The approach of choosing outcome measurement instruments in clinical trials_Chinese Journal of Evidence-Based Medicine

Authors：

QIU Ruijin ¹ , SUN Yang ¹ , HU Jiayuan ¹ , LI Min ¹ , HE Tianmai ¹ , HUANG Ya ¹ , HAN Songjie ¹ ,  CHEN Jing ² ,  SHANG Hongcai ¹

1. Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Traditional Chinese Medicine, Beijing, 100700, P.R China;
2. Baokang Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, P.R.China;

Corresponding author：

CHEN Jing, Email: cjshcsyc@126.com; SHANG Hongcai, Email: shanghongcai@foxmail.com

Keywords：

Clinical trial; Mixed methods research; Core outcome set; Core outcome measurement instrument set

DOI：

10.7507/1672-2531.201709017

Video：

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It is crucial to select outcomes in clinical trials. Appropriate outcomes can improve value and significance of trials and reduce the cost of investment. This paper describes how to develop core outcome sets and core outcome measurement instrument sets with the theory of mixed methods research, so as to standardize the choice of outcomes and outcome measurement instruments in clinical trials.

Citation： QIU Ruijin, SUN Yang, HU Jiayuan, LI Min, HE Tianmai, HUANG Ya, HAN Songjie, CHEN Jing, SHANG Hongcai. The approach of choosing outcome measurement instruments in clinical trials. Chinese Journal of Evidence-Based Medicine, 2018, 18(2): 238-243. doi: 10.7507/1672-2531.201709017 Copy

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2.	Gabriel SE, Normand SL. Getting the methods right-the foundation of patient-centered outcomes research. N Engl J Med, 2012, 367(9): 787-790.
3.	Adams CE. Content and quality of 10 000 controlled trials in schizophrenia over 60 years. Schizophr Bull, 2013, 39(1): 226-229.
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5.	Coyne K, Margolis MK, Grandy S, et al. The state of patient-reported outcomes in atrial fibrillation. Pharmacoeconomics, 2005, 23(7): 687-708.
6.	Spertus J, Dorian P, Bubien R, et al. Development and validation of the atrial fibrillation effect on quality-of-life (AFEQT) questionnaire in patients with atrial fibrillation. Circ Arrhythm Electrophysiol, 2011, 4(1): 15-25.
7.	Caraceni A, Cherny N, Fainsinger R, et al. Pain measurement tools and methods in clinical research in palliative care: recommendations of an expert working group of the European Association of Palliative Care. J Pain Symptom Manage, 2002, 23(3): 239-255.
8.	Schmelzer M, Daniels G. Measurement tool requirements. Gastroenterol Nurs, 2007, 30(2): 136-138.
9.	Mokkink LB, Terwee CB, Stratford PW, et al. Evaluation of the methodological quality of systematic reviews of health status measurement instruments. Qual Life Res, 2009, 18(3): 313-333.
10.	Mokkink LB, Prinsen CA, Bouter LM, et al. The consensus-based standards for the selection of health measurement instruments (COSMIN) and how to select an outcome measurement instrument. Braz J Phys Ther, 2016, 20(2): 105-113.
11.	Boers M, Kirwan JR, Wells G, et al. Developing Core outcome measurement sets for clinical trials: OMERACT Filter 2.0. J Clin Epidemiol, 2014, 67(7): 745-753.
