Dataset Information

External validity of randomized controlled trials in older adults, a systematic review.

ABSTRACT:

Background

To critically assess the external validity of randomized controlled trials (RCTs) it is important to know what older adults have been enrolled in the trials. The aim of this systematic review is to study what proportion of trials specifically designed for older patients report on somatic status, physical and mental functioning, social environment and frailty in the patient characteristics.

Methods

PubMed was searched for articles published in 2012 and only RCTs were included. Articles were further excluded if not conducted with humans or only secondary analyses were reported. A random sample of 10% was drawn. The current review analyzed this random sample and further selected trials when the reported mean age was ? 60 years. We extracted geriatric assessments from the population descriptives or the in- and exclusion criteria.

Results

In total 1396 trials were analyzed and 300 trials included. The median of the reported mean age was 66 (IQR 63-70) and the median percentage of men in the trials was 60 (IQR 45-72). In 34% of the RCTs specifically designed for older patients somatic status, physical and mental functioning, social environment or frailty were reported in the population descriptives or the in- and exclusion criteria. Physical and mental functioning was reported most frequently (22% and 14%). When selecting RCTs on a mean age of 70 or 80 years the report of geriatric assessments in the patient characteristics was 46% and 85% respectively but represent only 5% and 1% of the trials.

Conclusion

Somatic status, physical and mental functioning, social environment and frailty are underreported even in RCTs specifically designed for older patients published in 2012. Therefore, it is unclear for clinicians to which older patients the results can be applied. We recommend systematic to transparently report these relevant characteristics of older participants included in RCTs.

SUBMITTER: van Deudekom FJ

PROVIDER: S-EPMC5367677 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

External validity of randomized controlled trials in older adults, a systematic review.

van Deudekom Floor J FJ Postmus Iris I van der Ham Danielle J DJ Pothof Alexander B AB Broekhuizen Karen K Blauw Gerard J GJ Mooijaart Simon P SP

PloS one 20170327 3

<h4>Background</h4>To critically assess the external validity of randomized controlled trials (RCTs) it is important to know what older adults have been enrolled in the trials. The aim of this systematic review is to study what proportion of trials specifically designed for older patients report on somatic status, physical and mental functioning, social environment and frailty in the patient characteristics.<h4>Methods</h4>PubMed was searched for articles published in 2012 and only RCTs were inc ...[more]

PMID: 28346503

Similar Datasets

Project description:ObjectivesTo assess aspects of the internal validity of recently published cluster randomised trials and explore the reporting of information useful in assessing the external validity of these trials.DesignReview of 34 cluster randomised trials in primary care published in 2004 and 2005 in seven journals (British Medical Journal, British Journal of General Practice, Family Practice, Preventive Medicine, Annals of Internal Medicine, Journal of General Internal Medicine, Pediatrics).Data sourcesNational Library of Medicine (Medline) via PubMed.Data extractionTo assess aspects of internal validity we extracted data on appropriateness of sample size calculations and analyses, methods of identifying and recruiting individual participants, and blinding. To explore reporting of information useful in assessing external validity we extracted data on cluster eligibility, cluster inclusion and retention, cluster generalisability, and the feasibility and acceptability of the intervention to health providers in clusters.Results21 (62%) trials accounted for clustering in sample size calculations and 30 (88%) in the analysis; about a quarter were potentially biased because of procedures surrounding recruitment and identification of patients; individual participants were blind to allocation status in 19 (56%) and outcome assessors were blind in 15 (44%). In almost half the reports, information relating to generalisability of clusters was poorly reported, and in two fifths there was no information about the feasibility and acceptability of the intervention.ConclusionsCluster randomised trials are essential for evaluating certain types of interventions. Issues affecting their internal validity, such as appropriate sample size calculations and analysis, have been widely disseminated and are now better addressed by researchers. Blinding of those identifying and recruiting patients to allocation status is recommended but is not always carried out. There may be fewer barriers to internal validity in trials in which individual participants are not recruited. External validity seems poorly addressed in many trials, yet is arguably as important as internal validity in judging quality as a basis for healthcare intervention.

Project description:OBJECTIVES:To identify geriatric obesity interventions that can guide clinical recommendations. DESIGN:Systematic review using Medline (PubMed), Cochrane Central Register of Controlled Trials, Web of Science, CINAHL, EMBASE (Ovid), and PsycINFO (Proquest) from January 1, 2005, to October 12, 2015, to identify English-language randomized controlled trials. PARTICIPANTS:Individuals aged 60 and older (mean age ?65) and classified as having obesity (body mass index ?30 kg/m2 ). INTERVENTIONS:Behavioral weight loss interventions not involving pharmacological or procedural therapies lasting 6 months or longer. MEASUREMENTS:Two investigators performed the systematic review using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses criteria and achieved a high concordance rate (97.3%) in summarizing the primary outcomes. The three primary outcomes were weight loss, physical performance, and quality of life. RESULTS:Of 5,741 citations, 19 were included. (Six studies were unique, and the remaining 13 were based on the same study population.) Duration ranged from 6 to 18 months (n = 405 participants, age range 66.7-71.1). Weight loss in the intervention groups ranged from 0.5 to 10.7 kg (0.1-9.3%). Five studies had a resistance exercise program accompanying a dietary component. Greater weight loss was observed in groups with a dietary component than those with exercise alone. Exercise alone led to better physical function but no significant weight loss. Combined dietary and exercise components led to the greatest improvement in physical performance measures and quality of life and mitigated reductions in muscle and bone mass observed in diet-only study arms. Heterogeneous outcomes were observed, which limited the ability to synthesize the data quantitatively. CONCLUSIONS:The evidence supporting geriatric obesity interventions to improve physical function and quality of life is of low to moderate quality. Well-designed trials are needed in this population.

