Search

ObjectivesTo chart the global literature on gender equity in academic health research.DesignScoping review.ParticipantsQuantitative studies were eligible if they examined gender equity within academic institutions including health researchers.Primary and secondary outcome measuresOutcomes related to equity across gender and other social identities in academia: (1) faculty workforce: representation of all genders in university/faculty departments, academic rank or position and salary; (2) service: teaching obligations and administrative/non-teaching activities; (3) recruitment and hiring data: number of applicants by gender, interviews and new hires for various rank; (4) promotion: opportunities for promotion and time to progress through academic ranks; (5) academic leadership: type of leadership positions, opportunities for leadership promotion or training, opportunities to supervise/mentor and support for leadership bids; (6) scholarly output or productivity: number/type of publications and presentations, position of authorship, number/value of grants or awards and intellectual property ownership; (7) contextual factors of universities; (8) infrastructure; (9) knowledge and technology translation activities; (10) availability of maternity/paternity/parental/family leave; (11) collaboration activities/opportunities for collaboration; (12) qualitative considerations: perceptions around promotion, finances and support.ResultsLiterature search yielded 94 798 citations; 4753 full-text articles were screened, and 562 studies were included. Most studies originated from North America (462/562, 82.2%). Few studies (27/562, 4.8%) reported race and fewer reported sex/gender (which were used interchangeably in most studies) other than male/female (11/562, 2.0%). Only one study provided data on religion. No other PROGRESS-PLUS variables were reported. A total of 2996 outcomes were reported, with most studies examining academic output (371/562, 66.0%).ConclusionsReviewed literature suggest a lack in analytic approaches that consider genders beyond the binary categories of man and woman, additional social identities (race, religion, social capital and disability) and an intersectionality lens examining the interconnection of multiple social identities in understanding discrimination and disadvantage. All of these are necessary to tailor strategies that promote gender equity.Trial registration numberOpen Science Framework:https://osf.io/8wk7e/.

Importance Unprovoked venous thromboembolism (VTE) can be the first manifestation of cancer. It is unclear if extensive screening for occult cancer including a comprehensive computed tomography (CT) scan of the abdomen/pelvis is cost-effective in this patient population. Objective To assess the health care related costs, number of missed cancer cases and health related utility values of a limited screening strategy with and without the addition of a comprehensive CT scan of the abdomen/pelvis and to identify to what extent testing should be done in these circumstances to allow early detection of occult cancers. Participants and setting Cost effectiveness analysis using data that was collected alongside the SOME randomized controlled trial which compared an extensive occult cancer screening including a CT of the abdomen/pelvis to a more limited screening strategy in patients with a first unprovoked VTE, was used for the current analyses. Main outcomes and measures Analyses were conducted with a one-year time horizon from a Canadian health care perspective. Primary analysis was based on complete cases, with sensitivity analysis using appropriate multiple imputation methods to account for missing data. Results Data from a total of 854 patients with a first unprovoked VTE were included in these analyses. The addition of a comprehensive CT scan was associated with higher costs ($551 CDN) with no improvement in utility values or number of missed cancers. Results were consistent when adopting multiple imputation methods. Conclusions and relevance The addition of a comprehensive CT scan of the abdomen/pelvis for the screening of occult cancer in patients with unprovoked VTE is not cost effective, as it is both more costly and not more effective in detecting occult cancer.

Background The aim of this study was to evaluate the wage losses incurred by spouses of women with nonmetastatic breast cancer in the 6 months after the diagnosis. Methods A prospective cohort study of spouses of women diagnosed with nonmetastatic breast cancer who were recruited in 8 hospitals in the province of Quebec (Canada) was performed. Information for estimating wage losses was collected by telephone interviews conducted 1 and 6 months after the diagnosis. Log-binomial regressions were used to identify personal, medical, and employment characteristics associated with experiencing wage losses, and generalized linear models were used to identify characteristics associated with the proportion of usual wages lost. Results Overall, 829 women (86% participation) and 406 spouses (75% participation) consented to participate. Among the 279 employed spouses, 78.5% experienced work absences because of breast cancer. Spouses were compensated for 66.3% of their salary on average during their absence. The median wage loss was $0 (mean, $1820) (2003 Canadian dollars). Spouses were more likely to experience losses if they were self-employed or lived 50 km or farther from the hospital. Among spouses who experienced wage losses, those who were self-employed or whose partners had invasive breast cancer lost a higher proportion of wages. Conclusions Although spouses took some time off work, for many, the resulting wage losses were modest because of compensation received. Still, the types of compensation used may hide other forms of burden for families facing breast cancer.

