A practical guide to estimating treatment effects in patients with rheumatic diseases using real-world data.

OBJECTIVE: Randomized controlled trials are considered the gold standard in study methodology. However, due to their study design and inclusion criteria, these studies may not capture the heterogeneity of real-world patient populations. In contrast, the lack of randomization and the presence of both measured and unmeasured confounding factors could bias the estimated treatment effect when using observational data. While causal inference methods allow for the estimation of treatment effects, their mathematical complexity may hinder their application in clinical research. METHODS: We present a practical, nontechnical guide using a common statistical package (Stata) and a motivational simulated dataset that mirrors real-world observational data from patients with rheumatic diseases. We demonstrate regression analysis, regression adjustment, inverse-probability weighting, propensity score (PS) matching and two robust estimation methods. RESULTS: Although the methods applied to control for confounding factors produced similar results, the commonly used one-to-one PS matching method could yield biased results if not thoroughly assessed. CONCLUSION: The guide we propose aims to facilitate the use of readily available methods in a common statistical package. It may contribute to robust and transparent epidemiological and statistical methods, thereby enhancing effectiveness research using observational data in rheumatology.

Protocol for a systematic review and meta-analysis on Janus kinase inhibitors in the management of vitiligo.

BACKGROUND: Vitiligo is a disease that affects people of all skin shades and can impact their quality of life. Reliable evidence on the effectiveness and adverse events associated with the recent use of Janus kinase (JAK) inhibitors to treat vitiligo is needed. This protocol for a systematic review and meta-analysis seeks to collect evidence from both randomized controlled trials (RCTs) and observational studies to determine the effectiveness and patient-centered outcomes concerning treatment with JAK inhibitors. METHODS: We will conduct a systematic review of the literature for RCTs and observational studies that used upadacitinib, ritlecitinib, brepocitinib, ifidancitinib, cerdulatinib, deglocitinib, baricitinib, tofacitinib, and ruxolitinib JAK inhibitors as treatments for vitiligo compared to placebo, no treatment, or combination therapies. We will systematically search from inception in Epistemonikos, MEDLINE, Scopus, Cochrane Central Register of Controlled Trials, EMBASE, ClinicalTrials.gov, PsycINFO, Allied and Complementary Medicine Database, Latin American and Caribbean Health Sciences Literature, Web of Science Core Collection, relevant preprint servers, and the gray literature. Ethics approval was not sought as the protocol and systematic review will not involve human participants, but rather summarized and anonymous data from studies. Primary outcomes include quality of life, percentage repigmentation, decreased vitiligo within 1 year or more, lasting repigmentation after a 2-year follow-up, cosmetic acceptability of repigmentation and tolerability or burden of treatment, and adverse events. Secondary outcomes are patient and study characteristics. We will include full-text articles, preprints, and clinical trial data in any language and all geographic regions. For data sources unavailable in English, we will obtain translations from global collaborators via the Cochrane Engage network. We will exclude articles for which sufficient information cannot be obtained from the authors of articles and systematic reviews. At least two investigators will independently assess articles for inclusion and extract data; reliability will be assessed before subsequent selection and data extraction of remaining studies. The risk of bias and certainty of evidence with Grading of Recommendations Assessment, Development, and Evaluation guidelines will be assessed independently by at least two investigators. We will estimate treatment effects by random-effects meta-analyses and assess heterogeneity using I2. Data that cannot be included in the meta-analysis will be reported narratively using themes. DISCUSSION: The proposed systematic review and meta-analysis describe the methods for summarizing and synthesizing the evidence on the effectiveness and patient-centered outcomes concerning the treatment of vitiligo with JAK inhibitors that were recently approved for this indication. To disseminate further the results of our systematic review, we plan to present them at international conferences and meetings. Our findings will provide robust evidence to facilitate decision-making at the policy or practitioner level. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42023383920.

Alcohol - a scoping review for Nordic Nutrition Recommendations 2023.

