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Optimizing Study Design for Evaluating Complex Interventions: An Example of a Feasibility Study in Person-Centered and Integrated Chronic Disease Care in Dutch General Practice Cover

Optimizing Study Design for Evaluating Complex Interventions: An Example of a Feasibility Study in Person-Centered and Integrated Chronic Disease Care in Dutch General Practice

Open Access
|Nov 2025

References

  1. 1Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, et al. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ (Clinical research ed). 2021;374:n2061. DOI: 10.1136/bmj.n2061
  2. 2Raaijmakers LHA, Schermer TR, Wijnen M, van Bommel HE, Michielsen L, Boone F, et al. Development of a Person-Centred Integrated Care Approach for Chronic Disease Management in Dutch Primary Care: A Mixed-Method Study. Int J Environ Res Public Health. 2023;20(5). DOI: 10.3390/ijerph20053824
  3. 3Birke H, Jacobsen R, Jonsson AB, Guassora ADK, Walther M, Saxild T, et al. A complex intervention for multimorbidity in primary care: A feasibility study. J Comorb. 2020;10:2235042X20935312. DOI: 10.1177/2235042X20935312
  4. 4Grant AM, Guthrie B, Dreischulte T. Developing a complex intervention to improve prescribing safety in primary care: mixed methods feasibility and optimisation pilot study. Bmj Open. 2014;4(1). DOI: 10.1136/bmjopen-2013-004153
  5. 5North T-L, Harrison S, Bishop DC, Wootton RE, Carter AR, Richardson TG, et al. Educational inequality in multimorbidity: causality and causal pathways. A mendelian randomisation study in UK Biobank. BMC Public Health. 2023;23(1):1644. DOI: 10.1186/s12889-023-16369-1
  6. 6Dalstra J, Kunst A, Borrell C, Breeze E, Cambois E, Costa G, et al. Socioeconomic differences in the prevalence of common chronic diseases: an overview of eight European countries. International Journal of Epidemiology. 2005;34(2):31626. DOI: 10.1093/ije/dyh386
  7. 7Sikka R, Morath JM, Leape L. The Quadruple Aim: care, health, cost and meaning in work. BMJ Qual Saf. 2015;24(10):60810. DOI: 10.1136/bmjqs-2015-004160
  8. 8Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985;49(1):715. DOI: 10.1207/s15327752jpa4901_13
  9. 9Fugl-Meyer AR, Bränholm I-B, Fugl-Meyer KS. Happiness and domain-specific life satisfaction in adult northern Swedes. Clinical Rehabilitation. 1991;5(1):2533. DOI: 10.1177/026921559100500105
  10. 10Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5 L). Qual Life Res. 2011;20(10):172736. DOI: 10.1007/s11136-011-9903-x
  11. 11Ware J Jr., Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996;34(3):22033. DOI: 10.1097/00005650-199603000-00003
  12. 12Postma SAE, van Boven K, Ten Napel H, Gerritsen DL, Assendelft WJJ, Schers H, et al. The development of an ICF-based questionnaire for patients with chronic conditions in primary care. J Clin Epidemiol. 2018;103:92100. DOI: 10.1016/j.jclinepi.2018.07.005
  13. 13Hibbard JH, Stockard J, Mahoney ER, Tusler M. Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. Health services research. 2004;39(4 Pt 1):100526. DOI: 10.1111/j.1475-6773.2004.00269.x
  14. 14Hays RD, Bjorner JB, Revicki DA, Spritzer KL, Cella D. Development of physical and mental health summary scores from the patient-reported outcomes measurement information system (PROMIS) global items. Qual Life Res. 2009;18(7):87380. DOI: 10.1007/s11136-009-9496-9
  15. 15Hackert MQN, van Exel J, Brouwer WBF. Content validation of the Well-being of Older People measure (WOOP). Health Qual Life Outcomes. 2021;19(1):200. DOI: 10.1186/s12955-021-01834-5
  16. 16Makai P, Koopmanschap MA, Brouwer WB, Nieboer AA. A validation of the ICECAP-O in a population of post-hospitalized older people in the Netherlands. Health Qual Life Outcomes. 2013;11:57. DOI: 10.1186/1477-7525-11-57
  17. 17Glasgow RE, Wagner EH, Schaefer J, Mahoney LD, Reid RJ, Greene SM. Development and validation of the Patient Assessment of Chronic Illness Care (PACIC). Med Care. 2005;43(5):43644. DOI: 10.1097/01.mlr.0000160375.47920.8c
  18. 18Meuwissen LE, de Bakker DH. [‘Consumer quality’-index ‘General practice care’ measures patients’ experiences and compares general practices with each other]. Ned Tijdschr Geneeskd. 2009;153:A180.
