Nerve transfer for upper extremity reanimation in people with spinal cord injury: A 2-year follow-up case series.

OBJECTIVE: To describe the 2-year functional outcomes of nerve transfer (NT) for upper extremity reanimation. STUDY DESIGN: A prospective case series. SETTING: A highly specialized rehabilitation hospital for spinal cord injury (SCI) in Italy. INTERVENTION: Upper limb nerve transfer (32 NTs, 15 upper limbs). PARTICIPANTS: Twelve male individuals with traumatic SCI (AIS A or B, neurological level from C4 to C7) were enrolled; 24-month follow-up data were available for 11. OUTCOME MEASURES: We evaluated the strength recovery of recipient muscles through the Medical Research Council (MRC) Scale for Muscle Strength. Upper limb function and independence were assessed with the Graded Redefined Assessment of Strength Sensibility and Prehension (GRASSP) test version 1 and the Spinal Cord Independent Measure III (SCIM III). Patient satisfaction was also evaluated. RESULTS: After 24 months, median MRC scores (range) were: triceps 2 (1-2); extensor digitorum communis 3 (1-4); extensor pollicis longus 2.5 (1-4); flexor digitorum profundus 2 (0-4); flexor pollicis longus 2 (0-4). No complication occurred. GRASSP prehension ability and prehension performance total scores significantly improved at 24 months from 1 (0-4) to 2 (0-7) and from 1 (0-8) to 5 (0--22), respectively. The SCIM III self-care sub-scale score improved at 24-month follow-up (p = 0.009).This study has important limitations, including a limited generalizability of the results and a small sample size that does not allow definitive conclusions to be drawn. A large multicenter prospective study is needed to confirm our findings. CONCLUSIONS: NT represents a functional surgery option with few complications for the resuscitation of upper limbs in persons with tetraplegia.

Overview of Cochrane Systematic Reviews for Rehabilitation Interventions in Individuals with Upper Limb Fractures: A Mapping Synthesis.

Background and Objectives. This overview of Cochrane systematic reviews (CSRs) reports on current evidence on the effectiveness of rehabilitation interventions for persons with upper limb fractures (ULFs), and the quality of the evidence. Materials and Methods. Following the inclusion criteria defined by the World Health Organization, all CSRs tagged in the Cochrane Rehabilitation database that were relevant for persons with ULFs were included. A mapping synthesis was used to group outcomes and comparisons of included CSRs, indicating the effect of rehabilitation interventions and the certainty of evidence. Results. A total of three CSRs were included in the evidence map. The certainty of evidence was judged as low to very low. Early occupational and hand therapy, cyclic pneumatic soft tissue compression, and cross-education, when started during immobilization, may improve grip strength and wrist range of motion, with results maintained up to 12 weeks from the cast removal, compared to no intervention. Approaches such as occupational therapy and passive mobilisation, started post-immobilization, are probably safe in terms of secondary complications. However, the overall evidence of rehabilitative interventions related to proximal humeral fractures has been judged insufficient for all the outcomes considered. A paucity of primary studies and CSRs for elbow fractures was noted. Conclusions. This overview provided the effect and the certainty of evidence of rehabilitation interventions available after ULFs using a mapping synthesis. To date, there is a need to further the effectiveness and safety of these interventions for persons with ULFs, improving methodological quality of the research in the field.

Evidence-based position paper on Physical and Rehabilitation Medicine (PRM) professional practice on telerehabilitation. The European PRM position (UEMS PRM Section).

INTRODUCTION: The evidence on the utility and effectiveness of rehabilitation interventions delivered via telerehabilitation is growing rapidly. Telerehabilitation is expected to have a key role in rehabilitation in the future. AIM: The aim of this evidence-based position paper (EBPP) is to improve PRM physicians' professional practice in telerehabilitation to be delivered to improve functioning and to reduce activity limitations and/or participation restrictions in individuals with a variety of disabling health conditions. METHODS: To produce recommendations for PRM physicians on telerehabilitation, a systematic review of the literature and a consensus procedure by means of a Delphi process have been performed involving the delegates of all European countries represented in the UEMS PRM Section. RESULTS: The systematic literature review is reported together with the 32 recommendations resulting from the Delphi procedure. CONCLUSIONS: It is recommended that PRM physicians deliver rehabilitation services remotely, via digital means or using communication technologies to eligible individuals, whenever required and feasible in a variety of health conditions in favor of the patient and his/her family, based on evidence of effectiveness and in compliance with relevant regulations. This EBPP represents the official position of the European Union through the UEMS PRM Section and designates the professional role of PRM physicians in telerehabilitation.