Project description:BackgroundDepression is a severe psychological concern that negatively affects health in older adults. Serious games applied in various fields are considered appropriate interventions, especially in mental health care. However, there is a lack of evidence regarding the effects of serious games on depression in older adults.ObjectiveThis study aimed to investigate the characteristics and effectiveness of serious games for depression in older adults.MethodsA systematic review and meta-analysis of randomized controlled trials were conducted. In total, 5 electronic databases (PubMed, CINAHL, Embase, PsycINFO, and Cochrane Library) were searched to identify relevant studies published until July 6, 2021. A total of 2 reviewers independently conducted study selection, data extraction, and quality appraisals. The risk of bias in the included studies was assessed using the JBI Critical Appraisal Checklist. For the meta-analysis, the effect size was calculated as the standardized mean difference (SMD) by using a random effects model.ResultsA total of 17 studies with 1280 older adults were included in the systematic review, and 15 studies were included in the meta-analysis. Serious game interventions were classified into 3 types: physical activity (PA), cognitive function, and both PA and cognitive function. The meta-analysis demonstrated that serious games reduced depression in older adults (SMD -0.54, 95% CI -0.79 to -0.29; P<.001). Serious games had a more significant effect size in community or home settings (SMD -0.61, 95% CI -0.95 to -0.26; P<.001) than in hospital settings (SMD -0.46, 95% CI -0.85 to -0.08; P=.02); however, the difference between groups was not significant. Among the types of games, games for PA (SMD -0.60, 95% CI -0.95 to -0.25; P<.001) and games for both (SMD -0.73, 95% CI -1.29 to -0.17; P=.01) had a significant effect on reducing depression in older adults. However, no significant correlations were observed between the duration or number of serious games and depression.ConclusionsSerious games were beneficial in reducing depression in older adults. Regardless of the study setting, serious games appeared to reduce depression. Particularly, serious games including PA had a significant impact on reducing depression. Furthermore, high-quality randomized controlled trials are needed to establish substantial evidence for the effectiveness of serious games on depression in older adults.Trial registrationPROSPERO CRD42021242573; https://tinyurl.com/26xf7ym5.

Project description:ObjectiveThe objective of this review was to systematically evaluate the effectiveness of exergaming on walking in older adults. In addition, the aim was to investigate the relationship between the exergaming effect and age, baseline walking performance, exercise traits, technology used, and the risk of bias.MethodsA literature search was carried out in the databases MEDLINE, CINAHL, CENTRAL, EMBASE, WoS, PsycInfo, and PEDro up to January 10, 2020. Studies with a randomized controlled trial design, people ≥60 years of age without neurological disorders, comparison group with other exercise or no exercise, and walking-related outcomes were included. Cochrane RoB2, meta-analysis, meta-regression, and Grading of Recommendations, Assessment, Development and Evaluation were used to estimate quality, treatment effect, covariates' effect, and the certainty of evidence, respectively.ResultsIn the studies included (n = 66), the overall risk of bias was low (n = 2), unclear (n = 48), or high (n = 16). Compared with comparison groups, exergaming interventions were more effective for walking improvements (standardized mean difference = -0.21; 95% CI = -0.36 to -0.06; 3102 participants, 58 studies; moderate-quality evidence) and more or equally effective (standardized mean difference = -0.32; 95% CI = -0.64 to 0.00; 1028 participants, 13 studies; low-quality evidence) after nonexergaming follow-up. The strongest effect for covariates was observed with the type of comparison group, explaining 18.6% of the variance.ConclusionFor older adults without neurological disorders, exergame-based training improved walking, and improvements were maintained at follow-up. Greater benefits were observed when exergaming groups were compared with inactive comparison groups. To strengthen the evidence, further randomized controlled trials on the effectiveness of gamified exercise intervention are needed.ImpactExergaming has an effect equivalent to other types of exercising on improving walking in older adults. Physical therapists and other rehabilitation professionals may consider exergaming as a promising form of exercise in this age group.

Dataset Information

External validity of randomized controlled trials in older adults, a systematic review.

Background

Methods

Results

Conclusion

Publications

External validity of randomized controlled trials in older adults, a systematic review.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets