Health Care Professionals

In collaboration with others in the CONSORT Group, we have extended the current CONSORT Statement to develop a checklist of essential items that authors should consider when reporting the main (i.e., those reporting the pre-specified primary outcome) results of a RCT in any journal or conference abstract.
First, we established a steering committee (MC, SH, DM, PM, and EW). Second, we generated a list of items from existing quality assessment and reporting tools, including the CONSORT Statement [22 (link)] and other guidance for the structured reporting of journal abstracts and short reports [25 (link)–28 ]. Third, additional items were generated as part of an empirical study assessing the quality of trials reported in conference proceedings and journal abstracts [29 ].
We then used a modified Delphi consensus method [30 (link)] to select and reduce the number of possible checklist items. A total of 109 participants, who were known to have an interest in the reporting of RCTs, the structure of abstracts, or both were invited (by e-mail) to participate in a Web-based survey and rate the importance of 27 suggested checklist items. The response rate was 61% (n = 63) for the first round of the Delphi survey. Respondents included journal editors (13%), health-care professionals (22%), methodologists (40%), statisticians (5%), trialists (7%), and other individuals with expertise in the reporting of RCTs (13%). During three rounds of the survey, participants were asked about their views on the relative importance of the possible checklist items. A more detailed discussion of the Delphi process is included in Text S1.
The results of the survey were presented at a one-day meeting (part of a three-day CONSORT Group meeting) in January 2007, in Montebello, Canada, attended by 26 participants, several of whom also participated in the Delphi survey. The meeting began with a review of the checklist items proposed as a result of the Delphi process. Participants then discussed in small groups whether proposed checklist items should be included, excluded, or modified in the final checklist. These small-group deliberations were further discussed during plenary sessions.
Following the meeting, the checklist was revised and circulated to the steering committee and meeting participants to ensure that it reflected the discussions. The steering committee also developed this explanation and elaboration document, which was circulated through several iterations among the authors.

The study was conducted at the University of Gondar Comprehensive Specialized Hospital, Amhara regional state, Northwest Ethiopia. The University of Gondar Comprehensive Specialized Hospital is found in Gondar city, which is found 738 kilometers (km) from the Northwest of Addis Ababa, the capital city of Ethiopia. It gives services to more than seven million persons in the catchment area (17 (link)). The hospital has specializations in pediatrics, internal medicine, surgery, gynecology, and other health related specializations and it serves more than five million people in inpatient and outpatient departments (18 (link)). The health service units include maternity clinics, outpatient clinics, adult in-patients, emergency wards, community clinics, pediatrics in-patients, radiology, dermatology, pathology, ophthalmology, dentistry, pharmacy and medical laboratory (19 ). The hospital has about 700 beds in 27 wards for inpatient, emergency, and outpatient departments (17 (link)). It is staffed by about 1,040 health care professionals (20 (link)).

This study was based on combined semi-structured interview data from two sources: (1) secondary analysis of semi-structured interview data obtained in a previous mixed methods study [13 ]; and 2) semi-structured interview data collected as part of an environmental scan with the aim of preparing a strategy to integrate PROMs and PREMs into pediatric care across Alberta. Data from Study 1 contained more perspectives from academic clinical researchers while Study 2 included a greater proportion of system-level perspectives (i.e., evaluation specialists and administrators). Combining these two datasets allowed us to gain a more comprehensive overview of the factors that could affect successful implementation of PROMs and PREMs users in Alberta. A similar semi-structured interview guide was used for Study 1 and 2, with some modifications in Study 2 to target participant perspectives on facilitators and barriers to PROM and PREM use (see Additional file 1 and Additional file 2).
Study 1. See [blinded for peer review] for a detailed account of the study, however, briefly, data were collected between May 2021 and April 2022 from 14 individuals who were PROMs and PREMs users in Alberta (7 physicians, 1 psychologist, 6 academic researchers). The focus of the qualitative arm was to understand the uses, benefits, and challenges associated with PROMs and PREMs in pediatric settings.
Study 2. Participants were recruited through newsletters and emails of professional groups (e.g., health professional associations, primary care networks, pediatric research institutions). Potential participants were also identified through publicly available profiles and through snowball sampling. Those individuals were emailed directly with an invitation to participate. All participants were invited to complete a survey where they were asked about the specific PROM and PREM instruments they used, their uses (clinical care, evaluation, research), modes of administration and challenges associated with their use. At the end of the survey, participants were asked if they wished to be contacted for an interview where their experiences with PROMs and PREMs would be explored in more depth. Data from those interviews were used in this study. Interviews were conducted between April and July 2022. The interview was focused on understanding the participant’s experiences with PROMs and PREMs, with an emphasis on the barriers and facilitators to implementing PROMs and PREMs in pediatrics. Interviews were conducted virtually using Zoom software and lasted between 30 and 45 min. They were audio-recorded and transcribed verbatim. Verbal informed consent was obtained from each participant prior to the start of the interview.