Chiara Arienti

Introduction: Given the characteristics of the literature in the field of rehabilitation, which is marked by substantial clinical heterogeneity, poor reporting, and complexity in terms of interventions and outcomes, conducting meta-analyses can be complex or, in some cases, impossible. In particular, the concept of clinical heterogeneity is addressed within the indirectness domain of the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) approach, which is assessed "by evaluating how closely the population, intervention, comparison, and outcomes in the available evidence align with those specified in the question of interest". Objectives: As a first step toward developing a structured tool to assist systematic review authors in determining whether downgrading for indirectness is warranted, assessing the severity of indirectness, and translating these judgments into appropriate levels of certainty downgrading in rehabilitation evidence synthesis according to GRADE’s threshold approach, this study aims to identify existing structured methods (i.e., tools, checklists and scales) for assessing indirectness in any biomedical field. Methods: This is a scoping review. MEDLINE, Embase, and CINAHL were searched using specifically designed search strategies up to May 20th, 2026. In addition, the GRADE Book, the Cochrane Handbook for Systematic Reviews of Interventions, the Joanna Briggs Institute Manual for Evidence Synthesis – 2024 Edition, and the Agency for Healthcare Research and Quality (AHRQ) website were consulted. Eligible studies were articles or book chapters describing the development, implementation, empirical validation, or use of any tool, checklist, or scale, aimed at assessing, measuring, or generally investigating indirectness (or related concepts) in evidence synthesis. Study selection and data extraction were performed by two independent authors. Results: From 2593 individual records identified through database searching, two tools were identified, namely the Clinical Diversity In Meta-analyses (CDIM) tool and the Clinical Diversity in Pediatric Meta-analyses (CDIPM) tool. The latter is a modified version of the former (specifically designed for paediatric populations), available as a conference proceeding only. Both tools include four domains (i.e., setting, population, intervention, and outcome) and 11 items, each to be scored as low, moderate, or high clinical heterogeneity/diversity (0-2 points). Additionally, indirectness tables for both a single trial and the entire body of evidence, and a summary table for applicability were identified from the GRADE Book and the AHRQ Methods Guide for Comparative Effectiveness Reviews on applicability, respectively. The former included four subdomains (i.e., population, intervention, comparison and outcome) and four possible options regarding whether the evidence is sufficiently direct (i.e., Yes, Probably Yes, Probably No, and No), informing an overall judgement of indirectness across the subdomains. The latter requires a narrative assessment of the applicability of the evidence across five domains (Population, Intervention, Comparators, Outcomes, and Setting). Conclusions: The findings highlight the paucity of structured methods available for assessing indirectness. At the same time, the identified methods largely share the same domains, likely suggesting that these may represent the key components that a tool for assessing indirectness should address. This work represents the first step that will inform the development of a tool to assess indirectness in the field of rehabilitation evidence synthesis.

Cochrane Rehabilitation and the World Health Organization (WHO) Rehabilitation Programme have collaborated to produce four Cochrane overviews of systematic reviews synthesizing evidence from health policy and systems research (HPSR) in rehabilitation. Each overview focuses on one of the four HPSR pillars identified by the Cochrane Effective Practice and Organisation of Care (EPOC) taxonomy: delivery, financial, and governance arrangements; and implementation strategies. This overview addresses delivery arrangements, which Cochrane EPOC defines as how health services are organized and delivered, including who provides care, how care is coordinated and managed, and where services are provided. This overview aimed to synthesize current evidence on delivery arrangements in rehabilitation from an HPSR perspective. Our series of four overviews has the following overarching objectives. • To offer a broad synthesis of existing evidence on health policy and systems interventions' effects. • To direct end-users, including policymakers, towards systematic reviews that may address their health policy questions. • To identify current research gaps and set