Basics of qualitative research: Grounded theory procedures and techniques

A Qualitative Study

Safety and efficacy data on many medicines used in children are surprisingly scarce. As a result children are sometimes given ineffective medicines or medicines with unknown harmful side effects. Better and more relevant clinical trials in children are needed to increase our knowledge of the effects of medicines and to prevent the delayed or non-use of beneficial therapies. Clinical trials provide reliable evidence of treatment effects by rigorous controlled testing of interventions on human subjects. Paediatric trials are more challenging to conduct than trials in adults because of the paucity of funding, uniqueness of children and particular ethical concerns. Although current regulations and initiatives are improving the scope, quantity and quality of trials in children, there are still deficiencies that need to be addressed to accelerate radically equitable access to evidence-based therapies in children.

https://bpspubs.onlinelibrary.wiley.com/doi/pdf/10.1111/bcp.12305

Clinical trials in children

Guidelines on informed consent intend to protect patients and promote ethical research conduct. To give informed consent, individuals should understand the purpose, process, risks, benefits, and alternatives to research (or a proposed clinical intervention) and make a free, voluntary decision about whether to participate. Many participants have incomplete understanding of various features of clinical trials. Issues associated with the length, format, and language of documents for written informed consent are common. Here, we analyse the written consent form, particularly in the context of clinical research, and the discussions that take place between clinician or investigator and patient. We review strategies to improve consent forms, particularly the use of plain language. Recommendations are made on discussions between investigator and patient to improve participant comprehension and satisfaction with the informed-consent process.

https://www.thelancet.com/pdfs/journals/lanonc/PIIS1470-2045(08)70128-1.pdf

Improvement of informed consent and the quality of consent documents.

Iconography : Improvement of informed consent and the quality of consent documents

OBJECTIVE. The objective of this study was to report suggestions for improving the informed consent process from the perspective of parents of children with leukemia. METHODS. Recommendations for improving informed consent were elicited from 140 parents of children who had been offered participation in a randomized clinical trial for the treatment of their acute leukemia. Four different methods and data collection time points were used with this group of parents, including open-ended, in-person interviews within 72 hours after the informed consent conference; follow-up telephone interviews 6 months after diagnosis; focus groups during year 3 of the project; and a parent advisory group on informed consent meeting in year 4. RESULTS. The most frequently cited suggestions for improving informed consent during the interviews and focus groups related to giving parents more time to make their decision, the amount and type of information provided, organization of the consent conference, communication style, and providing additional materials. During the parent advisory group on informed consent meeting, parents developed specific guidelines for organization of the information that is presented during the consent process that include 7 major components: timing, sequence, checklist, checking for understanding, anticipatory guidance, segue into randomized clinical trial discussion with historical perspective, and choice. CONCLUSIONS. Through the incorporation of parental perspectives that provide an authentic stakeholder voice, our research represents a true partnership approach to improving the consent process. Parents provided practical advice for improving informed consent that can be applied to most adult and pediatric patient populations.

Peter W. Wittmann

Papers

Improving informed consent: suggestions from parents of children with leukemia.