Introduction to target trial emulation in rehabilitation: a systematic approach to emulate a randomized controlled trial using observational data.

Rehabilitation providers and policymakers need valid evidence to make informed decisions about the healthcare needs of the population. Whenever possible, these decisions should be informed by randomized controlled trials (RCTs). However, there are circumstances when evidence needs to be generated rapidly, or when RCTs are not ethical or feasible. These situations apply to studying the effects of complex interventions, including rehabilitation as defined by Cochrane Rehabilitation. Therefore, we explore using the target trial emulation framework by Hernán and colleagues to obtain valid estimates of the causal effects of rehabilitation when RCTs cannot be conducted. Target trial emulation is a framework guiding the design and analysis of non-randomized comparative effectiveness studies using observational data, by emulating a hypothetical RCT. In the context of rehabilitation, we outline steps for applying the target trial emulation framework using real world data, highlighting methodological considerations, limitations, potential mitigating strategies, and causal inference and counterfactual theory as foundational principles to estimating causal effects. Overall, we aim to strengthen methodological approaches used to estimate causal effects of rehabilitation when RCTs cannot be conducted.

Relevance and use of health policy, health systems and health services research for strengthening rehabilitation in real-life settings: methodological considerations.

Research on health policy, systems, and services (HPSSR) has seen significant growth in recent decades and received increasing attention in the field of rehabilitation. This growth is driven by the imperative to effectively address real-life challenges in complex healthcare settings. A recent resolution on 'Strengthening rehabilitation in health systems' adopted by the World Health Assembly emphasizes the need to support societal health goals related to rehabilitation, particularly to promote high-quality rehabilitation research, including HPSSR. This conceptual paper, discussed with the participants in the 5th Cochrane Rehabilitation Methodological Meeting held in Milan on September 2023, outlines study designs at diverse levels at which HPSSR studies can be conducted: the macro, meso, and micro levels. It categorizes research questions into four types: those framed from the perspective of policies, healthcare delivery organizations or systems, defined patient or provider populations, and important data sources or research methods. Illustrative examples of appropriate methodologies are provided for each type of research question, demonstrating the potential of HPSSR in shaping policies, improving healthcare delivery, and addressing patient and provider perspectives. The paper concludes by discussing the applicability, usefulness, and implementation of HPSSR findings, and the importance of knowledge translation strategies, drawing insights from implementation science. The goal is to facilitate the integration of research findings into everyday clinical practice to bridge the gap between research and practice in rehabilitation.

The influence of bias in randomized controlled trials on rehabilitation intervention effect estimates: what we have learned from meta-epidemiological studies.

This study aimed to synthesize evidence from studies that addressed the influence of bias domains in randomized controlled trials on rehabilitation intervention effect estimates and discuss how these findings can maximize the trustworthiness of an RCT in rehabilitation. We screened studies about the influence of bias on rehabilitation intervention effect estimates published until June 2023. The characteristics and results of the included studies were categorized based on methodological characteristics and summarized narratively. We included seven studies with data on 227,806 RCT participants. Our findings showed that rehabilitation intervention effect estimates are likely exaggerated in trials with inadequate/unclear sequence generation and allocation concealment when using continuous outcomes. The influence of blinding was inconsistent and different from the rest of medical science, as meta-epidemiological studies showed overestimation, underestimation, or neutral associations for different types of blinding on rehabilitation treatment effect estimates. Still, it showed a more consistent pattern when looking at patient-reported outcomes. The impact of attrition bias and intention to treat has been analyzed only in two studies with inconsistent results. The risk of reporting bias seems to be associated with overestimation of treatment effects. Bias domains can influence rehabilitation treatment effects in different directions. The evidence is mixed and inconclusive due to the poor methodological quality of RCTs and the limited number and quality of studies looking at the influence of bias and treatment effects in rehabilitation. Further studies about the influence of bias in RCTs on rehabilitation intervention effect estimates are needed.

