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INTRODUCTION: Conservative treatments such as physical therapies are usually the most indicated for the management of musculoskeletal pain; therefore, a detailed description of interventions enables the reproducibility of interventions in clinical practice and future research. The objective of this study is to evaluate the description of physical interventions for musculoskeletal pain in children and adolescents. METHODS: We considered randomized controlled trials that included children and adolescents between 4 and 19 years old with acute or chronic/persistent musculoskeletal pain. We included physical therapies related to all types of physical modalities aimed at reducing the intensity of pain or disability in children and adolescents with musculoskeletal pain. The description of interventions was assessed using the Template for Intervention Description and Replication (TIDieR) checklist. We performed electronic searches in the following databases: CENTRAL, MEDLINE, EMBASE, CINAHL, PsyINFO and PEDro up to April 2024. The description of physical interventions was presented using frequencies, percentages and 95% confidence intervals (CIs) of the TIDieR checklist items described in each study. We also calculated the total TIDieR score for each study and presented these data as mean and standard deviation. RESULTS: We included 17 randomized controlled trials. The description measured through the TIDieR checklist scored an average of 11 (5.2) points out of 24. The item of the TIDieR that was most described was item 1 (brief name) and most absent was item 10 (modifications). CONCLUSION: The descriptions of physical interventions for the treatment of musculoskeletal pain in children and adolescents are partially described, indicating the need for strategies to improve the quality of description to enable true clinical reproducibility.

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INTRODUCTION: Although a well-established component of bone metabolism, the efficacy and safety of vitamin D supplementation for the prevention of fractures in elderly healthy individuals is still unclear. PURPOSE: To perform a meta-analysis comparing vitamin D supplementation with placebo and its contributions on fracture incidence. METHODS: This meta-analysis was registered in the International Prospective Register of Systematic Reviews (PROSPERO), under protocol CRD42023484979. We systematically searched PubMed, Embase, and Cochrane Central databases from inception to November 2023 for randomized controlled trials (RCTs) comparing vitamin D supplementation versus placebo in individuals with 60 years of age or more and without bone related medical conditions such as cancer and osteoporosis. RESULTS: Seven RCTs with 71,899 patients were included, of whom 36,822 (51.2%) were women. There was no significant difference in total fracture incidence (RR 1.03; 95% CI 0.93-1.14; p = 0.56; I2 = 58%) between groups or subgroups. However, women had an increased risk for hip fractures (164 vs. 121 events; RR 1.34; 95% CI 1.06-1.70; p = 0.01; I2 = 0%). There was no significant difference in non-vertebral fractures, osteoporotic fractures development, or falls (RR 1.02; 95% CI 0.94-1.12; p = 0.6; I2 = 47%; RR 0.97; 95% CI 0.87-1.08; p = 0.63; I2 = 0%; RR 1.01; 95% CI 0.97-1.04; p = 0.66; I2 = 55%, respectively). CONCLUSION: Vitamin D supplementation does not reduce the total fracture development rate in the elderly healthy population, and it may increase the incidence of hip fractures among elderly healthy women. This finding suggests refraining from prescribing high intermittent doses of vitamin D, without calcium, to individuals aged 60 or older with unknown vitamin D serum concentration or osteoporosis status and inadequate calcium intake.

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INTRODUCTION: Postural balance impairment can affect the quality of life of patients with Parkinson's disease. Previous studies have described connections of the vestibular system with postural functions, suggesting a potential participation of the basal ganglia in receiving vestibular stimuli. This systematic review aims to summarize the evidence on the effectiveness of vestibular rehabilitation on postural balance in patients with Parkinson's disease. METHODS: A systematic review was conducted using the electronic databases: PubMed, Embase, Scopus and PEDro. The study selection was independently conducted by two reviewers, and disagreements were evaluated by a third reviewer. The included studies had no restrictions on publication dates or languages and the last update occurred in July 2023. RESULTS: From the 485 studies found in the searches, only 3 studies were deemed eligible for the systematic review involving a total of 130 participants. The Berg Balance Scale was described as the tool for evaluation of postural balance in all studies. The meta-analysis showed statistically significant results in favor of vestibular rehabilitation (MD = 5.35; 95% CI = 2.39, 8.31; P < 0.001), regardless of the stage of Parkinson's disease. Although the effect size was suggested as a useful functional gain, the analysis was done with caution, as it only included 3 randomized controlled trials. The risk of bias using the RoB-2 was considered as being of "some concern" in all studies. Furthermore, the quality of the evidence based on the Grading of Recommendations Assessment Development and Evaluation system, produced by pooling the included studies was considered very low. CONCLUSION: Compared to other interventions, vestibular rehabilitation has potential to assist the postural balance of patients with Parkinson's disease. However, the very low quality of the evidence demonstrates uncertainty about the impact of this clinical practice. More robust studies are needed to confirm the benefits of this therapy in patients with Parkinson's disease. This study was prospectively registered in PROSPERO: CRD42020210185.

