Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 3/2017

Open Access 01-06-2017 | Review

The COMET Handbook: version 1.0

Authors: Paula R. Williamson, Douglas G. Altman, Heather Bagley, Karen L. Barnes, Jane M. Blazeby, Sara T. Brookes, Mike Clarke, Elizabeth Gargon, Sarah Gorst, Nicola Harman, Jamie J. Kirkham, Angus McNair, Cecilia A. C. Prinsen, Jochen Schmitt, Caroline B. Terwee, Bridget Young

Published in: Trials | Special Issue 3/2017

Login to get access

Abstract

The selection of appropriate outcomes is crucial when designing clinical trials in order to compare the effects of different interventions directly. For the findings to influence policy and practice, the outcomes need to be relevant and important to key stakeholders including patients and the public, health care professionals and others making decisions about health care. It is now widely acknowledged that insufficient attention has been paid to the choice of outcomes measured in clinical trials. Researchers are increasingly addressing this issue through the development and use of a core outcome set, an agreed standardised collection of outcomes which should be measured and reported, as a minimum, in all trials for a specific clinical area.
Accumulating work in this area has identified the need for guidance on the development, implementation, evaluation and updating of core outcome sets. This Handbook, developed by the COMET Initiative, brings together current thinking and methodological research regarding those issues. We recommend a four-step process to develop a core outcome set. The aim is to update the contents of the Handbook as further research is identified.
Appendix
Available only for authorised users
Literature
1.
Gartlehner G, et al. Criteria for Distinguishing Effectiveness From Efficacy Trials in Systematic Reviews. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006. (Technical Reviews, No. 12.)
2.
Meinert CL. Clinical trials – design, conduct and analysis. 2nd ed. New York: Oxford University Press; 2012.
3.
Sackett D, et al. Evidence-Based Medicine: How to Practice and Teach EBM. Edinburgh: Churchill Livingstone; 1997.
4.
Flay BR. Efficacy and effectiveness trials (and other phases of research) in the development of health promotion programs. Prev Med. 1986;15(5):451–74.PubMedCrossRef
5.
Godwin M, et al. Pragmatic controlled clinical trials in primary care: the struggle between external and internal validity. BMC Med Res Methodol. 2003;3:28.PubMedPubMedCentralCrossRef
6.
Sedgwick P. Primary and secondary outcome measures. BMJ. 2010;340:c1938.
7.
8.
Higgins J, Green S, editors. Cochrane handbook for systematic reviews of interventions Version 5.1.0 [Updated March 2011]. 2011.
9.
AHRQ. Developing a protocol for observational comparative effectiveness research: a user’s guide. In: Velentgas P, editor. Rockville: Agency for Healthcare Research and Quality; 2013.
10.
Grimes DA, Schulz KF. Surrogate end points in clinical research: hazardous to your health. Obstet Gynecol. 2005;105(5 Pt 1):1114–8.PubMedCrossRef
11.
12.
13.
Chalmers I, Glasziou P. Avoidable waste in the production and reporting of research evidence. Lancet. 2009;374(9683):86–9.PubMedCrossRef
14.
15.
Hirsch BR, et al. Characteristics of oncology clinical trials: insights from a systematic analysis of ClinicalTrials.gov. JAMA Intern Med. 2013;173(11):972–9.PubMedCrossRef
16.
Kirkham JJ, et al. Can a core outcome set improve the quality of systematic reviews?—a survey of the Co-ordinating Editors of Cochrane Review Groups. Trials. 2013;14:21.PubMedPubMedCentralCrossRef
17.
Miyar J, Adams CE. Content and quality of 10,000 controlled trials in schizophrenia over 60 years. Schizophr Bull. 2013;39(1):226–9.PubMedCrossRef
18.
Hutton JL, Williamson PR. Bias in meta-analysis due to outcome variable selection within studies. Appl Stat. 2000;49:359–70.
19.
20.
21.
22.
23.
24.
25.
26.
Boers M, et al. World Health Organization and International League of Associations for Rheumatology core endpoints for symptom modifying antirheumatic drugs in rheumatoid arthritis clinical trials. J Rheumatol Suppl. 1994;41:86–9.PubMed
27.
28.
Kirwan JR, et al. Incorporating the patient perspective into outcome assessment in rheumatoid arthritis—progress at OMERACT 7. J Rheumatol. 2005;32(11):2250–6.
29.
Kirwan J, et al. Outcomes from the Patient Perspective Workshop at OMERACT 6. J Rheumatol. 2003;30(4):868–72.PubMed
30.
