Monitoring and evaluation of breast cancer screening programmes: selecting candidate performance indicators.

BACKGROUND: In the scope of the European Commission Initiative on Breast Cancer (ECIBC) the Monitoring and Evaluation (M&E) subgroup was tasked to identify breast cancer screening programme (BCSP) performance indicators, including their acceptable and desirable levels, which are associated with breast cancer (BC) mortality. This paper documents the methodology used for the indicator selection. METHODS: The indicators were identified through a multi-stage process. First, a scoping review was conducted to identify existing performance indicators. Second, building on existing frameworks for making well-informed health care choices, a specific conceptual framework was developed to guide the indicator selection. Third, two group exercises including a rating and ranking survey were conducted for indicator selection using pre-determined criteria, such as: relevance, measurability, accurateness, ethics and understandability. The selected indicators were mapped onto a BC screening pathway developed by the M&E subgroup to illustrate the steps of BC screening common to all EU countries. RESULTS: A total of 96 indicators were identified from an initial list of 1325 indicators. After removing redundant and irrelevant indicators and adding those missing, 39 candidate indicators underwent the rating and ranking exercise. Based on the results, the M&E subgroup selected 13 indicators: screening coverage, participation rate, recall rate, breast cancer detection rate, invasive breast cancer detection rate, cancers > 20 mm, cancers ≤10 mm, lymph node status, interval cancer rate, episode sensitivity, time interval between screening and first treatment, benign open surgical biopsy rate, and mastectomy rate. CONCLUSION: This systematic approach led to the identification of 13 BCSP candidate performance indicators to be further evaluated for their association with BC mortality.

Regional variation in healthcare spending and mortality among senior high-cost healthcare users in Ontario, Canada: a retrospective matched cohort study.

BACKGROUND: Senior high cost health care users (HCU) are a priority for many governments. Little research has addressed regional variation of HCU incidence and outcomes, especially among incident HCU. This study describes the regional variation in healthcare costs and mortality across Ontario's health planning districts [Local Health Integration Networks (LHIN)] among senior incident HCU and non-HCU and explores the relationship between healthcare spending and mortality. METHODS: We conducted a retrospective population-based matched cohort study of incident senior HCU defined as Ontarians aged ≥66 years in the top 5% most costly healthcare users in fiscal year (FY) 2013. We matched HCU to non-HCU (1:3) based on age, sex and LHIN. Primary outcomes were LHIN-based variation in costs (total and 12 cost components) and mortality during FY2013 as measured by variance estimates derived from multi-level models. Outcomes were risk-adjusted for age, sex, ADGs, and low-income status. In a cost-mortality analysis by LHIN, risk-adjusted random effects for total costs and mortality were graphically presented together in a cost-mortality plane to identify low and high performers. RESULTS: We studied 175,847 incident HCU and 527,541 matched non-HCU. On average, 94 out of 1000 seniors per LHIN were HCU (CV = 4.6%). The mean total costs for HCU in FY2013 were 12 times higher that of non-HCU ($29,779 vs. $2472 respectively), whereas all-cause mortality was 13.6 times greater (103.9 vs. 7.5 per 1000 seniors). Regional variation in costs and mortality was lower in senior HCU compared with non-HCU. We identified greater variability in accessing the healthcare system, but, once the patient entered the system, variation in costs was low. The traditional drivers of costs and mortality that we adjusted for played little role in driving the observed variation in HCUs' outcomes. We identified LHINs that had high mortality rates despite elevated healthcare expenditures and those that achieved lower mortality at lower costs. Some LHINs achieved low mortality at excessively high costs. CONCLUSIONS: Risk-adjusted allocation of healthcare resources to seniors in Ontario is overall similar across health districts, more so for HCU than non-HCU. Identified important variation in the cost-mortality relationship across LHINs needs to be further explored.

Safety and efficacy of dipeptidyl peptidase-4 inhibitors vs sulfonylurea in metformin-based combination therapy for type 2 diabetes mellitus: Systematic review and meta-analysis.

