Application of natural language processing to predict final recommendation of Brazilian health technology assessment reports.

INTRODUCTION: Health technology assessment (HTA) plays a vital role in healthcare decision-making globally, necessitating the identification of key factors impacting evaluation outcomes due to the significant workload faced by HTA agencies. OBJECTIVES: The aim of this study was to predict the approval status of evaluations conducted by the Brazilian Committee for Health Technology Incorporation (CONITEC) using natural language processing (NLP). METHODS: Data encompassing CONITEC's official report summaries from 2012 to 2022. Textual data was tokenized for NLP analysis. Least Absolute Shrinkage and Selection Operator, logistic regression, support vector machine, random forest, neural network, and extreme gradient boosting (XGBoost), were evaluated for accuracy, area under the receiver operating characteristic curve (ROC AUC) score, precision, and recall. Cluster analysis using the k-modes algorithm categorized entries into two clusters (approved, rejected). RESULTS: The neural network model exhibited the highest accuracy metrics (precision at 0.815, accuracy at 0.769, ROC AUC at 0.871, and recall at 0.746), followed by XGBoost model. The lexical analysis uncovered linguistic markers, like references to international HTA agencies' experiences and government as demandant, potentially influencing CONITEC's decisions. Cluster and XGBoost analyses emphasized that approved evaluations mainly concerned drug assessments, often government-initiated, while non-approved ones frequently evaluated drugs, with the industry as the requester. CONCLUSIONS: NLP model can predict health technology incorporation outcomes, opening avenues for future research using HTA reports from other agencies. This model has the potential to enhance HTA system efficiency by offering initial insights and decision-making criteria, thereby benefiting healthcare experts.

Effectiveness of metformin to pregnant women with PCOS to reduce spontaneous abortion and gestational diabetes mellitus: a protocol for an overview of reviews.

INTRODUCTION: Polycystic ovary syndrome (PCOS) is a globally prevalent endocrinological disorder and has been associated with poor pregnancy outcomes, including a higher rate of gestational diabetes and miscarriage. Metformin is among the drugs investigated to improve the prognosis of pregnant women with PCOS. OBJECTIVE: To conduct an overview of systematic reviews examining the effects of metformin versus placebo or no intervention throughout pregnancy among pregnant women with a preconception PCOS diagnosis to reduce the incidence of miscarriage and gestational diabetes. METHODS AND ANALYSIS: We will perform an overview of systematic reviews by searching Embase, PubMed, Virtual Health Library, Cochrane Central Register of Controlled Trials, Trip Database, Scopus, Web of Science and Cumulative Index to Nursing and Allied Health Literature from inception to 17 August 2023. Language, publication status and year indexed or published filters will not be applied. Two reviewers will independently screen and select papers, assess their quality, evaluate their risk of bias and collect the data. The included reviews will be summarised narratively. The quality and risk of bias of the systematic review and meta-analysis studies included will be assessed using AMSTAR 2 (A Measurement Tool to Assess Systematic Reviews, Second Version) and ROBIS (Risk of Bias in Systematic Reviews), respectively. ETHICS AND DISSEMINATION: This overview of reviews will analyse data from systematic reviews on the use of metformin for prepregnancy diagnosis of PCOS to reduce adverse outcomes. As there will be no primary data collection, a formal ethical analysis is unnecessary. The study outcomes will be submitted to a peer-reviewed journal and presented at conferences. PROSPERO REGISTRATION NUMBER: CRD42023441488.

Economic evaluation of non-invasive liver tests for the diagnosis of liver fibrosis in chronic liver diseases: a systematic review protocol.

OBJECTIVE: The objective of this review is to determine the costs and benefits of non-invasive liver tests vs liver biopsy in patients with chronic liver diseases. INTRODUCTION: Hepatic diseases can lead to liver fibrosis, cirrhosis, and hepatocellular carcinoma. In the past, liver biopsy was the only option for diagnosing fibrosis degree. Liver biopsy is an invasive procedure that depends on the sample size to be able to deliver an accurate diagnosis. In recent years, non-invasive liver tests have been increasingly used to estimate liver fibrosis degree; however, there is a lack of economic assessments of technology implementation outcomes. INCLUSION CRITERIA: This review will include partial (cost studies) and complete economic evaluation studies on hepatitis B, hepatitis C, alcoholic liver disease, and non-alcoholic fatty liver disease that compare non-invasive liver tests with liver biopsies. Studies published in English, French, Spanish, German, Italian, or Portuguese will be included. No date limits will be applied to the search. METHODS: This review will identify published and unpublished studies. Published studies will be identified using MEDLINE (PubMed), Cochrane Library (CENTRAL), Embase, Web of Science, Scopus, and LILACS. Sources of unpublished studies and gray literature will include sources from health technology assessment agencies, clinical practice guidelines, regulatory approvals, advisories and warnings, and clinical trial registries, as well as Google Scholar. Two independent reviewers will screen and assess studies, and extract and critically appraise the data. Data extracted from the included studies will be analyzed and summarized to address the review objective using narrative text, and the JBI dominance ranking matrix. REVIEW REGISTRATION: PROSPERO CRD42023404278.