Kirwan JR, et al. Patient perspective: fatigue as a recommended patient centered outcome measure in rheumatoid arthritis. J Rheumatol. 2007;34(5):1174–7.PubMed
31.
Boers M, et al. Developing core outcome measurement sets for clinical trials: OMERACT filter 2.0. J Clin Epidemiol. 2014;67(7):745–53.PubMedCrossRef
32.
33.
34.
35.
36.
Gargon E, et al. COMET IV meeting summary. Trials. 2015;16(Suppl 1):M1.
37.
Gorst SL, et al. COMET V meeting summary. Trials. 2015;16(Suppl 3):A1.
38.
39.
Gorst SL, et al. Choosing Important Health Outcomes for Comparative Effectiveness Research: An Updated Review and User Survey. PLoS One. 2016;11(1):e0146444.PubMedPubMedCentralCrossRef
40.
41.
42.
43.
Mokkink LB, et al. The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments: an international Delphi study. Qual Life Res. 2010;19(4):539–49.PubMedPubMedCentralCrossRef
44.
Prinsen CA, et al. How to select outcome measurement instruments for outcomes included in a ‘Core Outcome Set’ – a practical guideline. Trials. 2016;17:449.PubMedPubMedCentralCrossRef
45.
46.
47.
Schmitt J, et al. The Harmonizing Outcome Measures for Eczema (HOME) roadmap: a methodological framework to develop core sets of outcome measurements in dermatology. J Investig Dermatol. 2015;135(1):24–30.PubMedCrossRef
48.
Chiarotto A, et al. Core outcome domains for clinical trials in non-specific low back pain. Eur Spine J. 2015;24(6):1127–42.PubMedCrossRef
49.
Karas J, et al. A core outcome set for clinical trials in acute diarrhoea. Arch Dis Child. 2015;100(4):359–63.PubMedCrossRef
50.
Haywood KL, et al. Developing a core outcome set for hip fracture trials. Bone Joint J. 2014;96-B(8):1016–23.PubMedCrossRef
51.
Rider LG, et al. International consensus on preliminary definitions of improvement in adult and juvenile myositis. Arthritis Rheum. 2004;50(7):2281–90.PubMedCrossRef
52.
Kirchhof P, et al. Outcome parameters for trials in atrial fibrillation: executive summary—Recommendations from a consensus conference organized by the German Atrial Fibrillation Competence NETwork (AFNET) and the European Heart Rhythm Association (EHRA). Eur Heart J. 2007;28(22):2803–17.PubMedCrossRef
53.
Zannad F, et al. Clinical outcome endpoints in heart failure trials: a European Society of Cardiology Heart Failure Association consensus document. Eur J Heart Fail. 2013;15(10):1082–94.PubMedCrossRef
54.
Ruperto N, et al. Preliminary core sets of measures for disease activity and damage assessment in juvenile systemic lupus erythematosus and juvenile dermatomyositis. Rheumatology. 2003;42(12):1452–9.PubMedCrossRef
55.
Harman NL, et al. The importance of integration of stakeholder views in core outcome set development: otitis media with effusion in children with cleft palate. PLoS One. 2015;10(6):e0129514.PubMedPubMedCentralCrossRef
56.
57.
van’t Hooft J, et al. A core outcome set for evaluation of interventions to prevent preterm birth. Obstet Gynecol. 2016;127(1):49–58.CrossRef
58.
Blazeby JM, et al. Core information set for oesophageal cancer surgery. Br J Surg. 2015;102(8):936–43.PubMedCrossRef
59.
Reddel HK, et al. An official American Thoracic Society/European Respiratory Society statement: asthma control and exacerbations: standardizing endpoints for clinical asthma trials and clinical practice. Am J Respir Crit Care Med. 2009;180(1):59–99.PubMedCrossRef
60.
Sinha IP, et al. Development of a core outcome set for clinical trials in childhood asthma: a survey of clinicians, parents, and young people. Trials. 2012;13:103.PubMedPubMedCentralCrossRef
61.
Clayton AH, et al. Standards for clinical trials in sexual dysfunction in women: research designs and outcomes assessment. J Sex Med. 2010;7(1 Pt 2):541–60.PubMedCrossRef
62.
Basson R, et al. Report of the international consensus development conference on female sexual dysfunction: definitions and classifications. J Urol. 2000;163(3):888–93.PubMedCrossRef
63.
Smolen JS, et al. Randomized clinical trials and longitudinal observational studies in systemic lupus erythematosus: consensus on a preliminary core set of outcome domains. J Rheumatol. 1999;26(2):504–7.PubMed
64.
