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Statement of problem Bilateral balanced occlusion has been advocated over nonbalanced occlusion for improved removable complete denture stability and function. However, assessments of quality of life and patient satisfaction studies between the 2 occlusion schemes are lacking. Purpose The objective of this parallel randomized control trial was to determine the difference in quality of life and patient satisfaction between the nonbalanced and bilaterally balanced occlusal schemes. Material and methods Sixty participants were included in the parallel randomized control trial of nonbalanced and bilaterally balanced complete dentures. Thirty were recruited into each group with definitive inclusion and exclusion criteria as per the Consolidated Standards of Reporting Trials (CONSORT) guidelines. Quality of life was estimated from the oral health quality of life (Oral Health Impact profile) for edentulous patients questionnaire, and patient satisfaction was analyzed from a visual analog scale. The estimation was made at 0, 3, and 6 months after denture insertion. The data were statistically analyzed with the Friedman, Mann-Whitney, and t test (α=.05). Results The mean ±standard deviation Oral Health Impact profile score was 60.81 ±8.87 for nonbalanced dentures and 64.12 ±8.98 for bilaterally balanced dentures. The mean ±standard deviation visual analog scale score was 2.84 ±0.28 for nonbalanced dentures and 2.90 ±0.31 for bilaterally balanced dentures. The Mann-Whitney and t test indicated nonsignificant differences between the 2 groups and at different time intervals for Oral Health Impact profile and visual analog scale scores (P>.05). Conclusions The study detected no significant differences between the 2 occlusal schemes in quality of life or patient satisfaction.

Statement of problem Denture stomatitis and other oral infections are prevalent in denture wearers and can be treated effectively with an antimicrobial agent such as a silver nanoparticle-based polymer. However, the physical properties of the denture should not be adversely affected by the addition. Purpose The purpose of this systematic review and meta-analysis of in vitro studies was to analyze the effects of a silver nanoparticle-based antimicrobial resin on the properties of polymethyl methacrylate(PMMA)–based denture resin. Material and methods Full-length English language articles reporting silver nanoparticle-based PMMA resin were included in the review, with no limitation on the year till May 2020. Scopus, Web of Sciences, and PubMed databases were accessed for the literature survey. The review was formulated based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and used the Consolidated Standards of Reporting Trials (CONSORT) guidelines and risk of bias Cochrane tool for quality assessment. A meta-analysis of flexural strength was performed by using a random-effects model at a 95% confidence interval. The other properties were analyzed descriptively. Results Silver nanoparticle reinforcement caused considerable differences in the inherent physical material properties of PMMA. Conclusions An antimicrobial polymer nanocomposite formulation can either negatively affect or bring no improvement to the physical properties of denture resin.

Research Objectives Rheumatoid arthritis (RA) is one of the leading causes of work disability in the United States. Ergonomic interventions offer an individualized treatment approach, and when used in conjunction with pharmacological treatment interventions, may improve work outcomes and improve the overall quality of life for individuals with RA. To identify the current body of evidence regarding the effectiveness of ergonomic interventions in reducing work activity limitations in adults with RA. Design A systematic review was conducted to identify articles of ergonomic interventions targeting working adults with RA. The CONsolidated Standards of Reporting Trials (CONSORT) checklist and Non-Pharmacological Treatment (NPT) Extension evaluated the reporting quality of each randomized controlled trial (RCT), and the Grading of Recommendation Assessment, Development, and Evaluation (GRADE) evaluated the quality of the evidence. Setting N/A. Participants N/A. Interventions N/A. Main Outcome Measures N/A. Results Six studies were identified and reviewed for the quality of their reporting on evidence related to work activity limitations. Sixty-six percent of the items on the CONSORT checklist were fully reported by all studies and analysis through the GRADE framework demonstrated moderate confidence that the reported effects of ergonomic interventions on work activity limitations in the studies are accurate. This review revealed varied results for the effectiveness of ergonomic interventions on work activity limitations and at-work productivity. Conclusions The results of this review indicate a need for further investigation. Future studies should focus on reviewing specific ergonomic interventions to determine the dosage needed to see results in reducing work activity limitations for working adults with RA.

Background Previous articles have assessed the evidence-base for the treatment of burns, but the latest was published in 2010, examining data up to and inclusive of 2008. The aim of this article is to examine the trend in the number of high-evidence publications over the subsequent 11-year period and quality-assess RCTs within this timeframe. Materials and Methods All articles published in Burns and Journal of Burn Care and Research (JBCR) were identified using PubMed Search Tools and its Single Citation Matcher function. These journals were manually screened from 01/01/2009 to 01/06/2020 inclusive. Additionally, a PubMed search was conducted searching for RCTs and meta-analyses in English with the MESH term burns to identify meta-analyses and RCTs in all other journals. The reporting of RCTs was assessed using a modified CONsolidated Standards of Reporting Trials (CONSORT) checklist. Results A total of 5,145 articles were evaluated from Burns and JBCR, with 3,230 (62.78%) from Burns and 1,915 (37.22%) from JBCR. 0.012% were meta-analyses of RCTs, 0.30% were other meta-analyses, and 2.52% were initially identified as RCTs. Whilst a significant increase in the number of high-evidence publications is observed, these represent 2.83% (n=237) of the total. An additional 95 RCTs were identified in other journals, 58 being included in quality-analysis. A total 128 RCTs were thus eligible for quality-assessment, the most popular individual topic being wound healing (n=28; 21.88%). The most highly reported criterion was listed inclusion and exclusion criteria (n=111; 86.72%) and the least reported criterion was allocation concealment (n=22; 13.92%). Conclusions This study observes a positive trend in high-evidence publications. The reporting of several CONSORT criteria in RCTs remains poor. Observation to standard reporting guidelines is advocated to improve the quality of reporting.

Called the "Rehabilitation - COVID-19 Evidencebased Response" (REH-COVER), the project has been organised around five main activities related to Covid-19 rehabilitation: production of rapid living systematic reviews, production of an Interactive living evidence map, prioritisation of research topics on rehabilitation and Covid-19 In collaboration with the World Health Organization (WHO), production of a Cochrane Library Special Collection on Covid-19 and rehabilitation for patients with functional consequences of acute Illness, and lastly, collaboration with the COVID-19 Evidence Network to support decision-making (https://rehabilitation.cochrane.org/resources/ cochrane-rehabilitatIon-versus-covId-19). The CONSORT statement Is a list of criteria endorsed by all leading health science journals, Including the New Zealand Journal of Physiotherapy, that describes a minimum level of reporting required In any published article on a clinical trial. The CONSORT statement ensures that when researchers publish findings from randomised controlled trials, all key Information needed to evaluate the quality of the study and to apply It to clinical practice has been Included In the report.

