Evidence-informed and consensus-based statements about SAFEty of Physical Agent Modalities Practice in physiotherapy and rehabilitation medicine (SAFE PAMP): a national Delphi of healthcare scientific societies.

OBJECTIVE: A shared consensus on the safety about physical agent modalities (PAMs) practice in physiotherapy and rehabilitation is lacking. We aimed to develop evidence-informed and consensus-based statements about the safety of PAMs. STUDY DESIGN AND SETTING: A RAND-modified Delphi Rounds' survey was used to reach a consensus. We established a steering committee of the Italian Association of Physiotherapy (Associazione Italiana di Fisioterapia) to identify areas and questions for developing statements about the safety of the most commonly used PAMs in physiotherapy and rehabilitation. We invited 28 National Scientific and Technical Societies, including forensics and lay members, as a multidisciplinary and multiprofessional panel of experts to evaluate the nine proposed statements and formulate additional inputs. The level of agreement was measured using a 9-point Likert scale, with consensus in the Delphi Rounds assessed using the rating proportion with a threshold of 75%. RESULTS: Overall, 17 (61%) out of 28 scientific and technical societies participated, involving their most representative members. The panel of experts mainly consisted of clinicians (88%) with expertise in musculoskeletal (47%), pelvic floor (24%), neurological (18%) and lymphatic (6%) disorders with a median experience of 30 years (IQR=17-36). Two Delphi rounds were necessary to reach a consensus. The final approved criteria list comprised nine statements about the safety of nine PAMs (ie, electrical stimulation neuromodulation, extracorporeal shock wave therapy, laser therapy, electromagnetic therapy, diathermy, hot thermal agents, cryotherapy and therapeutic ultrasound) in adult patients with a general note about populations subgroups. CONCLUSIONS: The resulting consensus-based statements inform patients, healthcare professionals and policy-makers regarding the safe application of PAMs in physiotherapy and rehabilitation practice. Future research is needed to extend this consensus on paediatric and frail populations, such as immunocompromised patients.

Effectiveness of Telemedicine for Musculoskeletal Disorders: Umbrella Review.

BACKGROUND: Several systematic reviews (SRs) assessing the use of telemedicine for musculoskeletal conditions have been published in recent years. However, the landscape of evidence on multiple clinical outcomes remains unclear. OBJECTIVE: We aimed to summarize the available evidence from SRs on telemedicine for musculoskeletal disorders. METHODS: We conducted an umbrella review of SRs with and without meta-analysis by searching PubMed and EMBASE up to July 25, 2022, for SRs of randomized controlled trials assessing telemedicine. We collected any kind of patient-reported outcome measures (PROMs), patient-reported experience measures (PREMs), and objective measures, including direct and indirect costs. We assessed the methodological quality with the AMSTAR 2 tool (A Measurement Tool to Assess systematic Reviews 2). Findings were reported qualitatively. RESULTS: Overall, 35 SRs published between 2015 and 2022 were included. Most reviews (n=24, 69%) were rated as critically low quality by AMSTAR 2. The majority of reviews assessed "telerehabilitation" (n=29) in patients with osteoarthritis (n=13) using PROMs (n=142 outcomes mapped with n=60 meta-analyses). A substantive body of evidence from meta-analyses found telemedicine to be beneficial or equal in terms of PROMs compared to conventional care (n=57 meta-analyses). Meta-analyses showed no differences between groups in PREMs (n=4), while objectives measures (ie, "physical function") were mainly in favor of telemedicine or showed no difference (9/13). All SRs showed notably lower costs for telemedicine compared to in-person visits. CONCLUSIONS: Telemedicine can provide more accessible health care with noninferior results for various clinical outcomes in comparison with conventional care. The assessment of telemedicine is largely represented by PROMs, with some gaps for PREMs, objective measures, and costs. TRIAL REGISTRATION: PROSPERO CRD42022347366; https://osf.io/pxedm/.

Performance of ChatGPT Compared to Clinical Practice Guidelines in Making Informed Decisions for Lumbosacral Radicular Pain: A Cross-sectional Study.

OBJECTIVE: To compare the accuracy of an artificial intelligence chatbot to clinical practice guidelines (CPGs) recommendations for providing answers to complex clinical questions on lumbosacral radicular pain. DESIGN: Cross-sectional study. METHODS: We extracted recommendations from recent CPGs for diagnosing and treating lumbosacral radicular pain. Relative clinical questions were developed and queried to OpenAI's ChatGPT (GPT-3.5). We compared ChatGPT answers to CPGs recommendations by assessing the (1) internal consistency of ChatGPT answers by measuring the percentage of text wording similarity when a clinical question was posed 3 times, (2) reliability between 2 independent reviewers in grading ChatGPT answers, and (3) accuracy of ChatGPT answers compared to CPGs recommendations. Reliability was estimated using Fleiss' kappa (κ) coefficients, and accuracy by interobserver agreement as the frequency of the agreements among all judgments. RESULTS: We tested 9 clinical questions. The internal consistency of text ChatGPT answers was unacceptable across all 3 trials in all clinical questions (mean percentage of 49%, standard deviation of 15). Intrareliability (reviewer 1: κ = 0.90, standard error [SE] = 0.09; reviewer 2: κ = 0.90, SE = 0.10) and interreliability (κ = 0.85, SE = 0.15) between the 2 reviewers was "almost perfect." Accuracy between ChatGPT answers and CPGs recommendations was slight, demonstrating agreement in 33% of recommendations. CONCLUSION: ChatGPT performed poorly in internal consistency and accuracy of the indications generated compared to clinical practice guideline recommendations for lumbosacral radicular pain. J Orthop Sports Phys Ther 2024;54(3):1-7. Epub 29 January 2024. doi:10.2519/jospt.2024.12151.