Background: Tobacco-related illnesses are leading causes of death and healthcare use. Our objective was to determine whether implementation of a hospitalinitiated smoking cessation intervention would reduce mortality and downstream healthcare usage. Methods: A 2-group effectiveness study was completed comparing patients who received the ‘Ottawa Model’ for Smoking Cessation intervention (n=726) to usual care controls (n=641). Participants were current smokers, >17 years old, and recruited during admission to 1 of 14 participating hospitals in Ontario, Canada. Baseline data were linked to healthcare administrative data. Competing-risks regression analysis was used to compare outcomes between groups. Results: The intervention group experienced significantly lower rates of all-cause readmissions, smoking-related readmissions, and all-cause emergency department (ED) visits at all time points. The largest absolute risk reductions (ARR) were observed for allcause readmissions at 30 days (13.3% vs 7.1%; ARR, 6.1% (2.9% to 9.3%); p

All rights reserved. No commercial use is permitted unless otherwise expressly granted. Introduction Adverse drug events (ADEs) are common in older persons and contribute significantly to emergency department visits, hospitalisations and mortality. ADEs are often due to potentially inappropriate prescriptions (PIP) or potentially inappropriate omissions (PIO), and are avoidable if inappropriate prescriptions or omissions are identified and prevented. Identifying PIP/PIO at the population level through the application of PIP/PIO assessment tools to health administrative data can provide a unique opportunity to assess the economic burden of PIP/PIO on the healthcare system beyond medication costs which is yet to be done. The objective of this study is to assess the economic burden associated with PIP/PIO and to estimate the incremental costs associated with distinct PIP/PIO in the province of Ontario. Methods and analysis We will conduct a retrospective cohort study using Ontario's health administrative databases. Eligible patients aged 66 years and older who were prescribed at least one medication between 1 April 2003 and 31 March 2014 (approximately 2.4 million patients) will be included. Population attributable fraction methodology will be used to assess the overall burden of PIP in Ontario, while regression analyses will be used to estimate the incremental costs of having specific PIP criteria and aid in prioritising targets for intervention. Ethics and dissemination This study was approved by the Institutional Review Board at Sunnybrook Health Sciences Centre, Toronto, Canada. Dissemination will occur via publication, presentation at national and international conferences, and knowledge exchange with various stakeholders.

Introduction The standard gamble is considered the ‘gold standard’ technique for measuring quality of life. We recently used the standard gamble to estimate quality of life in acute venous thrombosis, and found unexpected variability in the responses. The current study aimed to explore the reasons for variability by comparing the standard gamble technique in patients with acute venous thrombosis to other quality of life measurement tools. Materials and Methods Thrombosis clinic patients treated for venous thrombosis were eligible to participate. Patients evaluated their current health state by performing a standard gamble interview, reporting on a visual analogue scale, completing the SF-36 and disease specific questionnaires (PEmb-Qol and VEINES-QOL/Sym). Validity was assessed by correlating the standard gamble utilities with the other methods. Test-retest reliability, responsiveness and acceptability were also assessed. Results Forty-four patients were interviewed, with 16 attending for a repeat interview. The median standard gamble utility was 0.97 (0.84-1.0), SF-6D 0.64 (0.59 - 0.80) and visual analogue score 70 (60 - 80). Participants with pulmonary embolism had lower standard gamble estimates than those with deep vein thrombosis. There was good discriminant validity in that the standard gamble estimates were not associated with risk taking behavior, negative outlook, sex or education. Test-retest reliability with the standard gamble was moderate and there was evidence of a ceiling effect. Conclusions Standard gamble utilities are higher than other methods of measuring quality of life in venous thrombosis. The choice of utility values adopted in studies will impact on future economic studies.

