Methodological and reporting quality of systematic reviews on aesthetics and reconstructive breast surgery: A meta-research.

OBJECTIVE: To evaluate the methodological and reporting quality of systematic reviews (SR) of randomized controlled trials on esthetics and reconstructive breast surgery. METHODS: Meta-research study with a broad search strategy was developed to retrieve all relevant systematic reviews. We evaluated the methodological and reporting guidance adopted by these reviews and assessed their adequacy to items from AMSTAR-2 (methodological quality) and PRISMA 2020 (reporting quality). The protocol of this study was prospectively published in: https://osf.io/preprints/osf/ucpgd. RESULTS: After the selection process, 15 SR were included; eight (60%) referred the use of a methodological guide and five (33.3%) invertedly referred PRISMA as the methodological guide. Reporting guidelines were referred by none of the included systematic review. The median adequacy to PRISMA-2020 items was 42.9% (Q1 - 38.1%/Q3 - 95.2%) and to AMSTAR-2 items was 33.3% (Q1 - 23.3%/Q3 - 93.3%) which reflects overall low reporting and methodological quality of included SR. The overall confidence in the results using AMSTAR-2 framework was critically low in 73.3% of included SR. Although a small number of SR were included, a high correlation between the methodological and reporting quality was observed (Spearmean rho = 0.96, 95% bias-corrected confidence interval = 0.84 to 0.99). CONCLUSION: Methodological and reposting quality of SR of randomized clinical trials on esthetic or reconstructive breast surgery is poor. Half of the authors referred to the use of valid guidance to plan and conduct their reviews and none of them referred the use of a guidance for reporting their results.

Mapping Systematic Reviews on the Management of Dental Caries in Primary Teeth: A Meta-Research.

BACKGROUND: Systematic reviews (SRs) represent the most robust source of evidence for informing decision-making. While there are rigorous protocols for properly conducting SRs, sometimes the methodological biases in the primary studies are accounted for in the conclusions of the SRs. OBJECTIVE: This study aimed to map the evidence regarding the management of caries lesions in primary teeth. METHODS: Two reviewers conducted a systematic search up to March 2024 in electronic data-bases. Any SR concerning the management of caries lesions in primary teeth was considered eli-gible. RESULTS: About 162 SRs were included. Among these, 80 focused on restorative treatments, 64 on endodontic treatments, and 18 on non-invasive treatments. Only 42.6% presented a study registra-tion protocol. The majority (67.9%) performed a meta-analysis, while a minority exclusively car-ried out qualitative data analysis. Despite 92.6% of the SRs evaluating the methodological quality or risk of bias of the primary studies using some tool, only 24% assessed the certainty of evidence using the GRADE approach, resulting in classifications ranging from very low to moderate. CONCLUSION: There is a limited adherence to study registration protocols, indicating a need for improvements in this practice. Additionally, among the few SRs that used the GRADE approach, the majority demonstrated levels of very low to moderate certainty.

Methodological quality of evidence-based clinical practice guidelines in cariology.

OBJECTIVE: The present study aimed to appraise the methodological quality of evidence-based Clinical Practice Guidelines (CPGs) in the cariology field. MATERIALS AND METHODS: A systematic search on electronic databases (MEDLINE/Pubmed, EMBASE, DARE and Epistemonikos), websites, and guideline organizations were undertaken. Evidence-based CPGs including at least one recommendation for clinical prevention and/or management of dental caries, developed for any clinical setting, were included. The quality of each guideline was evaluated using the AGREE II tool. Descriptive analysis was performed and the average overall score for each domain was calculated. RESULTS: Thirty-two guidelines were included. Most of the CPGs achieved higher scores for the domains of clarity of presentation (66.7%, 95% IC 37.3-52.2) and scope and purpose (59.6%, 95% IC 53.7-65.5) domains; and lower scores for editorial independence (46.1%, 95% IC 37.8-55.7) and applicability domain (44.7%, 95% IC 37-55.3). The reviewers assessed 12 CPGs (37.5%) as recommended for use, 15 (46.9%) recommended with modifications, and 5 (15.6%) as not recommended. CONCLUSION: The overall methodological quality of evidence-based CPGs in the cariology field is moderate, and there is a need for improvements in reporting related to most domains. The poorest reporting was found in the description of the domains' applicability of its recommendations and editorial independence. CLINICAL RELEVANCE: Clinical Practice Guidelines provide guidance to patients, healthcare professionals, and stakeholders. The quality of these documents is essential for establishing trust in their recommendations.

A scoping review and critical evaluation of the methodological quality of clinical practice guidelines on nutrition in the preconception.

