43 research outputs found
Health technology assessment for digital health technologies
Health technology assessment (HTA) frameworks used for making public funding decisions on digital health technologies (DHTs) have not been informed by large stakeholder preference studies and rarely cover all nine domains of the widely used EUnetHTA “Core Model”. Our aim was to develop a literature-informed and stakeholder-prioritised checklist of DHT-specific considerations for DHTs that manage chronic disease that extends an internationally established HTA framework. We conducted two systematic reviews to identify: (i) DHT evaluation frameworks and (ii) primary research on DHTs published until 20 March 2020. Stakeholder prioritisation of issues was performed using a best-worst preference study among a broad cross-section of patients, carers, health professionals, and the general population in Australia, Canada, New Zealand, and the UK. Systematic review issues were prioritised and adapted for use as a practical checklist. DHT evaluation content was recommended by 44 identified frameworks for 28 of the 145 issues in the Core Model and for 22 new DHT-specific issues. A coverage assessment of 112 clinical studies of remote treatment and self-management DHTs for patients with cardiovascular disease or diabetes revealed that less than half covered DHT-specific content in all but one domain, or traditional HTA content in clinical effectiveness and ethical analysis. The preference survey of 1,251 stakeholders identified broad agreement on the 12 most important DHT attributes, six of which were related to safety. The most important attribute was “helps health professionals respond quickly when changes in patient care are needed”, which is not a focus of existing DHT HTA frameworks. Using the thesis-developed checklist in conjunction with the Core Model can enable users to perform a DHT-specific and comprehensive HTA on DHTs that manage chronic disease and can assist primary researchers to collect appropriate data to inform this HTA
Stakeholder preferences for attributes of digital health technologies to consider in health service funding
Objectives: Health service providers are currently making decisions on the public funding of digital health technologies (DHTs) for managing chronic diseases with limited understanding of stakeholder preferences for DHT attributes. This study aims to understand the community, patient/carer, and health professionals' preferences to help inform a prioritized list of evaluation criteria. Methods: An online best-worst scaling survey was conducted in Australia, New Zealand, Canada, and the United Kingdom to ascertain the relative importance of twenty-four DHT attributes among stakeholder groups using an efficient incomplete block design. The attributes were identified from a systematic review of DHT evaluation frameworks for consideration in a health technology assessment. Results were analyzed with multinomial models by stakeholder group and latent class. Results: A total of 1,251 participants completed the survey (576 general community members, 543 patients/carers, and 132 health professionals). Twelve attributes achieved a preference score above 50 percent in the stakeholder group model, predominantly related to safety but also covering technical features, effectiveness, ethics, and economics. Results from the latent class model supported this prioritization. Overall, connectedness with the patient's healthcare team seemed the most important; with Helps health professionals respond quickly when changes in patient care are needed as the most highly prioritized of all attributes. Conclusions: It is proposed that these prioritized twelve attributes be considered in all evaluations of DHTs that manage chronic disease, supplemented with a limited number of attributes that reflect the specific perspective of funders, such as equity of access, cost, and system-level implementation considerations
Randomised clinical trial using Coronary Artery Calcium Scoring in Australian Women with Novel Cardiovascular Risk Factors (CAC-WOMEN Trial): study protocol
