Guiding better research or stifling it?

The pick of the month’s academic papers from Parastou Donyai, chief scientist at the Royal Pharmaceutical Society.

I read an interesting article in The Psychologist magazine earlier this month. In it, the author discusses ‘registered reports’ as a format for journal publications. The concept of registered reports is that authors first submit a study protocol for their research to a participating journal, detailing the introduction and methods for their work. This is then peer-reviewed to examine the research question and the methods proposed to answer it. If peer review is successful, the authors are sanctioned to conduct their work and the journal commits to publishing the final paper of their results, irrespective of the findings. This is an ‘in-principle acceptance’ (IPA) and, as the author of the piece points out, it certainly sounds like a good plan for preventing only positive, eye-catching results from being published. 

For me though, the greatest benefit of such a process is its potential to improve the design and conduct of research — including that in our field — before it takes place. Admittedly, there is a small part of me that questions the impact of such a practice on researcher autonomy. As a result, I spent a few minutes checking the list of journals that have so far adopted the registered reports format. Perhaps I was not surprised to learn that none of the 300 or so journals on the list was pharmacy specific. Nonetheless, with the idea of the registered reports in mind, I read this month’s articles with a particular focus on the ‘Introduction’ and ‘Method’ sections, asking myself what feedback — if any — I might have given these had they been submitted for my review as a registered report. 

The first paper I read was published in the International Journal of Pharmacy Practice on 13 May 2024 — ‘The role of community pharmacists as oral health advisors in the management of oral effects of asthma medications: an exploratory survey‘.

If I were reviewing this as a registered report, my first question about the work — on seeing the title — would be around the rationale for such a study. I would expect the introduction to broadly explain the oral ill effects of asthma medications, before providing a brief history of prior pharmacist involvement in this field and then the rationale for conducting an ‘exploratory survey’, and with whom. In the introduction, a brief opening paragraph outlines the mainstay of asthma management with bronchodilators and corticosteroids, with a mention of potential side effects. The next paragraph details community pharmacists’ general potential for giving advice in this field, while the subsequent section focuses on some of the causes of inhaler-associated oral ill-health and the potential for pharmacists to educate patients on the side effects of asthma medication. The closing paragraph of the introduction reasons that a lack of published research on whether pharmacists dispense such advice in practice warrants a new survey with community pharmacists in Australia. A set of research questions are then listed as the broad study aims. 

My feedback on the methods would focus on ensuring the questionnaire devised was fully tested with a range of users, so that as well as face validity, formal content validity was carried out. It was interesting to see that while three past papers were cited in the methods section as similar prior work, the findings of only one of these was weaved into the reasoning for the current paper within the introduction. Importantly — again with hindsight to my advantage — I would have advised the authors to conduct a sample size calculation to guide recruitment into their study. As it turns out, 38 pharmacists took part in the survey representing an “approximate response rate of 34.5% from the study region”. It is hard to say if I would have accepted the paper had it been submitted to me as a registered report, not least of all because the work was initiated in 2016. Perhaps that it’s taken so long for this research to be published speaks volumes about another problem in pharmacy-related research — would readers care to write in and share their own views on what these might be?

The next paper I read was published in Journal of Pharmaceutical Health Services Research — ‘Impact of COVID-19 on asthma and COPD patients’ hospital care: a lesson for future pandemics‘.

I expected it to be a review paper, because the title did not specify a particular setting, but it was in fact a population-based cohort study of patients with either asthma or COPD “seeking medical care during 2019–2021 at a tertiary hospital in Jordan”. The study aims certainly seemed far-reaching: to examine the impact of the COVID-19 pandemic and lockdowns on the provision of care to this group, as well as the attitudes of the affected patients.

The study took place over a three-year period, and involved identifying and consenting eligible patients for inclusion in the research by accessing their medical records at the Jordan University Hospital. Three sets of data were collected: general socio-demographics, clinical data, and patients’ attitude towards their care during the pandemic. While there is information in the methods on how the clinical data were collected (e.g. hospital archives for hospitalisation records, outpatient visits and medication refills), there is no indication of how patients’ attitudes were measured.

However, the most pressing advice I would have provided concerns the specific aim of this research, namely narrowing down the research questions and clearly stating the a priori hypotheses as the basis for conducting the research. The lack of these is not unique to the current paper, but stating these in advance would help improve the work, not least of all to help prevent the probability of a type I statistical error

A small libertarian part of me has questioned the impact of the registered reports format on researchers’ freedom to pursue their work. If you asked me now whether I think that the benefits of introducing registered reports within pharmacy practice research would outweigh such concerns, I know what the answer would be. 

Last updated
The Pharmaceutical Journal, PJ, May 2024, Vol 312, No 7985;312(7985)::DOI:10.1211/PJ.2024.1.317271

    Please leave a comment 

    You may also be interested in