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. 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. 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. 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. 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. 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. 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. DOI 10.23736/S1973-9087.24.08833-6.
The 2023 iteration of the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) estimated prevalence, incidence, and health burden for 375 diseases and injuries, including 12 mental disorders. We assess past, current, and emerging trends in the prevalence and burden of mental disorders across sexes and age groups, for 21 regions, 204 countries and territories, and by Socio-demographic Index (SDI) quintile, from 1990 to 2023. Mental disorders included in GBD 2023 were anxiety disorders, major depressive disorder, dysthymia, bipolar disorder, schizophrenia, autism spectrum disorders, conduct disorder, attention-deficit hyperactivity disorder, anorexia nervosa, bulimia nervosa, idiopathic developmental intellectual disability, and a residual category of other mental disorders. A literature review identified epidemiological data for each disorder. These were analysed via a Bayesian meta-regression to estimate prevalence by disorder, sex, age, location, and year. Disorder-specific prevalence was multiplied by disability weights representing the severity of health loss associated with each disorder to estimate years lived with disability (YLDs). Deaths due to anorexia nervosa were assessed with a Cause of Death Ensemble modelling strategy to estimate deaths by sex, age, location, and year, and then multiplied by the standard life expectancy at age of death to estimate years of life lost (YLLs). YLDs equalled disability-adjusted life-years (DALYs) for all mental disorders except anorexia nervosa (the only mental disorder considered as an underlying cause of death in GBD), for which DALYs represented the sum of YLDs and YLLs. We presented prevalence, deaths, YLDs, YLLs, and DALYs as counts, age-specific rates per 100 000 population, and age-standardised rates per 100 000 population. We estimated 1·17 billion (95% uncertainty interval 1·06-1·31) prevalent cases of mental disorders globally in 2023, equivalent to an age-standardised prevalence rate of 14 210·7 cases (12 849·5-15 940·1) per 100 000 population. These estimates represented a 95·5% (75·0-121·2) increase in prevalent cases and 24·2% (11·4-41·4) increase in age-standardised prevalence rate between 1990 and 2023. All mental disorders showed increases in prevalent cases between 1990 and 2023, while notable increases were seen in age-standardised prevalence rates for anxiety disorders, major depressive disorder, dysthymia, anorexia nervosa, bulimia nervosa, schizophrenia, and conduct disorder. There were an estimated 171 million (127-228) DALYs due to mental disorders globally across sex and age in 2023, equivalent to an age-standardised DALY rate of 2070·5 DALYs (1519·1-2750·5) per 100 000 population. Mental disorders contributed to 6·1% (4·8-7·6) of all-cause DALYs in 2023, making them the fifth leading cause of global DALYs (up from 12th in 1990). DALYs were almost entirely composed of YLDs. Mental disorders were the leading cause of YLDs in 2023 (up from second in 1990), explaining 17·3% (14·8-20·6) of all-cause global YLDs. Leading causes of mental disorder DALYs were anxiety disorders (ranked 11th among the 304 diseases and injuries at Level 4 of the GBD cause hierarchy), major depressive disorder (15th), and schizophrenia (41st). Globally in 2023, mental disorder age-standardised DALY rates were higher among females (2239·6 [1643·7-3014·1] per 100 000) than among males (1900·2 [1399·8-2510·8] per 100 000), and peaked in the 15-19 years age group (2617·3 [1850·6-3696·8] per 100 000). All locations showed increased mental disorder DALY rates in 2023 compared with 1990, ranging across countries and territories from 1302·4 (952·7-1683·7) per 100 000 in Viet Nam to 3555·8 (2661·9-4715·0) per 100 000 in the Netherlands. Across SDI quintiles, DALY rates ranged from 1853·0 (1352·1-2469·3) per 100 000 for middle SDI to 2184·1 (1606·1-2890·3) per 100 000 for high SDI. A significant health burden was imposed by mental disorders in all countries and territories in 2023, irrespective of the health resources available. In some instances, this burden has increased over time and is unevenly distributed across populations. Stronger surveillance systems, particularly in low-income and middle-income countries, are required. Additionally, we need more coordinated and inclusive policies to reduce the burden through early treatment and prevention, tailored to sex and age differences across locations. Responding to the mental health needs of our global population, especially those most vulnerable, is an obligation, not a choice. Gates Foundation, Queensland Health, and University of Queensland.
