PURPOSE: Fatigue is a common and potentially disabling symptom in patients with cancer. It can often be effectively reduced by exercise. Yet, effects of exercise interventions might differ across subgroups. We conducted a meta-analysis using individual patient data of randomized controlled trials (RCTs) to investigate moderators of exercise intervention effects on cancer-related fatigue.METHODS: We used individual patient data from 31 exercise RCTs worldwide, representing 4,366 patients, of whom 3,846 had complete fatigue data. We performed a one-step individual patient data meta-analysis, using linear mixed-effect models to analyze the effects of exercise interventions on fatigue (z-score) and to identify demographic, clinical, intervention- and exercise-related moderators. Models were adjusted for baseline fatigue and included a random intercept on study level to account for clustering of patients within studies. We identified potential moderators by testing their interaction with group allocation, using a likelihood ratio test.RESULTS: Exercise interventions had statistically significant beneficial effects on fatigue (β= -0.17 [95% confidence interval (CI) -0.22;-0.12]). There was no evidence of moderation by demographic or clinical characteristics. Supervised exercise interventions had significantly larger effects on fatigue than unsupervised exercise interventions (βdifference= -0.18 [95%CI -0.28;-0.08]). Supervised interventions with a duration ≤12 weeks showed larger effects on fatigue (β= -0.29 [95% CI -0.39;-0.20]) than supervised interventions with a longer duration. CONCLUSIONS: In this individual patient data meta-analysis, we found statistically significant beneficial effects of exercise interventions on fatigue, irrespective of demographic and clinical characteristics. These findings support a role for exercise, preferably supervised exercise interventions, in clinical practice. Reasons for differential effects in duration require further exploration.
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Abstract: Background: Chronic obstructive pulmonary disease (COPD) and asthma have a high prevalence and disease burden. Blended self-management interventions, which combine eHealth with face-to-face interventions, can help reduce the disease burden. Objective: This systematic review and meta-analysis aims to examine the effectiveness of blended self-management interventions on health-related effectiveness and process outcomes for people with COPD or asthma. Methods: PubMed, Web of Science, COCHRANE Library, Emcare, and Embase were searched in December 2018 and updated in November 2020. Study quality was assessed using the Cochrane risk of bias (ROB) 2 tool and the Grading of Recommendations, Assessment, Development, and Evaluation. Results: A total of 15 COPD and 7 asthma randomized controlled trials were included in this study. The meta-analysis of COPD studies found that the blended intervention showed a small improvement in exercise capacity (standardized mean difference [SMD] 0.48; 95% CI 0.10-0.85) and a significant improvement in the quality of life (QoL; SMD 0.81; 95% CI 0.11-1.51). Blended intervention also reduced the admission rate (relative ratio [RR] 0.61; 95% CI 0.38-0.97). In the COPD systematic review, regarding the exacerbation frequency, both studies found that the intervention reduced exacerbation frequency (RR 0.38; 95% CI 0.26-0.56). A large effect was found on BMI (d=0.81; 95% CI 0.25-1.34); however, the effect was inconclusive because only 1 study was included. Regarding medication adherence, 2 of 3 studies found a moderate effect (d=0.73; 95% CI 0.50-0.96), and 1 study reported a mixed effect. Regarding self-management ability, 1 study reported a large effect (d=1.15; 95% CI 0.66-1.62), and no effect was reported in that study. No effect was found on other process outcomes. The meta-analysis of asthma studies found that blended intervention had a small improvement in lung function (SMD 0.40; 95% CI 0.18-0.62) and QoL (SMD 0.36; 95% CI 0.21-0.50) and a moderate improvement in asthma control (SMD 0.67; 95% CI 0.40-0.93). A large effect was found on BMI (d=1.42; 95% CI 0.28-2.42) and exercise capacity (d=1.50; 95% CI 0.35-2.50); however, 1 study was included per outcome. There was no effect on other outcomes. Furthermore, the majority of the 22 studies showed some concerns about the ROB, and the quality of evidence varied. Conclusions: In patients with COPD, the blended self-management interventions had mixed effects on health-related outcomes, with the strongest evidence found for exercise capacity, QoL, and admission rate. Furthermore, the review suggested that the interventions resulted in small effects on lung function and QoL and a moderate effect on asthma control in patients with asthma. There is some evidence for the effectiveness of blended self-management interventions for patients with COPD and asthma; however, more research is needed. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42019119894; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=119894
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Background—Self-management interventions are widely implemented in care for patients with heart failure (HF). Trials however show inconsistent results and whether specific patient groups respond differently is unknown. This individual patient data meta-analysis assessed the effectiveness of self-management interventions in HF patients and whether subgroups of patients respond differently. Methods and Results—Systematic literature search identified randomized trials of selfmanagement interventions. Data of twenty studies, representing 5624 patients, were included and analyzed using mixed effects models and Cox proportional-hazard models including interaction terms. Self-management interventions reduced risk of time to the combined endpoint HF-related all-0.71- in Conclusions—This study shows that self-management interventions had a beneficial effect on time to HF-related hospitalization or all-cause death, HF-related hospitalization alone, and elicited a small increase in HF-related quality of life. The findings do not endorse limiting selfmanagement interventions to subgroups of HF patients, but increased mortality in depressed patients warrants caution in applying self-management strategies in these patients.