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Alzheimer's disease (AD) represents the most common type of dementia. A crucial mechanism attributed to its development is amyloid beta (Aß) dynamics dysregulation. The extent to which exercise can modulate this phenomenon is uncertain. The aim of this study was to summarize the existing literature evaluating this issue. A comprehensive systematic search was performed in Pubmed, Scopus, Embase, Web of Science, and SciELO databases and completed in August 2023, aiming to identify randomized controlled trials investigating the effect of exercise upon Aß-related pathology. The keywords "exercise" and "amyloid beta", as well as all their equivalents and similar terms, were used. For the analysis, the negative or positive dementia status of the subjects was initially considered and then the soluble amyloid precursor protein (sAPP) components and Aß fragments separately. A meta-analysis was performed and involved eight studies (moderate-to-high quality) and 644 assessments, which were 297 for control and 347 for exercise. No overall effect favoring exercise interventions was observed for both negative (SMD95%=0,286 [-0,131; 0,704]; p = 0,179) or positive AD dementia status (SMD95%=0,110 [-0,155; 0,375]; p = 0,416). The absence of an overall effect favoring exercise interventions was also found for Aß peptides (SMD95%=0,226 [-0,028; 0,480]; p = 0,081) and for sAPP components (SMD95%=-0,038 50 [-0,472; 0,396]; p = 0,863) levels. Our findings suggest that exercise interventions do not improve Aß-related pathology in both healthy individuals and individuals with dementia (SMD95%=0,157 [-0,059; 0,373]; p = 0,155), indicating that the beneficial effects of exercise for AD reported in previous studies are related to other mechanistic effects rather than direct amyloid effects (PROSPERO registration number: CRD42023426912).

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BACKGROUND AND OBJECTIVES: The preferred osmotic agent used for brain relaxation during craniotomies remains unclear, either mannitol (MAN) or hypertonic saline (HTS). Hence, we sought to compare these solutions in this population. METHODS: MEDLINE, Embase, and Cochrane databases were systematically searched until August 02, 2023. Data were examined using the Mantel-Haenszel method and 95% CIs. Heterogeneity was assessed using I2 statistics. Meta-regression analysis was conducted to evaluate a possible link between Brain Relaxation Score and tumor volume. R, version 4.2.3, was used for statistical analysis. RESULTS: A total of 16 randomized controlled trials and 1031 patients were included, of whom 631 (61%) underwent surgery for supratentorial tumor resection. Compared with MAN, HTS achieved better rates of brain relaxation (80% vs 71%; odds ratio [OR] 1.68; 95% CI 1.22-2.33; P = .001; I2 = 0%), which was also demonstrated in the subgroup analysis of patients with supratentorial brain tumor (78% vs 65%; OR 2.02; 95% CI 1.36-2.99; P = .0005; I2 = 0%); a minor number of patients requiring a second dose of osmotic agent (14% vs 28%; OR 0.43; 95% CI 0.27-0.69; P = .0003; I2 = 0%); a lower fluid intake (mean difference -475.9341 mL; 95% CI -818.8952 to -132.9730; P = .007; I2 = 88%); and lower urine output (mean difference -462.0941 mL; 95% CI -585.3020 to -338.8862; P = <.001; I2 = 96%). Hospital length of stay and focal neurological deficits did not reach a statistically significant difference between groups. CONCLUSION: In this updated meta-analysis, consistent results suggest that HTS is associated with more beneficial outcomes than MAN in patients undergoing craniotomy.

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OBJECTIVE: To analyze the effects of using foam roller on pain intensity in individuals with chronic and acute musculoskeletal pain. METHODS: This systematic review was registered in the National Institute for Health Research's prospective online registry of systematic reviews (PROSPERO) under CRD42023456841. The databases Pubmed, Medline (via Ovid), Embase, BVS, and PEDro (Physiotherapy Evidence Database) were consulted to carry out this systematic review. Notably, the records of clinical trials characterized as eligible were manually searched. The search terms were: (foam rolling OR foam rolling vibration) AND (acute musculoskeletal pain) AND (chronic musculoskeletal pain). The search was performed until August 22, 2023. For the analysis of the methodological quality, the PEDro scale was used for each of the manuscripts included in the systematic review. Due to the heterogeneity in the studies included in this systematic review, performing a meta-analysis of the analyzed variables was impossible. RESULTS: Only six manuscripts were eligible for data analysis. The type of FR used was non-vibrational, being applied by a therapist in only one of the manuscripts. With an application time ranging from at least 45 s to 15 min, the non-vibrational FR was applied within a day up to six weeks. Using the PEDro scale, scores were assigned that varied between 4 and 8 points, with an average of 6 ± 1.29 points. Only two randomized clinical trials found a significant benefit in pain intensity of adding FR associated with a therapeutic exercise protocol in individuals with patellofemoral pain syndrome and chronic neck pain. CONCLUSION: The results of this systematic review do not elucidate or reinforce the clinical use of FR in pain intensity in individuals with chronic and acute musculoskeletal pain.

