Commentary: core descriptor sets using consensus methods support 'table one' consistency.

BACKGROUND: Inconsistent reporting of patient characteristics in clinical research hampers reproducibility and limits analysis opportunities. This paper proposes condition-specific 'Core Descriptor Sets' comprising key factors like demographics, disease severity, comorbidities, and prognosis to standardize Table 1 reporting. METHODS: Development entails stakeholder involvement, systematic identification of descriptors, value rating, and consensus-building using multiple Delphi rounds. Final agreement comes at an expert meeting. CONCLUSION: Benefits include easier cross-study comparison, for example, through individual patient meta-analysis, facilitated by comparison of consistently reported individual data rather than group-level analysis. This may also support routine data analyses, subgroup and risk identification, and reduced research waste. Core Descriptor Sets describe cohorts thoroughly while minimizing research burden. They are intended to enable improved clinical characterization, personalization, reproducibility, data sharing, and knowledge building.

Leadership at work and risk of treatment for depressive and anxiety disorders in Denmark. A nationwide prospective study with register-based follow up.

Positive leadership behaviours at work are associated with worker well-being and performance. However there is less knowledge about whether exposure to low levels of positive leadership behaviours increase workers' risk of clinical mental disorders. We investigated whether low levels of positive leadership behaviours are prospectively associated with risk of treatment for depressive and anxiety disorders. In a cohort study, we linked survey data from 59,743 respondents from the Work Environment and Health in Denmark survey with national health register data. Leadership behaviours were measured with an eight-item scale. Treatment was defined as redeemed prescription for antidepressants or anxiolytics or hospital treatment for depression or anxiety. Using Cox proportional hazard regression, adjusting for demographic variables, job type and sector, adverse life events and childhood adversities, we estimated the association between leadership behaviours at baseline and risk of treatment during follow-up. We identified 999 cases of depression and anxiety treatment during follow-up. Compared to high levels of leadership behaviours, exposure to medium low and low levels were associated with an increased risk of treatment after adjustment for covariates. The results suggest that low levels of positive leadership behaviours are associated with an increased risk of treatment for depressive or anxiety disorders.

Reporting guidelines and a touch of critical appraisal.

The biomedical research process must follow certain quality criteria in its design and development to ensure that the results are credible and reliable. Once completed, the time comes to write an article for publication. The article must present in sufficient detail, and in a clear and transparent manner, all the information on the research work that has been carried out. In this way, readers, after a critical reading of the published content, will be able to judge the validity and relevance of the study and, if they so wish, make use of the findings. In order to improve the description of the research process for publication, a series of guidelines have been developed which, in a simple and structured way, guide authors in the preparation of a manuscript. They are presented in the form of a list, flowchart, or structured text, and are an invaluable aid when writing an article. This article presents the reporting guidelines for the most common designs along with the corresponding checklists.

Guías para la elaboración de manuscritos y unas pinceladas de lectura crítica / Reporting guidelines and a touch of critical appraisal

El proceso de investigación biomédica debe seguir unos criterios de calidad en su diseño y elaboración que garanticen que los resultados son creíbles y fiables. Una vez finalizado, llega el momento de escribir un artículo para su publicación. Este debe presentar con suficiente detalle, y de forma clara y transparente, toda la información del trabajo de investigación realizado. De esta forma, los lectores, tras una lectura crítica de lo publicado, podrán juzgar la validez y la relevancia del estudio, y si lo consideran, utilizar los hallazgos. Con el objetivo de mejorar la descripción del proceso de investigación para su publicación, se han desarrollado una serie de guías que, de forma sencilla y estructurada, orientan a los autores a la hora de elaborar un manuscrito. Se presentan en forma de lista, diagrama de flujo, o texto estructurado, y son una ayuda inestimable a la hora de escribir un artículo. Este artículo presenta las guías de elaboración de manuscritos de los diseños más habituales, con sus listas de verificación.(AU)

The biomedical research process must follow certain quality criteria in its design and development to ensure that the results are credible and reliable. Once completed, the time comes to write an article for publication. The article must present in sufficient detail, and in a clear and transparent manner, all the information on the research work that has been carried out. In this way, readers, after a critical reading of the published content, will be able to judge the validity and relevance of the study and, if they so wish, make use of the findings. In order to improve the description of the research process for publication, a series of guidelines have been developed which, in a simple and structured way, guide authors in the preparation of a manuscript. They are presented in the form of a list, flowchart, or structured text, and are an invaluable aid when writing an article. This article presents the reporting guidelines for the most common designs along with the corresponding checklists.(AU)

Safety signal identification for COVID-19 bivalent booster vaccination using tree-based scan statistics in the Vaccine Safety Datalink.