Introduction: Clinical practice guidelines (CPGs) contain recommendations for specific clinical circumstances, including maternal malnutrition. This study aimed to identify the CPGs that provide recommendations for preventing, diagnosing, and treating women's malnutrition. Additionally, we sought to assess the methodological quality using the Appraisal of Guidelines for Research and Evaluation (AGREE II) instrument. Methods: An online search for CPGs was performed, looking for those that contained lifestyle and nutritional recommendations to prevent, diagnose and treat malnutrition in women during the preconception period using PubMed and different websites. The reviewers utilized the AGREE II instrument to appraise the quality of the CPGs. We defined high-quality guidelines with a final score of > 70%. Results: The titles and abstracts from 30 guidelines were screened for inclusion, of which 20 guidelines were fully reviewed for quality assessment. The overall quality assessment of CPGs was 73%, and only 55% reached a high-quality classification. The domains in the guidelines classified as high-quality had the highest scores in "Scope and Purpose" and "Clarity of Presentation" with a median of 98.5 and 93%, respectively. Discussion: Further assessment is needed to improve the quality of the guidelines, which is an opportunity to strengthen them, especially in the domains with the lowest scores.

Methodological quality and reporting standards in systematic reviews with meta-analysis of physical activity studies: a report from the Strengthening the Evidence in Exercise Sciences Initiative (SEES Initiative).

BACKGROUND: Several resources have been developed (e.g., reporting guidelines) to promote high-standard practices in health research. However, there was no continuous and systematic assessment of recommended practices in published systematic reviews with meta-analysis (SRMAs), which increases the usability of the available resources. Therefore, we aimed to assess the methodological and reporting standards in SRMAs of physical activity studies. This report presents the main results of the SEES Initiative in 2019. METHODS: Our approach is based on a prospective systematic review methodology to implement post-publication surveillance of research practices in exercise sciences. Briefly, during the year 2019, pre-specified searches were conducted monthly (PubMed/MEDLINE) in journals from the exercise sciences (n = 9) and medicine (n = 5). The assessments were independently conducted by two authors, based on 36 items/practices derived from established statements/tools (PRISMA, AMSTAR 2, ROBIS). To be eligible, SRMAs should summarize studies that had, at least, one arm consisting of physical activity interventions/exposures and one health or behavioral outcome. RESULTS: Out of 1028 studies assessed for eligibility, 103 SRMAs were included. The minimum adherence was 13/36 items, whereas only one SRMA adhered to all items. Some highly contemplated items included identification of title as SRMA (97.1%) and descriptions of the main outcome in the abstract (95.1%) and risk of bias (RoB) assessment (95.1%). Some poorly contemplated items included publicly available protocol (4.9%), discussion of the results in light of RoB in studies included (32.0%), and data sharing statements (35.9%). CONCLUSION: In summary, there is a suboptimal adherence to recommended practices on methodological quality and reporting standards in the SRMAs of physical activity intervention/exposure evaluated from the selected journals in 2019, which likely reduce the reproducibility and usefulness of these studies. This incipient evidence from our first 12 months of post-publication surveillance should serve as a call for attention and action for multiple stakeholders (e.g., authors, reviewers, editors, funders, academic institutions) in this important health research field.

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

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

How are systematic reviews of prevalence conducted? A methodological study.

BACKGROUND: There is a notable lack of methodological and reporting guidance for systematic reviews of prevalence data. This information void has the potential to result in reviews that are inconsistent and inadequate to inform healthcare policy and decision making. The aim of this meta-epidemiological study is to describe the methodology of recently published prevalence systematic reviews. METHODS: We searched MEDLINE (via PubMed) from February 2017 to February 2018 for systematic reviews of prevalence studies. We included systematic reviews assessing the prevalence of any clinical condition using patients as the unit of measurement and we summarized data related to reporting and methodology of the reviews. RESULTS: A total of 235 systematic reviews of prevalence were analyzed. The median number of authors was 5 (interquartile range [IQR] 4-7), the median number of databases searched was 4 (3-6) and the median number of studies included in each review was 24 (IQR 15-41.5). Search strategies were presented for 68% of reviews. Forty five percent of reviews received external funding, and 24% did not provide funding information. Twenty three percent of included reviews had published or registered the systematic review protocol. Reporting guidelines were used in 72% of reviews. The quality of included studies was assessed in 80% of reviews. Nine reviews assessed the overall quality of evidence (4 using GRADE). Meta-analysis was conducted in 65% of reviews; 1% used Bayesian methods. Random effect meta-analysis was used in 94% of reviews; among them, 75% did not report the variance estimator used. Among the reviews with meta-analysis, 70% did not report how data was transformed; 59% percent conducted subgroup analysis, 38% conducted meta-regression and 2% estimated prediction interval; I2 was estimated in 95% of analysis. Publication bias was examined in 48%. The most common software used was STATA (55%). CONCLUSIONS: Our results indicate that there are significant inconsistencies regarding how these reviews are conducted. Many of these differences arose in the assessment of methodological quality and the formal synthesis of comparable data. This variability indicates the need for clearer reporting standards and consensus on methodological guidance for systematic reviews of prevalence data.

Overall confidence in the results of systematic reviews on exercise therapy for chronic low back pain: a cross-sectional analysis using the Assessing the Methodological Quality of Systematic Reviews (AMSTAR) 2 tool.