PURPOSE: The purpose of this study was to compare the safety and efficacy of DPP-4 inhibitors versus sulfonylurea as adjunctive second-line therapy in patients with type 2 diabetes mellitus, inadequately controlled with metformin mono-therapy. SOURCES: A systematic review of published randomized controlled trials (RCTs) was performed in MEDLINE, EMBASE, PubMed and Cochrane library. Two reviewers independently selected the studies, extracted the data and assessed the risk of bias. Clinical outcomes were cardiovascular events, HbA1c % change from baseline, body weight and hypoglycemic event rate. A direct comparison meta-analysis using a random effect model was conducted to calculate mean differences in treatment effects and risk ratio between DPP-4 inhibitors and sulfonylurea. PRINCIPLE FINDINGS: Ten RCTs on adult patients with type 2 diabetes and inadequate glycemic control were included in the final analysis. DPP-4 inhibitors compared to sulfonylureas produced a non-significant difference in HbA1c% change in 10,139 subjects, whereas a significant decrease in the rate of hypoglycemic events was observed in favor of DPP-4 inhibitors (RR= 0.12; P<0.00001) involving 10,616 patients, with at least one hypoglycemic event during the follow-up period (12-104 weeks). Body weight decreased by 2.2 kg (95% CI 1.7-2.7) with DPP-4 inhibitors, compared with sulfonylureas. There were insufficient data to assess a difference in the risk for cardiovascular events. CONCLUSION: The review shows that, in terms of clinical efficacy, there is no significant difference between DPP4-inhibitors and sulfonylurea when either is added to metformin mono-therapy. In contrast, the safety assessment analysis showed a significant decrease in the risk of hypoglycemic events in patients using DPP4-inhibitors.

Loss of health related quality of life following low-trauma fractures in the elderly.

BACKGROUND: To estimate the long-term change in health related quality of life (HRQoL) following low-trauma fractures among individuals receiving home care (HC) services or living in long-term care (LTC) facilities using linked healthcare administrative data from Ontario, Canada. METHODS: HRQoL was estimated using the Health Utility Index (HUI-2) with the InterRai Minimum Data Set (MDS), a mandatory questionnaire for LTC and HC in the province of Ontario (population 14 million). The HUI-2, a validated HRQoL instrument, allows the calculation of health utility where 0 represents death and 1 the best imaginable health state. For reference, the HUI-2 utility value for Canadians aged 80-84 years is 0.61 and the minimal clinically important difference is 0.03. The MDS was linked to Ontario acute care databases for fiscal years 2007-2011 to identify low-trauma fractures using ICD-10-CA codes. Regression models were used to identify predictors of change in HRQoL from pre-fracture levels to 3 years post fracture for several populations. Low-trauma fractures included hip, humerus, vertebral, wrist, multiple and other. RESULTS: Twenty-three thousand six-hundred fifty-five unique patients with low-trauma fractures were identified with pre- and post-fracture HRQoL assessments, of which 5057 individuals had at least 3 years of follow-up. Compared to patients receiving HC services (N = 3303), individuals residing in LTC (N = 1754) were older, taking more medications, and had more comorbidities. LTC patients had more hip fractures (49 % of total versus 29 %). For all fracture types, HRQoL decreased immediately following fracture. Although levels rebounded after the first month, HRQoL up to 36 months never returned to pre-fracture levels even for non-hip fracture. For both HC and LTC cohorts, clinically important and statistically significant decreases in HUI-2 utility scores were observed 36 months post fracture. Of the 6 HUI-2 domains, mobility had the largest impact on change in HRQoL. Regression analysis indicated that living with a musculoskeletal disorder or a neurological condition and living in LTC were associated with greater decrements in utility following a fracture. CONCLUSIONS: Based on the analysis of one of the largest studies on HRQoL to date, among individuals living in LTC facilities or receiving HC services, fractures have a significant permanent impact on HRQoL up to 3 years following fracture.

Mentoring a health technology assessment initiative in Kazakhstan.

OBJECTIVES: The aim of this study was to assist in the development of a health technology assessment (HTA) program for the Ministry of Health (MOH) of the Republic of Kazakhstan METHODS: Mentoring of an initial HTA program in Kazakhstan was provided by the Canadian Society for International Health (CSIH) by means of a partnership with the Kazakhstan MOH. HTA materials, courses, and one-on-one support for the preparation of a series of initial HTA reports by MOH HTA staff were provided by a seven-member CSIH team over a 2.5-year project. RESULTS: Guidance documents on HTA and institutional strengthening were prepared in response to an extensive set of deliverables developed by the MOH and the World Bank. Introductory and train-the-trainer workshops in HTA and economic evaluation were provided for MOH staff members, experts from Kazakhstan research institutes and physicians. Five short HTA reports were successfully developed by staff in the Ministry's HTA Unit with assistance from the CSIH team. Challenges that may be relevant to other emerging HTA programs included lack of familiarity with some essential underlying concepts, organization culture, and limited time for MOH staff to do HTA work. CONCLUSIONS: The project helped to define the need for HTA and mentored MOH staff in taking the first steps to establish a program to support health policy decision making in Kazakhstan. This experience offers practical lessons for other emerging HTA programs, although these should be tailored to the specific context.