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Videolaryngoscopes are thought to improve glottic view and facilitate tracheal intubation compared with the Macintosh direct laryngoscope. However, we currently do not know which one would be the best choice in most patients undergoing anaesthesia. We designed this systematic review with network meta-analyses to rank the different videolaryngoscopes and the Macintosh direct laryngoscope. We conducted searches in PubMed and a further five databases on 11 January 2021. We included randomised clinical trials with patients aged ≥16 years, comparing different videolaryngoscopes, or videolaryngoscopes with the Macintosh direct laryngoscope for the outcomes: failed intubation; failed first intubation attempt; failed intubation within two attempts; difficult intubation; percentage of glottic opening seen; difficult laryngoscopy; and time needed for intubation. We assessed the quality of evidence according to GRADE recommendations and included 179 studies in the meta-analyses. The C-MAC and C-MAC D-Blade were top ranked for avoiding failed intubation, but we did not find statistically significant differences between any two distinct videolaryngoscopes for this outcome. Further, the C-MAC D-Blade performed significantly better than the C-MAC Macintosh blade for difficult laryngoscopy. We found statistically significant differences between the laryngoscopes for time to intubation, but these differences were not considered clinically relevant. The evidence was judged as of low or very low quality overall. In conclusion, different videolaryngoscopes have differential intubation performance and some may be currently preferred among the available devices. Furthermore, videolaryngoscopes and the Macintosh direct laryngoscope may be considered clinically equivalent for the time taken for tracheal intubation. However, despite the rankings from our analyses, the current available evidence is not sufficient to ensure significant superiority of one device or a small set of them over the others for our intubation-related outcomes.

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OBJECTIVE: One-third of patients with severe rheumatoid arthritis (RA) do not achieve remission or low disease activity, or they have side effects from cDMARD and bDMARD. They will need a new treatment option such as the small molecule JAK inhibitors. In this systematic review, we evaluate the efficacy and safety data of the current jakinibs: tofacitinib, peficitinib, decernotinib, upadacitinib, baricitinib and filgotinib in patients in whom treatment with conventional or biological disease-modifying antirheumatic drugs (cDMARD and/or bDMARD) failed. METHODS: We searched for randomized controlled trials comparing efficacy and safety of jakinibs for RA treatment using the Web of Science, Scopus, PubMed, and clinicaltrials.gov databases with the terms: "rheumatoid arthritis" OR "arthritis rheumatoid" OR "RA" AND "inhibitor" OR "jak inhibitor" AND "clinical trial" OR "treatment" OR "therapy". RESULTS: All jakinibs achieved good results in ACR 20, 50, 70 and with CRP-DAS28 for LDA and remission, upadacitinib showed better results compared to the others. In ESR-DAS28 for remission, tofacitinib achieved the best result. Regarding the safety of all jakinibs, peficitinib, baricitinib and filgotinib did not register deaths in their studies unlike tofacitinib that presented 11 deaths. Despite all benefits of jakinibs, the use in patients with severe liver and kidney disease should be avoided. CONCLUSIONS: Jakinibs in monotherapy or in combination with methotrexate can be considered a viable alternative in the treatment of moderate-to-severe RA. Even after failures with combination of cDMARDS and bDMARDS, jakinibs demonstrated efficacy.

