Opportunities to improve reporting of rapid response in health technology assessment.

INTRODUCTION: Mini health technology assessment (HTA) reports have been used to support policy makers and health systems by providing a timely summary of scientific evidence. The objective of this meta-epidemiologic study was to evaluate the quality of reporting of mini-HTA reports published in Brazil. METHODS: An electronic search for all mini-HTA reports published between 2014 and March 2019 was conducted in the SISREBRATS and CONITEC databases. The study selection and data extraction were performed by two independent assessors. The following data were extracted: bibliographic data; research question; characteristics of the population, health technologies and outcomes assessed; eligibility criteria; information about searches and study selection; risk of bias assessment; quality of evidence assessment; synthesis of results; and recommendation about the technology evaluated. A descriptive analysis was used to summarize the information retrieved from all the included mini-HTA reports. RESULTS: We included 103 mini-HTA reports, the great majority of which (92.3 percent) focused on the coverage of the technologies in the healthcare system, with more than 60 percent being about drugs. Only five mini-HTA reports (4.8 percent) gave reasons for the choice of outcomes, and fifteen (14.5 percent) discriminated between primary and secondary outcomes. All mini-HTAs reported the databases searched and 99 percent of them reported using Medline. Sixty percent of the mini-HTA reported assessing the risk of bias, and 52 percent reported assessing the quality of evidence. CONCLUSION: The quality of reporting of the mini-HTA reports performed in Brazil is insufficient and needs to be improved to guarantee transparency and replicability.

Body postural realignment in the first 2 months after orthognathic surgery.

INTRODUCTION: This study aimed to assess the static posture in patients with Angle Class II and III malocclusions in the first 2 months after orthognathic surgery. METHODS: This was a longitudinal observational study. Eligible participants were adult patients who had an indication of orthognathic surgery (bilateral sagittal split osteotomy of the maxilla and/or mandible, can be associated or not with genioplasty). Thirty-five patients were evaluated from the orthognathic surgery group (OSG) and control group (CG). Measurements in OSG were performed at 3 time points: preoperative orthognathic surgery (P0), first postoperative month (P1), and second postoperative month (P2). Static posture was evaluated using the PostureScreen Mobile (PostureCo Inc, Trinity, Fla) application in 4 views. RESULTS: Patients with Angle Class II malocclusion in the OSG evidenced a tendency to a left hip translation at P1 with a significant difference at P2 in the anterior view (P = 0.052). In the right lateral view, patients with Angle Class II malocclusion in the OSG at P1 presented an accentuated anterior shoulder translation when compared with CG (P <0.001). At P1, patients with Angle Class II malocclusion in the OSG showed a significant anterior knee translation compared with the CG and OSG at P0 and P2 (P <0.001 for all). Patients in the OSG with Angle Class III malocclusion presented an average posterior head translation in the right lateral view at P1 when compared with those in the CG and OSG at P0, who presented an anterior translation (P = 0.0008). CONCLUSIONS: These findings suggest a realignment of static posture in the first 2 months after orthognathic surgery.

Decrease in Talocrural Joint Mobility is Related to Alteration of the Arterial Blood Flow Velocity in the Lower Limb in Diabetic Women.

[Purpose] The purpose of this study was to correlate the talocrural range of motion (ROM) and blood flow velocity in the lower limb arteries of diabetic women. [Subjects and Methods] Thirty women were divided into a control group (G1), consisting of 15 sedentary right-handed subjects (41.27 ± 7.24 years old) who had no history of blood system disorder, and a diabetes group (G2), consisting of 15 sedentary right-handed subjects (57.87 ± 6.20 years old) who had type 2 diabetes mellitus. Talocrural ROM was measured by using goniometry for dorsiflexion and plantar flexion movements. In addition, blood flow velocity of the dorsalis pedis, posterior tibial, and popliteal arteries was also assessed. [Results] No significant differences were found between the groups by comparing talocrural ROM and arterial blood velocity. However, a significant association was found in G2 only between the following variables: plantar flexion and blood flow velocity of the dorsalis pedis artery (rs = 0.57), plantar flexion and blood flow velocity of the popliteal artery (rs = 0.50), and dorsiflexion and blood flow velocity of the posterior tibial artery (rs = 0.57). [Conclusion] The decrease in talocrural ROM is related to a decrease in the arterial blood flow velocity in diabetic women.

