Efficacy and safety of hemodialysis strategies for pregnant women with chronic kidney disease: Systematic review.

Pregnancy in chronic kidney disease (CKD) women is relatively rare, and the less risky choice of hemodialysis is unknown. The objective of this systematic review was to identify, systematically evaluate and summarize the available evidence on the efficacy and safety of hemodialysis strategies for pregnant CKD women. Sensitive search strategies were applied to six databases without data or language restrictions. Comparative (randomized and non-randomized) studies were prioritized. Two reviewers independently selected, extracted, and critically evaluated data from studies. The risk of bias assessment was performed using the ROBINS-I tool, considering the study design (non-randomized comparative observational studies). The certainty of the evidence was assessed using the GRADE approach. From 7210 references identified, six retrospective cohort studies were included (576 women). The effects of intensive hemodialysis (over 20 h/week) are uncertain for maternal and neonatal mortality (Peto odds ratio [OR] 0.85; 95% confidence interval [95% CI] 0.26-2.80), miscarriage (Peto OR 0, 38; 95% CI 0.12-1.23), stillbirths (Peto OR 0, 56; 95% CI 0.13-2.31), preterm birth (Peto OR 0.87; 95% CI 0.33-2.28), low birth weight (Peto OR 0.71; 95% CI 0.20-2.50) and congenital anomalies rates. The certainty of the evidence was very low due to studies methodological limitations and effect estimates imprecision. The uncertainty about intensive versus conventional hemodialysis effects for pregnant women with CKD and the imprecision in the estimated effects precludes any recommendation. The strategy choice must consider treatment availability, costs, and maternal social aspects until future studies provide more reliable evidence. PROSPERO CRD42021259237.

Strategies for communicating scientific evidence on healthcare to managers and the population: a scoping review.

BACKGROUND: Health evidence needs to be communicated and disseminated in a manner that is clearly understood by decision-makers. As an inherent component of health knowledge translation, communicating results of scientific studies, effects of interventions and health risk estimates, in addition to understanding key concepts of clinical epidemiology and interpreting evidence, represent a set of essential instruments to reduce the gap between science and practice. The advancement of digital and social media has reshaped the concept of health communication, introducing new, direct and powerful communication platforms and gateways between researchers and the public. The objective of this scoping review was to identify strategies for communicating scientific evidence in healthcare to managers and/or population. METHODS: We searched Cochrane Library, Embase®, MEDLINE® and other six electronic databases, in addition to grey literature, relevant websites from related organizations for studies, documents or reports published from 2000, addressing any strategy for communicating scientific evidence on healthcare to managers and/or population. RESULTS: Our search identified 24 598 unique records, of which 80 met the inclusion criteria and addressed 78 strategies. Most strategies focused on risk and benefit communication in health, were presented by textual format and had been implemented and somehow evaluated. Among the strategies evaluated and appearing to yield some benefit are (i) risk/benefit communication: natural frequencies instead of percentages, absolute risk instead relative risk and number needed to treat, numerical instead nominal communication, mortality instead survival; negative or loss content appear to be more effective than positive or gain content; (ii) evidence synthesis: plain languages summaries to communicate the results of Cochrane reviews to the community were perceived as more reliable, easier to find and understand, and better to support decisions than the original summaries; (iii) teaching/learning: the Informed Health Choices resources seem to be effective for improving critical thinking skills. CONCLUSION: Our findings contribute to both the knowledge translation process by identifying communication strategies with potential for immediate implementation and to future research by recognizing the need to evaluate the clinical and social impact of other strategies to support evidence-informed policies. Trial registration protocol is prospectively available in MedArxiv (doi.org/10.1101/2021.11.04.21265922).

Efficacy and safety of therapeutic use of cannabis derivatives and their synthetic analogs: Overview of systematic reviews.

