Advanced therapy with mesenchymal stromal cells for knee osteoarthritis: Systematic review and meta-analysis of randomized controlled trials.

Background: Advanced cell therapies emerged as promising candidates for treatment of knee articular diseases, but robust evidence regarding their clinical applicability is still lacking. Objective: To assess the efficacy and safety of advanced mesenchymal stromal cells (MSC) therapy for knee osteoarthritis (OA) and chondral lesions. Methods: Systematic review of randomized controlled trials conducted in accordance with Cochrane Handbook and reported following PRISMA checklist. GRADE approach was used for assessing the evidence certainty. Results: 25 randomized controlled trials that enrolled 1048 participants were included. Meta-analyses data showed that, compared to viscosupplementation (VS), advanced MSC therapy resulted in a 1.91 lower pain VAS score (95 % CI -3.23 to -0.59; p < 0.00001) for the treatment of knee OA after 12 months. Compared to placebo, the difference was 0.99 lower pain VAS points (95 % CI -1.94 to -0.03; p = 0.76). According to the GRADE approach, the evidence was very uncertain for both comparisons. By excluding studies with high risk of bias, there was a similar size of effect (VAS MD -1.54, 95 % CI -2.09 to -0.98; p = 0.70) with improved (moderate) certainty of evidence, suggesting that MSC therapy probably reduces pain slightly better than VS. Regarding serious adverse events, there was no difference from advanced MSC therapy to placebo or to VS, with very uncertain evidence. Conclusion: Advanced MSC therapy resulted in lower pain compared to placebo or VS for the treatment of knee OA after 12 months, with no difference in adverse events. However, the evidence was considered uncertain. The Translational Potential of this Article: Currently, there is a lack of studies with good methodological structure aiming to evaluate the real clinical impact of advanced cell therapy for knee OA. The present study was well structured and conducted, with Risk of Bias, GRADE certainty assessment and sensitivity analysis. It explores the translational aspect of the benefits and safety of MSC compared with placebo and gold-standard therapy to give practitioners and researchers support to expand this therapy in their practice. PROSPERO registration number: CRD42020158173. Access at https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=158173.

Supporting evidence-based judicial decisions on health care in Brazil: an experience report / Apoio técnico-científico à tomada de decisão judicial em saúde no Brasil: um relato de experiência / Apoyo técnico-científico a la toma de decisiones judiciales en salud en Brasil: un relato de experiencia

Objective: The main objective of this study is to report on the implementation and results of the "Supporting Health-Related Judicial Decisions in Brazil" project conducted at the Health Technology Assessment Center, Hospital Sírio-Libanês through the "Programa de Apoio ao Desenvolvimento Institucional do Sistema Único de Saúde", in Brazil. Methods: This study is an experience report of a project conducted at the Health Technology Assessment Center, Hospital Sírio-Libanês. Results: The activities of the project occurred in 2023 and included two online training courses on primary studies and systematic reviews, 11 one-day workshops with technical-scientific content for members of the Technical Support Centers for the Judiciary (NATJus), 40 online technical-scientific consultations for magistrates on a digital platform, 11 technical-scientific reports addressing the most legally claimed technologies in Brazil; two methodological tools, a national forum (hybrid event), 10 chat-based mentorships for NATJus members; and the maintenance of an open-access blog, by publishing news on relevant topics on law and health. Discussion and conclusion: This project has contributed to the improvement of the judicial decision-making process by providing a range of activities aimed at aiding the prioritization of health technologies that are clearly effective and safe over those that are ineffective, harmful, or have uncertain effects.

Objetivo: O objetivo principal deste estudo é relatar a implementação e os resultados do projeto "Apoio técnico-científico à tomada de decisão judicial em Saúde no Brasil" realizado no Hospital Sírio-Libanês por meio do "Programa de Apoio ao Desenvolvimento Institucional do Sistema Único de Saúde". Métodos: Este estudo é um relato de experiência de um projeto realizado no Núcleo de Avaliação de Tecnologias em Saúde do Hospital Sírio-Libanês. Resultados: As atividades do projeto ocorreram em 2023 e incluíram dois cursos de formação online sobre estudos primários e revisões sistemáticas, 11 oficinas de um dia com conteúdo técnico-científico para membros dos Núcleos de Apoio Técnico ao Judiciário (NATJus), 40 consultas on-line técnico-científicas para magistrados em plataforma digital, 11 relatórios técnico-científicos abordando as tecnologias mais reivindicadas judicialmente no Brasil; duas ferramentas metodológicas, um fórum nacional (evento híbrido), 10 mentorias via chat para membros do NATJus; e a manutenção de um blog de acesso aberto, com publicação de notícias sobre temas relevantes de direito e saúde. Discussão e conclusão: Este projeto contribuiu para a melhoria do processo de tomada de decisão judicial, fornecendo uma série de atividades destinadas a ajudar na priorização de tecnologias de saúde que sejam claramente eficazes e seguras em detrimento daquelas que são ineficazes, prejudiciais ou têm efeitos incertos.

