Original Article

Paediatric patient family engagement with clinical research at a tertiary care paediatric hospital Carson Gill MSc1, Mark J Ansermino MBBCH MMed MSc2, Shubhayan Sanatani MD3, Kishore Mulpuri MBBS MS MHSc4, Quynh Doan MDCM MHSc PhD3 C Gill, MJ Ansermino, S Sanatani, K Mulpuri, Q Doan. Paediatric patient family engagement with clinical research at a tertiary care paediatric hospital. Paediatr Child Health 2014;19(10):537-542.

L’engagement de la famille de patients pédiatriques dans la recherche clinique à un hôpital pédiatrique de soins tertiaires

background: Subject recruitment is essential for conducting

HISTORIQUE : Il est essentiel de recruter des sujets pour mener

clinical research; however, there are very few studies evaluating research uptake by families in a paediatric setting. Objectives: To determine how frequently paediatric patients and their families receiving care at a tertiary paediatric hospital participated in research. The secondary objectives were to explore factors that influence patient families’ decisions to participate in research and how they perceived their experiences. Methods: A cross-sectional study surveying families of children receiving care in a sample of clinical areas at a tertiary care paediatric hospital in British Columbia was conducted. A self-administered questionnaire was used, and was facilitated by trained interviewers. Descriptive statistics were used to report the proportion of patient families that have previously been invited to participate in research and, among these, the proportion who had agreed to participate. Patient families’ perceptions of research and their past experiences therein were also reported. Results: A total of 657 families were approached, of which 543 were enrolled (82.6% response rate). Among the 439 families that had visited the hospital previously, 114 (26.0%) had been invited to participate in research and 99 (87%) had consented to participate. Of these 99 families, only one had a negative experience, and 84 (85%) of these participant families were at least somewhat likely to participate in research again in the future. Conclusions: Only one-quarter of families that had previously visited the hospital had been invited to participate in a research project. Of the families approached previously, there was a high rate of participation and willingness to participate in future research. Key Words: Evidence-based health care and medicine; Participation; Questionnaire

P

atient-focused research is the cornerstone of evidenceinformed health care (1), which can improve the health of patients while improving the cost effectiveness of the health care system (2). While evidence-based care is imperative, undertaking clinical research in the paediatric population presents many unique legal and ethical issues (3,4). Children are considered to be a vulnerable population and, as such, numerous methodological challenges related to their participation in research arise (3). Predictably, these difficulties may deter researchers and funding bodies and may have contributed to the dearth of high-quality paediatric research (4,5). As a result, 80% of all families surveyed in the present study emphasized that they are at least somewhat likely to participate in research again. This highlights the importance of a personal, yet convenient, approach, with onefifth of families emphasizing that personal face-to-face interactions 540

and conversations were imperative in the recruitment process. This finding complies with Knox and Burkhart (3), who suggest that a personal approach in a professional paediatric setting is an effective method of recruitment. While it would also be interesting to determine whether a correlation exists between previous research area and type, and participating in research again, the much larger number of families that expressed willingness to participate in the future compared with a negligible number of subjects who did not, as well as a considerable variety of previous research experience precluded correlation analyses. The limitations to our study include it being a single-centre study and including a small proportion of potentially eligible subjects. The latter is due to convenience sampling as a result of limited research assistant availability and being unable to recruit subjects at all hours of the day. Our recruitment was also limited by including only English-speaking participants in the study, which may have introduced a selection bias. It is probable that language barriers are a significant factor in families’ willingness to participate in research, in addition to being common exclusion criteria. Recall bias was also probable in our study because subjects who participated in research previously were more likely to remember being approached. Paediatr Child Health Vol 19 No 10 December 2014

Family engagement in clinical research

Moreover, families who believed that they were consenting to research may have actually only been consenting to clinical care, and vice versa; however, it is important to note that all studies at our institution require informed consent and contact information for the principal investigator; as a result, it is unlikely that patients unknowingly participated. Finally, data from our study are not generalizable to high intensive-care areas, which present a different set of challenges and barriers to research participation (22).

a. If yes to question 8, did you/they agree to participate? Yes No i. If you answered YES to sub-question a. (agreed to participate) what area(s) of research did you/your child participate in? Anesthesia Cardiology Critical Care Emergency Surgical specialty (please specify): _______________ Other: _____________________________________

CONCLUSIONS

While the majority of families had never been invited to participate in research, there was a high rate of participation and willingness to participate again among those who had been invited. The present study provides some foundations for building and improving paediatric research programs, and highlights that a continuing effort must be made to educate the general public regarding the importance of evidence-based paediatric care, critical to enhancing the quality of care available for children.

ii. If you answered YES to sub-question a. (agreed to participate), what type of involvement was it? Answering a survey/questionnaire Undergoing experimental treatment Undergoing experimental testing Other: _____________________________________