Effectiveness of Rehabilitation Interventions on Adults With COVID-19 and Post-COVID-19 Condition. A Systematic Review With Meta-analysis.

OBJECTIVE: To evaluate the effectiveness of rehabilitation interventions for adults with COVID-19 and post COVID-19 condition (PCC) in all settings. DATA SOURCES: PubMed, EMBASE, CINAHL, Scopus, Web of Science, and Physiotherapy Evidence Database were searched from inception to December 31st, 2021. PROSPERO registration number: CRD42021258553. STUDY SELECTION: We included randomized controlled trials (RCTs) and non-randomized studies of interventions (NRSI) according to the University of Alberta Evidence-based Practice Center. DATA EXTRACTION: One author extracted data using a predetermined Excel form. DATA SYNTHESIS: The meta-analysis indicates uncertain evidence about the effect of pulmonary rehabilitation and self-activities on exercise capacity (MD 65.06, 95% CI 42.87 to 87.25), respiratory function (forced expiratory volume in the first second [FEV1]: MD 0.16, 95% CI 0.05 to 0.28; FEV1/forced vital capacity [FVC]: MD 0.05, 95% CI 0.01 to 0.09; FVC: MD 0.19, 95% CI -0.03 to 0.42) and anxiety (MD -12.03, 95% CI -21.16 to -2.90) in mild COVID-19 and PCC patients. According to the narrative synthesis, including RCTs and NRSI, prone positioning seems to show improvements in vital parameters in severe COVID-19 post intensive care unit (ICU) discharge, pulmonary rehabilitation in activities of daily living, and qigong exercise and acupressure rehabilitation program, and "twist and raise" walking technique in reducing dyspnea and weakness in any degree of severity of COVID-19 and PCC. Functional electrical stimulation-cycling or early rehabilitation programs seem to support a faster recovery in patients with moderate COVID-19 after ICU discharge. Yoga and naturopathy, Mandala coloring, and respiratory exercise seem to reduce anxiety and depression in patients with moderate and mild COVID-19. Cognitive motor training seems to improve cognitive function in PCC patients. CONCLUSIONS: There is very uncertain evidence about the effect of pulmonary rehabilitation on exercise capacity and respiratory function in patients with mild COVID-19 and PCC. Further high-quality research is required to improve the certainty of evidence available to support rehabilitation's crucial role in managing COVID-19.

Improving the quality of evidence production in rehabilitation. Results of the 5th Cochrane Rehabilitation Methodological Meeting.

The paper introduces the Special Sections of the European Journal of Physical and Rehabilitation Medicine dedicated to the 5th Methodological Meeting of Cochrane Rehabilitation. It introduces Cochrane Rehabilitation; its vision, mission and goals; discusses why the Methodological Meetings were created; and reports on their organisation and previous outcomes. The core content of this editorial is the 5th Methodological Meeting held in Milan in September 2023. The original title for this meeting was "The Rehabilitation Evidence Ecosystem: useful study designs." The focus of the Milan meeting was informed by the lessons learned by Cochrane Rehabilitation in the past few years, by the new rehabilitation definition for research purposes, by the collaboration with the World Health Organization (WHO), and by the REH-COVER (Rehabilitation COVID-19 Evidence-Based Response) action. During the Meeting, participants discussed the current methodological evidence on the following: RCTs in rehabilitation coming from meta-epidemiological studies; observational study designs - specifically the IDEAL Framework (Idea, Development, Exploration, Assessment, Long-term study) and its potential implementation in rehabilitation and the Target Trial Emulation framework: Single Case Experimental Designs; complex intervention studies: health services research studies, and studies using qualitative approaches. The Meeting culminated in the development of a first version of a "road map" to navigate the evidence production in rehabilitation according to the previous discussions. The Special Sections' papers present all topics discussed at the meeting, and a methodological paper about choosing the right research question, presenting final results and the "road map" for evidence production in rehabilitation.