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OBJECTIVES: To evaluate the efficacy of early treatment with prednisone to decrease the progression of COVID-19 pneumonia. TRIAL DESIGN: This is a pragmatic, non-blinded, randomized, two arms, parallel trial. PARTICIPANTS: Patients between 18 and 90 years, with COVID-19 pneumonia, confirmed by RT PCR. The setting for the trial is the Hospital Santiago Oriente which is a secondary level hospital with an emergency room, intensive care, and all basic specialties of medicine. INCLUSION CRITERIA: 18 years or more COVID-19 confirmed by RT-PCR Oxygen requirements up to 35% by venturi mask or 5 liters per minute by nasal cannula (approximately FiO2 40%) Consent form signed Exclusion Criteria: Previous steroid use for more than 48 hours. Pregnancy Chronic respiratory failure Requirements of mechanical ventilation (invasive or no invasive) Chronic liver damage Child Pugh B or C Chronic kidney disease stage IV or V. Immunosuppressed Participation in another trial. INTERVENTION AND COMPARATOR: Experimental arm Prednisone 40 mg days 1 to 4. Then Prednisone 20 mg days 5 to 8. Usual care defined by the attending physician. Control arm No intervention. Usual care defined by the attending physician. MAIN OUTCOMES: Primary outcome Composite Primary End-point: Admission to ICU, Need for Invasive Mechanical Ventilation or All-cause Death by Day 28 Secondary outcomes (followed until day 28). Time to respiratory deterioration Incidence of patients requiring mechanical ventilation: Number of days on mechanical ventilation Special emphasis will be placed on observing the following serious adverse events Deterioration of the glycemic profile that requires the use of insulin Delirium Incidence of hospital infections (pneumonia, urinary tract infection, device associated infections) Cumulative incidence of grade 3 and 4 adverse events (AE). Interruption or temporary suspension of treatment for any reason RANDOMISATION: Randomisation in permuted block. Computer generated random numbers in an allocation rate of 1:1. Stata 14.0 was used. Allocated by the principal investigator (direct communication). BLINDING (MASKING): Patients not blinded. Caregivers not blinded. Participants not blinded. Statistician will not know the allocation. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): 92 patients in each arm. 184 total number of patients. TRIAL STATUS: Protocol version 2.0., approved October 2, 2020. Trial ongoing. Recruitment start: June 23, 2020. Anticipate finish recruiting: November 30, 2020. The protocol has been submitted before the last patient and last visit. The delay in sending to publication is responsibility of the authors. TRIAL REGISTRATION: Early Use of Corticosteroids in Non-critical Patients With COVID-19 Pneumonia (PREDCOVID). Registration number NCT04451174 . Date of trial registration: June 26, 2020. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

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Tranexamic acid (TXA) is one of the measures indicated to reduce bleeding and the need for volume replacement. However, data on risks and benefits are controversial. This study analyzes the effectivity and risks of using tranexamic acid in neurosurgery. We selected articles, published from 1976 to 2019, on the PubMed, EMBASE, Science Direct, and The Cochrane Database using the descriptors: "tranexamic acid," "neurosurgery," "traumatic brain injury," "subdural hemorrhage," "brain aneurysm," and "subarachnoid hemorrhage." TXA can reduce blood loss and the need for blood transfusion in trauma and spinal surgery. Despite the benefits of TXA, moderate-to-high doses are potentially associated with neurological complications (seizures, transient ischemic attack, delirium) in adults and children. In a ruptured intracranial aneurysm, the use of TXA can considerably reduce the risk of rebleeding, but there is weak evidence regarding its influence on mortality reduction. The TXA use in brain surgery does not present benefit. However, this conclusion is limited because there are few studies. TXA in neurosurgeries is a promising method for the maintenance of hemostasis in affected patients, mainly in traumatic brain injury and spinal surgery; nevertheless, there is lack of evidence in brain and vascular surgeries. Many questions remain unanswered, such as how to determine the dosage that triggers the onset of associated complications, or how to adjust the dose for chronic kidney disease patients.

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ABSTRACT Objective: To evaluate resin- and bioceramic root canal sealers affect postoperative intensity and pain occurrence. Material and Methods: From the electronic databases, PubMed, Cochrane Library, Embase, ISI have been used to perform systematic literature until September 2020. Electronic titles were managed using the Endnote X8 software. They performed searches with mesh terms. Two reviewers blindly and independently extracted data from studies that included data for data extraction. Results: A total of 186 potentially relevant titles and abstracts were found. Finally, four studies were included. Pain score was (RR = -0.20; 95% CI -1.09-0.68; p= 0.65). This result showed no statistically significant difference for the resin-based and bioceramic root canal sealers after 24 hours between the VAS scores. Conclusion: Postoperative pain was low in Patients requiring root canal retreatment and obturated with resin-based or bioceramic-based sealers without extrusion beyond the apex. No differences were observed between postoperative pain in resin-based and bioceramic root canal sealers 24 and 48 hours postoperatively.