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ABSTRACT It is unknown whether heterogeneity in effects of self-management interventions in patients with chronic obstructive pulmonary disease (COPD) can be explained by differences in programme characteristics. This study aimed to identify which characteristics of COPD self-management interventions are most effective. Systematic search in electronic databases identified randomised trials on self-management interventions conducted between 1985 and 2013. Individual patient data were requested for meta-analysis by generalised mixed effects models. 14 randomised trials were included (67% of eligible), representing 3282 patients (75% of eligible). Univariable analyses showed favourable effects on some outcomes for more planned contacts and longer duration of interventions, interventions with peer contact, without log keeping, without problem solving, and without support allocation. After adjusting for other programme characteristics in multivariable analyses, only the effects of duration on all-cause hospitalisation remained. Each month increase in intervention duration reduced risk of all-cause hospitalisation (time to event hazard ratios 0.98, 95% CI 0.97–0.99; risk ratio (RR) after 6 months follow-up 0.96, 95% CI 0.92–0.99; RR after 12 months follow-up 0.98, 95% CI 0.96–1.00). Our results showed that longer duration of self-management interventions conferred a reduction in allcause hospitalisations in COPD patients. Other characteristics are not consistently associated with differential effects of self-management interventions across clinically relevant outcomes.
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Abstract Background: Lifestyle interventions for severe mental illness (SMI) are known to have small to modest efect on physical health outcomes. Little attention has been given to patient-reported outcomes (PROs). Aim: To systematically review the use of PROs and their measures, and quantify the efects of lifestyle interventions in patients with SMI on these PROs. Methods: Five electronic databases were searched (PubMed/Medline, Embase, PsycINFO, CINAHL, and Web of Science) from inception until 12 November 2020 (PROSPERO: CRD42020212135). Randomised controlled trials (RCTs) evaluating the efcacy of lifestyle interventions focusing on healthy diet, physical activity, or both for patients with SMI were included. Outcomes of interest were PROs. Results: A total of 11.267 unique records were identifed from the database search, 66 full-text articles were assessed, and 36 RCTs were included, of which 21 were suitable for meta-analyses. In total, 5.907 participants were included across studies. Lifestyle interventions had no signifcant efect on quality of life (g=0.13; 95% CI=−0.02 to 0.27), with high heterogeneity (I2 =68.7%). We found a small efect on depression severity (g=0.30, 95% CI=0.00 to 0.58, I2 =65.2%) and a moderate efect on anxiety severity (g=0.56, 95% CI=0.16 to 0.95, I2 =0%). Discussion: This meta-analysis quantifes the efects of lifestyle interventions on PROs. Lifestyle interventions have no signifcant efect on quality of life, yet they could improve mental health outcomes such as depression and anxiety symptoms. Further use of patient-reported outcome measures in lifestyle research is recommended to fully capture the impact of lifestyle interventions.