Gordon C, et al. EULAR points to consider for conducting clinical trials in systemic lupus erythematosus. Ann Rheum Dis. 2009;68(4):470–6.PubMedCrossRef
65.
66.
67.
Sinha IP, Williamson PR, Smyth RL. Outcomes in clinical trials of inhaled corticosteroids for children with asthma are narrowly focussed on short term disease activity. PLoS One. 2009;4(7):e6276.PubMedPubMedCentralCrossRef
68.
Saldanha IJ, et al. Social network analysis identified central outcomes for core outcome sets using systematic reviews of HIV/AIDS. J Clin Epidemiol. 2016;70:164–75.PubMedCrossRef
69.
Kirkham JJ, et al. The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews. BMJ. 2010;340:c365.PubMedCrossRef
70.
71.
72.
Harman NL, et al. MOMENT--Management of otitis media with effusion in cleft palate: protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey. Trials. 2013;14:70.PubMedPubMedCentralCrossRef
73.
Chiarotto A, et al. A core outcome set for clinical trials on non-specific low back pain: study protocol for the development of a core domain set. Trials. 2014;15:511.PubMedPubMedCentralCrossRef
74.
Waters AM, et al. The CONSENSUS study: protocol for a mixed methods study to establish which outcomes should be included in a core outcome set for oropharyngeal cancer. Trials. 2014;15:168.PubMedPubMedCentralCrossRef
75.
76.
Sanderson T, et al. What outcomes from pharmacologic treatments are important to people with rheumatoid arthritis? Creating the basis of a patient core set. Arthritis Care Res. 2010;62(5):640–6.CrossRef
77.
Klokker L, et al. The concept of physical limitations in knee osteoarthritis: as viewed by patients and health professionals. Qual Life Res. 2015;24(10):2423–32.PubMedCrossRef
78.
79.
Morris C, et al. Meaningful health outcomes for paediatric neurodisability: stakeholder prioritisation and appropriateness of patient reported outcome measures. Health Qual Life Outcomes. 2015;13:87.PubMedPubMedCentralCrossRef
80.
81.
Bruce I, et al. The management of otitis media with effusion in children with cleft palate (mOMEnt): a feasibility study and economic evaluation. Health Technol Assess. 2015;19(68):1–374.PubMedPubMedCentralCrossRef
82.
Potter S, et al. Reporting clinical outcomes of breast reconstruction: a systematic review. J Natl Cancer Inst. 2011;103(1):31–46.PubMedCrossRef
83.
Blencowe NS, et al. Reporting of short-term clinical outcomes after esophagectomy: a systematic review. Ann Surg. 2012;255(4):658–66.PubMedCrossRef
84.
Hopkins JC, et al. Outcome reporting in bariatric surgery: an in-depth analysis to inform the development of a core outcome set, the BARIACT Study. Obes Rev. 2015;16(1):88–106.PubMedCrossRef
85.
Whistance RN, et al. A systematic review of outcome reporting in colorectal cancer surgery. Colorectal Dis. 2013;15(10):e548–60.PubMedCrossRef
86.
87.
Hoppe LE. Qualitative systematic reviews to increase the volume and diversity of patient perspectives included in the development of core outcome sets. Tuberculosis: a pilot study. Trials. 2015;16(Suppl 1):O3.
88.
89.
Keeley TJH, Williamson P, Callery P, Jones L, Mathers J, Jones J, Young B, Calvert M. The use of qualitative methods to inform Delphi surveys in core outcome set development. Trials. 17:230
90.
Coulman KD, Howes N, Hopkins J, et al. A comparison of health professionals’ and patients’ views of the importance of the outcomes of bariatric surgery. Obesity Surgery. 2016;26:2738.
91.
92.
93.
94.
95.
Idzerda L, et al. Can we decide which outcomes should be measured in every clinical trial? A scoping review of the existing conceptual frameworks and processes to develop core outcome sets. J Rheumatol. 2014;41(5):986–93.PubMedCrossRef
96.
Kostanjsek N. Use of The International Classification of Functioning, Disability and Health (ICF) as a conceptual framework and common language for disability statistics and health information systems. BMC Public Health. 2011;11 Suppl 4:S3.PubMedPubMedCentralCrossRef
97.
Fries JF, et al. Measurement of patient outcome in arthritis. Arthritis Rheum. 1980;23(2):137–45.PubMedCrossRef
98.
Wilson IB, Cleary PD. Linking clinical variables with health-related quality of life. A conceptual model of patient outcomes. JAMA. 1995;273(1):59–65.PubMedCrossRef
99.
