Skip to main content
Mijn bibliotheek
Shop
Nieuws
Boeken
Tijdschriften
E-learning
Web-tv
Video
Audio
Tips voor Mijn BSL
UITGEBREID ZOEKEN
Inloggen
Top
Quality of Life Research

Tip

Swipe om te navigeren naar een ander artikel

Gepubliceerd in: Quality of Life Research 5/2018

29-01-2018

Do patients have a say? A narrative review of the development of patient-reported outcome measures used in elective procedures for coronary revascularisation

Auteurs: Geeske Peeters, Anna L. Barker, Jason Talevski, Ilana Ackerman, Darshini R. Ayton, Christopher Reid, Sue M. Evans, Johannes U. Stoelwinder, John J. McNeil

Gepubliceerd in: Quality of Life Research | Uitgave 5/2018

Log in om toegang te krijgen
share
DELEN

Deel dit onderdeel of sectie (kopieer de link)

  • Optie A:
    Klik op de rechtermuisknop op de link en selecteer de optie “linkadres kopiëren”
  • Optie B:
    Deel de link per e-mail
    Link delen
publish
Publiceer nu

Abstract

Purpose

Patient-reported outcome measures (PROMs) capture health information from the patient’s perspective that can be used when weighing up benefits, risks and costs of treatment. This is important for elective procedures such as those for coronary revascularisation. Patients should be involved in the development of PROMs to accurately capture outcomes that are important for the patient. The aims of this review are to identify if patients were involved in the development of cardiovascular-specific PROMs used for assessing outcomes from elective coronary revascularisation, and to explore what methods were used to capture patient perspectives.

Methods

PROMs for evaluating outcomes from elective coronary revascularisation were identified from a previous review and an updated systematic search. The studies describing the development of the PROMs were reviewed for information on patient input in their conceptual and/or item development.

Results

24 PROMs were identified from a previous review and three additional PROMs were identified from the updated search. Full texts were obtained for 26 of the 27 PROMs. The 26 studies (11 multidimensional, 15 unidimensional) were reviewed. Only nine studies reported developing PROMs using patient input. For eight PROMs, the inclusion of patient input could not be judged due to insufficient information in the full text.