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Objectives Meta-analyses using individual patient data (IPD) rather than aggregated data are increasingly applied to analyze sources of heterogeneity between trials and have only recently been applied to unravel multicomponent, complex interventions. This study reflects on methodological challenges encountered in two IPD meta-analyses on self-management interventions in patients with heart failure or chronic obstructive pulmonary disease. Study Design and Setting Critical reflection on prior IPD meta-analyses and discussion of literature. Results Experience from two IPD meta-analyses illustrates methodological challenges. Despite close collaboration with principal investigators, assessing the effect of characteristics of complex interventions on the outcomes of trials is compromised by lack of sufficient details on intervention characteristics and limited data on fidelity and adherence. Furthermore, trials collected baseline variables in a highly diverse way, limiting the possibilities to study subgroups of patients in a consistent manner. Possible solutions are proposed based on lessons learnt from the methodological challenges. Conclusion Future researchers of complex interventions should pay considerable attention to the causal mechanism underlying the intervention and conducting process evaluations. Future researchers on IPD meta-analyses of complex interventions should carefully consider their own causal assumptions and availability of required data in eligible trials before undertaking such resource-intensive IPD meta-analysis.
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Background: Exercise effects in cancer patients often appear modest, possibly because interventions rarely target patients most in need. This study investigated the moderator effects of baseline values on the exercise outcomes of fatigue, aerobic fitness, muscle strength, quality of life (QoL), and self-reported physical function (PF) in cancer patients during and post-treatment.Methods: Individual patient data from 34 randomized exercise trials (n = 4519) were pooled. Linear mixed-effect models were used to study moderator effects of baseline values on exercise intervention outcomes and to determine whether these moderator effects differed by intervention timing (during vs post-treatment). All statistical tests were two-sided.Results: Moderator effects of baseline fatigue and PF were consistent across intervention timing, with greater effects in patients with worse fatigue (Pinteraction = .05) and worse PF (Pinteraction = .003). Moderator effects of baseline aerobic fitness, muscle strength, and QoL differed by intervention timing. During treatment, effects on aerobic fitness were greater for patients with better baseline aerobic fitness (Pinteraction = .002). Post-treatment, effects on upper (Pinteraction < .001) and lower (Pinteraction = .01) body muscle strength and QoL (Pinteraction < .001) were greater in patients with worse baseline values.Conclusion: Although exercise should be encouraged for most cancer patients during and post-treatments, targeting specific subgroups may be especially beneficial and cost effective. For fatigue and PF, interventions during and post-treatment should target patients with high fatigue and low PF. During treatment, patients experience benefit for muscle strength and QoL regardless of baseline values; however, only patients with low baseline values benefit post-treatment. For aerobic fitness, patients with low baseline values do not appear to benefit from exercise during treatment.
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Study selection: Randomized controlled trials published after 2007 with (former) healthcare patients ≥ 21 years of age were included if physical activity was measured objectively using a wearable monitor for both feedback and outcome assessment. The main goal of included studies was promoting physical activity. Any concurrent strategies were related only to promoting physical activity. Data extraction: Effect sizes were calculated using a fixed-effects model with standardized mean difference. Information on study characteristics and interventions strategies were extracted from study descriptions. Data synthesis: Fourteen studies met the inclusion criteria (total n = 1,902), and 2 studies were excluded from meta-analysis. The overall effect size was in favour of the intervention groups (0.34, 95% CI 0.23–0.44, p < 0.01). Study characteristics and intervention strategies varied widely. Conclusion: Healthcare interventions using feedback on objectively monitored physical activity have a moderately positive effect on levels of physical activity. Further research is needed to determine which strategies are most effective to promote physical activity in healthcare programmes. Lay Abstract Wearable technology is progressively applied in health care and rehabilitation to provide objective insight into physical activity levels. In addition, feedback on physical activity levels delivered by wearable monitors might be beneficial for optimizing their physical activity. A systematic review and meta-analysis was conducted to evaluate the effectiveness of interventions using feedback on objectively measured physical activity in patient populations. Fourteen studies including 1902 patients were analyzed. Overall, the physical activity levels of the intervention groups receiving objective feedback on physical activity improved, compared to the control groups receiving no objective feedback. Mostly, a variety of other strategies were applied in the interventions next to wearable technology. Together with wearable technology, behavioral change strategies, such as goal-setting and action planning seem to be an important ingredient to promote physical activity in health care and rehabilitation. LinkedIn: https://www.linkedin.com/in/hanneke-braakhuis-b9277947/ https://www.linkedin.com/in/moniqueberger/