Nutritional and exercise interventions have shown beneficial effects after gastrectomy for gastric cancer. While digital health tools show promise in cancer care, their long-term effectiveness in patients with gastric cancer remains unclear. In addition, large-scale studies of personalized interventions initiated in the immediate postoperative period are lacking. This study aimed to determine whether a personalized mobile health intervention incorporating exercise and nutrition confers additional benefits in weight change, body composition, nutritional status, physical fitness, and quality of life compared with standard care when applied continuously for 12 months after gastrectomy. This multicenter, randomized controlled trial enrolled 257 patients who had undergone curative resection for stage I-III gastric cancer. Participants were randomly assigned (2:1) to either a 12-month personalized mobile health intervention group or a standard rehabilitation control group. The digital intervention incorporated a smartphone app and wearable device, offering exercise and dietary plans tailored to clinical parameters such as BMI, surgery type, and recovery stage. Standard care, including nutritional education, was provided to all patients. The primary outcome was a change in body weight over 12 months. Secondary outcomes included quality of life (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 [EORTC QLQ-C30] and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Stomach 22), nutritional status (Mini Nutritional Assessment Score), physical fitness (grip strength, 30-second chair stand test, and 2-minute walk test), physical activity (International Physical Activity Questionnaire-Short Form), pain intensity (average Numeric Rating Scale), body composition (skeletal muscle mass, lean body mass, and fat mass), BMI, hemoglobin, vitamin B12, and albumin. Assessments were conducted at baseline and at 1, 3, 6, and 12 months postoperatively. No significant group-by-time effects were observed for weight change. Secondary outcomes showed no between-group differences, except for 1 subscale of the EORTC QLQ-C30, which lacked clinical significance. The intervention group reported high satisfaction and adherence to the mobile app, and no adverse events or incidents were observed during the 12-month study period. The digital health program integrating exercise and nutrition was safe and feasible, with high satisfaction and adherence among patients with gastric cancer. However, it was not superior to standard education in modifying the postoperative trajectory in patients with gastric cancer after surgery, including body weight change and related functional or nutritional outcomes. These findings suggest that future digital health programs should be precisely targeted and tailored to specific patient populations and recovery phases. ClinicalTrials.gov NCT04907591; https://clinicaltrials.gov/ct2/show/NCT04907591.
The integration of innovative technologies in Physical and Rehabilitation Medicine (PRM) has significantly advanced patient care, enhancing functional recovery and optimizing rehabilitation processes. Despite growing clinical adoption, a translational gap persists between technological advancements and routine clinical implementation. This study aims to map the available evidence on rehabilitation technologies, identifying their applications, effectiveness, and existing limitations. A mapping review of systematic reviews was conducted to explore the role of technological innovations in PRM. A systematic search of the MEDLINE (PubMed) database was performed up to July 14th, 2024. Eligible studies were screened based on predefined inclusion and exclusion criteria. Data extraction focused on rehabilitation domains, technological interventions, target populations, and Health Technology Assessment (HTA) aspects. Of 5124 identified records, 623 systematic reviews (12.2%) met the inclusion criteria. Neurological conditions represented the primary focus (56.8%), followed by musculoskeletal (23.7%) and cardiovascular rehabilitation (11.5%). The most frequently studied technologies included virtual reality (28.5%), non-invasive brain stimulation (18.7%), robotics (16.3%), and telerehabilitation (13.4%). Most studies assessed motor recovery (45%), pain management (22%), and cognitive or language rehabilitation (18%). Only 4.8% addressed HTA aspects such as cost-effectiveness and acceptability, highlighting a gap in real-world implementation studies. This mapping review underscores the increasing interest in technology-assisted rehabilitation but also highlights critical gaps, particularly in HTA assessments and training for PRM specialists. Standardized guidelines, structured training programs, and economic evaluations are essential to optimize integrating rehabilitation technologies into clinical practice. Further research should focus on long-term efficacy, accessibility, and sustainability to ensure equitable access to innovative rehabilitation solutions.
The Italian version of Rehabilitation Complexity Scale-Extended v13 (RCS-E v13) introduced the possibility to objectively assessing rehabilitation patients' needs in terms of clinical complexity integrating tools to assess disability and comorbidity in Italy. To evaluate the contribution of RCS-E v13 in combination with Barthel Index and Cumulative Illness Rating Scale in profiling patients at admission in intensive rehabilitation (IR), extensive rehabilitation (ER) and highly specialized post-acute rehabilitation (HSR). Observational multicenter prospective cross-sectional study. Adult patients admitted to 25 Italian Rehabilitation accredited facilities both public and private in eight different regions. Overall, 2809 subjects were included (2454 in IR; 333 in HSR and 22 in ER). Only IR and HSR data were analyzed since the paucity of ER data. Spearman correlation showed a strong association between RCS-E v13 and BI (ρ=-0.61) and weak correlation with CIRS total score (ρ=0.36 and 0.32), SI (ρ=0.35 and 0.29) and CI (ρ=0.30 and 0.27). EFA revealed two factors (85% variance; KMO=0.747; P<0.001): Factor 1 (CIRS) weakly correlated with LoS (ρ=0.219), Factor 2 (RCS, BI) strongly (ρ=0.677). RCS-Ev13 and BI predicted rehabilitation LoS, with their interaction significantly improving model fit (ΔR2=+0.034; P<0.001) and were able to profile differences across IR levels within various MDCs (Kruskal-Wallis Test P<0.001). Brunner-Munzel Test showed Statistical differences (P<0.001) between neurological patients admitted to IR and HSR, as assessed by RCS-E and BI, respectively. Sensitivity analyses - stratified by age (≥75), LoS (> median), and outlier status (±1.5 IQR) confirmed the robustness of the main results across subgroups and conditions. Findings support the combined use of RCS-E v13 and BI for patient profiling at admission, with CIRS showing comparatively lower effectiveness in this context. This study contributes to defining rehabilitation complexity in the Italian context. RCS-E v13 and BI emerged as complementary, objective tools for profiling care needs across MDCs and settings, with potential use for admission appropriateness, prognostic stratification, and care planning. Findings highlight that rehabilitation complexity requires a multifactorial assessment, not fully captured by comorbidity alone.