Conclusions

Only nine of the 26 reviewed PROMs used in elective coronary revascularisation reported involving patients in their conceptual and/or item development, while patient input was unclear for eight PROMs. These findings suggest that the patient’s perspective is often overlooked or poorly described in the development of PROMs.
vorige artikel PROMIS depression measures perform similarly to legacy measures relative to a structured diagnostic interview for depression in cancer patients
volgende artikel Conflict and well-being: a comparative study of health-related quality of life, stress, and insecurity of university students in the West Bank and Jordan
Bijlagen
Alleen toegankelijk voor geautoriseerde gebruikers
Literatuur
1.
U.S. Department of Health and Human Services Food and Drug Administration. (2009). Guidance for industry patient-reported outcomes measures: Use in medical product development to support labeling claims.
2.
McKenna S. P. (2011). Measuring patient-reported outcomes: Moving beyond misplaced common sense to hard science. BMC Medicine, 9(1), 1–12. CrossRef
3.
Brod, M., Tesler, L. E., & Christensen, T. L. (2009). Qualitative research and content validity: Developing best practices based on science and experience. Quality of Life Research, 18(9), 1263–1278. CrossRefPubMed
4.
Patrick, D. L., Burke, L. B., Gwaltney, C. J., et al. (2011). Content validity—establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: Part 1—eliciting concepts for a new PRO instrument. Value in Health, 14(8), 967–977. CrossRefPubMed
5.
Woodend, A. K., Nair, R. C., & Tang, A. S. (1997). Definition of life quality from a patient versus health care professional perspective. International Journal of Rehabilitation Research, 20(1), 71–80. CrossRefPubMed
6.
Morris, D. B., Wilson, K. G., Clinch, J. J., et al. (2006). Identification of domains relevant to health-related quality of life in patients undergoing major surgery. Quality of Life Research, 15(5), 841–854. CrossRefPubMed
7.
Staniszewska, S., Haywood, K. L., Brett, J., & Tutton, L. (2012). Patient and public involvement in patient-reported outcome measures: Evolution not revolution. Patient, 5(2), 79–87. CrossRefPubMed
8.
Rumsfeld, J. S., Alexander, K. P., Goff, D. C. Jr., et al. (2013). Cardiovascular health: The importance of measuring patient-reported health status: A scientific statement from the American Heart Association. Circulation, 127(22), 2233–2249. CrossRefPubMed
9.
Anker, S. D., Agewall, S., Borggrefe, M., et al. (2014). The importance of patient-reported outcomes: A call for their comprehensive integration in cardiovascular clinical trials. European Heart Journal, 35(30), 2001–2009. CrossRefPubMed
10.
Wijeysundera, H. C., Nallamothu, B. K., Krumholz, H. M., Tu, J. V., & Ko, D. T. (2010). Meta-analysis: Effects of percutaneous coronary intervention versus medical therapy on angina relief. Annals of Internal Medicine, 152(6), 370–379. CrossRefPubMed
11.
Trikalinos, T. A., Alsheikh-Ali, A. A., Tatsioni, A., Nallamothu, B. K., & Kent, D. M. (2009). Percutaneous coronary interventions for non-acute coronary artery disease: A quantitative 20-year synopsis and a network meta-analysis. Lancet, 373(9667), 911–918. CrossRefPubMedPubMedCentral
12.
Stergiopoulos, K., & Brown, D. L. (2012). Initial coronary stent implantation with medical therapy vs medical therapy alone for stable coronary artery disease: Meta-analysis of randomized controlled trials. Annals of Internal Medicine, 172(4), 312–319. CrossRef
13.
Thomas, S., Gokhale, R., Boden, W. E., & Devereaux, P. J. (2013). A meta-analysis of randomized controlled trials comparing percutaneous coronary intervention with medical therapy in stable angina pectoris. Canadian Journal of Cardiology, 29(4), 472–482. CrossRefPubMed
14.
Pursnani, S., Korley, F., Gopaul, R., et al. (2012). Percutaneous coronary intervention versus optimal medical therapy in stable coronary artery disease: A systematic review and meta-analysis of randomized clinical trials. Circulation, 5(4), 476–490. PubMed
15.
Mackintosh, A., Gibbons, E., Casanas i Comabella, C., & Fitzpatrick, R. (2010). A structured review of patient-reported outcome measures used in elective procedures for coronary revascularisation. Oxford: University of Oxford, Department of Public Health.
16.
Baumeister, H., Abberger, B., Haschke, A., Boecker, M., Bengel, J., & Wirtz, M. (2013). Development and calibration of an item bank for the assessment of activities of daily living in cardiovascular patients using Rasch analysis. Health and Quality of Life Outcomes, 11, 133.
17.
Oldridge, N., Hofer, S., McGee, H., Conroy, R., Doyle, F., & Saner, H. (2014). The HeartQoL: Part I. Development of a new core health-related quality of life questionnaire for patients with ischemic heart disease. European journal of preventive cardiology, 21(1), 90–97. CrossRefPubMed
18.
Wan, C., Li, H., Fan, X., et al. (2014). Development and validation of the coronary heart disease scale under the system of quality of life instruments for chronic diseases QLICD-CHD: Combinations of classical test theory and Generalizability Theory. Health and Quality of Life Outcomes, 12, 82. CrossRefPubMedPubMedCentral
19.