Johnson and others, 1 in their response to our recent paper, 2 highlight the need for transparency with respect to economic evaluations within rare diseases. We agree and wish to stress our belief that the same concern must be attached to reimbursement decisions with respect to such diseases. To demonstrate our commitment to such transparency, we would like to take this opportunity to respond to the specific concerns raised by Johnson and others. In addressing the external validity of our model, Johnson and others compare their interpolation of our results to the results of extension studies relating to the use of eculizumab, 3,4 Open-label extension studies in which patients are followed beyond the randomized phase of a clinical trial can be unreliable in assessing the efficacy of therapies primarily due to thelackofacomparatorgroupandpotentialselection bias due to dropouts. 5 At best, such studies may provide useful information relating to safety. The study by Hillmen and others 3 illustrates the concern over dropouts. The number of patients at onset, 195, had declined to 26 patients by 3 years and further to 9 patients by 5 years: the two time frames cited by

BACKGROUND: We lack comprehensive information about the extent of out-of-pocket costs after diagnosis of early breast cancer and their effects on the family's financial situation. METHODS: This longitudinal study assessed out-of-pocket costs and wage losses during the first year after diagnosis of early breast cancer among Canadian women and spouses. Out-of-pocket costs for treatments and follow-up, consultations with other practitioners, home help, clothing, and natural health products were estimated, with information collected from telephone interviews. Generalized linear models were used to identify women at risk of having higher costs and the effects of out-of-pocket costs on perceptions of the family's financial situation. RESULTS: Overall, 829 women (participation, 86.2%) and 391 spouses participated. Women's median net out-of-pocket costs during the year after diagnosis were $1002 (2003 Canadian dollars; mean = $1365; SD = $1238), and 74.4% of these costs resulted from treatments and follow-up. Spouses' median costs were $111 (mean = $234; SD = $320), or 9% of couples' total expenses. In multivariable analyses, the percentage of women with out-of-pocket costs of $1773 or more (upper quartile) was statistically significantly associated with higher education, working at diagnosis, living more than 50 km from the hospital where surgery was performed, and having two and three different types of adjuvant treatment (all 2-sided P values ≤ .01). However, when considered simultaneously with wage losses, out-of-pocket costs were not associated with perceived deterioration in the family's financial situation; rather, wage losses were the driving factor. CONCLUSIONS: Overall, out-of-pocket costs from breast cancer for the year after diagnosis are probably not unmanageable for most women. However, some women were at higher risk of experiencing financial burden resulting from these costs.

Purpose An Institute of Medicine report recommends that patients with cancer receive a survivorship care plan (SCP). The trial objective was to determine if an SCP for breast cancer survivors improves patient-reported outcomes. Patients and Methods Women with early-stage breast cancer who completed primary treatment at least 3 months previously were eligible. Consenting patients were allocated within two strata: less than 24 months and ≥ 24 months since diagnosis. All patients were transferred to their own primary care physician (PCP) for follow-up. In addition to a discharge visit, the intervention group received an SCP, which was reviewed during a 30-minute educational session with a nurse, and their PCP received the SCP and guideline on follow-up. The primary outcome was cancer-related distress at 12 months, assessed by the Impact of Event Scale (IES). Secondary outcomes included quality of life, patient satisfaction, continuity/coordination of care, and health service measures. Results Overall, 408 survivors were enrolled through nine tertiary cancer centers. There were no differences between groups on cancer-related distress or on any of the patient-reported secondary outcomes, and there were no differences when the two strata were analyzed separately. More patients in the intervention than control group correctly identify their PCP as primarily responsible for follow-up (98.7% v 89.1%; difference, 9.6%; 95% CI, 3.9 to 15.9; P = .005). Conclusion The results do not support the hypothesis that SCPs are beneficial for improving patient-reported outcomes. Transferring follow-up to PCPs is considered an important strategy to meet the demand for scarce oncology resources. SCPs were no better than a standard discharge visit with the oncologist to facilitate transfer.

In Canada, antimicrobial treatment is the most common approach for acute otitis media. The aim of the present study was to compare the cost effectiveness of treatment with amoxicillin versus a watch-and-wait approach (WAIT) within a Canadian pediatric setting. Four hundred eighty-eight children, six months to five years of age, who participated in a randomized controlled trial were included in the study. The average medication costs per patient were higher for the amoxicillin group ($17.26) than for the WAIT group ($4.33). However, both health care ($148.44 versus $162.48) and patient costs ($23.50 versus $31.87) were greater for the WAIT group. The mean cost of treatment for the amoxicillin group was $189.20, compared with $198.68 for the WAIT group. Amoxicillin may be cost effective in treating children with acute otitis media. The potential development of antimicrobial resistance was not addressed in the present study.