The debate on the use of cannabinoids for therapeutic purposes is constantly on the rise. This overview aimed to map the evidence on the therapeutic effects of cannabis derivatives and their synthetic analogs. Systematic reviews (SRs) of randomized trials were identified through a comprehensive search in several databases, and their methodological quality were evaluated with AMSTAR-2. The results for main outcomes are presented, prioritizing those from updated and better quality SRs. Finally, 68 SRs, addressing 37 different health conditions, were included. The methodological quality was high for eight SRs. The evidence certainty (GRADE) for the effects of cannabinoids is not high for any of the outcomes identified. Evidence certainty was moderate for the following: (a) cannabidiol appears to be beneficial for quality of life but increases the risk of adverse events in ulcerative colitis; (b) cannabinoids in general appear to have no clinically important benefit for chronic non-oncologic pain, spasticity-related pain in multiple sclerosis, or for acute post-operative pain; (c) cannabinoids in general appear to have a benefit in reducing chemotherapy-related nausea and vomiting. For all other outcomes from remaining comparisons, the evidence certainty was low, very low, or not evaluated, which prevents recommendations for or against their routine use.

Frequency, signs and symptoms, and criteria adopted for long COVID-19: A systematic review.

AIMS: To identify, systematically evaluate and summarise the best available evidence on the frequency of long COVID-19 (post-acute COVID-19 syndrome), its clinical manifestations, and the criteria used for diagnosis. METHODS: Systematic review conducted with a comprehensive search including formal databases, COVID-19 or SARS-CoV-2 data sources, grey literature, and manual search. We considered for inclusion clinical trials, observational longitudinal comparative and non-comparative studies, cross-sectional, before-and-after, and case series. We assessed the methodological quality by specific tools based on the study designs. We presented the results as a narrative synthesis regarding the frequency and duration of long COVID-19, signs and symptoms, criteria used for diagnosis, and potential risk factors. RESULTS: We included 25 observational studies with moderate to high methodological quality, considering 5440 participants. The frequency of long COVID-19 ranged from 4.7% to 80%, and the most prevalent signs/symptoms were chest pain (up to 89%), fatigue (up to 65%), dyspnea (up to 61%), and cough and sputum production (up to 59%). Temporal criteria used to define long COVID-19 varied from 3 to 24 weeks after acute phase or hospital discharge. Potentially associated risk factors were old age, female sex, severe clinical status, a high number of comorbidities, hospital admission, and oxygen supplementation at the acute phase. However, limitations related to study designs added uncertainty to this finding. None of the studies assessed the duration of signs/symptoms. CONCLUSION: The frequency of long COVID-19 reached up to 80% over the studies included and occurred between 3 and 24 weeks after acute phase or hospital discharge. Chest pain, fatigue, dyspnea, and cough were the most reported clinical manifestations attributed to the condition. Based on these systematic review findings, there is an urgent need to understand this emerging, complex and challenging medical condition. Proposals for diagnostic criteria and standard terminology are welcome.

Photobiomodulation with low-level laser therapy for treating Achilles tendinopathy: a systematic review and meta-analysis.

OBJECTIVE: The purpose of this study was to determine the benefits and harms of low-level laser therapy for Achilles tendinopathy. DATA SOURCES: Search strategies were conducted (from inception to February 2020) in Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Literatura Latino Americana em Ciências da Saúde e do Caribe (LILACS), Physiotherapy Evidence Database (PEDro), SPORTDiscus, ClinicalTrials.gov, World Health Organization (WHO)-ICTRP and OpenGrey databases, to retrieve all randomized controlled trials that compared laser therapy with inactive/active interventions. REVIEW METHODS: This study was reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. The risk of bias was assessed using the Cochrane Risk of bias table. Meta-analyses were performed on dependence of homogeneity, otherwise results were reported narratively. The certainty of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. RESULTS: Four trials (119 participants) were analyzed. Laser therapy associated to eccentric exercises when compared to eccentric exercises and sham had very low to low certainty of evidence in pain and function assessment. Despite one trial favored laser therapy at two months (mean difference (MD) -2.55, 95% confidence interval (95% CI) -3.87 to -1.23), the CIs did not include important differences between groups at 3 and 13 months. The function assessment showed an improvement favoring the placebo group at one month (MD 9.19, 95% CI -16.16 to -2.23) and non-significant difference between groups at 3 and 13 months. Adverse events were poorly reported but restricted to minor events related to the exercises. CONCLUSION: The certainty of evidence was low to very low, and the results are insufficient to support the routine use laser therapy for Achilles tendinopathy.