The objective of this scoping review is to evaluate the updated evidence on the consumption of alcohol and health outcomes regarded as relevant for the Nordic and Baltic countries, including cardiovascular disease, cancer, and all-cause mortality. It is based on the previous Nordic Nutrition Recommendations of 2012 and relevant papers published until 31 May 2021. Current evidence from mainly observational epidemiological studies suggests that regular, moderate alcohol consumption may confer protective effects against myocardial infarction (MI) and type 2 diabetes. Mendelian randomization analyses do not fully support these findings, possibly because these analyses may fail to identify low alcohol intake. For several cancers, it is not possible to set any safe limit. All-cause mortality is not increased with light to moderate alcohol intake in middle-aged and older adults who do not engage in binge drinking. Total abstinence is associated with the lowest risk of mortality in young adults. Observational studies on alcohol consumption are hampered by a number of inherent methodological issues such as ascertainment of alcohol intake, selection of appropriate exposure groups, and insufficient control of confounding variables, colliders, and mediators. It should also be emphasized that there is a socio-economic contribution to the alcohol-health axis with a stronger detrimental effect of alcohol in the lower social classes. The above issues contribute to the complexity of unravelling the causal web between alcohol, mediators, confounders, and health outcome.

Balance diagnostics in propensity score analysis following multiple imputation: A new method.

The combination of propensity score analysis and multiple imputation has been prominent in epidemiological research in recent years. However, studies on the evaluation of balance in this combination are limited. In this paper, we propose a new method for assessing balance in propensity score analysis following multiple imputation. A simulation study was conducted to evaluate the performance of balance assessment methods (Leyrat's, Leite's, and new method). Simulated scenarios varied regarding the presence of missing data in the control or treatment and control group, and the imputation model with/without outcome. Leyrat's method was more biased in all the studied scenarios. Leite's method and the combine method yielded balanced results with lower mean absolute difference, regardless of whether the outcome was included in the imputation model or not. Leyrat's method had a higher false positive ratio and Leite's and combine method had higher specificity and accuracy, especially when the outcome was not included in the imputation model. According to simulation results, most of time, Leyrat's method and Leite's method contradict with each other on appraising the balance. This discrepancy can be solved using new combine method.

Aspirin in Patients with Viral Hepatitis: Systematic Review and Meta-Analysis of Observational Studies.

BACKGROUND: Hepatocellular carcinoma (HCC) is a disease demonstrating increasing morbidity and mortality, especially in patients with chronic viral hepatitis. Studies have shown that aspirin can reduce the incidence of liver cancer; however, the degree of benefit in patients with viral hepatitis is unclear. This study focused on the association between aspirin use and HCC risk in patients with chronic viral hepatitis. METHODS: A systematic search of the PubMed, Embase, Web of Science, and Cochrane Library databases was performed from the earliest available date to December 16, 2023. The primary outcome was HCC incidence, and the secondary outcome was gastrointestinal bleeding. The results were expressed as hazard ratios (HRs) and 95% confidence intervals (CIs). Meta-analyses were performed by using random or fixed-effects models based on the heterogeneity assessed via the I2 statistic. RESULTS: A total of 13 articles (303,414 participants and 14,423 HCC patients) were included in the analysis. The incidence of HCC in aspirin users was lower than that in non-aspirin users (HR 0.75; 95% CI, 0.68-0.83; P < 0.001; I2 = 90.0%). Subgroup analysis further showed that this effect may be more obvious in HCV patients, non-cirrhotic patients, patients with statins, and long-term aspirin users, but it may have the risk of gastrointestinal bleeding (HR 1.13; 95% CI, 1.07-1.20; P = 0.906; I2 = 0.0%). CONCLUSIONS: Our meta-analysis shows that in patients with chronic viral hepatitis, aspirin use is associated with a significantly reduced risk of liver cancer, but attention should be paid to the possible risk of gastrointestinal bleeding, and this conclusion needs further validation in the future.