Few studies have compared changes in cardiorespiratory fitness between aerobic training only or in combination with resistance training. In addition, no study to date has compared strength gains between resistance training and combined exercise training in type II diabetes mellitus (T2DM). Purpose: We evaluated the effects of aerobic exercise training (A group), resistance exercise training (R group), combined aerobic and resistance training (A + R group), and sedentary lifestyle (C group) on cardiorespiratory fitness and muscular strength in individuals with T2DM. Methods: Two hundred and fifty-one participants in the Diabetes Aerobic and Resistance Exercise trial were randomly allocated to A, R, A + R, or C. Peak oxygen consumption (V[spacing dot above]O2peak), workload, and treadmill time were determined after maximal exercise testing at 0 and 6 months. Muscular strength was measured as the eight-repetition maximum on the leg press, bench press, and seated row. Responses were compared between younger (aged 39-54 yr) and older (aged 55-70 yr) adults and between sexes. Results: V[spacing dot above]O2peak improved by 1.73 and 1.93 mL O2[middle dot]kg-1[middle dot]min-1 with A and A + R, respectively, compared with C (P < 0.05). Strength improvements were significant after A + R and R on the leg press (A + R: 48%, R: 65%), bench press (A + R: 38%, R: 57%), and seated row (A + R: 33%, R: 41%; P < 0.05). There was no main effect of age or sex on training performance outcomes. There was, however, a tendency for older participants to increase V[spacing dot above]O2peak more with A + R (+1.5 mL O2[middle dot]kg-1[middle dot]min-1) than with A only (+0.7 mL O2[middle dot]kg-1[middle dot]min-1). Conclusions: Combined training did not provide additional benefits nor did it mitigate improvements in fitness in younger subjects compared with aerobic and resistance training alone. In older subjects, there was a trend to greater aerobic fitness gains with A + R versus A alone.

This article is available open access through the publisher’s website at the link below. © The Author 2008. Background - Wage losses after breast cancer may result in considerable financial burden. Their assessment is made more urgent because more women now participate in the workforce and because breast cancer is managed using multiple treatment modalities that could lead to long work absences. We evaluated wage losses, their determinants, and the associations between wage losses and changes for the worse in the family's financial situation among Canadian women over the first 12 months after diagnosis of early breast cancer. Methods - We conducted a prospective cohort study among women with breast cancer from eight hospitals throughout the province of Quebec. Information that permitted the calculation of wage losses and information on potential determinants of wage losses were collected by three pretested telephone interviews conducted over the year following the start of treatment. Information on medical characteristics was obtained from medical records. The main outcome was the proportion of annual wages lost because of breast cancer. Multivariable analysis of variance using the general linear model was used to identify personal, medical, and employment characteristics associated with the proportion of wages lost. All statistical tests were two-sided. Results - Among 962 eligible breast cancer patients, 800 completed all three interviews. Of these, 459 had a paying job during the month before diagnosis. On average, these working women lost 27% of their projected usual annual wages (median = 19%) after compensation received had been taken into account. Multivariable analysis showed that a higher percentage of lost wages was statistically significantly associated with a lower level of education (Ptrend = .0018), living 50 km or more from the hospital where surgery was performed (P = .070), lower social support (P = .012), having invasive disease (P = .086), receipt of chemotherapy (P < .001), self-employment (P < .001), shorter tenure in the job (Ptrend < .001), and part-time work (P < .001). Conclusion - Wage losses and their effects on financial situation constitute an important adverse consequence of breast cancer in Canada. The Canadian Breast Cancer Research Alliance, Canadian Institutes of Health Research, and Fondation de l’Université Laval.

Background Both the prevalence of breast cancer and the number of breast cancer patients seeking breast reconstruction are increasing, highlighting the importance for evidence to direct the clinician in the follow-up of these patients. Current practice guidelines recommend surveillance mammography of the contralateral breast in all breast cancer patients, and of the ipsilateral breast in women treated with breast-conserving surgery. However, there are no guidelines specifically addressing the role of surveillance mammography for women who have undergone mastectomy and breast reconstruction. Methods A systematic review was conducted to identify studies specifically addressing the issue of surveillance mammography among women with breast reconstruction following treatment for primary breast cancer. Results This systematic review identified eight articles, consisting of case reports and case series, that address the issue of surveillance mammography of the ipsilateral breast in women with breast reconstruction. The articles demonstrated that certain local recurrences are able to be detected by surveillance mammography. Conclusion This study has demonstrated the paucity of evidence and highlighted the need for further research to evaluate this issue.

