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
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 1/2013

Open Access 01-12-2013 | Methodology

Using qualitative evidence on patients’ views to help understand variation in effectiveness of complex interventions: a qualitative comparative analysis

Authors: Bridget Candy, Michael King, Louise Jones, Sandy Oliver

Published in: Trials | Issue 1/2013

Login to get access

Abstract

Background

Complex healthcare interventions consist of multiple components which may vary in trials conducted in different populations and contexts. Pooling evidence from trials in a systematic review is challenging because it is unclear which components are needed for effectiveness. The potential is recognised for using recipients’ views to explore why some complex interventions are effective and others are not. Methods to maximise this potential are poorly developed.

Methods

We used a novel approach to explore how patients’ views may explain the disparity in effectiveness of complex interventions. We used qualitative comparative analysis to explore agreement between qualitative syntheses of data on patients’ views and evidence from trialed interventions to increase adherence to treatments. We first populated data matrices to reflect whether the content of each trialed intervention could be matched with suggestions arising from patients’ views. We then used qualitative comparative analysis software to identify, by a process of elimination, the smallest number of configurations (patterns) of components that corresponded with patients’ suggestions and accounted for whether each intervention was effective or ineffective.

Results

We found suggestions by patients were poorly represented in interventions. Qualitative comparative analysis identified particular combinations of components corresponding with patients’ suggestions and with whether an intervention was effective or ineffective. Six patterns were identified for an effective and four for an ineffective intervention. Two types of patterns arose for the effective interventions, one being didactic (providing clear information or instruction) and the other interactive (focusing on personal risk factors).