Should we add antiplatelet agents to current deep venous thrombosis treatments? A Cochrane Review summary with commentary.

BACKGROUND: Venous thromboembolism (VTE) is an important complication in rehabilitation practice despite preventive measures. The management can be complicated because patients may have co-existing cardiovascular comorbidities. OBJECTIVE: To assess the effects of antiplatelet agents in addition to current best medical practice (BMP) compared to current BMP (with or without placebo) for the treatment of deep venous thrombosis (DVT). METHODS: A summary of the Cochrane Review by Flumignan et al. (2022), with comments from a rehabilitation perspective. RESULTS: The review included six studies with 1625 eligible participants, with data up to 37.2 months of follow-up. When used after standard initial treatment with anticoagulants, antiplatelet agents such as aspirin in addition to BMP, may reduce recurrence of DVT or pulmonary embolism, when compared to BMP plus placebo in a chronic DVT setting and there may be a lower risk for post-thrombotic syndrome in patients with acute DVT. There is no clear difference in side effects, major bleeding, or pulmonary embolism (PE) with the use of antiplatelet agents. CONCLUSION: Adding antiplatelet agents to standard anticoagulation treatment in patients with VTE could provide benefit without increasing risks in selected patient groups. However, high quality studies with a long-term follow up are needed, including patients in rehabilitation settings.

Advancing the World Health Assembly's landmark Resolution on Strengthening Rehabilitation in Health Systems: unlocking the Future of Rehabilitation.

In May 2023, the historic Resolution on Strengthening Rehabilitation in Health Systems was adopted unanimously by the 194 Member States of the World Health Assembly (WHA), the highest health policy-setting body. The resolution aims to scale up and integrate rehabilitation into health systems as part of Universal Health Coverage (UHC) to address the growing rehabilitation needs due to the global ageing population, the increasing prevalence of non-communicable diseases, and the emergence of new infectious diseases such as COVID-19. Globally, data extracted from the Global Burden of Disease Study in 2019 showed that one out of three people could benefit from rehabilitation, while more than half of the population in many countries is not receiving essential rehabilitation services. This special article highlights the global challenges in meeting rehabilitation needs and emphasizes the importance of affordable, accessible, and quality rehabilitation services for vulnerable populations. The resolution's path, which started in 2017 with the "Rehabilitation 2030: a Call for Action" initiative by the World Health Organization (WHO), is outlined. We summarize the key aspects of the WHA resolution, including its requests for Member States, international organizations, and the WHO Director-General. Finally, we discuss the way forward towards implementation, involving advocacy and concrete actions by all stakeholders, with the support of the newly established World Rehabilitation Alliance. The goal is to integrate rehabilitation into health systems worldwide, thus improving the well-being and socio-economic participation of those in need.

Prognostic validity of trunk control scales for mobility in individuals with motor complete thoracic SCI: a prospective cohort study.

STUDY DESIGN: Prospective cohort study. OBJECTIVES: To investigate the sensitivity to change and prognostic validity of Trunk Control Test (TCT) and Thoracic-Lumbar Control Scale (TLC) in terms of mobility in persons with motor complete thoracic spinal cord injury (SCI). SETTING: Participants were recruited at an Italian SCI rehabilitation facility from October 2015 to January 2020. METHODS: Inclusion criteria were acute traumatic or non-traumatic event and T1-L1 neurological level. Trunk control and mobility were assessed at baseline, discharge, and at 6 and 18-month follow-ups. Mobility was measured using Spinal Cord Independence Measure III mobility subscale. Linear regression models were used to analyze changes in trunk control and mobility over time, and the relationship between these measures. RESULTS: The 39 participants were predominantly male, with a mean age of 38 years. Trunk control improved during rehabilitation, at 6-month follow-up, and remained stable thereafter, according to TCT and TLC scales. A higher baseline TCT score was associated with improvements in mobility at discharge and at follow-ups. Baseline TLC score and its change during rehabilitation were unrelated with changes in mobility. CONCLUSIONS: Results suggest that the TCT and TLC scales are useful to capture changes in trunk control during the acute and subacute phases. Improvements in functional mobility are however associated with TCT score only, suggesting the potential of this test as a useful prognostic indicator. Further research with larger sample sizes is warranted to determine whether these findings are consistent across neurological level strata.

