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OBJECTIVES: Reporting bias, prevalent in biomedical fields, can undermine evidence credibility. Our objective was to evaluate the proportion of discrepancies between registered protocols and published manuscripts in randomized controlled trials (RCTs) on exercise interventions for patients with chronic low back pain (CLBP). STUDY DESIGN AND SETTING: We conducted a cross-sectional meta-research study, starting from the 2021 "Exercise therapy for CLBP" Cochrane Review. We selected all RCTs reporting a protocol registration on a primary register of the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) or in ClinicalTrials.gov. We extracted data from both registered protocol and published manuscript of RCTs, collecting recruitment and administrative information (eg, record dates) and details of trial characteristics (eg, outcomes, arms, statistical analysis plan details [SAPs]). Independent pairs of reviewers assessed discrepancies between registered protocol and published manuscript for the reporting of primary and secondary outcomes domains, measurement instruments, time-points, number of arms and SAPs(if attached). Outcome discrepancies were characterized as addition, omission, upgrade or downgrade. RESULTS: We included 116 RCTs reporting an available protocol registration. Overall, 100 RCTs (86.2%) distinguished between primary and secondary outcomes. Of these, 39 RCTs (39.0%) reported one or more discrepancies in primary outcomes, and 78 RCTs (78.0%) reported one or more discrepancies in secondary outcomes. Focusing on discrepancies for the primary outcome, 64.5% of added, upgraded or downgraded outcomes favored statistically significant effects. Few RCTs (n = 6) reported discrepancies in the number of arms. SAPs were poorly reported in the registered protocols (n = 3) for being compared to the publications. CONCLUSION: We found substantial outcome discrepancies comparing registered protocols and published manuscripts in RCTs assessing exercise interventions for patients with CLBP, with some impacting the statistical significance of the effects. Readers are encouraged to approach RCTs results in this field with caution.
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BACKGROUND: Artificial intelligence (AI) chatbots are emerging educational tools for students in healthcare science. However, assessing their accuracy is essential prior to adoption in educational settings. This study aimed to assess the accuracy of predicting the correct answers from three AI chatbots (ChatGPT-4, Microsoft Copilot and Google Gemini) in the Italian entrance standardized examination test of healthcare science degrees (CINECA test). Secondarily, we assessed the narrative coherence of the AI chatbots' responses (i.e., text output) based on three qualitative metrics: the logical rationale behind the chosen answer, the presence of information internal to the question, and presence of information external to the question. METHODS: An observational cross-sectional design was performed in September of 2023. Accuracy of the three chatbots was evaluated for the CINECA test, where questions were formatted using a multiple-choice structure with a single best answer. The outcome is binary (correct or incorrect). Chi-squared test and a post hoc analysis with Bonferroni correction assessed differences among chatbots performance in accuracy. A p-value of < 0.05 was considered statistically significant. A sensitivity analysis was performed, excluding answers that were not applicable (e.g., images). Narrative coherence was analyzed by absolute and relative frequencies of correct answers and errors. RESULTS: Overall, of the 820 CINECA multiple-choice questions inputted into all chatbots, 20 questions were not imported in ChatGPT-4 (n = 808) and Google Gemini (n = 808) due to technical limitations. We found statistically significant differences in the ChatGPT-4 vs Google Gemini and Microsoft Copilot vs Google Gemini comparisons (p-value < 0.001). The narrative coherence of AI chatbots revealed "Logical reasoning" as the prevalent correct answer (n = 622, 81.5%) and "Logical error" as the prevalent incorrect answer (n = 40, 88.9%). CONCLUSIONS: Our main findings reveal that: (A) AI chatbots performed well; (B) ChatGPT-4 and Microsoft Copilot performed better than Google Gemini; and (C) their narrative coherence is primarily logical. Although AI chatbots showed promising accuracy in predicting the correct answer in the Italian entrance university standardized examination test, we encourage candidates to cautiously incorporate this new technology to supplement their learning rather than a primary resource. TRIAL REGISTRATION: Not required.