priorities for future primary HPSR. • To pinpoint needs and priorities for new evidence syntheses where no reliable, up-to-date systematic reviews currently exist. We searched Epistemonikos Health Systems Evidence databases and EPOC Group systematic reviews with no language limitations to identify reviews published between 2015 and 17 November 2024. We included Cochrane systematic reviews (CSRs) and non-CSRs of randomized controlled trials (RCTs) and non-randomized studies of interventions (NRSIs) evaluating the effectiveness of health policy and systems interventions for rehabilitation in health systems, specifically related to delivery arrangements as defined in the EPOC taxonomy. All four overview teams screened reviews and extracted data. We used AMSTAR 2 to critically appraise the reviews, and we analyzed the results descriptively. We included 25 systematic reviews. Three overlapped, and for 17 the AMSTAR 2 rating was low or critically low confidence. Five systematic reviews (2 CSRs and 3 non-CSRs) contributed to our synthesis. Most outcomes focused on patients, caregivers, or service use (e.g. access to rehabilitation). Equity-related outcomes were absent, and quality of care, adverse events, and our important outcomes were rarely reported. Below, we report the results of three of the five reviews judged to have moderate to high confidence for our outcomes of interest, in which authors conducted meta-analysis and assessed the certainty of the evidence. Who provides care One review analyzed advanced practice physiotherapy (APP) models, which may result in little to no difference in health-related outcomes measured by the Pain Disability Index and EuroQol 5-Dimension questionnaire after the intervention, compared with usual care in adults with spinal pain (standardized mean difference [SMD] 0.05, 95% confidence interval [CI] -0.32 to 0.42; 2 studies, 225 participants; low certainty). Information and communication technology We included two reviews in this category. One compared telerehabilitation with usual care in older adults, finding that telerehabilitation may have little or no effect on quality of life after seven to 20 weeks (SMD -0.09, 95% CI -0.23 to 0.40; 3 studies, 179 participants; low certainty). There was very low-certainty evidence on mobility after seven to 26 weeks (SMD 0.63, 95% CI -0.25 to 1.51; 5 studies, 302 participants), strength after 12 and 26 weeks (SMD 0.73, 95% CI -0.10 to 1.56; 4 studies, 226 participants), and balance after seven to 26 weeks (SMD 0.40, 95% CI -0.35 to 1.15; 3 studies, 199 participants). Another review on stroke survivors living in the community found that telerehabilitation compared with usual care probably has little or no effect on independence in activities of daily living (ADL) after 24 weeks (SMD 0.00, 95% CI -0.15 to 0.15; 2 studies, 661 participants; moderate certainty), self-reported quality of life after six to 24 weeks (SMD 0.03, 95% CI -0.14 to 0.20; 3 studies, 569 participants; moderate certainty), and depression after six to 24 weeks (SMD -0.04, 95% CI -0.19 to 0.11; 6 studies, 1145 participants; moderate certainty); and may have little or no effect on upper limb function after 12 weeks (SMD 0.33, 95% CI -0.21 to 0.87; 2 studies, 54 participants; low certainty) and mobility after six weeks (mean difference 0.01, 95% CI -0.12 to 0.14; 1 study; 144 participants; low certainty). This review also compared telerehabilitation with in-person rehabilitation and found that there may be little to no difference in independence in ADL, measured with the Modified Barthel Index at four to 12 weeks (MD 0.59, 95% CI -5.50 to 6.68; 2 studies, 75 participants; low certainty); balance, measured with the Berg Balance Scale at four to 12 weeks (MD 0.48, 95% CI -1.36 to 2.32; 3 studies, 106 participants; low certainty); and upper limb function, evaluated with the Fugl-Meyer Assessment (Upper Extremity) four weeks after intervention (MD 1.23, 95% CI -2.17 to 4.64; 3 studies, 170 participants; low certainty). Current evidence on delivery arrangements in rehabilitation is limited, mostly of low certainty, and derived from high-income countries. Reviews covered five EPOC categories, but reliable evidence for our outcomes of interest was available for only two categories. Most evidence was on telerehabilitation. Compared with usual care, APP models may have little to no effect on health outcomes in adults with spinal pain. In people with stroke, telerehabilitation compared with usual care probably has little or no effect on independence in daily living, quality of life, and depression, and may have little to no effect on upper limb function and mobility. Compared with in-person care, telerehabilitation may have little to no effect on ADL, balance, and upper limb function. Further...