BACKGROUND: Traditional active vaccine safety monitoring involves pre-specifying health outcomes and biologically plausible outcome-specific time windows of concern, limiting the adverse events that can be evaluated. In this study, we used tree-based scan statistics to look broadly for >60,000 possible adverse events after bivalent COVID-19 vaccination. METHODS: Vaccine Safety Datalink enrollees aged ≥5 years receiving Moderna or Pfizer-BioNTech bivalent COVID-19 vaccine through November 2022 were followed for 56 days post-vaccination. Incident diagnoses in inpatient or emergency department settings were analyzed for clustering within the hierarchical ICD-10-CM diagnosis code "tree" and temporally within post-vaccination follow-up. The conditional self-controlled tree-temporal scan statistic was used, conditioning on total number of cases of each diagnosis and total number of cases of any diagnosis occurring during the scanning risk window across the entire tree. P = 0.01 was the pre-specified cut-off for statistical significance. RESULTS: Analysis included 352,509 doses of Moderna and 979,189 doses of Pfizer-BioNTech bivalent vaccines. After Moderna vaccination, no statistically significant clusters were found. After Pfizer-BioNTech, there were clusters of unspecified adverse events (Days 1-3, p = 0.0001-0.0007), influenza (Days 35-56, p = 0.0001), cough (Days 44-55, p = 0.0002), and COVID-19 (Days 52-56, p = 0.0004). CONCLUSIONS: For Pfizer-BioNTech only, we detected clusters of: (1) unspecified adverse effects, as have been observed in other vaccine studies using this method, and (2) respiratory disease toward the end of follow-up. The respiratory clusters were likely due to overlap of follow-up with the spread of respiratory syncytial virus, influenza, and COVID-19, i.e., confounding by seasonality. The untargeted nature of the method and its inherent adjustment for the many diagnoses and risk intervals evaluated are unique advantages. Limitations include susceptibility to time-varying confounding, lower statistical power for assessing risks of specific outcomes than in traditional studies targeting fewer outcomes, and the possibility of missing adverse events not strongly clustered in time or within the "tree."

Future Research by the Australian Chiropractic Profession: Analysis of Comments and Suggestions From a Nationwide Survey of Academics and Practitioners.

OBJECTIVE: The purpose of this study was to identify and compare the research priorities of Australian practicing chiropractors and academics across listed research domains and to seek their views on existing chiropractic research strategies. Concurrent objectives were to gain insight into the perspectives on characteristics of research and solicit ideas and suggestions for future research from both groups. METHODS: This study used a mixed-method research design to collect data using an online survey portal. Australian chiropractic academics (n = 220) and practicing chiropractors who were also members of a nationally representative, practice-based research network database (n = 1680) were invited to participate. Data were collected (February 19, 2019, to May 24, 2019). The free-text data were analyzed primarily via semantic coding and verbatim referential units in cases where the category was an exact match for the textual data. Content analyses of the qualitative data were presented in a tabulated and narrative manner as identified domains. Selected representative examples were provided verbatim. RESULTS: The response rate for the survey was 44% for full-time equivalent academics, 8% for casuals and part-time chiropractic academics, and 21.5% for Australian Chiropractic Research Network database chiropractic practitioners. Open-text data comprised a narrower focus on musculoskeletal (MSK) conditions and opposition or reservations by academics and some practitioners toward the research agenda of those espousing traditional concepts and terminology. Comments from both groups illustrate the strongly held views that characterize divergent factions of the chiropractic profession. Some practitioners were highly critical of the narrow focus and epistemological paradigm of Australian university-based research, while others were strongly supportive of the traditional focus of the Australian Spinal Research Foundation. Australian academics at the 4 university-based programs held the view that MSK and spinal pain, for which some evidence already exists, should be the priority of future research, building on what is known. Practitioners believed that future research should be directed toward expanded areas such as basic science, younger populations, and non-MSK conditions. Respondents were sharply divided on attitudes toward traditional chiropractic terminology, concepts, and philosophy and the utility of future research on these topics. CONCLUSION: Our qualitative findings suggest there is a division in the Australian chiropractic profession regarding research direction and priorities. This divide exists between academics and researchers and within field practitioners. This study highlights the attitudes, opinions, and perceptions of important stakeholder groups, which should be considered by decision-makers when formulating research policy, strategy, and prioritization of funding.