Wearable Devices to Improve Physical Activity and Reduce Sedentary Behaviour: An Umbrella Review.

BACKGROUND: Several systematic reviews (SRs), with and without meta-analyses, have investigated the use of wearable devices to improve physical activity, and there is a need for frequent and updated syntheses on the topic. OBJECTIVE: We aimed to evaluate whether using wearable devices increased physical activity and reduced sedentary behaviour in adults. METHODS: We conducted an umbrella review searching PubMed, Cumulative Index to Nursing and Allied Health Literature, the Cochrane Library, MedRxiv, Rxiv and bioRxiv databases up to February 5th, 2023. We included all SRs that evaluated the efficacy of interventions when wearable devices were used to measure physical activity in adults aged over 18 years. The primary outcomes were physical activity and sedentary behaviour measured as the number of steps per day, minutes of moderate to vigorous physical activity (MVPA) per week, and minutes of sedentary behaviour (SB) per day. We assessed the methodological quality of each SR using the Assessment of Multiple Systematic Reviews, version 2 (AMSTAR 2) and the certainty of evidence of each outcome measure using the GRADE (Grading of Recommendations, Assessment, Development, and Evaluations). We interpreted the results using a decision-making framework examining the clinical relevance and the concordances or discordances of the SR effect size. RESULTS: Fifty-one SRs were included, of which 38 included meta-analyses (302 unique primary studies). Of the included SRs, 72.5% were rated as 'critically low methodological quality'. Overall, with a slight overlap of primary studies (corrected cover area: 3.87% for steps per day, 3.12% for MVPA, 4.06% for SB) and low-to-moderate certainty of the evidence, the use of WDs may increase PA by a median of 1,312.23 (IQR 627-1854) steps per day and 57.8 (IQR 37.7 to 107.3) minutes per week of MVPA. Uncertainty is present for PA in pathologies and older adults subgroups and for SB in mixed and older adults subgroups (large confidence intervals). CONCLUSIONS: Our findings suggest that the use of WDs may increase physical activity in middle-aged adults. Further studies are needed to investigate the effects of using WDs on specific subgroups (such as pathologies and older adults) in different follow-up lengths, and the role of other intervention components.

Olympic Weightlifting Training for Sprint Performance in Athletes: A Systematic Review with Meta-analysis.

This systematic review and meta-analysis aimed to determine whether Olympic weightlifting (OW) exercises would improve sprint performance when compared to a control intervention, (no training, standard sport-specific training, traditional resistance training, or plyometric training). Medline, Web of Science, SportDiscus, CINAHL, and Biological Science from inception to September 2022 was searched. Two authors independently selected the included studies, extracted data, and appraised the risk of bias. Certainty of the evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation methodology. The primary meta-analysis combined the results of the sprint performance over the full length of each sprint test. The secondary meta-analyses combined the results of the sprint performance at 5, 10, and 20 m distance to capture information about the acceleration phase of the sprint tests. Eight studies with 206 athletes (female n=10, age range: 18.9-24.2 years) were identified. Sprint performance did not differ significantly comparing OW to the control intervention, nor at the full length (standardized mean difference=-0.07, 95% CI=-0.47 to 0.34, p=0.75, I2=46%) or during the acceleration phase (p≥0.26) of the sprint test. OW training does not improve sprint performance to a greater extent than comparator interventions.

Shear-wave elastography for the evaluation of tendinopathies: a systematic review and meta-analysis.

