Skip to main content
Top
Published in: BMC Medical Research Methodology 1/2016

Open Access 01-12-2016 | Research article

Should we embed randomized controlled trials within action research: arguing from a case study of telemonitoring

Authors: Karen Day, Timothy W. Kenealy, Nicolette F. Sheridan

Published in: BMC Medical Research Methodology | Issue 1/2016

Login to get access

Abstract

Background

Action research (AR) and randomized controlled trials (RCTs) are usually considered to be theoretically and practically incompatible. However, we argue that their respective strengths and weaknesses can be complementary. We illustrate our argument from a recent study assessing the effect of telemonitoring on health-related quality of life, self-care, hospital use, costs and the experiences of patients, informal carers and health care professionals in two urban hospital services and one remote rural primary care service in New Zealand.

Methods

Data came from authors’ observations and field notes of discussions with three groups: the healthcare providers and healthcare consumers who participated in the research, and a group of 17 researchers and collaborators. The consumers had heart failure (Site A, urban), airways disease (Site B, urban), and diabetes (Site C, rural). The research ran from 2008 (project inception) until 2012 (project close-off). Researchers came from a wide range of disciplines. Both RCT and AR methods were recognised from early in the process but often worked in parallel rather than together. In retrospect, we have mapped our observed research processes to the AR cycle characteristics (creation of communicative space, democracy and participation, iterative learning and improvement, emergence, and accommodation of different ways of knowing).

Results

We describe the context, conduct and outcomes of the telemonitoring trial, framing the overall process in the language of AR. Although not fully articulated at the time, AR processes made the RCT sensitive to important context, e.g. clinical processes. They resulted in substantive changes to the design and conduct of the RCT, and to interpretation and uptake of findings, e.g. a simpler technology procurement process emerged. Creating a communicative space enabled co-design between the researcher group and collaborators from the provider participant group, and a stronger RCT design.

Conclusions

It appears possible to enhance the utility of RCTs by explicitly embedding them in an AR framework to shape stronger RCT design. The AR process and characteristics may enable researchers to evaluate telehealth while enhancing rather than compromising the quality of an RCT, where research results are returned to practice as part of the research process.