Effectiveness and Safety of Ozone Therapy in Dental Caries Treatment: Systematic Review and Meta-analysis.

OBJECTIVE: This systematic review and meta-analysis aimed to investigate the effectiveness and safety of ozone therapy for treating dental caries. METHODS: We searched for randomized controlled trials (RCTs) in 8 databases, from inception to April 4, 2020 (MEDLINE, EMBASE, CENTRAL, LILACS, Bibliografia Brasileira de Odontologia, ClinicalTrials.gov, WHO, and OpenGrey). Primary outcome measures were antimicrobial effect and adverse events. We used the Cochrane risk of bias tool to evaluate methodological quality of included RCTs and GRADE approach to evaluate the certainty of the evidence. We used the Review Manager software to conduct meta-analyses. RESULTS: We included 12 RCTs comparing ozone therapy with no ozone, chlorhexidine digluconate, fissure sealants (alone and added to ozone), and fluoride. Considering primary outcomes, ozone therapy showed (a) lower reduction in the bacterial number than chlorhexidine digluconate in children (mean difference [MD]: -5.65 [-9.79 to -1.51]), but no difference was observed in adults (MD: -0.10 [-1.07 to 0.88]); (b) higher reduction in the bacterial number than sealant (MD: 12.60 [3.86-21.34]), but no difference was observed after final excavation (MD: -0.00 [-0.01 to 0.01]). Regarding safety of ozone therapy, results from individual studies presented no adverse events during or after treatment. Most of these results are imprecise and should be interpreted with caution because of clinical and methodological concerns, small sample size, and wide confidence interval, precluding to determine the real effect direction. CONCLUSION: Based on a very low certainty of evidence, there is not enough support from published RCTs to recommend the use of ozone for the treatment of dental caries. Well-conducted studies should be encouraged, measuring mainly the antimicrobial effects of ozone therapy at long term and following the recommendations of the CONSORT statement for the reporting of RCTs.

Modafinil for poststroke patients: A systematic review.

INTRODUCTION: Stroke is a major cause of death and disability worldwide. The use of modafinil, a wakefulness-promoting agent, is hypothesised to benefit stroke patients. METHODS: We performed a systematic review in accordance with the Cochrane Handbook for Systematic Reviews of Interventions recommendations to assess the efficacy and safety of modafinil in poststroke patients. We prospectively registered the review protocol in PROSPERO (CRD42017078465) and reported the systematic review following the PRISMA statement. RESULTS: Two published studies (77 participants) and one ongoing randomised controlled trial, with limited methodological quality, assessed the effects of modafinil (200 mg or 400 mg) for adults from 14 days poststroke up to 3 months poststroke and fulfilled our inclusion criteria. The clinical and methodological variability between studies precluded meta-analyses. Overall, these studies showed some benefit of modafinil for fatigue, but no benefit for disability, cognition, and for subscores of stroke-specific quality of life. Data for adverse events were scarce and mortality was not considered by studies. Due to very low quality related to the evidence, we are uncertain about the effects of modafinil for all outcomes assessed by our systematic review. CONCLUSION: Based on two small randomised controlled trial, which provided very low quality evidence, the effects (benefits and harms) of modafinil for stroke patients are unclear and do not support its routinely use in clinical practice for this clinical situation. Number of Protocol registration in PROSPERO database: CRD42017078465 (available from http://www.crd.york.ac.uk/PROSPERO/display_record.php?ID=CRD42017078465).

Mindfulness for palliative care patients. Systematic review.