PURPOSE: To compare pathologic and healthy tendons using shear-wave elastography (SWE). METHODS: A systematic review with meta-analysis was done searching Pubmed and EMBASE up to September 2022. Prospective, retrospective and cross-sectional studies that used SWE in the assessment of pathologic tendons versus control were included. Our primary outcome were SWE velocity (m/s) and stiffness (kPa). Methodological quality was assessed by the methodological index for non-randomized studies (MINORS). We used the mean difference (MD) with corresponding 95% confidence intervals (CIs) to quantify effects between groups. We performed sensitivity analysis in case of high heterogeneity, after excluding poor quality studies according to MINORS assessment. We used Grades of Recommendation, Assessment, Development and Evaluation to evaluate the certainty of evidence (CoE). RESULTS: Overall, 16 studies with 676 pathologic tendons (188 Achilles, 142 patellar, 96 supraspinatus, 250 mixed) and 723 control tendons (484 healthy; 239 contralateral tendon) were included. Five studies (31.3%) were judged as poor methodological quality. Shear-wave velocity and stiffness meta-analyses showed high heterogeneity. According to a sensitivity analysis, pathologic tendons had a lower shear wave velocity (MD of - 1.69 m/s; 95% CI 1.85; - 1.52; n = 274; I2 50%) compared to healthy tendons with very low CoE. Sensitivity analysis on stiffness still showed high heterogeneity. CONCLUSION: Pathological tendons may have reduced SWE velocity compared to controls, but the evidence is very uncertain. Future robust high-quality longitudinal studies and clear technical indications on the use of this tool are needed. PROTOCOL: PROSPERO identifier: CRD42023405410 CLINICAL RELEVANCE STATEMENT: SWE is a relatively recent modality that may increase sensitivity and diagnostic accuracy of conventional ultrasound imaging promoting early detection of tendinopathy. Non-negligible heterogeneity has been observed in included studies, so our findings may encourage the conduct of future high-quality longitudinal studies which can provide clear technical indications on the use of this promising tool in tendon imaging.

Adverse effects of immunotherapies for multiple sclerosis: a network meta-analysis.

BACKGROUND: Multiple sclerosis (MS) is a chronic disease of the central nervous system that affects mainly young adults (two to three times more frequently in women than in men) and causes significant disability after onset. Although it is accepted that immunotherapies for people with MS decrease disease activity, uncertainty regarding their relative safety remains. OBJECTIVES: To compare adverse effects of immunotherapies for people with MS or clinically isolated syndrome (CIS), and to rank these treatments according to their relative risks of adverse effects through network meta-analyses (NMAs). SEARCH METHODS: We searched CENTRAL, PubMed, Embase, two other databases and trials registers up to March 2022, together with reference checking and citation searching to identify additional studies. SELECTION CRITERIA: We included participants 18 years of age or older with a diagnosis of MS or CIS, according to any accepted diagnostic criteria, who were included in randomized controlled trials (RCTs) that examined one or more of the agents used in MS or CIS, and compared them versus placebo or another active agent. We excluded RCTs in which a drug regimen was compared with a different regimen of the same drug without another active agent or placebo as a control arm. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods for data extraction and pairwise meta-analyses. For NMAs, we used the netmeta suite of commands in R to fit random-effects NMAs assuming a common between-study variance. We used the CINeMA platform to GRADE the certainty of the body of evidence in NMAs. We considered a relative risk (RR) of 1.5 as a non-inferiority safety threshold compared to placebo. We assessed the certainty of evidence for primary outcomes within the NMA according to GRADE, as very low, low, moderate or high. MAIN RESULTS: This NMA included 123 trials with 57,682 participants. Serious adverse events (SAEs) Reporting of SAEs was available from 84 studies including 5696 (11%) events in 51,833 (89.9%) participants out of 57,682 participants in all studies. Based on the absolute frequency of SAEs, our non-inferiority threshold (up to a 50% increased risk) meant that no more than 1 in 18 additional people would have a SAE compared to placebo. Low-certainty evidence suggested that three drugs may decrease SAEs compared to placebo (relative risk [RR], 95% confidence interval [CI]): interferon beta-1a (Avonex) (0.78, 0.66 to 0.94); dimethyl fumarate (0.79, 0.67 to 0.93), and glatiramer acetate (0.84, 0.72 to 0.98). Several drugs met our non-inferiority criterion versus placebo: moderate-certainty evidence for teriflunomide (1.08, 0.88 to 1.31); low-certainty evidence for ocrelizumab (0.85, 0.67 to 1.07), ozanimod (0.88, 0.59 to 1.33), interferon beta-1b (0.94, 0.78 to 1.12), interferon beta-1a (Rebif) (0.96, 0.80 to 1.15), natalizumab (0.97, 0.79 to 1.19), fingolimod (1.05, 0.92 to 1.20) and laquinimod (1.06, 0.83 to 1.34); very low-certainty evidence for daclizumab (0.83, 0.68 to 1.02). Non-inferiority with placebo was not met due to imprecision for the other drugs: low-certainty evidence for cladribine (1.10, 0.79 to 1.52), siponimod (1.20, 0.95 to 1.51), ofatumumab (1.26, 0.88 to 1.79) and rituximab (1.01, 0.67 to 1.52); very low-certainty evidence for immunoglobulins (1.05, 0.33 to 3.32), diroximel fumarate (1.05, 0.23 to 4.69), peg-interferon beta-1a (1.07, 0.66 to 1.74), alemtuzumab (1.16, 0.85 to 1.60), interferons (1.62, 0.21 to 12.72) and azathioprine (3.62, 0.76 to 17.19). Withdrawals due to adverse events Reporting of withdrawals due to AEs was available from 105 studies (85.4%) including 3537 (6.39%) events in 55,320 (95.9%) patients out of 57,682 patients in all studies. Based on the absolute frequency of withdrawals, our non-inferiority threshold (up to a 50% increased risk) meant that no more than 1 in 31 additional people would withdraw compared to placebo. No drug reduced withdrawals due to adverse events when compared with placebo. There was very low-certainty evidence (meaning that estimates are not reliable) that two drugs met our non-inferiority criterion versus placebo, assuming an upper 95% CI RR limit of 1.5: diroximel fumarate (0.38, 0.11 to 1.27) and alemtuzumab (0.63, 0.33 to 1.19). Non-inferiority with placebo was not met due to imprecision for the following drugs: low-certainty evidence for ofatumumab (1.50, 0.87 to 2.59); very low-certainty evidence for methotrexate (0.94, 0.02 to 46.70), corticosteroids (1.05, 0.16 to 7.14), ozanimod (1.06, 0.58 to 1.93), natalizumab (1.20, 0.77 to 1.85), ocrelizumab (1.32, 0.81 to 2.14), dimethyl fumarate (1.34, 0.96 to 1.86), siponimod (1.63, 0.96 to 2.79), rituximab (1.63, 0.53 to 5.00), cladribine (1.80, 0.89 to 3.62), mitoxantrone (2.11, 0.50 to 8.87), interferons (3.47, 0.95 to 12.72), and cyclophosphamide (3.86, 0.45 to 33.50). Eleven drugs may have increased withdrawals due to adverse events compared with placebo: low-certainty evidence for teriflunomide (1.37, 1.01 to 1.85), glatiramer acetate (1.76, 1.36 to 2.26), fingolimod (1.79, 1.40 to 2.28), interferon beta-1a (Rebif) (2.15, 1.58 to 2.93), daclizumab (2.19, 1.31 to 3.65) and interferon beta-1b (2.59, 1.87 to 3.77); very low-certainty evidence for laquinimod (1.42, 1.01 to 2.00), interferon beta-1a (Avonex) (1.54, 1.13 to 2.10), immunoglobulins (1.87, 1.01 to 3.45), peg-interferon beta-1a (3.46, 1.44 to 8.33) and azathioprine (6.95, 2.57 to 18.78); however, very low-certainty evidence is unreliable. Sensitivity analyses including only studies with low attrition bias, drug dose above the group median, or only patients with relapsing remitting MS or CIS, and subgroup analyses by prior disease-modifying treatments did not change these figures. Rankings No drug yielded consistent P scores in the upper quartile of the probability of being better than others for primary and secondary outcomes. AUTHORS' CONCLUSIONS: We found mostly low and very low-certainty evidence that drugs used to treat MS may not increase SAEs, but may increase withdrawals compared with placebo. The results suggest that there is no important difference in the occurrence of SAEs between first- and second-line drugs and between oral, injectable, or infused drugs, compared with placebo. Our review, along with other work in the literature, confirms poor-quality reporting of adverse events from RCTs of interventions. At the least, future studies should follow the CONSORT recommendations about reporting harm-related issues. To address adverse effects, future systematic reviews should also include non-randomized studies.