Deficiencies in reporting inclusion/exclusion criteria and characteristics of patients in randomized controlled trials of therapeutic interventions in pressure injuries: a systematic methodological review.

Wound care is a complex procedure and the related research may include many variables. Deficiencies in the sample inclusion and exclusion criteria may limit the generalizability of randomized controlled trials (RCTs) for wound patients in the real world. This study aimed to evaluate deficiencies in reporting the inclusion and exclusion criteria and the characteristics of patients in RCTs of pressure injuries (PI) therapeutic interventions. We conducted a systematic methodological review in which 40 full text RCTs of PI treatment interventions published in English, from 2008 to 2020, were identified. Data on the general characteristics of the included RCTs and data about inclusion/exclusion criteria and characteristics of patients were collected. The inclusion/exclusion criteria were categorized into five domains (definition of disease, precision, safety, ethical/legal and administrative). Study duration (in weeks) was 8.0 (quartile 1: 2.0; quartile 3: 48.0); only 5.0% of the trials mentioned race, skin colour or ethnicity, and 37.5% reported the duration of the wound. Only 9 (22.5%) studies reported the drugs that the included patients were using and 10 (25.0%) RCTs reported adverse events. The presence of the five domains was observed only in 12.5% of RCTs and only 12 (30.0%) had the precision domain. Much more research is required in systematic assessments of the external validity of trials because there is substantial disparity between the information that is provided by RCTs and the information that is required by clinicians. We concluded that there are deficiencies in reporting of data related to inclusion/exclusion criteria and characteristics of patients of RCTs assessing PI therapeutic interventions.

Exploring the COVID-19 Pandemic's Impact on the Health Technology Assessment Process of the National Commission for the Incorporation of Technologies Into the Brazilian Health System.

OBJECTIVES: This study aimed to evaluate the impact of the COVID-19 pandemic on Brazilian health technology assessment processes based on public reports from the National Committee for Health Technology Incorporation (CONITEC). METHODS: This descriptive study analyzed CONITEC's official reports on Brazil available on its website between 2018 and 2021 that aimed to propose recommendations for technologies to be incorporated into its public healthcare system. We used descriptive statistics covering the number of technologies and number of reports about drugs per year, objective, type of technology, demanding sector, and outcome before 2018 to 2019 and during the COVID-19 pandemic (2020-2021). Furthermore, we used logistic regression to explore any association between the final decision labeled as "incorporated" and the emergence of the COVID-19 pandemic. RESULTS: A total of 278 reports were analyzed. Approximately 85% (136 of 278), 79% (220 of 278), and 45% of the reports (125 of 278) were about drugs, for incorporation, and requested by the government, respectively. Moreover, 74 of 130 (57%) and 56 of 148 decisions (38%) were "incorporated" before and during the pandemic, respectively. No significant association was noted between incorporated decisions and the arrival of the COVID-19 pandemic for all technologies (odds ratio 1.43; 95% CI 0.84-2.46; P = .192) and for drugs (odds ratio 1.43; 95% confidence interval 0.81-2.53; P = .223) while adjusting for the type of technology and demandant. CONCLUSIONS: The COVID-19 pandemic has brought many challenges, but it does not seem to have had a significant impact on the health technology assessment approval decisions of CONITEC in Brazil.

Effect of early treatment with metformin on risk of emergency care and hospitalization among patients with COVID-19: The TOGETHER randomized platform clinical trial.

