Effectiveness of rehabilitation interventions in adults with asthma: a systematic review and meta-analysis.

OBJECTIVE: To evaluate the effectiveness of pulmonary rehabilitation (PR) programs and other rehabilitation interventions in adults with asthma. DESIGN: Systematic review and meta-analysis. RESULTS: MEDLINE (PubMed), EMBASE, Cumulative Index to Nursing & Allied Health Literature and CENTRAL were searched from inception to 31 May 2023. PROSPERO registration number: CRD42022331440. Thirty-six randomised controlled trials (RCTs) were analysed, and only 26 were pooled in the meta-analysis due to the heterogeneity of comparisons and outcomes across the studies. Pulmonary rehabilitation, compared with education associated with breathing exercises, may result in little to no difference in the Asthma Quality of Life Questionnaire (AQLQ) (mean difference 0.01 score, 95% confidence interval -0.48 to 0.50, 163 participants, three studies, low certainty). CONCLUSION: Our findings show that pulmonary rehabilitation, compared with education associated with breathing exercises, may result in little to no difference in the impact of asthma on health-related quality of life. Overall, the certainty of evidence was low or very low preventing any firm conclusion on the effects of single or combined rehabilitation interventions.

In vitro CAR-T cell killing: validation of the potency assay.

For advanced therapy medicinal products, the development and validation of potency assays are required, in accordance with international guidelines, to characterise the product and obtain reliable and consistent data. Our purpose was to validate the killing assay for the evaluation of autologous anti-CD19 chimeric antigen receptor (CAR) T potency. We used CD4 + and CD8 + lymphocytes or anti-CD19 CAR-T cells as effector cells and REH (CD19 +) or MOLM-13 (CD19 -) cell lines as target cells. After co-culturing target and effector cells (1:1 ratio) for 24 h, samples were labelled with 7-AAD, anti-CD3 and anti-CD19 antibodies and the frequency of CD19 + dead cells was evaluated by flow cytometry. In order to verify the CAR-T specificity for the CD19 + target, the co-culture between CAR-T and REH or MOLM-13 at different effector-to-target ratios was scheduled. Moreover, not transduced CD4 + and CD8 + lymphocytes were tested in comparison with CAR-T from the same donor to demonstrate the assay specificity. Linearity and accuracy were evaluated, and established acceptance criteria were compiled for both parameters (r2 ≥ 0.97 for linearity and average relative error ≤ 10% for accuracy). Furthermore, the method was considered robust when performed between 23 and 25 h of co-culture, and the intra-assay, inter-assay and inter-day precision was obtained. Finally, in order to verify the inter-analyst precision, the test was executed by three different operators and the intra-class correlation coefficient was > 0.4 in both cases. In conclusion, we consider this CAR-T potency assay as validated and usable in all steps of product development and quality control.

Lumbar braces and other assistive devices for treatment of chronic low back pain.

OBJECTIVES: This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the benefits and harms of assistive technologies (i.e. non-rigid and rigid lumbar braces, belts, supports, and devices to assist mobility and gait) for improving pain and function (and consequently reducing disability) in adults with chronic low back pain.

Dendritic cell vaccines as cancer treatment: focus on 13 years of manufacturing and quality control experience in advanced therapy medicinal products.

BACKGROUND AIMS: Dendritic cells (DCs) are professional antigen-presenting cells of the mammalian immune system. Ex vivo differentiated DCs represent a unique Advanced Therapy Medicinal Product (ATMP), used in several clinical trials as personalized cancer immunotherapy. The therapy's reliability depends on its capacity to produce high-quality mature DCs (mDCs) in compliance with Good Manufacturing Practices. AIMS: From March 2010 to December 2023, 103 patients were enrolled in multiple clinical trials at the Immuno-Gene Therapy Factory at IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori". Six hundred forty-two doses were produced, and the manufacturing process was implemented to optimize production. Our study is a retrospective analysis focusing on the quality control results. METHODS: We retrospectively analyzed the results of the quality control tests carried out on each produced batch, evaluating viability, purity and phenotype of mDCs and their quality in terms of microbiological safety. The data obtained are given with median and interquartile range. RESULTS: The batches were found to be microbiologically safe in terms of sterility, mycoplasma, and endotoxins. An increase in DC maturation markers was found. The release criteria checks showed a high percentage of viability and purity was maintained during the production process. CONCLUSIONS: Our findings have confirmed that the measures implemented have ensured the safety of the products and have contributed to the establishing a robust "Pharmaceutical Quality System." This has enabled many safe mDCs to be produced for clinical trials.