Gardening/yardwork in people with knee osteoarthritis is not associated with symptom or structural progression over 48 months: data from the Osteoarthritis Initiative.

OBJECTIVE: To evaluate the relationship of gardening/yardwork with symptomatic and structural progression in those with pre-existing radiographic knee osteoarthritis (OA) in the Osteoarthritis Initiative (OAI), an observational study designed to evaluate potential and known biomarkers and risk factors of knee OA. METHODS: We conducted a cohort study nested within the OAI, including participants ≥ 50 years old with radiographic OA in at least one knee at the time of OAI enrollment. A participant reported the level of gardening/yardwork activity in a self-administered survey. Logistic regression analyses were used to evaluate the association of gardening/yardwork on new frequent knee pain, Kellgren-Lawrence (KL) worsening, medial joint space narrowing (JSN) worsening, and improved frequent knee pain. RESULTS: Of 1808 knees (1203 participants), over 60% of knees had KL grade = 2, 65% had medial JSN, and slightly more than a third had frequent knee symptoms. Gardeners/yardworkers and non-gardners/yardworkers had similar "worsening" outcomes for new knee pain (29% vs. 29%), KL worsening (19% vs. 18%), and medial JSN (23% vs. 24%). The adjusted odds ratio (OR) for the "worsening" outcomes of new knee pain, KL worsening, and medial JSN worsening were 1.0 (0.7-1.3), 1.0 (0.8-1.3), and 1.1 (0.9-1.4), respectively. The gardeners/yardworkers had an adjusted OR of 1.2 (0.9-1.7) for improved knee pain compared with non-gardners/yardworkers. CONCLUSION: Gardening/yardwork is not associated with knee OA progression and should not be discouraged in those with knee OA. Key Points • Gardening/yardwork is not associated with knee OA symptomatic or structural progression. • Gardening/yardwork should not be discouraged in people with knee OA.

Towards uniform case-identification criteria in observational studies on peripheral arterial disease: A scoping review.

OBJECTIVE: The diagnosis peripheral arterial disease (PAD) is commonly applied for symptoms related to atherosclerotic obstructions in the lower extremity, though its clinical manifestations range from an abnormal Ankle Brachial Index to critical limb ischemia. Subsequently, management and prognosis of PAD vary widely with the disease stage. A critical aspect is how this variation is addressed in administrative databases-based studies that rely on diagnosis codes for case identification. The objective of this scoping review is to inventory the identification strategies used in studies on PAD that rely on administrative databases, to map the pros and cons of the ICD codes applied, and propose a first outline for a consensus framework for case identification in administrative databases. METHODS: Registry-based reports published between 2010 to 2021 were identified through a systematic PubMed search. Studies were sub-categorized on the basis of the expressed study focus: claudication, critical limb ischemia, or general peripheral arterial disease and the ICD code(s) applied for case identification mapped. RESULTS: Ninety studies were identified, of which thirty-six (40%) did not specify the grade of PAD studied. Forty-nine (54%) articles specified PAD grade studied. Five (6%) articles specified different PAD subgroups in methods and baseline demographics, but not in further analyses. Mapping of the ICD codes applied for case identification for studies that specified the PAD grade studied indicated a remarkable heterogeneity, overlap, and inconsistency. CONCLUSION: A large proportion of registry-based studies on PAD fails to define the study focus. In addition, inconsistent strategies are used for PAD case-identification in studies that report a focus. These findings challenge study validity, and interfere with inter-study comparison. This scoping review provides a first initiative for a consensus framework for standardized case selection in administrative studies on PAD. It is anticipated that more uniform coding will improve study validity, and facilitate inter-study comparisons.

Creating more comparable cohorts in observational palliative care studies: A proposed framework to improve applicability and replicability of research.