BACKGROUND: Observational studies have postulated a therapeutic role of metformin in treating COVID-19. We conducted an adaptive platform clinical trial to determine whether metformin is an effective treatment for high-risk patients with early COVID-19 in an outpatient setting. METHODS: The TOGETHER Trial is a placebo-controled, randomized, platform clinical trial conducted in Brazil. Eligible participants were symptomatic adults with a positive antigen test for SARS-CoV-2. We enroled eligible patients over the age of 50 years or with a known risk factor for disease severity. Patients were randomly assigned to receive either placebo or metformin (750 mg twice daily for 10 days or placebo, twice daily for 10 days). The primary outcome was hospitalization defined as either retention in a COVID-19 emergency setting for > 6 h or transfer to tertiary hospital due to COVID-19 at 28 days post randomization. Secondary outcomes included viral clearance at day 7, time to hospitalization, mortality, and adverse drug reactions. We used a Bayesian framework to determine probability of success of the intervention compared to placebo. FINDINGS: The TOGETHER Trial was initiated June 2, 2020. We randomized patients to metformin starting January 15, 2021. On April 3, 2021, the Data and Safety Monitoring Committee recommended stopping enrollment into the metformin arm due to futility. We recruited 418 participants, 215 were randomized to the metformin arm and 203 to the placebo arm. More than half of participants (56.0%) were over the age of 50 years and 57.2% were female. Median age was 52 years. The proportion of patients with the primary outcome at 28 days was not different between the metformin and placebo group (relative risk [RR] 1.14[95% Credible Interval 0.73; 1.81]), probability of superiority 0.28. We found no significant differences between the metformin and placebo group on viral clearance through to day 7 (Odds ratio [OR], 0.99, 95% Confidence Intervals 0.88-1.11) or other secondary outcomes. INTERPRETATION: In this randomized trial, metformin did not provide any clinical benefit to ambulatory patients with COVID-19 compared to placebo, with respect to reducing the need for retention in an emergency setting or hospitalization due to worsening COVID-19. There were also no differences between metformin and placebo observed for other secondary clinical outcomes.

Effect of early treatment with fluvoxamine on risk of emergency care and hospitalisation among patients with COVID-19: the TOGETHER randomised, platform clinical trial.

BACKGROUND: Recent evidence indicates a potential therapeutic role of fluvoxamine for COVID-19. In the TOGETHER trial for acutely symptomatic patients with COVID-19, we aimed to assess the efficacy of fluvoxamine versus placebo in preventing hospitalisation defined as either retention in a COVID-19 emergency setting or transfer to a tertiary hospital due to COVID-19. METHODS: This placebo-controlled, randomised, adaptive platform trial done among high-risk symptomatic Brazilian adults confirmed positive for SARS-CoV-2 included eligible patients from 11 clinical sites in Brazil with a known risk factor for progression to severe disease. Patients were randomly assigned (1:1) to either fluvoxamine (100 mg twice daily for 10 days) or placebo (or other treatment groups not reported here). The trial team, site staff, and patients were masked to treatment allocation. Our primary outcome was a composite endpoint of hospitalisation defined as either retention in a COVID-19 emergency setting or transfer to tertiary hospital due to COVID-19 up to 28 days post-random assignment on the basis of intention to treat. Modified intention to treat explored patients receiving at least 24 h of treatment before a primary outcome event and per-protocol analysis explored patients with a high level adherence (>80%). We used a Bayesian analytic framework to establish the effects along with probability of success of intervention compared with placebo. The trial is registered at ClinicalTrials.gov (NCT04727424) and is ongoing. FINDINGS: The study team screened 9803 potential participants for this trial. The trial was initiated on June 2, 2020, with the current protocol reporting randomisation to fluvoxamine from Jan 20 to Aug 5, 2021, when the trial arms were stopped for superiority. 741 patients were allocated to fluvoxamine and 756 to placebo. The average age of participants was 50 years (range 18-102 years); 58% were female. The proportion of patients observed in a COVID-19 emergency setting for more than 6 h or transferred to a teritary hospital due to COVID-19 was lower for the fluvoxamine group compared with placebo (79 [11%] of 741 vs 119 [16%] of 756); relative risk [RR] 0·68; 95% Bayesian credible interval [95% BCI]: 0·52-0·88), with a probability of superiority of 99·8% surpassing the prespecified superiority threshold of 97·6% (risk difference 5·0%). Of the composite primary outcome events, 87% were hospitalisations. Findings for the primary outcome were similar for the modified intention-to-treat analysis (RR 0·69, 95% BCI 0·53-0·90) and larger in the per-protocol analysis (RR 0·34, 95% BCI, 0·21-0·54). There were 17 deaths in the fluvoxamine group and 25 deaths in the placebo group in the primary intention-to-treat analysis (odds ratio [OR] 0·68, 95% CI: 0·36-1·27). There was one death in the fluvoxamine group and 12 in the placebo group for the per-protocol population (OR 0·09; 95% CI 0·01-0·47). We found no significant differences in number of treatment emergent adverse events among patients in the fluvoxamine and placebo groups. INTERPRETATION: Treatment with fluvoxamine (100 mg twice daily for 10 days) among high-risk outpatients with early diagnosed COVID-19 reduced the need for hospitalisation defined as retention in a COVID-19 emergency setting or transfer to a tertiary hospital. FUNDING: FastGrants and The Rainwater Charitable Foundation. TRANSLATION: For the Portuguese translation of the abstract see Supplementary Materials section.