Ferrans CE, et al. Conceptual model of health-related quality of life. J Nurs Scholarsh. 2005;37(4):336–42.PubMedCrossRef
100.
Gliklich RE, et al. A framework for creating standardized outcome measures for patient registries. J Comp Eff Res. 2014;3(5):473–80.PubMedCrossRef
101.
Smith V, et al. Survey of new 2007 and 2011 Cochrane reviews found 37% of prespecified outcomes not reported. J Clin Epidemiol. 2015;68(3):237–45.PubMedCrossRef
102.
Davey J, et al. Characteristics of meta-analyses and their component studies in the Cochrane Database of Systematic Reviews: a cross-sectional, descriptive analysis. BMC Med Res Methodol. 2011;11:160.PubMedPubMedCentralCrossRef
103.
Collins D. Pretesting survey instruments: an overview of cognitive methods. Qual Life Res. 2003;12(3):229–38.PubMedCrossRef
104.
Drennan J. Cognitive interviewing: verbal data in the design and pretesting of questionnaires. J Adv Nurs. 2003;42(1):57–63.PubMedCrossRef
105.
106.
Hussler C, Muller P, Rondé P. Is diversity in Delphi panelist groups useful? Evidence from a French forecasting exercise on the future of nuclear energy. Technol Forecast Soc Chang. 2011;78(9):1642–53.CrossRef
107.
Taylor WJ, et al. A modified Delphi exercise to determine the extent of consensus with OMERACT outcome domains for studies of acute and chronic gout. [Erratum appears in Ann Rheum Dis. 2008 Nov;67(11):1652. Note: Mellado, J Vazquez [corrected to Vazquez-Mellado, J]. Ann Rheum Dis. 2008;67(6):888–91.PubMedCrossRef
108.
Smith CA, Betts D. The practice of acupuncture and moxibustion to promote cephalic version for women with a breech presentation: implications for clinical practice and research. Complement Ther Med. 2014;22(1):75–80.PubMedCrossRef
109.
110.
Kloppenburg M, et al. Report from the OMERACT Hand Osteoarthritis Special Interest Group: advances and future research priorities. J Rheumatol. 2014;41(4):810–8.PubMedCrossRef
111.
Smaïl-Faugeron V, et al. Development of a core set of outcomes for randomized controlled trials with multiple outcomes—Example of pulp treatments of primary teeth for extensive decay in children. PLoS ONE. 2013;8(1):e51908.
112.
Lux AL, Osborne JP. A proposal for case definitions and outcome measures in studies of infantile spasms and West syndrome: consensus statement of the West Delphi group. Epilepsia. 2004;45(11):1416–28.PubMedCrossRef
113.
Cross H. A Delphi consensus on criteria for contraindications, assessment indicators and expected outcomes related to tibialis posterior transfer surgery. Int J Lepr Other Mycobact Dis. 2005;73(1):13–21.PubMedCrossRef
114.
Vargus-Adams JN, Martin LK. Measuring what matters in cerebral palsy: a breadth of important domains and outcome measures. Arch Phys Med Rehabil. 2009;90(12):2089–95.PubMedCrossRef
115.
Custer RL, Scarcella JA, Stewart BR. The modified Delphi technique—A rotational modification. J Career Technical Educ. 1999;15(2):1–10.CrossRef
116.
117.
Moser CA, Kalton G. Survey methods in social investigation. 2nd ed. Aldershot: Gower; 1971.
118.
McColl E, et al. Design and use of questionnaires: a review of best practice applicable to surveys of health service staff and patients. Health Technol Assess. 2001;5(31):1–256.PubMedCrossRef
119.
Bradburn NM, Mason WM. The effect of question order on responses. J Market Res. 1964;1(4):57–61.CrossRef
120.
Sudman S, Bradburn N. Asking questions: a practical guide to questionnaire design. San Francisco: Jossey-Bass; 1982.
121.
Hippler H-J, Schwarz N. Response effects in surveys. In: Hippler H-J, Schwarz N, Sudman S, editors. Social information processing and survey methodology. New York: Springer-Verlag; 1987. p. 102–22.CrossRef
122.
Siminski P. Order effects in batteries of questions. Qual Quant. 2006;42(4):477–90.CrossRef
123.
Chalmers K, et al. What is the effect of patient-reported outcome (PRO) item order on prioritisation of PROs in the development of a core outcome set? Trials. 2015;16 Suppl 2:073.CrossRef
124.
125.
Mease PJ, et al. Fibromyalgia syndrome. J Rheumatol. 2005;32(11):2270–7.PubMed
126.
