Important research outcomes for treatment studies of perinatal depression: systematic overview and development of a core outcome set

Abstract

Objective To develop a Core Outcome Set (COS) for treatment of perinatal depression Design Systematic overview of outcomes reported in the literature and consensus development study using a Delphi survey and modified nominal group technique. Setting International. Population Two hundred and twenty-two participants, representing thirteen countries. Methods A systematic overview of outcomes reported in recently published research, a two-round Delphi survey, a consensus meeting at which the final COS was decided. Main results In the literature search, 1772 abstracts were identified and evaluated, 284 papers/protocols were assessed in full and 165 studies were finally included in the review. In all, 106 outcomes were identified and thus included in the Delphi survey. 222 participants registered for the first round of the Delphi survey and 151 (68%) responded. In the second round, 123 (55%) participants responded. The following 9 outcomes were agreed upon for inclusion in the final COS: self-assessed symptoms of depression, diagnosis of depression by a clinician, parent to infant bonding, self-assessed symptoms of anxiety, quality of life, satisfaction with intervention, suicidal thoughts, attempted or committed suicide, thoughts of harming the baby, and adverse events. Conclusions The relevant stakeholders prioritised outcomes and reached consensus on a COS comprising nine outcomes. We hope that this COS will contribute to consistency and uniformity of outcome selection and reporting in future clinical trials involving treatment of perinatal depression Funding This article is adapted from a report by SBU, which provided funding for the study. Keywords: perinatal depression, postpartum depression, antenatal depression, COS

Core Outcome Sets (COS) related to pregnancy and childbirth: a systematic review

“…2C, Table 1). Only a few studies had less than 10 outcomes in the final COS. Only one study mentioned that a possible maximum limit to the number of outcomes to be included in the COS had been determined or discussed in advance, in order to enable implementation and feasibility in research [27]. Six studies described using a "modified nominal group technique" during the consensus meeting in order to reduce the number of outcomes (Table 1) [20, 27-29, 34, 37].…”

“…Most of the finalized studies lacked information about whether outcomes had been excluded at some stage or if outcomes had been merged. Only one study mentioned whether they deviated from the study protocol in any way [27].…”

“…Six of the 27 studies were not registered in the COMET databases (Table 1). Of those registered only two did not yet provide a link to the published paper [27,37].…”

“…There are few COS studies focusing on labour, birth and physical conditions associated with giving birth. Also, a limited number of studies, one finalized and two ongoing, were identified relating to mental health during pregnancy or after childbirth [27,39,49]. Since the focus of our review is Core Outcome Sets relating to pregnancy and childbirth and not neonatal and fetal aspects only a few finalized COS have been included which presents both outcomes related to the women as well as the featus/ newborn.…”

Frequency Of pRenatal CAre viSiTs (FORCAST): study protocol to develop a core outcome set for prenatal care schedules

“…Consensus for an outcome to be excluded from the COS will be defined when ≥70% of participants in the stakeholder group scored the outcome of "limited importance for decision-making" (a score of 1-3) and <15% of participants in the stakeholder group scored the outcome as "critical for decision-making" (a score of 7-9) [10]. Though there is no consensus regarding the ideal number of outcomes to include in a COS, based on existing literature and expert opinion, the steering committee has established a preset goal of 10 outcomes for the COS to enable implementation and use of the COS [15]. Items that reach consensus to be included (as defined above) for all three stakeholder groups will be automatically included in the final set of FORCAST COS recommendations, even if there are more than 10 core outcomes.…”