Abstract
ObjectivesHealth economics analysis plans (HEAPs) currently lack consistency, with uncertainty surrounding appropriate content. We aimed to develop a list of essential items that should be included in HEAPs for economic evaluations conducted alongside randomized trials. MethodsA list of potential items for inclusion was developed by examining existing HEAPs. An electronic Delphi survey was conducted among professional health economists. Respondents were asked to rate potential items from 1 (least important) to 9 (most important), suggest additional items, and comment on proposed items (round 1). A second survey (round 2) was emailed to participants, including the participant’s own scores from round 1 along with summary results from the whole panel; participants were asked to rerate each item. Consensus criteria for inclusion in the final list were predefined as >70% of participants rating an item 7-9 and <15% rating it 1-3 after round 2. A final item selection meeting was held to scrutinize the results and adjudicate on items lacking consensus. Results62 participants completed round 1 of the survey. The initial list included 72 potential items; all 72 were carried forward to round 2, and no new items were added. 48 round 1 respondents (77.4%) completed round 2 and reached consensus on 53 items. At the final meeting, the expert panel (n = 9) agreed that 58 items should be included in the essential list, moved 9 items to an optional list, and dropped 5 items. ConclusionsVia expert consensus opinion, this study identified 58 items that are considered essential in a HEAP.
Highlights
The use of statistical analysis plans (SAPs) is an accepted means of reducing bias in randomized controlled trials (RCTs) by minimizing selective reporting of results and undeclared post hoc analyses
A recent survey of current practice found that only around 30% of 28 responding clinical trials units in the UK always use some form of health economics analysis plans (HEAPs), and there was little consistency in the approach taken by different units.[3]
106 potential items for inclusion in the Delphi survey were extracted from a total of 18 HEAPs and 4 standard operating procedures (SOPs)
Summary
The use of statistical analysis plans (SAPs) is an accepted means of reducing bias in randomized controlled trials (RCTs) by minimizing selective reporting of results and undeclared post hoc analyses. SAPs are used routinely in RCTs by trial statisticians. In contrast to SAPs, health economics analysis plans (HEAPs) are not universally implemented by health economists, are not mandated in SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials2) or other such guidelines,[1] and lack standardization in their content. A recent survey of current practice found that only around 30% of 28 responding clinical trials units in the UK always use some form of HEAP, and there was little consistency in the approach taken by different units.[3]
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