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AIM: Evidence-based medicine uses high-quality methods, such as randomization and blinding prcedures, to support and inform clinical practice. The investigation of trials registered in clinical research databases may help understand the main characteristics of studies conducted in countries, such as Brazil. This study aimed to investigate the characteristics of Brazilian clinical trials registered in ClinicalTrials.gov in the last decade. METHODS: Cross-sectional study performed in ClinicalTrials.gov database with clinical studies registered in Brazil between 2010 and 2020. A search was conducted in the database considering this period using filters for country (Brazil), start date (01 January 2010) and end date (date of the search: 07 May 2020). Descriptive statistics were used to characterize the studies. All analyses were conducted on Stata 14.2. RESULTS: In total, 5368 studies were retrieved, which were mostly randomized (93.2%), blinded (63.2%), Phase III (48.7%) interventional studies (89.9%) with small sample sizes (57.2%) conducted with adults (93.0%) using drugs (42.7%) with a treatment purpose (77.3%), with funding from institutions other than the industry, the NIH, and the US Federal (71.3%). CONCLUSIONS: The majority of Brazilian clinical studies used blinding and randomization procedures in the last 10 years. However, the predominance of trials with small sample sizes and with a focus on adult patients indicate the need of larger studies conducted with the pediatric population.

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Depression is a mental disorder that affects millions of people around the world. However, depressive symptoms can be seen in other psychiatric and medical conditions. Here, we investigate the effect of DHEA treatment on depressive symptoms in individuals with depression and/or other clinical conditions in which depressive symptoms are present. An electronic search was performed until October 2019, with no restrictions on language or year of publication in the following databases: Medline, EMBASE, LILACS, and Cochrane Library. Randomized controlled trials comparing DHEA versus placebo were included if the depressive symptoms were assessed. Fifteen studies with 853 female and male individuals were included in this review. To conduct the meta-analysis, data were extracted from 14 studies. In comparison with placebo, DHEA improved depressive symptoms (standardized mean difference [SMD] -0.28, 95% (CI) -0.45 to -0.11, p =.001, 12 studies, 742 individuals (375 in the experimental group and 367 in the placebo group), I2  = 24%), very low quality of evidence, 2 of 14 studies reporting this outcome were removed in a sensitivity analysis as they were strongly influencing heterogeneity between studies. No hormonal changes that indicated any risk to the participants' health were seen. Side effects observed were uncommon, mild, and transient, but commonly related to androgyny. In conclusion, DHEA was associated with a beneficial effect on depressive symptoms compared to placebo. However, these results should be viewed with caution, since the quality of evidence for this outcome was considered very low according to the GRADE criteria.

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STUDY DESIGN: Systematic with meta-analysis OBJECTIVES.: The aim of this study was to investigate the efficacy and safety of epidural corticosteroid injections compared with placebo injection in reducing leg pain and disability in patients with sciatica. SUMMARY OF BACKGROUND DATA: Conservative treatments, including pharmacological and nonpharmacological treatments, are typically the first treatment options for sciatica but the evidence to support their use is limited. The overall quality of evidence found by previous systematic reviews varies between moderate and high, which suggests that future trials may change the conclusions. New placebo-controlled randomized trials have been published recently which highlights the importance of an updated systematic review. METHODS: The searches were performed without language restrictions in the following databases from 2012 to 25 September 2019: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, PubMed, Embase, CINAHL, PsycINFO, International Pharmaceutical Abstracts, and trial registers. We included placebo-controlled randomized trials investigating epidural corticosteroid injections in patients with sciatica. The primary outcomes were leg pain intensity and disability. The secondary outcomes were adverse events, overall pain, and back pain intensity. We grouped similar trials according to outcome measures and their respective follow-up time points. Short-term follow-up (>2 weeks but ≤3 months) was considered the primary follow-up time point due to the expected mechanism of action of epidural corticosteroid injection. Weighted mean differences (MDs) and risk ratios (RRs) with their respective 95% confidence intervals (CIs) were estimated. We assessed the overall quality of evidence using the GRADE approach and conducted the analyses using random effects. RESULTS: We included 25 clinical trials (from 29 publications) providing data for a total of 2470 participants with sciatica, an increase of six trials when compared to the previous review. Epidural corticosteroid injections were probably more effective than placebo in reducing short-term leg pain (MD -4.93, 95% CI -8.77 to -1.09 on a 0-100 scale), short-term disability (MD -4.18, 95% CI: -6.04 to -2.17 on a 0-100 scale) and may be slightly more effective in reducing short-term overall pain (MD -9.35, 95% CI -14.05 to -4.65 on a 0-100 scale). There were mostly minor adverse events (i.e., without hospitalization) after epidural corticosteroid injections and placebo injections without difference between groups (RR 1.14, 95% CI: 0.91-1.42). The quality of evidence was at best moderate mostly due to problems with trial design and inconsistency. CONCLUSION: A review of 25 placebo-controlled trials provides moderate-quality evidence that epidural corticosteroid injections are effective, although the effects are small and short-term. There is uncertainty on safety due to very low-quality evidence. LEVEL OF EVIDENCE: 1.

