Do Positivist Assumptions Hold True In Complex Interventions?

Introduction

Randomized control trials, RCT, are widely considered as the gold standard for evaluating the effectiveness of clinical interventions. However their appropriateness for evaluation of complex interventions has been called into question. Since year 2000, the british Medical Research Council, MRC, has been developing and improving guidelines for adapting RCTs to real-world situations such as complex public health interventions [1]. Such approaches have been criticized [2] for ignoring the fundamental conflicts between positivist assumptions underpinning an experimental study design and the realist paradigms. The goal of this case study is to investigate if the positivist assumptions hold true in real-word cases. Our cases so far include a prospective non-randomized, matched control, before-and-after study (case 1), The effectiveness and cost effectiveness of the PAtient-Centred Team (PACT) model: study protocol of a prospective matched control before-and-after study [3], and an RCT (case 2), Long-term integrated telerehabilitation of COPD Patients: A multicentre randomised controlled trial (iTrain) [4]. We are planning to add two more cases.

Methods

We take an exploratory qualitative case study approach [5] to review complex intervention evaluation studies in which the study designs are based on positivist assumptions. The criteria for selecting the cases are that the interventions must be complex, study protocol must be published or accessible for review and the researchers available for interviews. Our starting point is the review of study protocol and we follow-up with semi-structured interviews with the principal investigators and research team members and request supplemental information if needed.

Results

We are currently finishing review of case 1. This is a real-world evaluation case where randomization was not possible due to operational reasons. Therefore the research team chose propensity score matching.

Conclusions

The study has started in late October 2018 and is currently underway.

References

1. Adat D, Agama DAN, Dominasi M, Tinggi S, Kristen A, Negeri P. A Framework for development and evaluation of RCTs for Complex Interventions to Improve Health. Medical Research Council. 2000.

2. Marchal B, Westhorp G, Wong G, Belle S Van, Greenhalgh T, Kegels G, et al. Realist RCTs of complex interventions – An oxymoron. Soc Sci Med [Internet]. 2013 [cited 2016 Sep 14];94:124–8. Available from: http://dx.doi.org/10.1016/j.so...

3. Bergmo TS, Berntsen GK, Dalbakk M, Rumpsfeld M. The effectiveness and cost effectiveness of the PAtient-Centred Team (PACT) model: study protocol of a prospective matched control before-and-after study. BMC Geriatr [Internet]. 2015;15(1):1–9. Available from: http://dx.doi.org/10.1186/s128...

4. Zanaboni P, Dinesen B, Hjalmarsen A, Hoaas H, Holland AE, Oliveira CC, et al. Long-term integrated telerehabilitation of COPD Patients: A multicentre randomised controlled trial (iTrain). BMC Pulm Med [Internet]. 2016;16(1):1–9. Available from: http://dx.doi.org/10.1186/s128...

5. Baxter P, Jack S. Qualitative Case Study Methodology: Study Design and Implementation for Novice Researchers. Qual Rep [Internet]. 2008 [cited 2018 Nov 17];13(4):12–3. Available from: https://nsuworks.nova.edu/tqr/...