Trial registration

Australian New Zealand Clinical Trials Registry, reference ACTRN12610000269​033.
Literature
1.
go back to reference Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS. Evidence based medicine: what it is and what it isn't. Br Med J. 1996;312(7023):71.CrossRef Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS. Evidence based medicine: what it is and what it isn't. Br Med J. 1996;312(7023):71.CrossRef
2.
go back to reference Lewis MW, Kelemen ML. Multiparadigm inquiry: Exploring organizational pluralism and paradox. Hum Relat. 2002;55:251.CrossRef Lewis MW, Kelemen ML. Multiparadigm inquiry: Exploring organizational pluralism and paradox. Hum Relat. 2002;55:251.CrossRef
3.
go back to reference Geertz C. Thick description: Toward an interpretive theory of culture. In M. Martin & L.C. McIntyre (eds.). Readings in the philosophy of social science. Cambridge, Mass: MIT Press; 1994. pp. 213–31. Geertz C. Thick description: Toward an interpretive theory of culture. In M. Martin & L.C. McIntyre (eds.). Readings in the philosophy of social science. Cambridge, Mass: MIT Press; 1994. pp. 213–31.
4.
go back to reference Greenhalgh T, Russel J, Ashcroft RE, Parsons W. Why National eHealth Programs Need Dead Philosophers:Wittgensteinian Reflections on Policymakers’ Reluctance to Learn from History. Milbank Q. 2011;89(4):533–63.CrossRefPubMedPubMedCentral Greenhalgh T, Russel J, Ashcroft RE, Parsons W. Why National eHealth Programs Need Dead Philosophers:Wittgensteinian Reflections on Policymakers’ Reluctance to Learn from History. Milbank Q. 2011;89(4):533–63.CrossRefPubMedPubMedCentral
5.
go back to reference Reason P. Choice and quality in action research practice. J Manag Inq. 2006;15(2):187–203. Reason P. Choice and quality in action research practice. J Manag Inq. 2006;15(2):187–203.
6.
go back to reference Myers MD. Qualitative research in information systems. MIS Quarterly. 1997;June:241–2. Myers MD. Qualitative research in information systems. MIS Quarterly. 1997;June:241–2.
7.
go back to reference Mohr DC, Cheung K, Schueller SM, Brown CH, Duan N. Continuous evaluation of evolving behavioral intervention technologies. Am J Prev Med. 2013;45(4):517–23.CrossRefPubMed Mohr DC, Cheung K, Schueller SM, Brown CH, Duan N. Continuous evaluation of evolving behavioral intervention technologies. Am J Prev Med. 2013;45(4):517–23.CrossRefPubMed
8.
go back to reference Liu JL, Wyatt JC. The case for randomized controlled trials to assess the impact of clinical information systems. JAMIA. 2011;18:173–80.PubMedPubMedCentral Liu JL, Wyatt JC. The case for randomized controlled trials to assess the impact of clinical information systems. JAMIA. 2011;18:173–80.PubMedPubMedCentral
9.
go back to reference Kaldoudi E, Chatzopoulou A, Vargemezis V. Adapting the STARE-HI guidelines for the evaluation of home care telehealth applications: An interpretive approach. J Inf Technol Healthc. 2009;7(5):293–303. Kaldoudi E, Chatzopoulou A, Vargemezis V. Adapting the STARE-HI guidelines for the evaluation of home care telehealth applications: An interpretive approach. J Inf Technol Healthc. 2009;7(5):293–303.
10.
go back to reference Ekeland AG, Bowes A, Flottrop S. Methodologies for assessing telemedicine: A systematic review of reviews. Int J Med Inform. 2012;81:1–11.CrossRefPubMed Ekeland AG, Bowes A, Flottrop S. Methodologies for assessing telemedicine: A systematic review of reviews. Int J Med Inform. 2012;81:1–11.CrossRefPubMed
11.
go back to reference Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008;337:a1655. doi:10.1136/bmj.a1655. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008;337:a1655. doi:10.​1136/​bmj.​a1655.
12.
go back to reference Lewin S, Glenton C, Oxman AD. Use of qualitative methods alongside randomised controlled trials of complex healthcare interventions: methodological study. BMJ. 2009;339:b3496.CrossRefPubMedPubMedCentral Lewin S, Glenton C, Oxman AD. Use of qualitative methods alongside randomised controlled trials of complex healthcare interventions: methodological study. BMJ. 2009;339:b3496.CrossRefPubMedPubMedCentral
13.