Conclusions

Our analysis highlights how data on patients’ views has the potential to identify key components across trials of complex interventions or inform the content of new interventions to be trialed.
Appendix
Available only for authorised users
Literature
1.
Langhorne P, Pollock A, in conjunction with the Stroke Unit Trialists’ Collaboration: What are the components of effective stroke unit care?. Age Ageing. 2002, 31: 365-371. 10.1093/ageing/31.5.365.CrossRefPubMed
2.
Lamb SE, Becker C, Gillespie LD, Smith JL, Finnegan S, Potter R, Pfeiffer K, for The Taxonomy Investigators: Reporting of complex interventions in clinical trials: development of a taxonomy to classify and describe fall-prevention interventions. Trials. 2011, 12: 125-10.1186/1745-6215-12-125.CrossRefPubMedPubMedCentral
3.
Gardner B, Whittington C, McAteer J, Eccles MP, Michie S: Using theory to synthesise evidence from behaviour change interventions: the example of audit and feedback. Soc Sci Med. 2010, 70: 1618-1625. 10.1016/j.socscimed.2010.01.039.CrossRefPubMed
4.
Thomas J, Harden A, Oakley A, Oliver S, Sutcliffe K, Rees R, Brunton G, Kavanagh J: Integrating qualitative research with trials in systematic reviews. BMJ. 2004, 328: 1010-1012. 10.1136/bmj.328.7446.1010.CrossRefPubMedPubMedCentral
5.
Noyes J, Popay J, Pearson A, Hannes K, Booth A, on behalf of the Cochrane Qualitative Research Methods Group: Qualitative research and Cochrane reviews. Cochrane Handbook for Systematic Reviews of Interventions. Version 5.1.0 [updated March 2011]. Edited by: The Cochrane Collaboration, Higgins JPT, Green S. 2011, Chapter 20. Available at [http://​www.​cochrane-handbook.​org]
6.
Glasziou P, Heneghan C, Shepperd S: What is missing from descriptions of treatment in trials and reviews?. BMJ. 2008, 336: 1472-1474. 10.1136/bmj.39590.732037.47.CrossRefPubMedPubMedCentral
7.
Schroter S, Glasziou P, Heneghan C: Quality of descriptions of treatments: a review of published randomised controlled trials. BMJ Open. 2012, 2: e001978-10.1136/bmjopen-2012-001978.CrossRefPubMedPubMedCentral
8.
Candy B, King M, Jones L, Oliver S: Using qualitative synthesis to explore heterogeneity of complex interventions. BMC Med Res Methodol. 2008, 11: 124-CrossRef
9.
Totten AM, Wagner J, Tiwari A, O’Haire C, Griffin J, Walker M: Closing the quality gap: revisiting the state of science. Public Reporting as a Quality Improvement Strategy. (Evidence Reports/Technology Assessments, No.208.5.) Vol 5. 2012, Rockville (MD): Agency for Healthcare Research and Quality (US), Available at [http://​www.​ncbi.​nlm.​nih.​gov/​books/​NBK99887/​]
10.
Rihoux B, Ragin CC: Configurational comparative methods. Qualitative comparative analysis (QCA) and related techniques. 2008, Los Angeles: Sage Publications
11.
12.
Cooper B, Glaesser J: Qualitative work and the testing and development of theory: lessons from a study combining cross-case and within-case analysis via Ragin’s QCA. Proceedings of the Economic and Social Research Council Research UK Methods 5th Festival 2-5. 2012, Oxford, Available at: [http://​www.​ncrm.​ac.​uk/​RMF2012/​programme.​php?​id=​D4], July
13.
Blackman T, Wistow J, Byrne D: A qualitative comparative analysis of factors associated with trends in narrowing health inequalities in England. Soc Sci Med. 2011, 72: 1965-1974. 10.1016/j.socscimed.2011.04.003.CrossRefPubMed
14.
Pope C, May N, Popay J: Synthesizing qualitative and quantitative health evidence. 2007, Maidenhead, UK: Open University Press
15.
Berg Schlosser D, De Meur G: Comparative research design: case and variable selection. Configurational comparative methods. Qualitative comparative analysis (QCA) and related techniques. Edited by: Rihoux B, Ragin C. 2009, Thousand Oaks: Sage
16.
Haynes RB, Ackloo E, Sahota N, McDonald HP, Yao X: Interventions for enhancing medication adherence. Cochrane Database Syst Rev. 2008, 2: CD000011
17.
Vervoort SCJM, Borleffs JCC, Hoepelman AIM, Grypdonck MHF: Adherence in antiretroviral therapy: a review of qualitative studies. AIDS. 2007, 21: 271-281. 10.1097/QAD.0b013e328011cb20.CrossRefPubMed
18.