Case-control studies: Increasing scientific rigor in control selection.

The case-control design is an observational study design in which the investigative team identifies individuals with disease (ie, cases) and individuals without disease (ie, controls) and then compares the prevalence of an exposure between the 2 groups. Forethought is needed while designing case-control studies. This is particularly true when selecting controls. This tutorial briefly reviews the case-control design, discusses scenarios of poor case-control study design with an emphasis on control selection, and provides tips for proper control selection. Optimizing control selection to maximize causal inference will increase the scientific rigor of hematologic case-control studies.

Caracterización epidemiológica, clínica y cefalométrica del brote anormal de los terceros molares / Epidemiological, clinical and cephalometric characterization of the abnormal eruption of third molars

Introducción: El brote de los terceros molares es un proceso que no está del todo explicado, pero durante su erupción puede provocar diferentes accidentes o complicaciones. Objetivo: Caracterizar el brote anormal de los terceros molares según variables epidemiológicas, clínicas y cefalométricas. Método: Se realizó un estudio observacional, descriptivo y transversal en la Clínica Estomatológica Provincial Docente «Mártires del Moncada», de Santiago de Cuba, desde noviembre de 2019 a febrero de 2020. La población estuvo conformada por jóvenes de 18 a 25 años de edad; la muestra fue seleccionada por muestreo aleatorio simple. Se tuvieron en cuenta las siguientes variables: sexo, color de la piel, brote anormal y otras variables cefalométricas. Resultados: De los 84 dientes incluidos en el estudio, se detectaron 66 terceros molares con brote anormal (78,6 %). El promedio asociado al brote de estos molares de espacio óseo superior insuficiente fue igual para los superiores con medias de 25,9 mm; el de angulación inadecuada resultó obtuso en el superior izquierdo con 128,3º y agudo en los inferiores derechos con 58,8º; asimismo el mayor diámetro mesiodistal inadecuado fue el de los inferiores derechos con 15,7 mm. Conclusiones: El brote anormal de los terceros molares se caracteriza por afectar, de forma importante, a féminas y a individuos mestizos. Su observación se singulariza, fundamentalmente, en molares inferiores con espacios óseos posteriores reducidos, mesioangulaciones y diámetros mesiodistales considerables.

Introduction: eruption of the third molars is a process that is not fully explained in the literature; however it is known that their eruption can cause different complications. Objective: to characterize the abnormal eruption of third molars according to epidemiological, clinical and cephalometric variables. Methods: an observational, descriptive and cross-sectional study was carried out at "Mártires del Moncada" Provincial Teaching Dental Clinic, in Santiago de Cuba, from November 2019 to February 2020. The population consisted of young people aged 18-25 years; the sample was selected by simple random sampling. Gender, skin color, abnormal eruption and other cephalometric variables were taken into account. Results: sixty-six third molars with abnormal eruption were detected from the 84 teeth included in the study (78.6%). The average associated with the eruption of these molars with insufficient upper bone space was the same for the upper ones with means of 25.9 mm; the average with inadequate angulation was obtuse in the upper left third molar with 128.3º and the acute one in the lower right third molars with 58.8º; the lower right third molars likewise had the largest inadequate mesiodistal diameter with 15.7 mm. Conclusions: the abnormal eruption of third molars is characterized by significantly affecting females and mixed-race individuals. Its observation is singled out, fundamentally, in lower molars with reduced posterior bone spaces, mesioangulations and considerable mesiodistal diameters.

Tree-based data mining for safety assessment of first COVID-19 booster doses in the Vaccine Safety Datalink.