Objective This study collected randomized controlled trials (RCTs) published in the social sciences in China and assessed their risk of bias and reporting quality. Study Design and Setting Three databases were systematically searched for publications from January 2000 to June 2020 for RCTs in the social sciences published by Chinese researchers. The risk of bias was assessed using the Cochrane Collaboration Risk of Bias Tool (CCRBT), and reporting quality was assessed using the Consolidated Standards of Reporting Trials for Social and Psychological Interventions (CONSORT-SPI). Results A total of 316 RCTs were identified, including 204 articles in English and 112 articles in Chinese. The most frequently researched interventions focused on education (33.9%), and the most frequently studied population were students (32.9%). Eighty-seven percent of RCTs had intermediate reporting quality. Twenty-four of the 43 CONSORT-SPI sub-items had a compliance rate of less than 50%. Most RCTs had an unclear risk of bias for blinding outcome assessors (84.5%), blinding participants and personnel (82.9%), allocation concealment (73.1%), and random sequence generation (68.0%). A low proportion of CONSORT-SPI items were reported and, high proportion of the papers had unclear risk of bias. Conclusion The quality and reporting of RCTs in the social sciences needs improvement in China, especially for reporting methods and results. Most studies had an unclear risk of bias as they lacked important methodological information.

Summary Background The conduct and reporting of pilot studies is important to assess the feasibility of future randomized controlled trials (RCT). The Consolidated Standards of Reporting Trials (CONSORT) statement extension to pilot/feasibility studies addresses the reporting quality of the pilot studies (Summary Table 1). The aims of this systematic review are (1) to assess the reporting quality of pilot studies in pediatric urology and (2) to explore the factors that are associated with the reporting quality of these studies. Methods A comprehensive search was conducted through MEDLINE® and EMBASE® to identify pilot RCTs from 2005 to 2018. Two reviewers independently performed title and abstract screening and full text review, with discrepancies resolved by consensus. CONSORT extension reported items were summarized and overall proportion of reported items for each article was estimated. A linear regression model was conducted to determine factors associated with higher reporting quality. Publication year, biostatistician/epidemiologist support, sample size justification and journal impact factor were collected. Results Of the 1463 titles duplicates were removed and 1347 were screened, 36 studies were included. Overall, 36 pilot studies reported about 8–9 of 17 items [51% (95% CI: 46 – 56%)]. The most reported items were contact details for the corresponding author (97%), title identification of study as randomised pilot or feasibility trial (95%), eligibility criteria and setting (81%), both interventions (78%), and specific objectives of the pilot trial (75%). Less fulfilled items were blinding (11%), registration of the trial (11%), randomization details (28%), detailing recruitment status in the pilot study (19%), trial design (31%), and source of funding for pilot trial (34%). Interpretation of the results of pilot trial and their implications for the future definitive trial was reported by 34% of the studies. Factors associated with higher reporting quality were the presence of biostatistician or epidemiologist (P = 0.004), and if the sample size for the pilot study was justified (P = 0.002). Discussion Overall reporting quality of pilot studies in pediatric urology literature from 2005-2018 was suboptimal. The quality of pilot RCTs included in the present review were lower than that observed in the orthopedic literature, however, it appears to be consistent with the trends regarding OQS in chronic kidney disease and allopathic medicine. While we endeavoured to maintain utmost rigidity of this systematic review, there are inherent limitations. The CONSORT 2010 extension for pilot RCTs was published in 2016. Clinical trials can take several years, many pilot studies published pre-2016 would not have had the guidance of the extension during designing phases. Not all pilot RCTs are published, so this could potentially reduce the generalizability of the findings from this review. Only studies in English, published in full peer-reviewed journals were included, and this review only addressed the reporting quality of pilot studies in pediatric urology. Conclusion This review demonstrated that reporting quality of pilot studies in pediatric urology is currently suboptimal. Including biostatistician and/or epidemiologist, can ameliorate the quality of future pilot studies. Implementing CONSORT 2010 extension by journals as a prerequisite for submission of pilot or feasibility trials is recommended to improve the robustness and transparency of future pilot studies.

OBJECTIVE The aim of the present study was to evaluate the effect of a brief version of the behavioral intervention Acceptance and Commitment Therapy (ACT) on reducing gingivitis and plaque levels after 18 weeks. MATERIALS AND METHODS One hundred thirty-five caries-active young adults (18-25 years of age), recruited from two public dental clinics, participated in this parallel group randomized control trial (RCT). Participants in the intervention (n = 67) received two ACT sessions in combination with standard information on oral health, and participants allocated to the control group (n = 68) received standard information only. Gingivitis and plaque levels were recorded at baseline and at the 9- and 18-week follow-ups. The effect of the intervention versus standard information alone was analyzed by intention-to-treat and per protocol, applying the General Linear Model (GLM). Exploratory analyses for the intervention and control groups were conducted to evaluate the effect of gender and smoking habits on the gingivitis and plaque outcome. The CONSORT guidelines for RCT were followed. RESULTS A significant decrease in gingivitis and plaque levels was observed over time, irrespective of treatment allocation. However, the ACT intervention was not significantly more effective at reducing gingivitis and plaque scores than standard information alone, even though the intervention participants had maintained their improvement to a greater extent. The exploratory analysis revealed that females improved their gingivitis and plaque levels significantly more than the males in the intervention group (p = 0.025 for gingivitis and p = 0.013 for plaque). CONCLUSION A brief ACT intervention was not proven to be more effective than standard information alone at improving oral health in a sample of young adults with poor oral health. However, ACT seems to have a positive effect on oral health among females. (TRN ISRCTN15009620).

BACKGROUND Randomized control trials (RCTs) serve as evidentiary support for recommendations underpinning clinical practice guidelines (CPGs) with the goal of optimizing patient care. A knowledge gap exists within scientific literature when evaluating the quality of RCTs used as evidence in the American Academy of Orthopaedic Surgery (AAOS) pediatric CPGs. We aim to evaluate the reporting quality and risk of bias in RCTs underlying AAOS Pediatric CPG recommendations. METHODS We located all AAOS Pediatric CPGs. We then extracted all RCTs from the CPG reference sections. All included RCTs were evaluated using the Consolidated Standards of Reporting Trials (CONSORT) checklist and Cochrane Collaboration risk of bias assessment tool (RoB 2.0). Descriptive statistics were recorded, and bivariate analysis was used to account for variance in CONSORT scores. A Mann-Whitney U test was completed to compare CONSORT studies published before and after 2010. RESULTS Three CPGs and 23 RCTs met inclusion criteria. Mean CONSORT adherence was 69.8% (21.6/31). The lowest adhered to CONSORT items were 10, 23, and 24, while items 2a, 13a, and 18 displayed the highest adherence. Ten RCTs (43.5%, 10/23) had "low" risk of bias, 5 RCTs (21.7%, 5/23) were of "some concerns," and 8 RCTs (34.8%, 8/23) received a "high" designation for risk of bias. There were no statistically significant associations in the bivariate regression analysis or Mann-Whitney U test. CONCLUSIONS Our results suggest that CONSORT adherence within RCTs used as evidence in AAOS Pediatric CPGs is substandard-relying on evidence that, in some cases, is >20 years old. Many of the RCTs cited as supporting evidence have a "high" risk of bias. Altogether, these CPGs may need to be updated or expanded to include more recent evidence relevant to pediatric orthopaedic surgery.