Effectiveness and safety of biological and target synthetic drugs treatment for psoriatic arthritis: a systematic review with network meta-analysis.

BACKGROUND: Psoriatic arthritis (PA) is a chronic inflammatory systemic arthritis that can result in loss of functional capacity and joint deformation. This systematic review assessed the effectiveness and safety of biological and target synthetic drugs for treating PA. METHODS: We searched for randomized clinical trials (RCTs) that evaluated the use of Adalimumab, Etanercept, Infliximab, Golimumab, Secukinumab, Certolizumab Pegol and Tofacitinib in the main general databases and clinical trial registers databases. The primary outcomes were ACR 50, PsARC, and serious adverse events. Two independent reviewers performed study selection and data extraction. Network meta-analyses were conducted using a random effects model and frequentist approach. The CINeMA software was used to assess the certainty of evidence. RESULTS: We included 33 RCTs (n = 11,034). The results from the network meta-analysis for the ACR 50 at 6-months follow-up showed that all drugs were superior to placebo, with Secukinumab (high certainty of evidence), Infliximab (very low certainty of evidence) and Adalimumab (high certainty of evidence) ranking the highest. Regarding the PsARC (at 6-months follow-up), all drugs, except for Golimumab (very low certainty of evidence), were superior to placebo, with Etanercept (low certainty of evidence), Infliximab (low certainty of evidence) and Certolizumab Pegol (low certainty of evidence) being the most effective drugs. There were no significant differences in the risk of serious adverse events between the drugs and placebo. Golimumab (very low certainty of evidence), Secukinumab (low certainty of evidence), and Adalimumab (very low certainty of evidence) ranked the highest for safety. CONCLUSIONS: In conclusion, based on the balance between efficacy and safety, Secukinumab and Adalimumab may be the preferred options among the evaluated drugs for treating patients with PsA. However, caution is necessary when interpreting the safety findings, as they are supported by evidence of low to very low certainty. Consequently, the balance between benefits and potential risks may change as new safety evaluation studies become available. PROTOCOL REGISTRATION: PROSPERO: CRD42022315577.

Effectiveness and safety of multidrug therapy containing clofazimine for paucibacillary leprosy and clarithromycin for rifampicin-resistant leprosy: a systematic review and meta-analysis.

Introduction: The present study aimed to evaluate leprosy cure and relapse rates as primary outcomes related to two additional strategies for leprosy treatment: clofazimine for paucibacillary (PB) leprosy patients and clarithromycin for patients with rifampicin-resistant leprosy. Methods: We conducted two systematic reviews (protocols CRD42022308272 and CRD42022308260). We searched the PubMed, EMBASE, Web of Science, Scopus, LILACS, Virtual Health Library and Cochrane Library databases, registers of clinical trial databases and gray literature. We included clinical trials evaluating the addition of clofazimine to PB leprosy treatment and the use of clarithromycin for treating patients with rifampicin-resistant leprosy. Risk of bias (RoB) in randomized clinical trials was assessed by the RoB 2 tool and that in non-randomized clinical trials was assessed by the ROBINS-I tool; and the certainty of the evidence was assessed by the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. A meta-analysis of dichotomous outcomes was performed. Results: For clofazimine, four studies were included. Cure and relapse rates were not different with the addition of clofazimine to PB leprosy treatment and demonstrated very low certainty of evidence. For clarithromycin, six studies were included. Considerable heterogeneity resulted from the difference between comparators, and studies showed no difference in the assessed outcomes with the addition of clarithromycin to rifampicin-resistant leprosy treatment. Mild adverse events were reported for both drugs but did not significantly impact treatment. Discussion: The effectiveness of both drugs still needs to be determined. Adding clofazimine to PB leprosy treatment may reduce the repercussions of an incorrect operational classification with no apparent relevant side effects. Systematic review registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022308272; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022308260, identifier: CRD42022308272; CRD42022308260.

Effectiveness and safety of non-steroidal anti-inflammatory drugs and opioid treatment for knee and hip osteoarthritis: network meta-analysis.