12.	Johnson RB, Onwuegbuzie AJ, Turner LA. Toward a definition of mixed methods research. J Mix Methods Res, 2007, 1(2): 112-133.
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14.	Campbell DT, Fiske DW. Convergent and discriminant validation by the multitrait-multimethod matrix. Psychological Bulletin, 1959, 56(2): 81-105.
15.	Tashakkori A, Creswell JW. The new era of mixed methods. J Mix Methods Res, 2007, 1 (1) :3-7.
16.	Johnson RB, Onwuegbuzie AJ. Mixed methods research: A research paradigm whose time has come. Edu Res, 2004, 33(7): 14-26.
17.	Giddings LS. Mixed methods research: Positivism dressed in drag? J Res Nurs, 2006, 11(3): 195-203.
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19.	Williamson PR, Altman DG., Bagley H., et al. The COMET handbook: version 1.0. Trials, 2017, 18(Suppl 3): 280.
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21.	Millar AN, Daffu-O'Reilly A, Hughes CM, et al. Development of a core outcome set for effectiveness trials aimed at optimising prescribing in older adults in care homes. Trials, 2017, 18(1): 175.
22.	Available at: http://www.comet-initiative.org/studies/details/669.
23.	Available at: http://www.comet-initiative.org/studies/Details/941.
24.	Prinsen CA, Vohra S, Rose MR, et al. How to select outcome measurement instruments for outcomes included in a " Core Outcome Set”-a practical guideline. Trials, 2016, 17(1): 449.
25.	Stiel S, Psych D, Kues K, et al. Assessment of quality of life in patients receiving palliative care: comparison of measurement tools and single item on subjective well-being. J Palliat Med, 2011, 14(5): 599-606.
26.	Mokkink LB, Terwee CB, Patrick DL, 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):539-549.
27.	Available at: http://www.cosmin.nl/.
28.	Karas J, Ashkenazi S, Guarino A, et al. Developing a core outcome measurement set for clinical trials in acute diarrhea. Acta Paediatr, 2016, 105(4): e176-180.
29.	Available at: http://www.comet-initiative.org/.
30.	Karanicolas PJ, Bhandari M, Kreder H, et al. Evaluating agreement: conducting a reliability study. J Bone Joint Surg Am, 2009, 91(Suppl 3): 99-106.
31.	Terwee CB, Bot SD, de Boer MR, et al. Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol, 2007, 60(1): 34-42.
32.	Kirkham JJ, Gargon E, Clarke M, 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.
33.	Kirkham JJ, Dwan KM, Altman DG, et al. The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews. BMJ, 2010, 340: c365.
34.	Hirsch BR, Califf RM, Cheng SK, et al. Characteristics of oncology clinical trials: insights from a systematic analysis of ClinicalTrials.gov. JAMA Intern Med, 2013, 173(11): 972-973.
35.	Clarke M, Williamson PR. Core outcome sets and systematic reviews. Syst Rev, 2016, 5: 11.
36.	Higgins JPT, Green S, editors. Cochrane handbook for systematic reviews of intervention version 510. The Cochrane Collaboration, 2011. Available at: http://www.cochrane-handbook.org.
37.	Williamson P, Altman D, Blazeby J, et al. Driving up the quality and relevance of research through the use of agreed core outcomes. J Health Serv Res Policy, 2012, 17(1): 1-2.