BACKGROUND: Palliative care is characterised by heterogeneous patient and caregiver populations who are provided care in different health systems and a research base including a large proportion of observational, mostly retrospective studies. The inherent diversity of palliative care populations and the often inadequate study descriptions challenge the application of new knowledge into practice and reproducibility for confirmatory studies. Being able to define systematically study populations would significantly increase their generalisability and effective translation into practice. PROPOSAL: Based on an informal consensus process by active palliative care researchers challenged by this problem and a review of the current evidence, we propose an approach to creating more comparable cohorts in observational (non-randomised) palliative care studies that relies on defining the study population in relation to a fixed, well-defined event from which analyses are built ('anchoring'). In addition to providing a detailed and complete description of the study population, anchoring is the critical step in creating more comparable cohorts in observational palliative care studies. Anchoring can be done with respect to a single or multiple data points, and can support both prospective and retrospective data collection and analysis. DISCUSSION: Anchoring the cohort to reproducible data points will help create more comparable cohorts in palliative care whilst mitigating its inherent heterogeneity. This, in turn, will help optimise the generalisability, applicability and reproducibility of observational palliative care studies to strengthen the evidence base and improve practice.

Predicting the Length of Mechanical Ventilation in Acute Respiratory Disease Syndrome Using Machine Learning: The PIONEER Study.

Background: The ability to predict a long duration of mechanical ventilation (MV) by clinicians is very limited. We assessed the value of machine learning (ML) for early prediction of the duration of MV > 14 days in patients with moderate-to-severe acute respiratory distress syndrome (ARDS). Methods: This is a development, testing, and external validation study using data from 1173 patients on MV ≥ 3 days with moderate-to-severe ARDS. We first developed and tested prediction models in 920 ARDS patients using relevant features captured at the time of moderate/severe ARDS diagnosis, at 24 h and 72 h after diagnosis with logistic regression, and Multilayer Perceptron, Support Vector Machine, and Random Forest ML techniques. For external validation, we used an independent cohort of 253 patients on MV ≥ 3 days with moderate/severe ARDS. Results: A total of 441 patients (48%) from the derivation cohort (n = 920) and 100 patients (40%) from the validation cohort (n = 253) were mechanically ventilated for >14 days [median 14 days (IQR 8-25) vs. 13 days (IQR 7-21), respectively]. The best early prediction model was obtained with data collected at 72 h after moderate/severe ARDS diagnosis. Multilayer Perceptron risk modeling identified major prognostic factors for the duration of MV > 14 days, including PaO2/FiO2, PaCO2, pH, and positive end-expiratory pressure. Predictions of the duration of MV > 14 days showed modest discrimination [AUC 0.71 (95%CI 0.65-0.76)]. Conclusions: Prolonged MV duration in moderate/severe ARDS patients remains difficult to predict early even with ML techniques such as Multilayer Perceptron and using data at 72 h of diagnosis. More research is needed to identify markers for predicting the length of MV. This study was registered on 14 August 2023 at ClinicalTrials.gov (NCT NCT05993377).

Potassium Iodide Use and Patient Outcomes for Thyroid Storm: An Observational Study.

PURPOSE: Iodine, combined with antithyroid drugs, is recommended as an initial pharmacologic treatment for thyroid storm according to some clinical guidelines. However, the clinical efficacy of iodine in managing thyroid storm remains unexplored. This study aimed to determine whether early potassium iodide (KI) use is associated with mortality in patients hospitalized for thyroid storm. METHODS: Using the Japanese Diagnosis Procedure Combination database, we identified patients hospitalized with thyroid storm between July 2010 and March 2022. We compared in-hospital mortality, length of stay, and total hospitalization costs between patients who received KI within two days of admission (KI group) versus those who did not (non-KI group). Prespecified subgroup analyses were performed based on the presence of the diagnosis of Graves' disease. RESULTS: Among 3,188 eligible patients, 2,350 received KI within two days of admission. The crude in-hospital mortality was 6.1% (143/2,350) in the KI group and 7.8% (65/838) in the non-KI group. After adjusting for potential confounders, KI use was not significantly associated with in-hospital mortality (odds ratio [OR] for KI use, 0.91; 95% confidence interval [CI], 0.62-1.34). In patients with the diagnosis of Graves' disease, in-hospital mortality was lower in the KI group than in the non-KI group (OR, 0.46; 95% CI, 0.25-0.88). No significant difference in in-hospital mortality was observed in patients without the diagnosis of Graves' disease (OR, 1.11; 95% CI, 0.67-1.85). Length of stay was shorter (subdistribution hazard ratio, 1.15; 95% CI, 1.05-1.27), and total hospitalization costs were lower (OR, 0.92; 95% CI, 0.85-1.00) in the KI group compared with the non-KI group. CONCLUSION: Our findings suggest that KI may reduce in-hospital mortality among patients hospitalized for thyroid storm with Graves' disease.