OBJECTIVE: To assess the effectiveness and safety of different preparations and doses of non-steroidal anti-inflammatory drugs (NSAIDs), opioids, and paracetamol for knee and hip osteoarthritis pain and physical function to enable effective and safe use of these drugs at their lowest possible dose. DESIGN: Systematic review and network meta-analysis of randomised trials. DATA SOURCES: Cochrane Central Register of Controlled Trials (CENTRAL), Medline, Embase, regulatory agency websites, and ClinicalTrials.gov from inception to 28 June 2021. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Randomised trials published in English with ≥100 patients per group that evaluated NSAIDs, opioids, or paracetamol (acetaminophen) to treat osteoarthritis. OUTCOMES AND MEASURES: The prespecified primary outcome was pain. Physical function and safety outcomes were also assessed. REVIEW METHODS: Two reviewers independently extracted outcomes data and evaluated the risk of bias of included trials. Bayesian random effects models were used for network meta-analysis of all analyses. Effect estimates are comparisons between active treatments and oral placebo. RESULTS: 192 trials comprising 102 829 participants examined 90 different active preparations or doses (68 for NSAIDs, 19 for opioids, and three for paracetamol). Five oral preparations (diclofenac 150 mg/day, etoricoxib 60 and 90 mg/day, and rofecoxib 25 and 50 mg/day) had ≥99% probability of more pronounced treatment effects than the minimal clinically relevant reduction in pain. Topical diclofenac (70-81 and 140-160 mg/day) had ≥92.3% probability, and all opioids had ≤53% probability of more pronounced treatment effects than the minimal clinically relevant reduction in pain. 18.5%, 0%, and 83.3% of the oral NSAIDs, topical NSAIDs, and opioids, respectively, had an increased risk of dropouts due to adverse events. 29.8%, 0%, and 89.5% of oral NSAIDs, topical NSAIDs, and opioids, respectively, had an increased risk of any adverse event. Oxymorphone 80 mg/day had the highest risk of dropouts due to adverse events (51%) and any adverse event (88%). CONCLUSIONS: Etoricoxib 60 mg/day and diclofenac 150 mg/day seem to be the most effective oral NSAIDs for pain and function in patients with osteoarthritis. However, these treatments are probably not appropriate for patients with comorbidities or for long term use because of the slight increase in the risk of adverse events. Additionally, an increased risk of dropping out due to adverse events was found for diclofenac 150 mg/day. Topical diclofenac 70-81 mg/day seems to be effective and generally safer because of reduced systemic exposure and lower dose, and should be considered as first line pharmacological treatment for knee osteoarthritis. The clinical benefit of opioid treatment, regardless of preparation or dose, does not outweigh the harm it might cause in patients with osteoarthritis. SYSTEMATIC REVIEW REGISTRATION: PROSPERO number CRD42020213656.

Eficácia e segurança de romosozumabe para o tratamento de osteoporose grave em mulheres na pós-menopausa: revisão sistemática e meta-análise em rede / Efficacy and safety of romosozumab for the treatment of severe osteoporosis in postmenopausal women: systematic and network meta-analysis

Introdução: A osteoporose é uma das principais causas de morbimortalidade, principalmente em idosos e mulheres na pós-menopausa, devido ao aumento da fragilidade óssea e maior suscetibilidade a fraturas. Objetivo: Avaliar a eficácia e segurança do romosozumabe, comparado aos tratamentos farmacológicos atualmente disponíveis no Sistema Único de Saúde para o manejo de mulheres na pós-menopausa com osteoporose grave e alto risco de fraturas. Métodos: Foi realizada uma busca seguida por meta-análises indiretas, por ensaios clínicos randomizados (ECR) nas bases PubMed Central e Medline, Embase e Cochrane Library e por busca manual. O risco de viés (RoB 2.0) e a qualidade da evidência (GRADE) foram analisados. Meta-análises indiretas foram realizadas para desfechos de fraturas, densidade mineral óssea e eventos adversos. Resultados: Sete ECR (n= 19.951 mulheres) foram incluídos nesta revisão. Romosozumabe seguido de alendronato reduziu risco de fraturas não vertebrais em 12 meses (RR: 0,64, IC 95%: 0,49-0,84; alta certeza de evidência) e em 24 meses (RR: 0,52, IC 95%: 0,43-0,64; (alta certeza de evidência) na comparação ao alendronato. Achados semelhantes foram identificados para outros desfechos. Ácido zoledrônico foi associada a maior risco de descontinuação por evento adverso que placebo (RR: 1,02, IC 95%: 1,01-1,03). Conclusão: Foi identificado que romosozumabe ou romosozumabe seguido por alendronato são eficazes e seguros na comparação com alendronato.