Systematic review and meta-analysis of the safety of chloroquine and hydroxychloroquine from randomized controlled trials on malarial and non-malarial conditions.

BACKGROUND: Despite the expectations regarding the effectiveness of chloroquine (CQ) and hydroxychloroquine (HCQ) for coronavirus disease (COVID-19) management, concerns about their adverse events have remained. OBJECTIVES: The objective of this systematic review was to evaluate the safety of CQ and HCQ from malarial and non-malarial randomized clinical trials (RCTs). METHODS: The primary outcomes were the frequencies of serious adverse events (SAEs), retinopathy, and cardiac complications. Search strategies were applied to MEDLINE, EMBASE, LILACS, CENTRAL, Scopus, and Trip databases. We used a random-effects model to pool results across studies and Peto's one-step odds ratio (OR) for event rates below 1%. Both-armed zero-event studies were excluded from the meta-analyses. We used the Grading of Recommendations Assessment, Development, and Evaluation system to evaluate the certainty of evidence. RESULTS: One hundred and six RCTs were included. We found no significant difference between CQ/HCQ and control (placebo or non-CQ/HCQ) in the frequency of SAEs (OR: 0.98, 95% confidence interval [CI]: 0.76-1.26, 33 trials, 15,942 participants, moderate certainty of evidence). However, there was a moderate certainty of evidence that CQ/HCQ increases the incidence of cardiac complications (RR: 1.62, 95% CI: 1.10-2.38, 16 trials, 9908 participants). No clear relationship was observed between CQ/HCQ and retinopathy (OR: 1.63, 95% CI: - 0.4-6.57, 5 trials, 344 participants, very low certainty of evidence). CONCLUSIONS: CQ and HCQ probably do not increase SAEs, with low frequency of these adverse events on malarial and non-malarial conditions. However, they may increase cardiac complications especially in patients with COVID-19. No clear effect of their use on the incidence of retinopathy was observed. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42020177818.

Temporal Trends and Factors Associated With the Inclusion of Patient-Reported Outcomes in Heart Failure Randomized Controlled Trials: A Systematic Review.

Background Patient-reported outcomes (PROs) are important measures of treatment response in heart failure. We assessed temporal trends in and factors associated with inclusion of PROs in heart failure randomized controlled trials (RCTs). Methods and Results We searched MEDLINE, Embase, and CINAHL for studies published between January 2000 and July 2020 in journals with an impact factor ≥10. We assessed temporal trends using the Jonckheere-Terpstra test and conducted multivariable logistic regression to explore trial characteristics associated with PRO inclusion. We assessed the quality of PRO reporting using the Consolidated Standards of Reporting Trials (CONSORT) PRO extension. Of 417 RCTs included, PROs were reported in 226 (54.2%; 95% CI, 49.3%-59.1%), with increased reporting between 2000 and 2020 (P<0.001). The odds of PRO inclusion were greater in RCTs that were published in recent years (adjusted odds ratio [aOR] per year, 1.08; 95% CI, 1.04-1.12; P<0.001), multicenter (aOR, 1.89; 95% CI, 1.03-3.46; P=0.040), medium-sized (aOR, 2.35; 95% CI, 1.26-4.40; P=0.008), coordinated in Central and South America (aOR, 5.93; 95% CI, 1.14-30.97; P=0.035), and tested health service (aOR, 3.12; 95% CI, 1.49-6.55; P=0.003), device/surgical (aOR, 6.66; 95% CI, 3.15-14.05; P<0.001), or exercise (aOR, 4.66; 95% CI, 1.81-12.00; P=0.001) interventions. RCTs reported a median of 4 (interquartile interval , 3-6) of a possible of 11 CONSORT PRO items. Conclusions Just over half of all heart failure RCTs published in high impact factor journals between 2000 and 2020 included PROs, with increased inclusion of PROs over time. Trials that were large, tested pharmaceutical interventions, and coordinated in North America / Europe had lower adjusted odds of reporting PROs relative to other trials. The quality of PRO reporting was modest.

Effect of Early Treatment With Hydroxychloroquine or Lopinavir and Ritonavir on Risk of Hospitalization Among Patients With COVID-19: The TOGETHER Randomized Clinical Trial.