BACKGROUND: Nineteen million adults worldwide are in need of palliative care. Of those who have access to it, 80% fail to receive an efficient management of symptoms. OBJECTIVES: To assess the effectiveness and safety of mindfulness meditation for palliative care patients. METHODS: We searched CENTRAL, MEDLINE, Embase, LILACS, PEDro, CINAHL, PsycINFO, Opengrey, ClinicalTrials.gov and WHO-ICTRP. No restriction of language, status or date of publication was applied. We considered randomised clinical trials (RCTs) comparing any mindfulness meditation scheme vs any comparator for palliative care. Cochrane Risk of Bias (Rob) Table was used for assessing methodological quality of RCTs. Screening, data extraction and methodological assessments were performed by two reviewers. Mean differences (MD) (confidence intervals of 95% (CI 95%)) were considered for estimating effect size. Quality of evidence was appraised by GRADE. RESULTS: Four RCTs, 234 participants, were included. All studies presented high risk of bias in at least one RoB table criteria. We assessed 4 comparisons, but only 2 studies showed statistically significant difference for at least one outcome. 1. Mindfulness meditation (eight weeks, one session/week, daily individual practice) vs control: statistically significant difference in favour of control for quality of life - physical aspects. 2. Mindfulness meditation (single 5-minute session) vs control: benefit in favour of mindfulness for stress outcome in both time-points. None of the included studies analysed safety and harms outcomes. CONCLUSIONS: Although two studies have showed statistically significant difference, only one showed effectiveness of mindfulness meditation in improving perceived stress. This study focused on one single session of mindfulness of 5 minutes for adult cancer patients in palliative care, but it was considered as possessing high risk of bias. Other schemes of mindfulness meditation did not show benefit in any outcome evaluated (low and very low quality evidence).

Definition and reporting of composite outcomes are often inadequate in randomized clinical trials on pharmacological interventions for coronary artery disease.

OBJECTIVES: To estimate the frequency and critically appraise the use and reporting of composite outcomes in randomized clinical trials on pharmacological interventions for coronary artery disease. STUDY DESIGN AND SETTING: A metaresearch study. A search strategy was developed to retrieve references from MEDLINE. We considered articles, published from 1st January 2020, to December 31, 2021, reporting results of clinical primary outcomes from randomized clinical trials which assessed pharmacological interventions, used alone or in combination, for the treatment or secondary prevention (previous coronary event) of coronary artery disease. RESULTS: From the 34 included studies, 28 (82.35%) had a primary composite outcome. Thirteen unique composite primary outcomes were used with the most frequent being "cardiovascular death, myocardial infarction, stroke" (12/28, 42.86%). The term major adverse cardiac events was used for five distinct composite primary outcomes. A combination of 12 different components resulted in the 28 primary composite outcomes, with stroke being the most frequent component present in 96.43% (27/28) of the primary composite outcomes. From the included studies, 60.71% (17/28) reported the estimates for each individual component and the direction of the effect was consistent between all components and the composite outcomes in 58.82% (10/17) of them. Additionally, no included study discussed potential limitations and/or related advantages of the composite outcomes. CONCLUSION: In randomized clinical trials on pharmacological interventions for coronary artery disease, composite outcomes are frequently used, but the definition of their components is very heterogeneous. The estimate for individual components within the composite outcome is often not fully reported, which prevents a complete analysis of their adequacy for clinical practice. The term major adverse cardiac events was used inconsistently and to refer to different set of components, which can also be misleading and confusing.

Work-related musculoskeletal disorders in dockworkers. Systematic review and meta-analysis.

