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

2020 ◽  
Author(s):  
Christel Hellberg ◽  
Marie Österberg ◽  
AnnKristine Jonsson ◽  
Sara Fundell ◽  
Frida Trönnberg ◽  
...  
Keyword(s):  
Perinatal Depression ◽  
Core Outcome Set ◽  
Nominal Group Technique ◽  
Antenatal Depression ◽  
Delphi Survey ◽  
Nominal Group ◽  
Core Outcome ◽  
Systematic Overview ◽  
Outcome Set ◽  
Outcome Selection

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

scholarly journals The importance of stakeholder selection in core outcome set development: how surveying different health professionals may influence outcome selection

Trials ◽  
2015 ◽  
Vol 16 (S2) ◽  
Author(s):  
Kerry Avery ◽  
Katy Chalmers ◽  
Katie Whale ◽  
Natalie Blencowe ◽  
Rhiannon Macefield ◽  
...  
Keyword(s):  
Health Professionals ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Outcome Set ◽  
Outcome Selection

Delphi procedure in core outcome set development: rating scale and consensus criteria determined outcome selection

2019 ◽  
Vol 111 ◽  
pp. 23-31 ◽  
Author(s):  
Dorien De Meyer ◽  
Jan Kottner ◽  
Hilde Beele ◽  
Jochen Schmitt ◽  
Toni Lange ◽  
...  
Keyword(s):  
Rating Scale ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Outcome Set ◽  
Delphi Procedure ◽  
Outcome Selection

scholarly journals Choosing outcomes for a core outcome set: does provision of feedback between delphi survey rounds help prioritise items?

Trials ◽  
2015 ◽  
Vol 16 (S2) ◽  
Author(s):  
Karen Coulman ◽  
Sara Brookes ◽  
Katy Chalmers ◽  
James Hopkins ◽  
Noah Howes ◽  
...  
Keyword(s):  
Core Outcome Set ◽  
Delphi Survey ◽  
Core Outcome ◽  
Outcome Set

scholarly journals Core outcomes in neonatology: development of a core outcome set for neonatal research

2019 ◽  
Vol 105 (4) ◽  
pp. 425-431 ◽  
Author(s):  
James William Harrison Webbe ◽  
James M N Duffy ◽  
Elsa Afonso ◽  
Iyad Al-Muzaffar ◽  
Ginny Brunton ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Core Outcome Set ◽  
Neonatal Care ◽  
Consensus Meeting ◽  
High Income ◽  
Core Outcome ◽  
Outcome Set ◽  
Outcome Selection ◽  
Survey Results ◽  
Meta Analyses

BackgroundNeonatal research evaluates many different outcomes using multiple measures. This can prevent synthesis of trial results in meta-analyses, and selected outcomes may not be relevant to former patients, parents and health professionals.ObjectiveTo define a core outcome set (COS) for research involving infants receiving neonatal care in a high-income setting.DesignOutcomes reported in neonatal trials and qualitative studies were systematically reviewed. Stakeholders were recruited for a three-round international Delphi survey. A consensus meeting was held to confirm the final COS, based on the survey results.ParticipantsFour hundred and fourteen former patients, parents, healthcare professionals and researchers took part in the eDelphi survey; 173 completed all three rounds. Sixteen stakeholders participated in the consensus meeting.ResultsThe literature reviews identified 104 outcomes; these were included in round 1. Participants proposed 10 additional outcomes; 114 outcomes were scored in rounds 2 and 3. Round 1 scores showed different stakeholder groups prioritised contrasting outcomes. Twelve outcomes were included in the final COS: survival, sepsis, necrotising enterocolitis, brain injury on imaging, general gross motor ability, general cognitive ability, quality of life, adverse events, visual impairment/blindness, hearing impairment/deafness, retinopathy of prematurity and chronic lung disease/bronchopulmonary dysplasia.Conclusions and relevanceA COS for clinical trials and other research studies involving infants receiving neonatal care in a high-income setting has been identified. This COS for neonatology will help standardise outcome selection in clinical trials and ensure these are relevant to those most affected by neonatal care.

scholarly journals Development of a Core Outcome Set for Effectiveness Studies of Breech Birth at Term (Breech-COS)- An International Multi-Stakeholder Delphi Study: Study Protocol

2021 ◽  
Author(s):  
Shawn Walker ◽  
Tisha Dasgupta ◽  
Andrew Shennan ◽  
Jane Sandall ◽  
Catey Bunce ◽  
...  
Keyword(s):  
Literature Review ◽  
Core Outcome Set ◽  
Delphi Survey ◽  
Neonatal Outcomes ◽  
Core Outcome ◽  
Care Providers ◽  
Outcome Set ◽  
Increased Risk ◽  
Breech Birth ◽  
Effectiveness Studies

Abstract Background: Women pregnant with a breech-presenting foetus at term are at increased risk of adverse pregnancy outcomes. The most common intervention used to improve neonatal outcomes is planned delivery by caesarean section. But this is not always possible, and some women prefer to plan a vaginal birth. A number of providers have proposed alternative interventions, such as delivery protocols or specialist teams, but heterogeneity in reported outcomes and their measurements prevents meaningful comparisons. The aim of this paper is to present a protocol for a study to develop a Breech Core Outcome Set (Breech-COS) for studies evaluating the effectiveness of interventions to improve outcomes associated with term breech birth.Methods: The development of a Breech-COS includes three phases. First, a systematic literature review will be conducted to identify outcomes previously used in effectiveness studies of breech birth at term. A focus group discussion will be conducted with the study’s pre-established Patient and Public Involvement (PPI) group, to enable service user perspectives on the results of literature review to influence the design of Delphi survey instrument. Second, an international Delphi survey will be conducted to prioritize outcomes for inclusion in the Breech-COS from the point of view of key stakeholders, including perinatal care providers and families who have experienced a term breech pregnancy. Finally, a consensus meeting will be held with stakeholders to ratify the Breech-COS and disseminate findings for application in future effectiveness studies.Discussion: The expectation is that the Breech-COS will always be collected in all clinical trials, audits of practice and other forms of observation research that concern breech birth at term, along with other outcomes of interest. This will facilitate comparing, contrasting and combining studies with the ultimate goal of improved maternal and neonatal outcomes. Trial registration: Core Outcome Measures in Effectiveness Trials (COMET): #1749; Core Outcomes in Women’s and Newborn Health (CROWN) Initiative.

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