Objetivo: El objetivo principal de este estudio es informar sobre la implementación y los resultados del proyecto "Apoyo a las Decisiones Judiciales Relacionadas con la Salud en Brasil" realizado en el Centro de Tecnología en Salud del Hospital Sírio-Libanês a través del "Programa de Apoio ao Desenvolvimento Institucional do Sistema Único de Saúde", en Brasil. Métodos: Este estudio es un informe de experiencia de un proyecto realizado en el Centro de Tecnología en Salud del Hospital Sírio-Libanês. Resultados: Las actividades del proyecto ocurrieron en 2023 e incluyeron dos cursos de capacitación en línea sobre estudios primarios y revisiones sistemáticas, 11 talleres de un día de contenido técnico-científico para miembros de los Centros de Apoyo Técnico al Poder Judicial (NATJus), 40 consultas técnico-científicas en línea para magistrados en plataforma digital, 11 informes técnico-científicos que abordan las tecnologías más reclamadas legalmente en Brasil; dos herramientas metodológicas, un foro nacional (evento híbrido), 10 mentorías basadas en chat para miembros de NATJus; y el mantenimiento de un blog de acceso abierto, mediante la publicación de noticias sobre temas relevantes en derecho y salud. Discusión y conclusión: Este proyecto ha contribuido a mejorar el proceso de toma de decisiones judiciales proporcionando actividades para priorizar las tecnologías sanitarias claramente eficaces y seguras frente a aquellas que son ineficaces, nocivas o de efectos inciertos.

Nonpharmacological Interventions for Treating Breastfeeding Nipple Pain: Systematic Review and Meta-Analysis.

Objective: To evaluate the efficacy and safety of nonpharmacological topical interventions for treating breastfeeding nipple pain. Methods: Randomized clinical trials (RCTs) assessing lactating women suffering from breastfeeding painful nipples were included. Primary outcomes were pain, healing process, and adverse events. A comprehensive search was conducted on June 02, 2023, without date or language restrictions. Methodological quality was assessed using the Cochrane risk of bias tool and the certainty of the evidence, the GRADE approach. Results: Nineteen RCTs with unclear to high risk of bias were included. There was uncertain evidence regarding the effects of photobiomodulation versus placebo on pain reduction (mean difference [MD] -0.15; 95% confidence interval [95% CI] -1 0.49 to 1.19; 139 participants, 2 RCTs). There are uncertainties concerning the effects of lanolin versus breast milk on pain (MD -1.80; 95% CI -2.43 to -1.17; 1 RCT; 180 participants), wound healing (MD 0.10; 95% CI -0.26 to -0.46; 1 RCT; 180 participants), and any adverse events (zero events in both groups). Similar effects were observed by the other interventions assessed. Conclusion: The evidence of nonpharmacological topical interventions for painful nipples is imprecise, and future RCTs with higher methodological quality are needed to support recommendations. Considering the accessibility and low cost of these alternative treatments, the findings of this evidence synthesis could support clinical decision-making and guide future research. PROSPERO CRD42020170320.

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.

The methodological and reporting quality of randomized controlled trials of tyrosine kinase inhibitors for advanced differentiated thyroid cancer: Meta-research study.

