Core Outcome Measures in Effectiveness Trials

Development of a Core Outcome Set for Digital Replantation

General Information

Summary:
This study aims to identify all outcomes and outcome measures utilized in clinical studies pertaining to digital replantation. The identified list of outcomes will then be used for the development of a core outcome set (COS).

To create the COS, we will use the Delphi Process, an iterative survey-based method using various stakeholder groups. Our stakeholders will include patients, surgeons, nurses, physiotherapists, and occupational therapists. We will conclude with a final consensus meeting, whereby an agreement of 70% must be met for the item to appear on the Core Outcome Set.

Contributors:
Syena Moltaji, BSc, MD(c)1; Matteo Gallo, BHSc(c)2; Jessica Murphy, MSc3; Lucas Gallo, MD3; Daniel Waltho, MD3; Andrea Copeland, MD3; Marta Karpinski, BHSc2; Sadek Mowakket, BHSc(c)2; Eric Duku, PhD, PStat4, Achilleas Thoma*, MD, MSc3, 5, 6
1Michael G. DeGroote School of Medicine, McMaster University;
2 Faculty of Health Sciences, McMaster University;
3 Division of Plastic surgery, McMaster University;
4 Department of Psychiatry and Behavioral Neurosciences, McMaster University, Hamilton, ON, Canada
5 Department of Surgery, McMaster University;
6 Department of Health Research Methods, Evidence, and Impact, McMaster University
*Principal Investigator

Further Study Information

Current Stage:
Ongoing
Date:
2018 - 2019
Funding source(s):
None

Health Area

Disease Category
Orthopaedics & trauma

Disease Name
Digital amputation/replantation

Target Population

Age Range
18 - 100

Sex
Either


Nature / type of Intervention
Surgery

Method(s)

Consensus meeting
Delphi process
Focus group(s)
Interview
Semi structured discussion
Systematic review

Consensus meeting
Delphi process
Interview
Systematic review
A systematic review was conducted to identify an exhaustive list of outcomes and outcome measures in digital replantation. The identified list of outcomes will then be used a starting point for the development of the COS.

To create the COS, we will use the Delphi Process, an iterative survey-based method using various stakeholder groups. Our stakeholders will include patients, surgeons, nurses, physiotherapists, and occupational therapists. We will conclude with a final consensus meeting, whereby an agreement of 70% must be met for the item to appear on the Core Outcome Set.


Stakeholders Involved

Clinical experts
Consumers (patients)
Epidemiologists
Researchers
Statisticians

Study Type

COS for clinical trials or clinical research

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