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Inteligencia Artificial , Evaluación Educacional , Estudios Transversales , Humanos , Italia , Evaluación Educacional/métodos , Femenino , MasculinoRESUMEN
The increasing demand for orthopedic surgeries, including joint replacements, is driven by an aging population and improved diagnosis of joint conditions. Orthopedic surgeries carry a risk of infection, especially in patients with comorbidities. The rise of antibiotic resistance exacerbates this issue, necessitating alternatives like in vitro bioengineered antimicrobial peptides (AMPs), offering broad-spectrum activity and multiple action mechanisms. This review aimed to assess the prevalence of antimicrobial potential and the yield after purification among recombinant AMP families. The antimicrobial potential was evaluated using the Minimum Inhibitory Concentration (MIC) values against the most common bacteria involved in clinical infections. This systematic review adhered to PRISMA guidelines, focusing on in vitro studies of recombinant AMPs. The search strategy was run on PubMed, Scopus and Embase up to 30th March 2023. The Population, Exposure and Outcome model was used to extract the data from studies and ToxRTool for the risk of bias analysis. This review included studies providing peptide production yield data and MIC values against pathogenic bacteria. Non-English texts, reviews, conference abstracts, books, studies focusing solely on chemical synthesis, those reporting incomplete data sets, using non-standard MIC assessment methods, or presenting MIC values as ranges rather than precise concentrations, were excluded. From 370 publications, 34 studies on AMPs were analyzed. These covered 46 AMPs across 18 families, with Defensins and Hepcidins being most common. Yields varied from 0.5 to 2,700 mg/L. AMPs were tested against 23 bacterial genera, with MIC values ranging from 0.125 to >1,152 µg/mL. Arenicins showed the highest antimicrobial activity, particularly against common orthopedic infection pathogens. However, AMP production yields varied and some AMPs demonstrated limited effectiveness against certain bacterial strains. This systematic review emphasizes the critical role of bioengineered AMPs to cope infections and antibiotic resistance. It meticulously evaluates recombinant AMPs, focusing on their antimicrobial efficacy and production yields. The review highlights that, despite the variability in AMP yields and effectiveness, Arenicins and Defensins are promising candidates for future research and clinical applications in treating antibiotic-resistant orthopedic infections. This study contributes significantly to the understanding of AMPs in healthcare, underscoring their potential in addressing the growing challenge of antibiotic resistance. Systematic review registration:https://osf.io/2uq4c/.
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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.
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Modalidades de Fisioterapia , Sociedades Científicas , Adulto , Humanos , Niño , Consenso , Atención a la Salud , Técnica DelphiRESUMEN
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/.
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Enfermedades Musculoesqueléticas , Osteoartritis , Telemedicina , Telerrehabilitación , Humanos , Atención a la Salud , Enfermedades Musculoesqueléticas/terapia , Revisiones Sistemáticas como Asunto , Metaanálisis como AsuntoRESUMEN
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.
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Inteligencia Artificial , Dolor de Espalda , Humanos , Estudios Transversales , Reproducibilidad de los Resultados , Toma de DecisionesRESUMEN
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.
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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.
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Diagnóstico por Imagen de Elasticidad , Tendinopatía , Humanos , Diagnóstico por Imagen de Elasticidad/métodos , Estudios Prospectivos , Estudios Retrospectivos , Estudios TransversalesRESUMEN
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.
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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.
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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.
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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.
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Artroplastia de Reemplazo de Rodilla , Osteoartritis de la Rodilla , Humanos , Masculino , Ejercicio Preoperatorio , Terapia por Ejercicio/métodos , Osteoartritis de la Rodilla/cirugía , Costos y Análisis de Costo , Resultado del Tratamiento , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
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.
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Estudios Transversales , Investigación en Rehabilitación , Humanos , Revisiones Sistemáticas como Asunto , Metaanálisis como AsuntoRESUMEN
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.
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Dolor Crónico , Dolor de la Región Lumbar , Humanos , Dolor de la Región Lumbar/epidemiología , Dolor de la Región Lumbar/terapia , Dolor Crónico/epidemiología , Dolor Crónico/terapia , Ensayos Clínicos Controlados Aleatorios como Asunto , Terapia por Ejercicio/métodos , Estudios EpidemiológicosRESUMEN
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.