BACKGROUND: Dockworkers are exposed to physical overloads that can contribute to the development of musculoskeletal disorders, leading to functional disability and absenteeism. OBJECTIVE: to map, critically appraise, and synthesize the available evidence on the prevalence of musculoskeletal diseases associated with port occupational activities. METHODS: A comprehensive search was conducted in structured and unstructured databases in August 2023, with no date or language restriction, to identify observational studies evaluating the prevalence of musculoskeletal disorders in dockworkers' occupational activity. The risk of bias was assessed using validated tools based on the included study designs. Data from studies were pooled in meta-analyses. The certainty of the evidence was assessed using the GRADE approach. RESULTS: We identified 12 analytical cross-sectional studies involving 7821 participants in ports of five countries. Most studies (75%) had a moderate methodological quality according to the Joanna Briggs Institute tool. Considering the overall worker categories and any musculoskeletal disorders, the meta-analysis showed a prevalence of 58% (95% Confidence Interval [95% CI] 37% to 78%), with degenerative spinal diseases 42% (95% CI -0.6% to 91%) and low back pain 36% (95% CI 21% to 50%) being the most prevalent conditions. Symptoms were predominantly in foremen and stevedores. The certainty of the evidence was very low. CONCLUSIONS: Musculoskeletal disorders seem prevalent among dockworkers, mainly degenerative spinal diseases and low back pain. Studies with greater methodological consistency are still needed to validate these hypotheses and assist in decision-making for implementing preventive and informational policies in maritime port management organizations. PROSPERO registry CRD42021257677.

High certainty evidence is stable and trustworthy, whereas evidence of moderate or lower certainty may be equally prone to being unstable.

OBJECTIVES: To assess to what extent the overall quality of evidence indicates changes to observe intervention effect estimates when new data become available. METHODS: We conducted a meta-epidemiological study. We obtained evidence from meta-analyses of randomized trials of Cochrane reviews addressing the same health-care question that was updated with inclusion of additional data between January 2016 and May 2021. We extracted the reported effect estimates with 95% confidence intervals (CIs) from meta-analyses and corresponding GRADE (Grading of Recommendations Assessment, Development, and Evaluation) assessments of any intervention comparison for the primary outcome in the first and the last updated review version. We considered the reported overall quality (certainty) of evidence (CoE) and specific evidence limitations (no, serious or very serious for risk of bias, imprecision, inconsistency, and/or indirectness). We assessed the change in pooled effect estimates between the original and updated evidence using the ratio of odds ratio (ROR), absolute ratio of odds ratio (aROR), ratio of standard errors (RoSE), direction of effects, and level of statistical significance. RESULTS: High CoE without limitations characterized 19.3% (n = 29) out of 150 included original Cochrane reviews. The update with additional data did not systematically change the effect estimates (mean ROR 1.00; 95% CI 0.99-1.02), which deviated 1.06-fold from the older estimates (median aROR; interquartile range [IQR]: 1.01-1.15), gained precision (median RoSE 0.87; IQR 0.76-1.00), and maintained the same direction with the same level of statistical significance in 93% (27 of 29) of cases. Lower CoE with limitations characterized 121 original reviews and graded as moderate CoE in 30.0% (45 of 150), low CoE in 32.0% (48 of 150), and very low CoE in 18.7% (28 of 150) reviews. Their update had larger absolute deviations (median aROR 1.12 to 1.33) and larger gains in precision (median RoSE 0.78-0.86) without clear and consistent differences between these categories of CoE. Changes in effect direction or statistical significance were also more common in the lower quality evidence, again with a similar extent across categories (without change in 75.6%, 64.6%, and 75.0% for moderate, low, very low CoE). As limitations increased, effect estimates deviated more (aROR 1.05 with zero, 1.11 with one, 1.25 with two, 1.24 with three limitations) and changes in direction or significance became more frequent (93.2% stable with no limitations, 74.5% with one, 68.2% with two, and 61.5% with three limitations). CONCLUSION: High-quality evidence without methodological deficiencies is trustworthy and stable, providing reliable intervention effect estimates when updated with new data. Evidence of moderate and lower quality may be equally prone to being unstable and cannot indicate if available effect estimates are true, exaggerated, or underestimated.

What is an "ongoing" clinical trial? An analysis of different sources revealed heterogeneous definitions of when a clinical trial starts and ends: a meta-research study.

