The association of spirometric small airways obstruction with respiratory symptoms, cardiometabolic diseases, and quality of life: results from the Burden of Obstructive Lung Disease (BOLD) study.

BACKGROUND: Spirometric small airways obstruction (SAO) is common in the general population. Whether spirometric SAO is associated with respiratory symptoms, cardiometabolic diseases, and quality of life (QoL) is unknown. METHODS: Using data from the Burden of Obstructive Lung Disease study (N = 21,594), we defined spirometric SAO as the mean forced expiratory flow rate between 25 and 75% of the FVC (FEF25-75) less than the lower limit of normal (LLN) or the forced expiratory volume in 3 s to FVC ratio (FEV3/FVC) less than the LLN. We analysed data on respiratory symptoms, cardiometabolic diseases, and QoL collected using standardised questionnaires. We assessed the associations with spirometric SAO using multivariable regression models, and pooled site estimates using random effects meta-analysis. We conducted identical analyses for isolated spirometric SAO (i.e. with FEV1/FVC ≥ LLN). RESULTS: Almost a fifth of the participants had spirometric SAO (19% for FEF25-75; 17% for FEV3/FVC). Using FEF25-75, spirometric SAO was associated with dyspnoea (OR = 2.16, 95% CI 1.77-2.70), chronic cough (OR = 2.56, 95% CI 2.08-3.15), chronic phlegm (OR = 2.29, 95% CI 1.77-4.05), wheeze (OR = 2.87, 95% CI 2.50-3.40) and cardiovascular disease (OR = 1.30, 95% CI 1.11-1.52), but not hypertension or diabetes. Spirometric SAO was associated with worse physical and mental QoL. These associations were similar for FEV3/FVC. Isolated spirometric SAO (10% for FEF25-75; 6% for FEV3/FVC), was also associated with respiratory symptoms and cardiovascular disease. CONCLUSION: Spirometric SAO is associated with respiratory symptoms, cardiovascular disease, and QoL. Consideration should be given to the measurement of FEF25-75 and FEV3/FVC, in addition to traditional spirometry parameters.

The impact of self-selection based on HIV risk on the cost-effectiveness of preexposure prophylaxis in South Africa.

OBJECTIVES: We explored the impact and cost-effectiveness of preexposure prophylaxis (PrEP) provision to different populations in South Africa, with and without effective self-selection by individuals at highest risk of contracting HIV (through concurrent partnerships and/or commercial sex). DESIGN AND METHODS: We used a previously developed HIV transmission model to analyse the epidemiological impact of PrEP provision to adolescents, young adults, pregnant women, female sex workers (FSWs) and (MSM), and data from South African PrEP programmes to estimate the cost and cost-effectiveness of PrEP (cost in 2019 USD per HIV infection averted over 20 years, 2019, 38). PrEP uptake followed data from early implementation sites, scaled-up linearly over 3 years, with target coverage set to 18% for adolescents, young adults and pregnant women, 30% for FSW and 54% for MSM. RESULTS: The annual cost of PrEP provision ranges between $75 and $134 per person. PrEP provision adolescents and young adults, regardless of risk behaviour, will each avert 3.2--4.8% of HIV infections over 20 years; provision to high-risk individuals only has similar impact at lower total cost. The incremental cost per HIV infection averted is lower in high-risk vs. all-risk sub-populations within female adolescents ($507 vs. $4537), male adolescents ($2108 vs. $5637), young women ($1592 vs. $10 323) and young men ($2605 vs. $7715), becoming cost saving within 20 years for high-risk adolescents, young women, MSM and FSWs. CONCLUSION: PrEP is an expensive prevention intervention but uptake by those at the highest risk of HIV infection will make it more cost-effective, and cost-saving after 14-18 years.

Incidence and costs of cardiac device infections: retrospective analysis using German health claims data.

