Hostname: page-component-848d4c4894-2pzkn Total loading time: 0 Render date: 2024-06-07T16:09:14.882Z Has data issue: false hasContentIssue false
  • English
  • Français

Comparison of participants and non-participants in patient-reported outcome surveys: the case of Assessment of Patterns of Patient-Reported Outcomes in Adults with Congenital Heart disease – International Study

Published online by Cambridge University Press:  11 May 2016

Malin C. Berghammer ,
Eva Mattsson ,
Bengt Johansson ,
Philip Moons  and
Mikael Dellborg
Malin C. Berghammer*
Affiliation:
Institute of Medicine, The Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden Centre for Person-Centred Care (GPCC), University of Gothenburg, Gothenburg, Sweden Department of Health Science, University West, Trollhättan, Sweden
Eva Mattsson
Affiliation:
Department of Cardiology, Karolinska University Hospital, Stockholm, Sweden
Bengt Johansson
Affiliation:
Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden
Philip Moons
Affiliation:
Centre for Person-Centred Care (GPCC), University of Gothenburg, Gothenburg, Sweden Institute of Health and Caring Sciences, The Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden KU Leuven Department of Public Health and Primary Care, KU Leuven – University of Leuven, Leuven, Belgium
Mikael Dellborg
Affiliation:
Institute of Medicine, The Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden Centre for Person-Centred Care (GPCC), University of Gothenburg, Gothenburg, Sweden Adult Congenital Heart Unit, Sahlgrenska University Hospital/Östra, Göteborg, Sweden
*
Correspondence to: M. Berghammer, R.N, PhD. Forskningsenheten/GPCC, Medicinkliniken, Sahlgrenska Universitetssjukhuset/Östra, S-41685 Gothenburg, Sweden. Tel.: +46 31 3435922; Fax: +46 31 191416; E-mail: malin.berghammer@gu.se
Get access Rights & Permissions [Opens in a new window]

Abstract

Background

The last decade has seen a vast increase in the use of patient-reported outcomes. As patient-reported outcomes are used in order to capture patients’ perspectives of their health and illness, it is a prerequisite for accurate patient-reported outcome evaluations to use representative samples. In order to evaluate representativeness, the present study focussed on the comparison between participants and non-participants in the Swedish branch of the international study APPROACH-IS (Assessment of Patterns of Patient-Reported Outcomes in Adults with Congenital Heart disease – International Study), regarding demographic, clinical, and health status characteristics.

Methods

Eligible patients for APPROACH-IS were identified and selected from SWEDCON, the Swedish registry for congenital heart disease (CHD). Overall, 912 eligible patients were identified, of whom 471 participated, 398 did not participate, and 43 were either unreachable or declined to participate in APPROACH-IS. The participants and non-participants were compared in terms of statistical significance and effect sizes.

Results

Significant differences were observed between participants and non-participants for sex, age, primary diagnosis, number of cardiac operations, and fatigue; however, the effect sizes were in general small, except for the difference in primary diagnosis. No differences between the two groups were found in number of catheterisations, implanted device, the distribution of NYHA functional class, or health status and symptoms.

Conclusions

This study shows that participants and non-participants are relatively comparable groups, which confirms the representativeness of the participants. The Swedish data from APPROACH-IS can therefore be reliably generalised to the population of adults with CHD in Sweden.

Keywords

Adultsheart defectcongenitalpatient-reported outcomemulticentre studycomparison
Type
Original Articles
Information
Cardiology in the Young , Volume 27 , Issue 3 , March 2017 , pp. 427 - 434
Check for updates
Copyright
© Cambridge University Press 2016 

