Skip to main content

Table 1 Summary of survey responses and corresponding lessons learned from research team members at pilot and main study sites

From: The CANadian Pediatric Weight management Registry (CANPWR): lessons learned from developing and initiating a national, multi-centre study embedded in pediatric clinical practice

  Pilot Study (n = 4 sites; % YES) Main Study (n = 9 sites; % YES) Comments on lessons learned
Lesson 1: Site-specific regulatory requirements can be managed effectively through the use of a pilot study and central coordinating centre.
How much time did it take for Research Ethics Board (REB) approval? Mean number of days: 133 Mean number of days: 38 REB approval was faster in the Main Study.
REB approvals from other sites enabled expedited reviews for subsequent sites.
The Main Study included a final and refined protocol, so fewer amendments were required over time.
Did your REB require participants to complete a consent to contact prior to study recruitment? 0% 33%
Lesson 2: Effective team communication is essential for study coordination and conduct.
Did you experience challenges with recruitment? 75% 66% Pilot Study sites shared recruitment strategies with Main Study sites.
Hiring and training new research staff across study sites introduced gaps in recruitment and follow-up.
Lesson 3: Improving clarity and gaining consensus on measures can be time-consuming, but can also enhance study and data quality.
Were questions of the family difficult for the sites to acquire? 75% 33% Questionnaires and measures were refined and consensus reached for important data elements, allowing less difficulty with data collection in main study.
Were the questions on family eating patterns challenging for clinical staff or families? 50% 22%
Lesson 4: Integrating research with clinical practice can create logistical and operational challenges.
Was the medical history questionnaire difficult to complete? 75% 33% In the main study, sites were encouraged to integrate research questions and laboratory tests with clinical practice to make it easier to collect data consistently.
Was the physical exam difficult to complete? 25% 22% When data were not collected during a clinic visit it was difficult to obtain later.
Were labs results difficult to collect? 25% 11% Incorporating CRF into clinical care helped with data collection.
Increased length of CRF to accommodate health outcomes beyond cardiometabolic may have contributed to the observation that there was difficulty in entering data for the Main Study that was not present in the pilot.
Were families able to complete all questionnaires at their first visit? 0% 22%
Did your first encounter with the family occur at the time of a clinic visit? 100% 77%
Did you encounter difficulty in entering data? 0% 33%
Did you experience challenges in collecting clinical data that had been harmonized for the study? 0% 55%
Were the CANPWR CRF (Case Report Forms) used for clinical purposes, too? 25% 55%
Most common reasons for study participants choosing to enroll in CANPWR? -To help others
-To improve weight management program
Clinicians opinions on best reasons to participate in CANPWR? -Long-term family interactions
-Linking weight management programs nationally
Lesson 5: Study recruitment can be slow; retention is impacted by clinic attrition.
Did families first learn about CANPWR from clinical team members? 100% 100% In both the Pilot and Main Studies, clinical staff initially approached families about the study and then connected them with the research coordinators for further details.
Most common reason for families not to agree to recruitment    Lack of time was most commonly noted by the families as a reason not to participate
Did you have difficulty tracking participants over time? 50% 77% The Main Study extends to three years following the baseline assessment. Sites reported challenges tracking participants (e.g., no longer in clinic; frequent no-shows to appointments).