BACKGROUND: Although the concept of an "ongoing study" seems self-explanatory, it is difficult to determine whether a trial is underway. OBJECTIVE: To analyze the definitions of "ongoing clinical trial" across different clinical trial registries, methodological guidelines, and other sources. DESIGN AND SETTING: This meta-research study was conducted at the Universidade Federal de São Paulo (UNIFESP), Brazil. METHODS: We performed a cross-sectional analysis of relevant clinical trial registry databases, methodological guidelines for conducting systematic reviews, and other sources that would define or regulate clinical trials. RESULTS: We identified various heterogeneous definitions used by eligible sources at both the start and end of a clinical trial. The starting criteria used were as follows: when the team is planning the protocol, when permission is given to conduct the study, or when the first participant is enrolled. Some sources used the time at which the last outcome data was collected as a criterion to determine the end of the trial. The International Committee of Medical Journal Editors stated that a study is still "ongoing" during the analysis process. Several sources use a vague definition or present no clear criteria for defining the start or end of a study. CONCLUSION: The concept of "ongoing clinical trials" lacks a transparent and homogeneous definition across relevant sources. A consensus on this concept is important to facilitate the evaluation of available evidence and conduct research synthesis. Further efforts are necessary to determine the best definition for the start and end of a clinical trial.

Minimally invasive interventions for biopsy of malignancy-suspected pulmonary nodules: a systematic review and meta-analysis.

BACKGROUND: Imaging tests are important for diagnosis during the management of pulmonary nodules; however, biopsy is required to confirm the malignancy. OBJECTIVES: To compare the effects of different techniques used for the biopsy of a pulmonary nodule. DESIGN AND SETTING: Systematic review and meta-analysis were conducted using Cochrane methodology in São Paulo, São Paulo, Brazil. METHODS: We conducted a systematic review of randomized controlled trials (RCTs) on minimally invasive techniques, including tomography-guided percutaneous biopsy (PERCUT), transbronchial biopsies with fluoroscopy (FLUOR), endobronchial ultrasound (EBUSR), and electromagnetic navigation (NAVIG). The primary outcomes were diagnostic yield, major adverse events, and need for another approach. RESULTS: Seven RCTs were included (913 participants; 39.2% female, mean age: 59.28 years). Little to no increase was observed in PERCUT over FLUOR (P = 0.84), PERCUT over EBUSR (P = 0.32), and EBUSR over NAVIG (P = 0.17), whereas a slight increase was observed in NAVIG over FLUOR (P = 0.17); however, the evidence was uncertain. EBUSR may increase the diagnostic yield over FLUOR (P = 0.34). PERCUT showed little to no increase in all bronchoscopic techniques, with uncertain evidence (P = 0.02). CONCLUSION: No biopsy method is definitively superior to others. The preferred approach must consider availability, accessibility, and cost, as safety and diagnostic yield do not differ. Further RCTs planned, conducted, and reported with methodological rigor and transparency are needed, and additional studies should assess cost and the correlation between nodule size and location, as well as their association with biopsy results. SYSTEMATIC REVIEW REGISTRATION: PROSPERO database, CRD42018092367 -https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=92367.

Supporting Decisions of the Brazilian Regulatory Agency for Supplementary Healthcare: A Case Study.

OBJECTIVES: This study aimed to report implementation and partial results of the project "Supporting the Brazilian regulatory agency for supplementary healthcare through health technology assessment actions" conducted at Hospital Sírio-Libanês, Brazil, from 2020 to 2023, through Programa de Apoio ao Desenvolvimento Institucional do Sistema Único de Saúde, a Brazilian Ministry of Health initiative. METHODS: This was a case study conducted at Health Technology Center, Hospital Sírio-Libanês. RESULTS: From its inception, in 2020, to July 2022, the following activities and products were completed: 59 technical-methodological reports assessing the efficacy, safety, cost-effectiveness, and budget impact of technologies received by Agência Nacional de Saúde Suplementar (ANS) to compose its catalog of drugs products and services; 50 analyses of society contributions from public consultation; 34 methodological or clinical tutorial sessions to support ANS team; 2 templates to systematize the update process of ANS catalog; and one training course on systematic reviews and meta-analysis for ANS team. CONCLUSION: The project has contributed to increasing ANS autonomy in the health technology assessment, collaborating to efficiency in technologies offer to the users. By adopting and fostering evidence-based knowledge construction, the project reinforces its bridging role for supporting the consonance between public and supplementary healthcare sectors in Brazil.