Background: Osteoporosis is a major cause of morbidity and mortality, especially in the elderly and postmenopausal women, due to increased bone fragility and greater susceptibility to fractures. Objective: To evaluate the efficacy and safety of romosozumab, compared to pharmacological treatments currently available in the Unified Health System of Brazil for the management of postmenopausal women with severe osteoporosis and high risk of fractures. Methods: A search was carried out followed by indirect meta-analyses, randomized controlled trials (RCTs) in PubMed Central and Medline, EMBASE, and Cochrane Library databases and manual search. Risk of bias (RoB 2.0) and quality of evidence (GRADE) were assessed. Indirect frequentist meta-analyses were carried out for outcomes related to fractures, bone mineral density, and adverse events. Results: Seven RCTs (n= 19,951 woman) were included in this review. Romosozumab followed by alendronate reduced the risk of non-vertebral fractures at 12 months (RR: 0.64, 95% CI: 0.49-0.84; high certainty of evidence) and at 24 months (RR: 0.52, CI 95 %: 0.43-0.64; (high certainty of evidence) in comparison to alendronate. Similar findings were identified for other outcomes. Zoledronic acid was associated with a higher risk of discontinuation due to adverse events than placebo (RR: 1.02, 95% CI: 1.01-1.03). Conclusion: This review identified that romosozumab or romosozumab followed by alendronate are effective and safe compared to alendronate.

Alteration of Blood Circulation in the Upper Limb Before and After Surgery for Breast Cancer Associated with Axillary Lymph Node Dissection or Sentinel Lymph Node Biopsy.

BACKGROUND: This aim of this study was to assess and compare arterial and venous circulation in women with axillary lymph node dissection (ALND) and sentinel lymph node biopsy (SLNB) before and after breast cancer surgery. METHODS AND RESULTS: Fifty-two women took part in the study, divided into three groups: those undergoing ALND at levels I, II, and III (ALNDG), with mean age of 56.29 ± 10.85 years old; those undergoing sentinel lymph node biopsy (SLNBG), with mean age of 57.7 ± 7.07 years old; and controls without diagnosis of breast cancer (CG), with mean age of 53.92 ± 8.85 years old. Maximum venous and arterial flow velocities in upper limbs were assessed before and after surgical treatment for breast cancer by means of Doppler ultrasonography (Nicolet Vascular Versalab SE®). Data normality was assessed by using the Shapiro-Wilk's test, with normally distributed variables being analyzed with analysis of variance (ANOVA) and post hoc Tukey's test or t-test. For variables with non-normal distribution, Kruskal-Wallis' test and post hoc Dunn's test were used at p < 0.05. There was significant difference in the maximum blood flow velocities, both venous (ALNDG) and arterial (SLNBG). CONCLUSION: The results suggest that ALND and SLNB can interfere with the upper limp blood circulation.

Assessment of symptoms of urinary incontinence in women with polycystic ovary syndrome.

OBJECTIVES: The pelvic floor muscles are sensitive to androgens, and due to hyperandrogenism, women with polycystic ovary syndrome can have increased mass in these muscles compared to controls. The aim of this study is to compare reports of urine leakage and quality of life between women with and without polycystic ovary syndrome. METHODS: One hundred thirteen 18-to 40-year-old nulliparous women with polycystic ovary syndrome or without the disease (controls) were recruited at the University Hospital of School Medicine of São Paulo University at Ribeirão Preto City, Brazil. The subjects were not taking any hormonal medication, had not undergone previous pelvic surgery and did not exercise their pelvic floor muscles. The women were divided into the following four groups: I-polycystic ovary syndrome with normal body mass index (n = 18), II-polycystic ovary syndrome with body mass index >25 (n = 32), III-controls with normal body mass index (n = 29), and IV-controls with Body Mass Index >25 (n = 34). Quality of life was evaluated using the SF-36 questionnaire, and the subjects with urinary complaints also completed the International Consultation on Incontinence Questionnaire Short Form to evaluate the severity of their urinary incontinence. RESULTS: The replies to the International Consultation on Incontinence Questionnaire Short Form revealed a significant difference in urinary function between groups, with 24% of the subjects in group IV reporting urinary incontinence. The mean scores for the SF-36 questionnaire revealed that group II had the lowest quality of life. CONCLUSIONS: The control obese group (IV) reported a higher prevalence of urinary incontinence. There was no difference in the reported frequency of urine loss between the polycystic ovary syndrome and control groups with normal body mass index or between the polycystic ovary syndrome and control groups with body mass index >25.