BACKGROUND: The Centers for Disease Control and Prevention's Vaccine Safety Datalink (VSD) has been performing safety surveillance for COVID-19 vaccines since their earliest authorization in the United States. Complementing its real-time surveillance for pre-specified health outcomes using pre-specified risk intervals, the VSD conducts tree-based data-mining to look for clustering of a broad range of health outcomes after COVID-19 vaccination. This study's objective was to use this untargeted, hypothesis-generating approach to assess the safety of first booster doses of Pfizer-BioNTech (BNT162b2), Moderna (mRNA-1273), and Janssen (Ad26.COV2.S) COVID-19 vaccines. METHODS: VSD enrollees receiving a first booster of COVID-19 vaccine through April 2, 2022 were followed for 56 days. Incident diagnoses in inpatient or emergency department settings were analyzed for clustering within both the hierarchical ICD-10-CM code structure and the follow-up period. The self-controlled tree-temporal scan statistic was used, conditioning on the total number of cases for each diagnosis. P-values were estimated by Monte Carlo simulation; p = 0.01 was pre-specified as the cut-off for statistical significance of clusters. RESULTS: More than 2.4 and 1.8 million subjects received Pfizer-BioNTech and Moderna boosters after an mRNA primary series, respectively. Clusters of urticaria/allergy/rash were found during Days 10-15 after the Moderna booster (p = 0.0001). Other outcomes that clustered after mRNA boosters, mostly with p = 0.0001, included unspecified adverse effects, common vaccine-associated reactions like fever and myalgia, and COVID-19. COVID-19 clusters were in Days 1-10 after booster receipt, before boosters would have become effective. There were no noteworthy clusters after boosters following primary Janssen vaccination. CONCLUSIONS: In this untargeted data-mining study of COVID-19 booster vaccination, a cluster of delayed-onset urticaria/allergy/rash was detected after the Moderna booster, as has been reported after Moderna vaccination previously. Other clusters after mRNA boosters were of unspecified or common adverse effects and COVID-19, the latter evidently reflecting immunity to COVID-19 after 10 days.

Sequential Data-Mining for Adverse Events After Recombinant Herpes Zoster Vaccination Using the Tree-Based Scan Statistic.

Tree-based scan statistics have been successfully used to study the safety of several vaccines without prespecifying health outcomes of concern. In this study, the binomial tree-based scan statistic was applied sequentially to detect adverse events in days 1-28 compared with days 29-56 after recombinant herpes zoster (RZV) vaccination, with 5 looks at the data and formal adjustment for the repeated analyses over time. IBM MarketScan data on commercially insured persons ≥50 years of age receiving RZV during January 1, 2018, to May 5, 2020, were used. With 999,876 doses of RZV included, statistically significant signals were detected only for unspecified adverse effects/complications following immunization, with attributable risks as low as 2 excess cases per 100,000 vaccinations. Ninety percent of cases in the signals occurred in the week after vaccination and, based on previous studies, likely represent nonserious events like fever, fatigue, and headache. Strengths of our study include its untargeted nature, self-controlled design, and formal adjustment for repeated testing. Although the method requires prespecification of the risk window of interest and may miss some true signals detectable using the tree-temporal variant of the method, it allows for early detection of potential safety problems through early initiation of ongoing monitoring.

Seasonality of SARS-CoV-2 Infections in G20 Countries: Ecological Analysis of Publicly Available Data.

Previous laboratory studies of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) revealed that the stability of the virus in the air or on surfaces is sensitive to seasonally relevant environmental conditions. However, the seasonality of the virus in the real world remains unclear because each country adopted various infection control policies. Therefore, we investigated peak dates with regard to new confirmed cases of coronavirus disease 2019 (COVID-19) and an association of these dates with the timing of the lockdown among G20 countries that have four seasons from 1 June 2020 to 18 February 2021. As a result, countries in both hemispheres experienced seasonal peaks in the number of COVID-19 cases both in the middle of warm and cold seasons. In addition, there were no apparent relationships between the peak date and periods with stringent measures. Our study demonstrated that SARS-CoV-2 causes seasonal outbreaks in the winter and possibly summer and thus, countries might need to consider measures to prepare for resurgence of the virus in the middle of 2021.