INTRODUCTION: Clinical trials on tyrosine kinase inhibitors (TKI) treatment have shown an improvement in overall and progression-free survival in patients with advanced differentiated thyroid cancer. However, it is necessary to evaluate these studies to assess methodological biases and inconsistencies that may impact the effects. OBJECTIVE: To map and assess the methodological quality of randomized clinical trials (RCTs) regarding randomization, allocation concealment, blinding, and selective reporting bias. METHODS: RCTs assessing the efficacy and safety of TKI for the treatment of advanced differentiated thyroid cancer were included. The search was performed in the MEDLINE database. The included RCTs were assessed for the adequacy of the methodological steps, as recommended by the Cochrane Risk of Bias tool. RESULTS: Nine studies were analyzed, of which 77.7% were classified as low risk of bias regarding selective reporting and 33.3% as high risk of reporting bias. The mean time between protocol registration and study publication was approximately 5.11 years. Moreover, 66.7% were classified as low risk of bias for randomization and allocation concealment, and 33.3% did not specify the randomization process and allocation concealment in a way that would allow the identification of occurrences of bias. Concerning blinding of participants and outcome assessors, 77.8% of the RCTs reported adequate blinding and were classified as having a low risk of bias, 11.1% had a high risk of bias, and 11.1% had insufficient information and were classified as having unclear risk of bias. Regarding the blinding of the outcome assessors, 33.3% did the blinding correctly, 11.1% did not blind, and 55.6% did not provide enough information. CONCLUSION: Overall, the assessed RCTs were predominantly at low risk of bias. The critical evaluation of these studies is essential to have confidence in the treatment estimated effect that will support clinical decision-making and provide information to preclude future clinical study flaws.

Quality of systematic reviews on the treatment of vesiculobullous skin diseases. A meta-epidemiological study.

BACKGROUND: Systematic reviews of Randomized Controlled Trials (RCTs) are considered high-level evidence to support a decision on therapeutic interventions, and their methodological quality is essential to provide reliable and applicable results. OBJECTIVE: This meta-epidemiological study aimed to map and critically appraise systematic reviews assessing treatments for vesiculobullous skin diseases. METHODS: We conducted a comprehensive search strategy on MEDLINE (via Pubmed) in December 2022 without restrictions to find systematic reviews evaluating pharmacological interventions for vesiculobullous skin diseases. The methodological quality was assessed using the AMSTAR-2 tool, and additional information was extracted. We identified nine systematic reviews published between 2002 and 2021, seven assessing pemphigus. RESULTS: According to the AMSTAR-2 tool, 55.6% were classified as critically low quality, 22.2% as moderate quality, 11.1% as low and 11.1% as high quality. No review assessed the certainty of the evidence (GRADE); 86% of pemphigus reviews had at least two overlapping RCTs. There were some limitations regarding methodological flaws and the AMSTAR-2 tool use CONCLUSIONS: These findings reveal a frail methodological quality of systematic reviews about vesiculobullous diseases treatment that may impact the results. Therefore, methodological rigor is mandatory for future systematic reviews to avoid duplication of effort and increase the certainty of the evidence supporting decision-making.

Quality of systematic reviews on the treatment of vesiculobullous skin diseases. A meta-epidemiological study

Abstract Background Systematic reviews of Randomized Controlled Trials (RCTs) are considered high-level evidence to support a decision on therapeutic interventions, and their methodological quality is essential to provide reliable and applicable results. Objective This meta-epidemiological study aimed to map and critically appraise systematic reviews assessing treatments for vesiculobullous skin diseases. Methods We conducted a comprehensive search strategy on MEDLINE (via Pubmed) in December 2022 without restrictions to find systematic reviews evaluating pharmacological interventions for vesiculobullous skin diseases. The methodological quality was assessed using the AMSTAR-2 tool, and additional information was extracted. We identified nine systematic reviews published between 2002 and 2021, seven assessing pemphigus. Results According to the AMSTAR-2 tool, 55.6% were classified as critically low quality, 22.2% as moderate quality, 11.1% as low and 11.1% as high quality. No review assessed the certainty of the evidence (GRADE); 86% of pemphigus reviews had at least two overlapping RCTs. There were some limitations regarding methodological flaws and the AMSTAR-2 tool use Conclusions These findings reveal a frail methodological quality of systematic reviews about vesiculobullous diseases treatment that may impact the results. Therefore, methodological rigor is mandatory for future systematic reviews to avoid duplication of effort and increase the certainty of the evidence supporting decision-making.

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

ABSTRACT 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.

Cost analysis of photobiomodulation in tibia fracture in the Brazilian public health system.