Factors Associated With Longitudinal Patterns of Hearing Aid Use.

Background and Objectives: The objectives of this study are to identify patterns of hearing aid usage among U.S. National Health & Aging Trends Study (NHATS) participants and to examine users' characteristics associated with each pattern. Research Design and Methods: Using data from 666 adults ages 65 and above from NHATS, we analyzed individuals' self-reported hearing aid use from eight waves of data, 2011-2018, using group-based trajectory modeling to identify clusters of individuals with similar utilization patterns of use over time. Potential risk factors associated with membership to a specific group included baseline sociodemographic characteristics, problems with activities of daily living, presence of a caregiver, and experiencing problems with their hearing aid. We compute and analyze the odds ratios between individuals' baseline characteristics and group membership. Results: We identified three utilization group patterns: continued use (n = 510, 76.6%), interrupted use (n = 121, 18.2%), and ceased use (n = 35, 5.2%). Individuals with an income under the poverty line had 2.9 (95% CI: 1.09, 7.75) and 2.7 times (95% CI: 1.38, 5.27) the odds of being in the interrupted and ceased use group, respectively, compared with the continued use group. Other risk factors for interrupted and ceased use included lower education and having a caregiver. Discussion and Implications: Nearly a quarter of hearing aid users experience interrupted or ceased use of hearing aids. Socioeconomic factors, such as age, income, and education, may be relevant for how individuals use assistive medical devices over time and could inform policymakers to support maintained use of hearing aids.

High-dimensional generalized median adaptive lasso with application to omics data.

Recently, there has been a growing interest in variable selection for causal inference within the context of high-dimensional data. However, when the outcome exhibits a skewed distribution, ensuring the accuracy of variable selection and causal effect estimation might be challenging. Here, we introduce the generalized median adaptive lasso (GMAL) for covariate selection to achieve an accurate estimation of causal effect even when the outcome follows skewed distributions. A distinctive feature of our proposed method is that we utilize a linear median regression model for constructing penalty weights, thereby maintaining the accuracy of variable selection and causal effect estimation even when the outcome presents extremely skewed distributions. Simulation results showed that our proposed method performs comparably to existing methods in variable selection when the outcome follows a symmetric distribution. Besides, the proposed method exhibited obvious superiority over the existing methods when the outcome follows a skewed distribution. Meanwhile, our proposed method consistently outperformed the existing methods in causal estimation, as indicated by smaller root-mean-square error. We also utilized the GMAL method on a deoxyribonucleic acid methylation dataset from the Alzheimer's disease (AD) neuroimaging initiative database to investigate the association between cerebrospinal fluid tau protein levels and the severity of AD.

'Spin' in urology non-randomised studies comparing therapeutic interventions: a temporal analysis.