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

1. Moons, P, Bovijn, L, Budts, W, Belmans, A, Gewillig, M. Temporal trends in survival to adulthood among patients born with congenital heart disease from 1970 to 1992 in Belgium. Circulation 2010; 122: 2264–2272.CrossRefGoogle ScholarPubMed
2. Marelli, AJ, Mackie, AS, Ionescu-Ittu, R, Rahme, E, Pilote, L. Congenital heart disease in the general population: changing prevalence and age distribution. Circulation 2007; 115: 163–172.CrossRefGoogle ScholarPubMed
3. Marelli, AJ, Ionescu-Ittu, R, Mackie, AS, Guo, L, Dendukuri, N, Kaouache, M. Lifetime prevalence of congenital heart disease in the general population from 2000 to 2010. Circulation 2014; 130: 749–756.CrossRefGoogle ScholarPubMed
4. Baumgartner, H, Bonhoeffer, P, De Groot, NMS, et al. ESC Guidelines for the management of grown-up congenital heart disease (new version 2010). Eur Heart J 2010; 31: 2915–2957.Google ScholarPubMed
5. Fitzpatrick, R. Principles and problems in the assessment of quality of life in health care. Ethical Theory Moral Pract 1999; 2: 37–46.CrossRefGoogle ScholarPubMed
6. Calvert, M, Blazeby, J, Altman, DG, et al. Reporting of patient-reported outcomes in randomized trials: the consort pro extension. JAMA 2013; 309: 814–822.CrossRefGoogle ScholarPubMed
7. Dawson, J, Doll, H, Fitzpatrick, R, Jenkinson, C, Carr, AJ. The routine use of patient reported outcome measures in healthcare settings. BMJ 2010; 340: c186.CrossRefGoogle Scholar
8. US Department of Health and Human Services Food and Drug Administration. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims 2009. http://www.fda.gov/downloads/Drugs/Guidances/UCM193282.pdf, 43pp.Google Scholar
9. Marshall, S, Haywood, K, Fitzpatrick, R. Impact of patient-reported outcome measures on routine practice: a structured review. J Eval Clin Pract 2006; 12: 559–568.CrossRefGoogle Scholar
10. Lee, S, Monz, BU, Clemens, A, Brueckmann, M, Lip, GYH. Representativeness of the dabigatran, apixaban and rivaroxaban clinical trial populations to real-world atrial fibrillation patients in the United Kingdom: a cross-sectional analysis using the General Practice Research Database. BMJ Open 2012; 2.CrossRefGoogle ScholarPubMed
11. Hordijk-Trion, M, Lenzen, M, Wijns, W, et al. Patients enrolled in coronary intervention trials are not representative of patients in clinical practice: results from the Euro Heart Survey on Coronary Revascularization. Eur Heart J 2006; 27: 671–678.CrossRefGoogle Scholar
12. de Boer, SPM, Lenzen, MJ, Oemrawsingh, RM, et al. Evaluating the “all-comers” design: a comparison of participants in two “all-comers” PCI trials with non-participants. Eur Heart J 2011; 32: 2161–2167.CrossRefGoogle ScholarPubMed
13. Björklund, E, Lindahl, B, Stenestrand, U, et al. Outcome of ST-elevation myocardial infarction treated with thrombolysis in the unselected population is vastly different from samples of eligible patients in a large-scale clinical trial. Am Heart J 2004; 148: 566–573.CrossRefGoogle Scholar
14. Apers, S, Kovacs, AH, Luyckx, K, et al. Assessment of Patterns of Patient-Reported Outcomes in Adults with Congenital Heart disease – International Study (APPROACH-IS): Rationale, design, and methods. Int J Cardiol 2015; 179: 334–342.CrossRefGoogle Scholar
15. Apers, SKA, Luyckx, K, Thomet, C, et al. Quality-of-life in adult congenital heart disease in 15 countries: integrating population measures and cultural dimensions. J Am Coll Cardiol 2016; 67: 2237–2245.CrossRefGoogle Scholar
16. Brooks, R. EuroQol: the current state of play. Health Policy 1996; 37: 53–72.CrossRefGoogle ScholarPubMed
17. Dolan, P. Modeling valuations for EuroQol health states. Med Care 1997; 35: 1095–1108.CrossRefGoogle ScholarPubMed
18. Mitchell, SC, Korones, SB, Berendes, HW. Congenital heart disease in 56109 births incidence and natural history. Circulation 1971; 43: 323–332.CrossRefGoogle Scholar
19. Vind, AB, Andersen, HE, Pedersen, KD, Jørgensen, T, Schwarz, P. Baseline and follow-up characteristics of participants and nonparticipants in a randomized clinical trial of multifactorial fall prevention in denmark. J Am Geriatr Soc 2009; 57: 1844–1849.CrossRefGoogle Scholar
20. Apers, S, Luyckx, K, Moons, P. Quality of life in adult congenital heart disease: what do we already know and what do we still need to know? Curr Cardiol Rep 2013; 15: 1–6.CrossRefGoogle ScholarPubMed
21. Vigl, M, Niggemeyer, E, Hager, A, Schwedler, G, Kropf, S, Bauer, U. The importance of socio-demographic factors for the quality of life of adults with congenital heart disease. Qual Life Res 2011; 20: 169–177.CrossRefGoogle ScholarPubMed
22. Fteropoulli, T, Stygall, J, Cullen, S, Deanfield, J, Newman, SP. Quality of life of adult congenital heart disease patients: a systematic review of the literature. Cardiol Young 2013; 23: 473–485.CrossRefGoogle ScholarPubMed
23. Silva, AM, Vaz, C, Areias, MEG, et al. Quality of life of patients with congenital heart diseases. Cardiol Young 2011; 21: 670–676.CrossRefGoogle ScholarPubMed
24. Teixeira, F, Coelho, R, Proença, C, et al. Quality of life experienced by adolescents and young adults with congenital heart disease. Pediatr Cardiol 2011; 32: 1132–1138.CrossRefGoogle Scholar
25. Galea, S, Tracy, M. Participation rates in epidemiologic studies. Ann Epidemiol 2007; 17: 643–653.CrossRefGoogle ScholarPubMed
26. Berghammer, MC, Brink, E, Rydberg, AM, Dellborg, M, Ekman, I. Committed to life: adolescents’ and young adults’ experiences of living with fontan circulation. Congenit Heart Dis 2015; 10: 403–412.CrossRefGoogle Scholar
27. Rauch, JB, Kneen, KK. Accepting the gift of life. Soc Work Health Care 1989; 14: 47–59.CrossRefGoogle ScholarPubMed
28. Overgaard, D, Schrader, AM, Lisby, KH, et al. Patient-reported outcomes in adult survivors with single-ventricle physiology. Cardiology 2011; 120: 36–42.CrossRefGoogle ScholarPubMed
29. Burstrom, K, Johannesson, M, Diderichsen, F. Swedish population health-related quality of life results using the EQ-5D. Qual Life Res 2001; 10: 621–635.CrossRefGoogle ScholarPubMed