Recruitment in pediatric clinical research was influenced by study characteristics and pediatricians' perceptions: a multicenter survey

Kaguelidou, Florentia; Amiel, Philippe; Blachier, Audrey; Iliescu, C.; Rozé, Jean‐Christophe; Tsimaratos, Michel; Brandt, Christian; Kassai, Behrouz; Jacqz-Aigrain, Évelyne; Gaultier, Claude; Alberti, Corinne

doi:10.1016/j.jclinepi.2013.04.015

Cited by 20 publications

(21 citation statements)

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“…However, systematic reviews have identified only a small number of successful interventions directed at patients [4] and pointed to the lack of prospective research in ongoing RCTs and studies involving recruiters [5]. The research that has been done with recruiters includes a survey of pediatricians that suggested that their views could influence levels of participation [6] and two studies that have indicated that difficulties with equipoise can act as a barrier to recruitment to RCTs [7,8].…”

Section: Introductionmentioning

confidence: 99%

The intellectual challenges and emotional consequences of equipoise contributed to the fragility of recruitment in six randomized controlled trials

Donovan

Salis

Toerien

et al. 2014

Journal of Clinical Epidemiology

127

209

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ObjectiveThe aim of the study was to investigate how doctors considered and experienced the concept of equipoise while recruiting patients to randomized controlled trials (RCTs).Study Design and SettingIn-depth interviews with 32 doctors in six publicly funded pragmatic RCTs explored their perceptions of equipoise as they undertook RCT recruitment. The RCTs varied in size, duration, type of complex intervention, and clinical specialties. Interview data were analyzed using qualitative content and thematic analytical methods derived from grounded theory and synthesized across six RCTs.ResultsAll six RCTs suffered from poor recruitment. Doctors wanted to gather robust evidence but experienced considerable discomfort and emotion in relation to their clinical instincts and concerns about patient eligibility and safety. Although they relied on a sense of community equipoise to justify participation, most acknowledged having “hunches” about particular treatments and patients, some of which undermined recruitment. Surgeons experienced these issues most intensely. Training and support promoted greater confidence in equipoise and improved engagement and recruitment.ConclusionRecruitment to RCTs is a fragile process and difficult for doctors intellectually and emotionally. Training and support can enable most doctors to become comfortable with key RCT concepts including equipoise, uncertainty, patient eligibility, and randomization, promoting a more resilient recruitment process in partnership with patients.

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Section: Introductionmentioning

confidence: 99%

The intellectual challenges and emotional consequences of equipoise contributed to the fragility of recruitment in six randomized controlled trials

Donovan

Salis

Toerien

et al. 2014

Journal of Clinical Epidemiology

127

209

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“…Fifty-seven items reached the first level of consensus (57/86, 66%) ( Table 2 , column A ), while twenty-nine items were discarded (29/86, 34%): 16 (19%) because of a median rating lower than 7, and 13 (15%) because less than 65% of panellists gave rating in the top tertile [7]–[9].…”

Section: Resultsmentioning

confidence: 99%

“…As previously stated, drug research in neonates is difficult and, consequently, the number of neonatal drug trials is limited and sometimes of poor quality [7]. Therefore, collaborative, multicenter and multinational studies are essential to recruit neonates with similar diseases from various regions or countries in order to obtain a sample size of sufficient magnitude and to conduct scientific sound studies.…”

Section: Discussionmentioning

confidence: 99%

“…Evaluation of drug pharmacokinetics, efficacy and safety are required in the different neonatal age groups from 24 to 44 weeks' gestational age, characterised by differences in physiological and pharmacological maturation affecting drug disposition and effects [3], [4]. Suitable approaches, adapted to neonates are recommended but need to be more widely used: population pharmacokinetic and bridging studies [5], [6], adapted designs and other methodologies recognised as pertinent to evaluate efficacy when randomized controlled trials are not possible [7]–[9].…”