AIM: Estimate incidence and costs of cardiac device infections (CDIs) in Germany. MATERIALS & METHODS: Patients had an implantable cardioverter defibrillator implanted over 2010-2013 and were followed to December 2014 using German health insurance claims data. A case-controlled analysis was performed using propensity score matching methods. RESULTS: Risk of CDI 12 months post-implant was 3.4% overall, either 2.9% for de novo procedures versus 4.4% for replacement procedures. Mean 3-year incremental expenditure per patient for patients with CDI compared with controls was €31,493 for de novo implant patients and €33,777 for replacement patients. Mean incremental expenditure was €59,419 per patient with a major infection. CONCLUSION: CDIs are highly expensive to manage, reinforcing the need for strategies to reduce their occurrence.

HIV prevalence and risk among people who inject drugs in five South African cities.

BACKGROUND: Policy and programming for people who inject drugs (PWID) in South Africa is limited by the scarcity of epidemiological data. METHODS: We conducted a cross-sectional survey among 450 PWID (362 males and 88 females) from five South African cities in 2013, using outreach and peer referral to recruit participants. We carried out rapid HIV tests on participants' saliva and assessed drug-using and sexual practices by means of a questionnaire. RESULTS: We found that 26% of females and 13% of males reported to always share injecting equipment, while 49% of all participants had used contaminated injecting equipment the last time they injected. Only 6% of participants usually used bleach to clean their injecting equipment. We found that half of participants reported using a condom the last time they had sex. A quarter of participants reported symptoms of a sexually transmitted infection (STI) in the previous 12 months and 22% had ever worked as a sex worker (51% of females). HIV prevalence among participants was 14% (18% among females and 13% among males). In multivariate analysis HIV was significantly associated with being 25 years and older (adjusted odds ratio (aOR) 2.1, 95% confidence interval (CI) 1.0-4.6, p=0.06), belonging to a racial group other than white (aOR 4.2, 95% CI 1.9-9.4, p<0.001), coming from Gauteng province (aOR 2.3, 95% CI 1.1-5.5, p=0.023), having ever worked as a sex worker (aOR 3.4, 95% CI 1.7-7.2, p=0.001) and the presence of STI symptoms in the last 12 months (aOR 2.4, 95% CI 1.1-4.4, p=0.019). CONCLUSIONS: This study highlights the need for increased access to sterile injecting equipment, education around safer injecting practices and access to sexual and reproductive health services for PWID in South Africa. Programmes for PWID should also address the specific needs of female PWID, PWID who sell sex and PWID from previously disadvantaged communities.

Cost-effectiveness of an insertable cardiac monitor to detect atrial fibrillation in patients with cryptogenic stroke.

BACKGROUND AND AIMS: Documentation of atrial fibrillation is required to initiate oral anticoagulation therapy for recurrent stroke prevention. Atrial fibrillation often goes undetected with traditional electrocardiogram monitoring techniques. We evaluated whether atrial fibrillation detection using continuous long-term monitoring with an insertable cardiac monitor is cost-effective for preventing recurrent stroke in patients with cryptogenic stroke, in comparison to the standard of care. METHODS: A lifetime Markov model was developed to estimate the cost-effectiveness of insertable cardiac monitors from a UK National Health Service perspective using data from the randomized CRYSTAL-AF trial and other published literature. We also conducted scenario analyses (CHADS2 score) and probabilistic sensitivity analyses. All costs and benefits were discounted at 3.5%. RESULTS: Monitoring cryptogenic stroke patients with an insertable cardiac monitor was associated with fewer recurrent strokes and increased quality-adjusted life years compared to the standard of care (7.37 vs 7.22). Stroke-related costs were reduced in insertable cardiac monitor patients, but overall costs remained higher than the standard of care (£19,631 vs £17,045). The incremental cost-effectiveness ratio was £17,175 per quality-adjusted life years gained, compared to standard of care in the base-case scenario, which is below established quality-adjusted life years willingness-to-pay thresholds. When warfarin replaced non-vitamin-K oral anticoagulants as the main anticoagulation therapy, the incremental cost-effectiveness ratio was £13,296 per quality-adjusted life years gained. CONCLUSION: Insertable cardiac monitors are a cost-effective diagnostic tool for the prevention of recurrent stroke in patients with cryptogenic stroke. The cost-effectiveness results have relevance for the UK and across value-based healthcare systems that assess costs relative to outcomes.

