Recruitment difficulties in obstetric trials: A case study and review

Madan, Arushi; Tracy, Sally; Reid, R.; Henry, Amanda

doi:10.1111/ajo.12233

Cited by 16 publications

(18 citation statements)

References 28 publications

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“…Moreover, healthcare professionals from centres where the case-study was approved made individual judgements on the risk and voiced various concerns with regard to the study, in our case doubts about the pessary as an intervention. A lack of equipoise concerning an intervention has been suggested earlier as a reason for hampering recruitment [35] (also suggested in relation to the APOSTEL IV study [36]). Moreover, it could also explain why even minimal risk studies often get cancelled.…”

Section: Discussionmentioning

confidence: 99%

“…Moreover, it could also explain why even minimal risk studies often get cancelled. Cancellation can happen because of various reasons such as financial or safety issues, but also because of disappointing patient recruitment rates which might be traced back to gatekeeping by healthcare professionals [35] (APOSTEL IV study [36] and possibly also the APOSTEL VI study).…”

Section: Discussionmentioning

confidence: 99%

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A qualitative study on acceptable levels of risk for pregnant women in clinical research

et al. 2017

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BackgroundThere is ambiguity with regard to what counts as an acceptable level of risk in clinical research in pregnant women and there is no input from stakeholders relative to such research risks. The aim of our paper was to explore what stakeholders who are actively involved in the conduct of clinical research in pregnant women deem an acceptable level of risk for pregnant women in clinical research. Accordingly, we used the APOSTEL VI study, a low-risk obstetrical randomised controlled trial, as a case-study.MethodsWe conducted a prospective qualitative study using 35 in-depth semi-structured interviews and one focus group. We interviewed healthcare professionals, Research Ethics Committee members (RECs) and regulators who are actively involved in the conduct of clinical research in pregnant women, in addition to pregnant women recruited for the APOSTEL VI case-study in the Netherlands.ResultsThree themes characterise the way stakeholders view risks in clinical research in pregnant women in general. Additionally, one theme characterises the way healthcare professionals and pregnant women view risks with respect to the case-study specifically. First, ideas on what constitutes an acceptable level of risk in general ranged from a preference for zero risk for the foetus up to minimal risk. Second, the desirability of clinical research in pregnant women in general was questioned altogether. Third, stakeholders proposed to establish an upper limit of risk in potentially beneficial clinical research in pregnant women in order to protect the foetus and the pregnant woman from harm. Fourth and finally, the case-study illustrates that healthcare professionals’ individual perception of risk may influence recruitment.ConclusionsHealthcare professionals, RECs, regulators and pregnant women are all risk adverse in practice, possibly explaining the continuing underrepresentation of pregnant women in clinical research. Determining the acceptable levels of risk on a universal level alone is insufficient, because the individual perception of risk also influences behaviour towards pregnant women in clinical research. Therefore, bioethicists and researchers might be interested in changing the perception of risk, which could be achieved by education and awareness about the actual benefits and harms of inclusion and exclusion of pregnant women.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

A qualitative study on acceptable levels of risk for pregnant women in clinical research

et al. 2017

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“…Because of ethical concerns, safety data for analgesic use in pregnancy is largely limited to animal studies or observational studies in humans, and thus may be confounded by selection bias, and exposure or outcome misclassification . Many obstetric studies also have methodological issues, such as low recruitment rates and inadequate sample sizes, which may limit their feasibility and external validity . Safety data must therefore be interpreted carefully, which can be challenging for the busy clinician.…”

