Population health intervention research: what is the place for pilot studies?

Abstract

Background An international workshop on population health intervention research (PHIR) was organized to foster exchanges between experts from different disciplines and different fields. Aims This paper aims to summarize the discussions around one of the issues addressed: the place or role of pilot studies in PHIR. Pilot studies are well-established in biomedical research, but the situation is more ambiguous for PHIR, in which a pilot study could refer to different purposes. Methods The workshop included formal presentations of participants and moderated discussions. An oral synthesis was carried out by a rapporteur to validate by expert consensus the key points of the discussion and the recommendations. All discussions have been recorded and fully transcribed. Discussion PHIR generally addresses complex interventions. Thus, numerous tasks may be required to inform the intervention and test different aspects of its design and implementation. While in clinical research the pilot study mainly concerns the preparation of the trial, in PHIR the pilot study focuses on the preparation of both the intervention and the trial. In particular, pilot studies in PHIR could be used for viability evaluation and theory development. Recommendations from the workshop participants The following recommendations were generated by consensus from the workshop discussions: i) terms need to be clarified for PHIR; ii) reporting and publication should be standardized and transparency should be promoted; iii) the objectives and research questions should drive the methods used and be clearly stated; iv) a pilot study is generally needed for complex intervention evaluation and for research-designed programs; and v) for field-designed programs, it is important to integrate evaluability assessments as pilot studies . Conclusion Pilot studies play an important role in intervention development and evaluation. In particular, they contribute to a better understanding of the mechanisms of intervention and the conditions of its applicability and transferability. Pilot studies could therefore facilitate evidence-based decisions about design and conduct of main studies aimed to generate evidence to inform public health policy.

A Multinational Pilot Study on the Lived Experiences and Mental Health Impacts from the COVID-19 Pandemic

“…This is a plus to our recruitment strategy (Lin, et al 2010); it has thus revealed that, in order to access a large sample that is representative enough of everyone who are directly or indirectly affected by the pandemic, a sufficient timeframe with adequate financial resources, and more social media platforms will be required. The ability of this pilot study to reveal the requirements for our main study is in line with scholars' opinions about the importance of pilot studies (Teijlingen & Hundley, 2001;Maunder, 2009;Thabane, et al 2019;Malmqvist, et al 2019;Bidarbakhtnia, 2020).…”

“…Therefore, the current pilot study is aimed at creating a starting point for bridging the existing knowledge gaps. The current pilot study would also serve as among the first sources of knowledge for other researchers with similar interests to that of ours, given the importance of sharing lessons learnt from pilot studies (Teijlingen & Hundley, 2001;Thabane, et al 2019).…”

“…Before embarking on our multinational study, it is worthy to acknowledge that scholars have strongly opined that a pilot study is imperative for gaining insight into what is actually required for our main multinational study that is aimed at informing appropriate intervention or protection programs for everyone affected by the novel COVID-19 pandemic (Maunder, 2009;Bidarbakhtnia, 2020). Further, some other scholars have also submitted that pilot studies offer increased likelihood of success for a main study by establishing its feasibility (Teijlingen & Hundley, 2001;Thabane, et al 2019;Malmqvist, et al 2019). Thus, we decided to have this pilot phase as a starting point.…”

Researching Ageing

“…The proposal is to use an integrative validity approach, first proceeding to a viability study, second performing an effectiveness study considering the real conditions of implementation and last (and if necessary) conducting an efficacy study or directly proceeding to dissemination. Practically, if the intervention is research based, this viability analysis should be integrated into the objectives of a pilot study in addition to its classical objectives (Thabane et al, 2019) in research-design program evaluation in order to prepare as best as possible both trial and intervention by reporting essential information to transfer or scale up the intervention. If the intervention is field based, it is by nature adapted to the context, conceived with local and routine resources.…”

Social and Behavior Change Communication Interventions Delivered Face-to-Face and by a Mobile Phone to Strengthen Vaccination Uptake and Improve Child Health in Rural India: Randomized Pilot Study

“…We conducted a pilot randomized controlled trial (RCT) applying an implementation research lens to inform a future large-scale RCT. This paper presents the main (quantitative) evaluation of the pilot trial focusing on two objectives: (1) to assess the feasibility of processes critical to the success of the main study (recruitment, randomization, retention, and contamination) and intervention uptake (adoption) and (2) to study key implementation outcomes to optimize successful delivery of the interventions at scale [ 7 ]. Objectives pertained to cluster and individual levels.…”