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OBJECTIVE: This review will map and define the terminology used in health care literature for "best practice" as well as its underpinning framework/methodology. INTRODUCTION: Numerous international organizations and institutions have sought to develop models or frameworks to guide health care providers to integrate the best evidence into clinical practice. However, different concepts related to best practice have been used, both in the biomedical literature and by public institutions, leading to a lack of consistency in definitions of the term. This poses a potential difficulty for clinical professionals in applying evidence effectively to achieve desired patient outcomes. INCLUSION CRITERIA: This review will adopt the following inclusion criteria: i) the study must contain a definition of the term "best practice" or its related concepts; ii) the concept of best practice must refer to clinical activities and not have organizational features; and iii) any study design can be included. Studies will be excluded if they describe a definition of best practice that is not directly related to clinical practice (eg, business). METHODS: The review will follow the JBI methodology for scoping reviews. An initial search of MEDLINE identified keywords and MeSH terms. MEDLINE (PubMed), Embase, CINAHL (EBSCOhost), and Google Scholar will be searched from 2001 until the present, the year in which the first definition of best practice appeared in the literature. Four pairs of reviewers will independently select studies and perform data extraction and data synthesis. Data will be presented in figures or tables, accompanied by a narrative summary. Searches will be limited to articles in English, Italian, German, French, and Spanish. REVIEW REGISTRATION: Open Science Framework: https://osf.io/52vxe/.
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Instituciones de Salud , Personal de Salud , Humanos , Proyectos de Investigación , Literatura de Revisión como AsuntoRESUMEN
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/.
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Medicina Física y Rehabilitación , HumanosRESUMEN
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.
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Servicio de Urgencia en Hospital , Tomografía Computarizada por Rayos X , Humanos , Revisiones Sistemáticas como Asunto , Tomografía Computarizada por Rayos X/métodos , Tiempo de Internación , Puntaje de Gravedad del TraumatismoRESUMEN
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.
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Antifibrinolíticos , Lesiones Traumáticas del Encéfalo , Hemostáticos , Ácido Tranexámico , Humanos , Antifibrinolíticos/uso terapéutico , Calidad de Vida , Hemorragia/etiología , Ácido Tranexámico/uso terapéutico , Hemostáticos/uso terapéutico , Lesiones Traumáticas del Encéfalo/tratamiento farmacológicoRESUMEN
BACKGROUND: It is unclear whether femoroacetabular impingement syndrome (FAIS) affect hip range of motion (ROM). SOURCES OF DATA: We performed a systematic review with meta-analysis searching six electronic databases from inception to March 21, 2022. We included studies assessing hip ROM in FAIS, FAI morphology without symptoms (FAIm), and healthy controls. Mean differences between groups were measured in ROM degrees with 95% confidence interval (CI). AREAS OF AGREEMENT: A total of 17 studies (1702 hips) were included. Comparison of FAIS patients versus healthy controls showed that hip ROM was clinically and statistically reduced in FAIS for internal rotation (90° hip flexion, -8.01°, 95% CI: -11.21, -4.90; 0° hip flexion -6.38°, 95% CI: -9.79, -2.97); adduction (90° hip flexion, -4.74°, 95% CI: -8.13, -1.34); flexion (-5.41°, 95% CI: -7.05, -3.49), abduction (0° hip flexion, -5.76°, 95% CI: -8.38, -3.23), and external rotation (90° hip flexion, -3.5°, 95% CI: -5.32, -1.67) ranging from low to high certainty of evidence. Comparison of FAIm versus healthy controls showed no statistically significant differences in any direction of movement, albeit with uncertainty of evidence. AREAS OF CONTROVERSY: The certainty of evidence was unclear, particularly for asymptomatic FAIm. GROWING POINTS: Hip ROM may be reduced in all directions except extension in FAIS compared to controls. Hip ROM may not be restricted in asymptomatic FAIm. AREAS TIMELY FOR DEVELOPING RESEARCH: Further studies are needed to resolve the uncertainty of evidence about ROM restrictions in asymptomatic FAIm compared to healthy controls.