OBJECTIVE: To evaluate the overall confidence in the results of systematic reviews of exercise therapy for chronic non-specific low back pain using the AMSTAR 2 tool. METHODS: PubMed, Embase, Cochrane Database of Systematic Reviews, PEDro and CINAHL was searched up to February 2017. Two independent reviewers selected systematic reviews of randomized controlled trials that investigated exercise therapy in patients with low back pain. AMSTAR 2 assessment was performed by pairs of reviewers, and the overall confidence in the results of the systematic reviews were rated as 'High', 'Moderate', 'Low' and 'Critically low'. Descriptive analysis was used to summarize the characteristics of included systematic reviews. The percentage of systematic reviews achieving each item from the AMSTAR 2 and the overall confidence in the results were tabulated. RESULTS: The search identified 38 systematic reviews. Most of the reviews included a median of 10 clinical trials and total sample size of 813 participants per review. Five of 38 (13%) reviews were Cochrane reviews, and 8 (21%) systematic reviews had a protocol published or registered prospectively. The overall confidence in the results of 28 reviews (74%) was rated as 'Critically low', 6 (16%) as 'Low', 1 (2%) as Moderate, while 3 of 38 reviews (8%) were rated as 'High'. CONCLUSION: The results demonstrate very low confidence in the results of most systematic reviews of exercise in chronic non-specific low back pain. Clinicians are more likely to deliver the most efficacious interventions to patients by critically appraising systematic reviews using AMSTAR 2 before making their decisions.

Initial validation of a scale to measure methodological quality in prognosis studies: the MInCir proposal / Validación inicial de una escala para medir calidad metodológica en estudios de pronóstico: la propuesta de MInCir

Research in methodological quality (MQ) of prognosis studies (PS) is relevant in view of the important number of studies developed in this scenario. However, currently there are no instruments designed to measure MQ in PS, thus the aim of this study was to validate a scale to determine the MQ in PS. Scale validation study. Two independent researchers applied the scale (10 items/4 domains) in 119 articles found in 13 Journals of high, medium and low impact factor. Criterion validity was determined by contrasting MQ scores with Oxford Centre for Evidence-Based Medicine levels of evidence. Construct validity of extreme groups and high and low impact factors were estimated. Intraclass correlation coefficient was used to determine interobserver reliability, and the cut-off point was calculated using a ROC curve. The best cut-off point was 33, with an under curve area of 82.6 %. Criterion and construct validity were statistically significant with (p<0.001). Interobserver reliability was 0.91 and a scale to measure the MQ in PS was validated.

El objetivo de este estudio fue validar una escala para determinar calidad metodológica (CM) de estudios de pronóstico (EP). Se realizó un estudio de validación de escalas. La escala, compuesta por 10 ítems y 4 dominios; se aplicó a 119 artículos de 13 revistas, de factores de impacto alto, medio y bajo; por dos investigadores independientes. La validez del criterio se determinó al contrastar las puntuaciones de CM de cada artículo con los niveles de evidencia del Centro de Medicina Basada en la Evidencia de Oxford de la revista en la cual fueron publicados. Se estimó la validez de constructo de grupos extremos (factores de impacto alto y bajo). Se utilizó el coeficiente de correlación intraclase para determinar la confiabilidad interobservador, y el punto de corte se calculó construyendo curvas ROC. El mejor punto de corte fue 33 puntos (área bajo la curva de 82,6 %). La validez de criterio y de constructo fueron estadísticamente significativas (p<0,001). La confiabilidad interobservador fue 0,91. Se validó una escala para medir CM en EP.

The assessment of pharmacoeconomic studies quality of Levodopa's use for the management of Parkinson's diseases, 2010-2015 / Evaluación de la calidad de estudios farmacoeconómicos del uso de Levodopa para el manejo de la enfermedad de Parkinson, 2010-2015

SUMMARY Levodopa (LD) has been the first choice in the management of Parkinson's disease (PD), since its introduction in the drug market; however, its prolonged use is related to the occurrence of motor complications, affecting the functionality and quality of life. Parkinson's disease is one of the most frequent among the neurodegenerative diseases in the world, and it is expected that the number of people who suffer it, will increase due to global population aging. The PD represents, nowadays and for the future, a high economic burden from all perspectives, including patients, payers, and society. So it is necessary to know about the use of LD in its treatment and to realize the quality of pharmacoeconomic studies in the past five years, to identify reliable sources of information related to the costs and benefits of this medication to contribute in making decisions. The aim of this paper is to assess the methodological quality of pharmacoeconomic studies related to the use of LD in PD, specifically those that are identified as cost-utility studies, applying the QHES instrument. A total of19 articles were found, of which 5 met the inclusion criteria and were subjected to examination. The average overall score obtained after the evaluation was 77.2 out of 100, making evident a good quality of studies according to the method used.