Medication use and its impact on high-cost health care users among older adults: protocol for the population-based matched cohort HiCOSTT study.

BACKGROUND: Health interventions and policies for high-cost health care users (HCUs) who are older adults need to be informed by a better understanding of their multimorbidity and medication use. This study aims to determine the financial contribution of medications to HCU expenditures and explore whether potentially inappropriate prescribing is associated with incident HCU development. METHODS: This is a protocol for a retrospective population-based matched cohort analysis of incident older adult HCUs (those with the highest 5% of costs and 66 years of age or older) in Ontario during fiscal year 2013. We will obtain person-level data for the index year and year before HCU status from health administrative databases and match each HCU to 3 non-HCUs based on age, sex and geographic location. Average annual medication costs (per patient) and the ratio of medication to total health care costs (at population level) will be examined over the HCU transition period and compared with non-HCUs. We will explore potential quality improvement areas for prescribing by analyzing chronic conditions and the use of medications with a strong evidence base for either clinical benefit or risk of harms outweighing benefits in older adults with these diagnoses. The relation between these medication classes and incident HCU status will be explored using logistic regression. INTERPRETATION: Using a matched cohort design and focusing on incident rather than prevalent HCUs, this protocol will explore our hypotheses that medications and the quality of their prescribing may be important triggers of HCU status and facilitate the identification of potential preventive clinical interventions or policies. Dissemination of results will occur via publications in peer-reviewed journals, presentations at conferences and academic settings, and knowledge translation activities with relevant health system and patient stakeholder groups. STUDY REGISTRATION: Clinicaltrials.gov, no. NCT02815930.

Disease-specific Preference-based Measure of Glaucoma Health States: HUG-5 Psychometric Validation.

PURPOSE: Glaucoma is the second leading cause of irreversible blindness in the world, with 60 million people worldwide estimated to suffer from the condition. Health utility is an important outcome measure of treatment effect in economic outcomes. The available tools for the measurement of health utility in glaucoma patients do not support a preference-based algorithm required to estimate health utility. To resolve this gap in the literature, the HUG-5 (Health Utility for Glaucoma-5 dimensions) was developed. The objective of the present study was to validate the HUG-5 with accepted measures of health state and vision-specific quality of life. MATERIALS AND METHODS: The HUG-5 measures patient self-reported levels of visual discomfort, mobility, daily life activities, emotion, and social activities, as affected by the progression and management of glaucoma. To evaluate the psychometric properties, the HUG-5 was assessed for construct validity between similar and dissimilar dimensions of the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) and the EuroQol's 5 Dimensions. The HUG-5 was evaluated for test-retest reliability after a 2-week period. The HUG-5 composite distributions of mild/moderate and advanced glaucoma patients were tested for differences to measure sensitivity. RESULTS: A total of 124 patients with glaucoma were administered the NEI-VFQ-25, the HUG-5, and the EuroQol's 5 Dimensions. The HUG-5 demonstrated construct validity, with convergent and discriminant support for visual discomfort, mobility, daily life activities, emotional distress, and social activities. The HUG-5 concurrently measured health-related quality of life associated with best-eye visual field loss (r=0.63, P<0.001). The HUG-5 measured health state consistently with test-retest reliability (intraclass correlation=0.91, P<0.001). The HUG-5 was established to be sensitive in detecting differences between patients with mild/moderate glaucoma and those with advanced glaucoma with a rank-sum test with continuity correction (W=693.5, P<0.001). CONCLUSIONS: This study demonstrates promising results for the HUG-5's response range and relationship with the NEI-VFQ-25 and best-eye visual field loss, highlighting the value of disease-specific preference-based scoring systems in measuring health state changes in glaucoma patients.

Unplanned index hospital admissions among new older high-cost health care users in Ontario: a population-based matched cohort study.