Breast cancer is a leading cause of mortality and morbidity among females worldwide. As part of the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2023, we provided an updated comprehensive assessment of the epidemiological trends, disease burden, and risk factors associated with breast cancer globally, regionally, and nationally from 1990 to 2023. Breast cancer incidence, mortality, prevalence, years lived with disability (YLDs), years of life lost (YLLs), and disability-adjusted life-years (DALYs) were estimated by age and sex for 204 countries and territories from 1990 to 2023. Mortality estimates were generated using GBD Cause of Death Ensemble models, leveraging data from population-based cancer registration systems, vital registration systems, and verbal autopsies. Mortality-to-incidence ratios were calculated to derive both mortality and incidence estimates. Prevalence was calculated by combining incidence and modelled survival estimates. YLLs were established by multiplying age-specific deaths with the GBD standard life expectancy at the age of death. YLDs were estimated by applying disability weights to prevalence estimates. The sum of YLLs and YLDs equalled the number of DALYs. Breast cancer burden attributable to seven risk factors was examined through the comparative risk assessment framework. The GBD forecasting framework was used to forecast breast cancer incidence and mortality from 2024 to 2050. Age-standardised rates were calculated for each metric using the GBD 2023 world standard population. In 2023, there were an estimated 2·30 million (95% uncertainty interval [UI] 2·01 to 2·61) breast cancer incident cases, 764 000 deaths (672 000 to 854 000), and 24·1 million (21·3 to 27·5) DALYs among females globally. In the World Bank low-income group, where a low age-standardised incidence rate (ASIR) was estimated (44·2 per 100 000 person-years [31·2 to 58·4]), the age-standardised mortality rate (ASMR) was the highest (24·1 per 100 000 [16·8 to 31·9]). The highest ASIR was in the high-income group (75·7 per 100 000 [67·1 to 84·0]), and the lowest ASMR was in the upper-middle-income group (11·2 per 100 000 [10·2 to 12·3]). Between 1990 and 2023, the ASIR in the low-income group increased by 147·2% (38·1 to 271·7), compared with a 1·2% (-11·5 to 17·2) change in the high-income group. The ASMR decreased in the high-income group, changing by -29·9% (-33·6 to -25·9), but increased by 99·3% (12·5 to 202·9) in the low-income group. The increase in age-standardised DALY rates followed that of ASMRs. Risk factors such as dietary risks, tobacco use, and high fasting plasma glucose contributed to 28·3% (16·6 to 38·9) of breast cancer DALYs in 2023. The risk factors with a decrease in attributable DALYs between 1990 and 2023 were high alcohol use and tobacco. By 2050, the global incident cases of breast cancer among females were forecast to reach 3·56 million (2·29 to 4·83), with 1·37 million (0·841 to 2·02) deaths. The stable incidence and declining mortality rates of female breast cancer in high-income nations reflect success in screening, diagnosis, and treatment. In contrast, the concurrent rise in incidence and mortality in other regions signals health system deficits. Without effective interventions, many countries will fall short of the WHO Global Breast Cancer Initiative's ambitious target of achieving an annual reduction of 2·5% in age-standardised mortality rates by 2040. The mounting breast cancer burden, disproportionately affecting some of the world's most vulnerable populations, will further exacerbate health inequalities across the globe without decisive immediate action. Gates Foundation, St Jude Children's Research Hospital.
The relationship between changes in physical function and quality of life in pancreatic cancer patients undergoing chemotherapy is not yet fully understood. This study aimed to examine the physical function trajectories and their relationship with the quality of life in these patients. A total of 273 patients with pancreatic cancer were recruited for this study. Three physical functional tests (maximum grip strength, 2-minute step test [2-MST], and timed up and go) were performed at baseline (before chemotherapy) and at 2, 4, 6, 9, and 12 months of chemotherapy. Quality of life was measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire. A linear mixed-effects model was used to detect changes in physical function over time and to assess associations among the primary outcomes. The grip strength significantly decreased (P = .005), whereas the number of 2-MST repetitions significantly increased (P < .001) at 12 months of chemotherapy. Both outcomes were significantly correlated with the physical functioning domain (grip strength: P < .001, 2-MST: P < .001). However, only the 2-MST outcome was associated with the global health status domain (P < .001). Patients with pancreatic cancer showed reduced grip strength and improved 2-MST performance at 12 months of chemotherapy. Both outcomes correlated with health-related quality of life. These findings highlight the importance of monitoring functional performance in pancreatic cancer patients using both tests, particularly during the early phases of chemotherapy, and offer valuable insights for the development of rehabilitation and supportive care strategies.
