The Unanticipated Challenges Associated With Implementing an Observational Study Protocol in a Large-Scale Physical Activity and Global Positioning System Data Collection.

Paul McCrorie,Anne Ellaway,David Walker

doi:10.2196/resprot.9537

Abstract

BackgroundLarge-scale primary data collections are complex, costly, and time-consuming. Study protocols for trial-based research are now commonplace, with a growing number of similar pieces of work being published on observational research. However, useful additions to the literature base are publications that describe the issues and challenges faced while conducting observational studies. These can provide researchers with insightful knowledge that can inform funding proposals or project development work.ObjectivesIn this study, we identify and reflectively discuss the unforeseen or often unpublished issues associated with organizing and implementing a large-scale objectively measured physical activity and global positioning system (GPS) data collection.MethodsThe SPACES (Studying Physical Activity in Children’s Environments across Scotland) study was designed to collect objectively measured physical activity and GPS data from 10- to 11-year-old children across Scotland, using a postal delivery method. The 3 main phases of the project (recruitment, delivery of project materials, and data collection and processing) are described within a 2-stage framework: (1) intended design and (2) implementation of the intended design.ResultsUnanticipated challenges arose, which influenced the data collection process; these encompass four main impact categories: (1) cost, budget, and funding; (2) project timeline; (3) participation and engagement; and (4) data challenges. The main unforeseen issues that impacted our timeline included the informed consent process for children under the age of 18 years; the use of, and coordination with, the postal service to deliver study information and equipment; and the variability associated with when participants began data collection and the time taken to send devices and consent forms back (1-12 months). Unanticipated budgetary issues included the identification of some study materials (AC power adapter) not fitting through letterboxes, as well as the employment of fieldworkers to increase recruitment and the return of consent forms. Finally, we encountered data issues when processing physical activity and GPS data that had been initiated across daylight saving time.ConclusionsWe present learning points and recommendations that may benefit future studies of similar methodology in their early stages of development.

Highlights

There has been a strong movement to publish study protocols within the sociobehavioral sciences before or during data collection [1,2], for trials [3] and more recently larger scale observational work [4], there is very little published material that attempts to describe how the specific protocol was implemented, the hitherto unidentified challenges encountered, and lessons learned
SPACES data was collected between May 2015 and May 2016 by the Medical Research Council (MRC) and Chief Scientist Office (CSO) funded Social and Public Health Sciences Unit (SPHSU), University of Glasgow
In light of the United Nations Convention on the Rights of the Child [14], the research team wanted to ensure that the children of the study were actively involved in the full consent process: both participants and parents were required to read study documentation, initial consent substatements, and sign consent forms

Summary

Introduction

There has been a strong movement to publish study protocols within the sociobehavioral sciences before or during data collection [1,2], for trials [3] and more recently larger scale observational work [4], there is very little published material that attempts to describe how the specific protocol was implemented, the hitherto unidentified challenges encountered, and lessons learned This reflective process is commonplace in the stages of trial/intervention work where a high degree of testing is usually built in during the design, using the lessons learned to refine the intervention [5]. Conclusions: We present learning points and recommendations that may benefit future studies of similar methodology in their early stages of development

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Conclusion