the effects of acupuncture compared with no treatment, placebo or conventional therapies on cognitive function or other clinical outcomes in patients with VMCI. The quality of the trials selected was evaluated according to the ‘risk of bias’ assessment provided by the Cochrane Handbook for Systematic Reviews of Interventions. RevMan V.5.1 software was employed for data analysis. Results Twelve trials with 691 participants were included. The methodological quality of all included trials was unclear and/or they had a high risk of bias. Meta-analysis showed acupuncture in conjunction with other therapies could significantly improve Mini-Mental State Examination scores (mean difference 1.99, 95% CI 1.09 to 2.88, random model, p<0.0001, 6 trials). No included trials mentioned any adverse events of the treatment. Conclusions The current clinical evidence is not of sufficient quality for wider application of acupuncture to be recommended for the treatment of VMCI, and further large, rigorously designed trials are warranted.


Heart ◽  
2020 ◽  
Vol 106 (14) ◽  
pp. 1094-1101
Author(s):  
Achintya Dinesh Singh ◽  
Agrima Mian ◽  
Niveditha Devasenapathy ◽  
Gordon Guyatt ◽  
Ganesan Karthikeyan

AimPatients with severe mitral stenosis (MS) and their clinicians typically choose percutaneous transvenous mitral commissurotomy (PTMC) over surgical commissurotomy (SC). However, the durability of PTMC relative to SC is uncertain. We compared the efficacy, safety and durability of PTMC with SC for the treatment of MS.MethodsWe searched EMBASE, MEDLINE and WHO ICTRP registers for randomised controlled trials (RCTs) comparing PTMC, and open and/or closed mitral commissurotomy. The principal outcomes were rate of re-intervention and symptomatic improvement as inferred from the surrogate measures of immediate postprocedural mitral valve area (MVA), MVA at ≥6 month follow-up, incidence of mitral regurgitation (MR) and restenosis. We calculated weighted mean differences (WMD) for continuous outcomes, relative risks (RR) for binary outcomes and pooled outcomes using random-effects models and assessed the quality of evidence using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach.ResultsSeven RCTs with 553 patients proved eligible. Pooled estimates showed no convincing difference in the risk of restenosis or re-intervention (15/100 fewer with PTMC, 95% CI (−20 to +8); quality of evidence: moderate) or in symptoms as inferred from immediate MVA (WMD 0.15, 95% CI (−0.18 to 0.48): very low), from the incidence of postprocedural severe MR (3/100 more with PTMC, 95% CI (−1 to +10): moderate) or from MVA at 30 months.ConclusionUntil data demonstrating convincing superiority of SC over PTMC become available, our results support the current practice of recommending PTMC to young patients with MS and favourable valve morphology, as it is associated with lower peri-procedural morbidity.PROSPERO registration numberPROSPERO 2017 (CRD42017079512).


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