Liver resection patients face a heightened risk of pulmonary complications and decreased quality of life during the perioperative period. The enhanced recovery after surgery (ERAS)-based pulmonary rehabilitation exercise program may offer potential benefits in mitigating these issues. This study aims to develop and evaluate the clinical effectiveness of an ERAS-based pulmonary rehabilitation exercise program for liver resection patients during the perioperative period. A prospective, randomized controlled trial (RCT). A single-center study conducted in the Department of Hepatobiliary and Pancreatic Surgery at a tertiary hospital. Patients undergoing liver resection for the first time between July 2024 and December 2024. This prospective study included patients who underwent liver resection for the first time in the Department of Hepatobiliary and Pancreatic Surgery of our hospital between July 2024 and December 2024. Patients were randomly assigned to either the intervention group (ERAS pulmonary rehabilitation exercise program) or the control group (routine rehabilitation care). Primary outcome measures included changes in pulmonary function indicators at postoperative days 1, 3, and 5. Secondary outcomes included changes in exercise function, postoperative complications, and other rehabilitation indicators. A total of 202 patients were enrolled, with 100 in the intervention group and 102 in the control group. The intervention group showed significantly better improvements in pulmonary function indicators (FVC, FEV1, PEF, MEF75, and Borg score) on postoperative days 1, 3, and 5 compared to the control group. The time×group interaction effects were statistically significant (P<0.05). On postoperative day 5, the intervention group also demonstrated superior exercise capacity, grip strength, and ADL scores in the 6-minute walk test compared to the control group (P<0.05). Additionally, the incidence of postoperative complications, such as atelectasis and deep vein thrombosis, was lower in the intervention group (P<0.05). The intervention group had significantly shorter postoperative recovery times, including time to first bowel movement, time to first ambulation, antibiotic use, hospital stay, and hospitalization costs compared to the control group (P<0.05). The implementation of an ERAS-based pulmonary rehabilitation exercise program effectively promotes postoperative pulmonary recovery, reduces complications, and enhances activities of daily living, showing promising clinical applicability. This study supports the integration of ERAS-based pulmonary rehabilitation into perioperative care for liver resection patients to enhance pulmonary function, accelerate recovery, and improve overall postoperative outcomes.
Robotic exoskeletons offer a promising tool for gait rehabilitation in individuals with spinal cord injury (SCI). However, evidence of their additive benefit over conventional therapy, particularly in non-acute, motor-incomplete SCI, remains limited. To evaluate the efficacy of the EKSO-GT™ exoskeleton, used in an "add-on" mode, on walking performance and related clinical outcomes compared to standard neurorehabilitation alone. Randomized, controlled, multicenter trial. Rehabilitation centers. Thirty-six patients with chronic, motor-incomplete SCI (AIS C/D, 1-5 years post-injury) were randomized to receive either 4 weeks of exoskeleton-assisted training followed by 4 weeks of standard rehabilitation (RC+E), or 8 weeks of standard rehabilitation alone (RC). The primary outcome was the proportion of participants achieving ≥ 10% improvement in walking speed (10-meter walk test) at 4 weeks. Secondary outcomes included gait endurance, muscle strength, spasticity, proprioception, pain and mood. At 4 weeks, 33.3% of RC+E vs. 46.7% of RC patients improved in walking speed (P=0.44); at 8 weeks, 43.8% vs. 66.7%, respectively (P=0.20). No significant between-group differences were found for any outcome, including endurance, strength, or pain. Both groups demonstrated clinically relevant within-group improvements over time. No adverse events occurred. In individuals with chronic, motor-incomplete SCI, robotic gait training using the EKSO-GT™ exoskeleton was safe and well-tolerated, but did not show a superior statistical effect on walking performance compared with conventional rehabilitation when delivered as a short-term add-on intervention. These findings should be interpreted within the context of the study and small sample size. Continued structured rehabilitation remains essential for functional maintenance and improvement in this population. While robotic exoskeletons are feasible and safe in chronic SCI rehabilitation, their routine use as a short-term add-on to standard therapy may not yield additional functional benefits under the tested conditions. Emphasis should remain on comprehensive, individualized rehabilitation programs tailored to patient-specific needs. Larger, adequately powered studies are needed to confirm these findings.
Previous analyses demonstrated that Italian versions of the five short forms of the Brain Injury Rehabilitation Trust Personality Questionnaires (SF-BIRT-PQs) showed strong psychometric properties. However, evidence on their interpretability lacks. To calculate cutoffs for each of the SF-BIRT-PQ to discriminate between the subject's behavior that deviates significantly (D+) or not (D-) from the average of healthy individuals. Multicenter prospective study. One hundred and fifty-four subjects with acquired brain injury, their 154 caregivers, and 120 healthy subjects. SF-BIRT-PQs and disability measures were administered to the included subjects. Moreover, subjects scored the Satisfaction Profile (SAT-P) and disability measures, while the Caregiver Burden Inventory (CBI) and Frontal Behavioral Inventory (FBI) were administered to caregivers. Cutoffs between scores indicating D- or D+ patients were calculated with Z-scores, and Mann-Whitney Tests were used to assess the scores of the comparator instruments across the two groups (i.e., D+ and D-) generated by the cutoff for each SF-BIRT-PQs separately for the patient (using SAT-P, DRS, LCF) and caregiver samples (using CBI, FBI, DRS, LCF). Cutoffs to discriminate between D+ and D- were identified (SF-BMQ ≥25 points, SF-BREQ ≥19 points, SF-BSCQ ≥14 points, SF-BDQ ≥15 points, SF-BIQ ≥18 points indicated D+). Generally, for the patients' sample, between-group comparisons showed significant differences between all SF-BIRT-PQs (except BDQ and BIQ) and the SAT-P subscales (P<0.05) but not with disability measures (P>0.05). In contrast, for the caregivers' sample, between-group comparisons showed significant differences between all SF-BIRT-PQs and the CBI and FBI subscales (P<0.05) but not with disability measures (P>0.05). A digital ruler was devised to convert raw scores into interval measures. We provided evidence in support of the construct validity of the proposed cutoffs for each SF-BIRT-PQ. These cutoffs make the short forms of the BIRT-PQs interpretable by quantifying the amount of the patient's behavior divergence from that of the average healthy individual. The electronic rulers for each BIRT-PQ provide several functions that greatly facilitate the SF-BIRT-PQ administration and interpretation.