Volume replacement in the resuscitation of trauma patients with acute hemorrhage: an umbrella review.

BACKGROUND: The use of intravenous fluid therapy in patients with major trauma in prehospital settings is still controversial. We conducted an umbrella review to evaluate which is the best volume expansion in the resuscitation of a hemorrhagic shock to support the development of major trauma guideline recommendations. METHODS: We searched PubMed, Embase, and CENTRAL up to September 2022 for systematic reviews (SRs) investigating the use of volume expansion fluid on mortality and/or survival. Quality assessment was performed using AMSTAR 2 and the Certainty of the evidence was assessed with the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. RESULTS: We included 14 SRs investigating the effects on mortality with the comparisons: use of crystalloids, blood components, and whole blood. Most SRs were judged as critically low with slight overlapping of primary studies and high consistency of results. For crystalloids, inconsistent evidence of effectiveness in 28- to 30-day survival (primary endpoint) was found for the hypertonic saline/dextran group compared with isotonic fluid solutions with moderate certainty of evidence. Pre-hospital blood component infusion seems to reduce mortality, however, as the certainty of evidence ranges from very low to moderate, we are unable to provide evidence to support or reject its use. The blood component ratio was in favor of higher ratios among all comparisons considered with moderate to very low certainty of evidence. Results about the effects of whole blood are very uncertain due to limited and heterogeneous interventions in studies included in SRs. CONCLUSION: Hypertonic crystalloid use did not result in superior 28- to 30-day survival. Increasing evidence supports the scientific rationale for early use of high-ratio blood components, but their use requires careful consideration. Preliminary evidence is very uncertain about the effects of whole blood and further high-quality studies are required.

Teaching evidence-based practice to physiotherapy students in Italy: a cross sectional study.

