Richeal Burns

Establishing a population-based patient-reported outcomes study (PROMs) using national cancer registries across two jurisdictions: The Prostate Cancer Treatment, your experience (PiCTure) study

Objective To establish an international patient-reported outcomes (PROMs) study among prostate cancer survivors, up to 18 years postdiagnosis, in two countries with different healthcare systems and ethical frameworks. Design A cross-sectional, postal survey of prostate cancer survivors sampled and recruited via two population-based cancer registries. Healthcare professionals (HCPs) evaluated patients for eligibility to participate. Questionnaires contained validated instruments to assess health-related quality of life and psychological well-being, including QLQ-C30, QLQ-PR25, EQ-5D-5L, 21-question Depression, Anxiety and Stress Scale (DASS-21) and the Decisional Regret Scale. Setting Republic of Ireland (RoI) and Northern Ireland (NI). Primary outcome measures Registration completeness, predictors of eligibility and response, data missingness, unweighted and weighted PROMs. Results Prostate cancer registration was 80% (95% CI 75% to 84%) and 91% (95% CI 89% to 93%) complete 2 years postdiagnosis in NI and RoI, respectively. Of 12 322 survivors sampled from registries, 53% (n=6559) were classified as eligible following HCP screening. In the multivariate analysis, significant predictors of eligibility were: being ≤59 years of age at diagnosis (p<0.001), short-term survivor (<5 years postdiagnosis; p<0.001) and from RoI (p<0.001). 3348 completed the questionnaire, yielding a 54% adjusted response rate. 13% of men or their families called the study freephone with queries for assistance with questionnaire completion or to talk about their experience. Significant predictors of response in multivariate analysis were: being ≤59 years at diagnosis (p<0.001) and from RoI (p=0.016). Mean number of missing questions in validated instruments ranged from 0.12 (SD 0.71; EQ-5D-5L) to 3.72 (SD 6.30; QLQ-PR25). Weighted and unweighted mean EQ-5D-5L, QLQ-C30 and QLQ-PR25 scores were similar, as were the weighted and unweighted prevalences of depression, anxiety and distress. Conclusions It was feasible to perform PROMs studies across jurisdictions, using cancer registries as sampling frames; we amassed one of the largest, international, population-based data set of prostate cancer survivors. We highlight improvements which could inform future PROMs studies, including utilising general practitioners to assess eligibility and providing a freephone service.

Prostate cancer screening practices in the Republic of Ireland: the determinants of uptake.

Objectives: The objectives of this paper are to analyse the determinants of prostate cancer screening uptake in the Republic of Ireland and to compare the role of non-need factors in uptake of screening among those in and outside the age range recommended as cost-effective for screening according to the European Randomised Study of Screening for Prostate Cancer (ERSPC). Methods: The investigation combined a logistic regression analysis of uptake, with an estimation of income-related concentration indices and decomposition of the indices using data collected as part of the Survey of Lifestyle and Nutrition (SLAN) 2007. Comparisons were made across groups differentiated by age in terms of the expected value of the prostate cancer screening. Results: Uptake of prostate screening in men 40 years and over in the preceding 12 months was approximately 24%. Uptake was higher among those in age groups that are perceived to receive most benefit from a Prostate Specific Antigen (PSA) test based on the findings of the ERSPC trial. Screening is highest in those with highest socioeconomic status and educational attainment, and who also hold private insurance cover. The largest socioeconomic inequality is observed for men over 70 years of age (0.2298). The smallest inequality was observed for those aged 55-69 (0.1573). Decomposition of the concentration indices shows that possession of private insurance is the largest determinant of inequality among those aged 55-69 (36%) and remains a significant determinant for those aged 40-54 (26%) and those aged 70 and over (17%). Conclusions: There are high levels of prostate cancer screening uptake and significant income-related inequality in uptake in the Republic of Ireland. Given that the merits of prostate cancer screening overall and across different age groups are the subject of debate, the high levels of screening and income-related inequalities in uptake warrant closer attention and identification of potential policy responses.