Bennett WL, et al. High priority research needs for gestational diabetes mellitus. J Womens Health. 2012;21(9):925–32.CrossRef
127.
Schmitt J, et al. Core outcome domains for controlled trials and clinical recordkeeping in eczema: international multiperspective Delphi consensus process. J Investig Dermatol. 2011;131(3):623–30.PubMedCrossRef
128.
129.
Broder MS, et al. An agenda for research into uterine artery embolization: results of an expert panel conference. J Vasc Interv Radiol. 2000;11(4):509–15.PubMedCrossRef
130.
Brookes ST, et al. Three nested randomized controlled trials of peer-only or multiple stakeholder group feedback within Delphi surveys during core outcome and information set development. Trials. 2016;17:409.
131.
MacLennan S, Lam T, Williamson P. Are patients and health care professionals influenced by each others’ opinions about the outcomes to measure in localised prostate cancer effectiveness trials? Trials. 2015;16(Suppl 2):P64.
132.
Blackwood B, et al. Core Outcomes in Ventilation Trials (COVenT): protocol for a core outcome set using a Delphi survey with a nested randomised trial and observational cohort study. Trials. 2015;16:368.PubMedPubMedCentralCrossRef
133.
MacLennan S, et al. A core outcome set for localised prostate cancer effectiveness trials: protocol for a systematic review of the literature and stakeholder involvement through interviews and a Delphi survey. Trials. 2015;16:76.PubMedPubMedCentralCrossRef
134.
135.
Bardecki MJ. Participants’ response to the Delphi method: an attitudinal perspective. Technol Forecast Soc Chang. 1983;25(3):281–92.CrossRef
136.
Diamond IR, et al. Defining consensus: a systematic review recommends methodologic criteria for reporting of Delphi studies. J Clin Epidemiol. 2014;67(4):401–9.PubMedCrossRef
137.
Wylde V, et al. Assessment of chronic post-surgical pain after knee replacement: development of a core outcome set. Eur J Pain. 2015;19(5):611–20.PubMedCrossRef
138.
Sinha I, 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 Med. 2011;8(1):e1000393.PubMedPubMedCentralCrossRef
139.
Fong F, et al. Development of maternal and neonatal composite outcomes for trials evaluating management of late-onset pre-eclampsia. Hypertens Pregnancy. 2014;33(2):115–31.PubMedCrossRef
140.
Harvey N, Holmes CA. Nominal group technique: an effective method for obtaining group consensus. Int J Nurs Pract. 2012;18(2):188–94.PubMedCrossRef
141.
de Wit MP, et al. ‘If I wasn’t this robust’: patients’ expectations and experiences at the Outcome Measures in Rheumatology Conference 2010. Patient. 2013;6(3):179–87.PubMedCrossRef
142.
Kirkham JJ, Gorst S, Altman DG, Blazeby JM, Clarke M, Devane D, Gargon E, Moher D, Schmitt J, Tugwell P, Tunis S, Williamson PR. Core Outcome Set-STAndards for Reporting: The COS-STAR Statement. PLoS Medicine. 2016;13(10): e1002148
143.
Tong A, et al. Standardised outcomes in nephrology—Haemodialysis (SONG-HD): study protocol for establishing a core outcome set in haemodialysis. Trials. 2015;16:364.PubMedPubMedCentralCrossRef
144.
Mackie SL, et al. Polymyalgia Rheumatica (PMR) Special Interest Group at OMERACT 11: outcomes of importance for patients with PMR. J Rheumatol. 2014;41(4):819–23.PubMedCrossRef
145.
Allard A, et al. Key health outcomes for children and young people with neurodisability: qualitative research with young people and parents. BMJ Open. 2014;4(4):e004611.PubMedPubMedCentralCrossRef
146.
Keeley T, et al. Core outcome sets for use in effectiveness trials involving people with bipolar and schizophrenia in a community-based setting (PARTNERS2): study protocol for the development of two core outcome sets. Trials. 2015;16:47.PubMedPubMedCentralCrossRef
147.
Murphy E, et al. Qualitative research methods in health technology assessment: a review of the literature. Health Technol Assess. 1998;2(16):iii–ix. 1-274.PubMed
148.
Mathers J, et al. Using qualitative research to understand what outcomes matter to patients: direct and indirect approaches to outcome elicitation. Trials. 2015;16(Suppl 2):O39.
149.
Brett J, et al. Mapping the impact of patient and public involvement on health and social care research: a systematic review. Health Expect. 2014;17(5):637–50.PubMedCrossRef
150.