Background Cochrane Rehabilitation and the World Health Organization (WHO) Rehabilitation Programme have collaborated to produce four Cochrane overviews of systematic reviews that synthesize current available evidence from health policy and systems research (HPSR) in rehabilitation. Each overview focuses on one of the four pillars of HPSR as identified by the Cochrane Effective Practice and Organisation of Care (EPOC) taxonomy: delivery arrangements, financial arrangements, governance arrangements, and implementation strategies. This overview focuses on financial arrangements, which Cochrane EPOC defines as changes in how funds are collected, how insurance schemes are structured, how services are purchased, and the use of targeted financial incentives or disincentives. Objectives This overview aimed to synthesize the current evidence on financial arrangements in rehabilitation from a health policy and systems research (HPSR) perspective. Our series of four overviews, incorporating evidence on governance arrangements, delivery arrangements, financial arrangements, and implementation strategies, have the following overarching objectives. • To offer a broad synthesis of the existing evidence on health policy and systems interventions' effects. • To direct end‐users, including policymakers, towards systematic reviews that may address their health policy questions. • To identify current research gaps and set priorities for future primary HPSR. • To pinpoint the needs and priorities for new evidence syntheses where no reliable, up‐to‐date systematic reviews currently exist. Methods We searched the Epistemonikos database, the Health Systems Evidence database, and EPOC Group systematic reviews to identify reviews published between 1 January 2015 and 17 November 2024. We applied no language limitations. We included Cochrane and non‐Cochrane systematic reviews of randomized controlled trials (RCTs) and non‐randomized studies of interventions (NRSIs) that evaluated the effectiveness of health policy and systems interventions for rehabilitation in health systems, specifically related to financial arrangements as defined in the EPOC taxonomy. All four overview teams collaborated to screen reviews and extract data. We used AMSTAR 2 to critically appraise the quality of the reviews. Reviews with ratings of high‐to‐moderate confidence are reported separately from low‐confidence reviews. Main results We identified two non‐Cochrane systematic reviews relevant to rehabilitation and the EPOC category of financial arrangements. We excluded one review from the synthesis due to low methodological quality. The other review included 18 primary studies, but only one study reported data relevant to rehabilitation. This study, conducted in a single country (China), compared insured and uninsured children aged birth to 17 years with intellectual disabilities, focusing on the likelihood of receiving at least one rehabilitation service. The review reported that, based on this single study, enrollment in social health insurance, national health insurance, or community‐based health insurance schemes may be ⁠⁠⁠⁠⁠⁠⁠associated with increased utilization of mental health services, including outpatient rehabilitation. However, due to the complexity and variability of mental health service utilization across contexts, the review authors noted that it was difficult to draw definitive conclusions about the overall impact of insurance enrollment on mental health outcomes and services. Authors' conclusions We identified two non‐Cochrane systematic reviews aligned with the EPOC classification of financial arrangements that addressed rehabilitation. One review including one single‐center study on rehabilitation offered low‐certainty evidence on insurance schemes and access to rehabilitation services. As a result, this overview cannot provide a clear understanding of the effects of financial arrangements for rehabilitation or offer meaningful signposts to end‐users, including policymakers. Future Cochrane overviews in HPSR should broaden their scope to include qualitative and mixed‐methods study designs. Robust primary studies and inclusive systematic reviews are urgently needed to guide financial policy decisions that integrate rehabilitation into resilient and equitable health systems. Funding PC, CK, and SN were supported and funded by the Italian Ministry of Health (Ricerca Corrente). The funder played no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. Registration Protocol (2025): DOI 10.23736/S1973‐9087.24.08833‐6.

Background Cochrane Rehabilitation and the World Health Organization (WHO) Rehabilitation Programme have collaborated to produce four Cochrane overviews of systematic reviews that synthesize current available evidence from health policy and systems research (HPSR) in rehabilitation. Each overview focuses on one of the four pillars of HPSR as identified by the Cochrane Effective Practice and Organisation of Care (EPOC) taxonomy: delivery arrangements, financial arrangements, governance arrangements, and implementation strategies. This overview examined implementation strategies, defined by EPOC as interventions designed to bring about changes in healthcare organizations, the behavior of healthcare professionals, or the use of health services by healthcare recipients. Objectives This overview aimed to synthesize current evidence on implementation strategies in rehabilitation from a health policy and systems research (HPSR) perspective. Our series of four overviews have the following overarching objectives. • To offer a broad synthesis of the existing evidence on health policy and systems