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Target Product Profile for a mobile app to read rapid diagnostic tests to strengthen infectious disease surveillance.

ABSTRACT: The essential role of rapid diagnostic tests (RDTs) in disease control is compromised every time a test is not performed correctly or its result is not reported accurately and promptly. A mobile app that utilizes the camera and connectivity of a common smartphone can fill this role of supporting the test's proper execution and the automatic transmission of results. In a consensus process with 51 expert participants representing the needs of clinical users, healthcare programs, health information systems, surveillance systems, and global public health stakeholders, we developed a Target Product Profile describing the minimal and optimal characteristics of such an app. We collected feedback over two rounds and refined the characteristics to arrive at a preferred agreement level of greater than 75%, with an average of 92% agreement (range: 79-100%). As per this feedback, such an app should be compatible with many RDTs and mobile devices without needing accessories. The app should assist the user with RDT-specific instructions, include checks to facilitate quality control of the testing process and suggest results with ≥ 95% accuracy across common lighting conditions while allowing the user to determine the final result. Data from the app must be under the control of the health program that operates it, and the app should support at least one of the common data exchange formats HL7, FHIR, ASTM or JSON. The Target Product Profile also lays out the minimum data security and privacy requirements for the app.

SUBMITTER: Kadam R

PROVIDER: S-EPMC6988927 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BACKGROUND:Effective surveillance of influenza requires a broad network of health care providers actively reporting cases of influenza-like illnesses and positive laboratory results. Not only is this traditional surveillance system costly to establish and maintain but there is also a time lag between a change in influenza activity and its detection. A new surveillance system that is both reliable and timely will help public health officials to effectively control an epidemic and mitigate the burden of the disease. OBJECTIVE:This study aimed to evaluate the use of parent-reported data of febrile illnesses in children submitted through the Fever Coach app in real-time surveillance of influenza activities. METHODS:Fever Coach is a mobile app designed to help parents and caregivers manage fever in young children, currently mainly serviced in South Korea. The app analyzes data entered by a caregiver and provides tailored information for care of the child based on the child's age, sex, body weight, body temperature, and accompanying symptoms. Using the data submitted to the app during the 2016-2017 influenza season, we built a regression model that monitors influenza incidence for the 2017-2018 season and validated the model by comparing the predictions with the public influenza surveillance data from the Korea Centers for Disease Control and Prevention (KCDC). RESULTS:During the 2-year study period, 70,203 diagnosis data, including 7702 influenza reports, were submitted. There was a significant correlation between the influenza activity predicted by Fever Coach and that reported by KCDC (Spearman ?=0.878; P<.001). Using this model, the influenza epidemic in the 2017-2018 season was detected 10 days before the epidemic alert announced by KCDC. CONCLUSIONS:The Fever Coach app successfully collected data from 7.73% (207,699/2,686,580) of the target population by providing care instruction for febrile children. These data were used to develop a model that accurately estimated influenza activity measured by the central government agency using reports from sentinel facilities in the national surveillance network.

Project description:BackgroundSurgical site infections (SSIs) are the most common nosocomial infection and occur in 16.3% of patients undergoing colorectal surgery at our institution (The Ottawa Hospital), the majority of which are identified after discharge from hospital. Patients who suspect having an SSI generally present to the emergency department or surgery clinic. Both options for in-person interaction are costly to the health care system and patients. A mobile app, how2trak, has proven to be beneficial for patients with complex wounds at our institution by facilitating at-home monitoring and virtual consultations.ObjectiveThis study aims to assess the feasibility of a randomized controlled trial to assess if how2trak can improve patients' experience and increase detection of SSIs after colorectal surgery while reducing patients' risk of COVID-19 exposure.MethodsIn this single-center prospective feasibility trial, eligible patients undergoing colorectal surgery will be randomized to either standard care or how2trak postoperative monitoring of their incision, symptoms, and ostomy function. Patient self-assessments will be monitored by a nurse specialized in wound and ostomy care who will follow-up with patients with a suspected SSI. The primary outcome is feasibility as measured by enrollment, randomization, app usability, data extraction, and resource capacity.ResultsThis study was approved by our institution's ethics board on February 26, 2021, and received support from The Ottawa Hospital Innovation and Care Funding on November 12, 2021. Recruitment started June 3, 2021, and 29 were patients enrolled as of September 2021. We expect to publish results in spring 2022.ConclusionsThis study will determine the feasibility of using a mobile app to monitor patients' wounds and detect SSIs after colorectal surgery. If feasible, we plan to assess if this mobile app facilitates SSI detection, enhances patient experience, and optimizes their care.Trial registrationClinicalTrials.gov NCT04869774; https://clinicaltrials.gov/ct2/show/NCT04869774.International registered report identifier (irrid)DERR1-10.2196/26717.

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Target Product Profile for a mobile app to read rapid diagnostic tests to strengthen infectious disease surveillance.

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