go back to reference Campbell M, Fitzpatrick R, Haines A, Kinmonth AL, Sandercock P, Spiegelhalter D, et al. Framework for design and evaluation of complex interventions to improve health. BMJ. 2000;321(7262):694–6. Campbell M, Fitzpatrick R, Haines A, Kinmonth AL, Sandercock P, Spiegelhalter D, et al. Framework for design and evaluation of complex interventions to improve health. BMJ. 2000;321(7262):694–6.
14.
go back to reference Murray E, Treweek S, Pope C, MacFarlane A, Ballini L, Dowrick C, et al. Normalisation process theory: a framework for developing, evaluating and implementing complex interventions. BMC Med. 2010;8(1):1.CrossRef Murray E, Treweek S, Pope C, MacFarlane A, Ballini L, Dowrick C, et al. Normalisation process theory: a framework for developing, evaluating and implementing complex interventions. BMC Med. 2010;8(1):1.CrossRef
15.
go back to reference Reason P. Integrating action and reflection through co-operative inquiry. Manag Learn. 1999;30(2):207–26.CrossRef Reason P. Integrating action and reflection through co-operative inquiry. Manag Learn. 1999;30(2):207–26.CrossRef
16.
go back to reference Reason P, Bradbury H. Handbook of action research: Participative inquiry and practice. London: Sage; 2001. Reason P, Bradbury H. Handbook of action research: Participative inquiry and practice. London: Sage; 2001.
17.
go back to reference Dick B. Action research: Action and research. In: Shankar S, Dick B, Passfield R, Swepson P, editors. Effective change management using action learning and action research. Lismore, NSW: Southern Cross Press; 2002. Dick B. Action research: Action and research. In: Shankar S, Dick B, Passfield R, Swepson P, editors. Effective change management using action learning and action research. Lismore, NSW: Southern Cross Press; 2002.
18.
go back to reference Rapoport RN. Three dilemmas in action research with special reference to the Tavistock experience. Human Relations. 1970;23(6):499–513.CrossRef Rapoport RN. Three dilemmas in action research with special reference to the Tavistock experience. Human Relations. 1970;23(6):499–513.CrossRef
19.
go back to reference Kenealy TW, Parsons MJ, Rouse APB, Doughty RN, Sheridan NF, Hindmarsh JKH, et al. Telecare for Diabetes, CHF or COPD: Effect on Quality of Life, Hospital Use and Costs. A Randomised Controlled Trial and Qualitative Evaluation. PloS one. 2015;10(3). Kenealy TW, Parsons MJ, Rouse APB, Doughty RN, Sheridan NF, Hindmarsh JKH, et al. Telecare for Diabetes, CHF or COPD: Effect on Quality of Life, Hospital Use and Costs. A Randomised Controlled Trial and Qualitative Evaluation. PloS one. 2015;10(3).
20.
go back to reference Baskerville RL, Wood-Harper AT. A critical perspective on action research as a method for information systems research. J Inf Technol. 1996;11(3):235–46. Baskerville RL, Wood-Harper AT. A critical perspective on action research as a method for information systems research. J Inf Technol. 1996;11(3):235–46.
21.
go back to reference Kerr S, Penney L, Moewaka Barnes H, McCreanor T. Kaupapa Maori action research to improve heart disease services in Aotearoa, New Zealand. Ethn Health. 2010;15(1):15–31.CrossRefPubMed Kerr S, Penney L, Moewaka Barnes H, McCreanor T. Kaupapa Maori action research to improve heart disease services in Aotearoa, New Zealand. Ethn Health. 2010;15(1):15–31.CrossRefPubMed
22.
go back to reference Smith LT. Decolonizing methodologies: Research and indigenous peoples. New York: Zed Books & Dunedin: University of Otago Press; 1999. Smith LT. Decolonizing methodologies: Research and indigenous peoples. New York: Zed Books & Dunedin: University of Otago Press; 1999.
23.
go back to reference Zhang W, Xu X. Six Sigma and information systems project management: A revised theoretical model. Proj Manag J. 2008;39(3):59–74.CrossRef Zhang W, Xu X. Six Sigma and information systems project management: A revised theoretical model. Proj Manag J. 2008;39(3):59–74.CrossRef
25.
go back to reference Ash J, Berg M, Coiera E. Some unintended consequences of information technology in health care: the nature of patient care information system-related errors. J Am Inform Assoc. 2004;11:104–12.CrossRef Ash J, Berg M, Coiera E. Some unintended consequences of information technology in health care: the nature of patient care information system-related errors. J Am Inform Assoc. 2004;11:104–12.CrossRef
