CONSORT 2010 statement: extension to randomised pilot and feasibility trials [on behalf of the PAFS consensus group*]

The Consolidated Standards of Reporting Trials (CONSORT) statement is a guideline designed to improve the transparency and quality of the reporting of randomised controlled trials (RCTs). In this article we present an extension to that statement for randomised pilot and feasibility trials conducted in advance of a future definitive RCT. The checklist applies to any randomised study in which a future definitive RCT, or part of it, is conducted on a smaller scale, regardless of its design (eg, cluster, factorial, crossover) or the terms used by authors to describe the study (eg, pilot, feasibility, trial, study). The extension does not directly apply to internal pilot studies built into the design of a main trial, non-randomised pilot and feasibility studies, or phase II studies, but these studies all have some similarities to randomised pilot and feasibility studies and so many of the principles might also apply. The development of the extension was motivated by the growing number of studies described as feasibility or pilot studies and by research that has identified weaknesses in their reporting and conduct. We followed recommended good practice to develop the extension, including carrying out a Delphi survey, holding a consensus meeting and research team meetings, and piloting the checklist. The aims and objectives of pilot and feasibility randomised studies differ from those of other randomised trials. Consequently, although much of the information to be reported in these trials is similar to those in randomised controlled trials (RCTs) assessing effectiveness and efficacy, there are some key differences in the type of information and in the appropriate interpretation of standard CONSORT reporting items. We have retained some of the original CONSORT statement items, but most have been adapted, some removed, and new items added. The new items cover how participants were identified and consent obtained; if applicable, the prespecified criteria used to judge whether or how to proceed with a future definitive RCT; if relevant, other important unintended consequences; implications for progression from pilot to future definitive RCT, including any proposed amendments; and ethical approval or approval by a research review committee confirmed with a reference number. This article includes the 26 item checklist, a separate checklist for the abstract, a template for a CONSORT flowchart for these studies, and an explanation of the changes made and supporting examples. We believe that routine use of this proposed extension to the CONSORT statement will result in improvements in the reporting of pilot trials. Editor’s note: In order to encourage its wide dissemination this article is freely accessible on the BMJ and Pilot and Feasibility Studies journal websites

Mothers' View on Late Postoperative Pain Management by the Nursing Team in Children After Cardiac Surgery El manejo del dolor en niños, en el posoperatorio tardío de cirugía cardíaca, por los profesionales de enfermería, bajo la perspectiva de las madres O manejo da dor em crianças, no pós-operatório tardio de cirurgia cardíaca, pelos profissionais de enfermagem, na ótica das mães

Postoperative pain management in children is a complex, multidimensional and subjective phenomenon. It represents a challenge for children, parents and health professionals. This study aimed to understand how mothers assess their children&#39;s pain management by the nursing team in the late postoperative phase of cardiac surgery. Empirical data collection was carried out through semistructured interviews with 17 mothers who accompanied their children. Data were subject to qualitative analysis, revealing that, for the mothers, taking good care results from the confidence they vest in the nursing team and from the observation of the medication interventions this team performs. Not taking good care of their children is a consequence of lack of information or inadequate communication between the team and the mothers. The results of this study permit identifying aspects that strengthen and weaken nursing care for these clients, contributing to the improvement of the delivered care.<br>El manejo del dolor posoperatorio en el niño es un fenómeno complejo, multidimensional y subjetivo; siendo que se constituye en un desafío para los niños, padres y profesionales de la salud. El objetivo de este trabajo fue comprender como las madres evalúan el manejo del dolor de sus hijos, realizado por el equipo de enfermería, en el posoperatorio tardío de cirugía cardíaca. La recolección de datos empíricos fue realizada por medio de entrevista semiestructurada con 17 madres que acompañaron a sus hijos. Los datos fueron analizados cualitativamente. Aprendimos que para las madres cuidar bien es resultante de la confianza que ellas depositan en el equipo de enfermería y de la observación de las intervenciones medicamentosas que ese equipo realiza. El no cuidar bien de sus hijos es consecuencia de la falta de información o comunicación inadecuada entre el equipo y las madres. Los resultados de este estudio posibilitaron identificar aspectos que pueden fortalecer o fragilizar el cuidado de enfermería a esa clientela, de esa manera contribuyendo para la mejoría del cuidado prestado.<br>O manejo da dor pós-operatória na criança é fenômeno complexo, multidimensional e subjetivo. Constitui-se em desafio, para as crianças, pais e profissionais de saúde. O objetivo deste trabalho foi compreender como as mães avaliam o manejo da dor de seus filhos, implementado pela equipe de enfermagem, no pós-operatório tardio de cirurgia cardíaca. A coleta de dados empíricos foi realizada por meio de entrevista semiestruturada com 17 mães que acompanharam seus filhos. Procedeu-se à análise qualitativa dos dados e se apreendeu que, para as mães, cuidar bem é resultante da confiança que elas depositam na equipe de enfermagem e da observação das intervenções medicamentosas que essa equipe realiza. Não cuidar bem de seus filhos é consequência da falta de informação, ou comunicação inadequada entre equipe e mães. Os resultados deste estudo possibilitam identificar aspectos que fortalecem e fragilizam o cuidado de enfermagem a essa clientela, contribuindo para a melhoria do cuidado prestado

Cholecystocolonic fistula: facts and myths. A review of the 231 published cases

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