Tierney S, et al. Otitis media with effusion: experiences of children with cleft palate and their parents. Cleft Palate Craniofac J. 2015;52(1):23–30.PubMedCrossRef
151.
Carr A, et al. Rheumatology outcomes: the patient’s perspective. J Rheumatol. 2003;30(4):880–3.PubMed
152.
McAllister M, et al. Improving service evaluation in clinical genetics: identifying effects of genetic diseases on individuals and families. J Genet Couns. 2007;16(1):71–83.PubMedCrossRef
153.
McAllister M, Dunn G, Todd C. Empowerment: qualitative underpinning of a new clinical genetics-specific patient-reported outcome. Eur J Hum Genet. 2011;19(2):125–30.PubMedCrossRef
154.
O’Brien BC, et al. Standards for reporting qualitative research: a synthesis of recommendations. Acad Med. 2014;89(9):1245–51.PubMedCrossRef
155.
O’Cathain A, Murphy E, Nicholl J. The quality of mixed methods studies in health services research. J Health Serv Res Policy. 2008;13(2):92–8.PubMedCrossRef
156.
157.
158.
Whitehouse H, et al. How people with acne decide if their treatment works. A sub-project of the Acne Priority Setting Partnership. 2014: Unpublished slide set, COMET Involving People Meeting.
159.
Smelt AF, et al. What do patients consider to be the most important outcomes for effectiveness studies on migraine treatment? Results of a Delphi study. PLoS One. 2014;9(6):e98933.PubMedPubMedCentralCrossRef
160.
Prinsen CA, et al. Core Outcome Measures in Effectiveness Trials (COMET) initiative: protocol for an international Delphi study to achieve consensus on how to select outcome measurement instruments for outcomes included in a ‘core outcome set’. Trials. 2014;15(1):247.PubMedPubMedCentralCrossRef
161.
Schmitt J, Williams H, Group HD. Harmonising Outcome Measures for Eczema (HOME). Report from the First International Consensus Meeting (HOME 1), 24 July 2010, Munich, Germany. Br J Dermatol. 2010;163(6):1166–8.PubMedCrossRef
162.
McCann LJ, et al. Development of an internationally agreed minimal dataset for juvenile dermatomyositis (JDM) for clinical and research use. Trials. 2015;16:268.PubMedPubMedCentralCrossRef
163.
Olliaro P, et al. Cutaneous leishmaniasis (CL) clinical trial methodology using crowd sourcing to define core eligibility criteria and core outcome measures for cutaneous leishmaniasis clinical trials [cited 2016 April]. Available from: www.​comet-initiative.​org/​studies/​details/​807. Accessed 30 May 2017.
164.
Taïeb A, Stalder JF. Clearing up misunderstandings around core outcomes for atopic dermatitis: reply from the authors. Br J Dermatol. 2015;173(2):624–25.CrossRef
165.
166.
167.
Glasziou P, et al. Reducing waste from incomplete or unusable reports of biomedical research. Lancet. 2014;383(9913):267–76.PubMedCrossRef
168.
169.
170.
Bautista-Molano W, et al. How well are the ASAS/OMERACT Core Outcome Sets for Ankylosing Spondylitis implemented in randomized clinical trials? A systematic literature review. Clin Rheumatol. 2014;33(9):1313–22.PubMedCrossRef
171.
Bain E, Middleton P, Crowther CA. Progressing towards standard outcomes in gestational diabetes Cochrane reviews and randomised trials. Aust N Z J Obstet Gynaecol. 2016;56(1):113–6.PubMedCrossRef
172.
Clarke M, Loudon K. Effects on patients of their healthcare practitioner’s or institution’s participation in clinical trials: a systematic review. Trials. 2011;12:16.PubMedPubMedCentralCrossRef
173.
Devane D, et al. Evaluating maternity care: a core set of outcome measures. Birth. 2007;34(2):164–72.PubMedCrossRef
174.
Ghersi D, Pang T. From Mexico to Mali: four years in the history of clinical trial registration. J Evid Based Med. 2009;2(1):1–7.PubMedCrossRef
175.
176.
177.
Gargon E, Williamson PR, Clarke M. Collating the knowledge base for core outcome set development: developing and appraising the search strategy for a systematic review. BMC Med Res Methodol. 2015;15(1):26.PubMedPubMedCentralCrossRef
178.
179.
Guyatt GH, et al. GRADE guidelines: 2. Framing the question and deciding on important outcomes. J Clin Epidemiol. 2011;64(4):395–400.PubMedCrossRef
180.
181.
