Challenges Associated With the Use of Trial Technology
Technology was used in the SALTS trial to streamline study processes, deliver the intervention, collect outcome data, and communicate with participants. Information on the challenges encountered owing to the use of technology, which affected all 4 stages of the SALTS trial and CONSORT flow diagram, [Challenges associated with the use of technology and future recommendations.Not all smartphone owners use smartphone apps, and use may be lower in older populations.Face-to-face support may be required for confident connection and use of technologies such as smartphone apps and other Wi-Fi–enabled devices.Interoperability, or the exchange of information between technologies, is critical to harness the efficiencies they offer.Complete background research on the population of interest to understand their use of smartphone technology before using it widely in a research study.Plan for flexibility in the study design to enable face-to-face support for familiarization with study technology, particularly during the early phases.Incorporate funds and time in the study setup phase to ensure that technologies that need to exchange information with one another can do so correctly and efficiently. For example, ensure that web-based forms exchange data with data management systems and data management systems exchange data with participant booking systems. If funds and time cannot be included, consider the use of simple existing tools such as survey software and an ad hoc SMS text messaging service.Technology can behave in unanticipated ways in response to the variety of smartphone models and operating systems on the market, and it can be difficult to replicate “live” trial conditions for all individual circumstances.Not all smartphone users like or read notifications.Create technology test plans and implement them during all phases of the trial, from early development to the completion of the last participant. When testing technology, use Apple and Android phones and include different operating systems. Have a “soft” launch to enable rigorous early testing with a small group of real participants. To avoid the impacts of software fixes on unrelated functionality, build technology in separate blocks of code that only connect where necessary.Where possible, use SMS text messages rather than notifications to convey key study information to participants, particularly for those with limited Wi-Fi or data.The flexibility that technology provides to return outcome data at the participants’ convenience can increase the time frame for data return and the variability in measures.Set realistic time frames or windows for participants to return remote data to researchers. For example, for participants returning a casual urine sample by courier, a realistic number of days will be needed to provide the participant with options, they may need a reminder messages, or there could be courier delays. Set time frames for each outcome that is collected remotely and specify these before study start in the statistical analysis plan.In addition to using standardized methods for the collection of clinical outcome data, consider whether other aspects of outcome data collection should also be standardized. For example, blood pressure measures vary considerably between and within individuals and from day to day and even hour to hour; in this case, standardizing the time for data collection (eg, 8 AM), rather than allowing participants to choose a time in the morning that suits them, will result in reduced variation in blood pressure measures across the sample.