Introduction and Objectives:Massive hemorrhage (MH) is a growing pathology in military settings and increasingly in civilian settings; it is now considered a public health problem in the United States with large-scale programs. Tourniquets are the fastest and most effective intervention in MH if direct pressure is not effective.The Liaison Committee on Resuscitation (ILCOR) recognizes a knowledge gap in optimal education techniques for first aid providers. This review aims to describe training and evaluation methods for teaching tourniquet use to both health care and military professionals.Methods:The MEDLINE, CINAHL, WEB of Science, and Scopus databases were reviewed (from 2010 through April 2020). The quality of the selected studies was assessed using the Consolidated Standards of Reporting Trials (CONSORT) scale. Studies that met at least 65% of the included items were included. Data were extracted independently by two reviewers.Results:Ten of the 172 articles found were selected, of which three were randomized clinical trials. Heterogeneity was observed in the design of the studies and in the training and evaluative methods that limit the comparison between studies.Conclusions:The results suggest that the training strategies studied are effective in improving knowledge, attitudes, and practical skills. There is no universal method, learning is meaningful but research should be directed to find out which ones work best.

Introduction: On the topic of adjuncts to scaling and root planing (SRP), numerous randomized clinical trials (RCTs) were published by a single group of authors and frequently reported unusually large effect sizes. A meta-analysis in part 1 of this project failed to explain the causes for these unusual findings. We assessed the reporting quality and trial registration discrepancies to examine the possibility of replicating the work of this research group as well as the overall rigor of the research methodology. Methods: This study was preregistered at the Open Science Framework ( https://osf.io/4meyd/ ). The Scopus platform was utilized for the RCT search on SRP adjuncts in intrabony defects in patients with periodontitis as compared with SRP alone. The search analysis was limited from 2010 to 2017, and RCTs on SRP adjuncts published by a single research group were selected for screening and inclusion. RCT registration records were assessed for consistency. Results: Out of 92 studies that were retrieved from Scopus and PubMed, 32 were included for quality assessment per the CONSORT guidelines (Consolidated Standards of Reporting Trials). Results showed that all RCTs were characterized by a low reporting quality. The majority of CONSORT items scored Conclusion: RCTs by this group were characterized by poor adherence to reporting quality guidelines. Crucial RCT elements, such as randomization, blinding, and primary outcomes, were not reported properly. RCT registration records revealed systematic inconsistencies when compared with RCT publication. Therefore, the unusually large effects reported by this group should be viewed with extreme caution. Knowledge Transfer Statement: The included randomized clinical trials were characterized by poor adherence to reporting quality guidelines, missing information about important trial items, and discrepancies between the reports and trial registrations. This quality assessment should guide clinical research and show clinicians that they should be cautious when applying evidence in their clinical practice.

Objectives The aim of this study was to determine Relapse and TMD as postoperative complication in skeletal class III patients undergoing bimaxillary orthognathic surgery. Materials and methods Data was obtained by database searching using The Cochrane Central Register of Controlled Trials (central), PUBMED, SCOPUS, EMBASE, Google scholar, National Medical library, New Delhi. The titles and abstracts of the electronic search results were screened and evaluated by two observers for eligibility according to the inclusion and exclusion criteria. Results 5261 articles were retrieved for the review. Among these, 3474 duplicate articles were removed. 418 studies were selected based on the eligibility criteria. For the present review, 30 articles were included after elimination according to the inclusion criteria. The Prisma diagram flowchart demonstrates our selection scheme. Quality assessment criteria to evaluate the studies were decided by two review authors in accordance with CONSORT guidelines. Each study was assessed using the evaluation method described in the Cochrane Handbook for Systematic Reviews. Among the 30 studies included in the review, marked degree of relapse in the mandible was noted from 3 months - 1 year postoperatively in 8 studies, 5 studies reported both TMD prevalence and relapse, whereas only 4 studies reported TMD disorder alone. Conclusion Complications of relapse and TMD are associated with bimaxillary orthognathic surgery procedures. More RCTs and CCTs are needed in this regard to get better quality evidence. This review was registered with PROSPERO: CRD42020211342.

Aims The purpose of this systematic review was to investigate and synthesize the effects (benefits and harms) of electrical stimulation (EE), alone or in association with other interventions, compared with sham and other interventions, for the treatment of neurogenic bladder dysfunction in myelomeningocele. Methods This systematic review was conducted following the methodological recommendations of the Cochrane Handbook for Systematic Reviews of Interventions and registered at PROSPERO (CRD42020200425). A search was performed in the following electronic databases: MEDLINE, Cochrane Central Register of Controlled Trials, EMBASE, LILACS, and PEDro. Randomized clinical trials (RCTs) that assessed any EE in children diagnosed with myelomeningocele and neurogenic bladder and/or urinary incontinence were included and reported. Results When comparing EE versus sham groups, some estimated effects showed a wide confidence interval, probably due to the small sample size of the included studies. This indicates an imprecision in these findings. Regarding the safety of this intervention and safety of the lower urinary tract, no adverse events resulting from EE were reported. All the included studies have evaluated the efficacy of EE compared with sham, but different EE parameters and electrode positions among studies make it impossible to perform a meta-analysis. Conclusions Based on very low certainty evidence, the findings of this systematic review suggested no difference between EE and sham to improve urinary incontinence in children with myelomeningocele. However, the small sample size and the imprecision arising from the wide confidence intervals must be considered. Future RCTs following a rigorous methodology, as recommended by the CONSORT statement, should be conducted to support the use of this intervention in clinical practice.

Background Racial and ethnic minorities suffer significantly more than others in the wake of disasters. Despite the growing recognition of the importance of culturally competent health services, systematic cultural competence training in the medical education system is still scarce, especially in the field of emergency. The current study aimed to examine the effectiveness of an online culturally informed intervention for increasing cultural competence in emergencies among nursing students. Methods A randomized controlled trial was used to test the intervention effectiveness in increasing nursing students’ cultural competence in four domains: attitudes, knowledge, skills, and encounters. The study included 72 undergraduate nursing students recruited from two academic institutes. Participants were randomized (1:1 ratio) to an intervention (n = 34) and control group (n = 38). The study adheres to the Consolidated Standards of Reporting Trials (CONSORT). Data analysis was based on multivariate analysis of variance with repeated measures, followed by post hoc analyses with Bonferroni correction for multiple comparisons. Results Results showed that the intervention was effective in increasing the participants’ culturally competent knowledge. The effect of the intervention on the skills domain approached significance. No group differences were identified in the attitudes and the encounters domains. Conclusions An online culturally informed intervention, incorporated in the curriculum, was effective in enhancing the cognitive aspect of cultural competence (especially at the basic knowledge and understanding levels), but not other domains. Our results encourage the development of future intervention programs that are based on a deep understanding of local values, needs, and preferences.

