Evidence map›Paper›PMID 29421474›Full record

ArticleSocial science & medicine (1982)2018

Improving recruitment to clinical trials during pregnancy: A mixed methods investigation.

Sofia Strömmer, Wendy Lawrence, Taylor Rose, Christina Vogel, Daniella Watson, Joanne N Bottell, Janice Parmenter, Nicholas C Harvey, Cyrus Cooper, Hazel Inskip and 2 more

Open access · greenAbstract read
In one paragraph

Article in Social science & medicine (1982), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 1 pooled it
3.9field-weighted citation impact, top 7% of its field
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

29 citing papers in PubMed, 1 synthesis or guideline pooled it, 46 citations in OpenAlex.

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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

12 authors at 2 institutions in 1 country.

Sofia StrömmerMRC Lifecourse Epidemiology Unit, University of Southampton, Southampton General Hospital, Southampton SO16 6YD, UK; NIHR Southampton Biomedical Research Centre, University of Southampton and University Hospital Southampton NHS Foundation Trust, UK. Electronic address: ss3@mrc.soton.ac.uk.
Wendy LawrenceMRC Lifecourse Epidemiology Unit, University of Southampton, Southampton General Hospital, Southampton SO16 6YD, UK; NIHR Southampton Biomedical Research Centre, University of Southampton and University Hospital Southampton NHS Foundation Trust, UK.
Taylor RoseMRC Lifecourse Epidemiology Unit, University of Southampton, Southampton General Hospital, Southampton SO16 6YD, UK.
Christina VogelMRC Lifecourse Epidemiology Unit, University of Southampton, Southampton General Hospital, Southampton SO16 6YD, UK; NIHR Southampton Biomedical Research Centre, University of Southampton and University Hospital Southampton NHS Foundation Trust, UK.
Daniella WatsonMRC Lifecourse Epidemiology Unit, University of Southampton, Southampton General Hospital, Southampton SO16 6YD, UK.
Joanne N BottellMRC Lifecourse Epidemiology Unit, University of Southampton, Southampton General Hospital, Southampton SO16 6YD, UK.
Janice ParmenterNIHR Southampton Biomedical Research Centre, University of Southampton and University Hospital Southampton NHS Foundation Trust, UK.
Nicholas C HarveyMRC Lifecourse Epidemiology Unit, University of Southampton, Southampton General Hospital, Southampton SO16 6YD, UK; NIHR Southampton Biomedical Research Centre, University of Southampton and University Hospital Southampton NHS Foundation Trust, UK.
Cyrus CooperMRC Lifecourse Epidemiology Unit, University of Southampton, Southampton General Hospital, Southampton SO16 6YD, UK; NIHR Oxford Musculoskeletal Biomedical Research Unit, University of Oxford, UK.
Hazel InskipMRC Lifecourse Epidemiology Unit, University of Southampton, Southampton General Hospital, Southampton SO16 6YD, UK; NIHR Southampton Biomedical Research Centre, University of Southampton and University Hospital Southampton NHS Foundation Trust, UK.
Janis BairdMRC Lifecourse Epidemiology Unit, University of Southampton, Southampton General Hospital, Southampton SO16 6YD, UK; NIHR Southampton Biomedical Research Centre, University of Southampton and University Hospital Southampton NHS Foundation Trust, UK.
Mary BarkerMRC Lifecourse Epidemiology Unit, University of Southampton, Southampton General Hospital, Southampton SO16 6YD, UK; NIHR Southampton Biomedical Research Centre, University of Southampton and University Hospital Southampton NHS Foundation Trust, UK.
Southampton General Hospital · GBUniversity Hospital Southampton NHS Foundation Trust · GB

Funding

British Heart Foundation RG/07/009/23120Department of Health 10/33/04Department of Health HTA/10/33/04Department of Health RP-PG-0216-20004Medical Research Council G0400491Medical Research Council MC_U105960371Medical Research Council MC_U147585819Medical Research Council MC_U147585824Medical Research Council MC_U147585827Medical Research Council MC_UP_A620_1014Medical Research Council MC_UU_12011/1Medical Research Council MC_UU_12011/4Medical Research Council MR/N011848/1Versus Arthritis 17702Versus Arthritis 21231
6 · The paper itself

Abstract

objectiveTo identify reasons underlying women's refusal to participate in a pregnancy trial and to identify ways of increasing recruitment.

designMixed methods study using a questionnaire and qualitative interviews. SAMPLE: A questionnaire asking them to indicate reasons for their decision was completed by 296 pregnant women who declined to participate in one of two trials of nutritional supplementation in a large teaching hospital in southern England. Qualitative interview data were collected from two samples of pregnant women: 1) 30 women who declined to participate in a trial but completed the questionnaire; and 2) 44 women who participated in a trial.

resultsQuestionnaire data from pregnant women who declined to participate suggested the major barriers to participation were study requirements, including taking study medication, having a bone scan or blood tests, or being too busy. Thematic analysis of interview data identified differences in self-efficacy and levels of trust in medical research between participants and decliners. Participants believed that the research would cause no harm, while decliners felt they or their unborn child would be at risk. When faced with potential obstacles, participants found ways around them while decliners felt they were insurmountable.

conclusionsRecruitment methods for pregnancy trials should focus on building women's trust in the trial, and on enhancing women's self-efficacy so they feel able to meet trial requirements. Suggestions for building trust include investing time in open, honest discussion of the risks and benefits of participation, improving visibility of the research team, testimonials from previous participants and advertising study safety and ethical conduct. Self-efficacy can be enhanced by training research staff in empowering styles of communication enabling women to feel heard and supported to problem-solve. These strategies could be implemented relatively easily into pregnancy trial protocols, and their effectiveness tested through their impact on recruitment rates.

Indexed as

Clinical Trials as TopicPatient SelectionAdultDecision MakingFemaleHumansPregnancyPregnant PeopleQualitative ResearchRefusal to ParticipateSelf EfficacySurveys and QuestionnairesTrustClinical trialMixed methodsPregnancyQualitativeQuestionnaireRecruitmentThematic analysis

Identifiers

PMID29421474
PMCPMC6033317
OpenAlexW2784328521

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.