Section: Introductionmentioning

confidence: 99%

Medication Use and Pain Management in Pregnancy: A Critical Review

Black¹,

Khor

Kennedy

et al. 2019

Pain Practice

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Background Pain during pregnancy is common, and its management is complex. Certain analgesics may increase the risk for adverse fetal and pregnancy outcomes, while poorly managed pain can result in adverse maternal outcomes such as depression and hypertension. Guidelines to assist clinicians in assessing risks and benefits of exposure to analgesics for the mother and unborn infant are lacking, necessitating evidence‐based recommendations for managing pain in pregnancy. Methods A comprehensive literature search was conducted to assess pregnancy safety data for pharmacological and nonpharmacological pain management methods. Relevant clinical trials and observational studies were identified using multiple medical databases, and included studies were evaluated for quality and possible biases. Results Paracetamol and nonsteroidal anti‐inflammatory drugs (NSAIDs) are appropriate for mild to moderate pain, but NSAIDs should be avoided in the third trimester due to established risks. Short courses of weaker opioids are generally safe in pregnancy, although neonatal abstinence syndrome must be monitored following third trimester exposure. Limited safety data for pregabalin and gabapentin indicate that these are unlikely to be major teratogens, and tricyclic antidepressants and serotonin‐norepinephrine reuptake inhibitors have limited but overall reassuring safety data. Many of the included studies were limited by methodological issues. Conclusions Findings from this review can guide clinicians in their decision to prescribe analgesics for pregnant women. Treatment should be tailored to the lowest therapeutic dose and shortest possible duration, and management should involve a discussion of risks and benefits and monitoring for response. Further research is required to better understand the safety profile of various analgesics in pregnancy.

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“…The ability to identify, screen, and enroll potential research participants in an efficient and timely manner is crucial to the success of clinical trials. However, researchers continually emphasize insufficient accrual and subsequent challenges [ 1 - 3 ], with an estimated 31% of trials failing to meet original recruitment targets and 53% of trials requiring additional time to meet study recruitment goals [ 4 , 5 ]. Failure to reach recruitment targets may result in a loss of statistical power and increase trial duration and costs [ 6 , 7 ].…”

Section: Introductionmentioning

confidence: 99%

A Practical Do-It-Yourself Recruitment Framework for Concurrent eHealth Clinical Trials: Simple Architecture (Part 1)

Palac¹,

Alam²,

Kaiser³

et al. 2018

J Med Internet Res

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BackgroundThe ability to identify, screen, and enroll potential research participants in an efficient and timely manner is crucial to the success of clinical trials. In the age of the internet, researchers can be confronted with large numbers of people contacting the program, overwhelming study staff and frustrating potential participants.ObjectiveThis paper describes a “do-it-yourself” recruitment support framework (DIY-RSF) that uses tools readily available in many academic research settings to support remote participant recruitment, prescreening, enrollment, and management across multiple concurrent eHealth clinical trials.MethodsThis work was conducted in an academic research center focused on developing and evaluating behavioral intervention technologies. A needs assessment consisting of unstructured individual and group interviews was conducted to identify barriers to recruitment and important features for the new system.ResultsWe describe a practical and adaptable recruitment management architecture that used readily available software, such as REDCap (Research Electronic Data Capture) and standard statistical software (eg, SAS, R), to create an automated recruitment framework that supported prescreening potential participants, consent to join a research registry, triaging for management of multiple trials, capture of eligibility information for each phase of a recruitment pipeline, and staff management tools including monitoring of participant flow and task assignment/reassignment features. The DIY-RSF was launched in July 2015. As of July 2017, the DIY-RSF has supported the successful recruitment efforts for eight trials, producing 14,557 participant records in the referral tracking database and 5337 participants in the center research registry. The DIY-RSF has allowed for more efficient use of staff time and more rapid processing of potential applicants.ConclusionsUsing tools already supported at many academic institutions, we describe the architecture and utilization of an adaptable referral management framework to support recruitment for multiple concurrent clinical trials. The DIY-RSF can serve as a guide for leveraging common technologies to improve clinical trial recruitment procedures.

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Recruitment difficulties in obstetric trials: A case study and review

Cited by 16 publications

References 28 publications

A qualitative study on acceptable levels of risk for pregnant women in clinical research

A qualitative study on acceptable levels of risk for pregnant women in clinical research

Medication Use and Pain Management in Pregnancy: A Critical Review

A Practical Do-It-Yourself Recruitment Framework for Concurrent eHealth Clinical Trials: Simple Architecture (Part 1)

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