Nieveen, J. L., Zimmerman, L. M., Barnason, S. A., & Yates, B. C. (2008). Development and content validity testing of the Cardiac Symptom Survey in patients after coronary artery bypass grafting. Heart and Lung, 37(1), 17–27. CrossRefPubMed
20.
Green, C. P., Porter, C. B., Bresnahan, D. R., & Spertus, J. A. (2000). Development and evaluation of the Kansas City Cardiomyopathy Questionnaire: A new health status measure for heart failure. Journal of the American College of Cardiology, 35(5), 1245–1255. CrossRefPubMed
21.
Hillers, T. K., Guyatt, G. H., Oldridge, N., et al. (1994). Quality of life after myocardial infarction. Journal of Clinical Epidemiology, 47(11), 1287–1296. CrossRefPubMed
22.
Hlatky, M. A., Boineau, R. E., Higginbotham, M. B., et al. (1989). A brief self-administered questionnaire to determine functional capacity (the Duke Activity Status Index). American Journal of Cardiology, 64(10), 651–654. CrossRefPubMed
23.
Schroter, S., & Lamping, D. L. (2004). Coronary revascularisation outcome questionnaire (CROQ): Development and validation of a new, patient based measure of outcome in coronary bypass surgery and angioplasty. Heart, 90(12), 1460–1466. CrossRefPubMedPubMedCentral
24.
Jenkins, C. D., Stanton, B. A., Savageau, J. A., Denlinger, P., & Klein, M. D. (1983). Coronary artery bypass surgery. Physical, psychological, social, and economic outcomes six months later. JAMA, 250(6), 782–788. CrossRefPubMed
25.
Ferrans, C. E. (1992). Conceptualizations of quality of life in cardiovascular research. Progress in Cardiovascular Nursing, 7(1), 2–6. PubMed
26.
Ferrans, C. E., & Powers, M. J. (1985). Quality of life index: Development and psychometric properties. ANS, 8(1), 15–24.
27.
Spertus, J. A., Winder, J. A., Dewhurst, T. A., et al. (1995). Development and evaluation of the Seattle Angina Questionnaire: A new functional status measure for coronary artery disease. Journal of the American College of Cardiology, 25(2), 333–341. CrossRefPubMed
28.
Wan, C., Tu, X., Messing, S., et al. (2011). Development and validation of the general module of the system of quality of life instruments for chronic diseases and its comparison with SF-36. Journal of Pain and Symptom Management, 42(1), 93–104. CrossRefPubMed
29.
Bennett, S. J. (1992). Perceived threats of individuals recovering from myocardial infarction. Heart and Lung, 21(4), 322–326. PubMed
30.
Bennett, S. J., Puntenney, P. J., Walker, N. L., & Ashley, N. D. (1996). Development of an instrument to measure threat related to cardiac events. Nursing Research, 45(5), 266–270. CrossRefPubMed
31.
Goldman, L., Hashimoto, B., Cook, E. F., & Loscalzo, A. (1981). Comparative reproducibility and validity of systems for assessing cardiovascular functional class: Advantages of a new specific activity scale. Circulation, 64(6), 1227–1234. CrossRefPubMed
32.
Rose, G. A. (1962). The diagnosis of ischaemic heart pain and intermittent claudication in field surveys. Bull World Health Organ, 27, 645–658. PubMedPubMedCentral
33.
Rumbaugh, D. M., & Knapp, R. R. (1965). Prediction of work potential in heart patients through use of the cardiac adjustment scale. Journal of Consulting Psychology, 29(6), 597. CrossRefPubMed
34.
Barnason, S., Zimmerman, L., Atwood, J., Nieveen, J., & Schmaderer, M. (2002). Development of a self-efficacy instrument for coronary artery bypass graft patients. The Journal of Nursing Measurement, 10(2), 123–133. CrossRefPubMed
35.
Miller, K. H., & Grindel, C. G. (2004). Comparison of symptoms of younger and older patients undergoing coronary artery bypass surgery. Clinical Nursing Research, 13(3), 179–193.( discussion 194–178). CrossRefPubMed
36.
Plach, S. K., & Heidrich, S. M. (2001). Women’s perceptions of their social roles after heart surgery and coronary angioplasty. Heart and Lung, 30(2), 117–127. CrossRefPubMed
37.
The ENRICHD Investigators. (2000). Enhancing recovery in coronary heart disease patients (ENRICHD): Study design and methods. American Heart Journal, 139(1 Pt 1), 1–9.
38.
Hare, D. L., & Davis, C. R. (1996). Cardiac depression scale: Validation of a new depression scale for cardiac patients. Journal of Psychosomatic Research, 40(4), 379–386. CrossRefPubMed
39.
Peduzzi, P., & Hultgren, H. N. (1979). Effect of medical vs surgical treatment on symptoms in stable angina pectoris. The Veterans Administration Cooperative Study of surgery for coronary arterial occlusive disease. Circulation, 60(4), 888–900. CrossRefPubMed
40.
Sullivan, M. D., LaCroix, A. Z., Russo, J., & Katon, W. J. (1998). Self-efficacy and self-reported functional status in coronary heart disease: A six-month prospective study. Psychosomatic Medicine, 60(4), 473–478. CrossRefPubMed
41.
Moser, D. K., & Dracup, K. (1995). Psychosocial recovery from a cardiac event: The influence of perceived control. Heart and Lung, 24(4), 273–280. CrossRefPubMed
42.
Artinian, N. T., Duggan, C., & Miller, P. (1993). Age differences in patient recovery patterns following coronary artery bypass surgery. American Journal of Respiratory and Critical Care Medicine, 2(6), 453–461.
43.
Keresztes, P., Holm, K., Penckofer, S., & Merritt, S. (1993). Measurement of functional ability in patients with coronary artery disease. Journal of Nursing Measurement, 1(1), 19–28. PubMed
