Determine what to measure and how to measure in clinical trials for the treatment of pressure injury: a protocol for the development of a core outcome set

A core outcome set (COS) is an agreed minimum set of outcomes that should be reported in all clinical trials in specific areas of health care. A considerable amount of trials did not report essential outcomes or outcomes measurement methods, which makes it challenging to evaluate the efficacy and safety of treatment strategies for pressure injury (PI) and produced significant heterogeneity of reported outcomes. It is necessary to develop a COS, which can be used for clinical trials in PI treatment. The development of this COS will be guided by an advisory group composed of clinicians, senior nurses, patients, and methodologists. We will search six databases and two registry platforms to identify currently reported PI treatment outcomes and outcome measurement instruments in randomized controlled trials, meta-analysis, and systematic reviews. We will also conduct a semi-structured interview with clinicians, nurses, and adult PI patients to collect their opinions on important outcomes. Each outcome of the initial list generated from systematic review and interviews will be scored and reach a consensus through two rounds of international Delphi survey with all key stakeholders. A face-to-face consensus meeting with key stakeholders will be conducted to finish a final COS and recommend measurement instruments for each outcome.

Contributors

Jiyuan Shi Evidence-based Nursing Center, School of Nursing, Lanzhou University, China
Gao Ya Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, China
Liangliang Si Nursing Department, Henan Provincial People`s Hospital, Zhengzhou University People's Hospital, Henan University People's Hospital, Zhengzhou, China
Junmei Zhang Nursing Department, Henan Provincial People`s Hospital, Zhengzhou University People's Hospital, Henan University People's Hospital, Zhengzhou, China
Jinhui Tian Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, China

Further Study Information

Current Stage: Ongoing
Date: July 2019 - August 2021
Funding source(s): Science and Technology Program of Henan Province, China (162102310170)


Health Area

Disease Category: Wounds

Disease Name: Pressure injury

Target Population

Age Range: 18 - 100

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

- Clinical experts
- Consumers (patients)
- Journal editors
- Methodologists
- Researchers
- Statisticians

Study Type

- COS for clinical trials or clinical research

Method(s)

- Consensus conference
- Consensus meeting
- Delphi process
- Systematic review
- Interview
- Semi structured discussion

The development of this COS will be guided by an advisory group composed of clinicians, senior nurses, patients, and methodologists. We will search six databases and two registry platforms to identify currently reported PI treatment outcomes and outcome measurement instruments in randomized controlled trials, meta-analysis, and systematic reviews. We will also conduct a semi-structured interview with clinicians, nurses, and adult PI patients to collect their opinions on important outcomes. Each outcome of the initial list generated from systematic review and interviews will be scored and reach a consensus through two rounds of international Delphi survey with all key stakeholders. A face-to-face consensus meeting with key stakeholders will be conducted to finish a final COS and recommend measurement instruments for each outcome.

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