The purpose of this pilot study was to determine the feasibility ofconducting a prospective cohort study with sufficient follow-up in apopulation of caregivers of children with gastrostomy (G) tubes.
Pilot study outcomes are:
•Recruitment and adequate follow-up of caregivers at 12 months.
•Compliance with study protocol.
Feasibility of Conducting a Prospective Cohort Study inPediatric Surgery: Introducing the CARE StudyPemberton J1,3, Bailey K1,2,3, Ratcliffe E2, Walton JM1,2,31Department of Surgery, McMaster University 2McMaster Children’s Hospital3McMaster Pediatric Surgery Research Collaborative
Objective
Methodology
Results
Conclusion
Figure 1. CARE Recruitment Results
Results Continued
110Screened
59 Eligible
28 Enrolled
23 Missed
8 Declined
51 Ineligible
8 PreviousG-Tube
34Caregiverfed <50%
9 Could notConsent
Study Follow Up Schedule
Number of MissedAppointments
Number of ProtocolRequired Appointments
Adherence
1 month-Pre Insertion
0
28
100%
2 weeks-Pre Insertion
6
20
70%
2 weeks-Post Insertion
2
19
89.5%
3 months-Post Insertion
0
16
100%
6 months-Post Insertion
1
14
93%
9 months-Post Insertion
0
11
100%
12 months-Post Insertion
1
4
75%
Overall
10
112
91%
Prospective Cohort Study Design:
•A repeated measures cohort design was used to minimize thenumber needed to enroll. Each participant acted as their owncontrol (post G-tube insertion versus pre-insertion), minimizingintra-subject variation and sample size requirements.
•7 data collection time points were chosen: 2 pre-insertion and 5post-insertion. Increasing the number of data collection timepoints from 1 pre-insertion and 1 post-insertion reduced thesample size by 32% [1].
•3 quality of life questionnaires were chosen for caregivers tocomplete at each visit:
•Short Form 36 version 2 (SF-36v2)
•Parent Experience of Childhood Illness (PECI)
•Caregiver Strain Index (CSI)
References
[1] Vickers AJ. Multiple assessment in quality of life trials: How manyquestionnaires? How often should they be given? J Soc Integr Oncol2006;4(3):135-138.
Recruitment Methodology:
•Established study name, logo and newsletter
•Conducted study start-up meeting
•Created recruitment packages with instructions
•Developed and piloting of Case Report Forms (CRFs)
•Created a screening log of all G-tube surgeries
•Verified screening log with surgical billings
•Created study pocket cards for clinicians/residents forrecruitment
•Created personalized thank you cards for study participants
•Utilized reminder phone calls and personalized mail for all studypatients
•Utilized physicians and alternate contacts for follow-up
•Created Study flags for patient charts
Protocol Compliance Methodology:
•Created windows around follow-up appointments
•Created a protocol deviation log
Table 1. CARE Follow-Up and Adherence Results*
Figure 2. CARE Poster
A total of 110 participants were entered into the CARE screening logfrom September 9th, 2010 until March 15th 2011.
Of these total participants:
•The overall recruitment rate of caregivers was 47.5%.
•Of the Missed participants (N=23):
•2 (8.7%) left clinic before they could be recruited.
•1 (4.3%) decided to have surgery at a different institution.
•5 (21.7%) did not have time to complete 2 pre-insertion visits.
•13 (56.5%) were not identified by the research team.
Changes to recruitment and follow-up methodology once the studystarted included:
•Flags in patient chart to identify study participants who came toclinic outside of a scheduled follow-up visit.
•Collected family physician and alternative contact numbers toincrease follow-up compliance. Personal telephone calls from thePrincipal Investigator were also used.
•Completion of study visits over the phone, via email and at otherhospital visits to decrease participant burden helped increaseprotocol compliance.
*At time of presentation, not all recruited patients have completed each study visit
•Pilot studies are needed to identify feasibility challenges inherentin prospective cohort studies, and determine accuraterecruitment estimates.
•Challenges arise that are difficult to foresee in the planningstages; pilot studies allow the research team to find solutions toproblems without hindering a larger study and sacrificing funds.
•Intensive recruitment strategies and materials are imperative tolong term follow-up success in the Pediatric General Surgeryclinical setting.