Stroke often causes spasticity, impacting mobility and quality of life. Botulinum Toxin type A (BTX-A) and Dry Needling (DN) are treatments that reduce spasticity, although Botulinum Toxin type A injections can cause adverse effects. No studies have directly compared their effects at spinal, muscular, functional, quality-of-life, and cost-effectiveness levels. This study aims to determine the spinal mechanisms of BTX-A and DN on post-stroke lower limb spasticity, while also assessing feasibility, safety, and exploratory effects at muscular, functional, quality-of-life, and cost-effectiveness levels. This is a protocol of a proof-of-concept, feasibility randomized clinical trial including 90 participants from Canada, Belgium, and Spain who experienced a first stroke in the previous 12 months and present plantar flexor spasticity. Time since stroke (0-12 months) will be recorded and explored as a potential modifier of treatment response. Participants will be randomly assigned to receive either one session of BTX-A or 12 weekly sessions of DN. Blinded evaluators will assess outcomes before, during, and after treatment, with a 4-week follow-up. The primary outcome will be spinal mechanisms of spasticity, measured using the Tonic Stretch Reflex Threshold and its velocity sensitivity. Secondary outcomes will assess: a) muscular architecture and echotexture (measured with ultrasound); b) muscle tone/resistance using the Modified Ashworth Scale; c) gait and mobility (instrumented analysis, Timed Up and Go, 10-Meter Walk Test); d) muscle strength with dynamometry; e) quality of life with the EuroQoL questionnaire; and f) cost-effectiveness (analytic model). The findings will provide preliminary data to inform a future definitive trial. This research project has secured funding from the NEURON ERA-NET 2022 call, supported by the European Union's Horizon 2020 program (GA 964215) and co-funded by the European Union-Next Generation, and has undergone peer review. Ethical approval has been obtained from Spain, Canada, and Belgium. The study is registered in ClinicalTrials.gov (NCT06296082) and the Clinical Trials Information System (CTIS) under the number 2024-510866-18-00. The study protocol is registered on Zenodo (https://doi.org/10.5281/zenodo.20034064). Clinical Trials NCT06296082; https://clinicaltrials.gov/study/NCT06296082.
People with mental disorders have an increased risk of diabetes, yet conflicting evidence exists regarding the quality of diabetes care they receive. To address this evidence gap, we conducted a systematic review and meta-analysis to assess and compare diabetes quality of care in people with diabetes with mental disorders versus people with diabetes without mental disorders. In this systematic review and random-effects meta-analysis, we searched Scopus, Embase, MEDLINE, and PsycINFO for cohort and case-control studies published between database inception and Feb 8, 2025. We estimated summary odds ratios (ORs) for diabetes quality of care indicators in individuals with any mental disorder versus without mental disorders to investigate the association between the presence of a mental disorder and diabetes quality of care indicators, including overall diabetes monitoring and treatment. Studies were excluded if it was not possible to generate pooled quantitative data. The primary outcome was a binary composite measure of diabetes quality of care, meaning the percentage of people receiving any diabetes monitoring and treatment (ie, urine albumin-creatinine ratio test, HbA1c test, blood pressure measured, foot surveillance, serum creatinine test, serum cholesterol test, BMI recorded, smoking status recorded, retinal monitoring). Secondary outcomes were study-specific diabetes quality of care individual indicators matched to the nine NICE diabetes monitoring indicators and specific diabetes interventions and anti-diabetes medications. We analysed primary and secondary outcomes according to any mental disorder and to specific diagnostic subgroups. Study quality was evaluated using the Newcastle-Ottawa Scale (NOS). Data from 49 studies (42 cohort and seven case-control) were included, comprising 5 503 712 individuals with diabetes, of whom 838 366 (15·2%) had a diagnosed mental disorder (defined using ICD-9 or ICD-10 criteria in 40 studies). Sex was reported in 35 of 49 studies, comprising 4 250 666 individuals, 1 956 506 (46·0%) of whom were female and 2 294 160 (54·0%) were male. The mean age was 61·4 years (SD 8·7; range 47-82 years). 38 studies reported on various mental disorders, 21 on mood disorders spectrum, 21 on major depressive disorder, 20 on schizophrenia, 11 on bipolar disorder, 11 on substance use disorder spectrum, including alcohol use disorder, six on dementia, five on anxiety disorder spectrum, and one on personality disorder spectrum. Most studies were high quality and spanned Asia, North America, Europe, and Australasia. Significant negative associations were observed between having any mental disorder and the likelihood of receiving any recommended diabetes monitoring (29 studies, OR=0·81 [95% CI 0·70-0·94], p=0·0049). Negative associations were also observed for HbA1c measurement (24 studies, 0·81 [0·68-0·97], p=0·024), retinal screening (21 studies, 0·77 [0·63-0·95], p=0·013), lipid and cholesterol measurement (20 studies, 0·83 [0·69-0·99], p=0·043), foot examination (11 studies, 0·85 [0·76-0·95], p=0·0044), and renal investigation (16 studies, 0·78 [0·63-0·96], p=0·022). A significant positive association was found between any mental disorder and recorded smoking status (two studies, 1·09 [1·02-1·17]; p=0·0076). Any mental disorder was significantly associated with higher odds of receiving insulin (ten studies, 1·52 [95% CI 1·16-1·99]; p=0·0022), but negatively associated with treatment with a GLP-1 receptor agonist (two studies, 0·26 [0·13-0·49]; p<0·0001). There was no evidence of publication bias. Mental disorders are negatively associated with receiving adequate diabetes monitoring and GLP-1 agonist therapy. Addressing these disparities has the potential to address the increased mortality associated with mental disorders. None.