interventions' effects. • To direct end‐users, including policymakers, towards systematic reviews that may address their health policy questions. • To identify current research gaps and set priorities for future primary HPSR. • To pinpoint the needs and priorities for new evidence syntheses where no reliable, up‐to‐date systematic reviews currently exist. Methods We searched the Epistemonikos database, the Health Systems Evidence database, and EPOC Group systematic reviews to identify reviews published between 1 January 2015 and 17 November 2024. We applied no language limitations. We included Cochrane and non‐Cochrane systematic reviews of randomized controlled trials (RCTs) and non‐randomized studies of interventions (NRSIs) that evaluated the effectiveness of health policy and systems interventions for rehabilitation in health systems, specifically related to implementation strategies as defined in the EPOC taxonomy. All four overview teams collaborated to screen reviews and extract data. We used AMSTAR 2 to critically appraise the quality of the reviews. Results were analyzed descriptively and are based on reviews with ratings of high‐to‐moderate confidence, with low‐confidence reviews reported separately. Main results We identified 7882 systematic reviews, of which 15 met our inclusion criteria. Three reviews overlapped substantially with other reviews, and eight received low‐ or critically low‐confidence ratings. Ultimately, four moderate‐ to high‐confidence reviews contributed to the synthesis; two were Cochrane systematic reviews. Most primary studies were from high‐income countries; none were from low‐income countries. Most strategies targeting healthcare professionals (e.g. guideline dissemination, interactive workshops, opinion leaders, audit and feedback) or healthcare recipients (e.g. structured monitoring, telehealth support, counseling, motivational interviewing) included more than one component. Strategies targeting healthcare recipients' use of health services in cardiac rehabilitation may show small benefits in terms of participation (enrollment, adherence, completion), but effects on other outcomes are uncertain. The effects of strategies targeting older healthcare recipients via telehealth are uncertain. Strategies targeting healthcare professionals may have little to no effect on professional or patient and carer outcomes in stroke rehabilitation. For musculoskeletal conditions, there were no evidence‐certainty ratings, so intervention effects are unclear. We found no reviews of strategies targeting health service organizations or specific types of rehabilitation practice. The evidence certainty was generally low; evidence of adverse events was missing or uncertain; and reporting on organizational, implementation, economic, and equity outcomes was scarce. Authors' conclusions Current evidence on implementation strategies in rehabilitation is limited, mostly of low certainty, and derived from high‐income countries. Multicomponent, patient‐targeted strategies may modestly improve cardiac rehabilitation participation, but effects in other areas remain uncertain. Further high‐quality research using well‐defined frameworks is needed, especially in low‐ and middle‐income countries, to identify effective strategies and evaluate organizational, implementation, and equity outcomes. Future Cochrane overviews of reviews in HPSR should consider including a broader range of study designs, such as observational, qualitative, and mixed‐methods evidence, to better capture evidence on implementation strategies in rehabilitation. Funding This Cochrane review was funded by the Italian Ministry of Health (Ricerca Corrente). The funder played no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. Registration The protocol was first published in the European Journal of Physical and Rehabilitation Medicine online on 27 January 2025. The manuscript was received on 11 November 2024 and was accepted on 26 November 2024. Protocol: DOI 10.23736/S1973‐9087.24.08833‐6.

Rationale Oropharyngeal dysphagia is a common and disabling symptom in people with Parkinson’s disease, affecting the safety and efficiency of swallowing and increasing the risk of malnutrition and aspiration pneumonia. Despite its clinical relevance, the effectiveness of rehabilitation interventions for managing dysphagia in this population remains uncertain. Objectives To assess the effectiveness of rehabilitation interventions for oropharyngeal dysphagia in improving swallowing safety and efficiency in people with Parkinson’s disease. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature, Web of Science, and Speech Pathology Database for Best Interventions and Treatment Efficacy up to 26 September 2025. We also searched ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform to retrieve ongoing and recently completed trials, and OpenGrey for grey literature. Eligibility criteria We included randomised controlled trials (RCTs) of rehabilitation interventions aimed at improving oropharyngeal dysphagia in people with Parkinson’s disease. We included any rehabilitation intervention for oropharyngeal dysphagia, alone or in combination with another rehabilitation intervention, with or without concurrent pharmacological treatments. Comparators included no intervention, usual care, a placebo/sham stimulation or attention control intervention, or any other rehabilitation intervention. Outcomes Critical outcomes: swallowing safety and swallowing efficiency Important outcomes: dysphagia severity, saliva management, quality of life, respiratory outcomes, nutritional and dietary outcomes, and adverse events Risk of bias We assessed