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Abstract Background: One of the most challenging issues for the elderly population is the clinical state of frailty. Frailty is defined as a cumulative decline across psychological, physical, and social functioning. Hospitalization is one of the most stressful events for older people who are becoming frail. The aim of the present study was to determine the effectiveness of interventions focused on management of frailty in hospitalized frail older adults. Methods: A systematic review and meta-analysis of research was conducted using the Medline, Embase, Cochrane, ProQuest, CINAHL, SCOPUS and Web of Science electronic databases for papers published between 2000 and 2019. Randomized controlled studies were included that were aimed at the management of frailty in hospitalized older adults. The outcomes which were examined included frailty; physical, psychological, and social domains; length of stay in hospital; re-hospitalization; mortality; patient satisfaction; and the need for post discharge placement. Results: After screening 7976 records and 243 full-text articles, seven studies (3 interventions) were included, involving 1009 hospitalized older patients. The quality of these studies was fair to poor and the risk of publication bias in the studies was low. Meta-analysis of the studies showed statistically significant differences between the intervention and control groups for the management of frailty in hospitalized older adults (ES = 0.35; 95% CI: 0. 067–0.632; z = 2.43; P < 0.015). However, none of the included studies evaluated social status, only a few of the studies evaluated other secondary outcomes. The analysis also showed that a Comprehensive Geriatric Assessment unit intervention was effective in addressing physical and psychological frailty, re-hospitalization, mortality, and patient satisfaction. Conclusions: Interventions for hospitalized frail older adults are effective in management of frailty. Multidimensional interventions conducted by a multidisciplinary specialist team in geriatric settings are likely to be effective in the care of hospitalized frail elderly. Due to the low number of RCTs carried out in a hospital setting and the low quality of existing studies, there is a need for new RCTs to be carried out to generate a protocol appropriate for frail older people.
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AbstractObjective: Many older individuals receive rehabilitation in an out-of-hospital setting (OOHS) after acute hospitalization; however, its effect onmobility and unplanned hospital readmission is unclear. Therefore, a systematic review and meta-analysis were conducted on this topic.Data Sources: Medline OVID, Embase OVID, and CINAHL were searched from their inception until February 22, 2018.Study Selection: OOHS (ie, skilled nursing facilities, outpatient clinics, or community-based at home) randomized trials studying the effect ofmultidisciplinary rehabilitation were selected, including those assessing exercise in older patients (mean age 65y) after discharge from hospitalafter an acute illness.Data Extraction: Two reviewers independently selected the studies, performed independent data extraction, and assessed the risk of bias.Outcomes were pooled using fixed- or random-effect models as appropriate. The main outcomes were mobility at and unplanned hospitalreadmission within 3 months of discharge.Data Synthesis: A total of 15 studies (1255 patients) were included in the systematic review and 12 were included in the meta-analysis (7assessing mobility using the 6-minute walk distance [6MWD] test and 7 assessing unplanned hospital readmission). Based on the 6MWD, patientsreceiving rehabilitation walked an average of 23 m more than controls (95% confidence interval [CI]Z: 1.34 to 48.32; I2: 51%). Rehabilitationdid not lower the 3-month risk of unplanned hospital readmission (risk ratio: 0.93; 95% CI: 0.73-1.19; I2: 34%). The risk of bias was present,mainly due to the nonblinded outcome assessment in 3 studies, and 7 studies scored this unclearly.Conclusion: OOHS-based multidisciplinary rehabilitation leads to improved mobility in older patients 3 months after they are discharged fromhospital following an acute illness and is not associated with a lower risk of unplanned hospital readmission within 3 months of discharge.However, the wide 95% CIs indicate that the evidence is not robust.
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