Objectives The aim of this study was to determine the effect of omega-3 on the painful symptomatology of osteoarthritis (OA) in synovial joints. Study Design An electronic/manual search was conducted (2004-2019). Using pain as a primary outcome and stiffness/function and swelling as secondary outcomes, based on Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) criteria, Consolidated Standards of Reporting Trials (CONSORT) reporting quality, and Cochrane/RoB-2 risk of bias assessment. Data were processed using RevMan v5.2 (Cochrane Collaboration). Results Six randomized controlled trials were selected. The study population included 454 patients with OA. In 4 studies the pain in the intervention group presented significant pain reduction compared with the control group (mean difference = 22.89; 95% confidence interval, 3.37-42.42). Studies did not stablish the effective anti-inflammatory dose. The number of studies on stiffness/function and inflammation was low (n = 2). The evidence and degree of recommendation was 2B. The randomized controlled trials presented high clinical and methodological variability. Conclusion Omega-3 can significantly reduce painful symptoms in patients suffering from OA in synovial joints. However, the limited number of studies, range of doses, intervention periods, baseline characteristics of patients, and asymmetry in reporting bias, combined with the heterogeneity in the combined effect of the studies, offer low-quality evidence on which clinical guidance cannot be based.

To assess the reporting quality of randomized controlled trials (RCTs) with multicenter design, particularly whether necessary information related to multicenter characteristics was adequately reported.Through a search of 4 international electronic databases, we identified multicenter RCTs published in English from 1975 to 2019. Reporting quality was assessed by the CONSORT (Consolidated Standards of Reporting Trials) checklist (37 items) and by a self-designed multicenter-specific checklist (27 items covering multicenter design, implement and analysis). The scores of trials published in three time periods (1975-1995; 1996-2009; and 2010-2019) were also compared.A total of 2,844 multicenter RCTs were included. For the CONSORT checklist, the mean (standard deviation) reporting score was 24.1 (5.5), 12 items were assessed as excellent (90%), 12 items as good (50%-90%), and 13 items as poor (50%). For the multicenter checklist, the reporting score was 3.9 (2.2), only 3 items were excellent or good, and the remaining 24 items were poor. Time period comparison showed that reporting quality improved over time, especially after the CONSORT 2010 issued.Although CONSORT appears to have enhanced the reporting quality of multicenter RCTs, further improvement is needed. A "CONSORT extension for multicenter trials" should be developed.

Background Global effort is key to prevent and control infections effectively. Whereas pharmacists’ involvement in the immunization neighborhood, collaborative effort to meet immunization needs of the public, has reduced burden of vaccine-preventable diseases in Western countries, the impact of pharmacist-involved vaccination advocacy and delivery in Asia Pacific remains unclear. Objective To examine the evidence for impact of pharmacists on immunization advocacy and delivery in Asia Pacific and to assess Singaporean pharmacists’ experience in becoming immunizing pharmacists through the American Pharmacists Association’s Pharmacy-based Immunization certificate training program. Methods A mixed-method study consisted of systematic review and survey was conducted. The systematic review was conducted by searching PubMed and Cumulative Index to Nursing and Allied Health databases from inception to March 2021. Randomized controlled trials and observational studies related to pharmacist-involved immunization advocacy and training conducted in Asia Pacific were included. Eligible studies were appraised for quality using CONsolidated Standards of Reporting Trials (CONSORT) and STrengthening the Reporting of OBservational checklists. In addition, a 20-item Likert-scale survey evaluated the pharmacists’ experience in becoming immunizing pharmacists in Singapore. Frequencies of each response to the survey items were analyzed. Results Six studies were eligible for inclusion; 2 assessing impact of pharmacist as immunizer, 3 reporting outcomes of pharmacist-involved vaccine advocacy, and 1 evaluating the structure of pharmacist immunization training. Although study quality was minimal, all studies echoed positive findings as a result of pharmacist-provided immunization advocacy and delivery. Of the 23 pharmacists completing the survey, 91.3% strongly agreed that quality training was important to become immunizing pharmacists. Conclusion Although limited in number, studies conducted in Asia Pacific reported increased vaccination rates when involving pharmacists. Coupled with the enthusiasm to be trained in immunization advocacy and delivery as elucidated by the Singaporean pharmacists, pharmacists in Asia Pacific should also be advocated for their role in the immunization neighborhood as part of the global effort against vaccine-preventable infectious diseases.

Objectives: This review aims to identify types of the existing fall prevention education (FPE) and their effectiveness in promoting fall risk awareness, knowledge and preventive fall behaviour change among community-dwelling older people. Background: FPE is a cost-effective and helpful tool for reducing fall occurrences. Evaluation: This is a systematic review study using electronic searches via EBSCOHost® platform, ScienceDirect, Scopus and Google Scholar in March 2021. The review protocol was registered with PROSPERO (CRD42021232102). The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement flow chart guided the search strategy. Articles published from January 2010 to March 2021 were included for quality appraisal using the ‘Transparent Reporting of Evaluations with Non-randomised Designs’ (TREND) and the ‘Consolidated Standards of Reporting Trials’ (CONSORT) statement for randomised controlled trial studies. Key issues: Six FPE studies selected emphasised on personal health status, exercise and environmental risk factors. These studies reported an increase in fall risk awareness or knowledge and a positive change in fall preventive behaviours. Two studies included nurses as educators in FPE. Conclusion: FPE evidently improved awareness or knowledge and preventive fall behaviour change among older adults. Nurses are in great potential in planning and providing FPE for older adults in community settings. Implications for Nursing Management: Expand nurses’ roles in fall prevention programmes in community settings by using high-quality and evidence-based educational tools. Highlight the nurse’s role and collaborative management in FPE.