the risk of bias in the included studies using Cochrane's revised risk of bias (RoB 2) tool. Synthesis methods When two or more studies were pooled, we conducted a random‐effects meta‐analysis to calculate standardised mean differences (SMDs) and 95% confidence intervals (CIs). When only one study was available, we used a fixed‐effect model to estimate the effect, calculating mean differences (MDs) or odds ratios (ORs) with 95% CIs for all outcomes. We used the GRADE approach to assess the certainty of the evidence. Included studies We included 18 studies (1216 participants). Five studies were conducted in Europe, four in the USA, and nine in the rest of the world. Generally, studies were heterogeneous and often poorly reported. We included only two studies in the meta‐analysis. Ten studies tested behavioural interventions, while eight studies tested one or more stimulation interventions: neuromuscular treatments (three studies), repetitive transcranial magnetic stimulation (two studies), deep brain stimulation (two studies), and transcranial direct current stimulation (one study). Synthesis of results Compared to sham expiratory muscle strength training (EMST), EMST may improve swallowing safety at the end of four weeks of treatment (SMD ‐0.66, 95% CI ‐1.04 to ‐0.28; I² = 0%; 2 studies; 113 participants; very low‐certainty evidence), but the evidence is very uncertain. Similarly, the evidence is very uncertain about the effect of EMST compared to sham EMST on all the following outcomes: swallowing safety after three months of follow‐up (MD ‐0.18, 95% CI ‐0.69 to 0.33; 1 study, 45 participants); swallowing efficiency at the end of treatment (MD ‐4.4, 95% CI ‐7.5 to ‐1.3; 1 study, 45 participants), and after three months (MD ‐1.7, 95% CI ‐4.58 to 1.18; 1 study, 45 participants); dysphagia severity at the end of treatment (MD ‐2.78, 95% CI ‐18.04 to 12.48; 1 study; 45 participants) and after three months (MD ‐2.9, 95% CI ‐16.94 to 11.14; 1 study; 45 participants); quality of life at the end of treatment (MD 14.69, 95% CI ‐63.52 to 92.90; 1 study, 45 participants) and after three months (MD 11.4, 95% CI ‐67.95 to 90.75; 1 study, 45 participants). Lastly, EMST may result in little to no difference in peak expiratory flow after five weeks of treatment (MD ‐0.5 L/second, 95% CI ‐1.05 to 0.05; 1 study, 58 participants; low‐certainty evidence). The evidence is very uncertain about the effect of video‐assisted swallowing therapy (VAST) plus speech‐language therapy (SLT) compared to SLT alone on all the following outcomes: quality of life at the end of treatment (MD 1.62, 95% CI 0.33 to 2.91; 1 study, 42 participants), and after six months (MD 1.86, 95% CI 0.82 to 2.9; 1 study, 42 participants); and dysphagia severity at the end of treatment (MD ‐0.7, 95% CI ‐5.13 to 3.73; 1 study, 42 participants) and in the long term (MD ‐4.03, 95% CI ‐7.85 to ‐0.21; 1 study, 42 participants). The evidence is very uncertain about the effect of neuromuscular electrical stimulation (NMES) plus SLT compared to sham NMES plus SLT on swallowing safety (MD ‐1.34, 95% CI ‐2.32 to ‐0.36; 1 study, 18 participants; very low‐certainty evidence), and swallowing efficiency at the end of four weeks of treatment (MD ‐2.34, 95% CI ‐7.16 to 2.48; 1 study, 18 participants; very low‐certainty evidence). The evidence is also very uncertain about the effect of tongue strength training plus SLT compared to SLT alone on dysphagia severity after eight weeks of treatment (MD 0.13, 95% CI ‐0.17 to 0.43; 1 study, 60 participants; very low‐certainty evidence). Our certainty in these findings is very low due to imprecision (small sample size), high risk of bias related to deviations from intended interventions, measurement of the outcome, and the randomisation process, and poor reporting. Authors' conclusions Although the number of RCTs has increased since the publication of a previous Cochrane review...

Aim This work aimed to update and summarize the existing evidence on the effectiveness of robot-assisted training (RAT) in adults with Parkinson’s disease (PD). Methods We conducted a systematic review with meta-analysis, reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines (PROSPERO CRD42022371124). Seven databases and two trial registries were searched for randomized-controlled trials (RCTs) addressing RAT alone or in addition to other treatments in adults with PD up to January 2024. Primary outcomes were disease-specific motor impairment, balance, mobility, freezing of gait, falls, number of people who fell at least once, and adverse events. Meta-analysis using a random‐effects model was performed. Risk of bias (RoB) and certainty of the evidence for the primary outcomes were assessed using the Cochrane RoB Tool and the Grades of Recommendation Assessment, Development, and Evaluation (GRADE) approach, respectively. Results Fifteen RCTs (629 randomized adults with PD) were included. Our results show that the evidence is very uncertain about the effectiveness of any kind of RAT, either focused on gait, balance or upper limb impairment, compared to any comparator (treadmill training, overground gait training, exercises without the exoskeleton, conventional physical therapy, balance training, and no treatment), mainly because of RoB, inconsistency in individual studies results, and very limited number (less than 200) of participants considered in each comparison. Conclusion In light of the aforementioned very low certainty evidence, clinical considerations should be drawn very carefully. High-quality studies are thus highly needed to investigate potential benefits, risks, and cost/benefit ratio of RAT in adults with PD.