Managing tibial fractures requires substantial health resources, which costs the health system. This study aimed to describe the costs of photobiomodulation (PBM) with LEDs in the healing process of soft tissue lesions associated with tibial fracture compared to a placebo. Economic analysis was performed based on a randomized controlled clinical trial, with a simulation of the cost-effectiveness and incremental cost model. Adults (n = 27) hospitalized with tibia fracture awaiting definitive surgery were randomized into two distinct groups: the PBM Group (n = 13) and the Control Group with simulated phototherapy (n = 14). To simulate the cost-effectiveness and incremental cost model, the outcome was the evolution of wound resolution by the BATES-JENSEN scale and time of wound resolution in days. The total cost of treatment for the Control group was R$21,164.56, and a difference of R$7,527.10 more was observed when compared to the treatment of the PBM group. The proposed intervention did not present incremental cost since the difference in the costs to reduce measures between the groups was smaller for the PBM group. When analyzing the ICER (Incremental cost-effectiveness ratio), it would be possible to save R$3,500.98 with PBM and decrease by 2.15 points in the daily average on the BATES-JENSEN scale. It is concluded, therefore, that PBM can be a supportive therapy of clinical and economic interest in a hospital setting.

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.

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).

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

SUMMARY 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.

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.

Abnormal Activity of Masticatory Muscles in Patients with Diagnosis of Cerebral Palsy. A Systematic Review and Meta-Analysis of Observational Studies.

AIMS: to map and synthesize the results from studies that assessed whether individuals diagnosed with cerebral palsy (CP) have abnormal masseter and temporal muscles activation during the masticatory cycle. METHODS: Six databases were searched for comparative observational studies assessing masticatory muscles activation in individuals with CP through electromyography analysis. Methodological quality was evaluated using the Joanna Briggs Critical Appraisal Checklist. Outcome data were combined in meta-analysis using the Review Manager software. RESULTS: We included five cross-sectional studies with an overall low risk of bias. Meta-analyses showed no difference between CP and healthy individuals regarding maximum voluntary isometric contraction: right masseter (Standard mean difference [SMD] - 0.95; 95% CI -2.03 to 0.13); left masseter (SMD -0.92; 95% CI -1.93 to 0.09); right temporal (SMD -0.72; 95% CI -1.63 to 0.18); and left temporal (SMD -0.68; 95% CI -1.76 to 0.40). Electrical activity amplitude in the inactive period was superior in the CP group, and maximum bite pressure presented higher values in the control group (Mean difference [MD] - 17.38; CI 95% -26.62 to -10.15). CONCLUSIONS: Based on observational studies with a lower level of evidence, individuals with CP seem to present difficulties activating masticatory muscles. Future prospective cohort studies with rigorous methodology are still necessary to support these findings. PROSPERO register CRD42020208444.

Effects of multiwavelength photobiomodulation for the treatment of traumatic soft tissue injuries associated with bone fractures: A double-blind, randomized controlled clinical trial.

This study evaluated the efficacy and safety of multiwavelength photobiomodulation (MPBM) in healing soft tissue injuries associated with tibial and/or ankle fractures. Participants were randomized into the MPBM or control group. Primary outcome was wound healing, measured by the Bates-Jensen scale. Assessments were performed daily. Twenty-seven hospitalized adults were included. MPBM showed an improvement in the daily mean Bates-Jensen scale (MPBM 32.1 vs. control 34.2; p = 0.029), daily mean pain score change (MPBM 0.5 vs. control 0.2; p = 0.04) and occurrence of infection at the site of the external fixator pins (MPBM 15.3% vs. control 57.1%; p = 0.02). MPBM group also showed faster-wound resolution (MPBM 13.1 vs. control 23.1 days). Subgroup analysis showed improvement in the MPBM group among less severe patients on the Bates-Jensen scale (MPBM 27.4 vs. control 34.7; p = 0.0081) and mean time for wound resolution (MPBM 7.0 vs. control 14.6 days; p = 0.03). MPBM appears safe and effective in reducing wound resolution time, infection in the surgical pin sites, reported pain and time before definitive surgery.

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.

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.

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.

Antimicrobial Photodynamic Therapy in the Nasal Decolonization of Maintenance Hemodialysis Patients: A Pilot Randomized Trial.

