Development of a Core Outcome Set for the Benefits and Adverse Events of Acute Heart Failure in Clinical Trials of Traditional Chinese Medicine and Western Medicine: A Study Protocol

Abstract

Aims: To identify a minimum set of efficacy and adverse events for patients with acute heart failure (AHF) among different stakeholders in clinical trials of traditional Chinese medicine and Western medicine.Methods and Analysis: First, we will develop a preliminary long list of outcomes that includes efficacy and adverse events/reactions via three steps: (i) systematic reviews of efficacy and safety outcomes for clinical trials of AHF; (ii) drugs included in the National Medical Insurance Catalog, the National Essential Medicines Catalog, and the WHO Essential Medicines List will be collected and safety outcomes extracted from the package inserts; and (iii) patients' or caregivers' semi-structured interviews will be carried out to add new viewpoints to the list. Second, after merging outcomes and grouping them under different outcome domains, questionnaires for health professionals and patients will be separately developed. Further, two rounds of Delphi survey for health professionals and a survey for patients and the public will be carried out. Third, different stakeholders will discuss and determine the final core outcome set (COS) for AHF in a consensus meeting.Ethics and Dissemination: The entire project has been approved by the Ethics Committee of the main institution. After the final COS is developed, it will be published and discussed widely in conferences.Clinical Trial Registration: This study is registered with the Core Outcome Measures in Effectiveness Trials database as study 1566 (available at: https://www.cometinitiative.org/Studies/Details/1566).

Development of a Core Outcome Set in the Clinical Trials of Traditional Chinese Medicine for Stroke: A Study Protocol

“…When the systematic reviews and the semi-structured interviews are completed, the outcomes will be merged and grouped into different domains, based on the method recommended by previous COS studies ( 27 , 28 ). This process will be conducted by two researchers independently.…”

Establishing a core outcome set for neurogenic bladder trials: study protocol for a scoping review and Delphi surveys

“…More than 60 patients or caregivers will be recruited following the purpose of obtaining the overall outcomes. We believe this will achieve sufficient saturation in the semi-structured interview, which means no new ideas occur [ 24 ]. They can complete the questionnaire with the help of the investigator.…”

“…We will send emails or messages to remind potential participants to complete the Delphi survey at the end of the second weekend. A 9-point scoring system will be used in the questionnaire, wherein “1–3” indicates that the outcome is not important in the COS, “4–6” indicates that the outcome is important but not critical in the COS, and “7–9” indicates that the outcome is critical in the COS [ 24 , 27 ]. Participants will also have the option to choose “unclear” for each outcome, if they find it difficult to score in terms of importance.…”

“…Participants will also have the option to choose “unclear” for each outcome, if they find it difficult to score in terms of importance. At the end of the questionnaire, there will be one open-ended question: which outcomes do you think are important but are not included in the questionnaire [ 24 ]?…”

“…Data analysis for round 2 of the Delphi survey will include the response rate; the frequencies of the response options for each outcome from different stakeholders; the number of participants who score differently among those who complete both round 1 and round 2; the outcomes that achieve “consensus in,” “consensus out,” and “no consensus”; and the potential attrition bias. The statistically significant outcomes will be discussed in the consensus meeting [ 24 ]. As shown in Table 4 , each outcome will be defined as 3 categories [ 24 , 28 ].…”