Section: Introductionmentioning

confidence: 99%

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A Delphi Process to Optimize Quality and Performance of Drug Evaluation in Neonates

et al. 2014

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BackgroundNeonatal trials remain difficult to conduct for several reasons: in particular the need for study sites to have an existing infrastructure in place, with trained investigators and validated quality procedures to ensure good clinical, laboratory practices and a respect for high ethical standards. The objective of this work was to identify the major criteria considered necessary for selecting neonatal intensive care units that are able to perform drug evaluations competently.Methodology and Main FindingsThis Delphi process was conducted with an international multidisciplinary panel of 25 experts from 13 countries, selected to be part of two committees (a scientific committee and an expert committee), in order to validate criteria required to perform drug evaluation in neonates. Eighty six items were initially selected and classified under 7 headings: “NICUs description - Level of care” (21), “Ability to perform drug trials: NICU organization and processes (15), “Research Experience” (12), “Scientific competencies and area of expertise” (8), “Quality Management” (16), “Training and educational capacity” (8) and “Public involvement” (6). Sixty-one items were retained and headings were rearranged after the first round, 34 were selected after the second round. A third round was required to validate 13 additional items. The final set includes 47 items divided under 5 headings.ConclusionA set of 47 relevant criteria will help to NICUs that want to implement, conduct or participate in drug trials within a neonatal network identify important issues to be aware of.Summary Points1) Neonatal trials remain difficult to conduct for several reasons: in particular the need for study sites to have an existing infrastructure in place, with trained investigators and validated quality procedures to ensure good clinical, laboratory practices and a respect for high ethical standards. 2) The present Delphi study was conducted with an international multidisciplinary panel of 25 experts from 13 countries and aims to identify the major criteria considered necessary for selecting neonatal intensive care units (NICUs) that are able to perform drug evaluations competently. 3) Of the 86 items initially selected and classified under 7 headings - “NICUs description - Level of care” (21), “Ability to perform drug trials: NICU organization and processes (15), “Research Experience” (12), “Scientific competencies and area of expertise” (8), “Quality Management” (16), “Training and educational capacity” (8) and “Public involvement” (6) - 47 items were selected following a three rounds Delphi process. 4) The present consensus will help NICUs to implement, conduct or participate in drug trials within a neonatal network.

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“…In the past, this low rate of paediatric trials was thought to be mainly due to a concern for the vulnerability of children leading to a reluctance by clinicians to undertake clinical trials with young children [7, 14]. Nevertheless, high rates of patient or parent refusal have also been identified as a key barrier for successful completion of these trials [15], although a recent study has shown lower refusal rates for paediatric trials involving therapeutic drugs [16]. …”

Section: Introductionmentioning

confidence: 99%

Developing and evaluating multimedia information resources to improve engagement of children, adolescents, and their parents with trials (TRECA study): Study protocol for a series of linked randomised controlled trials

Martin-Kerry

Bower

Young

et al. 2017

Trials

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BackgroundRandomised controlled trials are widely established as the best method for testing health interventions whilst minimising bias. However, recruitment and subsequent retention of children and adolescents in healthcare trials is challenging. Participant information sheets are often lengthy and difficult to read and understand. Presenting key information using multimedia may help to overcome these limitations and better support young people and their parents in deciding whether to participate in a clinical trial.MethodsThe TRECA (TRials Engagement in Children and Adolescents) study has two phases. The first phase involves a qualitative study with children and adolescents and their parents to inform the development of multimedia information resources and iterative user testing to refine the resources. The second phase will embed the use of the multimedia information resources into six host trials in the United Kingdom. Patients and parents approached to participate in the host trials will be randomly allocated to either use the multimedia information resource in conjunction with standard participant information sheets, the multimedia information resource alone, or the standard participant information sheets alone. The primary outcome will be the effect of the multimedia information resources on recruitment into trials. Other outcomes measured include the effect of multimedia information resources on retention of participants into the host trials and the impact on family members’ decision-making processes, when compared to standard participant information sheets alone.DiscussionThis study will inform whether multimedia information resources, when developed using participatory design principles, are able to increase recruitment and retention of children and adolescents into trials. There is also the potential for patients to make better informed decisions through the use of multimedia information resources. The multimedia information resources also have the potential to assist with providing information on other healthcare decisions outside of clinical trials.Trial registrationISRCTN registry: ISRCTN73136092 (doi:10.1186/ISRCTN73136092). Registered on 24 August 2016.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-1962-z) contains supplementary material, which is available to authorized users.

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Recruitment in pediatric clinical research was influenced by study characteristics and pediatricians' perceptions: a multicenter survey

Cited by 20 publications

References 24 publications

The intellectual challenges and emotional consequences of equipoise contributed to the fragility of recruitment in six randomized controlled trials

The intellectual challenges and emotional consequences of equipoise contributed to the fragility of recruitment in six randomized controlled trials

A Delphi Process to Optimize Quality and Performance of Drug Evaluation in Neonates

Developing and evaluating multimedia information resources to improve engagement of children, adolescents, and their parents with trials (TRECA study): Study protocol for a series of linked randomised controlled trials

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