Background The number of people with chronic diseases and the subsequent pressure on health care is increasing. eHealth technology for diagnostic testing can contribute to more efficient health care and lower workload. Objective This systematic review examines the available methods for direct web-based access for patients to diagnostic testing and results in the absence of a health care professional in primary care. Methods We searched the PubMed, Embase, Web of Sciences, Cochrane Library, Emcare, and Academic Search Premier databases in August 2019 and updated in July 2021. The included studies focused on direct patient access to web-based triage leading to diagnostic testing, self-sampling or testing, or web-based communication of test results. A total of 45 studies were included. The quality was assessed using the Mixed Methods Appraisal Tool. Results Most studies had a quantitative descriptive design and discussed a combination of services. Diagnostic test services mainly focused on sexually transmitted infections. Overall, the use was high for web-based triage (3046/5000, >50%, who used a triage booked a test), for self-sampling or self-testing kits (83%), and the result service (85%). The acceptability of the test services was high, with 81% preferring home-based testing over clinic-based testing. There was a high rate of follow-up testing or treatment after a positive test (93%). Conclusions The results show that direct access to testing and result services had high use rates, was positively evaluated, and led to high rates of follow-up treatment. More research on cost-effectiveness is needed to determine the potential for other diseases. Direct access to diagnostic testing can lower the threshold for testing in users, potentially increase efficiency, and lower the workload in primary care.
Background Asthma and chronic obstructive pulmonary disease (COPD) affect millions of people worldwide. While medication can control and improve disease symptoms, incorrect use of medication is a common problem. The eHealth intervention SARA (Service Apothecary Respiratory Advice) aims to improve participants’ correct use of inhalation medication by providing information and as-needed tailored follow-up support by a pharmacist. Objective The primary aim of this study was to investigate the effect of SARA on exacerbation rates in participants with asthma and COPD. Secondary aims were to investigate its effects in terms of adherence to maintenance medication and antimycotic treatment. Methods In this nonrandomized pre-post study, medication dispensing data from 382 Dutch community pharmacies were included. Exacerbation rates were assessed with dispensed short-course oral corticosteroids. Medication adherence between new and chronic users was assessed by calculating the proportion of days covered from dispensed inhalation maintenance medication. Antimycotic treatment was investigated from dispensed oral antimycotics in participants who were also dispensed inhaled corticosteroids (ICS). Outcomes were assessed 1 year before and 1 year after implementation of SARA and were compared between SARA participants and control participants. More specifically, for exacerbation rates and medication adherence, a difference score was calculated (ie, 1 year after SARA minus 1 year before SARA) and was subsequently compared between the study groups with independent-samples t tests. For antimycotics, the relative number of participants who were dispensed antimycotics was calculated and subsequently analyzed with a mixed-effects logistic regression. Results The study population comprised 9452 participants, of whom 2400 (25.39%) were SARA participants. The mean age of the population was 60.8 (15.0) years, and approximately two-thirds (n=5677, 60.06%) were female. The results showed an increase in mean exacerbation rates over time for both study groups (SARA: 0.05; control: 0.15). However, this increase in exacerbation rates was significantly lower for SARA participants (t9450=3.10, 95% CI 0.04-0.16; P=.002; Cohen d=0.06). Chronic users of inhalation medication in both study groups showed an increase in mean medication adherence over time (SARA: 6.73; control: 4.48); however, this increase was significantly higher for SARA participants (t5886=–2.74, 95% CI –3.86 to –0.84; P=.01; Cohen d=–0.07). Among new users of inhalation medication, results showed no significant difference in medication adherence between SARA and control participants in the year after implementation of SARA (t1434=–1.85, 95% CI –5.60 to 0.16; P=.06; Cohen d=–0.10). Among ICS users, no significant differences between the study groups were found over time in terms of the proportion of participants who were dispensed antimycotics (t5654=0.29, 95% CI –0.40 to 0.54; P=.76; Cohen d=0). Conclusions This study provides preliminary evidence that the SARA eHealth intervention might have the potential to decrease exacerbation rates and improve medication adherence among patients with asthma and COPD.
Background The lack of an international standard for assessing and communicating health app quality and the lack of consensus about what makes a high-quality health app negatively affect the uptake of such apps. At the request of the European Commission, the international Standard Development Organizations (SDOs), European Committee for Standardization, International Organization for Standardization, and International Electrotechnical Commission have joined forces to develop a technical specification (TS) for assessing the quality and reliability of health and wellness apps. Objective This study aimed to create a useful, globally applicable, trustworthy, and usable framework to assess health app quality. Methods A 2-round Delphi technique with 83 experts from 6 continents (predominantly Europe) participating in one (n=42, 51%) or both (n=41, 49%) rounds was used to achieve consensus on a framework for assessing health app quality. Aims included identifying the maximum 100 requirement questions for the uptake of apps that do or do not qualify as medical devices. The draft assessment framework was built on 26 existing frameworks, the principles of stringent legislation, and input from 20 core experts. A follow-up survey with 28 respondents informed a scoring mechanism for the questions. After subsequent alignment with related standards, the quality assessment framework was tested and fine-tuned with manufacturers of 11 COVID-19 symptom apps. National mirror committees from the 52 countries that participated in the SDO technical committees were invited to comment on 4 working drafts and subsequently vote on the TS. Results The final quality assessment framework includes 81 questions, 67 (83%) of which impact the scores of 4 overarching quality aspects. After testing with people with low health literacy, these aspects were phrased as “Healthy and safe,” “Easy to use,” “Secure data,” and “Robust build.” The scoring mechanism enables communication of the quality assessment results in a health app quality score and label, alongside a detailed report. Unstructured interviews with stakeholders revealed that evidence and third-party assessment are needed for health app uptake. The manufacturers considered the time needed to complete the assessment and gather evidence (2-4 days) acceptable. Publication of CEN-ISO/TS 82304-2:2021 Health software – Part 2: Health and wellness apps – Quality and reliability was approved in May 2021 in a nearly unanimous vote by 34 national SDOs, including 6 of the 10 most populous countries worldwide. Conclusions A useful and usable international standard for health app quality assessment was developed. Its quality, approval rate, and early use provide proof of its potential to become the trusted, commonly used global framework. The framework will help manufacturers enhance and efficiently demonstrate the quality of health apps, consumers, and health care professionals to make informed decisions on health apps. It will also help insurers to make reimbursement decisions on health apps.
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