RESUMEN La Levodopa (LD) ha sido desde su introducción en el mercado la primera elección en el manejo de la enfermedad de Parkinson (EP); sin embargo, su uso prolongado está relacionado con la aparición de complicaciones motoras, afectándose la funcionalidad y calidad de vida. La EP es una de las enfermedades neurodegenerativas que se presenta con mayor frecuencia en el mundo y se espera que el número de personas que la padecen aumente, debido al envejecimiento poblacional a nivel mundial. La EP representa, actualmente y a futuro, una alta carga económica desde todas las perspectivas, incluyendo: pacientes, pagadores y la sociedad; por lo cual es necesario conocer el uso de la LD en el tratamiento de la misma y lograr determinar la calidad de los estudios farmacoeconómicos realizados en los últimos cinco años, para identificar fuentes fiables de información relacionadas con los costos y los beneficios de este medicamento que aporten en la toma de decisiones. El objetivo de este artículo es evaluar la calidad metodológica de los estudios farmacoeconómicos relacionados con el uso de la LD en la EP, específicamente aquellos que se cataloguen como estudios de costo-utilidad, aplicando el instrumento QHES. Se encontraron en total 19 artículos, de los cuales cinco cumplieron los criterios de inclusión y fueron sometidos al respectivo análisis. El puntaje global promedio obtenido posterior a la evaluación fue de 77,2 sobre 100, haciendo evidente una buena calidad de los estudios de acuerdo con el método utilizado.

Improving the adaptability of WHO evidence-informed guidelines for nutrition actions: results of a mixed methods evaluation.

BACKGROUND: Over the past decade, the World Health Organization (WHO) has implemented a standardized, evidence-informed guideline development process to assure technically sound and policy-relevant guidelines. This study is an independent evaluation of the adaptability of the guidelines produced by the Evidence and Programme Guidance unit, at the Department of Nutrition for Health and Development (NHD). The study systematizes the lessons learned by the NHD group at WHO. METHODS: We used a mixed methods approach to determine the adaptability of the nutrition guidelines. Adaptability was defined as having two components; methodological quality and implementability of guidelines. Additionally, we gathered recommendations to improve future guideline development in nutrition actions for health and development. Data sources for this evaluation were official documentation and feedback (both qualitative and quantitative) from key stakeholders involved in the development of nutrition guidelines. The qualitative data was collected through a desk review and two waves of semi-structured interviews (n = 12) and was analyzed through axial coding. Guideline adaptability was assessed quantitatively using two standardized instruments completed by key stakeholders. The Appraisal Guideline for Research and Evaluation questionnaire, version II was used to assess guideline quality (n = 6), while implementability was assessed with the electronic version of the GuideLine Implementability Appraisal (n = 7). RESULTS: The nutrition evidence-informed guideline development process has several strengths, among them are the appropriate management of conflicts of interest of guideline developers and the systematic use of high-quality evidence to inform the recommendations. These features contribute to increase the methodological quality of the guidelines. The key areas for improvement are the limited implementability of the recommendations, the lack of explicit and precise implementation advice in the guidelines and challenges related to collaborative work within interdisciplinary groups. CONCLUSIONS: Overall, our study found that the nutrition evidence-informed guidelines are of good methodological quality but that the implementability requires improvement. The recommendations to improve guideline adaptability address the guideline content, the dynamics shaping interdisciplinary work, and actions for implementation feasibility. As WHO relies heavily on a standardized procedure to develop guidelines, the lessons learned may be applicable to guideline development across the organization and to other groups developing guidelines.

The Development of a Checklist to Enhance Methodological Quality in Intervention Programs.

The methodological quality of primary studies is an important issue when performing meta-analyses or systematic reviews. Nevertheless, there are no clear criteria for how methodological quality should be analyzed. Controversies emerge when considering the various theoretical and empirical definitions, especially in relation to three interrelated problems: the lack of representativeness, utility, and feasibility. In this article, we (a) systematize and summarize the available literature about methodological quality in primary studies; (b) propose a specific, parsimonious, 12-items checklist to empirically define the methodological quality of primary studies based on a content validity study; and (c) present an inter-coder reliability study for the resulting 12-items. This paper provides a precise and rigorous description of the development of this checklist, highlighting the clearly specified criteria for the inclusion of items and a substantial inter-coder agreement in the different items. Rather than simply proposing another checklist, however, it then argues that the list constitutes an assessment tool with respect to the representativeness, utility, and feasibility of the most frequent methodological quality items in the literature, one that provides practitioners and researchers with clear criteria for choosing items that may be adequate to their needs. We propose individual methodological features as indicators of quality, arguing that these need to be taken into account when designing, implementing, or evaluating an intervention program. This enhances methodological quality of intervention programs and fosters the cumulative knowledge based on meta-analyses of these interventions. Future development of the checklist is discussed.