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Contexto y Antecedentes: LADIES TRIAL es uno de los ensayos más importantes referidos a peritonitis diverticular. A pesar de este y otros ensayos publicados, aún se debate cuáles son los procedimientos adecuados para cada escenario de peritonitis diverticular, haciendo necesaria una revisión profunda de la metodología empleada en los ensayos para validar u objetar sus conclusiones. Objetivos: Analizar la metodología empleada en el diseño, aplicación, análisis de resultados y conclusiones de sus publicaciones. Secundariamente, colaborar en el mejoramiento de la investigación de la peritonitis diverticular y facilitar el análisis del tema por parte de los lectores. Métodos: Se analizaron las partes centrales de toda investigación, desde la pregunta de investigación, elaboración de hipótesis, operacionalización de variables y diseño del ensayo, análisis estadístico de resultados y conclusiones. Se buscaron errores, sesgos y debilidades que pudiesen objetar los hallazgos del estudio. Resultados: LADIES se trató de un estudio randomizado, abierto con análisis de superioridad según intención de tratar modificada en aquellos casos de incumplimiento de los criterios de inclusión y exclusión. Su diseño fue en general correcto, aunque en su aplicación se detectaron errores, debilidades y sesgos. En cuanto a resultados LOLA mostró que en Hinchey III el lavado laparoscópico tiene mayor morbimortalidad temprana que la sigmoidectomía, con un tiempo operatorio menor. Por su parte, DIVA mostró que en Hinchey III y IV la anastomosis primaria tiene mayor sobrevida libre de ostomía con menor morbilidad, combinando la cirugía inicial y cierre ostomía, respecto de la operación de Hartmann. Conclusiones: El no haber llegado al tamaño de muestra calculado hizo que solo grandes diferencias consiguieran significancia estadística. Las bajas frecuencias de eventos adversos acentuaron este problema metodológico. La especialización de los centros y cirujanos intervinientes, como la exclusión de pacientes hemodinámicamente inestables o bajo corticoterapia comprometieron su validación externa.

Background: LADIES TRIAL is considered one of the most important trials related to diverticular peritonitis. Its protocol and results were published in 2010, 2015, 2017, and 2019. Despite this one and other published trials, the proper procedures for each diverticular peritonitis scenario are still being debated, a thorough review of the methodology used in this trial is necessary to validate or reject their conclusions. Aim: To analyze the methodology used in the design, application, analysis of results, and conclusions of all LADIES TRIAL publications. Secondly, to collaborate in the improvement of the research about diverticular peritonitis and to facilitate its analysis by the readers. Methods: The central parts of a research trial were analyzed, from the research question, hypothesis development, operationalization of variables and trial design, statistical analysis of results, to conclusions. Errors, biases and weaknesses were searched for to try and challenge the trial's findings. Results: LADIES was a randomized, open-label, superiority trial analyzed according to intention to treat modified in cases of non-compliance with the inclusion-exclusion criteria. Its design was generally correct, although errors, weaknesses, and biases were detected in its application. Regarding results, LOLA showed that, in Hinchey 3, laparoscopic lavage has a higher rate in early morbidity and mortality than sigmoidectomy, but with a shorter operative time. For its part, DIVA showed that, in Hinchey 3 and 4, the primary anastomosis has higher ostomy-free survival with less morbidity, combining the initial surgery and ostomy closure, compared to the Hartmann procedure. Conclusions: Not having reached the sample size calculated in its design implies that only large effect differences achieved statistical significance. The low frequencies of adverse events accentuated this methodological problem. The specialization of the intervening centers and surgeons, the exclusion of hemodynamically unstable patients or patients undergoing steroid therapy, compromised the external validation of their findings.