Factors Driving Inequality in Prostate Cancer Survival: A Population Based Study

Purpose As cancer control strategies have become more successful, issues around survival have become increasingly important to researchers and policy makers. The aim of this study was to examine the role of a range of clinical and socio-demographic variables in explaining variations in survival after a prostate cancer diagnosis, paying particular attention to the role of healthcare provider(s) i.e. private versus public status. Methods Data were extracted from the National Cancer Registry Ireland, for patients diagnosed with prostate cancer from 1998–2009 (N = 26,183). A series of multivariate Cox and logistic regression models were used to examine the role of healthcare provider and socio-economic status (area-based deprivation) on survival, controlling for age, stage, Gleason grade, marital status and region of residence. Survival was based on all-cause mortality. Results Older individuals who were treated in a private care setting were more likely to have survived than those who had not, when other factors were controlled for. Differences were evident with respect to marital status, region of residence, clinical stage and Gleason grade. The effect of socio-economic status was modified by healthcare provider, such that risk of death was higher in those men of lower socio-economic status treated by public, but not private providers in the Cox models. The logistic models revealed a socio-economic gradient in risk of death overall; the gradient was larger for those treated by public providers compared to those treated by private providers when controlling for a range of other confounding factors. Conclusion The role of healthcare provider and socio-economic status in survival of men with prostate cancer may give rise to concerns that warrant further investigation.

Economic burden of malignant blood disorders across Europe: a population-based cost analysis.

BACKGROUND Malignant blood disorders are a leading contributor to cancer incidence and mortality across Europe. Despite their burden, no study has assessed the economic effect of blood cancers in Europe. We aimed to assess the economic burden of malignant blood disorders across the 28 countries in the European Union (EU), Iceland, Norway, and Switzerland. METHODS Malignant blood disorder-related costs were estimated for 28 EU countries, Iceland, Norway, and Switzerland for 2012. Country-specific costs were estimated with aggregate data on morbidity, mortality, and health-care resource use obtained from international and national sources. Health-care costs were estimated from expenditure on primary, outpatient, emergency, inpatient care, and drugs. Costs of informal care and productivity losses due to morbidity and early death were also included. For countries in the EU, malignant blood disorders were compared with the economic burden of overall cancer. FINDINGS Malignant blood disorders cost the 31 European countries €12 billion in 2012. Health-care cost €7·3 billion (62% of total costs), productivity losses cost €3·6 billion (30%), and informal care cost €1 billion (8%). For the EU countries, malignant blood disorders cost €6·8 billion (12%) of the total health-care expenditure on cancer (€57 billion), with this proportion being second only to breast cancer. In terms of total cancer costs in the EU (€143 billion), malignant blood disorders cost €12 billion (8%). INTERPRETATION Malignant blood disorders represent a leading cause of death, health-care service use, and costs, not only to European health-care systems, but to society overall. Our results add to essential public health knowledge needed for effective national cancer-control planning and priorities for public research funding. FUNDING European Hematology Association.

''Bird in the hand'' cash was more effective than prize draws in increasing physician questionnaire response

OBJECTIVE To investigate the effects of two monetary incentives on response rates to postal questionnaires from primary care physicians (PCPs). STUDY DESIGN AND SETTING The PCPs were randomized into three arms (n=550 per arm), namely (1) €5 sent with the questionnaire (cash); (2) entry into a draw on return of completed questionnaire (prize); or (3) no incentive. Effects of incentives on response rates and item nonresponse were examined, as was cost-effectiveness. RESULTS Response rates were significantly higher in the cash (66.1%; 95% confidence interval [CI]: 61.9, 70.4%) and prize arms (44.8%; 95% CI: 40.1, 49.3%) compared with the no-incentive arm (39.9%; 95% CI: 35.4, 44.3%). Adjusted relative risk of response was 1.17 (95% CI: 1.02, 1.35) and 1.68 (95% CI: 1.48, 1.91) in the prize and cash arms, respectively, compared with the no-incentive group. Costs per completed questionnaire were €9.85, €11.15, and €6.31 for the cash, prize, and no-incentive arms, respectively. Compared with the no-incentive arm, costs per additional questionnaire returned in the cash and prize arms were €14.72 and €37.20, respectively. CONCLUSION Both a modest cash incentive and entry into a prize draw were effective in increasing response rates. The cash incentive was most effective and the most cost-effective. Where it is important to maximize response, a modest cash incentive may be cost-effective.