Pautas de chequeo, parte III: STROBE y ARRIVE / Cheklists, part III: STROBE and ARRIVE

Los ensayos clínicos controlados son el diseño por excelencia de la medicina basada en la evidencia. Sin embargo, son el final de un largo camino que comienza con interrogantes o hipótesis que se desprenden de otros tipos de diseños. Algunos de los diseños que se encuentran en este camino son los estudios observacionales analíticos y los estudios de experimentacion en animales. Para que la información entregada por estos tipos de diseños sea de buena calidad, requieren cumplir con estándares mínimos en su reporte, y para esto es que se han diseñado las pautas STROBE y ARRIVE, respectivamente. La iniciativa STROBE fue formada el 2004 tomando como base la experiencia CONSORT, con el objetivo de facilitar la comunicación de estudios observacionales; incluye 22 ítems agrupados en 6 dominios (título/resumen, introducción, método, resultados, discusión y otra información). La pauta ARRIVE comenzó su elaboración durante el 2009, para ser finalmente publicada durante el 2010; incluye 20 ítems, los cuales se agrupan en 5 dominios (título/resumen, introducción, método, resultados y discusión). El uso de estas pautas ha llevado a una mejora en la calidad del reporte de estos tipos de diseños. Sin embargo, la calidad metodológica de muchos estudios continúa siendo subóptima, por lo que se requiere además de otras estrategias para la mejora global de este constructo. Este tercer artículo de la serie describe ambas pautas de chequeo para su uso por parte de los autores de la REVISTA CHILENA DE CIRUGÍA, con el fin de lograr una mejora de sus artículos de una forma simple y eficiente.

Controlled clinical trials are the ultimate design of evidence-based medicine. However, they are the end of a long journey that begins with questions or hypotheses that arise from other types of designs. Some of the designs found in this way are analytical observational studies and experimental studies in animals. To reach a good quality standard by these types of designs, they are required to comply with minimum standards in his report, for this is that they have designed the STROBE and ARRIVE checklists respectively. The STROBE checklist was developed in 2004 based on the CONSORT experience, in order to facilitate the reporting of observational studies, includes 22 items grouped into 6 domains (title / abstract, introduction, methods, results, discussion and other information). The ARRIVE checklist began developing in 2009, to be finally published in 2010, includes 20 items, which are grouped as 5 domain (title / abstract, introduction, methods, results and discussion). Using these checklists has led to improved quality report these types of designs. However the methodological quality of many studies remains suboptimal, so it also requires other strategies for overall improvement of this construct. This third article in the series describes both checklists for use by the authors of the REVISTA CHILENA DE CIRUGÍA, in order to achieve an improvement of its items in a simple and efficient way.

Pautas de chequeo, parte IV: STARD y CARE / Checklists, part IV: STARD and CARE

Los ensayos clínicos controlados representan el diseño más destacado en la investigación biomédica. Sin embargo, existen otros diseños metodológicos que aportan información relevante para la medicina basada en la evidencia: los estudios sobre precisión de pruebas diagnósticas y reportes de caso. Al igual que con otros diseños, estos necesitan cumplir con estándares de calidad en su reporte, para lo que se han diseñados las pautas STARD y CARE, respectivamente. La pauta STARD comenzó a desarrollarse en 1999, siendo publicada en 2003, e incluye 25 ítems agrupados en 5 dominios (título/resumen/palabras clave, introducción, métodos, resultados, discusión). La pauta CARE se elaboró de acuerdo a la Guía para Desarrolladores de Guías de Reporte de Investigación en Salud, siendo publicada en 2013, e incluye 13 ítems, sin dominios declarados y que es de uso general para todos los ámbitos de la medicina. Así como con otras pautas de chequeo, el uso de STARD se ha asociado a una mejora en la calidad del reporte de estudios sobre precisión diagnóstica. En el caso de CARE, es necesario evaluar con el paso de los años su impacto en la calidad de los reportes de caso. Este último artículo de la serie describe ambas pautas de chequeo para su uso por parte de los autores de la REVISTA CHILENA DE CIRUGÍA, con el fin de lograr una mejora de sus artículos de una forma simple y eficiente.

Controlled clinical trials represent the design highlight in biomedical research. However, there are other methodological designs that provide relevant information for evidence-based medicine: studies of diagnostic test accuracy and case reports. As with other designs, they need to meet quality standards in their reporting, that is the reason for the design of STARD and CARE checklists, respectively. The STARD checklist began to develop in 1999, being published in 2003, it includes 25 items grouped into five domains (title / abstract / keywords, introduction, methods, results, discussion). The CARE checklist was made according to the Guidance for Developers of Health Research Reporting Guidelines, was published in 2013, it includes 13 items, without declared domains and is commonly used for all areas of medicine. As with other checklist, the use of STARD has been associated with an improvement in quality report of studies on diagnostic accuracy. In the case of CARE, it is necessary to assess over the years its impact on quality of case reports. This last article in the series describes both checklists for use by the authors of the REVISTA CHILENA DE CIRUGÍA, in order to achieve an improvement in their articles in a simple and efficient way.