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RATIONALE: Agonist-based pharmacologic intervention is an accepted approach in treatment of opioid and tobacco use disorders. OBJECTIVES: We conducted a systematic review and meta-analysis to evaluate usefulness of an agonist approach as treatment of (psycho)stimulant use disorder (PSUD). METHODS: We reviewed PubMed/Medline, LILACS, and ClinicalTrials.gov databases searching for randomized, double-blind, placebo-controlled, parallel-design studies evaluating outcomes of individuals treated for cocaine- or amphetamine-type substance use disorder. We combined results of all trials that included the following prescription psychostimulants (PPs): modafinil, methylphenidate, or amphetamines (mixed amphetamine salts, lisdexamphetamine, and dextroamphetamine). The combined sample consisted of 2889 patients. Outcomes of interest included the following: drug abstinence (defined as 2-3 weeks of sustained abstinence and the average maximum days of consecutive abstinence), percentage of drug-negative urine tests across trial, and retention in treatment. We conducted random-effects meta-analyses and assessed quality of evidence using the GRADE system. RESULTS: Thirty-eight trials were included. Treatment with PPs increases rates of sustained abstinence [risk ratio (RR) = 1.45, 95% confidence interval (CI) = (1.10, 1.92)] and duration of abstinence [mean difference (MD) = 3.34, 95% CI = (1.06, 5.62)] in patients with PSUD, particularly those with cocaine use disorder (very low-quality evidence). Prescription amphetamines were particularly efficacious in promoting sustained abstinence in patients with cocaine use disorder [RR = 2.44, 95% CI = (1.66, 3.58)], and higher doses of PPs were particularly efficacious for treatment of cocaine use disorder [RR = 1.95, 95% CI = (1.38, 2.77)] (moderate-quality evidence). Treatment with prescription amphetamines also yielded more cocaine-negative urines [MD = 8.37%, 95% CI = (3.75, 12.98)]. There was no effect of PPs on the retention in treatment. CONCLUSION: Prescription psychostimulants, particularly prescription amphetamines given in robust doses, have a clinically significant beneficial effect to promote abstinence in the treatment of individuals with PSUD, specifically the population with cocaine use disorder.

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Shared decision making (SDM) facilitates delivery of medical therapies that are in alignment with patients' goals and values. Medicare national coverage decision for several interventions now includes SDM mandates, but few have been evaluated in nationwide studies. Based upon a detailed needs assessment with diverse stakeholders, we developed pamphlet and video patient decision aids (PtDAs) for implantable cardioverter/defibrillator (ICD) implantation, ICD replacement, and cardiac resynchronization therapy with defibrillation to help patients contemplate, forecast, and deliberate their options. These PtDAs are the foundation of the Multicenter Trial of a Shared Decision Support Intervention for Patients Offered Implantable Cardioverter-Defibrillators (DECIDE-ICD), a multicenter, randomized trial sponsored by the National Heart, Lung, and Blood Institute aimed at understanding the effectiveness and implementation of an SDM support intervention for patients considering ICDs. Finalization of a Medicare coverage decision mandating the inclusion of SDM for new ICD implantation occurred shortly after trial initiation, raising novel practical and statistical considerations for evaluating study end points. METHODS/DESIGN: A stepped-wedge randomized controlled trial was designed, guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) planning and evaluation framework using an effectiveness-implementation hybrid type II design. Six electrophysiology programs from across the United States will participate. The primary effectiveness outcome is decision quality (defined by knowledge and values-treatment concordance). Patients with heart failure who are clinically eligible for an ICD are eligible for the study. Target enrollment is 900 participants. DISCUSSION: Study findings will provide a foundation for implementing decision support interventions, including PtDAs, with patients who have chronic progressive illness and are facing decisions involving invasive, preference-sensitive therapy options.

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In experimental studies, researchers apply an intervention to a group of study participants and analyze the effects over a future or prospective timeline. The prospective nature of these types of studies allows for the determination of causal relationships, but the interventions they are based on require rigorous bioethical evaluation, approval from an ethics committee, and registration of the study protocol prior to implementation. Experimental research includes clinical and preclinical testing of a novel intervention or therapy at different phases of development. The main objective of clinical trials is to evaluate an interventions efficacy and safety. Conventional clinical trials are blinded, randomized, and controlled, meaning that participants are randomly assigned to either the study intervention group or a comparator (a control group exposed to a placebo intervention or another non-placebo or active interventionor not exposed to any intervention) to reduce selection and confounding biases, and researchers are also unaware of the type of intervention being applied. Intention-to-treat analysis (inclusion of all originally randomized subjects) should be done to avoid the effects of attrition (dropout) and crossover (variance in the exposure or treatment over time). A quasi-experimental design and external controls may also be used. Metrics used to measure the magnitude of effects include relative risk, absolute and relative risk reductions, and numbers needed to treat and harm. Confounding factors are controlled by randomization. Other types of bias to consider are selection, performance, detection, and reporting. This review is the fifth of a methodological series on general concepts in biostatistics and clinical epidemiology developed by the Chair of Scientific Research Methodology at the School of Medicine, University of Valparaíso, Chile. It describes general theoretical concepts related to randomized clinical trials and other experimental studies in humans, including fundamental elements, historical development, bioethical issues, structure, design, association measures, biases, and reporting guidelines. Factors that should be considered in the execution and evaluation of a clinical trial are also covered.