Background: The Irbesartan in Reduction of Microalbuminuria trial and the Irbesartan in Diabetic Nephropathy Trial found that irbesartan is renoprotective in patients having hypertension with type 2 diabetes. Objective: The objective of this study was to assess whether treatment with irbesartan is cost-effective in Canada relative to conventional care in this patient population and whether it is more cost-effective to treat patients early rather than later in the development of renal disease from the perspective of the Canadian health and social care system. Methods: The analysis compared 3 alternative strategies for the management of hypertension in patients with type 2 diabetes and early renal disease: (1) conventional hypertensive treatment excluding the use of angiotensin II receptor antagonists (AIIRAs); (2) the early addition of irbesartan (an AIIRA) to conventional treatment; and (3) the late addition of irbesartan to conventional treatment. A Markov model was used to simulate the progression of renal disease (microalbuminuria to death) in hypertensive patients with type 2 diabetes over a 25-year time horizon. Transition probabilities were derived from the 2 randomized controlled trials. A cost-effectiveness analysis was conducted with outcome measured in life-years gained (LYGs). Results: The early addition of irbesartan during microalbuminuria was cost-saving and more effective than both delaying irbesartan treatment until advanced overt nephropathy (AON) (0.45 LYG, Can $54,100 saved) and conventional antihypertensive use (0.62 LYG, $68,400 saved). This was due to the increased drug costs associated with the use of irbesartan being offset by savings arising from delays in the development of overt nephropathy and the subsequent delay to end-stage renal disease (ESRD). Sensitivity analyses confirmed the robustness of the study results. Conclusions: The early use of irbesartan for patients with hypertension and type 2 diabetes who have yet to develop overt nephropathy is both more effective and less costly than delaying irbesartan treatment until AON and conventional antihypertensive use. Analysis suggests that the earlier irbesartan is added to conventional antihypertensive treatment, the greater the delays in the onset of ESRD and the overall savings in health care resource utilization from the perspective of the Canadian health and social care system.

Purpose This clinical focus article provides preliminary findings from a multicenter longitudinal study investigating auditory and communication development in children with mild bilateral or unilateral hearing loss of any degree. Method A total of 100 children (55 with mild bilateral or unilateral hearing loss and 45 with normal hearing) underwent 1 or more assessments from a battery of auditory and language measures. Results Children up to age 4 years demonstrated auditory and language skills similar to those of children with normal hearing. Conclusions Factors that affect outcomes in communication development will be explored as additional data are collected in this ongoing study.

Objectives: To review the sources and quality of evidence used in the development of economic decision models in health technology assessments (HTAs). Methods: All economic decision models developed as part of the NHS Research and Development HTA Programme between 1997 and 2003 were reviewed. Quality of evidence was assessed using a hierarchy of data sources developed for economic analyses. Results: Decision models are parameterized using diverse sources of evidence (e.g. randomized controlled trials, observational studies, expert opinion). Evidence on the main clinical effect was mostly identified and quality assessed as part of the companion systematic review/meta-analysis of the HTA and therefore reported in a transparent and reproducible way. For the other model inputs (i.e. adverse events, baseline clinical data, resource use and utilities), the search strategies for identifying relevant evidence were rarely made explicit and in a number of reports the sources of specific evidence were unclear due to poor reporting. Conclusions: A more formal and replicable approach to identification and assessment of quality of model inputs is required to reduce the 'black box' nature of decision models, and lead to less scepticism regarding model outputs.