Campbell R, Pound P, Pope C, Britten N, Pill R, Morgan M, Donovan J: Evaluating meta-ethnography: a synthesis of qualitative research on lay experiences of diabetes and diabetes care. Soc Sci Med. 2003, 56: 671-684. 10.1016/S0277-9536(02)00064-3.CrossRefPubMed
19.
Malpass A, Shaw A, Sharp D, Walter F, Feder G, Ridd M, Kessler D: “Medication career” or “Moral career”? The two sides of managing antidepressants: a meta-ethnography of patients’ experience of antidepressants. Soc Sci Med. 2009, 68: 154-168. 10.1016/j.socscimed.2008.09.068.CrossRefPubMed
20.
Schlomann P, Schmitke J: Lay beliefs about hypertension: an interpretive synthesis of the qualitative research. J Am Acad Nurse Pract. 2007, 19: 358-367. 10.1111/j.1745-7599.2007.00238.x.CrossRefPubMed
21.
Tong A, Flemming K, McInnes E, Oliver S, Craig J: Enhancing transparency in reporting the synthesis of qualitative research: ENTREQ. BMC Med Res Methodol. 2012, 12: 181-10.1186/1471-2288-12-181.CrossRefPubMedPubMedCentral
22.
Berrien V, Salazar J, Reynolds E, Mckay K: Adherence to antiretroviral therapy in HIV-infected paediatric patients improves with home-based intensive nursing intervention. AIDS Patient Care STDS. 2004, 18: 355-363. 10.1089/1087291041444078.CrossRefPubMed
23.
Farber HJ, Oliveria L: Trial of an asthma education program in an inner-city pediatric emergency department pediatric. Pediatr Asthma Allergy Immunol. 2004, 17: 107-115. 10.1089/0883187041269913.CrossRef
24.
Haynes RB, Sack DL, Gibson ES, Tayler DW, Hackett BC, Roberts RS, Johnson AL: Improvement of medication compliance in uncontrolled hypertension. Lancet. 1976, 1: 1265-1268.CrossRefPubMed
25.
Hill J, Bird H, Johnson S: Effect of patient education on adherence to drug treatment for rheumatoid arthritis: a randomised controlled trial. Ann Rheum Dis. 2001, 60: 869-875.PubMedPubMedCentral
26.
Kemp R, Hayward P, Applewhaite G, Everitt B, David A: Compliance therapy in psychotic patients: randomised controlled trial. BMJ. 1996, 312: 345-349. 10.1136/bmj.312.7027.345.CrossRefPubMedPubMedCentral
27.
Kemp R, Kirov G, Everitt B, Hayward P, David A: Randomised controlled trial of compliance therapy 18-month follow-up. Br J Psychiatry. 1998, 172: 413-419. 10.1192/bjp.172.5.413.CrossRefPubMed
28.
Laporte S, Quenet S, Buchmüller-Cordier A, Reynaud J, Tardy-Poncet B, Thirion C, Decousus H, Mismetti P: Compliance and stability of INR of two oral anticoagulants with different half-lives: a randomised trial. Thromb Haemost. 2003, 89: 458-467.PubMed
29.
Lee JK, Grace KA, Taylor AJ: Effect of a pharmacy care program on medication adherence and persistence, blood pressure, and low-density lipoprotein. Cholesterol: a randomized controlled trial. JAMA. 2006, 296: 2563-2571. 10.1001/jama.296.21.joc60162.CrossRefPubMed
30.
Levy LM, Robb M, Allen J, Doherty C, Bland JM, Winter RJ: A randomized controlled evaluation of specialist nurse education following accident and emergency department attendance for acute asthma. Respir Med. 2004, 94: 900-908.CrossRef
31.
Márquez Contreras E, Casado Martínez JJ, Corchado Albalat Y, Chaves Gonzalez R, Grandio A, Losada Velasco C, Obando J, de Eugenio JM, Barrera JM: [Efficacy of an intervention to improve treatment compliance in hyperlipidemias]. Aten Primaria. 2004, 33: 443-450.CrossRefPubMed
32.
Márquez Contreras E, GarcÍa OV, Claros NM, Gil-Guillen V, de la Figuera-Von WM, Casado-Martinez JJ, Martin-de Pablos JL, Figueras M, Galera J, Serra A, Compliance Group of the Spanish Society of Hypertension: Efficacy of a home blood pressure monitoring programme on therapeutic compliance in hypertension: the EAPACUM-study. J Hypertens. 2006, 24: 169-175. 10.1097/01.hjh.0000198023.53859.a2.CrossRefPubMed
33.
Peveler R, George C, Kinmonth AL, Campbell M, Thompson C: Effect of antidepressant drug counselling and information leaflets on adherence to drug treatment in primary care: randomised controlled trial. BMJ. 1999, 319: 612-615. 10.1136/bmj.319.7210.612.CrossRefPubMedPubMedCentral
34.
Piette JD, Weinberger M, McPhee SJ, Mah CA, Kraemer FB, Crapo LM: Do automated calls with nurse follow-up improve self-care and glycemic control among vulnerable patients with diabetes?. Am J Med. 2000, 108: 20-27.CrossRefPubMed