Overview of Cochrane Systematic Reviews on Interventions for Rehabilitation in People with Ischemic Heart Disease: A Mapping Synthesis.

Objectives: This overview of Cochrane Systematic Reviews (CSRs) reports on current evidence and its certainty of the effectiveness of interventions for the rehabilitation of people with ischemic heart disease (IHD), included in the World Health Organization Rehabilitation Programme Package of Interventions for Rehabilitation. Methods: We included all the CSRs relevant to people with IHD. We used a mapping synthesis to group outcomes and comparisons of included CSRs, indicating the effectiveness of interventions for rehabilitation and the certainty of evidence. Results: The evidence map included a total of 13 CSRs. The effect of the interventions varied across comparisons, and the certainty of evidence was inconsistent, ranging from high to very low. We found the best evidence for exercise-based cardiac rehabilitation in the reduction of fatal and non-fatal myocardial infarction and all-cause hospital admission up to 12 months follow-up. Also, combined interventions (work-directed interventions, physical conditioning interventions, and psychological interventions) reduce the days needed for returning to work. Conclusions: The current effect and certainty of evidence for several comparisons investigated support the role of exercise-based cardiac rehabilitation in the management of people with IHD, specifically reducing the risk of fatal and non-fatal myocardial infarction and hospitalisation. However, our findings highlight the lack of high-certainty evidence about hard endpoints, particularly total mortality. Future research should prioritise these primary endpoints to enhance the credibility of cardiac rehabilitation.

Retrograde and semantic amnesia in a case of post-treatment Lyme disease syndrome: did something lead to a psychogenic memory loss? A single-case study.

OBJECTIVE: To describe a case of Post-Treatment Lyme Disease Syndrome (PTLDS) with an atypical cognitive profile. METHOD: A 41-year-old PTLDS patient underwent comprehensive neuropsychological testing and psychological assessment. RESULTS: The patient exhibited impaired intensive attention but preserved selective attention. Executive functions were normal. Short-term and anterograde memory were intact, while retrograde and semantic memory were significantly impaired. The patient also experienced identity loss, specific phobias, dissociative symptoms, and depressed mood. CONCLUSIONS: Severe episodic-autobiographical and retrograde semantic amnesia was consistent with some reports of dissociative amnesia. Loss of identity and phobias were also highly suggestive of a psychogenic mechanism underlying amnesia.

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.

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.

Correction to: "Dysphagia, dysphonia and olfactory disease: a map of Cochrane evidence relevant to rehabilitation for people with post-COVID-19 condition".

This article was published in volume 58, issue 6 of publishing year 2022, with a mistake in Table II. The correct Table II is the one included in this erratum.

Therapeutic exercises for idiopathic scoliosis in adolescents.