Calidad metodológica de las evaluaciones económicas completas, publicadas en revistas médicas cubanas (1999-2014) / Methodological quality of complete economic evaluations published in Cuban medical journals from 1999 to 2014

Objetivo: determinar la calidad metodológica de las evaluaciones económicas completas publicadas en revistas médicas cubanas. Métodos: estudio observacional, descriptivo y transversal en 21 artículos, declarados por su autores como evaluaciones económicas completas, publicados entre 1999 y 2014 en 47 revistas médicas cubanas reconocidas por el Ministerio de Ciencia, Tecnología y Medio Ambiente. A todos se les aplicó una guía de evaluación que incluyó: año de publicación, revista, objetivo, problema, opciones, horizonte temporal, perspectiva, costo, efectos sobre la salud y cálculo de las razones costo/efectividad. Resultados: los artículos se concentraron en ocho revistas. La mayor cantidad está en la Revista Cubana de Farmacia. Le siguieron en importancia la Revista Cubana de Salud Pública y MEDISAN. Ninguno de los aspectos estaba correctamente tratado en más de 80 por ciento de los trabajos revisados. Los resultados más desfavorables estaban en la declaración de la perspectiva, presente en menos de 20 por ciento de los trabajos y el análisis de sensibilidad en menos de 30 por ciento. Menos de la mitad de los trabajos abordaron adecuadamente la presentación del problema de investigación, los objetivos, el horizonte temporal, los costos y la razón costo efectividad incremental. No se encontró ningún artículo en los últimos tres años. Conclusiones: son escasas las evaluaciones económicas publicadas. La mayoría tiene limitaciones metodológicas. Se observa insuficiente desarrollo de esta temática en el país y apunta hacia la importancia de continuar insistiendo en la divulgación de los aspectos metodológicos básicos de estas evaluaciones tanto para investigadores como para revisores y editores de revistas científicas(AU)

Objective: to determine the methodical quality of complete economic evaluations published in Cuban medical journals from 1999 to 2014. Methods: observational, descriptive and cross-sectional study of articles classified by their authors as complete economic evaluations and published from 1999 to 2014 in 47 Cuban medical journals authorized by the Ministry of Science, Technology and Environment. The applied evaluation guide included year of publication, journal, objective, problem, options, time frame, prospects, cost, health effects and estimation of the cost/effectiveness ratio. Results: twenty one papers were found, but in the last three years no paper has been published. These papers were mainly published in eight journals, being the first Revista Cubana de Farmacia, followed by Revista Cubana de Salud Publica and MEDISAN. None of the aspects was correctly addressed in over 80 percent of revised papers. The worst results were found in statement of perspective present in less than 20 percent of papers in addition to sensitivity analysis in less than 30 percent of them. Almost 50 of papers adequately dealt with the submission of research problems, objectives, time frame, costs and the incremental cost/effectiveness ratio. Conclusions: published economic evaluations are still scanty and most of them exhibit methodological faults. There is insufficient development in this area nationwide, which points to the importance of insisting once again on the dissemination of the basic methodological aspects of these evaluations aimed at researchers who act as reviewers and as editors of scientific journals(AU)

Calidad metodológica de ensayos clínicos sobre periodoncia publicados en revistas ISI / Methodological quality of periodontal clinical trials published in ISI Journals

Describir la calidad metodológica de los ensayos clínicos de periodoncia en revistas indexadas en el Institute for Scientific Information. Material y métodos: Estudio observacional descriptivo en el que se evaluaron los ensayos clínicos publicados entre Enero de 2008 y Diciembre de 2012, de las cuatro revistas de periodoncia indexadas a ISI, con mayor factor de impacto en los últimos 5 años según Journal Citation Reports. Se realizó una estrategia de búsqueda en PubMed para cada revista. Sólo los ensayos clínicos fueron seleccionados para el análisis cualitativo por medio de una escala de calidad metodológica. Los datos fueron analizados utilizando el paquete estadístico SPSS Statistics 20 para Windows (IBM., Chicago, USA.) y presentados mediante estadística descriptiva. Resultados: De las revistas que cumplieron los criterios de selección, Journal of Clinical Periodontology, Journal of Periodontology, Journal of Periodontal Research e International Journal of Periodontics & Restorative Dentistry, se analizaron 387 ensayos clínicos. De los 24 puntos máximos obtenibles de la escala, la media alcanzada por los manuscritos evaluados fue de 17,45 puntos. Conclusión: La calidad metódológica de los ensayos clínicos en periodoncia, indexados en revistas ISI, fue deficiente...

To describe the methodological quality of periodontal clinical trials in journals indexed by the Institute for Scientific Information (ISI).Materials and methods: Descriptive observational study in which the clinical trials published in four ISI-indexed periodontics journals between January 2008 and December 2012 were evaluated. The journals were selected as they had had the highest impact factor in the last 5 years according to the Journal Citation Reports.For each journal, papers were searched for in PubMed. Only clinical trials were selected to conduct the qualitative analysis using a methodological quality scale. Statistical analysis was conducted with SPSS Statistics 20 for Windows (IBM, Chicago, USA), and the data were presented through descriptive statistics. Results: The following journals fulfilled the selection criteria: Journal of Clinical Periodontology, Journal of Periodontology, Journal of Periodontal Research and International Journal of Periodontics & Restorative Dentistry. From these journals, 387 clinical trials were analyzed. Of the maximum of 24 points in the scale, the mean reached was 17.45 points. Conclusion: The methodological quality of periodontal clinical trials indexed in ISI is deficient...