Most systematic reviews that used the term "update" in title/abstract were not an updated version.

OBJECTIVES: To analyze whether articles labelled as systematic reviews or meta-analyses (SRs/MAs) in the title and used terms "updated" or "update" in the title or abstract are indeed a report of an updated version of a previously existing SR/MA. STUDY DESIGN AND SETTING: We searched PubMed for SRs/MAs, using descriptors updated/update in the title/abstract published in 2018-2019. We analyzed how the articles used the term "update"/"updated" and whether the previous version of SR was referenced. We surveyed authors who indicated that the SR was an updated version, but there was no reference to the original SR. RESULTS: Among 1,118 included articles, most (N = 716; 64%) used the term "update" only to denote that an SR includes recent data. Among 47 authors eligible for survey, 15 replied (32%). Six authors (40%) stated that their article was an updated version and gave reference to the previous version, while 9 authors (60%) stated that their SR was not an updated version of a previous SR. CONCLUSION: Most SRs that used the term "update" in title/abstract were not an updated version of an SR. Authors should use the descriptor "update"/"updated" in their title/abstract only to refer to a new version of an SR to avoid ambiguity.

Most Cochrane systematic reviews and protocols did not adhere to the Cochrane's risk of bias 2.0 tool.

OBJECTIVE: The aim of this study was to identify the frequency of Cochrane systematic reviews and Cochrane systematic reviews protocols using (or planning to use) the risk of bias 2.0 tool to assess the risk of bias of the included randomized clinical trials. STUDY DESIGN: This is a meta-research study. METHODS: We included Cochrane systematic reviews or Cochrane systematic reviews protocols that planned to include randomized clinical trials. We assessed the Cochrane Database of Systematic Reviews and screened for issues published after the launch of risk of bias 2.0 tool (2019-2022). Two independent investigators performed the study selection and data extraction. RESULTS: We analyzed 440 Cochrane systematic reviews and 536 Cochrane systematic reviews protocols. Overall, 4.8% of the Cochrane systematic reviews and 28.5% of the Cochrane systematic reviews protocols used or planned to use risk of bias 2.0 tool. Although low, adherence is increasing over time. In 2019, 0% of Cochrane systematic reviews used risk of bias 2.0 tool, compared to 24.1% in 2022. In Cochrane systematic reviews protocols, adherence increased from 6.9% in 2019 to 41.5% in 2022. A total of 274 (62.1%) Cochrane systematic reviews had their protocols published before 2018; only one used risk of bias 2.0 tool and reported the change of versions in the "Differences between protocol and revision" section. CONCLUSION: The Cochrane's risk of bias 2.0 tool has low adherence among Cochrane protocols and systematic reviews. Further efforts are necessary to facilitate the implementation of this new tool.

Resistance training for postmenopausal women: systematic review and meta-analysis.