Effect of Dietary-Based Lifestyle Modification Approaches on Anthropometric Indices and Dietary Intake Parameters in Women with Breast Cancer: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

This systematic review and meta-analysis aimed to investigate the effect of dietary-based lifestyle modification interventions ("diet," or "diet + exercise," or "diet + exercise + behavioral" intervention) on the measures of anthropometric and dietary intake parameters in women with breas cancer (BC). Databases were searched until June 2021. Inclusion criteria were randomized controlled trials that enrolled only women with BC. Studies that used exercise or behavioral interventions alone were not included. Mean ± SD changes were extracted for each outcome, and pooled using a random-effects model; 7315 studies were identified. Fifty-one studies (n = 7743) were included. The median ± SD duration of treatment was 24 ± 16.65 wk. Dietary-based interventions significantly reduced body weight [45 studies (n = 7239), weighted mean difference (WMD) (95% CI): -2.6 (-3.2, -2.1) kg], BMI [31 studies (n = 5384); WMD (95% CI): -1.0 (-1.3, -0.7) kg/m2], lean body mass [15 studies (n = 1194); WMD (95% CI): -0.6(-0.7, -0.4) kg], fat mass [11 studies (n = 913); WMD (95% CI): -2.6 (-3.3, -1.8) kg], fat percentage [17 studies (n = 897); WMD (95% CI): -1.5 (-1.9, -1.3)%], hip circumference [9 studies (n = 489); WMD (95% CI): -2.43 (-3.34, -1.54) cm], and waist circumference [7 studies (n = 309); WMD (95% CI): 0.02 (-0.03, -0.005) cm]. Significant reductions in energy intakes [20 studies (n = 4608), WMD (95% CI): -162 (-220, 104) kcal/d] and fat intakes [7 studies (n = 4316), WMD (95% CI): -7.5 (-7.8, -7.2)% of energy/d], and an increase in fiber intakes [11 studies (n = 4241), WMD (95% CI): 2.4 (0.7, 4.1) g/d] were observed. No significant changes were seen in protein, carbohydrate, and fruit and vegetable intakes. Subgroup analyses showed that changes in anthropometric and dietary intake indices were significant in studies that enrolled patients with both obesity and normal weight, studies that used diet therapy in combination with exercise and behavioral therapy, and studies that started the intervention during the treatment period. Overall, a multimodal dietary-based lifestyle intervention had significant effects on anthropometric and dietary intake parameters in women with BC, specifically when started as early as the diagnosis. This meta-analysis was registered at PROSPERO as CRD42021291488.

Causal Modeling to Mitigate Selection Bias and Unmeasured Confounding in Internet-Based Epidemiology of COVID-19: Model Development and Validation.

BACKGROUND: Selection bias and unmeasured confounding are fundamental problems in epidemiology that threaten study internal and external validity. These phenomena are particularly dangerous in internet-based public health surveillance, where traditional mitigation and adjustment methods are inapplicable, unavailable, or out of date. Recent theoretical advances in causal modeling can mitigate these threats, but these innovations have not been widely deployed in the epidemiological community. OBJECTIVE: The purpose of our paper is to demonstrate the practical utility of causal modeling to both detect unmeasured confounding and selection bias and guide model selection to minimize bias. We implemented this approach in an applied epidemiological study of the COVID-19 cumulative infection rate in the New York City (NYC) spring 2020 epidemic. METHODS: We collected primary data from Qualtrics surveys of Amazon Mechanical Turk (MTurk) crowd workers residing in New Jersey and New York State across 2 sampling periods: April 11-14 and May 8-11, 2020. The surveys queried the subjects on household health status and demographic characteristics. We constructed a set of possible causal models of household infection and survey selection mechanisms and ranked them by compatibility with the collected survey data. The most compatible causal model was then used to estimate the cumulative infection rate in each survey period. RESULTS: There were 527 and 513 responses collected for the 2 periods, respectively. Response demographics were highly skewed toward a younger age in both survey periods. Despite the extremely strong relationship between age and COVID-19 symptoms, we recovered minimally biased estimates of the cumulative infection rate using only primary data and the most compatible causal model, with a relative bias of +3.8% and -1.9% from the reported cumulative infection rate for the first and second survey periods, respectively. CONCLUSIONS: We successfully recovered accurate estimates of the cumulative infection rate from an internet-based crowdsourced sample despite considerable selection bias and unmeasured confounding in the primary data. This implementation demonstrates how simple applications of structural causal modeling can be effectively used to determine falsifiable model conditions, detect selection bias and confounding factors, and minimize estimate bias through model selection in a novel epidemiological context. As the disease and social dynamics of COVID-19 continue to evolve, public health surveillance protocols must continue to adapt; the emergence of Omicron variants and shift to at-home testing as recent challenges. Rigorous and transparent methods to develop, deploy, and diagnosis adapted surveillance protocols will be critical to their success.

A Broad Safety Assessment of the Recombinant Herpes Zoster Vaccine.