End-of-life decisions and involvement of Physical and Rehabilitation Medicine Physicians in Europe.

OBJECTIVE: As Physical and Rehabilitation Medicine physicians are experts in functional prognoses of disabling health conditions, the aim of this study was to gain insight into their involvement in end-of-life decisions in patients with neurological or terminal diseases in European countries. DESIGN: Exploratory cross-sectional survey. SUBJECTS: Delegates of the Union of European Medical Specialists, Physical and Rehabilitation Medicine Section. METHODS: In July 2020, a self-constructed survey was sent to 82 delegates from 38 European countries, who were asked to answer from the point of view of their country. Topics included the legal status of end-of-life decisions and the involvement of Physical and Rehabilitation Medicine physicians in these decisions. RESULTS: Between July 2020 and December 2020, 32 delegates from 28 countries completed the survey (response rate country level of 74%). If legal frameworks allow for these specific end-of-life decisions, involvement of Physical and Rehabilitation Medicine physicians was reported in 2 of 3 countries in euthanasia cases, 10 of 17 countries in non-treatment decision cases, and 13 of 16 countries in cases of intensified symptom management by the administration of drugs using potentially life-shortening doses. CONCLUSION: Estimated involvement of Physical and Rehabilitation Medicine physicians in end-of-life decisions varied between European countries, even when legal frameworks allow for these decisions.

Development of simple descriptions of the ICF Generic-30 Set in different languages: laying the foundation for an ICF-based clinical tool for Europe.

BACKGROUND: Functioning is considered a third indicator of health and a key outcome in rehabilitation. A universal practical tool for collecting functioning information is essential. This tool would be ideally based on the International Classification of Functioning, Disability and Health. AIM: To report the results of the development of country/language-specific versions of an ICF-based clinical tool in six European countries. DESIGN: Consensus process. SETTING: Expert conferences. POPULATION: Multi-professional group of rehabilitation professionals in six European countries. METHODS: 1) Developed an initial proposal by translating the published English-language version of the simple descriptions into the targeted language; 2) conducted a multi-stage consensus conference to finalize the descriptions; 3) employed a three-stage multi-professional expert panel translation back to English. The consensus conference model was modified for geographically large countries. RESULTS: Croatian, Flemish/Dutch, Greek, Polish, and Turkish versions were produced. CONCLUSIONS: The creation of the country/language-specific simple descriptions is a significant part of the "system-wide implementation of the ICF" initiative that will pave the way for the implementation of the ICF in national health systems. CLINICAL REHABILITATION IMPACT: The practical ICF-based clinical tool with country/language specific versions for standardized reporting of functioning will serve as a means of integrating functioning information in national health systems and additionally for monitoring the effects of rehabilitation interventions.

Overview of Cochrane systematic reviews for rehabilitation interventions in individuals with cerebral palsy: A mapping synthesis.

AIM: This overview of Cochrane systematic reviews (CSRs) reports on current evidence on the effectiveness of rehabilitation interventions for individuals with cerebral palsy (CP) and the quality of the evidence. METHOD: Following the inclusion criteria defined by the World Health Organization, all CSRs tagged in the Cochrane Rehabilitation database that were relevant for individuals with CP were included. A mapping synthesis was used to group outcomes and comparisons of included CSRs indicating the effect of rehabilitation interventions and the certainty of evidence. RESULTS: A total of eight CSRs were included in the evidence map. The effect of interventions varied across comparisons and the certainty of evidence was inconsistent, ranging from high to very low. The best evidence was found for botulinum neurotoxin A (BoNT-A) combined with occupational therapy in the management of spasticity. However, the effect of BoNT-A on drooling and salivation remains unclear. A paucity of randomized controlled trials studying treatments for both dystonia and postural deformities was noted. INTERPRETATION: This review emphasizes the need to further investigate the effectiveness and cost-benefit of rehabilitation interventions for individuals with CP. WHAT THIS PAPER ADDS: The quality and quantity of evidence on rehabilitation interventions for cerebral palsy is limited worldwide. Botulinum neurotoxin A plus occupational therapy showed robust efficacy for the management of upper-limb spasticity. Evidence on sleep-positioning systems for hip migration and trihexyphenidyl for dystonia is scarce.