Background With the improvement of therapeutic strategies from cytotoxic chemotherapy to immunotherapy, the possibility of achieving timely intervention for lung cancer has dramatically increased. This study aimed to systematically evaluate the reporting quality of randomized controlled trials (RCT) on immunotherapy in lung cancer. Methods The RCTs evaluating the efficacy of immunotherapy in lung cancer published up to 2021 were searched and collected from PUBMED and EMBASE by two investigators. The 2010 Consolidated Standards for Test Reports (CONSORT) statement‐based 28‐point overall quality score (OQS) and the 2001 CONSORT statement‐based 19‐point OQS was utilized for assessing the overall quality of each report. Results One hundred and fifty‐two related RCTs were retrieved in this study, including 81,931 patients. The average OQS in 2010 was 17.89 (range, 7.5–24.5). Overall, studies have sufficiently reported the eligibility criteria (143/152; 94.07%), described the scientific background (150/152; 98.7%) and discussed interventions (147/152; 96.7%). However, the RCTs did not consistently report the changes to trial after commencement (48/152; 31.6%), allocation, enrollment and assignment personnel (34/152; 22.4%), blinding (48/152; 31.6%), or randomization method (58/152; 38.2%). Conclusions The overall reporting quality of RCTs on immunotherapy in lung cancer was found to be unsatisfactory despite the fact that the CONSORT statement was issued more than a decade ago. Furthermore, there was virtual selectivity and heterogeneity in reporting some key issues in these trials. This is the first study to enlighten lung cancer researchers especially focusing on immunotherapy, and also to remind editors and peer reviewers to strengthen their due diligence., The 2010 Consolidated Standards for Test Reports (CONSORT) statement‐based 28‐point overall quality score (OQS) and the 2001 CONSORT statement‐based 19‐point OQS was utilized to assess the quality of randomized controlled trials (RCTs) on immunotherapy in lung cancer published in PUBMED and EMBASE, demonstrating an unsatisfactory overall reporting quality, enlightening lung cancer researchers to pay more attention to CONSORT projects when designing and reporting trials, and bringing up the necessity for editors and peer reviewers to be more scrutinizing and diligent for RCTs on immunotherapy in lung cancer.

Objectives (1) To determine whether new tools and items have been developed to evaluate the risk of bias (RoB) and reporting of randomized controlled trials (RCTs) in rehabilitation; (2) to determine which items are included in the existing reporting guidelines, and to create a matrix of items to report and conduct trials in rehabilitation as the first step for a starting a rigorous validation process. Data Sources Searches were conducted in MEDLINE, EMBASE, and Cumulative Index to Nursing and Allied Health databases. Study Selection Studies should describe a newly developed tool to evaluate the RoB or quality of reporting for RCTs in the area of rehabilitation. Data extraction (1) First, we extracted items from new tools identified by the electronic search strategies and then (2) we looked at the items provided by the Consolidated Standards of Reporting Trials statement and its relevant extensions. We determined whether these items were already included in our matrix of items. Items were classified based on methodological domains they accomplish, biases they were able to target, and whether they guide reporting or conduct. Data Synthesis Among the 1596 citations found, 23 articles were potentially relevant. From these, only 3 new scales (National Institute for Complementary Medicine Acupuncture Network, Quality of reports on spa and balneotherapy [SPAC], Assessment of Study Quality and Reporting in Exercise) were found. In addition, the newly updated Cochrane RoB tool (RoB 2.0) was included. Our matrix contained 122 unique items for any rehabilitation area, 46 items (37.7%) were related to conduct, and 58 (47.5%) were related to the reporting; 18 (14.8%) were related to both. Overall, 76 new items were added among all domains. Conclusions Many individual and diverse items have been used to guide the reporting and conduct of rehabilitation trials. This indicates a great variability in number of items and an apparent lack of consensus on a core set of items to be used in rehabilitation. Future research should look into developing a core set of items for the rehabilitation field.

Although the importance of real-world evidence should not be underestimated, randomised controlled trials (RCTs) remain the gold standard for direct treatment comparisons. Over the last two decades, numerous publications have presented results of RCTs investigating the safety and efficacy of therapies for the treatment of type 2 diabetes, for example long-acting basal insulin analogues [1–14]. RCTs such as these use a robust design and methodology that aims to avoid confounders and determine differences between basal insulins. However, interpreting the results of RCTs and making judgements about the quality of evidence and how results may be applicable to diabetes management can be difficult for healthcare practitioners (HCPs) because of differing trial methodologies, analysis plans, and endpoints. There are guidelines for those developing publications that report the results of RCTs, such as the Consolidated Standards of Reporting Trials (CONSORT) guidelines [15], and readers are advised to familiarise themselves with these if possible. However, we have developed a checklist of points we consider most important when reading and interpreting RCT publications (Fig. 1). This checklist is based on CONSORT, other published literature, and our own experience, and may serve as useful guidance for HCPs. This article will discuss these key points in more detail, progressing through the sections of a typical RCT publication. Open in a separate window Fig. 1 Interpreting publications reporting results from randomised controlled trials (RCTs): a guidance checklist

There has been a significant rise in robotic trajectory guidance devices that have been utilised for stereotactic neurosurgical procedures. These devices have significant costs and associated learning curves. Previous studies reporting devices usage have not undertaken prospective parallel-group comparisons before their introduction, so the comparative differences are unknown. We study the difference in stereoelectroencephalography electrode implantation time between a robotic trajectory guidance device (iSYS1) and manual frameless implantation (PAD) in patients with drug-refractory focal epilepsy through a single-blinded randomised control parallel-group investigation of SEEG electrode implantation, concordant with CONSORT statement. Thirty-two patients (18 male) completed the trial. The iSYS1 returned significantly shorter median operative time for intracranial bolt insertion, 6.36 min (95% CI 5.72–7.07) versus 9.06 min (95% CI 8.16–10.06), p = 0.0001. The PAD group had a better median target point accuracy 1.58 mm (95% CI 1.38–1.82) versus 1.16 mm (95% CI 1.01–1.33), p = 0.004. The mean electrode implantation angle error was 2.13° for the iSYS1 group and 1.71° for the PAD groups (p = 0.023). There was no statistically significant difference for any other outcome. Health policy and hospital commissioners should consider these differences in the context of the opportunity cost of introducing robotic devices.Trial registration: ISRCTN17209025 (https://doi.org/10.1186/ISRCTN17209025).

Objective To evaluate the quality of descriptions of interventions in health care research reports, based on a synthesis of reviews that used the Template for Intervention Description and Replication (TIDieR) to rate the completeness and quality of intervention reporting. Design Overview of published reviews. In a systematic search of the literature, 56 review articles were retrieved that had evaluated 3454 primary studies (index articles) using all or most of the 12 TIDieR items, applied to experimental treatment only or treatment and comparator both, separately. If available, percentages “reported completely” were extracted based on the index article, the index article supplemented by related information, and these 2 supplemented by e-mailing the author. Information on the review’s methodology was also extracted. Setting Not applicable. Participants Not applicable. Interventions Not applicable. Main Outcome Measures Percentage of primary studies receiving “adequately reported” ratings on each of the 12 TIDieR items. Results While for treatment arms TIDieR items 1 (name of treatment) and 2 (why of treatment) are generally judged to be reported adequately, the percentage is between 25% and 75% for most other items and is as low as 10% for item 10 (modifications). Comparators are reported even more poorly. Use of additional publications on a trial increased percentages “reported adequately” marginally; e-mailing resulted in significant increases in completeness of reporting. Rehabilitation trials were reported better than nonrehabilitation trials for some TIDieR items and worse for others. Conclusions Reporting on the interventions and comparators of trials is substandard. More extensive use of supplemental digital content and of versions of TIDieR customized for specific domains of research may improve the situation.