Cost-effectiveness of cardiac resynchronization therapy in patients with asymptomatic to mild heart failure: insights from the European cohort of the REVERSE (Resynchronization Reverses remodeling in Systolic Left Ventricular Dysfunction).

AIMS: To assess the cost-effectiveness of cardiac resynchronization therapy (CRT) compared with optimal medical therapy in patients with New York Heart Association (NYHA) II heart failure (HF) or NYHA I with previous HF symptoms. METHODS AND RESULTS: A proportion in state model with Monte Carlo simulation was developed to assess the costs, life years and quality-adjusted life year (QALYs) associated with CRT-ON and -OFF over a 10 year time period. Data from 262 patients in the European cohort of the REVERSE clinical trial (QRS ≥ 120 ms, left ventricular ejection fraction ≤ 40%, CRT-ON, n = 180, CRT-OFF, n = 82) were used to model all-cause mortality, change in NYHA class and resource use. EQ-5D preference weights were taken from a previous cost-effectiveness model of CRT and unit costs from national UK databases. Costs and benefits were discounted at 3.5% p.a. Extensive deterministic and probabilistic sensitivity analyses were performed. Compared with CRT-OFF, 0.94 life years or 0.80 QALYs were gained in the CRT ON group at an additional cost of €11 455, yielding an incremental cost-effectiveness ratio of €14.278 per quality-adjusted life year (QALY) gained. At a threshold of €33 000 (£30 000) per QALY gained, the probability that CRT is cost-effective is 79.6%. Cardiac resynchronization therapy becomes cost effective after ∼4.5 years. Cardiac resynchronization therapy needs only to demonstrate a modest impact on all cause mortality (hazard ratio = 0.82) in order to demonstrate cost-effectiveness. The results are robust to changes in all other parameters. CONCLUSION: Cardiac resynchronization therapy is a cost-effective intervention for patients with mildly symptomatic HF and for asymptomatic patients with left ventricular dysfunction and previous HF symptoms.

An economic evaluation of cetuximab combined with radiotherapy for patients with locally advanced head and neck cancer in Belgium, France, Italy, Switzerland, and the United Kingdom.

OBJECTIVES: A phase III randomized trial that compared the combination of cetuximab and radiotherapy to radiotherapy alone in patients with locally advanced squamous cell carcinoma of the head and neck provided a platform for a comprehensive economic evaluation. The study was conducted to estimate the cost-effectiveness of cetuximab in combination with radiotherapy compared to radiotherapy alone, for the treatment of locally advanced head and neck cancer in patients for whom chemoradiotherapy is inappropriate or intolerable. METHODS: Separate economic analyses were conducted for Belgium, France, Italy, Switzerland, and the United Kingdom. The economic model was based on individual patient data extracted from an international phase III trial. Country-specific costs of care from official sources were applied in each analysis. Clinical expert panels supplemented resource use estimates from the phase III trial and validated assumptions used to extrapolate costs and health outcomes beyond the follow-up of the phase III trial. RESULTS: In the base-case analysis, the incremental cost per quality-adjusted life-year for patients receiving radiotherapy in combination with cetuximab compared to radiotherapy alone among all countries was in the range of 7538 euros to 10,836 euros. Sensitivity analysis showed the results to be robust. CONCLUSION: This cost-effectiveness analysis indicated that the addition of cetuximab to high-dose radiotherapy offers a good value-for-money alternative to radiotherapy alone in the treatment of locally advanced head and neck cancer in five European countries.