En los estudios experimentales, el investigador aplica una intervención sobre los participantes, por lo que su eje temporal es prospectivo. Estas características permiten probar relaciones causales, pero implican una rigurosa evaluación bioética y una inscripción previa del protocolo de estudio. Entre las investigaciones experimentales se encuentran los estudios preclínicos y diversos ensayos con objetivos distintos según la fase de desarrollo en que se encuentre. Entre ellos se incluyen los ensayos clínicos, cuyo objetivo principal es evaluar la eficacia y la seguridad de alguna intervención o terapia. El diseño convencional de ensayo clínico es aleatorizado controlado enmascarado, donde se asigna aleatoriamente a los participantes a una intervención y a sus comparadores (otra intervención, placebo o nada); lo que permite controlar el sesgo de selección y el de confusión. Asimismo, los participantes y los investigadores no conocen la intervención que fue asignada. El análisis de sus resultados debe considerar a todos los sujetos originalmente aleatorizados, lo que se conoce como análisis por intención de tratar. Otros tipos de estudios experimentales incluyen los estudios cuasiexperimentales y los estudios experimentales con controles externos. Las medidas de magnitud del efecto utilizadas son el riesgo relativo, las reducciones absolutas y relativas de riesgo y los números necesarios a tratar y dañar. Si bien los factores de confusión son controlados por el proceso de aleatorización, otros sesgos que hay que considerar son los de selección, desarrollo, detección, desgaste y reporte. En este artículo, se abordan los conceptos teóricos generales sobre los estudios experimentales en seres humanos, fundamentalmente sobre los ensayos clínicos aleatorizados, considerando sus elementos fundamentales, desarrollo histórico, aspectos bioéticos, construcción, variantes en el diseño, medidas de asociación, sesgos y pautas de reporte. Finalmente, se sintetizan algunas consideraciones que siempre hay que tener en mente durante la ejecución y la evaluación de un ensayo clínico. Esta revisión es la quinta entrega de una serie metodológica sobre conceptos generales en bioestadística y epidemiologia clínica desarrollada por la Cátedra de Metodología de la Investigación Científica de la Escuela de Medicina de la Universidad de Valparaíso, Chile.

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Acupuncture is one of the therapeutic resources used for the management of chronic pain. Variability in outcome measurements in randomized clinical trials of non-oncologic chronic pain (RCT-NOCP) generates inconsistencies in determining effects of treatments. The objective of this survey was to assess the adherence to the recommendations made by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) in the measurement of RCT-NOCP of acupuncture. This methodological research made a systematic search for eligible studies from different sources of information. Eligible studies included those with number of patients ≥100, who randomized and allocated patients with chronic non-oncologic pain to be treated with acupuncture or with "sham" acupuncture, or non-acupuncture. This research included the recommendations for IMMPACT in the measurement of RCT-NOCP: presence of outcomes pain, physical function, emotional state and improvement perception of patient, the source of the outcome information pain and the tools used to measure such domains. From a total of 1,386 studies, 24 were included in this survey. Eleven studies presented low risk of bias. Pain outcome was measured in 23 studies, physical function in 22 studies, emotional state in 14 studies and improvement perception of patient in one study. As for the pain outcome, the patient was the information source in 50% of the studies. The measurement tools recommended for IMMPACT were included in eight studies (35%) that evaluated pain, one study that evaluated the emotional state (7%), and one study that evaluated the improvement perception and satisfaction of patient. It was observed that studies which did not adhere to the recommendations had more favorable results for acupuncture in the outcome pain. This study concludes that randomized clinical trials that used acupuncture to manage chronic pain failed to adhere to IMMPACT recommendations. Clinical societies and IMMPACT do not share the same recommendations. This fact reflects in the diversity of outcomes and instruments adopted in the studies, making it difficult to compare the results.

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The objective of this study was to compare the efficacy and safety of endoscopic papillary balloon dilation (EPBD), endoscopic sphincterotomy (ES), and the combination of large balloon dilation and ES (ES + EPLBD) in the treatment of common bile duct stones, with a special focus on postendoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). Individualized search strategies were developed in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. We included randomized controlled trials (RCTs) which evaluated at least one of the following outcomes: PEP, complete stone removal in the first ERCP, need for mechanical lithotripsy, recurrence of common bile duct stones, bleeding, and cholangitis. Twenty-five RCTs were selected for analysis. Pancreatitis rates were higher for EPBD than for ES (P = 0.003), as were severe pancreatitis rates (P = 0.04). However, in the 10-mm or greater balloon subgroup analysis, this difference was not shown (P = 0.82). Rates of PEP were higher in the subgroup of non-Asian subjects (P = 0.02), and the results were not robust when RCTs that used endoscopic nasobiliary drainage were omitted. The incidence of pancreatitis was comparable between EPLBD and ES + EPLBD. All 3 approaches were equally efficacious. Nevertheless, the results should be interpreted with caution, because pancreatitis is a multifactorial pathology, and RCTs can have limited generalizability.

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