Importance: Data on the efficacy of hydroxychloroquine or lopinavir-ritonavir for the treatment of high-risk outpatients with COVID-19 in developing countries are needed. Objective: To determine whether hydroxychloroquine or lopinavir-ritonavir reduces hospitalization among high-risk patients with early symptomatic COVID-19 in an outpatient setting. Design, Setting, and Participants: This randomized clinical trial was conducted in Brazil. Recently symptomatic adults diagnosed with respiratory symptoms from SARS-CoV-2 infection were enrolled between June 2 and September 30, 2020. The planned sample size was 1476 patients, with interim analyses planned after 500 patients were enrolled. The trial was stopped after the interim analysis for futility with a sample size of 685 patients. Statistical analysis was performed in December 2020. Interventions: Patients were randomly assigned to hydroxychloroquine (800 mg loading dose, then 400 mg daily for 9 days), lopinavir-ritonavir (loading dose of 800 mg and 200 mg, respectively, every 12 hours followed by 400 mg and 100 mg, respectively, every 12 hours for the next 9 days), or placebo. Main Outcomes and Measures: The primary outcomes were COVID-19-associated hospitalization and death assessed at 90 days after randomization. COVID-19-associated hospitalization was analyzed with a Cox proportional hazards model. The trial included the following secondary outcomes: all-cause hospitalization, viral clearance, symptom resolution, and adverse events. Results: Of 685 participants, 632 (92.3%) self-identified as mixed-race, 377 (55.0%) were women, and the median (range) age was 53 (18-94) years. A total of 214 participants were randomized to hydroxychloroquine; 244, lopinavir-ritonavir; and 227, placebo. At first interim analysis, the data safety monitoring board recommended stopping enrollment of both hydroxychloroquine and lopinavir-ritonavir groups because of futility. The proportion of patients hospitalized for COVID-19 was 3.7% (8 participants) in the hydroxychloroquine group, 5.7% (14 participants) in the lopinavir-ritonavir group, and 4.8% (11 participants) in the placebo group. We found no significant differences between interventions for COVID-19-associated hospitalization (hydroxychloroquine: hazard ratio [HR], 0.76 [95% CI, 0.30-1.88]; lopinavir-ritonavir: HR, 1.16 [95% CI, 0.53-2.56] as well as for the secondary outcome of viral clearance through day 14 (hydroxychloroquine: odds ratio [OR], 0.91 [95% CI, 0.82-1.02]; lopinavir-ritonavir: OR, 1.04 [95% CI, 0.94-1.16]). At the end of the trial, there were 3 fatalities recorded, 1 in the placebo group and 2 in the lopinavir-ritonavir intervention group. Conclusions and Relevance: In this randomized clinical trial, neither hydroxychloroquine nor lopinavir-ritonavir showed any significant benefit for decreasing COVID-19-associated hospitalization or other secondary clinical outcomes. This trial suggests that expedient clinical trials can be implemented in low-income settings even during the COVID-19 pandemic. Trial Registration: ClinicalTrials.gov Identifier: NCT04403100.

The future of precision medicine in opioid use disorder: inclusion of patient-important outcomes in clinical trials

Opioid use has reached an epidemic proportion in Canada and the United States that is mostly attributed to excess availability of prescribed opioids for pain. This excess in opioid use led to an increase in the prevalence of opioid use disorder (OUD) requiring treatment. The most common treatment recommendations include medication-assisted treatment (MAT) combined with psychosocial interventions. Clinical trials investigating the effectiveness of MAT, however, have a limited focus on effectiveness measures that overlook patient-important outcomes. Despite MAT, patients with OUD continue to suffer negative consequences of opioid use. Patient goals and personalized medicine are overlooked in clinical trials and guidelines, thus missing an opportunity to improve prognosis of OUD by considering precision medicine in addiction trials. In this mixed-methods study, patients with OUD receiving MAT (n=2,031, mean age 39.1 years [SD 10.7], 44% female) were interviewed to identify patient goals for MAT. The most frequently reported patient-important outcomes were to stop treatment (39%) and to avoid all drugs (25%). These results are inconsistent with treatment recommendations and trial outcome measures. We discuss theses inconsistencies and make recommendations to incorporate these outcomes to achieve patient-centered and personalized treatment strategies.

Global prevalence of burnout among postgraduate medical trainees: a systematic review and meta-regression.

BACKGROUND: Burnout among postgraduate medical trainees (PMTs) is increasingly being recognized as a crisis in the medical profession. We aimed to establish the prevalence of burnout among PMTs, identify risk and protective factors, and assess whether burnout varied by country of training, year of study and specialty of practice. METHODS: We systematically searched MEDLINE, Embase, PsycINFO, the Cochrane Database of Systematic Reviews, Web of Science and Education Resources Information Center from their inception to Aug. 21, 2018, for studies of burnout among PMTs. The primary objective was to identify the global prevalence of burnout among PMTs. Our secondary objective was to evaluate the association between burnout and country of training, year of study, specialty of training and other sociodemographic factors commonly thought to be related to burnout. We employed random-effects meta-analysis and meta-regression techniques to estimate a pooled prevalence and conduct secondary analyses. RESULTS: In total, 8505 published studies were screened, 196 met eligibility and 114 were included in the meta-analysis. The pooled prevalence of burnout was 47.3% (95% confidence interval 43.1% to 51.5%), based on studies published over 20 years involving 31 210 PMTs from 47 countries. The prevalence of burnout remained unchanged over the past 2 decades. Burnout varied by region, with PMTs of European countries experiencing the lowest level. Burnout rates among medical and surgical PMTs were similar. INTERPRETATION: Current wellness efforts and policies have not changed the prevalence of burnout worldwide. Future research should focus on understanding systemic factors and leveraging these findings to design interventions to combat burnout. STUDY REGISTRATION: PROSPERO no. CRD42018108774.

