Evidence map›Paper›PMID 34294124›Full record

ArticleTrials2021

The Core Outcome DEvelopment for Carrier Screening (CODECS) study: protocol for development of a core outcome set.

Ebony Richardson, Alison McEwen, Toby Newton-John, Karine Manera, Chris Jacobs

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Ebony RichardsonGraduate School of Health, University of Technology Sydney, Building 20, 100 Broadway, Chippendale, Sydney, NSW, 2008, Australia. ebony.j.richardson@student.uts.edu.au.ORCID http://orcid.org/0000-0003-4260-7356
Alison McEwenGraduate School of Health, University of Technology Sydney, Building 20, 100 Broadway, Chippendale, Sydney, NSW, 2008, Australia.
Toby Newton-JohnGraduate School of Health, University of Technology Sydney, Building 20, 100 Broadway, Chippendale, Sydney, NSW, 2008, Australia.
Karine ManeraSydney School of Public Health, The University of Sydney, Edward Ford Building, A27 Fisher Rd, Sydney, NSW, 2006, Australia.
Chris JacobsGraduate School of Health, University of Technology Sydney, Building 20, 100 Broadway, Chippendale, Sydney, NSW, 2008, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundReproductive genetic carrier screening is a type of genetic testing available to those planning a pregnancy, or during their first trimester, to understand their risk of having a child with a severe genetic condition. There is a lack of consensus for 'what to measure' in studies on this intervention, leading to heterogeneity in choice of outcomes and methods of measurement. Such outcome heterogeneity has implications for the quality and comparability of these studies and has led to a lack of robust research evidence in the literature to inform policy and decision-making around the offer of this screening. As reproductive genetic carrier screening becomes increasingly accessible within the general population, it is timely to investigate the outcomes of this intervention.

objectivesThe development of a core outcome set is an established methodology to address issues with outcome heterogeneity in research. We aim to develop a core outcome set for reproductive genetic carrier screening to clarify and standardise outcomes for research and practice.

methodsIn accordance with guidance from the COMET (Core Outcome Measures in Effectiveness Trials) Initiative, this study will consist of five steps: (i) a systematic review of quantitative studies, using narrative synthesis to identify previously reported outcomes, their definitions, and methods of measurement; (ii) a systematic review of qualitative studies using content analysis to identify excerpts related to patient experience and perspectives that can be interpreted as outcomes; (iii) semi-structured focus groups and interviews with patients who have undertaken reproductive genetic carrier screening to identify outcomes of importance to them; (iv) Delphi survey of key stakeholders, including patients, clinicians, and researchers, to refine and prioritise the list of outcomes generated from the previous steps; and (v) a virtual consensus meeting with a purposive sample of key stakeholders to finalise the core outcome set for reporting. DISCUSSION: This protocol outlines the core outcome set development process and its novel application in the setting of genetic testing. This core outcome set will support the standardisation of outcome reporting in reproductive carrier screening research and contribute to an evolving literature on outcomes to evaluate genetic testing and genetic counselling as health interventions. COMET CORE OUTCOME SET REGISTRATION: http://www.comet-initiative.org/Studies/Details/1381 .

Indexed as

Research DesignChildClinical Studies as TopicConsensusDelphi TechniqueEndpoint DeterminationFemaleHumansPregnancyTreatment OutcomeCore outcome setDelphi surveyGenetic counsellingOutcome reportingPatient-reported outcomesQualitative researchReproductive genetic carrier screening

Identifiers

PMID34294124
PMCPMC8296650

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.