REporting quality of PilOt randomised controlled trials in surgery (REPORTS): a methodological survey protocol.

INTRODUCTION: The aim of this methodological review is to evaluate the completeness of reporting of surgical pilot and feasibility randomised trials as per the Consolidated Standards of Reporting Trials (CONSORT) extension to randomised pilot and feasibility trials. Moreover, we aim to assess for the presence of spin reporting and inconsistency between abstract and main text reporting in surgical pilot and feasibility randomised trials. METHODS AND ANALYSIS: A comprehensive, electronic search strategy will be used to identify studies indexed in Medline, Embase and Cochrane Central Register of Controlled Trials (CENTRAL) databases. Studies will be included if they are pilot or feasibility randomised trials of surgical interventions. The primary outcome will be overall CONSORT statement extension to randomised pilot and feasibility trials checklist completeness. This will be defined as trials reporting each of the 40 items in the CONSORT statement extension to randomised pilot and feasibility trials checklist. Secondary outcomes will include the reporting of individual studies as per the CONSORT extension to randomised pilot and feasibility trials, the use of spin reporting strategies, trial factors associated with reporting quality and spin strategy use, and consistency between abstract and main text reporting. Poisson and logistic regressions will be performed to explore the association between trial factors and completeness of reporting as measured by the number of reported CONSORT items. ETHICS AND DISSEMINATION: This is a methodological survey that has been registered a priori on the International Prospective Register for Systematic Reviews (PROSPERO) (CRD42023475512). Local ethics approval is not required. We plan to disseminate study results through peer-reviewed publication and conference presentations.

Impact of a structured reporting template on the quality of HRCT radiology reports for interstitial lung disease.

PURPOSE: This QI study compared the completeness of HRCT radiology reports before and after the implementation of a disease-specific structured reporting template for suspected cases of interstitial lung disease (ILD). MATERIALS AND METHODS: A pre-post study of radiology reports for HRCT of the thorax at a multicenter health system was performed. Data was collected in 6-month period intervals before (June 2019-November 2019) and after (January 2021-June 2021) the implementation of a disease-specific template. The use of the template was voluntary. The primary outcome measure was the completeness of HRCT reports graded based on the documentation of ten descriptors. The secondary outcome measure assessed which descriptor(s) improved after the intervention. RESULTS: 521 HRCT reports before and 557 HRCT reports after the intervention were reviewed. Of the 557 reports, 118 reports (21%) were created using the structured reporting template. The mean completeness score of the pre-intervention group was 9.20 (SD = 1.08) and the post-intervention group was 9.36 (SD = 1.03) with a difference of -0.155, 95% CI [-0.2822, -0.0285, p < 0.0001]. Within the post-intervention group, the mean completeness score of the unstructured reports was 9.25 (SD = 1.07) and the template reports was 9.93 (SD = 0.25) with a difference of -0.677, 95% CI [-0.7871, -0.5671, p < 0.0001]. After the intervention, the use of two descriptors improved significantly: presence of honeycombing from 78.3% to 85.1% (p < 0.0039) and technique from 90% to 96.6% (p < 0.0001). DISCUSSION: Shifting to disease-specific structured reporting for HRCT exams of suspected ILD is beneficial, as it improves the completeness of radiology reports. Further research on how to improve the voluntary uptake of a disease-specific template is needed to help increase the acceptance of structured reporting among radiologists.

Recommended Guideline for Uniform Reporting of Neonatal Resuscitation: The Neonatal Utstein Style.

Clinical research on neonatal resuscitation has accelerated over recent decades. However, an important methodologic limitation is that there are no standardized definitions or reporting guidelines for neonatal resuscitation clinical studies. To address this, the International Liaison Committee on Resuscitation Neonatal Life Support Task Force established a working group to develop the first Utstein-style reporting guideline for neonatal resuscitation. The working group modeled this approach on previous Utstein-style guidelines for other populations. This reporting guideline focuses on resuscitation of newborns immediately after birth for respiratory failure, bradycardia, severe bradycardia, or cardiac arrest. We identified 7 relevant domains: setting, patient, antepartum, birth/preresuscitation, resuscitation process, postresuscitation process, and outcomes. Within each domain, relevant data elements were identified as core versus supplemental. Core data elements should be collected and reported for all neonatal resuscitation studies, while supplemental data elements may be collected and reported using standard definitions when possible. The Neonatal Utstein template includes both core and supplemental elements across the 7 domains, and the associated Data Table provides detailed information and reporting standards for each data element. The Neonatal Utstein reporting guideline is anticipated to assist investigators engaged in neonatal resuscitation research by standardizing data definitions. The guideline will facilitate data pooling in meta-analyses, enhancing the strength of neonatal resuscitation treatment recommendations and subsequent guidelines.

Diseño y validación de una rúbrica analítica para evaluar manuscritos científicos / Design and validation of an analytical rubric for evaluating scientific manuscripts

Introducción: La investigación científica tiende a ser presentada mediante reportes escritos, que inicialmente son denominados manuscritos, la revisión de su calidad es importante en el marco del rigor metodológico y científico. Objetivo: Diseñar y validar una rúbrica analítica para evaluar manuscritos científicos. Material y Métodos: Estudio instrumental. Donde se elabora una rúbrica analítica compuesta por 21 aspectos integrados en seis dimensiones y cuatro niveles de desempeño (Excelente, Bien, Regular, Por mejorar). Se utiliza la metodología de jueces expertos (n= 9), fiabilidad mediante el Alfa de Krippendorff (α) y relación prueba criterio externo e información cualitativa para la mejora de los indicadores. Resultados: El juicio de expertos indicó que los 21 aspectos a evaluar pueden ser considerados validos (V de Aiken ≥ 0.70) y fiables (α ≥ 0.70). Además, las sugerencias de los expertos permitieron mejoras cualitativas al instrumento. La aplicación piloto con un grupo de siete evaluadores indicó que la prueba cuenta con poder predictivo, porque se encontró que las puntuaciones de los jueces disminuyen mientras disminuye la calidad del manuscrito seleccionado. Conclusiones: La rúbrica analítica elaborada es un instrumento válido y fiable que puede ser utilizado para la valoración de manuscritos científicos en el ámbito de la educación médica. El proceso metodológico brinda evidencias solidas de su funcionamiento. A pesar de eso, se anima a continuar revisando el instrumento como parte de su proceso de mejora continua.

Introduction: Scientific research tends to be presented through written reports, which are initially called manuscripts. The review of their quality is important in the framework of methodological and scientific rigor. Objective: To design and validate an analytical rubric to evaluate scientific manuscripts. Material and Methods: Instrumental study. An analytical rubric composed of 21 aspects integrated into six dimensions and four performance levels (excellent, good, fair, to be improved) was developed. The methodology of expert judges (n = 9), reliability by means of Krippendorff's alpha (α), external criterion test, and qualitative information for the improvement of the indicators were used. Results: The expert judgment indicated that the 21 aspects to be evaluated can be considered valid (Aiken's V ≥ 0.70) and dependable (α ≥ 0.70). In addition, the experts' suggestions allowed qualitative improvements to the instrument. The pilot application with a group of seven evaluators indicated that the test has predictive power because it was found that the judges' scores decreased as the quality of the selected manuscript decreased. Conclusions: The analytical rubric elaborated is a valid and reliable instrument that can be used for the assessment of scientific manuscripts in the field of medical education. The methodological process provides solid evidence of its performance. Nevertheless, it is encouraged to continue revising the instrument as part of its continuous improvement process.