The future of precision medicine in opioid use disorder: inclusion of patient-important outcomes in clinical trials.

Opioid use has reached an epidemic proportion in Canada and the United States that is mostly attributed to excess availability of prescribed opioids for pain. This excess in opioid use led to an increase in the prevalence of opioid use disorder (OUD) requiring treatment. The most common treatment recommendations include medication-assisted treatment (MAT) combined with psychosocial interventions. Clinical trials investigating the effectiveness of MAT, however, have a limited focus on effectiveness measures that overlook patient-important outcomes. Despite MAT, patients with OUD continue to suffer negative consequences of opioid use. Patient goals and personalized medicine are overlooked in clinical trials and guidelines, thus missing an opportunity to improve prognosis of OUD by considering precision medicine in addiction trials. In this mixed-methods study, patients with OUD receiving MAT (n=2,031, mean age 39.1 years [SD 10.7], 44% female) were interviewed to identify patient goals for MAT. The most frequently reported patient-important outcomes were to stop treatment (39%) and to avoid all drugs (25%). These results are inconsistent with treatment recommendations and trial outcome measures. We discuss theses inconsistencies and make recommendations to incorporate these outcomes to achieve patient-centered and personalized treatment strategies.

Quality of reporting of outcomes in trials of therapeutic interventions for pressure injuries in adults: a systematic methodological survey.

Randomised controlled trials of therapeutic interventions for pressure injuries should include a clear description of outcomes to increase transparency and replicability and improve the construction of scientific evidence. The objective of this study was to assess the completeness of the descriptions of the outcomes of therapeutic interventions in adults with pressure injury (PI) and factors associated with completeness. This was a systematic methodological survey. The completeness of the outcome was assessed according to five criteria: domain (title), specific measure (technique/instrument used), specific metric, or format of the outcome data of each participant that was used for analysis, aggregation (method data from each group were summarised), and time that was used for analysis. Sixty-eight studies were included for analysis. A total of 265 outcomes were reported, and 46 trials (67.6%) had 73 primary outcomes, which were mainly intermediates/substitutes (78.8%). The main outcome evaluated was the ulcer area reduction (36.6%). Approximately 37.2% of the outcomes were incompletely reported, and the least described element was the data aggregation method (72.8%). Only 48.4% of the outcomes with the specified technique had the same reference or validation. Poor quality of reporting outcomes was associated with studies with an older year of publication and a small sample size, single-center studies, and those sponsored by industry. PI studies use many outcomes, mostly surrogates or intermediates, and some of them are incompletely described.

Evaluating Journal Impact Factor: a systematic survey of the pros and cons, and overview of alternative measures.

BACKGROUND: Journal Impact Factor (JIF) has several intrinsic flaws, which highlight its inability to adequately measure citation distributions or indicate journal quality. Despite these flaws, JIF is still widely used within the academic community, resulting in the propagation of potentially misleading information. A critical review of the usefulness of JIF is needed including an overview of the literature to identify viable alternative metrics. The objectives of this study are: (1) to assess the usefulness of JIF by compiling and comparing its advantages and disadvantages; (2) to record the differential uses of JIF within research environments; and (3) to summarize and compare viable alternative measures to JIF. METHODS: Three separate literature search strategies using MEDLINE and Web of Science were completed to address the three study objectives. Each search was completed in accordance with PRISMA guidelines. Results were compiled in tabular format and analyzed based on reporting frequency. RESULTS: For objective (1), 84 studies were included in qualitative analysis. It was found that the recorded advantages of JIF were outweighed by disadvantages (18 disadvantages vs. 9 advantages). For objective (2), 653 records were included in a qualitative analysis. JIF was found to be most commonly used in journal ranking (n = 653, 100%) and calculation of scientific research productivity (n = 367, 56.2%). For objective (3), 65 works were included in qualitative analysis. These articles revealed 45 alternatives, which includes 18 alternatives that improve on highly reported disadvantages of JIF. CONCLUSION: JIF has many disadvantages and is applied beyond its original intent, leading to inaccurate information. Several metrics have been identified to improve on certain disadvantages of JIF. Integrated Impact Indicator (I3) shows great promise as an alternative to JIF. However, further scientometric analysis is needed to assess its properties.