BACKGROUND: Most health care spending is concentrated within a small group of high-cost health care users. To inform health policies, we examined the characteristics of index hospital admissions and their predictors among incident older high-cost users compared to older non-high-cost users in Ontario. METHODS: Using Ontario administrative data, we identified incident high-cost users aged 66 years or more and matched them 1:3 on age, gender and Local Health Integration Network with non-high-cost users aged 66 years or more. We defined high-cost users as patients within the top 5% most costly high-cost users during fiscal year 2013/14 but not during 2012/13. An index hospital admission, the main outcome, was defined as the first unplanned hospital admission during 2013/14, with no hospital admissions in the preceding 12 months. Descriptively, we analyzed the attributes of index hospital admissions, including costs. We identified predictors of index hospital admissions using stratified logistic regression. RESULTS: Over half (95 375/175 847 [54.2%]) of all high-cost users had an unplanned index hospital admission, compared to 8838/527 541 (1.7%) of non-high-cost users. High-cost users had a poorer health status, longer acute length of stay (mean 7.5 d v. 2.9 d) and more frequent designation as alternate level of care before discharge (20.8% v. 1.7%) than did non-high-cost users. Ten diagnosis codes accounted for roughly one-third of the index hospital admission costs in both cohorts. Although many predictors were similar between the cohorts, a lower risk of an index hospital admission was associated with residence in long-term care, attachment to a primary care provider and recent consultation by a geriatrician among high-cost users. INTERPRETATION: The high prevalence of index hospital admissions and the corresponding costs are a distinctive feature of incident older high-cost users. Improved access to specialist outpatient care, home-based social care and long-term care when required are worth further investigation.

Incremental healthcare utilisation and costs among new senior high-cost users in Ontario, Canada: a retrospective matched cohort study.

OBJECTIVES: To describe healthcare use and spending before and on becoming a new (incident) senior high-cost user (HCU) compared with senior non-HCUs; to estimate the incremental costs, overall and by service category, attributable to HCU status; and to quantify its monetary impact on the provincial healthcare budget in Ontario, Canada. DESIGN: We conducted a retrospective, population-based comparative cohort study using administrative healthcare records. Incremental healthcare utilisation and costs were determined using the method of recycled predictions allowing adjustment for preincident and incident year values, and covariates. Estimated budget impact was computed as the product of the mean annual total incremental cost and the number of senior HCUs. PARTICIPANTS: Incident senior HCUs were defined as Ontarians aged ≥66 years who were in the top 5% of healthcare cost users during fiscal year 2013 (FY2013) but not during FY2012. The incident HCU cohort was matched with senior non-HCUs in a ratio of 1 HCU:3 non-HCU. RESULTS: Senior HCUs (n=175 847) reached the annual HCU threshold of CAD$10 192 through different combinations of incurred costs. Although HCUs had higher healthcare utilisation and costs at baseline, HCU status was associated with a substantial spike in both, with prolonged hospitalisations playing a major role. Twelve per cent of HCUs reached the HCU expenditure threshold without hospitalisation. Compared with non-HCUs (n=5 27 541), HCUs incurred an additional CAD$25 527 per patient in total healthcare costs; collectively CAD$4.5 billion or 9% of the 2013 Ontario healthcare budget. Inpatient care had the highest incremental costs: CAD$13 427, 53% of the total incremental spending. CONCLUSIONS: Costs attributable to incident senior HCU status accounted for almost 1/10 of the provincial healthcare budget. Prolonged hospitalisations made a major contribution to the total incremental costs. A subgroup of patients that became HCU without hospitalisation requires further investigation.

Managing High-Cost Healthcare Users: The International Search for Effective Evidence-Supported Strategies.

High-cost healthcare users (HCUs) are a small proportion of the population who use a disproportionate amount of healthcare resources. Although the phenomenon occurs across the entire age spectrum, older adults represent the majority of HCUs. HCUs have drawn increasing attention internationally from clinicians, health policy-makers, and government administrators. Many experts have suggested that the short- and long-term sustainability of the healthcare system is threatened unless current approaches to the care and healthcare costs of this population are modified. Complex case management and care coordination models are being implemented internationally to address HCUs despite a lack of strong evidence to support their effectiveness in improving clinical outcomes or savings in costs of care. We review what is known about HCUs and the available evidence for the effectiveness of interventions designed to manage their high and costly healthcare use.

Preference-based Glaucoma-specific Health-related Quality of Life Instrument: Development of the Health Utility for Glaucoma.

PURPOSE: To develop a descriptive system for a glaucoma-specific preference-based health-related quality of life (HRQoL) instrument: the Health Utility for Glaucoma (HUG-5). METHODS: The descriptive system was developed in 2 stages: item identification and item selection. A systematic literature review of HRQoL assessment of glaucoma was conducted using a comprehensive search strategy. Purposeful sampling was used to recruit patients with different clinical characteristics. Relevant items were presented to glaucoma patients through face-to-face, semistructured interviews. Framework methodology was applied to analyze interview content. The recurring themes identified through an iterative content analysis represented topics of most importance and relevance to patients. These themes formed the domains of the HUG-5 descriptive system. Three versions of the descriptive system, differing in explanatory detail, were pilot tested using a focus group. RESULTS: The literature review identified 19 articles which contained 266 items. These items were included for the full-text review and were used to develop an interview guide. From 12 patient interviews, 22 themes were identified and grouped into 5 domains that informed the 5 questions of the descriptive system. The HUG-5 measures visual discomfort, mobility, daily life activities, emotional well-being, and social activities. Each question has 5 response levels that range from "no problem" to "severe problem." The focus group comprised 7 additional patients unanimously preferred the version that contained detailed, specific examples to support each question. CONCLUSIONS: A 5-domain descriptive system of a glaucoma-specific preference-based instrument, the HUG-5, was developed and remains to be evaluated for validity and reliability in the glaucoma patient population.