OBJECTIVE: To determine the prevalence of 'spin' (i.e., reporting practices that distort the interpretation of results by positively reflecting negative findings or downplaying potential harms) strategies and level of spin in urological observational studies and whether the use of spin has changed over time. MATERIALS AND METHODS: MEDLINE and Embase were searched to identify observational studies comparing therapeutic interventions in the top five urology journals and major urological subspecialty journals, published between 2000 and 2001, 2010 and 2011, and 2020 and 2021. RESULTS: A total of 235 studies were included. Spin was identified in 81% of studies, with a median of two strategies per study. The most commonly used strategies were inadequate implication for clinical practice (30%), causal language or causal claim (29%), and use of linguistic spin (29%). Moderate to high levels of spin were found in 55% of conclusions. From 2000 to 2020, the average number of strategies used has significantly decreased each decade (H = 27.459, P < 0.001), and the median level of spin in conclusions was significantly lower in studies published in the 2020s and 2010s than in the 2000s (H = 11.649, P = 0.003). CONCLUSIONS: Our results suggest that 81% of urological observational studies comparing therapeutic interventions contained spin. Over the past two decades, the use of spin has significantly declined, but this remains an area for improvement, with 70% of included studies published in the 2020s employing spin. Medical writing should scrupulously avoid words or phrases that are not supported by data in the manuscript.

Gut microbiota composition in pediatric populations with obesity: a systematic review / Composición de la microbiota intestinal en población pediátrica con obesidad: una revisión sistemática

The increasing prevalence of obesity among children and adolescent’s wide is a public health problem, resulting from the interaction of genetic, environmental and lifestyle factors. Obesity can lead to dysbiosis of the gut microbiota. This systematic review aims to gather scientific information available on the composition of gut microbiota in children/ adolescents with overweight/obesity. Research studies were identified through a scientific database (PubMed). The key words used were “Obese” OR “Overweight” AND “adolescent” OR “children” AND “microbiota”. Observational and intervention studies in children/adolescents having either overweight or obesity were included in this review, belonging to the last ten years – from December 2012 to October 2022. The initial search resulted in 409 references, 379 of them were excluded because the participants had major pathologies other than obesity or overweight. From the remaining articles, others were excluded due to not providing information on the number of participants, or not including data on microbiota composition. A total of 16 articles were selected: 12 observational studies and 4 intervention studies. Among the observational studies that compared overweight/obesity vs. normal weight or metabolically unhealthy obese vs. metabolically healthy obese children/adolescents, at least two studies found higher levels of Firmicutes, Proteobacteria, Bacteroidales, Adlercreutzia, Bifidobacterium, Escherichia coli, and Clostridium. Moreover, lower abundances of Bacteroidetes, Verrucomicrobia, Bacteroides, and Akkermansia were observed. Regarding intervention studies consisting of supplementation of oligofructose- enriched inulin and a weight reduction program, higher proportions of Actinobacteria were observed after the intervention. Clostridia was also found in higher abundances after interventions that used a combined strength and endurance training program and a weight reduction program. The findings suggest that obesity decreased microbiota diversity and increases species associated with inflammation. The results are consistent with previous studies in adults. This information will be useful for designing dietary interventions to prevent or reverse dysbiosis in individuals with obesity.(AU)