Pautas de chequeo, parte I: consort y trend / Cheklists, part I: consort and trend

One of the most common problems in scientific articles is its poor reporting, a situation that leads to lack of information, affecting internal and external validity, questioning his contribution and usefulness. This has been studied leading to propositions by the international scientific community, reflected in a series of guidelines or checklists as CONSORT and TREND for randomized clinical trials (RCTs) and non-randomized intervention studies (NRISs) respectively. The CONSORT checklist was created in 1996, with a final version in 2010, consisting of 25 items, grouped into 6 domains: Title and Summary, Introduction, Methods, Results, Discussion, and Other information; representing the critical points in a RCT report. In many cases RCTs are no feasible so other research designs such as NRISs has to be executed, for this design the TREND checklist was developed in 2004, consisting of 22 items, grouped into 5 domains: Title and Summary, Introduction, Methods, Results and Discussion. Even when the evidence has been contradictory regarding the impact of these checklists, they represent an important tool to improve biomedical research. This article tries to explain these checklists and encourage its use by the authors of the Revista Chilena de Cirugía, in function to contribute to continuous improvement of their articles in a simple and efficient way.

Uno de los problemas más frecuentes en los artículos científicos es su deficiente reporte, situación que redunda en falta de información, afectando la validez interna y externa, cuestionando su aporte y utilidad. Esta situación ha sido motivo de estudio y propuestas por parte de la comunidad científica internacional, que se materializan en una serie de pautas de chequeo o checklists como CONSORT y TREND para ensayos clínicos aleatorizados (ECA) y estudios de intervención no aleatorizados (EINA) respectivamente. La propuesta CONSORT nace en 1996, con una última versión en 2010, constituida por 25 ítems, agrupados en 6 dominios: Título y Resumen, Introducción, Metodología, Resultados, Discusión y Otra información; representando puntos esenciales a reportar en un ECA. En muchas ocasiones se debe recurrir a otro tipo de diseños de investigación como los EINA, para los que en 2004 se desarrolló la pauta TREND, el cual consta de 22 ítems, agrupados en 5 dominios: Título y resumen, Introducción, Métodos, Resultados y Discusión. Aun cuando la evidencia ha sido contradictoria respecto al impacto de estas pautas, estas representan una herramienta relevante para mejorar la investigación biomédica. El presente artículo intenta dar a conocer estos checklists e incentivar su uso por parte de los autores de la Revista Chilena de Cirugía, con lo cual se espera contribuir a una mejora continua de sus artículos de una forma simple y eficiente.

Evaluación de la calidad de estudios farmacoeconómicos del uso de los inhibidores de la bomba de protones en enfermedad ácido péptica / Quality assessment of pharmacoeconomic studies of the use of proton pump inhibitors in peptic ulcer disease

Los inhibidores de la bomba de protones (IBP) son un grupo de fármacos que reducen la secreción de ácido en el estómago, por lo que son ampliamente utilizados en el tratamiento de la úlcera péptica. La notable prevalencia e incidencia de esta patología sugiere que los recursos económicos y humanos dedicados a su tratamiento son considerables y, por tanto, es necesario identificar fuentes fiables de información relacionadas con los costos y los beneficios de estos agentes terapéuticos que permitan valorarlos en términos de eficiencia para mejorar su prescripción racional. Este trabajo realizó una revisión de los estudios farmacoeconómicos correspondientes al uso de los ibp en la prevención y tratamiento de la enfermedad ácido péptica y se presenta una evaluación pareada de la calidad metodológica de la bibliografía basada en el instrumento qhes (Ofman et al., [10]). De los diez artículos revisados, cuatro son de costo-efectividad, dos de costo-utilidad, tres de descripción de costos y uno de minimización de costos. El puntaje global promedio obtenido por los estudios evaluados fue de 66,6 sobre 100. Cuatro de ellos puntuaron por debajo de 60, haciendo evidente deficiencias en la calidad de los estudios de acuerdo con el instrumento usado, además pone de manifiesto que se necesitan evaluaciones farmacoeconómicas en relación con el uso de los ibp para la prevención y el tratamiento de la úlcera péptica, especialmente estudios de costo-efectividad, que cumplan con los estándares de calidad metodológica.

Proton pump inhibitors (PPI) are a group of drugs that reduce gastric acid secretion and therefore are widely used in the treatment of peptic ulcer. The remarkable prevalence and incidence of this disease suggests that economic and human resources devoted to treatment are considerable and therefore it is necessary to identify reliable sources of information related to the costs and benefits of these therapeutic agents to appraise in terms of efficiency to improve rational prescribing. This paper conducted a review of pharmacoeconomic studies pertaining to the use of ppi in the prevention and treatment of peptic acid disease, as it presents a paired assessment of methodological quality of the literature instrument based on qhes (Ofman et al., [10]). Of the ten articles reviewed, four were cost-effectiveness, two cost-utility, three description of cost, and one of cost minimization. The average overall scored 66.6 out of 100. Four of them scored below 60.0, making it a clear need for pharmacoeconomic evaluations in connection with the use of ppi for prevention and treatment of peptic ulcer, especially cost-effectiveness studies that meet standards of methodological quality.