Senior high-cost healthcare users' resource utilization and outcomes: a protocol of a retrospective matched cohort study in Canada.

INTRODUCTION: Senior high-cost users (HCUs) are estimated to represent 60% of all HCUs in Ontario, Canada's most populous province. To improve our understanding of individual and health system characteristics related to senior HCUs, we will examine incident senior HCUs to determine their incremental healthcare utilisation and costs, characteristics of index hospitalisation episodes, mortality and their regional variation across Ontario. METHODS AND ANALYSIS: A retrospective, population-based cohort study using administrative healthcare records will be used. Incident senior HCUs will be defined as Ontarians aged ≥66 years who were in the top 5% of healthcare cost users during fiscal year 2013 but not during fiscal year 2012. Each HCU will be matched to three non-HCUs by age, sex and health planning region. Incremental healthcare use and costs will be determined using the method of recycled predictions. We will apply multivariable logistic regression to determine patient and health service factors associated with index hospitalisation and inhospital mortality during the incident year. The most common causes of admission will be identified and contrasted with the most expensive hospitalised conditions. We will also calculate the ratio of inpatient costs incurred through admissions of ambulatory care sensitive conditions to the total inpatient expenditures. The magnitude of variation in costs and health service utilisation will be established by calculating the extremal quotient, the coefficient of variation and the Gini mean difference for estimates obtained through multilevel regression analyses. ETHICS AND DISSEMINATION: This study has been approved by Hamilton Integrated Research Ethics Board (ID#1715-C). The results of the study will be distributed through peer-reviewed journals. They also will be disseminated at research events in academic settings, national and international conferences as well as with presentations to provincial health authorities.

Clinical practice guidelines were adapted and implemented meeting country-specific requirements--the example of Kazakhstan.

OBJECTIVES: In a twinning partnership between the Canadian Society for International Health and Kazakhstan's Ministry of Health, a project to build capacity and a process for the adaptation and implementation of international clinical practice guidelines (CPGs) was undertaken. STUDY DESIGN AND SETTING: A pragmatic CPG adaptation process was developed that took into consideration national and local contexts. A 15-step process ranging from topic prioritization to copyright clearance to final Ministry of Health approval was developed. An implementation strategy was developed and piloted in three local regions using a five-step approach. RESULTS: High-quality international CPG candidates were identified for all topics; forty-two CPGs were adapted locally by the clinical working groups. Three CPGs using 21 recommendations were implemented locally. Many challenges were identified including priority setting, obtaining permission to use and translate guidelines into Russian and producing high-quality translations, and organizational barriers during implementation. Facilitators included tools to guide the process and the creation of working groups. CONCLUSION: We describe a process of large-scale adaptation of international CPGs with the pilot implementation of selected adapted CPGs and recommendations. Further evaluation and monitoring are required to ensure its integrity.

Preference-based disease-specific health-related quality of life instrument for glaucoma: a mixed methods study protocol.

INTRODUCTION: A primary objective of healthcare services is to improve patients' health and health-related quality of life (HRQoL). Glaucoma, which affects a substantial proportion of the world population, has a significant detrimental impact on HRQoL. Although there are a number of glaucoma-specific questionnaires to measure HRQoL, none is preference-based which prevent them from being used in health economic evaluation. The proposed study is aimed to develop a preference-based instrument that is capable of capturing important effects specific to glaucoma and treatments on HRQoL and is scored based on the patients' preferences. METHODS: A sequential, exploratory mixed methods design will be used to guide the development and evaluation of the HRQoL instrument. The study consists of several stages to be implemented sequentially: item identification, item selection, validation and valuation. The instrument items will be identified and selected through a literature review and the conduct of a qualitative study. Validation will be conducted to establish psychometric properties of the instrument followed by a valuation exercise to derive utility scores for the health states described. ETHICS AND DISSEMINATION: This study has been approved by the Trillium Health Partners Research Ethics Board (ID number 753). All personal information will be de-identified with the identification code kept in a secured location including the rest of the study data. Only qualified and study-related personnel will be allowed to access the data. The results of the study will be distributed widely through peer-reviewed journals, conferences and internal meetings.