BACKGROUND: Adolescent idiopathic scoliosis (AIS) is a pathology that changes the three-dimensional shape of the spine and trunk. While AIS can progress during growth and cause cosmetic issues, it is usually asymptomatic. However, a final spinal curvature above the critical threshold of 30° increases the risk of health problems and curve progression in adulthood. The use of therapeutic exercises (TEs) to reduce the progression of AIS and delay or avoid other, more invasive treatments is still controversial. OBJECTIVES: To evaluate the effectiveness of TE, including generic therapeutic exercises (GTE) and physiotherapeutic scoliosis-specific exercises (PSSE) in treating AIS, compared to no treatment, other non-surgical treatments, or between treatments. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, four other databases, and two clinical trials registers to 17 November 2022. We also screened reference lists of articles. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing TE with no treatment, other non-surgical treatments (braces, electrical stimulation, manual therapy), and different types of exercises. In the previous version of the review, we also included observational studies. We did not include observational studies in this update since we found sufficient RCTs to address our study aims. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methodology. Our major outcomes were progression of scoliosis (measured by Cobb angle, trunk rotation, progression, bracing, surgery), cosmetic issues (measured by surface measurements and perception), and quality of life (QoL). Our minor outcomes were back pain, mental health, and adverse effects. MAIN RESULTS: We included 13 RCTs (583 participants). The percentage of females ranged from 50% to 100%; mean age ranged from 12 to 15 years. Studies included participants with Cobb angles from low to severe. We judged 61% of the studies at low risk for random sequence generation and 46% at low risk for allocation concealment. None of the studies could blind participants and personnel. We judged the subjective outcomes at high risk of performance and detection bias, and the objective outcomes at high risk of detection bias in six studies and at low risk of bias in the other six studies. One study did not assess any objective outcomes. Comparing TE versus no treatment, we are very uncertain whether TE reduces the Cobb angle (mean difference (MD) -3.6°, 95% confidence interval (CI) -5.6 to -1.7; 2 studies, 52 participants). Low-certainty evidence indicates PSSE makes little or no difference in the angle of trunk rotation (ATR) (MD -0.8°, 95% CI -3.8 to 2.1; 1 study, 45 participants), may reduce the waist asymmetry slightly (MD -0.5 cm, 95% CI -0.8 to -0.3; 1 study, 45 participants), and may result in little to no difference in the score of cosmetic issues measured by the Spinal Appearance Questionnaire (SAQ) General (MD 0.7 points, 95% CI -0.1 to 1.4; 1 study, 16 participants). PSSE may result in little to no difference in self-image measured by the Scoliosis Research Society - 22 Patient Questionnaire (SRS-22) (MD 0.3 points, 95% CI -0.3 to 0.9; 1 study, 16 participants) and improve QoL slightly measured by SRS-22 Total score (MD 0.3 points, 95% CI 0.1 to 0.4; 2 studies, 61 participants). Only Cobb angle results were clinically meaningful. Comparing PSSE plus bracing versus bracing, low-certainty evidence indicates PSSE plus bracing may reduce Cobb angle (-2.2°, 95% CI -3.8 to -0.7; 2 studies, 84 participants). Comparing GTE plus other non-surgical interventions versus other non-surgical interventions, low-certainty evidence indicates GTE plus other non-surgical interventions may reduce Cobb angle (MD -8.0°, 95% CI -11.5 to -4.5; 1 study, 80 participants). We are uncertain whether PSSE plus other non-surgical interventions versus other non-surgical interventions reduces Cobb angle (MD -7.8°, 95% CI -12.5 to -3.1; 1 study, 18 participants) and ATR (MD -8.0°, 95% CI -12.7 to -3.3; 1 study, 18 participants). PSSE plus bracing versus bracing alone may make little to no difference in subjective measurement of cosmetic issues as measured by SAQ General (-0.2 points, 95% CI -0.9 to 0.5; 1 study, 34 participants), self-image score as measured by SRS-22 Self-Image (MD 0.1 points, 95% CI -0.3 to 0.5; 1 study, 34 participants), and QoL measured by SRS-22 Total score (MD 0.2 points, 95% CI -0.1 to 0.5; 1 study, 34 participants). None of these results were clinically meaningful. Comparing TE versus bracing, we are very uncertain whether PSSE allows progression of Cobb angle (MD 2.7°, 95% CI 0.3 to 5.0; 1 study, 60 participants), changes self-image measured by SRS-22 Self-Image (MD 0.1 points, 95% CI -1.0 to 1.1; 1 study, 60 participants), and QoL measured by SRS-22 Total score (MD 3.2 points, 95% CI 2.1 to 4.2; 1 study, 60 participants). None of these results were clinically meaningful. Comparing PSSE with GTE, we are uncertain whether PSSE makes little or no difference in Cobb angle (MD -3.0°, 95% CI -8.2 to 2.1; 4 studies, 192 participants; very low-certainty evidence). PSSE probably reduces ATR (clinically meaningful) (MD -3.0°, 95% CI -3.4 to -2.5; 2 studies, 138 participants). We are uncertain about the effect of PSSE on QoL measured by SRS-22 Total score (MD 0.26 points, 95% CI 0.11 to 0.62; 3 studies, 168 participants) and on self-image measured by SRS-22 Self-Image and Walter Reed Visual Assessment Scale (standardised mean difference (SMD) 0.77, 95% CI -0.61 to 2.14; 3 studies, 168 participants). Further, low-certainty evidence indicates that 38/100 people receiving GTE may progress more than 5° Cobb versus 7/100 receiving PSSE (risk ratio (RR) 0.19, 95% CI -0.67 to 0.52; 1 study, 110 participants). None of the included studies assessed adverse effects. AUTHORS' CONCLUSIONS: The evidence on the efficacy of TE is currently sparse due to heterogeneity, small sample size, and many different comparisons. We found only one study following participants to the end of growth showing the efficacy of PSSE over TE. This result was weakened by adding studies with short-term results and unclear preparation of treating physiotherapists. More RCTs are needed to strengthen the current evidence and study other highly clinically relevant outcomes such as QoL, psychological and cosmetic issues, and back pain.