IMPORTANCE: Numerous studies have been published assessing the effects of resistance muscle training to mitigate menopausal symptoms, given the endocrine muscle function and its metabolic regulation. Therefore, mapping and synthesizing high-quality studies are necessary to help clinical decisions. OBJECTIVE: The aim of this study was to assess the effects (benefits and harms) of resistance muscle training for postmenopausal women. EVIDENCE REVIEW: Electronic searches were conducted in MEDLINE (via PubMed), EMBASE, CENTRAL, PEDro, LILACS, and SPORTDiscus up to December 2021. Two independent reviewers selected the retrieved references and extracted relevant data from included studies. The methodological quality (risk of bias) using the Cochrane Risk of Bias table and the certainty of the evidence (GRADE approach) were assessed. FINDINGS: Twelve randomized clinical trials (n = 452) with unclear to high risk of bias were identified. Compared with no exercise, resistance training (up to 16 weeks) seems to promote an improvement in functional capacity (mean difference [MD], 2.90 points; 95% CI, 0.60-5.20) and bone mineral density (MD, 0.10; 95% CI, 0.10-0.10) and a reduction in the hot flash frequency (13/29 vs 1/29; risk ratio, 13.0; 95% CI, 1.82-93.01) and fat mass (MD, -3.15; 95% CI, -6.68 to 0.38), and no differences were observed between groups regarding abdominal circumference and body mass index. When compared with aerobic exercises, resistance training may result in a reduction of hot flash frequency (7/18 vs 14/18; risk ratio, 0.50; 95% CI, 0.27-0.94) and fat mass (MD, -7.80; 95% CI, -14.02 to -1.58) and no difference in the quality of life and body mass index. Regarding safety, no serious adverse events were reported. Based on the GRADE approach, the certainty of this evidence was graded as very low to low, leading to imprecisely estimated effects. CONCLUSIONS AND RELEVANCE: Resistance muscle training seems to improve postmenopausal symptoms and functional capacity. Given the low to very low certainty of the evidence, further randomized clinical trials with higher methodological quality and better reports are still needed. As an implication for clinical practice, health professionals should consider individualized aspects such as the previous history of exercise practice, physical capacity, and adaptation period.

Open data and data sharing in articles about COVID-19 published in preprint servers medRxiv and bioRxiv.

This study aimed to analyze the content of data availability statements (DAS) and the actual sharing of raw data in preprint articles about COVID-19. The study combined a bibliometric analysis and a cross-sectional survey. We analyzed preprint articles on COVID-19 published on medRxiv and bioRxiv from January 1, 2020 to March 30, 2020. We extracted data sharing statements, tried to locate raw data when authors indicated they were available, and surveyed authors. The authors were surveyed in 2020-2021. We surveyed authors whose articles did not include DAS, who indicated that data are available on request, or their manuscript reported that raw data are available in the manuscript, but raw data were not found. Raw data collected in this study are published on Open Science Framework (https://osf.io/6ztec/). We analyzed 897 preprint articles. There were 699 (78%) articles with Data/Code field present on the website of a preprint server. In 234 (26%) preprints, data/code sharing statement was reported within the manuscript. For 283 preprints that reported that data were accessible, we found raw data/code for 133 (47%) of those 283 preprints (15% of all analyzed preprint articles). Most commonly, authors indicated that data were available on GitHub or another clearly specified web location, on (reasonable) request, in the manuscript or its supplementary files. In conclusion, preprint servers should require authors to provide data sharing statements that will be included both on the website and in the manuscript. Education of researchers about the meaning of data sharing is needed. Supplementary Information: The online version contains supplementary material available at 10.1007/s11192-022-04346-1.

Vitamin C-based regimens for sepsis and septic shock: Systematic review and meta-analysis of randomized clinical trials.

PURPOSE: to critically appraise and synthesize the evidence on the effects of vitamin C-based regimens for patients with sepsis or septic shock. METHODS: a broad search was performed on May 2021 to identify randomized clinical trials (RCTs) assessing vitamin C-based regimens as adjuvant therapy for adults with sepsis or septic shock. We used the Cochrane Risk of Bias table to assess the methodological quality of the included RCTs and the GRADE approach to evaluate the evidence certainty. RESULTS: We included 20 RCTs (2124 participants). Evidence from low to very low certainty showed that vitamin C compared to placebo may reduce all-cause mortality up to 28 days (relative risk [RR] 0.60, 95% confidence interval (CI) 0.45 to 0.80, 4 RCTs, 335 participants). Considering the other comparisons (vitamin C alone or combined with thiamine and/or hydrocortisone, compared to placebo, standard care or hydrocortisone), there were a little to no difference or very uncertain evidence for adverse events, SOFA score, ICU length of stay, acute kidney injury, mechanical ventilation- and vasoactive drugs-free days up to 28 days. CONCLUSION: Further RCTs with higher methodological quality, an increased number of participants and assessing clinically relevant outcomes are needed to provide better decision-making guidance. PROSPERO REGISTER: CRD42021251786.