26.
go back to reference Augestad KM, Bernsten G, Lassen K, Bellika JG, Wootton R, Lindsetmo RO, et al. Standards for reporting randomized controlled trials in medical informatics: A systematic review of CONSORT adherence in RCTs on clinical decision support. J Med Inform Assoc. 2012;19(1):13–21.CrossRef Augestad KM, Bernsten G, Lassen K, Bellika JG, Wootton R, Lindsetmo RO, et al. Standards for reporting randomized controlled trials in medical informatics: A systematic review of CONSORT adherence in RCTs on clinical decision support. J Med Inform Assoc. 2012;19(1):13–21.CrossRef
27.
go back to reference Baskerville R, Wood-Harper AT. A critical perspective on action research as a method for information systems research. In: Myers MD, Avison D, editors. Qualitative Research in Information Systems. London: SAGE Publications; 2002. Baskerville R, Wood-Harper AT. A critical perspective on action research as a method for information systems research. In: Myers MD, Avison D, editors. Qualitative Research in Information Systems. London: SAGE Publications; 2002.
28.
go back to reference Susman GI, Evered RD. An assessment of the scientific merits of action research. Adm Sci Q. 1978;582–603. Susman GI, Evered RD. An assessment of the scientific merits of action research. Adm Sci Q. 1978;582–603.
29.
go back to reference Scriven M. A summative evaluation of RCT methodology: And an alternative approach to causal research. J Multidiscip Eval. 2008;5(9):11–24. Scriven M. A summative evaluation of RCT methodology: And an alternative approach to causal research. J Multidiscip Eval. 2008;5(9):11–24.
30.
go back to reference Klein HK, Myers MD. A set of principles for conducting and evaluating interpretive field studies in information systems. MIS Q. 1999;23(1):67–94.CrossRef Klein HK, Myers MD. A set of principles for conducting and evaluating interpretive field studies in information systems. MIS Q. 1999;23(1):67–94.CrossRef
32.
go back to reference Gammon D, Johannessen LK, Sørensen T, Wynn R, Whitten P. An overview and analysis of theories employed in telemedicine studies. Methods Inf Med. 2008;47:260–9.PubMed Gammon D, Johannessen LK, Sørensen T, Wynn R, Whitten P. An overview and analysis of theories employed in telemedicine studies. Methods Inf Med. 2008;47:260–9.PubMed
33.
go back to reference Leykum LK, Pugh JA, Lanham HJ, Harmon J, McDaniel Jr RR. Implementation research design: integrating participatory action research into randomized controlled trials. Implement Sci. 2009;4:69.CrossRefPubMedPubMedCentral Leykum LK, Pugh JA, Lanham HJ, Harmon J, McDaniel Jr RR. Implementation research design: integrating participatory action research into randomized controlled trials. Implement Sci. 2009;4:69.CrossRefPubMedPubMedCentral
34.
go back to reference Heneghan C, Godlee F. Where next for evidence based healthcare? BMJ. 2013;346. Heneghan C, Godlee F. Where next for evidence based healthcare? BMJ. 2013;346.
35.
go back to reference Sein MK, Henfridsson O, Purao S, Rossi M, Lindgren R. Action design research. MIS Q. 2011;35(1):37–56. Sein MK, Henfridsson O, Purao S, Rossi M, Lindgren R. Action design research. MIS Q. 2011;35(1):37–56.
36.
go back to reference Steventon A, Bardsley M, Billings J, Dixon J, Doll H, Hirani S, et al. Effect of telehealth on use of secondary care and mortality: findings from the Whole System Demonstrator cluster randomised trial. BMJ. 2012;344, e3874.CrossRefPubMedPubMedCentral Steventon A, Bardsley M, Billings J, Dixon J, Doll H, Hirani S, et al. Effect of telehealth on use of secondary care and mortality: findings from the Whole System Demonstrator cluster randomised trial. BMJ. 2012;344, e3874.CrossRefPubMedPubMedCentral
Metadata
Title
Should we embed randomized controlled trials within action research: arguing from a case study of telemonitoring
Authors
Karen Day
Timothy W. Kenealy
Nicolette F. Sheridan
Publication date
01-12-2016
Publisher
BioMed Central
Published in
BMC Medical Research Methodology / Issue 1/2016
Electronic ISSN: 1471-2288
DOI
https://doi.org/10.1186/s12874-016-0175-6

Other articles of this Issue 1/2016

BMC Medical Research Methodology 1/2016 Go to the issue