Validación de escala MinCir de estudios de pronóstico / Methodological quality in prognostic papers (scale MinCir Pr)

Introduction: Our team reported the development of a scale for assessing methodological quality in prognostic papers (scale MinCir Pr). The aim of this paper is to report the process of validation of scale MinCir Pr. Material and Methods: We reviewed 121 papers about prognosis. Score was performed according to the scale MinCir Pr and level of evidence. In addition we recorded the number of publications of the author. For the construct validity of the measurement was made through the technique known extreme groups, which claims that the evaluations differ regarding the critical attribute. To this end, we used the level of evidence items 2 and 4, waiting for a difference in scale scores of articles published at the ends of the score. Results: For validation of extreme groups we compare the performance of the scale in relation to the level of evidence 2 and 4, since in these groups had more papers (55 and 48 respectively). The average score of the scale in papers with level of evidence 2 was 82.21 +/- 13.79 compared with the score in papers with level of evidence 4 which was 64.97 +/- 17.10 (p = 0.000). Conclusion: We performed the validity of the scale builder MinCir Pr using the technique known extreme groups.

Introducción: Nuestro equipo de trabajo reportó el desarrollo de una escala de evaluación de calidad metodológica de estudios de pronóstico (escala MinCir Pr). El objetivo del presente trabajo es reportar el proceso de validación de la escala MinCir Pr. Material y Método: Se revisaron 121 estudios de pronóstico. Se realizó la puntuación de los trabajos según la escala MinCir Pr y según el nivel de evidencia. Además se registró el número de publicaciones del autor. Para la validez de constructo se realizó la medición por medio de la técnica de grupos extremos conocidos, que presume que las evaluaciones diferirán respecto al atributo crítico. Para este fin, se utilizaron los artículos con nivel de evidencia 2 y 4, esperando una diferencia en la puntuación de la escala de los artículos publicados en los extremos de la puntuación. Resultados: Para realizar la validación de grupos extremos comparamos el desempeño de la nueva escala en relación a los niveles de evidencia 2 y 4; ya que en estos grupos había mayor número de artículos (55 y 48 respectivamente). El promedio de puntuación de la nueva escala de los trabajos con nivel de evidencia 2 fue de 82,21 +/- 13,79 en comparación con la puntuación de los trabajos con nivel de evidencia 4 que fue de 64,97 +/- 17,10 (p = 0,000). Conclusión: Se realizó la validez de constructor de la escala MinCir Pr utilizando la técnica de grupos extremos conocidos.

Diseño de una escala para evaluar calidad metodológica de estudios de pruebas diagnósticas: estudio piloto / Construction of a scale to assess methodological quality of diagnostic tests articles

Introduction: Despite the methodological quality (MQ) of scientific publications is a multidimensional concept difficult to understand, their evaluation is essential at the time of making decisions that support our clinical practice. However, in the field of diagnostic tests (DT), which is in a steady and rapid development, there are no valid and reliable instruments to assess MQ. Aim: To report the results of the generation of items and domains of a scale to determine MQ in studies of DT and to determine interobserver reliability of this scale. Material and Methods: Construction of a scale to assess MQ of DT articles and pilot study to determine interobserver reliability. Designed scale was applied to 20 DT studies randomly selected. Interobserver reliability of the scale and each of the domains that compose it was determined by applying intraclass correlation coefficient. Results: The created scale has 9 items grouped into three domains. The ICC observed was 1.0 for the domain 1, 0.90 for the domain 2 and 0.86 for the domain 3. The overall ICC was 0.96. Conclusion: A scale to determine MQ in DT studies was created and it interobserver reliability was determined with a significant level of agreement between observers.

Introducción: A pesar que la calidad metodológica (CM) de las publicaciones científicas es un concepto multidimensional de difícil comprensión, su evaluación es fundamental para la toma de decisiones que apoyen nuestra práctica clínica. No obstante ello, en el ámbito de las pruebas diagnósticas (PD), que se encuentra en constante y rápido desarrollo, no existen instrumentos válidos y confiables que permitan evaluar CM. Objetivo: Reportar los resultados del proceso de generación de ítems y dominios de una escala para determinar CM en estudios de PD; y determinar la confiabilidad interobservador de esta escala. Material y Método: Construcción de una escala de CM de estudios de PD y estudio de confiabilidad interobservador. Se aplicó la escala diseñada a 20 artículos de PD seleccionados en forma aleatoria. Se determinó confiabilidad interobservador de la escala en general y de cada uno de los dominios que la componen mediante aplicación del coeficiente de correlación intraclase. Resultados: La escala generada quedó compuesta por 9 ítems agrupados en tres dominios. El CCI observado para el dominio uno fue de 1,0; para el dominio dos de 0,90; y para el dominio tres de 0,86. El CCI general de la escala fue de 0,96. Conclusión: Se generó una escala para medir CM en estudios de PD y se determinó confiabilidad interobservador de ella y los dominios que la componen. Se observó un nivel de acuerdo significativo entre los evaluadores.