Background Immune‐related adverse events (irAEs) are of great interest and importance in clinical practice, and many deficiencies and controversies have been noted in the reporting of irAEs. Herein, we aimed to evaluate the current status of irAE reporting in randomized controlled clinical trials (RCTs) of PD‐1/PD‐L1 inhibitors and to attempt to explain and solve the current pitfalls associated with this reporting. Materials and Methods We conducted a systematic review across multiple databases, including PubMed, Web of Science, Embase, and the Cochrane Library. The RCTs that compared PD‐1/PD‐L1 inhibitors with standard treatments were included. The Harms extension of the Consolidated Standards of Reporting Trials (CONSORT) was used to evaluate the completeness of irAE reporting. Results A total of 44 articles and 23,759 patients were included in the analysis. The terminology of the irAEs changed over time (p = .01) and was different among immune checkpoint inhibitors (ICIs) (p = .005). Twenty‐two of the studies provided a definition of irAE, but only four of them concretely addressed this definition. The incidence of any grade of irAEs ranged from 16.9% to 96%, whereas grade 3–4 irAE ranged from 2% to 23%. The RCTs with combined therapy exhibited a higher incidence of grade 3–4 irAEs (p = .012). Thirty‐two studies reported irAEs in the control arms, whereas seven studies reported irAEs only in the experimental arms. Respiratory, endocrine, and gastrointestinal disorders were the most commonly reported irAEs. IrAEs were generally neglected in the introduction or conclusion sections in all of the study reviews and were never subjected to subgroup analyses. Moreover, withdrawals due to severe irAEs, as well as clarifications of the irAE collection methods, were also poorly reported. RCTs using combination therapies in the experimental arms were associated with a higher reporting quality (p = .032). However, the completeness of the reporting did not improve over the last 5 years (p = .076). Conclusion The reporting of irAEs was inadequate, and there are still inconsistencies and controversies in the reporting of irAEs. In the future, authors should be encouraged to adhere to the Harms extension of the CONSORT statement. Implications for Practice PD‐1/PD‐L1 inhibitors profoundly changed the landscape of cancer treatment, and thousands of randomized controlled clinical trials (RCTs) were active or completed over the past decade. However, different from chemotherapy or targeted therapy, the profile of immune‐related adverse effects (irAE) was unique. An understanding of irAEs is developed mainly from clinical trials; however, inconsistencies and controversies between trials were noted. This study primarily reviewed the evolution of irAE terminology and definitions and evaluated the reporting quality of each RCT. It was found that RCTs using combined immunotherapy were associated with higher quality of irAE reporting. This article identifies the controversies and deficiencies in current irAE reporting and provides possible explanations and suggestions for these inadequacies., Reporting of immune‐related adverse events (irAEs) has not yet been standardized. This review evaluates the current state of irAE reporting in clinical trials, focusing on shortcomings associated with this reporting and possible solutions.

Aim To test the effectiveness of a new ethics educational e-learning intervention, Ethics Quarter, in supporting nurse managers' ethical activity profile. Background Health care organisations need evidence-based ethics interventions to support nurse managers' ethical activity profile. Methods A parallel-group, individually randomized controlled trial was conducted in 2020. Finnish nurse managers nationwide [members of the Union of Health and Social Care Professionals in Finland (Tehy) trade union] were randomly allocated to intervention (n = 169) or control group (n = 172). The intervention group participated in the Ethics Quarter comprising twelve 15-min evidence-based educational 'quarters' spread over 6 weeks. The control group had standard organisational ethics structures. The primary and secondary outcomes were ethical activity profile and ethics knowledge, respectively. The Consolidated Standards of Reporting Trials (CONSORT) statement for study design and reporting was adopted. Results Ethical activity profile showed statistically significant differences in mean changes between the groups from baseline to 10 weeks: all five dimensions were statistically significantly higher in the intervention group compared with the control group (p = Conclusion The Ethics Quarter was effective in increasing nurse managers' ethical activity profile. Implications for nursing management Applying this ethics educational e-learning intervention would benefit nursing management education and health care organisations. Trial registration clinicaltrials.gov: NCT04234503.

AIMS AND OBJECTIVES The aim of this study was to investigate the effect of training, given by the nurses to coronary artery patients, on treatment adherence of the patients. BACKGROUND Treatment adherence can be defined as adherence of drug use and healthy lifestyle habits to healthcare recommendations. Training programmes enable to reduce healthcare expenditures and risk of mortality by increasing treatment adherence. DESIGN This study is a single-blind randomised controlled trial. The requirements of CONSORT statement were followed. The study was registered with clinicaltrial.gov. NCT04556006. METHODS The study was conducted with 58 patients hospitalised in the cardiology clinic of a state hospital (intervention = 30 and control = 28). Personal information form, anthropometric measurements, Framingham risk score and compliance questionnaire were used to collect the data. After the first data of the patients were collected, the training on treatment adherence was provided to those in the intervention group. The content of the training was repeated in 2nd , 4th , 8th and 12th weeks. At the end of 12th week, the data of the patients in both groups were collected again and evaluated. RESULTS Compliance questionnaire scores were 22.53 ± 5.48 in the intervention group and 22.25 ± 7.02 in the control group at the beginning of the study (p > .05); whereas, they were 32.33 ± 4.82 in the intervention group and 24.04 ± 5.98 in the control group at the end of 12th week (p

Background Comprehensive reporting of clinical trials is essential to allow the trial reader to evaluate the methodological rigor of the trial and interpret the results. Since publication of the updated Consolidated Standards of Reporting Trials (CONSORT) guidelines for reporting of parallel clinical trials in humans, extensions for reporting of abstracts and crossover trials have been published. Objectives To describe the types of trials using dogs and cats published from 2015 to 2020 and to evaluate the quality of reporting of a sample of recently published parallel and crossover trials. Animals None. Methods A comprehensive search was conducted to identify parallel or crossover design clinical trials using dogs and cats published from January 1, 2015 onwards. Quality of reporting was evaluated on a subset of trials published during 2019. The reporting of items recommended in the CONSORT reporting guidelines for abstracts, parallel trials, and crossover trials was evaluated independently by 2 reviewers using standardized forms created for this study. Disagreements among reviewers were resolved by consensus. Results were tabulated descriptively. Results The frequency of reporting of trial features varied from low to high. There remain deficiencies in the quality of reporting of key methodological features and information needed to evaluate and interpret trial results. Conclusions and Clinical Importance There is still a need for authors, peer‐reviewers, and editors to follow reporting guidelines such as CONSORT to maximize the value of clinical trials and to increase confidence in the validity of the trial results.