Page MJ, et al. Bias due to selective inclusion and reporting of outcomes and analyses in systematic reviews of randomised trials of healthcare interventions. Cochrane Database Syst Rev. 2014;10:MR000035.
182.
183.
Stewart LA, et al. Preferred Reporting Items for Systematic Review and Meta-Analyses of individual participant data: the PRISMA-IPD Statement. JAMA. 2015;313(16):1657–65.PubMedCrossRef
184.
185.
186.
Rosenbaum SE, Glenton C, Oxman AD. Summary-of-findings tables in Cochrane reviews improved understanding and rapid retrieval of key information. J Clin Epidemiol. 2010;63:620–6
187.
IHS. Guidelines for controlled trials of drugs in migraine. First edition. International Headache Society Committee on Clinical Trials in Migraine. Cephalalgia. 1991;11(1):1–12.
188.
Tfelt-Hansen P, et al. Guidelines for controlled trials of drugs in migraine: second edition. Cephalalgia. 2000;20(9):765–86.PubMedCrossRef
189.
Schoenen J. Guidelines for trials of drug treatments in tension-type headache. First edition: International Headache Society Committee on Clinical Trials. Cephalalgia. 1995;15(3):165–79.PubMedCrossRef
190.
Bendtsen L, et al. Guidelines for controlled trials of drugs in tension-type headache: second edition. Cephalalgia. 2010;30(1):1–16.PubMedCrossRef
191.
du Bois A, et al. 2004 consensus statements on the management of ovarian cancer: final document of the 3rd International Gynecologic Cancer Intergroup Ovarian Cancer Consensus Conference (GCIG OCCC 2004). Ann Oncol. 2005;16 Suppl 8:viii7–12.PubMed
192.
Stuart GCE, et al. 2010 Gynecologic Cancer InterGroup (GCIG) consensus statement on clinical trials in ovarian cancer: report from the Fourth Ovarian Cancer Consensus Conference. Int J Gynecol Cancer. 2011;21(4):750–5.PubMedCrossRef
193.
Gonzalez U, et al. Guidelines for designing and reporting clinical trials in vitiligo. Arch Dermatol. 2011;147(12):1428–36.PubMedCrossRef
194.
Eleftheriadou V, et al. Which outcomes should we measure in vitiligo? Results of a systematic review and a survey among patients and clinicians on outcomes in vitiligo trials. Br J Dermatol. 2012;167(4):804–14.PubMedCrossRef
195.
Eleftheriadou V, et al. Developing core outcome set for vitiligo clinical trials: international e-Delphi consensus. Pigment Cell Melanoma Res. 2015;28(3):363–9.PubMedCrossRef
196.
197.
Chan AW, et al. Discrepancies in sample size calculations and data analyses reported in randomised trials: comparison of publications with protocols. BMJ. 2008;337:a2299.PubMedPubMedCentralCrossRef
198.
Jones AP, et al. The use of systematic reviews in the planning, design and conduct of randomised trials: a retrospective cohort of NIHR HTA funded trials. BMC Med Res Methodol. 2013;13:50.PubMedPubMedCentralCrossRef
199.
200.
Barnes K, et al. Citation analysis: a new approach to assess the uptake of core outcome sets. Trials. 2015;16(Suppl 2):P50.
201.
Copsey B, et al. Appraising the uptake and use of recommendations for a common outcome data set for clinical trials: a case study in fall injury prevention. Trials. 2016;17(1):131.PubMedPubMedCentralCrossRef
202.
Chalmers I, et al. How to increase value and reduce waste when research priorities are set. Lancet. London. 2014;383(9912):156–65.
203.
AgencyEM. Guideline on the clinical investigation of medicinal products for the treatment of asthma CHMP/EWP/2922/01 Rev.1. European Medicines Agency; 2016.
204.
205.
Altman DG, Simera I. A history of the evolution of guidelines for reporting medical research: the long road to the EQUATOR Network. J R Soc Med. 2016;109(2):67–77.PubMedCrossRef
206.
Altman DG, Moher D, Schulz KF. Improving the reporting of randomised trials: the CONSORT Statement and beyond. Stat Med. 2012;31(25):2985–97.PubMedCrossRef
207.
208.
Main BG, et al. Core information sets for informed consent to surgical interventions: baseline information of importance to patients and clinicians. BMC Med Ethics. 2017. In press.
209.
Beauchamp TL, Childress JF. Principles of biomedical ethics. Oxford: Oxford University Press; 2001.
210.
211.
212.