More older adults with displaced proximal humerus fracture (PHF) are managed nonsurgically and referred to supervised rehabilitation, but its effectiveness is unknown. The primary objective of this trial was to investigate if supervised rehabilitation is superior to a single session of advice on patient-reported shoulder pain and function at 6 months postinjury, in older adults with displaced PHF treated nonoperatively. This is a pragmatic, single center randomized controlled trial conducted in an orthopedic outpatient clinic at a Danish university hospital. Eighty adults aged ≥60 with displaced PHF treated nonoperatively were screened between May 5, 2022 and November 11 2023. Patients were excluded if they presented with competing injuries. Sixty patients (mean age 75 years, 44 (73%) female) were enrolled. All patients received a session of advice on gradual return to daily activities. After randomization, 30 patients were allocated to referral to the experimental supervised rehabilitation by physiotherapists in the municipalities (usual care). The remaining 30 patients did not receive further training (comparator group). All patients received routine clinical follow-up with radiographs at six weeks and six months. The primary outcome was patient-reported shoulder function measured with Oxford Shoulder Score 6 months after injury. A 95% confidence interval excluding differences greater than 10 units between groups was prespecified as indicating the absence of a clinically meaningful difference. Secondary outcomes included Oxford Shoulder Score at 12 months, quality of life assessed with European Quality of life-5 Dimensions-3-Level at 6 and 12 months, conversion to surgery, and adverse events at any time point. Analyses were on an intention to-treat basis adjusted for age, sex, and fracture type. Fifty-six (93%) completed the primary outcome score (n = 29 allocated to advice and supervised rehabilitation, n = 27 allocated to advice only). The least squares mean Oxford Shoulder Score at 6 months was 33.9 in the supervised rehabilitation group and 33.8 in the advice-only group. Consequently, in the main analysis, there was no difference between groups (mean difference, 0.05; 95% confidence interval, -4.5 to 4.6 P = .98), potentially corresponding to a negligible effect size <0.01. All secondary outcomes aligned with the primary endpoint. At 12 months, 4 patients had converted to surgery (3 supervised rehabilitation vs. 1 single advice session). Adverse events were similar across the 2 groups. The self-reported outcomes of supervised rehabilitation were comparable to those of a single advice session. Routine referral to supervised rehabilitation may not be necessary for all patients.
Background and Objectives: Knee osteoarthritis (OA) is a leading cause of pain and disability, with radiographic severity influenced by age, biomechanical alignment, and structural joint features. Data describing the association between common radiographic parameters and OA severity in Eastern European clinical populations remain limited. This study aimed to evaluate the associations between radiographic OA severity and coronal alignment, patellar height, and chondrocalcinosis in a Romanian clinical cohort. Materials and Methods: This single-center cross-sectional study included adult patients undergoing knee radiography for knee-related symptoms and/or functional assessment at a rehabilitation hospital between 2023 and 2025. Radiographs were obtained in the supine, non-weight-bearing position and included anteroposterior and lateral views. OA severity was graded using the Kellgren-Lawrence (KL) classification. Coronal alignment was assessed using the femorotibial angle, patellar height using the Insall-Salvati ratio (ISR), and chondrocalcinosis was recorded as present or absent. Associations between radiographic parameters and KL grade were analyzed using non-parametric statistics. Receiver operating characteristic (ROC) analyses were performed for exploratory assessment of limited separation between distributions. Results: Moderate to severe OA (KL ≥ 3) was present in 49% of patients. KL grade showed a moderate positive correlation with age (r = 0.50, p < 0.001) and differed significantly across coronal alignment categories (p < 0.001). Varus/valgus and pathological alignment classifications demonstrated moderate sensitivity (0.69-0.85) and variable specificity (0.52-0.85) for higher KL grades. ROC analyses of continuous alignment and ISR measures yielded area under the curve values ranging from approximately 0.65 to 0.68, indicating limited separation between distributions. Radiographically detected chondrocalcinosis was present in 5.3% of patients and showed no significant association with OA severity, and neither did patellar height. Conclusions: In this single-center Romanian clinical cohort, radiographic OA severity was associated with coronal plane alignment but not with patellar height or chondrocalcinosis. Alignment measures demonstrated limited discriminative ability and should be interpreted as complementary rather than diagnostic indicators of OA severity. These findings provide descriptive radiographic data from an Eastern European clinical population and highlight the need for longitudinal and population-based studies incorporating mechanical axis assessment and functional outcomes.