44.
Tong, A., Sainsbury, P., & Craig, J. (2007). Consolidated criteria for reporting qualitative research (COREQ): A 32-item checklist for interviews and focus groups. International Journal for Quality in Health Care, 19(6), 349–357. CrossRefPubMed
45.
Moser, D. K., Riegel, B., McKinley, S., et al. (2009). The Control attitudes scale-revised: Psychometric evaluation in three groups of patients with cardiac illness. Nursing Research, 58(1), 42–51. CrossRefPubMedPubMedCentral
46.
LaPier, T. K., & Chunkwon, J. (2002). Development and content validity of the heart surgery symptom inventory. Acute Care Perspectives, 11, 5–12.
47.
Wiering, B., de Boer, D., & Delnoij, D. (2017). Patient involvement in the development of patient-reported outcome measures: A scoping review. Health Expectations, 20(1), 11–23. CrossRefPubMed
48.
49.
Haywood, K. L., Staniszewska, S., & Chapman, S. (2012). Quality and acceptability of patient-reported outcome measures used in chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME): A systematic review. Quality of Life Research, 21(1), 35–52. CrossRefPubMed
50.
McLean, S., Holden, M. A., Potia, T., et al. (2017). Quality and acceptability of measures of exercise adherence in musculoskeletal settings: A systematic review. Rheumatology, 56(3), 426–438. PubMed
51.
Bredart, A., Marrel, A., Abetz-Webb, L., Lasch, K., & Acquadro, C. (2014). Interviewing to develop patient-reported outcome (PRO) measures for clinical research: Eliciting patients’ experience. Health and Quality of Life Outcomes, 12, 15. CrossRefPubMedPubMedCentral
52.
Lasch, K. E., Marquis, P., Vigneux, M., et al. (2010). PRO development: Rigorous qualitative research as the crucial foundation. Quality of Life Research, 19(8), 1087–1096. CrossRefPubMedPubMedCentral
53.
Boers, M., Brooks, P., Simon, L. S., Strand, V., & Tugwell, P. (2005). OMERACT: An international initiative to improve outcome measurement in rheumatology. Clinical and Experimental Rheumatology, 23(5 Suppl 39), S10–S13. PubMed
54.
Gargon, E., Williamson, P. R., Altman, D. G., Blazeby, J. M., & Clarke, M. (2014). The COMET Initiative database: Progress and activities from 2011 to 2013. Trials, 15, 279. CrossRefPubMedPubMedCentral
55.
McNamara, R. L., Spatz, E. S., Kelley, T. A., et al. (2015). Standardized outcome measurement for patients with coronary artery disease: Consensus from the International Consortium for Health Outcomes Measurement (ICHOM). Journal of the American Heart Association, 4(5), e001767 CrossRefPubMedPubMedCentral
56.
Peduzzi, P., & Hultgren, H. (1985). Angina scoring method in the Veterans Administration randomized study of bypass surgery. American Journal of Epidemiology, 122(3), 477–484. CrossRefPubMed
57.
Patrick, D. L., Burke, L. B., Powers, J. H., et al. (2007). Patient-reported outcomes to support medical product labeling claims: FDA perspective. Value in Health, 10(Suppl 2), S125–S137. CrossRefPubMed
58.
Mokkink, L. B., Terwee, C. B., Knol, D. L., et al. (2010). The COSMIN checklist for evaluating the methodological quality of studies on measurement properties: A clarification of its content. BMC Medical Research Methodology, 10, 22. CrossRefPubMedPubMedCentral
59.
Lim, L. L., Valenti, L. A., Knapp, J. C., et al. (1993). A self-administered quality-of-life questionnaire after acute myocardial infarction. Journal of Clinical Epidemiology, 46(11), 1249–1256. CrossRefPubMed
60.
Jenkins, C. D., Jono, R. T., Stanton, B. A., Stroup-Benham, C. A., (1990). The measurement of health-related quality of life: major dimensions identified by factor analysis. Social Science Medicine, 31(8), 925–931.
61.
Rose, G. A., Blackburn, H. (1968). Cardiovascular survey methods. Monograph Series World Health Organization, 56, 1–188.
Metagegevens
Titel
Do patients have a say? A narrative review of the development of patient-reported outcome measures used in elective procedures for coronary revascularisation
Auteurs
Geeske Peeters
Anna L. Barker
Jason Talevski
Ilana Ackerman
Darshini R. Ayton
Christopher Reid
Sue M. Evans
Johannes U. Stoelwinder
John J. McNeil
Publicatiedatum
29-01-2018
Uitgeverij
Springer International Publishing
Gepubliceerd in
Quality of Life Research / Uitgave 5/2018
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649
DOI
https://doi.org/10.1007/s11136-018-1795-6

Andere artikelen Uitgave 5/2018

Quality of Life Research 5/2018 Naar de uitgave

OriginalPaper

Assessing the equivalence of Web-based and paper-and-pencil questionnaires using differential item and test functioning (DIF and DTF) analysis: a case of the Four-Dimensional Symptom Questionnaire (4DSQ)

OriginalPaper

Measuring health related quality of life (HRQoL) in community and facility-based care settings with the interRAI assessment instruments: development of a crosswalk to HUI3

Review

Quality of life among parents of preterm infants: a scoping review

OriginalPaper

COSMIN guideline for systematic reviews of patient-reported outcome measures

OriginalPaper

Lifestyle-related attitudes: do they explain self-rated health and life-satisfaction?

OriginalPaper

Health state utilities and subjective well-being among psoriasis vulgaris patients in mainland China