Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2020 Sep 15;4(1):77.
doi: 10.1186/s41687-020-00244-3.

Core outcome sets in cancer and their approaches to identifying and selecting patient-reported outcome measures: a systematic review

Imogen Ramsey  1 , Marion Eckert  2 , Amanda D Hutchinson  3 , Julie Marker  4 , Nadia Corsini  2
Affiliations
Review

Core outcome sets in cancer and their approaches to identifying and selecting patient-reported outcome measures: a systematic review

Imogen Ramsey et al. J Patient Rep Outcomes. .

Abstract

Objectives: Issues arising from a lack of outcome standardisation in health research may be addressed by the use of core outcome sets (COS), which represent agreed-upon recommendations regarding what outcomes should be measured as a minimum in studies of a health condition. This review investigated the scope, outcomes, and development methods of consensus-based COS for cancer, and their approaches and criteria for selecting instruments to assess core patient-reported outcomes (PROs).

Methods: Studies that used a consensus-driven approach to develop a COS containing PROs, for use in research with cancer populations, were sought via MEDLINE, CINAHL, Embase, Cochrane Library, and grey literature.

Results: Seventeen studies met the inclusion criteria. Most COS (82%) were specific to a cancer type (prostate, esophageal, head and neck, pancreatic, breast, ovarian, lung, or colorectal) and not specific to an intervention or treatment (76%). Conducting a systematic review was the most common approach to identifying outcomes (88%) and administering a Delphi survey was the most common approach to prioritising outcomes (71%). The included COS contained 90 PROs, of which the most common were physical function, sexual (dys) function, pain, fatigue, and emotional function. Most studies (59%) did not address how to assess the core PROs included in a set, while 7 studies (41%) recommended specific instruments. Their approaches to instrument appraisal and selection varied.

Conclusion: Efforts to standardise outcome assessment via the development of COS may be undermined by a lack of recommendations on how to measure core PROs. To optimise COS usefulness and adoption, valid and reliable instruments for the assessment of core PROs should be recommended with the aid of resources designed to facilitate this process.

Keywords: Cancer; Core outcome set; Patient-reported outcomes.

PubMed Disclaimer

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Identification and selection of studies
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Williamson, P. R., Altman, D. G., Bagley, H., Barnes, K. L., Blazeby, J. M., Brookes, S. T., … Young, B. (2017). The COMET handbook: Version 1.0. Trials, 18(3), 280. 10.1186/s13063-017-1978-4. - PMC - PubMed
    1. Williamson PR, Altman DG, Blazeby JM, Clarke M, Devane D, Gargon E, Tugwell P. Developing core outcome sets for clinical trials: Issues to consider. Trials. 2012;13(1):132. doi: 10.1186/1745-6215-13-132. - DOI - PMC - PubMed
    1. Macefield, R. C., Jacobs, M., Korfage, I. J., Nicklin, J., Whistance, R. N., Brookes, S. T., … Blazeby, J. M. (2014). Developing core outcomes sets: Methods for identifying and including patient-reported outcomes (PROs). Trials, 15, 49. 10.1186/1745-6215-15-49. - PMC - PubMed
    1. Sinha IP, Smyth RL, Williamson PR. Using the Delphi technique to determine which outcomes to measure in clinical trials: Recommendations for the future based on a systematic review of existing studies. PLoS Medicine. 2011;8(1):e1000393. doi: 10.1371/journal.pmed.1000393. - DOI - PMC - PubMed
    1. Chiarotto A, Ostelo RW, Turk DC, Buchbinder R, Boers M. Core outcome sets for research and clinical practice. Brazilian Journal of Physical Therapy. 2017;21(2):77–84. doi: 10.1016/j.bjpt.2017.03.001. - DOI - PMC - PubMed

LinkOut - more resources