Early identification and appropriate management of dysphagia are critical for improving outcomes of acute ischemic stroke. To develop a simple and reliable scoring system to predict the severity of dysphagia in patients with acute ischemic stroke by integrating ultrasound (US) parameters with clinical variables. Prospective, cross-sectional observational study. Inpatient neurology department of a university-affiliated hospital. A total of 212 patients with acute ischemic stroke were prospectively enrolled in this study. The mild dysphagia group and severe dysphagia group comprised 146 patients and 66 patients, respectively. Group assignment was based on the need for dietary modifications confirmed via retrospective review of dietary status, videofluoroscopic swallowing study results, and the occurrence of aspiration pneumonia during hospitalization. Dynamic M-mode US of the suprahyoid muscle (SHM) was performed during swallowing. The following six SHM parameters were obtained: SHM thickness (baseline thickness of the SHM); SHM displacement (peak-to-peak amplitude of SHM movement); SHM difference (SHM displacement - SHM thickness); SHM ratio (SHM displacement/SHM thickness); peak-to-peak time; and total duration. The study population was randomly split into training (70%) and test (30%) sets. Least absolute shrinkage and selection operator and logistic regression analyses were performed to identify significant predictors of severe dysphagia. These predictors were used to develop and validate a simple scoring system. Brainstem lesion, bilateral lesion, National Institutes of Health Stroke Scale (NIHSS) score, SHM difference, and total duration were identified as key predictors of severe dysphagia. A simple scoring system based on these variables showed excellent discriminative performance. Areas under the receiver-operating characteristic curves (AUCs) of the training set and the test set were 0.963 and 0.935, respectively. A cutoff of ≥3 points yielded sensitivity of 97.9% and specificity of 86.4% for the training set as well as sensitivity of 78.9% and specificity of 95.3% for the test set. This simple scoring system combining US and clinical parameters enabled early identification of patients at increased risk for severe dysphagia. The dysphagia severity prediction score can facilitate timely management of patients with acute ischemic stroke, thus potentially reducing complications and enhancing dysphagia rehabilitation.
Chronic primary pain is a leading cause of disability worldwide and requires a multimodal management approach. Instrumental physical therapies are widely used in rehabilitation, although their effectiveness remains heterogeneous across conditions and modalities. The objective of this paper is to synthesize the evidence and recommendations from the 2026 Clinical Practice Guideline developed by the Italian Society of Physical and Rehabilitation Medicine (SIMFER) on the use of instrumental physical therapies in chronic primary pain (i.e., complex regional pain syndrome, fibromyalgia, and primary bone marrow edema syndromes). The guideline was developed following the GRADE methodology. Systematic searches of Medline, Embase, and Cochrane Library were performed to identify systematic reviews and randomized controlled trials. Evidence was appraised in terms of risk of bias, inconsistency, indirectness, imprecision, and publication bias. Recommendations were formulated using the Evidence-to-Decision framework. The panel issued a conditional recommendation in favor of adding instrumental physical therapies to conventional treatment in patients with fibromyalgia, complex regional pain syndrome, and primary bone marrow edema syndromes. Evidence suggests modest to large improvements in pain and disability for specific modalities such as TENS, low-level laser therapy, and electromagnetic field therapy. However, overall certainty of evidence ranged from moderate to very low due to methodological limitations and heterogeneity. Adverse events were generally mild and transient, and patient acceptability was high. Instrumental physical therapies may be considered as adjunctive interventions within a multimodal rehabilitation approach for chronic primary pain. Despite encouraging findings, the low certainty of evidence highlights the need for high-quality trials with standardized protocols and long-term follow-up to strengthen future recommendations.
Motor learning (MoL) plays a key role in restorative therapies after neurological injury. However, its integration into clinical protocols is not yet fully systematized. This study aims to identify and organize essential MoL variables (practice, task, feedback, environment, individual, and therapist), contributing to the development of a practical checklist to support clarity, coherence, and reproducibility in neurorehabilitation. A two-level approach was employed to identify and structure MoL variables relevant to neurorehabilitation. In the first level, three expert raters independently reviewed chapters from authoritative MoL manuals to extract and hierarchically organize variables into core, intermediate, and peripheral categories. In the second level, a comprehensive literature review was conducted following PRISMA guidelines. Natural language processing (NLP) techniques, including latent dirichlet allocation (LDA) and N-gram analysis, were used to validate and expand the initial taxonomy, assess terminology frequency, and examine semantic relationships among variables. This combined expert-driven and data-driven process ensured both theoretical consistency and empirical relevance. The final outcome of this methodology was the development of a practical and structured checklist to support the clear and reproducible application of MoL variables in neurorehabilitation protocols. The analysis led to the identification of six core variables Practice, Task, Feedback, Environment, Individual, and Therapist consistently recognized across expert manuals and validated through NLP-based literature analysis. While four variables (Practice, Task, Feedback, Individual) were confirmed by both methods, Environment and Therapist emerged exclusively from manual analysis, highlighting their conceptual relevance despite lower recurrence in literature. Semantic analysis confirmed approximately 80% of related intermediate and peripheral variables, supporting the robustness of the taxonomy. Based on this framework, two structured checklists were developed: one to characterize each task before its delivery, and one to document key variables during execution. These tools aim to translate the taxonomy into a usable format for both clinical and research contexts. This work introduces practical, standardized MoL checklists, bridging research and clinical practice. It supports reproducibility, optimizes rehabilitation protocols, and lays a foundation for future neurorehabilitation research and innovation.