Comparison between measurements obtained with three different perineometers.

OBJECTIVE: To analyze the results obtained in the evaluation of intra-vaginal pressure using three different brands of perineometers in nulliparous volunteers. MATERIALS AND METHODS: Twenty nulliparous women with no anatomical alterations and/or dysfunction of the pelvic floor were enrolled in our study. All the women had the ability to voluntarily contract their PFM (Pelvic Floor Muscles), as assessed by digital palpation. The intra-vaginal pressure was assessed using three different brands of perineometer (Neurodyn Evolution, SensuPower and Peritron). Each volunteer was evaluated on three alternate days by a single examiner using a single brand of perineometer on each day. In the assessment, the volunteers were required to pull (contract) their PFM in and up as strongly as possible 3 times and to sustain the contraction for 5 seconds, with an interval of 30 seconds between each pull. For the statistical analysis, a concordance correlation coefficient was used to compare the values that were obtained with each brand of perineometer. RESULTS: A moderate concordance (0.51) was found between the results from the Peritron and Neurodyn perineometers, a fair concordance (0.21) between the Peritron and SensuPower brands and a poor concordance (0.19) between the Neurodyn and SensuPower brands. CONCLUSION: The concordance of the measurements of the intra-vaginal pressure ranged from poor to moderate, suggesting that perineometers of different brands generate different results.

Assessment of symptoms of urinary incontinence in women with polycystic ovary syndrome

OBJECTIVES: The pelvic floor muscles are sensitive to androgens, and due to hyperandrogenism, women with polycystic ovary syndrome can have increased mass in these muscles compared to controls. The aim of this study is to compare reports of urine leakage and quality of life between women with and without polycystic ovary syndrome. METHODS: One hundred thirteen 18-to 40-year-old nulliparous women with polycystic ovary syndrome or without the disease (controls) were recruited at the University Hospital of School Medicine of São Paulo University at Ribeirão Preto City, Brazil. The subjects were not taking any hormonal medication, had not undergone previous pelvic surgery and did not exercise their pelvic floor muscles. The women were divided into the following four groups: I-polycystic ovary syndrome with normal body mass index (n = 18), II-polycystic ovary syndrome with body mass index >25 (n = 32), III-controls with normal body mass index (n = 29), and IV-controls with Body Mass Index >25 (n = 34). Quality of life was evaluated using the SF-36 questionnaire, and the subjects with urinary complaints also completed the International Consultation on Incontinence Questionnaire Short Form to evaluate the severity of their urinary incontinence. RESULTS: The replies to the International Consultation on Incontinence Questionnaire Short Form revealed a significant difference in urinary function between groups, with 24 percent of the subjects in group IV reporting urinary incontinence. The mean scores for the SF-36 questionnaire revealed that group II had the lowest quality of life. CONCLUSIONS: The control obese group (IV) reported a higher prevalence of urinary incontinence. There was no difference in the reported frequency of urine loss between the polycystic ovary syndrome and control groups with normal body mass index or between the polycystic ovary syndrome and control groups with body mass index >25.

Comparison between measurements obtained with three different perineometers

OBJECTIVE: To analyze the results obtained in the evaluation of intra-vaginal pressure using three different brands of perineometers in nulliparous volunteers. MATERIALS AND METHODS: Twenty nulliparous women with no anatomical alterations and/or dysfunction of the pelvic floor were enrolled in our study. All the women had the ability to voluntarily contract their PFM (Pelvic Floor Muscles), as assessed by digital palpation. The intra-vaginal pressure was assessed using three different brands of perineometer (Neurodyn EvolutionTM, SensuPowerTM and PeritronTM). Each volunteer was evaluated on three alternate days by a single examiner using a single brand of perineometer on each day. In the assessment, the volunteers were required to pull (contract) their PFM in and up as strongly as possible 3 times and to sustain the contraction for 5 seconds, with an interval of 30 seconds between each pull. For the statistical analysis, a concordance correlation coefficient was used to compare the values that were obtained with each brand of perineometer. RESULTS: A moderate concordance (0.51) was found between the results from the PeritronTM and NeurodynTM perineometers, a fair concordance (0.21) between the PeritronTM and SensuPowerTM brands and a poor concordance (0.19) between the NeurodynTM and SensuPowerTM brands. CONCLUSION: The concordance of the measurements of the intra-vaginal pressure ranged from poor to moderate, suggesting that perineometers of different brands generate different results.