Review and critical appraisal of studies mapping from quality of life or clinical measures to EQ-5D: an online database and application of the MAPS statement

BackgroundThe Health Economics Research Centre (HERC) Database of Mapping Studies was established in 2013, based on a systematic review of studies developing mapping algorithms predicting EQ-5D. The Mapping onto Preference-based measures reporting Standards (MAPS) statement was published in 2015 to improve reporting of mapping studies. We aimed to update the systematic review and assess the extent to which recently-published studies mapping condition-specific quality of life or clinical measures to the EQ-5D follow the guidelines published in the MAPS Reporting Statement.MethodsA published systematic review was updated using the original inclusion criteria to include studies published by December 2016. We included studies reporting novel algorithms mapping from any clinical measure or patient-reported quality of life measure to either the EQ-5D-3L or EQ-5D-5L. Titles and abstracts of all identified studies and the full text of papers published in 2016 were assessed against the MAPS checklist.ResultsThe systematic review identified 144 mapping studies reporting 190 algorithms mapping from 110 different source instruments to EQ-5D. Of the 17 studies published in 2016, nine (53%) had titles that followed the MAPS statement guidance, although only two (12%) had abstracts that fully addressed all MAPS items. When the full text of these papers was assessed against the complete MAPS checklist, only two studies (12%) were found to fulfil or partly fulfil all criteria. Of the 141 papers (across all years) that included abstracts, the items on the MAPS statement checklist that were fulfilled by the largest number of studies comprised having a structured abstract (95%) and describing target instruments (91%) and source instruments (88%).ConclusionsThe number of published mapping studies continues to increase. Our updated database provides a convenient way to identify mapping studies for use in cost-utility analysis. Most recent studies do not fully address all items on the MAPS checklist.

Supporting prostate cancer survivors in primary care: Findings from a pilot trial of a nurse-led psycho-educational intervention (PROSPECTIV)

PURPOSE This study sought to test the acceptability and feasibility of a nurse-led psycho-educational intervention (NLPI) delivered in primary care to prostate cancer survivors, and to provide preliminary estimates of the effectiveness of the intervention. METHODS Men who reported an ongoing problem with urinary, bowel, sexual or hormone-related functioning/vitality on a self-completion questionnaire were invited to participate. Participants were randomly assigned to the NLPI plus usual care, or to usual care alone. Recruitment and retention rates were assessed. Prostate-related quality of life, self-efficacy, unmet needs, and psychological morbidity were measured at baseline and 9 months. Health-care resource use data was also collected. An integrated qualitative study assessed experiences of the intervention. RESULTS 61% eligible men (83/136) participated in the trial, with an 87% (72/83) completion rate. Interviews indicated that the intervention filled an important gap in care following treatment completion, helping men to self-manage, and improving their sense of well-being. However, only a small reduction in unmet needs and small improvement in self-efficacy was observed, and no difference in prostate-related quality of life or psychological morbidity. Patients receiving the NLPI recorded more primary care visits, while the usual care group recorded more secondary care visits. Most men (70%; (21/30)) felt the optimal time for the intervention was around the time of diagnosis/before the end of treatment. CONCLUSIONS Findings suggest a nurse-led psycho-educational intervention in primary care is feasible, acceptable and potentially useful to prostate cancer survivors.

Challenges in generating costs and utilisation rates associated with castration-resistant prostate cancer

Background Prostate cancer (PCa), the most commonly diagnosed cancer among men in the United States and Europe, is an escalating resource allocation issue across healthcare systems in the Western world. The impact of skeletal-related events, associated with castration-resistant prostate cancer (CRPC), is considerable with many new therapies being sought to treat these events in a cost-effective manner. Aims The aim of this paper is to provide insight into the level of constraints associated with devising cost frameworks for economic analysis of CRPC in the Irish healthcare setting. Methods An informal questionnaire was devised to obtain estimates of utilisation to populate a decision tree model; existing parameters from the literature were also employed. Cost parameters included Irish reference costs, and a costs literature review was undertaken; a healthcare payer perspective was adopted. Pharmacy dosages used for modelling costs were calculated for an average 75 kg male. Results The estimated average cost of care associated with adverse events in CRPC was €23,264. Approximately 40% of the costs of CRPC are attributed to skeletal-related events; therefore, reducing the number of skeletal-related events could significantly reduce the cost of care. In attempting to generate accurate and reliable cost parameters, this study highlights the challenges of conducting economic analysis in the Irish healthcare setting. Conclusion This study presents leading treatments and associated costs for CRPC patients in the Republic of Ireland (RoI), which are expected to steadily increase with demographic shifts. Further research is warranted in this area due to the limitations encountered in the study.