Research has shown that late fatigue post-stroke is associated with poorer long-term outcomes, but the association between early fatigue with concurrent outcomes like physical function within six months is underexplored. To explore the interrelationship between stroke survivors' adaptation to fatigue and physical function changes during hospitalization and at one, three, and six months post-stroke. A prospective longitudinal cohort study with a convergent mixed-methods design. Adults (≥18 years) with first-ever ischemic stroke were included. Fatigue, physical function, and data from semi-structured interviews were collected at four time points. A mixed-effect model was used to explore the quantitative relationship, with physical function as the dependent outcome and fatigue as the fixed-effect variable. Directed content analysis was used for qualitative data. A side-by-side display was used to present mixed-methods findings. Thirty-two survivors were in the quantitative arm; nine of those were in the qualitative arm. Quantitative analysis showed that each unit increase in fatigue decreased physical function by 0.27, adjusting for age, depression, and time. Qualitative findings confirmed that fatigue hindered recovery and pre-stroke activity resumption. Survivors described a vicious cycle between fatigue and function, with varying fatigue patterns and exacerbating factors within six months. Fatigue and physical function were interrelated within six months after stroke. Given the small, single-center sample, these results should be interpreted cautiously. Still, our findings highlight the value of early, systematic fatigue assessment and collaborative discussions between survivors and health professionals to guide individualized management strategies. Managing post-stroke fatigue requires both survivor-led strategies (e.g., self-monitoring, rest, pacing) and professional support to address contributing conditions. Routine follow-up should include systematic fatigue assessment, collaborative discussion of management options, and periodic re-evaluation to optimize recovery.
Few studies have evaluated the long-term effects of head and neck cancer (HNC) and its treatment. Therefore, the objective was to study nutritional rehabilitation needs by assessing nutritional problems, dietary adjustments, muscle mass, muscle strength, physical performance, prevalence of sarcopenia, and health-related quality of life (HRQoL) among long-term HNC survivors. This cross-sectional study included HNC survivors more than 5 years after diagnosis. Nutritional status, sarcopenia, and physical performance were assessed through questions about dietary adjustments, muscle mass (bioelectrical impedance analysis), grip strength, and maximum walking speed measurements. HRQoL and nutrition impact symptoms (NISs) were assessed using quality of life questionnaires from the European Organization for Research and Treatment of Cancer (EORTC), QLQ-C30 and QLQ-HN35, and were compared with reference values from a normal Swedish population. Almost 80% of 114 participating survivors needed dietary adjustments, most commonly extra liquid with meals and/or moist food and increased time to consume meals. Relatively few patients had reduced muscle mass and low BMI, and none had sarcopenia. Compared with reference values, survivors reported severe HNC-specific symptoms on the EORTC QLQ-HN35. Survivors with the most problems swallowing solid food had a higher NIS burden and more problems with role and social functioning. In this cross-sectional study, many long-term HNC survivors experienced chronic NISs and had worse HRQoL than a matched reference group from the normal population. The findings suggest that survivors with nutritional problems may have adapted and used dietary adjustments to facilitate food intake. For some survivors, nutritional rehabilitation may be needed long after treatment has ended.
Balneotherapy is used since ancient times, effects on hand osteoarthritis however are not well elucidated. To evaluate therapeutic effects of serial thermal brine hand baths (tbhb) in patients experiencing painful hand osteoarthritis (HOA). Randomized, double-blind, sham-controlled monocentric clinical trial. Outpatient clinic, monocentric. Patients with painful bilateral painful HOA meeting the 1990 American College of Rheumatology classification criteria with a baseline pain level >30 mm on the Visual Analog Scale (VAS) and radiographic evidence of hand osteoarthritis in posteroanterior X-ray projection, classified as Kellgren and Lawrence grade ≥2. Probands were randomized to the intervention group (IG) receiving tbhb or the control group (CG) receiving tap water hand baths (sham). Both hand baths (tbhb and sham) were performed 6 times in 3 weeks with 15 min/bath at a water temperature of 25 °C. The primary outcome was the change in pain intensity (VAS [mm]) following the intervention. Secondary outcomes were changes in the Australian Canadian Osteoarthritis Hand Index (AUSCAN), grip strength, functional parameters of microcirculation (by O2C method), vascular endothelial growth factor (VEGF) and safety. Outcomes were primarily analysed after the last intervention followed by secondary analysis of the follow-up visits 4 and 12 weeks after intervention and during intervention. A total of 38 patients successfully completed the trial. Pain intensity significantly decreased due to tbhb (P<0.001), with sustained benefits observed up to 3 months post-intervention. The AUSCAN pain subscore was significantly reduced (P<0.001). There was no significant change in other AUSCAN subscores, nor in grip strength or functional parameters of microcirculation including VEGF due to tbhb. No adverse events due to tbhb were observed. Thermal brine hand baths represent a simple, effective, and well-tolerated method to achieve pain relief in HOA with results lasting up to 12 weeks after intervention. Thermal brine hand baths can be used to reduce pain in HOA.