Factors that influence the provision of home-based rehabilitation services for people needing rehabilitation: a qualitative evidence synthesis.

BACKGROUND: To increase people's access to rehabilitation services, particularly in the context of the COVID-19 pandemic, we need to explore how the delivery of these services can be adapted. This includes the use of home-based rehabilitation and telerehabilitation. Home-based rehabilitation services may become frequently used options in the recovery process of patients, not only as a solution to accessibility barriers, but as a complement to the usual in-person inpatient rehabilitation provision. Telerehabilitation is also becoming more viable as the usability and availability of communication technologies improve. OBJECTIVES: To identify factors that influence the organisation and delivery of in-person home-based rehabilitation and home-based telerehabilitation for people needing rehabilitation. SEARCH METHODS: We searched PubMed, Global Health, the VHL Regional Portal, Epistemonikos, Health Systems Evidence, and EBM Reviews as well as preprints, regional repositories, and rehabilitation organisations websites for eligible studies, from database inception to search date in June 2022.  SELECTION CRITERIA: We included studies that used qualitative methods for data collection and analysis; and that explored patients, caregivers, healthcare providers and other stakeholders' experiences, perceptions and behaviours about the provision of in-person home-based rehabilitation and home-based telerehabilitation services responding to patients' needs in different phases of their health conditions.   DATA COLLECTION AND ANALYSIS: We used a purposive sampling approach and applied maximum variation sampling in a four-step sampling frame. We conducted a framework thematic analysis using the CFIR (Consolidated Framework for Implementation Research) framework as our starting point. We assessed our confidence in the findings using the GRADE-CERQual (Confidence in the Evidence from Reviews of Qualitative research) approach.  MAIN RESULTS: We included 223 studies in the review and sampled 53 of these for our analysis. Forty-five studies were conducted in high-income countries, and eight in low-and middle-income countries. Twenty studies addressed in-person home-based rehabilitation, 28 studies addressed home-based telerehabilitation services, and five studies addressed both modes of delivery. The studies mainly explored the perspectives of healthcare providers, patients with a range of different health conditions, and their informal caregivers and family members.  Based on our GRADE-CERQual assessments, we had high confidence in eight of the findings, and moderate confidence in five, indicating that it is highly likely or likely respectively that these findings are a reasonable representation of the phenomenon of interest. There were two findings with low confidence. High and moderate confidence findings Home-based rehabilitation services delivered in-person or through telerehabilitation  Patients experience home-based services as convenient and less disruptive of their everyday activities. Patients and providers also suggest that these services can encourage patients' self-management and can make them feel empowered about the rehabilitation process. But patients, family members, and providers describe privacy and confidentiality issues when services are provided at home. These include the increased privacy of being able to exercise at home but also the loss of privacy when one's home life is visible to others.  Patients and providers also describe other factors that can affect the success of home-based rehabilitation services. These include support from providers and family members, good communication with providers, the requirements made of patients and their surroundings, and the transition from hospital to home-based services. Telerehabilitation specifically Patients, family members and providers see telerehabilitation as an opportunity to make services more available. But providers point to practical problems when assessing whether patients are performing their exercises correctly. Providers and patients also describe interruptions from family members.  In addition, providers complain of a lack of equipment, infrastructure and maintenance and patients refer to usability issues and frustration with digital technology. Providers have different opinions about whether telerehabilitation is cost-efficient for them. But many patients see telerehabilitation as affordable and cost-saving if the equipment and infrastructure have been provided. Patients and providers suggest that telerehabilitation can change the nature of their relationship. For instance, some patients describe how telerehabilitation leads to easier and more relaxed communication. Other patients describe feeling abandoned when receiving telerehabilitation services.  Patients, family members and providers call for easy-to-use technologies and more training and support. They also suggest that at least some in-person sessions with the provider are necessary. They feel that telerehabilitation services alone can make it difficult to make meaningful connections. They also explain that some services need the provider's hands. Providers highlight the importance of personalising the services to each person's needs and circumstances. AUTHORS' CONCLUSIONS: This synthesis identified several factors that can influence the successful implementation of in-person home-based rehabilitation and telerehabilitation services. These included factors that facilitate implementation, but also factors that can challenge this process. Healthcare providers, program planners and policymakers might benefit from considering these factors when designing and implementing programmes.

