TY - JOUR

T1 - Content of Health Economics Analysis Plans (HEAPs) for trial-based economic evaluations: expert Delphi consensus survey

AU - Thorn, Joanna

AU - Davies, Charlotte F.

AU - Brookes, Sara

AU - Noble, Sian

AU - Dritsaki, Melina

AU - Gray, Ewan

AU - Hughes, Dyfrig

AU - Mihaylova, Borislava

AU - Petrou, Stavros

AU - Ridyard, Colin

AU - Sach, Tracey

AU - Wilson, Edward

AU - Wordsworth, Sarah

AU - Hollingworth, William

N1 - This work was undertaken with the support of the MRC ConDuCT-II Hub (Collaboration and innovation for Difficult and Complex randomized controlled Trials In Invasive procedures - MR/K025643/1), the MRC NWHTMR (North West Hub for Trials Methodology Research - MR/K025635/1) and the MRC Network of Hubs for Trials Methodology Research (MR/L004933/1-N65). BM and SW acknowledge support by the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (BRC).

PY - 2021/4/1

Y1 - 2021/4/1

N2 - OBJECTIVES: Health 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.METHODS: A 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.RESULTS: 62 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.CONCLUSIONS: Via expert consensus opinion, this study identified 58 items that are considered essential in a HEAP.

AB - OBJECTIVES: Health 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.METHODS: A 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.RESULTS: 62 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.CONCLUSIONS: Via expert consensus opinion, this study identified 58 items that are considered essential in a HEAP.

KW - analysis plans

KW - bias

KW - economic evaluation

U2 - 10.1016/j.jval.2020.10.002

DO - 10.1016/j.jval.2020.10.002

M3 - Article

C2 - 33840432

VL - 24

SP - 539

EP - 547

JO - Value in Health

JF - Value in Health

SN - 1524-4733

IS - 4

ER -