Economic analysis of oral dexamethasone for symptom relief of sore throat: the UK TOAST study

Objectives To undertake an economic analysis assessing the cost-effectiveness of a single dose of oral dexamethasone compared with placebo for the relief of sore throat. Design A UK-based, multicentre, two arm, individually randomised, double blind trial. Setting and population Adults (≥18 years) with acute sore throat and painful swallowing judged to be infective in origin, recruited and randomised in primary care. Intervention: a single dose of 10 mg oral dexamethasone compared with placebo given at primary care visit. Main outcome Incremental cost-effectiveness ratios (ICERs), cost per quality-adjusted symptom resolution using the EuroQol-five dimensions-five levels instrument, were estimated as part of a cost–utility analysis performed on an intention-to-treat cohort adopting a health payers perspective. Results Differences in health-related quality of life (HRQoL) over 7 days from baseline and at 24 hours in the dexamethasone compared with the placebo group (2.9% and 2.5% higher, respectively) were observed. After controlling for the baseline HRQoL imbalances, the economic impact of the intervention was not statistically significant: the quality-adjusted life year difference was −0.00005 (95% CI −0.0002 to 0.00011) equivalent to a loss in HRQoL of a half hour in the dexamethasone group. The average cost per patient associated in the dexamethasone and placebo groups in the basecase analysis was £73 and £69, respectively. In the basecase probabilistic analysis, the mean ICER was −£6440 (95% CI −£132 151 to £126 335) and the median ICER was −£304 (IQR-£5816 to £3877); suggesting considerable uncertainty. Conclusions and relevance The economic burden associated with sore throat is substantial and was estimated at £2.35 billion to the healthcare services payer based on reported resource use and 2015 UK unit costs. There is considerable uncertainty regarding the cost-effectiveness of a single dose of oral dexamethasone as a treatment strategy and therefore insufficient evidence to support its use in clinical practice. Trial registration number ISRCTN17435450; Post-results.

Modelling-based evaluation of the costs, benefits and cost-effectiveness of multipathogen point-of-care tests for sexually transmitted infections in symptomatic genitourinary medicine clinic attendees

Objectives To quantify the costs, benefits and cost-effectiveness of three multipathogen point-of-care (POC) testing strategies for detecting common sexually transmitted infections (STIs) compared with standard laboratory testing. Design Modelling study. Setting Genitourinary medicine (GUM) services in England. Population A hypothetical cohort of 965 988 people, representing the annual number attending GUM services symptomatic of lower genitourinary tract infection. Interventions The decision tree model considered costs and reimbursement to GUM services associated with diagnosing and managing STIs. Three strategies using hypothetical point-of-care tests (POCTs) were compared with standard care (SC) using laboratory-based testing. The strategies were: A) dual POCT for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG); B) triplex POCT for CT-NG and Mycoplasma genitalium (MG); C) quadruplex POCT for CT-NG-MG and Trichomonas vaginalis (TV). Data came from published literature and unpublished estimates. Primary and secondary outcome measures Primary outcomes were total costs and benefits (quality-adjusted life years (QALYs)) for each strategy (2016 GB, £) and associated incremental cost-effectiveness ratios (ICERs) between each of the POC strategies and SC. Secondary outcomes were inappropriate treatment of STIs, onward STI transmission, pelvic inflammatory disease in women, time to cure and total attendances. Results In the base-case analysis, POC strategy C, a quadruplex POCT, was the most cost-effective relative to the other strategies, with an ICER of £36 585 per QALY gained compared with SC when using microcosting, and cost-savings of £26 451 382 when using tariff costing. POC strategy C also generated the most benefits, with 240 467 fewer clinic attendances, 808 fewer onward STI transmissions and 235 135 averted inappropriate treatments compared with SC. Conclusions Many benefits can be achieved by using multipathogen POCTs to improve STI diagnosis and management. Further evidence is needed on the underlying prevalence of STIs and SC delivery in the UK to reduce uncertainty in economic analyses.