BACKGROUND: Evidence-based practice (EBP) is being rapidly adopted by the Italian physiotherapy community, although a knowledge gap persists at clinical level with consequent lack of integration of EBP into ground roots practice. Teaching of EBP during the Bachelor of Science (BSc) undergraduate course in physiotherapy likely has a vital role to play in the spread of knowledge, providing a grounding in the fundamental concepts of EBP. The aim of the present study was to investigate the prevalence of EBP educational content in Italian BSc courses in physiotherapy. METHODS: This is a cross-sectional study during which characteristics of EBP teaching in BSc degree courses of physiotherapy in Italy were collected from institutional websites during the period May to September 2021 with an update in August 2022. We used the STrengthening the Reporting of Observational studies in Epidemiology (STROBE) guidelines for our manuscript. RESULTS: Forty-two physiotherapy BSc degree programs were retrieved, accounting for all the BSc delivered in the 2021-2022 academic year. Fourteen of these (33.3%) did not report EBP content. Northern universities provided EBP content in 16 out of 18 (88%) degree courses. Central Italian universities provided EBP content in 6 out of 9 (66.6%) degree courses. Southern universities delivered EBP content in 3 out of 9 (33.3%) degree courses. The universities of Sicily and Sardinia provided EBP content in 2 out of 5 (40%) degree courses. The degree courses taught in public universities were more likely to contain EBP material (25 out of 37, 67.4%), compared to those taught within the private system (3 out of 5, 60%). CONCLUSIONS: The prevalence of EBP content within physiotherapy BSc degree programs in Italy can be considered suboptimal, with both regional differences and according to the system (public vs private). The results of this study could be used as a stimulus for increasing investment in the teaching of EBP in Italian physiotherapy degree courses, thereby improving educational standards.

Reasons for missing evidence in rehabilitation meta-analyses: a cross-sectional meta-research study.

BACKGROUND: Systematic reviews of randomized controlled trials are the best evidence for informing on intervention effectiveness. Their results, however, can be biased due to omitted evidence in the quantitative analyses. We aimed to assess the proportion of randomized controlled trials omitted from meta-analyses in the rehabilitation field and explore related reasons. METHODS: This is a cross-sectional meta-research study. For each systematic review included in a published selected sample in the rehabilitation field, we identified an index meta-analysis on the primary outcome and the main comparison. We then looked at all the studies considered eligible for the chosen comparison in the systematic review and identified those trials that have been omitted (i.e., not included) from each index meta-analysis. Reasons for omission were collected based on an eight-reason classification. We used descriptive statistics to describe the proportion of omitted trials overall and according to each reason. RESULTS: Starting from a cohort of 827 systematic reviews, 131 index meta-analyses comprising a total of 1761 eligible trials were selected. Only 16 index meta-analyses included all eligible studies while 15 omitted studies without providing references. From the remaining 100 index meta-analyses, 717 trials (40,7%) were omitted overall. Specific reasons for omission were: "unable to distinguish between selective reporting and inadequate planning" (39,3%, N = 282), "inadequate planning" (17%, N = 122), "justified to be not included" (15,1%, N = 108), "incomplete reporting" (8,4%, N = 60), "selective reporting" (3,3%, N = 24) and other situations (e.g., outcome present but no motivation for omission) (5,2%, N = 37). The 11,7% (N = 84) of omitted trials were not assessed due to non-English language or full text not available. CONCLUSIONS: Almost half of the eligible trials were omitted from their index meta-analyses. Better reporting, protocol registration, definition and adoption of core outcome sets are needed to prevent omission of evidence in systematic reviews.

Effects of tele-prehabilitation on clinical and muscular recovery in patients awaiting knee replacement: protocol of a randomised controlled trial.

BACKGROUND: The increasing prevalence of knee osteoarthritis and total knee arthroplasty (TKA) impose a significant socioeconomic burden in developed and developing countries. Prehabilitation (rehabilitation in the weeks immediately before surgery) may be crucial to prepare patients for surgery improving outcomes and reducing assistance costs. Moreover, considering the progress of telemedicine, candidates for TKA could potentially benefit from a tele-prehabilitation programme. We aim to evaluate the effects of a home-based tele-prehabilitation program for patients waiting for total knee replacement. METHODS AND ANALYSIS: Forty-eight male patients, aged 65-80, on a waiting list for TKA will be recruited and randomly assigned to the tele-prehabilitation intervention or control groups. Both groups will undergo the same 6-week exercise program (five sessions/week) and the same educational session (one per week). The tele-prehabilitation group will perform asynchronous sessions using a tablet, two accelerometers and a balance board (Khymeia, Padova, Italy), while the control group will use a booklet. The Western Ontario and McMaster Universities Osteoarthritis Index Questionnaire, at the end of the prehabilitation, will be the primary outcome. Secondary outcomes will include self-reported outcomes, performance tests and change in expressions of blood and muscle biomarkers. Ten healthy subjects, aged 18-30, will be also recruited for muscle and blood samples collection. They will not undergo any intervention and their data will be used as benchmarks for the intervention and control groups' analyses. ETHICS AND DISSEMINATION: This randomised controlled trial will be conducted in accordance with the ethical principles of the Declaration of Helsinki. This study has been approved by the Ethics Committee of Vita-Salute San Raffaele University (Milan, Italy. No. 50/INT/2022). The research results will be published in peer-reviewed publications. TRIAL REGISTRATION NUMBER: NCT05668312.