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.

Combining preclinical tools and models to unravel tumor complexity: Jump into the next dimension.

Tumors are complex and heterogeneous diseases characterized by an intricate milieu and dynamically in connection with surrounding and distant tissues. In the last decades, great efforts have been made to develop novel preclinical models able to recapitulate the original features of tumors. However, the development of an in vitro functional and realistic tumor organ is still utopic and represents one of the major challenges to reproduce the architecture of the tumor ecosystem. A strategy to decrypt the whole picture and predict its behavior could be started from the validation of simplified biomimetic systems and then proceed with their integration. Variables such as the cellular and acellular composition of tumor microenvironment (TME) and its spatio-temporal distribution have to be considered in order to respect the dynamic evolution of the oncologic disease. In this perspective, we aim to explore the currently available strategies to improve and integrate in vitro and in vivo models, such as three-dimensional (3D) cultures, organoids, and zebrafish, in order to better understand the disease biology and improve the therapeutic approaches.

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.

Overview of Cochrane Systematic Reviews of rehabilitation interventions for persons with rheumatoid arthritis: a mapping synthesis.

The aim of this paper was to provide an overview of Cochrane Systematic Reviews (CSRs), which synthesizes the quality and quantity of available evidence on the effectiveness of rehabilitation interventions in rheumatoid arthritis (RA). The World Health Organization (WHO) requested Cochrane Rehabilitation the CSRs search to develop the Package of Interventions in Rehabilitation (PIR). We searched the Cochrane Library using the terms "rheumatoid arthritis" and "rehabilitation." We screened the CSRs according to the search strategy based on the methodology developed for the WHO PIR. The search period for the data provided to WHO was between 1 September 2009 and 2019. We updated the search to 1 September 2022 for this paper. We summarized the CSRs identified after the screening process using an evidence map, grouping outcomes, and comparisons of included CSRs indicating the effect and the quality of evidence to provide a comprehensive view of current knowledge. We identified 10 CSRs, including 92 primary studies with 10,801 participants and 23 comparisons. They explored the effectiveness and/or safety of either non-pharmacological or pharmacological (for symptom control only) interventions. Outcomes were pain, muscle strength, grip/pinch strength, tender joints, swollen joints, fatigue, disease activity, radiological damage, physical function, hand function, participant adherence, clinical improvement, withdrawals, and adverse events. Our mapping synthesis indicates that physical activity and exercises in RA are effective non-pharmacological interventions for some outcomes, such as hand function, muscle strength and fatigue, without any deterioration of pain, disease activity and radiological involvement. Psychosocial interventions show a small beneficial effect on fatigue. Regarding pharmacological agents, celecoxib presents similar analgesic effects with traditional NSAIDs but fewer gastric adverse events. Current evidence supports physical activity and exercise programs for individuals with RA. However, well-designed studies will help document the exact effects of these programs on different outcomes and physiological mechanisms in RA. There were inconclusive results for some of the interventions due to low and very-low quality of evidence. Furthermore, due to the lack of CSRs on therapeutic patient education, orthoses, physical modalities and assistive devices in the search period, it was impossible to synthesise the evidence on those interventions.

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.

An overview of Cochrane systematic reviews for pulmonary rehabilitation interventions in people with chronic obstructive pulmonary disease: a mapping synthesis.