Study protocol to investigate biomolecular muscle profile as predictors of long-term urinary incontinence in women with gestational diabetes mellitus.

BACKGROUND: Pelvic floor muscles (PFM) and rectus abdominis muscles (RAM) of pregnant diabetic rats exhibit atrophy, co-localization of fast and slow fibers and an increased collagen type I/III ratio. However, the role of similar PFM or RAM hyperglycemic-related myopathy in women with gestational diabetes mellitus (GDM) remains poorly investigated. This study aims to assess the frequency of pelvic floor muscle disorders and pregnancy-specific urinary incontinence (PS-UI) 12 months after the Cesarean (C) section in women with GDM. Specifically, differences in PFM/RAM hyperglycemic myopathy will be evaluated. METHODS: The Diamater is an ongoing cohort study of four groups of 59 pregnant women each from the Perinatal Diabetes Research Centre (PDRC), Botucatu Medical School (FMB)-UNESP (São Paulo State University), Brazil. Diagnosis of GDM and PS-UI will be made at 24-26 weeks, with a follow-up at 34-38 weeks of gestation. Inclusion in the study will occur at the time of C-section, and patients will be followed at 24-48 h, 6 weeks and 6 and 12 months postpartum. Study groups will be classified as (1) GDM plus PS-UI; (2) GDM without PS-UI; (3) Non-GDM plus PS-UI; and (4) Non-GDM without PS-UI. We will analyze relationships between GDM, PS-UI and hyperglycemic myopathy at 12 months after C-section. The mediator variables to be evaluated include digital palpation, vaginal squeeze pressure, 3D pelvic floor ultrasound, and 3D RAM ultrasound. RAM samples obtained during C-section will be analyzed for ex-vivo contractility, morphological, molecular and OMICS profiles to further characterize the hyperglycemic myopathy. Additional variables to be evaluated include maternal age, socioeconomic status, educational level, ethnicity, body mass index, weight gain during pregnancy, quality of glycemic control and insulin therapy. DISCUSSION: To our knowledge, this will be the first study to provide data on the prevalence of PS-UI and RAM and PFM physical and biomolecular muscle profiles after C-section in mothers with GDM. The longitudinal design allows for the assessment of cause-effect relationships between GDM, PS-UI, and PFMs and RAMs myopathy. The findings may reveal previously undetermined consequences of GDM.

Effectiveness of non-pharmacological strategies in the management of type 2 diabetes in primary care: a protocol for a systematic review and network meta-analysis.

INTRODUCTION: Despite the increasing number of drugs and various guidelines on the management of type 2 diabetes mellitus (T2DM), several patients continue with the disease uncontrolled. There are several non-pharmacological treatments available for managing T2DM, but various of them have never been compared directly to determine the best strategies. OBJECTIVE: This study will evaluate the comparative effects of non-pharmacological strategies in the management of T2DM in primary care or community settings. METHODS AND ANALYSIS: We will perform a systematic review and network meta-analysis (NMA), and will include randomised controlled trials if one of the following interventions were applied in adult patients with T2DM: nutritional therapy, physical activity, psychological interventions, social interventions, multidisciplinary lifestyle interventions, diabetes self-management education and support (DSMES), technology-enabled DSMES, interventions delivered only either by pharmacists or by nurses, self-blood glucose monitoring in non-insulin-treated T2DM, health coaching, benchmarking and usual care. The primary outcome will be glycaemic control (glycated haemoglobin (HbA1c) (%)), and the secondary outcomes will be weight loss, quality of life, patient satisfaction, frequency of cardiovascular events and deaths, number of patients in each group with HbA1c <7, adverse events and medication adherence. We have developed search strategies for Embase, Medline, Latin American and Caribbean Health Sciences Literature, Cochrane Central Register of Controlled Trials, Trip database, Scopus, Web of Science, Cumulative Index to Nursing and Allied Health Literature Australasian Medical Index and Chinese Biomedical Literature Database. Four reviewers will assess the studies for their eligibility and their risk of bias in pairs and independently. An NMA will be performed using a Bayesian hierarchical model, and the treatment hierarchy will be obtained using the surface under the cumulative ranking curve. To determine our confidence in an overall treatment ranking from the NMA, we will follow the Grading of Recommendations Assessment, Development and Evaluation approach. ETHICS AND DISSEMINATION: As no primary data collection will be undertaken, no formal ethical assessment is required. We plan to present the results of this systematic review in a peer-reviewed scientific journal, conferences and the popular press. PROSPERO REGISTRATION NUMBER: CRD42019127856.