La creciente prevalencia de obesidad en niños y adolescentes es un problema de salud pública, resultado de la interacción de factores genéticos, ambientales y de estilo de vida. La obesidad puede provocar una disbiosis de la microbiota intestinal. Esta revisión sistemática tiene como objetivo recopilar información científica disponible sobre la composición de la microbiota intestinal en niños/adolescentes con sobrepeso/obesidad. Los estudios de investigación se identificaron a través de una base de datos científica (PubMed). Las palabras clave utilizadas fueron “obeso” O “Sobrepeso” Y “adolescente” O “niños” Y “microbiota”. En esta revisión se incluyeron estudios observacionales y de intervención en niños/adolescentes con sobrepeso u obesidad, pertenecientes a los últimos diez años, de diciembre de 2012 a octubre de 2022. La búsqueda inicial resultó en 409 referencias, de las cuales 379 fueron excluidas porque los participantes tenían patologías mayores además de la obesidad o el sobrepeso. De los artículos restantes, se excluyeron otros por no proporcionar información sobre el número de participantes o por no incluir datos sobre la composición de la microbiota. Se seleccionaron un total de 16 artículos: 12 estudios observacionales y 4 estudios de intervención. Entre los estudios observacionales que compararon el sobrepeso/obesidad frente al peso normal o los niños y adolescentes obesos metabólicamente no saludables frente a los obesos metabólicamente sanos, al menos dos estudios encontraron niveles más altos de Firmicutes, Proteobacterias, Bacteroidales, Adlercreutzia, Bifidobacterium, Escherichia coli y Clostridium. Además, se observaron menores abundancias de Bacteroidetes, Verrucomicrobia, Bacteroides y Akkermansia. En cuanto a los estudios de intervención consistentes en suplementación con inulina enriquecida con oligofructosa y un programa de reducción de peso, se observaron mayores proporciones de Actinobacteria después de la intervención. Los clostridios también se encontraron en mayor abundancia después de las intervenciones que utilizaron un programa combinado de entrenamiento de fuerza y resistencia y un programa de reducción de peso. Los hallazgos sugieren que la obesidad disminuye la diversidad de la microbiota y aumenta las especies asociadas con la inflamación. Los resultados son consistentes con estudios previos en adultos. Esta información será útil para diseñar intervenciones dietéticas que prevengan o reviertan la disbiosis en individuos con obesidad.(AU)

Effectiveness and safety of the combination of sodium-glucose transport protein 2 inhibitors and glucagon-like peptide-1 receptor agonists in patients with type 2 diabetes mellitus: a systematic review and meta-analysis of observational studies.

BACKGROUND: Randomized controlled trials and real-world studies suggest that combination therapy with sodium-glucose transport protein 2 inhibitors (SGLT2is) and glucagon-like peptide-1 receptor agonists (GLP-1RAs) is associated with improvement in fasting plasma glucose (FPG), glycated hemoglobin (HbA1c), systolic blood pressure (SBP), body mass index (BMI), and total cholesterol levels. However, a systematic review of available real-world evidence may facilitate clinical decision-making in the real-world scenario. This meta-analysis assessed the safety and effectiveness of combinations of SGLT2is + GLP-1RAs with a focus on their cardioprotective effects along with glucose-lowering ability in patients with type 2 diabetes mellitus (T2DM) in a real-world setting. METHODS: Electronic searches were performed in the PubMed/MEDLINE, PROQuest, Scopus, CINAHL, and Google Scholar databases. Qualitative analyses and meta-analyses were performed using the Joanna Briggs Institute SUMARI software package and Review Manager v5.4, respectively. RESULTS: The initial database search yielded 1445 articles; of these, 13 were included in this study. The analyses indicated that SGLT2is + GLP-1RAs combinations were associated with significantly lower all-cause mortality when compared with individual therapies (odds ratio [95% confidence interval [CI] 0.49 [0.41, 0.60]; p < 0.00001). Significant reductions in BMI (- 1.71 [- 2.74, - 0.67]; p = 0.001), SBP (- 6.35 [- 10.17, - 2.53]; p = 0.001), HbA1c levels (- 1.48 [- 1.75, - 1.21]; p < 0.00001), and FPG (- 2.27 [- 2.78, - 1.76]; p < 0.00001) were associated with the simultaneous administration of the combination. Changes in total cholesterol levels and differences between simultaneous and sequential combination therapies for this outcome were not significant. CONCLUSION: This systematic review and meta-analysis based on real-world data suggests that the combination of SGLT2is + GLP-1RAs is associated with lower all-cause mortality and favorable improvements in cardiovascular, renal, and glycemic measurements. The findings drive a call-to-action to incorporate this combination early and simultaneously in managing T2DM patients and achieve potential cardiovascular benefits and renal protection.

Prevalence of disabling musculoskeletal pain in children and adolescents in Brazil: A cross-sectional study.