The recombinant herpes zoster vaccine (RZV), approved as a 2-dose series in the United States in October 2017, has proven highly effective and generally safe. However, a small risk of Guillain-Barré syndrome after vaccination was identified after approval, and questions remain about other possible adverse events. This data-mining study assessed RZV safety in the United States using the self-controlled tree-temporal scan statistic, scanning data on thousands of diagnoses recorded during follow-up to detect any statistically unusual temporal clustering of cases within a large hierarchy of diagnoses. IBM MarketScan data on commercially insured persons at least 50 years of age receiving RZV between January 1, 2018, and May 5, 2020, were used, including 56 days of follow-up; 1,014,329 doses were included. Statistically significant clustering was found within a few days of vaccination for unspecified adverse effects, complications, or reactions to immunization or other medical substances/care; fever; unspecified allergy; syncope/collapse; cellulitis; myalgia; and dizziness/giddiness. These findings are consistent with the known safety profile of this and other injected vaccines. No cluster of Guillain-Barré syndrome was detected, possibly due to insufficient sample size. This signal-detection method has now been applied to 5 vaccines, with consistently plausible results, and seems a promising addition to vaccine-safety evaluation methods.

Knowledge of evidence-based research methodology amongst orthodontic postgraduate residents in four universities: An international survey.

AIM: The aim of this international survey was to assess knowledge concerning the design, conduct, critical appraisal and synthesis of clinical studies among senior orthodontic postgraduate residents. MATERIALS AND METHODS: Senior postgraduate residents from four universities in Europe and the United States were invited to complete a custom questionnaire. The overall correct answer score and proportion of residents correctly answering each of the 10 questions within the survey were analysed with descriptive statistics, analysis-of-variance, chi-squares test and linear regression at 5%. RESULTS: A total of 46 residents with mean age of 30.4 years scored an overall % correct score of 48.8%±13.8%, with the % of correct answers to each question ranging from 7 to 89%. The worst-answered questions pertained to correctly characterizing sensitivity and specificity (7%), number needed to treat (9%), credibility of trial synthesis in meta-analysis (35%) and publication bias (37%). The vast majority of postgraduate students could correctly identify entities that can be blinded in a randomized trial (89%), statistical power of a trial (74%) and proper methods for random allocation sequence (67%). No statistically significant differences were found among the four included universities, while residents having obtained another degree apart from dentistry scored better than others (+9.5%; 95% confidence interval: 0.6% to 18.5%; P=0.04). CONCLUSIONS: Postgraduate residents in orthodontics possessed moderate knowledge on evidence-based methodology. Efforts should be reinforced to assimilate research methodology perspectives in the postgraduate curricula of universities, in order to further augment critical training of orthodontic specialists.

Dental caries and depression in pregnant women: The role of oral health self-perception as mediator.

OBJECTIVE: This study investigated the role of oral health self-perception as mediator of association between dental caries and depression among pregnant women from the 2015 Pelotas Birth Cohort Study, Brazil. MATERIALS AND METHODS: Overall, 2,496 pregnant women participated of this oral health sub-study. Data related to demographic and socioeconomic conditions, lifetime and current depression, and oral health self-perception were collected. Participants were also assessed for dental caries (DMF-T index). Depression was assessed using the Edinburgh Postnatal Depression Scale. For analysis, six outcomes related to dental caries experience were considered. Causal mediation analysis was performed using parametric regression models. RESULTS: When it was assumed that all subjects had poor perception about oral health, it was observed that the presence of moderate/severe depressive signals and symptoms was higher in subjects with dental caries experience (OR 1.13; CI 95% 1.06-1.20), with severity of untreated dental caries (OR 2.08; CI 95% 1.16-3.78), untreated dental caries (OR 1.18; 95% CI 1.07-1.29), tooth loss (OR 1.08; 95% CI 1.02-1.14), and filled tooth (OR 1.07; 95% CI 1.02-1.16). CONCLUSIONS: Our findings show the effect of dental caries on depression is mediated by self-perception about oral health in pregnant women.