1. Kimberlin CL, Winterstein AG. Validity and reliability of measurement instruments used in research. Am J Health Syst Pharm, 2008, 65(23): 2276-2284.
2. Gabriel SE, Normand SL. Getting the methods right-the foundation of patient-centered outcomes research. N Engl J Med, 2012, 367(9): 787-790.
3. Adams CE. Content and quality of 10 000 controlled trials in schizophrenia over 60 years. Schizophr Bull, 2013, 39(1): 226-229.
4. Wells GA, Russell AS, Haraoui B, et al. Validity of quality of life measurement tools-from generic to disease-specific. J Rheumatol Suppl, 2011, 88: 2-6.
5. Coyne K, Margolis MK, Grandy S, et al. The state of patient-reported outcomes in atrial fibrillation. Pharmacoeconomics, 2005, 23(7): 687-708.
6. Spertus J, Dorian P, Bubien R, et al. Development and validation of the atrial fibrillation effect on quality-of-life (AFEQT) questionnaire in patients with atrial fibrillation. Circ Arrhythm Electrophysiol, 2011, 4(1): 15-25.
7. Caraceni A, Cherny N, Fainsinger R, et al. Pain measurement tools and methods in clinical research in palliative care: recommendations of an expert working group of the European Association of Palliative Care. J Pain Symptom Manage, 2002, 23(3): 239-255.
8. Schmelzer M, Daniels G. Measurement tool requirements. Gastroenterol Nurs, 2007, 30(2): 136-138.
9. Mokkink LB, Terwee CB, Stratford PW, et al. Evaluation of the methodological quality of systematic reviews of health status measurement instruments. Qual Life Res, 2009, 18(3): 313-333.
10. Mokkink LB, Prinsen CA, Bouter LM, et al. The consensus-based standards for the selection of health measurement instruments (COSMIN) and how to select an outcome measurement instrument. Braz J Phys Ther, 2016, 20(2): 105-113.
11. Boers M, Kirwan JR, Wells G, et al. Developing Core outcome measurement sets for clinical trials: OMERACT Filter 2.0. J Clin Epidemiol, 2014, 67(7): 745-753.
12. Johnson RB, Onwuegbuzie AJ, Turner LA. Toward a definition of mixed methods research. J Mix Methods Res, 2007, 1(2): 112-133.
13. Creswell JW(著), 李敏谊 (译). 混合方法研究导论. 上海: 格致出版社, 上海人民出版社, 2015: 1.
14. Campbell DT, Fiske DW. Convergent and discriminant validation by the multitrait-multimethod matrix. Psychological Bulletin, 1959, 56(2): 81-105.
15. Tashakkori A, Creswell JW. The new era of mixed methods. J Mix Methods Res, 2007, 1 (1) :3-7.
16. Johnson RB, Onwuegbuzie AJ. Mixed methods research: A research paradigm whose time has come. Edu Res, 2004, 33(7): 14-26.
17. Giddings LS. Mixed methods research: Positivism dressed in drag? J Res Nurs, 2006, 11(3): 195-203.
18. Zhang L, Zhang JH, Chen J, et al. Clinical research of Traditional Chinese Medicine needs to develop its own system of core outcome sets. Evid Based Complement Alternat Med, 2013, 2013: 202703.
19. Williamson PR, Altman DG., Bagley H., et al. The COMET handbook: version 1.0. Trials, 2017, 18(Suppl 3): 280.
20. Guyatt GH, Oxman AD, Vist GE, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ, 2008, 336: 924e6.
21. Millar AN, Daffu-O'Reilly A, Hughes CM, et al. Development of a core outcome set for effectiveness trials aimed at optimising prescribing in older adults in care homes. Trials, 2017, 18(1): 175.
22. Available at: http://www.comet-initiative.org/studies/details/669.
23. Available at: http://www.comet-initiative.org/studies/Details/941.
24. Prinsen CA, Vohra S, Rose MR, et al. How to select outcome measurement instruments for outcomes included in a " Core Outcome Set”-a practical guideline. Trials, 2016, 17(1): 449.
25. Stiel S, Psych D, Kues K, et al. Assessment of quality of life in patients receiving palliative care: comparison of measurement tools and single item on subjective well-being. J Palliat Med, 2011, 14(5): 599-606.
26. Mokkink LB, Terwee CB, Patrick DL, 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):539-549.
27. Available at: http://www.cosmin.nl/.
28. Karas J, Ashkenazi S, Guarino A, et al. Developing a core outcome measurement set for clinical trials in acute diarrhea. Acta Paediatr, 2016, 105(4): e176-180.
29. Available at: http://www.comet-initiative.org/.
30. Karanicolas PJ, Bhandari M, Kreder H, et al. Evaluating agreement: conducting a reliability study. J Bone Joint Surg Am, 2009, 91(Suppl 3): 99-106.
31. Terwee CB, Bot SD, de Boer MR, et al. Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol, 2007, 60(1): 34-42.
32. Kirkham JJ, Gargon E, Clarke M, 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.
33. Kirkham JJ, Dwan KM, Altman DG, et al. The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews. BMJ, 2010, 340: c365.
34. Hirsch BR, Califf RM, Cheng SK, et al. Characteristics of oncology clinical trials: insights from a systematic analysis of ClinicalTrials.gov. JAMA Intern Med, 2013, 173(11): 972-973.
35. Clarke M, Williamson PR. Core outcome sets and systematic reviews. Syst Rev, 2016, 5: 11.
36. Higgins JPT, Green S, editors. Cochrane handbook for systematic reviews of intervention version 510. The Cochrane Collaboration, 2011. Available at: http://www.cochrane-handbook.org.
37. Williamson P, Altman D, Blazeby J, et al. Driving up the quality and relevance of research through the use of agreed core outcomes. J Health Serv Res Policy, 2012, 17(1): 1-2.

Chinese Journal of Evidence-Based Medicine

The approach of choosing outcome measurement instruments in clinical trials

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