MacLennan S, Williamson PR, Lam TB, Re: Martin NE, Massey L, Stowell C, et al. Defining a standard set of patient-centered outcomes for men with localized prostate cancer. Eur Urol. 2015;67:460–7.
213.
Mainz J. Defining and classifying clinical indicators for quality improvement. Int J Qual Health Care. 2003;15(6):523–30.PubMedCrossRef
214.
215.
Donabedian A. Evaluating the quality of medical care. Milbank Q. 1966;83(4):691–729.CrossRef
216.
217.
218.
219.
220.
Petzold T, et al. Evidenzbasierte Qualitätsmessung als Voraussetzung für Value-based Healthcare. Monitor Versorgungsforschung. 2015;8(3):49–54.CrossRef
221.
Schmitt J, et al. Requirements for quality indicators. The relevance of current developments in outcomes research for quality management. Z Evid Fortbild Qual Gesundhwes. 2013;107(8):516–22.PubMedCrossRef
222.
223.
Ormerod AD, et al. Challenges for synthesising data in a network of registries for systemic psoriasis therapies. Dermatology. 2012;224(3):236–43.PubMedCrossRef
224.
225.
Duncan PW, Jorgensen HS, Wade DT. Outcome measures in acute stroke trials: a systematic review and some recommendations to improve practice. Stroke. 2000;31(6):1429–38.PubMedCrossRef
226.
Roberts L, Counsell C. Assessment of clinical outcomes in acute stroke trials. Stroke. 1998;29(5):986–91.PubMedCrossRef
227.
Sinha I, et al. A systematic review of studies that aim to determine which outcomes to measure in clinical trials in children. PLoS Med. 2008;5(4):e96.PubMedPubMedCentralCrossRef
228.
Distler O, et al. Defining appropriate outcome measures in pulmonary arterial hypertension related to systemic sclerosis: a Delphi consensus study with cluster analysis. [Erratum appears in Arthritis Rheum. 2008 Aug 15;59(8):1202]. Arthritis Rheum. 2008;59(6):867–75.PubMedCrossRef
229.
Merkies ISJ, Lauria G. 131st ENMC international workshop: selection of outcome measures for peripheral neuropathy clinical trials 10–12 December 2004, Naarden, The Netherlands. Neuromuscul Disord. 2006;16(2):149–56.PubMedCrossRef
230.
Rahn DD, et al. Systematic review highlights difficulty interpreting diverse clinical outcomes in abnormal uterine bleeding trials. J Clin Epidemiol. 2011;64(3):293–300.PubMedCrossRef
231.
Chow E, et al. International consensus on palliative radiotherapy endpoints for future clinical trials in bone metastases. Radiother Oncol. 2002;64(3):275–80.PubMedCrossRef
232.
Van Der Heijde D, et al. Preliminary core sets for endpoints in ankylosing spondylitis. J Rheumatol. 1997;24(11):2225–9.PubMed
233.
Chiu AKC, Din N, Ali N. Standardising reported outcomes of surgery for intermittent exotropia—a systematic literature review. Strabismus. 2014;22(1):32–6.PubMedCrossRef
234.
Fraser JF, et al. Reporting standards for endovascular chemotherapy of head, neck and CNS tumors. J Neurointerventional Surg. 2013;5(5):396–9.CrossRef
235.
Goldhahn J, et al. Recommendation for measuring clinical outcome in distal radius fractures: a core set of domains for standardized reporting in clinical practice and research. Arch Orthop Trauma Surg. 2014;134(2):197–205.PubMedCrossRef
236.
237.
Michlovitz SL, et al. Distal radius fractures: therapy practice patterns. J Hand Ther. 2001;14(4):249–57.PubMedCrossRef
238.
Saketkoo LA, et al. Connective tissue disease related interstitial lung diseases and idiopathic pulmonary fibrosis: provisional core sets of domains and instruments for use in clinical trials. Thorax. 2014;69(5):428–36.PubMedCrossRef
239.
Dworkin RH, et al. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005;113(1-2):9–19.PubMedCrossRef
Metadata
Title
The COMET Handbook: version 1.0
Authors
Paula R. Williamson
Douglas G. Altman
Heather Bagley
Karen L. Barnes
Jane M. Blazeby
Sara T. Brookes
Mike Clarke
Elizabeth Gargon
Sarah Gorst
Nicola Harman
Jamie J. Kirkham
Angus McNair
Cecilia A. C. Prinsen
Jochen Schmitt
Caroline B. Terwee
Bridget Young
Publication date
01-06-2017
Publisher
BioMed Central
Published in
Trials / Issue Special Issue 3/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-1978-4