Introduction: Cardiovascular disease (CVD) is the leading cause of death in women around the world. Aboriginal and Torres Strait Islander women (Australian Indigenous women) have a high burden of CVD, occurring on average 10–20 years earlier than non-Indigenous women. Traditional risk prediction tools (eg, Framingham) underpredict CVD risk in women and Indigenous people and do not consider female-specific ‘risk-enhancers’ such as hypertensive disorders of pregnancy (HDP), gestational diabetes mellitus (GDM) and premature menopause. A CT coronary artery calcium score (‘CT-calcium score’) can detect calcified atherosclerotic plaque well before the onset of symptoms, being the single best predictor for future cardiac events. A CT-calcium score may therefore help physicians intensify medical therapy in women with risk-enhancing factors. Methods and analysis: This multisite, single-blind randomised (1:1) controlled trial of 700 women will assess the effectiveness of a CT-calcium score-guided approach on cardiovascular risk factor control and healthy lifestyle adherence, compared with standard care. Women without CVD aged 40–65 (35–65 for Aboriginal and Torres Strait Islander women) at low-intermediate risk on standard risk calculators and with at least one risk-enhancing factor (eg, HDP, GDM, premature menopause) will be recruited. Aboriginal and Torres Strait Islander women will be actively recruited, aiming for ~10% of the sample size. The 6-month coprimary outcomes will be low-density lipoprotein cholesterol and systolic blood pressure. Barriers and enablers will be assessed, and a health economic analysis performed. Ethics and dissemination: Western Sydney Local Health District Research Ethics Committee (HREC 2021/ETH11250) provided ethics approval. Written informed consent will be obtained before randomisation. Consent will be sought for access to individual participant Medicare Benefits Schedule, Pharmaceutical Benefits Scheme claims usage through Medicare Australia and linked Admitted Patient Data Collection. Study results will be disseminated via peer-reviewed publications and presentations at national and international conferences. Trial registration number: ACTRN12621001738819p.Simone Marschner, Edwina Wing-Lun, Clara Chow, Louise Maple-Brown, Sian Graham, Stephen J Nicholls, Alex Brown, Anna Wood, Abdul Ihdayhid, Amy Von Huben, Sarah Zama
Development and validation of a risk score to predict unplanned hospital readmissions in ICU survivors:A data linkage study
Background: Intensive Care Unit (ICU) follow-up clinics are growing in popularity internationally; however, there is limited evidence as to which patients would benefit most from a referral to this service. Objectives: The objective of this study was to develop and validate a model to predict which ICU survivors are most likely to experience an unplanned hospital readmission or death in the year after hospital discharge and derive a risk score capable of identifying high-risk patients who may benefit from referral to follow-up services. Methods: A multicentre, retrospective observational cohort study using linked administrative data from eight ICUs was conducted in the state of New South Wales, Australia. A logistic regression model was developed for the composite outcome of death or unplanned readmission in the 12 months after discharge from the index hospitalisation. Results: 12,862 ICU survivors were included in the study, of which 5940 (46.2%) patients experienced unplanned readmission or death. Strong predictors of readmission or death included the presence of a pre-existing mental health disorder (odds ratio [OR]: 1.52, 95% confidence interval [CI]: 1.40–1.65), severity of critical illness (OR: 1.57, 95% CI: 1.39–1.76), and two or more physical comorbidities (OR: 2.39, 95% CI: 2.14–2.68). The prediction model demonstrated reasonable discrimination (area under the receiver operating characteristic curve: 0.68, 95% CI: 0.67–0.69) and overall performance (scaled Brier score: 0.10). The risk score was capable of stratifying patients into three distinct risk groups—high (64.05% readmitted or died), medium (45.77% readmitted or died), and low (29.30% readmitted or died). Conclusions: Unplanned readmission or death is common amongst survivors of critical illness. The risk score presented here allows patients to be stratified by risk level, enabling targeted referral to preventative follow-up services.</p
Assessment of Human Genitourinary Tumors and Chemosensitivity Testing In 3-Dimensional Collagen Gel Culture
Diagnostic accuracy of handheld electrocardiogram devices in detecting atrial fibrillation in adults in community versus hospital settings : a systematic review and meta-analysis