Effectiveness and safety of virtual reality rehabilitation after stroke: an overview of systematic reviews.

Background: Virtual reality (VR) is an innovative neurorehabilitation modality that has been variously examined in systematic reviews. We assessed VR effectiveness and safety after cerebral stroke. Methods: In this overview of systematic reviews, we searched eleven databases (Cochrane Database of Systematic Reviews, EMBASE, MEDLINE, SCOPUS, ISI Web of Science, CINAHL, PsycINFO, Pedro, Otseeker, Healthevidence.org, Epistemonikos) and grey literature from inception to January 17, 2023. Studies eligible for inclusion were systematic reviews published in English that included adult patients with a clinical diagnosis of stroke (acute to chronic phase) undergoing any kind of immersive, semi-immersive or non-immersive VR intervention with or without conventional therapy versus conventional therapy alone. The primary outcome was motor upper limb function and activity. The secondary outcomes were gait and balance, cognitive and mental function, limitation of activities, participation, and adverse events. We calculated the degree of overlap between reviews based on the corrected covered area (CCA). Methodological quality was assessed using the A MeaSurement Tool to Assess systematic Reviews (AMSTAR 2) and the Certainty of Evidence (CoE) using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach. Discordances between results were examined using a conceptual framework based on the Jadad algorithm. This overview is registered with PROSPERO, CRD42022329263. Findings: Of the 58 reviews included (n = 345 unique primary studies), 42 (72.4%) had conducted meta-analysis. More than half of the reviews (58.6%) were published between 2020 and 2022 and many (77.6%) were judged critically low in quality by AMSTAR 2. Most reported the Fugl Meyer Assessment scale (FMA-UE) to measure upper limb function and activity. For the primary outcome, there was a moderate overlap of primary studies (CCA 9.0%) with discordant findings. Focusing on upper limb function (FMA-UE), VR with or without conventional therapy seems to be more effective than conventional therapy alone, with low to moderate CoE and probable to definite clinical relevance. For secondary outcomes there was uncertainty about the superiority or no difference between groups due to substantial heterogeneity of measurement scales (eg, methodological choices). A few reviews (n = 6) reported the occurrence of mild adverse events. Interpretation: Current evidence suggests that multiple meta-analyses agreed on the superiority of VR with or without conventional therapy over conventional therapy on FME-UE for upper limb. Clinicians may consider embedding VR technologies into their practice as appropriate with patient's goals, abilities, and preferences. However, caution is needed given the poor methodological quality of reviews. Funding: Italian Ministry of Health.

Milk Quality Conceptualization: A Systematic Review of Consumers', Farmers', and Processing Experts' Views.

Milk consumption has traditionally been recognized as a fundamental element of global dietary patterns due to its perceived nutritional advantages. Nonetheless, a substantial decrease in milk consumption has been identified within diverse populations in recent times. Specifically, consumers' expectations and representations of milk quality have undergone notable transformations, contributing to the observed reduction in consumption. The objective of this systematic review was to conduct a comprehensive examination and categorization of the conceptual attributes associated with milk quality, considering the representations of citizen-consumers, farmers, and processing experts. This review was conducted following the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines. The titles and abstracts of 409 articles were screened, and 20 full-text articles were assessed for eligibility. The results demonstrate the existence of a dual articulation in the conceptual definition of milk quality. Farmers and processing experts exhibited a relatively similar representation of milk quality, focusing on technical indicators. In contrast, citizen-consumers held more simplistic and subjective concepts that are challenging to quantify. This study emphasized the critical need for establishing a platform for communication and knowledge exchange to foster shared representations and expectations regarding milk quality.

Bias in the measurement of the outcome is associated with effect sizes in randomized clinical trials on exercise therapy for chronic low back pain: a meta-epidemiological study.

OBJECTIVES: To explore the relationships between the risk of bias and treatment effect estimates for exercise therapy interventions on pain intensity and physical functioning outcomes in randomized controlled trials (RCTs) involving patients with chronic low back pain. STUDY DESIGN AND SETTING: A cross-sectional meta-epidemiological study of the 230 RCTs (31,674 participants) in the 2021 'Exercise therapy for chronic low back pain' Cochrane Review were included. Study design characteristics, sample size, prospective trial registration, flowchart information, interventions, and comparisons were extracted. Independent pairs of reviewers assessed the risk of bias using the Cochrane Risk of Bias 2 tool. RESULTS: The metaregression included 220 (pain intensity) and 203 (physical functioning) effect sizes. Unadjusted and adjusted metaregression models showed no significant associations between the bias domains and pain intensity effect sizes. Only domain 'bias in the measurement of the outcome' was significantly associated with physical functioning (standardized mean difference: -0.40, 95% confidence interval: -0.77 to -0.02) when adjusted for flowchart reported (yes/no), prospective trial registration, sample size, and comparator type. CONCLUSION: The risk of bias in the measurement of the outcome could lead to slight overestimates of the effect size for physical functioning. Clinicians should consider this when they read and assess RCT results in this field. We encourage metaresearchers to replicate our findings using a consistent approach for evaluating the risk of bias (i.e., the RoB 2 tool) in other musculoskeletal conditions and interventions to investigate their generalizability.