RATIONALE & OBJECTIVE: Infections are an important cause of mortality among patients receiving maintenance hemodialysis. Staphylococcus aureus is a frequent etiological agent, and previous nasal colonization is a risk factor for infection. Repeated antimicrobial decolonization reduces infection in this population but can induce antibiotic resistance. We compared photodynamic therapy, a promising bactericidal treatment that does not induce resistance, to mupirocin treatment among nasal carriers of S aureus. STUDY DESIGN: Randomized controlled pilot study. SETTING & PARTICIPANTS: 34 patients receiving maintenance hemodialysis who had nasal carriage of S aureus. INTERVENTIONS: Patients were randomly assigned to decolonization with a single application of photodynamic therapy (wavelength of 660nm, 400mW/cm2, 300 seconds, methylene blue 0.01%) or with a topical mupirocin regimen (twice a day for 5 days). OUTCOME: Nasal swabs were collected at time 0 (when the carrier state was identified), directly after treatment completion, 1 month after treatment, and 3 months after treatment. Bacterial isolates were subjected to proteomic analysis to identify the species present, and antimicrobial susceptibility was characterized. RESULTS: All 17 participants randomized to photodynamic therapy and 13 of 17 (77%) randomized to mupirocin were adherent to treatment. Directly after treatment was completed, 12 participants receiving photodynamic therapy (71%) and 13 participants treated with mupirocin (77%) had cultures that were negative for S aureus (risk ratio, 0.92 [95% CI, 0.61-1.38]; P=0.9). Of the patients who had negative cultures directly after completion of photodynamic therapy, 67% were recolonized within 3 months. There were no adverse events in the photodynamic therapy group. LIMITATIONS: Testing was restricted to assessing nasal colonization; infectious complications were not assessed. CONCLUSIONS: Photodynamic therapy is a feasible approach to treating nasal carriage of S aureus. Future larger studies should be conducted to determine whether photodynamic therapy is equivalent to the standard of care with mupirocin. FUNDING: Government grant (National Council for Scientific and Technological Development process 3146682020-9). TRIAL REGISTRATION: Registered at ClinicalTrials.gov with study number NCT04047914.

Dietary calcium intake in Brazilian preschoolers and schoolchhildren: review of the literature / Ingesta de cálcio dietético em pré-escolares e escolares brasileiros: revisão da literatura

ABSTRACT Objective: The objective of this study was to map and synthesize evidence on the adequacy of dietary calcium intake and dairy products in Brazilian preschoolers and schoolchildren. Data source: Evidence searches were performed in the MEDLINE (via PubMed) and Latin American and Caribbean Health Sciences Literature (LILACS; via BVS) databases, with no restriction on date or language of publication. Experimental or observational studies that evaluated healthy Brazilian children between 2 and 12 incomplete years old were included. Data synthesis: A total of 18 studies were included. Seven of 11 studies of 11 studies (63.6%) identified mean values of dietary calcium intake below the age recommendation, especially in schoolchildren, with the progression of the age group. Among preschoolers, studies with direct weighing of food showed higher mean values of dietary calcium ingested compared to those with dietary recall. Children attending public daycare centers on a part-time basis tended to have inadequate calcium intake. The consumption of milk and dairy products was lower among older children, especially schoolchildren. Conclusions: Inadequate dietary calcium intake seems to be prevalent in Brazil during childhood, especially among schoolchildren. Therefore, the evaluation of milk and dairy products intake must be considered in order to desgn appropriate corrective actions.

RESUMO Objetivo: Mapear e sintetizar as evidências sobre a adequação do consumo de cálcio dietético e laticínios em crianças brasileiras pré-escolares e escolares. Fontes de dados: As buscas pelas evidências foram realizadas nas bases de dados Medical Literature Analysis and Retrieval System Online (Medline, via PubMed) e Literatura Latino-Americana e do Caribe em Ciências da Saúde (Lilacs, via Biblioteca Virtual em Saúde — BVS), sem restrição de data ou idioma de publicação. Foram incluídos estudos experimentais ou observacionais que avaliaram crianças brasileiras saudáveis com idade entre dois e 12 anos incompletos. Síntese dos dados: Foram incluídos 18 estudos. Sete de 11 estudos (63,6%) identificaram valores médios da ingesta de cálcio dietético abaixo do recomendado para a idade, principalmente em escolares, com a progressão da faixa etária. Entre os pré-escolares, estudos com pesagem direta dos alimentos apresentaram maiores valores médios de cálcio dietético ingerido comparados aos obtidos com recordatório alimentar. Crianças frequentadoras de creches públicas em regime de meio período tiveram a maior inadequação da ingesta de cálcio. A ingesta de leite e derivados foi menor entre as crianças com idade mais avançada, principalmente em escolares. Conclusões: A inadequação da ingesta de cálcio dietético parece ser prevalente no Brasil, principalmente em escolares. Sendo assim, a avaliação da ingestão de leite e derivados é um ponto a ser observado para a realização de ações corretivas nessa faixa etária.