Background. Rhodiola is a worldwide used medicinal plant for its various medicinal functions, and the number of randomized controlled trials (RCTs) of Rhodiola is increasing in recent years. This study aims to evaluate the reporting quality and risk of bias of the current RCT reports of different Rhodiola species. Methods. Six databases including Embase, PubMed, Web of Science, the Cochrane Library, ClinicalTrial.gov, and China National Knowledge Infrastructure were searched to identify RCTs that used Rhodiola as a single intervention and were published in English or Chinese from inception to December 2020. The Consolidated Standards of Reporting Trials (CONSORT) 2010 statement was used as the checklist for assessment, and a scoring system was applied to the evaluation of RCTs. Score 0 represents no reporting or inadequate reporting, and score 1 represents adequate reporting. The risk of bias of the included studies was also assessed using the Cochrane Risk of Bias tool. Results. A total of 39 RCTs were included in this study, including 23 RCTs of Rhodiola rosea (R. rosea), 8 RCTs of Rhodiola crenulata (R. crenulata), and 8 RCTs of Rhodiola wallichiana (R. wallichiana). None of the included studies met all the CONSORT statement criteria, and the reporting quality of RCTs of the three Rhodiola species was all generally poor. Based on the risk of bias assessment, the majority of included studies were judged to have an unclear risk of bias in most domains due to inadequate reporting. Conclusions. There is inadequate reporting among the included RCTs of different Rhodiola species, and RCTs of Rhodiola with higher reporting quality and better methodological quality are needed.

Background Irritable bowel syndrome (IBS) is a debilitating and costly disorder. Cognitive behavior therapy (CBT) is effective in the treatment of IBS, both when delivered over the internet and in face-to-face settings. CBT consists of different components and little is known about their relative importance. We have in an earlier study showed that inclusion of exposure in the CBT for IBS makes it even more effective. In the present study we wanted to evaluate the economic effects for society of inclusion vs exclusion of exposure in an internet delivered CBT for IBS. Methods We used data from a previous study with 309 participants with IBS. Participants were randomized to internet delivered CBT with (ICBT) or without exposure (ICBT-WE). We compared direct and indirect costs at baseline, after treatment, and 6 months after treatment (primary endpoint; 6MFU). Data was also collected on symptom severity and time spent by therapists and participants. The relative Incremental Cost Effectiveness Ratio (ICER) was calculated for the two treatment conditions and the return on investment (ROI). Results Results showed that ICBT cost $213.5 (20%) more than ICBT-WE per participant. However, ICBT was associated with larger reductions regarding both costs and symptoms than ICBT-WE at 6MFU. The ICER was − 301.69, meaning that for every point improvement on the Gastrointestinal Symptom Rating Scale—IBS version in ICBT, societal costs would be reduced with approximately $300. At a willingness to pay for a case of clinically significant improvement in IBS symptoms of $0, there was an 84% probability of cost-effectiveness. ROI analysis showed that for every $1 invested in ICBT rather than ICBT-WE, the return would be $5.64 six months after treatment. Analyses of post-treatment data showed a similar pattern although cost-savings were smaller. Conclusions Including exposure in Cognitive Behavior Treatment for IBS is more cost-effective from a societal perspective than not including it, even though it may demand more therapist and patient time in the short term. Trial registration This study is reported in accordance with the CONSORT statement for non-pharmacological trials [1]. Clinicaltrials.gov registration ID: NCT01529567 (14/02/2013).

Physical Activity and Fatigue in Multiple Sclerosis: Secondary Outcomes from a Double-blinded Randomized Controlled Trial of Cocoa Flavonoid Drinks Maedeh Mansoubi()1,2, Shelly Coe1,2,3, Jo Cossington1, Johnny Collet1,2, Miriam Clegg4, Jacqueline Palace5, Ana Cavey5, Gabriele C DeLuca5, Martin Ovington1 and Helen Dawes1,2,6 1Center for Movement, Occupational and Rehabilitation Sciences, Oxford Institute of Nursing, Midwifery and Allied Health Research, Oxford Brookes University, Oxford, United Kingdom 2Oxford Clinical Allied Technology and Trial Services Unit (OxCATTS), Oxford, United Kingdom 3Oxford Brookes Center for Nutrition and Health, Oxford Brookes University, Oxford, United Kingdom 4Hugh Sinclair Unit of Human Nutrition, Department of Food and Nutritional Sciences, University of Reading, Reading, United Kingdom 5Department of Neurology, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, United Kingdom 6Oxford Health NHS Foundation Trust, United Kingdom © The Authors Abstract Fatigue is a common and pervasive symptom reducing physical activity in people with multiple sclerosis (pwMS). Exercise may reduce fatigue, although evidence to guide optimal prescription is limited. Specifically, supportive evidence for the timing of exercise for fatigue management or the impact of dietary supplements is unavailable. We performed intensive phenotyping of the interrelation of time of day, physical activity levels, and fatigue to evidence exercise prescription in 40 pwMS participating in a six week randomized controlled trial of morning flavonoid intake (n=19) or a control (n=21). Physical activity was measured over seven days by using an accelerometer at baseline, week three and week six. Participants self-reported their fatigue on a 1–10 rating scale at 10 am, 3 pm, and 8 pm daily. Physical activity levels were calculated for 2.5 h before and after fatigue was reported. Generalized estimating equations were used to explore the time of day fatigue profiles, the relationship of physical activity to fatigue, and the effect of morning flavonoids on this relationship. Participants experienced higher fatigue at 8 pm (4.64±2.29) than at 3 pm (4.39±2.28) and 10 am (3.90±2.10) (P0.05). Morning flavonoid cocoa consumption reduced the relationship of fatigue to physical activity (P=0.049) and fatigue to time of the day (P

Background: Sleep problems are prevalent among perinatal women, contributing to the poor overall well-being of mother and child. Exercise is an inexpensive and sustainable intervention to improve sleep outcomes and can be personalized accordingly to individuals. This systematic review and meta-analysis aim to consolidate available evidence to evaluate the effectiveness of exercise on improving sleep outcomes among perinatal women.Methods: Eight databases (CINAHL, Cochrane, EMBASE, PsycINFO, PubMed, Scopus, Web of Science and ProQuest) were used to perform a systematic search for studies in the English language from the inception of each database to 7 December 2019. The quality of studies was assessed using the risk of bias and GRADE. Review Manager was used for meta-analyses. Heterogeneity was determined by Cochran's Q (chi-square) and I2 values. The overall effect was evaluated using effect size and Z-statistics.Results: A total of 2,139 records were identified. Ten randomized controlled trials were included, with seven in the meta-analysis, involving 998 pregnant and postpartum women across eight countries. With medium to very large effect sizes, the results favored exercise interventions on sleep quality, sleep efficiency, sleep duration, sleep latency, insomnia, diurnal tiredness and daytime dysfunction.Conclusion: Exercise interventions produced significant effects on improving sleep among perinatal women. This can increase advocacy for exercise among perinatal women to improve sleep and general health. Future randomized controlled trial designs should adhere to the Consolidated Standards of Reporting Trials and Template to ensure reliability when conducting and reporting such studies.