What is the landscape of evidence about the safety of physical agents used in physical medicine and rehabilitation? A scoping review.

BACKGROUND: Several systematic reviews (SRs) assessing the effectiveness of superficial physical agents have been published, but the evidence about their safety remains controversial. OBJECTIVE: To identify areas where there is evidence of the safety of physical agents by a scoping review. DESIGN: Four databases were systematically searched for including English SRs that explored and reported safety in terms of adverse events (AEs) related to the application of physical agents in outpatient and inpatient physical medicine and rehabilitation settings managed by healthcare professionals, published in January 2011-29 September 2021. The severity of AEs was classified according to the Common Terminology Criteria. Then, AE findings were summarised according to the SR syntheses. Finally, the reporting of the certainty of the evidence was mapped. RESULTS: Overall, 117 SRs were retrieved. Most of the SRs included randomised controlled trials (77%) and patients with musculoskeletal disorders (67%). The most investigated physical agents were extracorporeal shock wave therapy (ESWT) (15%), transcutaneous electrical nerve stimulation (13%) and electrical stimulation (12%). No AE (35%) was reported in one-third of the included primary studies in SRs, whereas few severe AEs occurred in less than 1% of the sample. Among physical agents, ESWT showed an increased risk of experiencing mild AEs compared with the control. Most SRs reported a qualitative AE synthesis (65.8%), and few reported the certainty of the evidence (17.9%), which was mainly low. CONCLUSION: We found evidence of safety on several physical agents coming mostly from qualitative synthesis. No significant harms of these interventions were found except for ESWT reporting mild AEs. More attention to the AEs reporting and their classification should be pursued to analyse them and assess the certainty of evidence quantitatively. REVIEW REGISTRATION: https://osf.io/6vx5a/.

The role of free-from symbols on consumer perceptions of healthiness, quality and intention to buy baked food products.

Little is known about the impact of "free-from" symbols on people's consumption choices - particularly for controversial ingredients such as palm oil. We investigated how "free-from" symbols influence consumers' perceptions of food products and whether the absence of an ingredient, whether real or fabricated, is seen as a sign of improved healthiness or quality. We conducted an experiment with a sample of 1215 adults representing the Italian population, showing them two products - crackers and sweet snacks - each with four different symbols. We created the "free-from CO2" and "free-from polyunsaturated fats" symbols, while "palm oil-free" and blank symbols were used for comparison. "free-from" symbols influence consumers' perceptions of the food as being of better quality and healthiness, regardless of the ingredient removed. This symbol also influenced purchasing intentions. Consumers' perceptions of the product were influenced by the "free-from" wording, rather than the type of ingredient or product presented.

Health consciousness and pro-environmental behaviors in an Italian representative sample: A cross-sectional study.

Individual health-related behavior is among the most influential yet modifiable factors affecting both climate change and chronic disease. To encourage behaviors bringing about environmental and health co-benefits, it is important to understand the underlying factors of behavior change for healthy and sustainable lifestyles. One area of potential overlap concerns people's health consciousness. The purpose of this study was to examine the relationship between health consciousness and pro-environmental behavior. We investigated whether health consciousness correlates with five clusters of pro-environmental behaviors: sustainable food consumption, recycling, green purchasing, sustainable mobility, and energy saving. Research data were collected via cross-sectional survey involving a representative sample of n = 1011 Italian citizens. Statistically significant differences emerged in the frequency of the different classes of pro-environmental behaviors: people living in Italy most frequently implement sustainable behaviors related to energy saving and recycling while sustainable mobility behaviors are the least implemented. Moreover, the stepwise linear regression model demonstrated the predictive role of citizens' health consciousness on the adoption of specific classes of pro-environmental behaviors showing how higher involvement in one's own health determines higher levels of pro-environmental behaviors. These results highlight the relevance of developing and testing complex programs featuring educational, sensitization, and structural strategies to increase citizens involvement in public health and pro-environmental behaviors.

Determinants of the willingness to buy products certified by omics technology: differences between regular and occasional consumers of organic food.

