ProsCan for Couples: Randomised controlled trial of a couples-based sexuality intervention for men with localised prostate cancer who receive radical prostatectomy

Background: Prostate cancer is the most common male cancer in the Western world. The most substantial long term morbidity from this cancer is sexual dysfunction with consequent adverse changes in couple and intimate relationships. Research to date has not identified an effective way to improve sexual and psychosocial adjustment for both men with prostate cancer and their partners. As well, the efficacy and cost effectiveness of peer counselling as opposed to professional models of service delivery has not yet been empirically tested. This paper presents the design of a three arm randomised controlled trial (peer vs. nurse counselling vs. usual care) that will evaluate the efficacy of two couples-based sexuality interventions (ProsCan for Couples: Peer support vs. nurse counselling) on men's and women's sexual and psychosocial adjustment after surgical treatment for localised prostate cancer; in addition to cost-effectiveness. Methods/design: Seventy couples per condition (210 couples in total) will be recruited after diagnosis and before treatment through urology private practices and hospital outpatient clinics and randomised to (1) usual care; (2) eight sessions of peer-delivered telephone support with DVD education; and (3) eight sessions of oncology nurse-delivered telephone counselling with DVD education. Two intervention sessions will be delivered before surgery and six over the six months post-surgery. The intervention will utilise a cognitive behavioural approach along with couple relationship education focussed on relationship enhancement and helping the couple to conjointly manage the stresses of cancer diagnosis and treatment. Participants will be assessed at baseline (before surgery) and 3, 6 and 12 months post-surgery. Outcome measures include: Sexual adjustment; unmet sexuality supportive care needs; attitudes to sexual help seeking; psychological adjustment; benefit finding and quality of life. Discussion: The study will provide recommendations about the efficacy of peer support vs. nurse counselling to facilitate better sexual and couple adjustment after prostate cancer as well as recommendations on whether the interventions represent efficient health service delivery

A modelled economic evaluation comparing atomoxetine with methylphenidate in the treatment of children with attention-deficit/hyperactivity disorder in Spain

Background Attention Deficit/Hyperactivity Disorder (ADHD) is a neurobehavioural disorder, affecting 3–6% of school age children and adolescents in Spain. Methylphenidate (MPH), a mild stimulant, had long been the only approved medication available for ADHD children in Spain. Atomoxetine is a non-stimulant alternative in the treatment of ADHD with once-a-day oral dosing. This study aims to estimate the cost-effectiveness of atomoxetine compared to MPH. In addition, atomoxetine is compared to 'no medication' for patient populations who are ineligible for MPH (i.e. having stimulant-failure experience or co-morbidities precluding stimulant medication). Methods An economic model with Markov processes was developed to estimate the costs and benefits of atomoxetine versus either MPH or 'no medication'. The incremental cost per quality-adjusted life-year (QALY) was calculated for atomoxetine relative to the comparators. The Markov process incorporated 14 health states, representing a range of outcomes associated with treatment options. Utility values were obtained from the utility valuation survey of 83 parents of children with ADHD. The clinical data were based on a thorough review of controlled clinical trials and other clinical literature, and validated by international experts. Costs and outcomes were estimated using Monte Carlo simulation over a 1-year duration, with costs estimated from the perspective of the National Health Service in Spain. Results For stimulant-naïve patients without contra-indications to stimulants, the incremental costs per QALY gained for atomoxetine were € 34 308 (compared to an immediate-release MPH) and € 24 310 (compared to an extended-release MPH). For those patients who have stimulant-failure experience or contra-indications to stimulants, the incremental costs per QALY gained of atomoxetine compared to 'no medication' were € 23 820 and € 23 323, respectively. Conclusion The economic evaluation showed that atomoxetine is an effective alternative across a range of ADHD populations and offers value-for money in the treatment of ADHD

Cost-effectiveness of dual-energy X-ray absorptiometry plus antiresorptive treatment in Australian women with breast cancer who receive aromatase inhibitors

Postmenopausal women with breast cancer on aromatase inhibitor (AI) treatment are at increased risk of bone mineral density loss, which may lead to minimal trauma fractures. We examined the cost-effectiveness of dual energy X-ray absorptiometry (DXA) with antiresorptive (AR) therapy compared with fracture risk assessment, lifestyle advice, and vitamin supplementation. We used a hypothetical Markov cohort model of lifetime duration for 60-year-old women with early stage breast cancer receiving AIs. The data to inform the model came from medical literature, epidemiological reports, and costing data sets. Two eligibility scenarios for AR therapy were considered: (A) osteoporosis and (B) osteopenia or osteoporosis. The main outcomes were incremental cost per quality-adjusted life years gained and cumulative fractures per 1000 women, calculated relative to the comparator. Key aspects of the model were explored in sensitivity analyses. Due to relatively low effectiveness gains, the outcomes were primarily driven by the costs. The incremental cost per quality-adjusted life year gained was A$47,556 and A$253,000 for scenarios A and B, respectively. The numbers of fractures avoided were 56 and 77 per 1000 women, respectively. The results were most sensitive to the initial probability of osteoporosis, baseline risk of fracture, and cohort starting age. Compared with risk assessment and lifestyle advice only, a DXA scan followed by an AR treatment is potentially cost-effective for women aged 60 and over undergoing AI therapy for early breast cancer. However, the number of fractures averted through this intervention is small.No Full Tex