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NPJ Digital Medicine Oct 2021COVID-19 pandemic challenges have accelerated the reliance on digital health fuelling the expanded incorporation of mobile apps into healthcare services, particularly... (Review)
Review
COVID-19 pandemic challenges have accelerated the reliance on digital health fuelling the expanded incorporation of mobile apps into healthcare services, particularly for the management of long-term conditions such as chronic diseases (CDs). However, the impact of health apps on outcomes for CD remains unclear, potentially owing to both the poor adoption of formal development standards in the design process and the methodological quality of studies. A systematic search of randomised trials was performed on Medline, ScienceDirect, the Cochrane Library and Scopus to provide a comprehensive outlook and review the impact of health apps on CD. We identified 69 studies on diabetes (n = 29), cardiovascular diseases (n = 13), chronic respiratory diseases (n = 13), cancer (n = 10) or their combinations (n = 4). The apps rarely adopted developmental factors in the design stage, with only around one-third of studies reporting user or healthcare professional engagement. Apps differed significantly in content, with a median of eight behaviour change techniques adopted, most frequently pertaining to the 'Feedback and monitoring' (91%) and 'Shaping knowledge' (72%) categories. As for the study methodologies, all studies adopted a traditional randomised control trial (RCT) design, with relatively short follow-ups and limited sample sizes. Findings were not significant for the majority of studies across all CD, with most RCTs revealing a high risk of bias. To support the adoption of apps for CD management, this review reinforces the need for more robust development and appropriate study characteristics to sustain evidence generation and elucidate whether study results reflect the true benefits of apps or a biased estimate due to unsuitable designs.
PubMed: 34611287
DOI: 10.1038/s41746-021-00517-1 -
Expert Review of Pharmacoeconomics &... Oct 2014Assessing the value of health technologies, through health technology assessment is critically dependent on the existence of relevant and robust clinical data on the... (Review)
Review
Assessing the value of health technologies, through health technology assessment is critically dependent on the existence of relevant and robust clinical data on the efficacy, safety and ideally, effectiveness of the technologies concerned. However, in the case of medical devices, such clinical data may not always be available, because of the different nature of the regulatory requirements in different jurisdictions. Therefore, we conducted a systematic review of the regulatory requirements in seven major jurisdictions in order to identify current challenges and to suggest possible improvements. There are differences in the requirements across jurisdictions and in the balance between pre-market and post-market controls. Several improvements are required in order to generate adequate clinical data for health technology assessment.
Topics: Cost-Benefit Analysis; Device Approval; Equipment and Supplies; Evidence-Based Medicine; Government Regulation; Health Care Costs; Humans; Medical Device Legislation; Patient Safety; Product Surveillance, Postmarketing; Risk Assessment; Technology Assessment, Biomedical
PubMed: 25196848
DOI: 10.1586/14737167.2014.950233 -
Annals of Saudi Medicine 2020The evidence for optimal blood pressure (BP) targets in Asian patients with hypertension is insufficient and controversial. Western guidelines should be used with... (Meta-Analysis)
Meta-Analysis
BACKGROUND
The evidence for optimal blood pressure (BP) targets in Asian patients with hypertension is insufficient and controversial. Western guidelines should be used with caution in clinical practice until there is supporting evidence.
OBJECTIVE
Systematically synthesize the evidence on the efficacy of achieving the strict 2018 European Society of Cardiology (ESC) guideline BP targets versus standard BP targets in Asian patients.
DATA SOURCES
We searched PubMed, Web of Science, Scopus, the Cochrane Central Register of controlled trials, and additional databases to retrieve relevant Asian studies.
STUDY SELECTION
Randomized controlled trials (RCTs) and observational studies that reported clinical endpoints, had a minimal follow-up period of one year and included Asian patients older than 18 years with essential hypertension.
DATA EXTRACTION
Two investigators independently conducted the study selection with any discrepancies resolved between team members.
DATA SYNTHESIS
We selected 15 studies for analysis (4 RCTs, 7 observational studies, and 4 post-hoc analyses). The evidence for the strict BP targets in elderly patients was insufficient. In middle-aged patients, the meta-analysis of observational studies revealed a significant reduction in major adverse cardiac events (MACCE) (hazard ratio (HR)=0.78; 95% confidence interval (CI: 0.74-0.81). For studies that reported results for patients of any age, the tight systolic BP-lowering therapy was associated with a decrease in MACCE (HR=0.80; 95% CI: 0.69-0.92), stroke (HR=0.82; 95% CI: 0.71-0.94), but not in cardiac events (HR=0.91; 95% CI: 0.72-1.14, =.41), all-cause (HR=0.80; 95% CI: 0.57-1.13) and cardiovascular mortality (HR=0.73; 95% CI: 0.40-1.33, =.30). Similar findings were obtained for the strict diastolic BP targets.
CONCLUSION
Our findings provide evidence for Asian patients that support the efficacy of the strict antihypertensive treatment with BP targets proposed by the 2018 ESC hypertension guidelines for the prevention of cardiovascular events. However, these data were obtained from only observational studies and the results were not confirmed by RCTs, probably due to insufficient power. Therefore, further high-quality RCTs are crucial.
LIMITATIONS
Use of aggregated data, the subgroup and meta-regression analyses are inconclusive, limited to English language, unable to estimate summary measures for some outcomes, publication bias difficult to assess, and unclear that results could be extrapolated.
REGISTRATION
The protocol registered in PROSPERO (CRD42018115570).
CONFLICT OF INTEREST
None.
Topics: Adult; Aged; Asian People; Blood Pressure Monitoring, Ambulatory; Cardiology; Female; Guidelines as Topic; Humans; Hypertension; Male; Middle Aged; Observational Studies as Topic; Proportional Hazards Models; Randomized Controlled Trials as Topic; Reference Standards; Societies, Medical
PubMed: 32493048
DOI: 10.5144/0256-4947.2020.234