With increasing use of handheld ECG devices for atrial fibrillation (AF) screening, it is important to understand their accuracy in community and hospital settings and how it differs among settings and other factors. A systematic review of eligible studies from community or hospital settings reporting the diagnostic accuracy of handheld ECG devices (ie, devices producing a rhythm strip) in detecting AF in adults, compared with a gold standard 12-lead ECG or Holter monitor, was performed. Bivariate hierarchical random-effects meta-analysis and meta-regression were performed using R V.3.6.0. The search identified 858 articles, of which 14 were included. Six studies recruited from community (n=6064 ECGs) and eight studies from hospital (n=2116 ECGs) settings. The pooled sensitivity was 89% (95% CI 81% to 94%) in the community and 92% (95% CI 83% to 97%) in the hospital. The pooled specificity was 99% (95% CI 98% to 99%) in the community and 95% (95% CI 90% to 98%) in the hospital. Accuracy of ECG devices varied: sensitivity ranged from 54.5% to 100% and specificity ranged from 61.9% to 100%. Meta-regression showed that setting (p=0.032) and ECG device type (p=0.022) significantly contributed to variations in sensitivity and specificity. The pooled sensitivity and specificity of single-lead handheld ECG devices were high. Setting and handheld ECG device type were significant factors of variation in sensitivity and specificity. These findings suggest that the setting including user training and handheld ECG device type should be carefully reviewed
Utility decrements associated with adult overweight and obesity in Australia: A systematic review and meta-analysis
Objective
The aim was to conduct a systematic review and meta-analysis of health state utility decrements associated with overweight and obesity in adults 18 years and over, for use in modelled economic evaluations in Australia.
Methods
A systematic review was conducted in nine databases to identify studies that reported health state utility values by weight status. Random-effects meta-analysis was used to synthesise average utility decrements (from healthy weight) associated with overweight, all obesity and obesity classes 1, 2 and 3. Heterogeneity surrounding utility decrements was assessed via sub-group analysis, random-effects meta-regression and sensitivity analyses.
Results
Twelve studies were found for which data were used to synthesise utility decrements, estimated as overweight = 0.020 (95% confidence interval 0.010–0.030), all obesity = 0.055 (0.034–0.076), obesity class 1 = 0.047 (0.017–0.077), class 2 = 0.072 (0.028–0.116) and class 3 = 0.084 (0.039–0.130). There was considerable heterogeneity in our results, which could be accounted for by the different ages and utility instruments used in the contributing studies.
Conclusions
Our results demonstrate that elevated weight status is associated with small but statistically significant reductions in utility compared with healthy weight, which will result in reduced quality-adjusted life years when extrapolated across time and used in economic evaluations
Trends in modifiable risk factors amongst first presentation ST elevation myocardial infarction patients in a large longitudinal registry
Background: Recent studies suggest that the risk factor profile of patients presenting with ST elevation myocardial infarction (STEMI) is changing. Aim: The aim is to determine if there has been a shift of cardiovascular risk factors to cardiometabolic causes in the first presentation STEMI population. Method: We analysed data from a STEMI registry from a large tertiary referral percutaneous coronary intervention centre to determine the prevalence and trends of the modifiable risk factors of hypertension, diabetes, smoking and hypercholesterolaemia. Participants: Consecutive first presentation STEMI patients between January 2006 to December 2018. Results: Among the 2,366 patients included (mean age 59, SD 12.66, 80% male) the common risk factors were hypertension (47%), hypercholesterolaemia (47%) current smoking (42%) and diabetes (27%). Over the 13 years, patients with diabetes (20% to 26%, OR 1.09 per year, CI 1.06–1.11, p<0.001) and patients with no modifiable risk factors increased (9% to 17%, OR 1.08, CI 1.04–1.11, p<0.001). Concurrently there was a fall in prevalence of hypercholesterolaemia, (47% to 37%, OR 0.94 per year, CI 0.92–0.96, p<0.001) and smoking (44% to 41%, OR 0.94, CI 0.92–0.96, p<0.001) but no significant change in rates of hypertension (53% to 49%, OR 0.99, CI 0.97–1.01, p=0.25). Conclusion: The risk factor profile of first presentation STEMI has changed over time with a reduction in smoking and a concurrent rise in patients with no traditional risk factors. This suggests the mechanism of STEMI may be changing and further investigation of potential causal factors is warranted for the prevention and management of cardiovascular disease