BACKGROUND: Estimates of prevalence of musculoskeletal pain in children and adolescents vary considerably and the impact of pain on children's life is often not considered. OBJECTIVE: To determine the one-month prevalence of disabling musculoskeletal pain in children and adolescents. The secondary aims are to: 1) determine the body region with the highest prevalence; 2) understand the characteristics of the children with disabling musculoskeletal pain; and 3) describe the parents' perception of the prevalence. METHODS: This cross-sectional study was conducted in public and private schools in the states of São Paulo and Ceará, Brazil. Children self-reported presence and impact of pain, pain intensity, psychosomatic symptoms, and quality of life. Parents completed parent-proxy versions and perception of the child's sleep quality. Descriptive statistics were used to summarise the data. RESULTS: A total of 2,688 children and adolescents were included in this study. The prevalence of disabling musculoskeletal pain in the previous month was 27.1%. The back was the region most often affected (51.8%). Children with disabling musculoskeletal pain were older, heavier, had worse relationships with their family, perceived their backpacks as heavy, carried their backpacks more with one shoulder, had more negative psychosomatic symptoms, had poorer quality of life, and had higher pain intensity. Parents tended to underestimate the presence of pain in their children. CONCLUSION: The one-month prevalence of activity limiting musculoskeletal pain in children and adolescents was 27.1% with the back being the most often affected body region. Parents tended to underestimate the presence of pain in their children.

Designing and analyzing studies of coronavirus disease 2019 and post-acute sequelae of severe acute respiratory syndrome coronavirus 2 among immunocompromised individuals.

Observational studies of coronavirus disease 2019 (COVID-19) among transplant candidates and recipients remain important as immunocompromised patients formed a very small proportion of patients included in COVID-19 trials and large database analyses. We discuss methods that have been used in such analyses to evaluate the impact of vaccination on the risk of symptomatic COVID-19 in such patients and on the probability of developing post-acute sequelae of severe acute respiratory syndrome coronavirus 2 after the onset of infection. We also propose future directions for research and discuss the methods that will be useful to conduct such investigations. The study design and analytical issues that we consider have the potential to be helpful not only for COVID-19 research but also for other infections as well.

Motivations for investigating health inequities in observational epidemiology: a content analysis of 320 studies.

OBJECTIVES: To enhance equity in clinical and epidemiological research, it is crucial to understand researcher motivations for conducting equity-relevant studies. Therefore, we evaluated author motivations in a randomly selected sample of equity-relevant observational studies published during the COVID-19 pandemic. STUDY DESIGN AND SETTING: We searched MEDLINE for studies from 2020 to 2022, resulting in 16,828 references. We randomly selected 320 studies purposefully sampled across income setting (high vs low-middle-income), COVID-19 topic (vs non-COVID-19), and focus on populations experiencing inequities. Of those, 206 explicitly mentioned motivations which we analyzed thematically. We used discourse analysis to investigate the reasons behind emerging motivations. RESULTS: We identified the following motivations: (1) examining health disparities, (2) tackling social determinants to improve access, and (3) addressing knowledge gaps in health equity. Discourse analysis showed motivations stem from commitments to social justice and recognizing the importance of highlighting it in research. Other discourses included aspiring to improve health-care efficiency, wanting to understand cause-effect relationships, and seeking to contribute to an equitable evidence base. CONCLUSION: Understanding researchers' motivations for assessing health equity can aid in developing guidance that tailors to their needs. We will consider these motivations in developing and sharing equity guidance to better meet researchers' needs.

STROBE, CONSORT, PRISMA, MOOSE, STARD, SPIRIT, and other guidelines - Overview and application.

The purpose of research is to seek answers and new knowledge. When conducted properly and systematically, research adds to humanity's corpus of knowledge and hence to our general advancement. However, this is only possible if reported research is accurate and transparent. Guidelines for all the major types of studies (STROBE, CONSORT, PRISMA, MOOSE, STARD, and SPIRIT) have been developed and refined over the years, and their inception, development, and application are briefly discussed in this paper. Indeed, there are currently over 250 of these guidelines for various types of medical research, and these are published by the EQUATOR network. This paper will also briefly review progress in acceptance and adoption of these guidelines.