  19. 19Hendriks M, Krol M, Zuizewind C. PREM Eerstelijnszorg en PREM Chronische zorg: cognitieve validatie van twee vragenlijsten over patiëntervaringen met de zorg in de eerste lijn; 2016.
  20. 20Lloyd H, Fosh B, Whalley B, Byng R, Close J. Validation of the person-centred coordinated care experience questionnaire (P3CEQ). International journal for quality in health care: journal of the International Society for Quality in Health Care. 2019;31(7):50612. DOI: 10.1093/intqhc/mzy212
  21. 21Etz RS, Zyzanski SJ, Gonzalez MM, Reves SR, O’Neal JP, Stange KC. A New Comprehensive Measure of High-Value Aspects of Primary Care. Annals of family medicine. 2019;17(3):22130. DOI: 10.1370/afm.2393
  22. 22Uijen AA, Schellevis FG, van den Bosch WJ, Mokkink HG, van Weel C, Schers HJ. Nijmegen Continuity Questionnaire: development and testing of a questionnaire that measures continuity of care. J Clin Epidemiol. 2011;64(12):13919. DOI: 10.1016/j.jclinepi.2011.03.006
  23. 23Pharos Checklist for Questionnaires in Healthcare. Pharos; Available from: https://www.pharos.nl/kennisbank/test-je-vragenlijst-op-begrijpelijkheid/.
  24. 24Klinkende Taal. Available from: https://klinkendetaal.nl/.
  25. 25Common European Framework of References and Languages (CEFR). Council of Europe; Available from: https://www.coe.int/en/web/common-european-framework-reference-languages.
  26. 26Tuinenburg A, Determann D, Quik EH, van der Willik EM, Hofstra G, Hallegraeff JM, et al. Evaluating Comprehensibility of 157 Patient-Reported Outcome Measures (PROMs) in the Nationwide Dutch Outcome-Based Healthcare Program: More Attention for Comprehensibility of PROMs is Needed. The Patient – Patient-Centered Outcomes Research. 2024. DOI: 10.1007/s40271-024-00710-w
  27. 27Norman GR, Sloan JA, Wyrwich KW. Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med Care. 2003;41(5):58292. DOI: 10.1097/01.MLR.0000062554.74615.4C
  28. 28Ross S. Composite outcomes in randomized clinical trials: arguments for and against. American Journal of Obstetrics and Gynecology. 2007;196(2):119.e1–e6. DOI: 10.1016/j.ajog.2006.10.903
  29. 29Physical Activity Guidelines. Health Council of the Netherlands; 2017.
  30. 30Masnoon N, Shakib S, Kalisch-Ellett L, Caughey GE. What is polypharmacy? A systematic review of definitions. BMC geriatrics. 2017;17(1):230. DOI: 10.1186/s12877-017-0621-2
  31. 31van Marum RJ, Burgers JS, Bouvy ML. Polypharmacy in elderly patients. Ned Tijdschr Geneeskd. 2021;165.
  32. 32Greene J, Hibbard JH, Sacks R, Overton V, Parrotta CD. When Patient Activation Levels Change, Health Outcomes And Costs Change, Too. Health Affairs. 2015;34(3):4317. DOI: 10.1377/hlthaff.2014.0452
  33. 33Campbell MK, Mollison J, Steen N, Grimshaw JM, Eccles M. Analysis of cluster randomized trials in primary care: a practical approach. Fam Pract. 2000;17(2):1926. DOI: 10.1093/fampra/17.2.192
  34. 34van Bommel H, Raaijmakers LHA, van den Muijsenbergh M, Schermer T, Burgers JS, van Loenen T, et al. Patient experiences with person-centred and integrated chronic care, focussing on patients with low socioeconomic status: a qualitative study. Br J Gen Pract. 2024. DOI: 10.3399/BJGP.2024.0400
  35. 35Cordoba G, Schwartz L, Woloshin S, Bae H, Gøtzsche PC. Definition, reporting, and interpretation of composite outcomes in clinical trials: systematic review. BMJ (Clinical research ed). 2010;341:c3920. DOI: 10.1136/bmj.c3920
  36. 36Sloan JA. Assessing the Minimally Clinically Significant Difference: Scientific Considerations, Challenges and Solutions. COPD: Journal of Chronic Obstructive Pulmonary Disease. 2005;2(1):5762. DOI: 10.1081/COPD-200053374
  37. 37Nundy S, Cooper LA, Mate KS. The Quintuple Aim for Health Care Improvement: A New Imperative to Advance Health Equity. Jama. 2022;327(6):5212. DOI: 10.1001/jama.2021.25181
DOI: https://doi.org/10.5334/ijic.8998 | Journal eISSN: 1568-4156
Language: English
Submitted on: Oct 2, 2025
Accepted on: Oct 24, 2025
Published on: Nov 6, 2025
Published by: Ubiquity Press
In partnership with: Paradigm Publishing Services
Publication frequency: 4 issues per year

© 2025 Lena H. A. Raaijmakers, Tjard R. Schermer, Hester E. van Bommel, Jan H. Vercoulen, Tessa van Loenen, Erik W. M. A. Bischoff, published by Ubiquity Press
This work is licensed under the Creative Commons Attribution 4.0 License.