eCite Digital Repository

Rethinking the gold standard - The feasibility of randomized controlled trials within health services effectiveness research


Serhal, S and Mitchell, B and Krass, I and Emmerton, L and Bereznicki, B and Bereznicki, L and Shan, S and Billot, L and Bosnic-Anticevich, S and Saini, B and Armour, C, Rethinking the gold standard - The feasibility of randomized controlled trials within health services effectiveness research, Research in social & administrative pharmacy : RSAP, 18, (9) pp. 3656-3668. ISSN 1551-7411 (2022) [Refereed Article]

PDF (Fully published version)
Pending copyright assessment - Request a copy
Pending copyright assessment - Request a copy

DOI: doi:10.1016/j.sapharm.2022.03.017


Background: An evidence-based randomized controlled trial for a novel Pharmacy Asthma Service was tested in 3 Australian states. Positive asthma outcomes were achieved after the 12-month intervention, albeit in both the intervention and comparator arms. The current investigation uses a mixed methods approach to 1) qualitatively explore how comparator arm pharmacists implemented the trial protocol and 2) quantitatively examine how this may have impacted patient outcomes in this trial.

Methods: Post-intervention semi-structured qualitative interviews were conducted with 20 pharmacists, representing 21 of 37 (57%) comparator arm pharmacies that completed the trial. Based on these interviews, pharmacies were classified as 'adherent' to the trial protocol (reporting no interventions other than general practitioner referral) or 'non-adherent' (reporting at least one extra intervention to the trial protocol), or 'inconclusive'. These subgroups were compared descriptively in relation to patient outcomes.

Results: Overall, 33% (n = 8/24) of the comparator pharmacies who were interviewed (n = 21) or determined to have monitoring by a project officer to ensure adherence to the protocol (n = 3) were classified as adherent), 58% (n = 14/24) as non-adherent, 8% inconclusive (n = 2/24). While all patients commenced with uncontrolled asthma (Asthma Control Questionnaire score (ACQ) > 1.5), after 12 months the mean ACQ score for patients from adherent comparator pharmacies ('true control') was 1.8 (still uncontrolled asthma) compared to a score of 1.4 (controlled asthma) in the non-adherent comparator group. Quality of life significantly improved in the non-adherent comparator group over the 12 months of the trial.

Conclusion: The majority of pharmacists in the comparator arm who were interviewed, introduced their own interventions, which may have influenced the outcomes of the trial. The naturalistic setting of the study was not protective against these confounders. These findings question the feasibility of comparator arms within primary care settings and that alternative study designs should be considered when designing future intervention studies in pharmacy practice.

Item Details

Item Type:Refereed Article
Keywords:Research design; Pharmacy services; Asthma management; Implementation science; Randomized controlled trials; Health services
Research Division:Biomedical and Clinical Sciences
Research Group:Pharmacology and pharmaceutical sciences
Research Field:Clinical pharmacy and pharmacy practice
Objective Division:Health
Objective Group:Clinical health
Objective Field:Treatment of human diseases and conditions
UTAS Author:Bereznicki, B (Dr Bonnie Bereznicki)
UTAS Author:Bereznicki, L (Professor Luke Bereznicki)
ID Code:152768
Year Published:2022
Deposited By:Medicine
Deposited On:2022-08-24
Last Modified:2022-09-20

Repository Staff Only: item control page