Developing a Core Outcome Set (COS) for melanoma trials

In melanoma research there is no uniformity in outcome reporting. Further, it is unknown which outcomes, for example ‘survival’ and ‘health-related quality of life’, are most important to patients and healthcare providers. This causes inconsistencies in outcome reporting, potential for selective outcome reporting (bias), and difficulties in comparing and pooling the outcomes in systematic reviews and meta-analyses at the cost of the best possible care for melanoma patients. The urgency of standardizing outcome reporting is now even bigger in the era of new developed costly treatments. High quality systematic reviews and meta analyses are needed to accurately inform healthcare providers on the most (cost-)effective treatments .
With an international collaboration representing melanoma patients, researchers, healthcare providers and methodologists, we aim to develop a standardized set of outcomes (i.e., what to measure), and recommendations on outcome measurement instruments that can be used to measure these outcomes (i.e., how to measure). With the standardization in outcome reporting in clinical trials, comparative effectiveness research will largely be improved. This will ultimately lead to an improvement of evidence-based healthcare decisions.

Contributors

Dr CAC Prinsen (clinical epidemiologist, the Netherlands) Dr A van Akkooi (surgical oncologist, the Netherlands) Dr MW Bekkenk (dermatologist, the Netherlands) Prof Dr M Boers (rheumatologist, the Netherlands) Ms C Chauhan (patient research partner, USA) Ms S Deckert (scientific researcher, Germany) Ms A Nollen (chair Dutch Melanoma Foundation, the Netherlands) Prof Dr J Schmitt (dermatologist, Germany) Prof Dr PhI Spuls (dermatologist, the Netherlands) Prof Dr R Stern (dermatologist, USA) Dr CB Terwee (epidemiologist, the Netherlands)

Further Study Information

Current Stage: Planning
Date:
Funding source(s): Funding is being sought


Health Area

Disease Category: Cancer, Skin

Disease Name: Skin cancer , Melanoma

Target Population

Age Range: 18 - 100

Sex: Either

Nature of Intervention:

Stakeholders Involved

- Clinical experts
- Consumers (patients)
- Epidemiologists
- Journal editors
- Methodologists
- Patient/ support group representatives
- Pharmaceutical industry representatives
- Policy makers
- Regulatory agency representatives
- Researchers

Study Type

- COS for clinical trials or clinical research

Method(s)

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

Following the methodological framework of the Harmonising Outcome Measures for Eczema (HOME) initiative, a core outcome set for melanoma will be developed.

The HOME framework comprises a four step development process:

1. Our target population includes adult patients with melanoma, defined as cutaneous stage 0-IV melanoma.

2. A systematic literature review will be conducted to identify all outcomes that have been reported in melanoma trials, and all existing outcome measurement instruments used to measure these outcomes. We will systematically summarize all outcomes and, subsequently, we will critically appraise the identified outcome measurement instruments per outcome by means of an additional systematic reviews, using the COSMIN checklist (www.cosmin.nl) and the quality criteria as defined by Terwee at al. (2007) The results of the systematic reviews will be used to inform the Delphi consensus process.

3. Consensus will be based on an international collaboration representing melanoma patients, researchers (including methodologists), healthcare providers (including dermatologists, oncologists, surgeons, and nurses), policy makers (including regulators and payers), representatives from the pharmaceutical industry, representatives from drug regulatory authorities, and journal editors. A Delphi study, followed by group discussions and a plenary discussion plus voting, will be used to achieve consensus on the core set of outcomes and outcome measurement instruments.

4. An implementation plan will be developed to disseminate the entire core set among the scientific community and healthcare providers. The degree to which the core set has been implemented will be evaluated

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