Aim: Knee osteoarthritis is a degenerative disease complicated by pain and functional limitation. Newer pain-relieving interventions include pulsed radiofrequency (PRF), but studies on its efficacy have limitations including lack of control group and retrospective design that prevent sound conclusions. Materials & methods: We conducted a blind prospective randomized sham-controlled crossover pilot trial according to the CONSORT guidelines, to evaluate the efficacy of ultrasound-guided saphenous nerve PRF in gonarthritis pain. Results: Sixteen patients completed the study. Pain and function significantly improved after real PRF (numerical rating scale mean difference = 3.31), which was superior to sham PRF over time for pain (3 months) and function (6 months). Conclusion: PRF of the saphenous nerve is an alternative to relieve pain in gonarthritis. Our results provide data to support a sample size calculation for future trials. Clinical trial registration: NCT04454710

Context Inflammatory bowel diseases are chronic, relapsing diseases that compromise life quality and expectancy. The increased incidence and prevalence of these diseases reinforce the need for research on prevention, therapy, and management innovations. Synbiotics (ie, probiotic plus prebiotic combinations) are suggested as an alternative or complementary therapy to conventional treatments for inflammatory bowel disease. Objective The aim for this systematic review was to gather and analyze data from randomized controlled trials to provide more information to increase the current evidence level about the safety and efficacy of synbiotic use as a supplemental treatment for ulcerative colitis. Data Sources Searches were performed in the Medline, Science Direct, Scielo, Scopus, and Embase databases between January 2017 and March 2019, using the keywords “colitis” and ”synbiotics”. Data Extraction The data extraction method performed for each trial was based on the recommendations of the Consolidated Standards of Reporting Trials for randomized clinical trials. The trials included in this meta-analysis presented low risk of bias, based on the Cochrane Handbook for Systematic Reviews of Interventions guidelines. Data Analysis The results demonstrated that synbiotics significantly improved colonic endoscopic and histologic scores, the Clinical Activity Index, serum C-reactive protein levels, intestinal microbiota, Bowel Habits Index, and levels of messenger RNAs, tumor necrosis factor-α, interleukin-1α, interleukin-10, and myeloperoxidase in the patients. In addition, the use of synbiotics increased probiotic microorganisms, reduced proinflammatory colonic cytokines, and elevated anti-inflammatory cytokines. Conclusions Therefore, the results of this meta-analysis reinforce the evidence that synbiotics provide benefits to patients when used as an alternative or complementary therapy for those with ulcerative colitis.

Purpose: To evaluate the safety and efficacy of remdesivir in adult patients with COVID-19. Methods: PubMed, Embase, Scopus, Web of Science, Cochrane Library, ClinicalTrials.gov, and medRxiv databases were searched using a search strategy tailored to each database. The Consolidated Standards of Reporting Trials (CONSORT) and Strengthening the reporting of observational studies in epidemiology (STROBE) checklists were used for the studies' qualitative assessment. The outcomes studied were mortality, all adverse events, serious adverse events, and clinical improvement. The quantitative synthesis was conducted using fixed and random effects models in the CMA 2.2. Heterogeneity was tested using the I-squared (I2) measure. Results: In general, six studies, including five randomized controlled trials and one cohort study were found eligible. Comparison of the findings related to both groups receiving remdesivir (10-day remdesivir group) and placebo/control group showed that remdesivir treatment had no significant effect on mortality at day 14 of the treatment (RR=0.769; 95% CI :0.563-1.050; p=0.098), and all adverse events (RR= 1.078; 95% CI: 0.908-1.279; p= 0.392). However, remdesivir had a significant effect on clinical improvement at day 14 compared to placebo/control (OR= 1.447; 95% CI: 1.005-2.085; p= 0.047) and reduced serious adverse events (RR= 0.736; 95% CI: 0.611-0.887; p= 0.001). Conclusion: Remdesivir has positive effects on clinical improvement, and reduction of the risk of serious adverse events. However, it does not influence the mortality at day 14 of treatment.

Introducción. El envejecimiento de la población y el aumento en la expectativa de vida imponen al médico rehabilitador un reto en el manejo de las comorbilidades que este acarrea. Así, la enfermedad osteodegenerativa de cadera se ha convertido una causa frecuente de consulta; además, la evolución progresiva de la enfermedad en algunos casos requiere manejo quirúrgico el cual puede llegar a ocasionar compromiso en la calidad de vida y funcionalidad. Es aquí donde el médico rehabilitador y un adecuado proceso terapéutico impactan en el reintegro familiar, social y laboral de los pacientes. Así mismo, es fundamental el reentrenamiento de la marcha para la adecuada realización de las actividades de la vida diaria. Objetivos. Revisar la literatura científica sobre las opciones terapéuticas en rehabilitación de la capacidad funcional para la marcha en pacientes intervenidos para reemplazo total de cadera. Método. Revisión sistemática. Se realizó búsqueda de la literatura pertinente en las bases de datos PubMed, Cochrane, ClinicalKey y ScienceDirect, de artículos publicados en revistas indexadas en los últimos 20 años con corte hasta el 1 de diciembre de 2019. Resultados. La primera búsqueda en las bases de datos electrónicas identificó 219 artículos totales distribuidos así: PubMed 105, Cochrane 8, ClinicalKey 103 y ScienceDirect 3; a partir de estos se obtuvieron 196 artículos al retirar duplicados, se excluyeron 166 artículos según su título y resumen, y fueron evaluados 53 artículos a los que se les aplicaron las guías sobre calidad metodológica STROBE y CONSORT, dependiendo del tipo de estudio. Finalmente se seleccionaron 10 artículos que cumplieron los criterios de inclusión y exclusión y lograron llegar a meta-análisis; estos evaluaban programas de fisioterapia supervisada. Es importante realizar una búsqueda de la literatura específica para otras estrategias de rehabilitación como los ejercicios con soporte de peso intensificado e hidroterapia entre otros. Conclusiones. Los estudios evaluados en el metaanálisis eran muy heterogéneos y poco consistentes, y no permiten definir una conclusión a favor o en contra de la fisioterapia supervisada. Serán necesarios más estudios primarios alrededor del tema que permitan responder fehacientemente la pregunta de investigación. Se deberá plantear estudios en el contexto local, ya que los estudios disponibles provienen de países con sistemas de salud diferentes.