The Deficits of the Methodological and Reporting Quality of Randomized Controlled Trials in the Field of Prosthetics and Orthotics in Iran: A Systematic Review.

INTRODUCTION: Due to the development of the academic field of prosthetics and orthotics (P&O) in recent years, scientific studies in this domain have increased. However, relevant published studies, especially randomized controlled trials (RCTs), are not always of acceptable quality. Therefore, this study aimed to evaluate the methodological and reporting quality of RCTs in the field of P&O in Iran to recognize existing shortcomings. METHODS: Six electronic databases, including PubMed, Scopus, Embase, Web of Science, the Cochrane Central Register of Controlled Trials, and the Physiotherapy Evidence Database, were searched from January 1, 2000, to July 15, 2022. The Cochrane risk of bias tool was applied to evaluate the methodological quality of the included studies. In addition, the Consolidated Standards of Reporting Trials (CONSORT) 2010 checklist was used to assess the reporting quality of the included studies. RESULTS: 35 RCTs published from 2007 to 2021 were included in our final analysis. The methodological quality of 18 RCTs was poor, and the quality of the rest of the studies was good (n = 7) or fair (n = 10). In addition, the median score (IQR) of the reporting quality of RCTs in accordance with the CONSORT items was 18 (13-24.5) out of 35. The results of the relationship analysis indicated a moderate correlation between the CONSORT score and the publication year of the included RCTs. Nonetheless, there was a low correlation between the CONSORT scores and the journals' impact factors. CONCLUSION: The overall methodological and reporting quality of RCTs in the field of P&O in Iran was not found to be optimal. To enhance the methodological quality, some items should be considered more strictly, such as blinding of outcome assessment, allocation concealment, and random sequence generation. Furthermore, the criteria of CONSORT, as reporting quality checklist, should be adopted in writing the papers, especially methods-related items.

Multidisciplinary treatment protocol for ischiatic, sacral, trochanteric or other pressure injuries in people with spinal cord injury: a retrospective cohort study.

STUDY DESIGN: Retrospective cohort study Objectives: to describe the incidence and the associated risk factors of post-surgical complications and recurrence in individuals with spinal cord injury/disorder (SCI/D) presenting deep pressure injuries (PIs), treated with a specific surgical and rehabilitation treatment protocol. SETTING: Tertiary Rehabilitation Hospital for SCI/D in Italy. METHODS: Retrospective analysis of the medical records of adult individuals with SCI/D, who developed a PI after the first discharge from a Spinal Unit, underwent flap surgery for PI between July 2011 and January 2018. The statistical unit of analysis was the surgical intervention. Logistic regression analysis with robust standard errors was performed to assess risk factors of post-surgical complications. RESULTS: 434 surgical intervention records were included, for a total of 378 patients. The treated PIs were ischiatic in 56.2% of the cases, sacral in 32.5%, trochanteric in 15.7%, and 5.8% were in other sites. In 239 cases (55.1%) a histological diagnosis of osteomyelitis was confirmed. Minor complications occurred in 13.6% of interventions, while major complications were 3.9%. Sacral PI (OR = 2.55, 95%CI: 1.50-4.35) and muscular/musculocutaneous flap (OR = 2.12, 95%CI: 1.05-4.28) were significant factors associated with risk of post-surgical complications. After a mean follow-up of 21 months (range 12-36), six people (1.4%) had a recurrence. Patients with a recurrence had at least one comorbidity compared to 57% of people without recurrences (p = 0.036). CONCLUSION: Our results demonstrate that complication and recurrence rates can be minimized when an established interdisciplinary and rehabilitation protocol is integrated in the clinical management.