Evaluating Journal Impact Factor: a systematic survey of the pros and cons, and overview of alternative measures

Journal Impact Factor (JIF) has several intrinsic flaws, which highlight its inability to adequately measure citation distributions or indicate journal quality. Despite these flaws, JIF is still widely used within the academic community, resulting in the propagation of potentially misleading information. A critical review of the usefulness of JIF is needed including an overview of the literature to identify viable alternative metrics. The objectives of this study are: (1) to assess the usefulness of JIF by compiling and comparing its advantages and disadvantages; (2) to record the differential uses of JIF within research environments; and (3) to summarize and compare viable alternative measures to JIF. Methods: Three separate literature search strategies using MEDLINE and Web of Science were completed to address the three study objectives. Each search was completed in accordance with PRISMA guidelines. Results were compiled in tabular format and analyzed based on reporting frequency. Results: For objective (1), 84 studies were included in qualitative analysis. It was found that the recorded advantages of JIF were outweighed by disadvantages (18 disadvantages vs. 9 advantages). For objective (2), 653 records were included in a qualitative analysis. JIF was found to be most commonly used in journal ranking (n = 653, 100%) and calculation of scientific research productivity (n = 367, 56.2%). For objective (3), 65 works were included in qualitative analysis. These articles revealed 45 alternatives, which includes 18 alternatives that improve on highly reported disadvantages of JIF. Conclusion: JIF has many disadvantages and is applied beyond its original intent, leading to inaccurate information. Several metrics have been identified to improve on certain disadvantages of JIF. Integrated Impact Indicator (I3) shows great promise as an alternative to JIF. However, further scientometric analysis is needed to assess its properties.(AU)

Evaluating Journal Impact Factor: a systematic survey of the pros and cons, and overview of alternative measures

Journal Impact Factor (JIF) has several intrinsic flaws, which highlight its inability to adequately measure citation distributions or indicate journal quality. Despite these flaws, JIF is still widely used within the academic community, resulting in the propagation of potentially misleading information. A critical review of the usefulness of JIF is needed including an overview of the literature to identify viable alternative metrics. The objectives of this study are: (1) to assess the usefulness of JIF by compiling and comparing its advantages and disadvantages; (2) to record the differential uses of JIF within research environments; and (3) to summarize and compare viable alternative measures to JIF. Methods: Three separate literature search strategies using MEDLINE and Web of Science were completed to address the three study objectives. Each search was completed in accordance with PRISMA guidelines. Results were compiled in tabular format and analyzed based on reporting frequency. Results: For objective (1), 84 studies were included in qualitative analysis. It was found that the recorded advantages of JIF were outweighed by disadvantages (18 disadvantages vs. 9 advantages). For objective (2), 653 records were included in a qualitative analysis. JIF was found to be most commonly used in journal ranking (n = 653, 100%) and calculation of scientific research productivity (n = 367, 56.2%). For objective (3), 65 works were included in qualitative analysis. These articles revealed 45 alternatives, which includes 18 alternatives that improve on highly reported disadvantages of JIF. Conclusion: JIF has many disadvantages and is applied beyond its original intent, leading to inaccurate information. Several metrics have been identified to improve on certain disadvantages of JIF. Integrated Impact Indicator (I3) shows great promise as an alternative to JIF. However, further scientometric analysis is needed to assess its properties.(AU)

Effects of piezocision in orthodontic tooth movement: A systematic review of comparative studies.

BACKGROUND: The aim of this systematic review was to evaluate the effects of piezocision in accelerating orthodontic tooth movement (OTM) and its possible adverse effects. MATERIAL AND METHODS: The Databases Medline, Embase, CENTRAL and LILACS were searched until March 2019, for randomized controlled trials (RCTs) and controlled clinical trials (CCTs) that used piezocision associated with orthodontic treatment. A manual search was also performed. The search, studies selection, assessment of risk of bias and data collection were carried out by two independent reviewers. RESULTS: Eleven publications were included in this review (4 CCTs and 7 RCTs). No study presented low risk of bias. Different types of tooth movement were evaluated: lower anterior alignment, en-masse retraction, overall orthodontic treatment and canine distalization. A total of 240 participants were analyzed in the included studies. Seven studies found significant acceleration in the piezocision group, while two studies found no differences. Adverse effects regarding patient's satisfaction, pain perception, or worsening of periodontal parameters were not observed. There was no consensus concerning anchorage loss and root resorption. CONCLUSIONS: The literature does not provide high-quality evidence to confirm that Piezocision results in significant OTM acceleration. Therefore, high-quality RCTs should be conducted to allow reliable conclusions about the effects of piezocision in orthodontics. Key words:Piezosurgery, tooth movement techniques, orthodontics.