ACKNOWLEDGEMENTS: The authors thank the research students, Garrett Huwyler, Hedi Chable, Sapanpreet Sahota, Carlos Gabriel, Noah Pawlowski and Carol Ng, for their contributions to this study.

ii. If you answered YES to sub-question a. (agreed to participate), how has your research experience at Positive Negative Neutral BCCH been? iv. If you answered NO to sub-question a. (i.e. did not agree to participate in research), for what reason(s) did you decline? Inconvenient (timing) No direct benefits for my child and/or I Did not understand what the study was about Too demanding Child declined to participate (upset) Other: _____________________________________

Funding Source: This study was supported by a nominal seed grant from the Innovations in Acute Care & Technology cluster at the Child & Family Research Institute (Vancouver, British Columbia). disclosures: The authors have no financial disclosures or conflicts of interest to declare.

Appendix 1

9. On a scale of 1 to 10, how important do you think it is for children and families to be involved in research? 1 being not important at all and 10 being extremely important (please circle).

Paitient Survey Screening #: Enrolment #: Date (d/m/y): Time (24h):

_________ _________ _________ _________

1

1. Location within BCCH at time of the survey: Anesthesia Cardiology Critical Care Emergency Other: ___________________________________________ 2. Patient’s Age: Less than 1 year old 13 years or older

1-5 years old

6-12 years old

3. Your relationship to the patient: I am the Patient Parent Aunt/Uncle Grandparent Sitter/Nanny Sibling Other (please specify): ______________________________ 4. Parent/Guardian’s Age: < 18 19-29 30-39 60-69 70-79 80+

40-49

Yes

No

7. Number of visits in the past 12 months: 0 1 2 3 or more 8. Have you or any member of your family been invited to participate in a research study on behalf of one of your children Yes No at BCCH? Paediatr Child Health Vol 19 No 10 December 2014

3

4

5

6

7

8

9

10

10. How likely are you to participate in research again? Very likely Somewhat likely Unsure Not likely Definitely not likely 11. How can we increase participation in research at BCCH (suggestions)? ______________________________________ __________________________________________________ Thank you for your participation in this survey! RA use only: RA initials: ______ Notes: ______________________________

REFERENCES

50-59

5. How would you rate your child’s general health? Excellent Good Fair Poor 6. Has your child ever visited BCCH before?

2

1. Guyatt G, Cairns J, Churchill D, et al. Evidence-based medicine: A new approach to teaching the practice of medicine. JAMA 1992;268:2420-5. 2. Canadian Institutes of Health Research (CIHR). Canada’s strategy for patient-oriented research: Improving health outcomes through evidence-informed care. (Accessed December 1, 2012). 3. Knox CA, Burkhart PV. Issues related to children participating in clinical research. J Pediatr Nurs 2007;22:310-8. 4. Smyth RL. Research with children: Paediatric practice needs better evidence – gained in collaboration with parents and children. BMJ 2001;322:1377. 5. Viergever RF, Rademaker CM. Finding better ways to fill gaps in pediatric health research. Pediatrics 2014;133:e824-6.

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14. Majumdar SR, Roe MT, Peterson ED, Chen AY, Gibler W, Armstrong PW. Better outcomes for patients treated at hospitals that participate in clinical trials. Arch Intern Med 2008;168:657-62. 15. Berkowitz J. Module 4: Study Designs II (Surveys). 2014. (Accessed September 1, 2014). 16. Abernethy LE, Paulsen EL, Monuteaux MC, Berry MP, Neuman MI. Parental perceptions of clinical research in the pediatric emergency department. Pediatr Emerg Care 2013;29:897-902. 17. Morris MC, Besner D, Vazquez H, Nelson RM, Fischbach RL. Parental opinions about clinical research. J Pediatr 2007;151:532-7. 18. Diekema DS. Conducting ethical research in pediatrics: A brief historical overview and review of pediatric regulations. J Pediatr 2006;149:S3-11. 19. Trauth JM, Musa D, Siminoff L, Jewell IK, Ricci E. Public attitudes regarding willingness to participate in medical research studies. J Health Soc Policy 2000;12:23-43. 20. Ehrlich NJ, Tasmin F, Safi H, Barnett J, Lasley B. Pilot study of ER utilization at Tulsa hospitals. J Okla State Med Assoc 2004;97:64-8. 21. Pileggi C, Raffaele G, Angelillo IF. Paediatric utilization of an emergency department in Italy. Eur J Pub Health 2006;16:565-9. 22. Menon K, Ward R; Canadian Critical Care Trials Group. A study of consent for participation in a non-therapeutic study in the pediatric intensive care population. J Med Ethics 2014;40:123-6.

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