Parental comprehension of the benefits/risks of first-line randomised clinical trials in children with solid tumours: a two-stage cross-sectional interview study

Abstract

ObjectivesTo analyse the parental understanding of informed consent information in first-line randomised clinical trials (RCTs) including children with malignant solid tumours and to assess parents’ needs for decision-making.DesignObservational prospective study.Setting3 paediatric oncology centres in the Parisian region in France.Participants53 parents were approached to participate in a RCT for their child with malignant solid tumour, over a 1-year period. 40 parents have been interviewed in our study.Primary and secondary outcome measuresParental understanding of information in RCTs, parents’ needs for decision-making. Parents were questioned by a psychologist, independent of the paediatric oncology teams, using a semidirected interview, 1 (M1) and 6 months (M6) after the consent was sought.Results18 parents (45%) did not understand the concept of randomisation. Half of the parents could explain neither the aim of the clinical trial nor the potential benefit to their child of inclusion. 35 parents (87.5%) expressed very few specific risks related to the trial. Being mostly French-speaking (p=0.03) and the reading of the information sheet by the parents (p=0.0025) improved their understanding. The parental comprehension did not differ between M1 and M6. The principal factors underlying their decision were confidence in the medical team (39%), wish to access to the best treatment (37%) and the best quality of life (37%).ConclusionsDespite medical explanations, parents have limited knowledge in some areas in first-line RCTs and improvements of information process are required. The risks specific to the randomised trial are underestimated by parents and the unproven nature of the treatment is not well-known or understood.

Ethical issues of clinical trials in paediatric oncology from 2003 to 2013: a systematic review

“…Despite good communication, accurate understanding is difficult to obtain in daily practice due to various obstacles, 32 mainly emotional and psychosocial factors, [37][38][39] clinical technicalities or study design. 29,35,40 Authors outline categories ("therapeutic misconception", "therapeutic misestimation", "unrealistic optimism") to discriminate a serious misunderstanding making consent invalid from attitudes merely reflecting preferences (risk aversion) or mindset (hope, optimism). 28,33,41 Urgency to decide soon after diagnosis is a known aggravating factor, 27,42 even if randomisation -a research aspect which is difficult to understand -is planned at distance from inclusion (three months in Alberto's case).…”

“…Likewise, research participation is often experienced as a choice out of necessity. 1,26,31,35,40,43,45 Phase 1 trials, often seen as last chance for controlling the disease, and correlative biological studies 23 raise particular issues in this regard; for instance, it is argued that families should be offered the choice to opt for trial participation while refusing correlative (non-beneficial) studies. 46 Hence, offering research participation can have clinical and personal impact, both on patients and parents, either positive (better follow-up, improved self-image or sense of control, "a glimmer of hope") 21,36,[47][48][49] or negative (health insurance coverage, anxiety or remorse, medical futility or broken alliance).…”

“…Although training and techniques can help, 21,34,39,56 communication first requires lay virtues (empathy, consistency, truthfulness). 40,42,44,57,66 Except for one series of articles, [13][14][15][16][17][18] little attention is paid to the return of research results to participants, although this issue is ethically challenging, especially with intensification of genetic research, and can be important to honour participation or to fulfil patients' right to know. 23,27 Reward or benefit sharing issues are marginally addressed.…”

Doing challenging research studies in a patient-centred way: a qualitative study to inform a randomised controlled trial in the paediatric emergency care setting

“…Studies have shown how qualitative research can inform trial development in challenging settings, including the identification of barriers and potential solutions to successful recruitment21–23 and acceptability of approaches to consent procedures 24 25. Historically, there has been a paucity of such research, despite its potential to help trialists understand the complexities and challenges arising from the social contexts in which trials are based 26. A recent systematic mapping review of qualitative research in the clinical trials setting indicated27 that while such work had considerable potential to inform trials, this potential is often lost because the qualitative study findings are too late to inform the partner trials.…”

Trial Characteristics That Affect Parental Consent in Neonatal Drug Trials

“…6,7 Decision makers might not fully understand trial characteristics; however, some study characteristics like randomization procedures and the use of placebos might negatively affect consent in clinical trials. [8][9][10][11] Study characteristics' effects on consent rates in neonatal clinical trials have not been reported.…”