Consumers' demand for organic food has increased in the last years, together with a growing request for food authentication and safety. Omics technologies represent a viable analytical strategy to respond to such needs, strengthen food safety information transmission between consumers and industry, and differentiate between organic and conventional products. However, little is known about consumers' perception of such a novel certification approach. The present research ought to provide insights into the perspectives of consumers, exploring the antecedents of their intention to purchase organic vegetables certified through omics technologies and differentiating between regular and occasional consumers of organic foods. Data were collected from a representative sample of 807 Italian respondents who completed a self-report questionnaire, and Structural Equation Modeling was performed to analyze the data. Results show that several factors influence consumers' approach to omics technology, among which trust in actors in the food industry, attitudes towards the technology and environmental food concerns. In addition, the study drew attention to the differential path impacting consumers with distinct eating habits. Indeed, the degree of importance attributed to food in one's life and the interest towards innovative food are significant predictors of the intention to adopt omics technology only for people consuming organic products with higher frequency. Also, trust in industry actors follows a different path for regular and occasional organic food consumers. The present study sheds light on consumers' perspective on omics technologies, a relatively unexplored topic. Moreover, it allowed to differentiate consumers based on their organic consumption habits, which has been rarely done in previous research. The evidence collected suggests the need for tailored communication programs to stimulate the adoption of omics technologies and foster consumers' confidence in novel food technologies.

Structured approach with primary and secondary survey for major trauma care: an overview of reviews.

BACKGROUND: A structured approach involves systematic management of trauma patients. We aim to conduct an overview of reviews about the clinical efficacy and safety of structured approach (i.e., primary and secondary survey) by guideline checklist compared to non-structured approach (i.e. clinical examination); moreover, routine screening whole-body computer tomography (WBCT) was compared to non-routine WBCT in patients with suspected major trauma. METHODS: We systematically searched MEDLINE (PubMed), EMBASE and Cochrane Database of Systematic Reviews up to 3 May 2022. Systematic reviews (SRs) that investigated the use of a structured approach compared to a non-structured approach were eligible. Two authors independently extracted data, managed the overlapping of primary studies belonging to the included SRs and calculated the corrected covered area (CCA). The certainty of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology. RESULTS: We included nine SRs investigating two comparisons in stable trauma patients: structured approach vs non-structured approach (n = 1) and routine WBCT vs non-routine WBCT (n = 8). The overlap of included primary studies was generally high across outcomes (CCA ranged between 20.85 and 42.86%) with some discrepancies in the directions of effects across reviews. The application of a structured approach by checklist may improve adherence to guidelines (e.g. Advanced Trauma Life Support) during resuscitation and might lead to a reduction in mortality among severely injured patients as compared to clinical examination (Adjusted OR 0.51; 95% CI 0.30-0.89; p = 0.018; low certainty of evidence). The use of routine WBCT seems to offer little to no effects in reducing mortality and time spent in emergency room or department, whereas non-routine WBCT seems to offer little to no effects in reducing radiation dose, intensive care unit length of stay (LOS) and hospital LOS (low-to-moderate certainty of evidence). CONCLUSIONS: The application of structured approach by checklist during trauma resuscitation may improve patient- and process-related outcomes. Including non-routine WBCT seems to offer the best trade-offs between benefits and harm. Clinicians should consider these findings in the light of their clinical context, the volume of patients in their facilities, the need for time management, and costs.

Systemic hemostatic agents initiated in trauma patients in the pre-hospital setting: a systematic review.

PURPOSE: The effect of systemic hemostatic agents initiated during pre-hospital care of severely injured patients with ongoing bleeding or traumatic brain injury (TBI) remains controversial. A systematic review and meta-analysis was therefore conducted to assess the effectiveness and safety of systemic hemostatic agents as an adjunctive therapy in people with major trauma and hemorrhage or TBI in the context of developing the Italian National Institute of Health guidelines on major trauma integrated management. METHODS: PubMed, Embase, and Cochrane Library databases were searched up to October 2021 for studies that investigated pre-hospital initiated treatment with systemic hemostatic agents. The certainty of evidence was evaluated with the Grading of Recommendations Assessment, Development, and Evaluation approach, and the quality of each study was determined with the Cochrane risk-of-bias tool. The primary outcome was overall mortality, and secondary outcomes included cause-specific mortality, health-related quality of life, any adverse effects and blood product use, hemorrhage expansion, and patient-reported outcomes. RESULTS: Five trials of tranexamic acid (TXA) met the inclusion criteria for this meta-analysis. With a high certainty of evidence, when compared to placebo TXA reduced mortality at 24 h (relative risk = 0.83, 95% confidence interval = 0.73-0.94) and at 1 month among trauma patients (0.91, 0.85-0.97). These results depend on the subgroup of patients with significant hemorrhage because in the subgroup of TBI there are no difference between TXA and placebo. TXA also reduced bleeding death and multiple organ failure whereas no difference in health-related quality of life. CONCLUSION: Balancing benefits and harms, TXA initiated in the pre-hospital setting can be used for patients experiencing major trauma with significant hemorrhage since it reduces the risk of mortality at 24 h and one month with no difference in terms of adverse effects when compared to placebo. Considering the subgroup of severe TBI, no difference in mortality rate was found at 24 h and one month. These results highlight the need to conduct future studies to investigate the role of other systemic hemostatic agents in the pre-hospital settings.