INTRODUCTION: There is a global unmet need for rehabilitation to meet which the World Health Organization, in collaboration with Cochrane Rehabilitation, is developing the Package of Interventions for Rehabilitation with the aim of identifying rehabilitation interventions relevant to a range of key health conditions, including chronic obstructive pulmonary disease (COPD). The purpose of this paper is to describe the best available evidence on pulmonary rehabilitation interventions for people with COPD. EVIDENCE ACQUISITION: An Overview of Cochrane Systematic Reviews (CSRs). Through the search strategy, COPD-related systematic reviews published from January 2009 to November 2021 were identified. Data were extracted on each reported outcome related to an intervention and judgements about the quality of evidence were made, using the GRADE approach. EVIDENCE SYNTHESIS: Seventeen reviews were analyzed, for a total of 314 primary studies that included 22,206 participants. CSRs provided information on the effectiveness of rehabilitation on functioning, activity, quality of life, anxiety, depression, mortality, and health care resource utilization. CONCLUSIONS: Our findings report that comprehensive pulmonary rehabilitation programs and water exercises improve the exercise capacity and quality of life (QoL) in people with COPD. Different exercise modalities, intensities, and settings for different muscle groups, breathing exercises, and counseling can improve exercise capacity, QoL, dyspnea, hospitalizations, and physical activity. It is uncertain whether breathing exercise, low-intensity exercise, neuromuscular electrical stimulation, and psychological intervention have an effect on exercise capacity, dyspnea, QoL, and physical activity. The protocol was registered on OSF (registration DOI: 10.17605/OSF.IO/8A26Q).

Overview of Cochrane Systematic Reviews for Rehabilitation Interventions in Persons With Spinal Cord Injury: A Mapping Synthesis.

OBJECTIVE: This article aims to describe the evidence on rehabilitation interventions for persons with spinal cord injury (SCI) identified in Cochrane Systematic Reviews (CSRs) selected for inclusion in the World Health Organization Rehabilitation Programme-Package of Interventions for Rehabilitation. DATA SOURCES: The CSRs search was led by the Cochrane Rehabilitation team, using the tagging process, using the terms "spinal cord injury" and "rehabilitation" in the Cochrane Library. STUDY SELECTION: We performed an overview of all the CSRs according to the inclusion criteria defined with the World Health Organization: rehabilitation interventions in persons with SCI. DATA EXTRACTION: The CSRs identified after the screening process were summarized using an evidence map, grouping outcomes, and comparisons of included CSRs indicating the effect and the quality of evidence to provide a comprehensive view of what is known. DATA SYNTHESIS: Out of 248 CSRs from the past 10 years tagged in the Cochrane Rehabilitation database, 3 were related to SCI. They provide data on 13 outcomes analyzed within 11 comparisons for a total of 64 primary studies, including 2024 participants with SCI. Of these, 7 outcomes and 1 comparison focused on people with cervical SCI. Rehabilitation interventions might improve respiratory outcomes and pain relief in people with SCI. There is uncertainty whether bodyweight-supported treadmill training, robotic-assisted training, and functional electrostimulation affect walking speed and capacity. CONCLUSIONS: The current evidence needs to be confirmed by better quality research. Therefore, future priorities are the improvement of methodological quality of the studies in people with SCI, particularly considering the complexity of this health condition. Further, there is a need for more CSRs in the field.

Functional and Clinical Characteristics of Individuals Attending Pulmonary Rehabilitation After Severe COVID-19.

BACKGROUND: A proportion of patients with COVID-19 need hospitalization due to severe respiratory symptoms. We sought to analyze characteristics of survivors of severe COVID-19 subsequently admitted to in-patient pulmonary rehabilitation and identify their rehabilitation needs. METHODS: From the COVID-19 Registry of Fondazione Don Gnocchi, we extracted 203 subjects admitted for in-patient pulmonary rehabilitation after severe COVID-19 from April 2020-September 2021. Specific information on acute-hospital stay and clinical and functional characteristics on admission to rehabilitation units were collected. RESULTS: During the acute phase of disease, 168 subjects received mechanical ventilation for 26 d; 85 experienced delirium during their stay in ICU. On admission to rehabilitation units, 20 subjects were still on mechanical ventilation; 57 had tracheostomy; 142 were on oxygen therapy; 49 were diagnosed critical illness neuropathy; 162 showed modified Barthel Index < 75; only 51 were able to perform a 6-min walk test; 32 of 90 scored abnormal at Montreal Cognitive Assessment; 43 of 88 scored abnormal at Hospital Anxiety and Depression Scale; 65 scored ≥ 2 at Malnutrition Universal Screening Tool, and 95 showed dysphagia needing logopedic treatment. CONCLUSIONS: Our analysis shows that subjects admitted for in-patient pulmonary rehabilitation after severe COVID-19 represent an extraordinarily multifaceted and clinically complex patient population who need customized, comprehensive rehabilitation programs carried out by teams with different professional skills. The need for step-down facilities, such as sub-intensive rehabilitation units, is also highlighted.