35.
Remien RH, Stirratt MJ, Dolezal C, Lobozzo JS, Wagner GJ, Carballo-Dieguez A, El-Bassel N, Jung TM: Couple-focused support to improve HIV medication adherence: a randomized controlled trial. AIDS. 2005, 19: 807-814. 10.1097/01.aids.0000168975.44219.45.CrossRefPubMed
36.
Schaffer SD, Tian L: Promoting adherence: effects of theory-based asthma education. Clin Nurs Res. 2004, 13: 69-89. 10.1177/1054773803259300.CrossRefPubMed
37.
Schroeder K, Fahey T, Hollinghurst S, Peters TJ: Nurse-led adherence support in hypertension: a randomized controlled trial. Fam Pract. 2005, 22: 144-151. 10.1093/fampra/cmh717.CrossRefPubMed
38.
van Es SM, Nagelkerke AF, Colland VT, Scholten RJ, Bouter LM: An intervention programme using the ASE-model aimed at enhancing adherence in adolescents with asthma. Patient Educ Couns. 2001, 44: 193-203. 10.1016/S0738-3991(00)00195-6.CrossRefPubMed
39.
Vergowen AC, Bakker A, Burger H, Verheij TJ, Koerselman F: A cluster randomized trial comparing two interventions to improve treatment of major depression in primary care. Psychol Med. 2005, 35: 25-33. 10.1017/S003329170400296X.CrossRef
40.
Volume CI, Farris KB, Kassam R, Cox CE, Cave A: Pharmaceutical care research and education project: patient outcomes. J Am Pharm Assoc. 2001, 41: 411-420.CrossRef
41.
Walley JD, Khan AM, Newell JN, Khan MH: Effectiveness of the direct observation component of DOTS for tuberculosis: a randomised controlled trial in Pakistan. Lancet. 2001, 357: 664-669. 10.1016/S0140-6736(00)04129-5.CrossRefPubMed
42.
Weber R, Christen L, Christen S, Tschopp S, Znoj H, Schneider C, Schmitt J, Opravil M, Gunthard HF, Ledergerber B, Swiss HIV Cohort Study: Effect of individual cognitive behaviour intervention on adherence to antiretroviral therapy: prospective randomized trial. Antivir Ther. 2004, 9: 85-95.PubMed
43.
Cochrane Handbook for Systematic Reviews of Interventions Version 4.2.5 (updated May 2005). The Cochrane Library. Edited by: Higgins JPT, Green S. 2005, Chichester, UK: John Wiley & Sons, Ltd
44.
Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P, CONSORT Group: Methods and process of the CONSORT group: example of an extension for trials assessing nonpharmacologic treatments. Ann Intern Med. 2008, 148: 295-309. 10.7326/0003-4819-148-4-200802190-00008.CrossRefPubMed
45.
46.
Oakley A, Strange V, Bonell C, Allen E, Stephenson J: Process evaluation in randomised controlled trials of complex interventions. BMJ. 2006, 332: 413-416. 10.1136/bmj.332.7538.413.CrossRefPubMedPubMedCentral
47.
Atkins S, David Biles D, Lewin S, Ringsberg K, Thorson A: Patients’ experiences of an intervention to support tuberculosis treatment adherence in South Africa. J Health Serv Res Policy. 2010, 15: 163-170. 10.1258/jhsrp.2010.009111.CrossRefPubMed
Metadata
Title
Using qualitative evidence on patients’ views to help understand variation in effectiveness of complex interventions: a qualitative comparative analysis
Authors
Bridget Candy
Michael King
Louise Jones
Sandy Oliver
Publication date
01-12-2013
Publisher
BioMed Central
Published in
Trials / Issue 1/2013
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-14-179

Other articles of this Issue 1/2013

Trials 1/2013 Go to the issue

Study protocol

Cardiovascular disease risk reduction in rural China: a clustered randomized controlled trial in Zhejiang

Study protocol

Short-term psychotherapeutic treatment in adolescents engaging in non-suicidal self-injury: a randomized controlled trial

Research

A reinvestigation of recruitment to randomised, controlled, multicenter trials: a review of trials funded by two UK funding agencies

Study protocol

Effect of oral nitrates on pulse pressure and arterial elasticity in patients aged over 65 years with refractory isolated systolic hypertension: study protocol for a randomized controlled trial

Study protocol

Effects of an aquatic physical exercise program on glycemic control and perinatal outcomes of gestational diabetes: study protocol for a randomized controlled trial

Study protocol

Efficacy of composite versus ceramic inlays and onlays: study protocol for the CECOIA randomized controlled trial