Comparison of sampling designs from the two editions of the Brazilian National Health Survey, 2013 and 2019 / Comparação de desenhos amostrais das duas edições da Pesquisa Nacional de Saúde, 2013 e 2019 / Comparación entre diseños muestrales de las dos ediciones de la Encuesta Nacional de Salud Brasil, 2013 y 2019

Our objective is to describe the differences in the sampling plans of the two editions of the Brazilian National Health Survey (PNS 2013 and 2019) and to evaluate how the changes affected the coefficient of variation (CV) and the design effect (Deff) of some estimated indicators. Variables from different parts of the questionnaire were analyzed to cover proportions with different magnitudes. The prevalence of obesity was included in the analysis since anthropometry measurement in the 2019 survey was performed in a subsample. The value of the point estimate, CV, and the Deff were calculated for each indicator, considering the stratification of the primary sampling units, the weighting of the sampling units, and the clustering effect. The CV and the Deff were lower in the 2019 estimates for most indicators. Concerning the questionnaire indicators of all household members, the Deffs were high and reached values greater than 18 for having a health insurance plan. Regarding the indicators of the individual questionnaire, for the prevalence of obesity, the Deff ranged from 2.7 to 4.2, in 2013, and from 2.7 to 10.2, in 2019. The prevalence of hypertension and diabetes per Federative Unit had a higher CV and lower Deff. Expanding the sample size to meet the diverse health objectives and the high Deff are significant challenges for developing probabilistic household-based national survey. New probabilistic sampling strategies should be considered to reduce costs and clustering effects.

Nosso objetivo é descrever as diferenças nos desenhos amostrais das duas edições da Pesquisa Nacional de Saúde (PNS 2013 e 2019) e avaliar como suas mudanças afetaram o coeficiente de variação (CV) e o efeito do desenho (Deff) de alguns dos indicadores avaliados. Variáveis de diferentes partes do questionário foram analisadas para avaliar proporções com diferentes magnitudes. A prevalência de obesidade foi incluída na análise uma vez que a medição de antropometria na pesquisa de 2019 foi realizada em uma subamostra. Os valores do estimador pontual, CV e Deff foram calculados para cada indicador considerando a estratificação das unidades amostrais primárias, a ponderação das unidades amostrais, e o efeito do agrupamento. Para a maioria dos indicadores, CV e Deff foram menores nas estimativas de 2019. Em relação aos indicadores para todos os membros familiares, Deffs foram elevados e atingiram valores superiores a 18 para a posse de um plano de saúde. Quanto aos indicadores no questionário individual, Deff variou de 2,7 a 4,2 em 2013 e de 2,7 a 10,2 em 2019 para a prevalência de obesidade. A prevalência de hipertensão arterial e diabetes por Unidade Federativa apresentou CV maior e Deff menor. A expansão do tamanho da amostra para atender aos diversos objetivos de saúde e Deff altos são desafios expressivos para o desenvolvimento de uma pesquisa nacional domiciliar probabilística. Novas estratégias de amostragem probabilística devem ser consideradas para reduzir custos e efeitos do agrupamento.

Nuestro objetivo es describir las diferencias en los diseños muestrales de las dos ediciones de la Encuesta Nacional de Salud (PNS 2013 y 2019) y evaluar cómo sus cambios afectaron el coeficiente de variación (CV) y el efecto de diseño (Deff) de algunos de los indicadores evaluados. Se analizaron variables de diferentes partes del cuestionario para evaluar proporciones con diferentes magnitudes. La prevalencia de obesidad se incluyó en el análisis, ya que la medición de la antropometría en la encuesta de 2019 se realizó en una submuestra. Los valores del estimador puntual, CV y Deff se calcularon para cada indicador considerando la estratificación de las unidades de muestreo primarias, la ponderación de las unidades de muestreo y el efecto de agrupamiento. Para la mayoría de los indicadores, CV y Deff fueron más bajos en las estimaciones de 2019. En cuanto a los indicadores para todos los miembros de la familia, los Deff fueron altos y alcanzaron valores superiores a 18 por tener un plan de salud. En cuanto a los indicadores del cuestionario individual, Deff osciló entre 2,7 y 4,2 en 2013, y entre 2,7 y 10,2 en 2019 para la prevalencia de obesidad. La prevalencia de hipertensión arterial y diabetes por Unidad Federativa tuvo mayor CV y menor Deff. Un mayor tamaño de la muestra para cumplir con los diversos objetivos de salud y un alto valor de Deff son desafíos importantes para el desarrollo de una encuesta nacional domiciliar probabilística. Se deben considerar nuevas estrategias de muestreo probabilístico para reducir los costos y efectos de agrupamiento.