With increasing pressure on health care resources, it is necessary to demonstrate that new treatments are both effective and cost effective. The purpose of this study was to assess the cost effectiveness of pimecrolimus (Elidel) compared to usual therapy in the treatment of both adults and children with atopic eczema in Canada. Analysis was performed using a decision model which estimated the incremental cost per quality adjusted life year (QALY) gained from both a societal and health care perspective. For children, Elidel leads an incremental cost per QALY of $38,000 from a societal perspective. For adults, the incremental cost per QALY was $35,000. Elidel will lead to an overall increase in costs but with an improvement in clinical outcomes. The cost effectiveness ratios for Elidel were consistently below $50,000 per QALY gained. Given previous funding decisions in Canada, Elidel may be considered a cost-effective use of health care resources. Avec la demande accrue pour les ressources en soins de sante, il devient essentiel de prouver aussi bien l'efficacite que la rentabilite de tout nouveau traitement. Evaluer la rentabilite de pimecrolimus (Elidel) par rapport au traitement traditionnel de l'eczema atopique chez les adultes et les enfants au Canada. Des analyses ont ete faites au moyen d'un modele decisionnel qui estime le cout par annee-personne sans invalidite des points de vue societal et de sante. Dans le cas des enfants, le cout par annee-personne sans invalidite du point de vue societal est de 38 000 $. Pour les adultes, le cout est de 35 000 $. Elidel menera a une augmentation generale des couts mais sera accompagne d'une amelioration des resultats cliniques. Les taux de rentabilite de l'Elidel etaient toujours inferieurs a 50 000 $ pour chaque annee-personne additionnelle. En effectuant une comparaison avec les decisions de financement anterieures au Canada, le recours a l'Elidel pourrait etre considere comme usage rentable des ressources en soins de sante.

In probabilistic economic analysis, the uncertainty concerning input parameters is quantified, and determines the level of uncertainty over the optimal decision. Researchers from a wide range of disciplines employ mathematical models to simulate complex processes. Common through many such disciplines is the conduct of importance analysis to determine those input parameters that contribute most to the uncertainty over the optimal decision based on the results of the analysis. In this study, we compare a range of potential importance measures to see how they compare with methods used in economic analysis. Techniques were classified as variance/correlation, information, probability, entropy, or elasticity-based measures. A selection of the most commonly used measures were applied to an economic model of treatment for patients with Parkinson's disease. Techniques were evaluated in terms of their ranking of variables, complexity, and interpretation.

The use of probabilistic analysis as a means for analyzing uncertainty within economic analysis has grown in popularity in recent years as it has been recognized as the most complete method for propagating uncertainty with respect to input parameters in terms of uncertainty about outcomes of interest. The World Health Organization (WHO) in a series of recent reports and publications have recognized the role of probabilistic analysis in what they term generalized cost-effectiveness analysis. However, there are fundamental problems with the analysis and the interpretation of such analysis as proposed by WHO. This study highlights three specific points for concern and offers constructive criticism by recommending more appropriate approaches.

The cost-effectiveness of new health care technologies is conditional upon who receives what therapy and under what circumstances. Understanding this heterogeneity in cost-effectiveness, health care payers often limit reimbursement of therapies to a more restrictive sub-group of patients than that indicated in a product's licensing. Such limits may be based upon clinical or demographic criteria that are prognostic of costs, outcomes or both. However, there is little guidance on how to estimate and interpret stratified cost-effectiveness analysis. In this paper we present a framework for estimating the benefits from stratification that permits consideration of both the opportunity cost resulting from a lack of adherence with criteria and the efficiency loss associated with incorporating equity concerns.

Introduction: Clinical practice guidelines are systematically developed statements to assist practitioner and patient decisions about appropriate healthcare for specific clinical circumstances. When adhered to, they have been shown to have the potential to improve both the process of care and patient health outcomes. Economic issues can be incorporated into guidelines with respect to both recommendations (based on the criteria of cost effectiveness) and defining outcomes for assessing adherence with guidelines. Methods: We reviewed 217 Canadian clinical practice guidelines relating to prescription medications. The role of economics within existing practice guidelines was assessed using standardized abstracting techniques. Results: Costs or economics were considered in only 26% of the guidelines identified. The role of economic considerations within these guidelines varied considerably from a relatively minor to major role. Furthermore, only 4% of guidelines defined measurable outcomes, including economic outcomes, that could be monitored to assess adherence with recommendations. Conclusions: The inclusion of economic considerations in clinical guidelines in Canada is limited. The possible reasons for this lack of economic considerations need to be explored further. Without consideration of economic issues when developed, clinical practice guidelines may lead to a more inefficient healthcare system.

Introduction: The objective of this study was to assess the cost effectiveness of a continuous combined oral preparation of norethisterone (norethindrone) acetate and ethinylestradiol (NA/EE) [FemHRT®] as both a first-line and second-line therapy for menopausal women. Perspective: Third-party payer. Methods: The cost effectiveness of NA/EE was assessed as both a first- and second-line therapy in comparison with conjugated equine oestrogen 0.625mg and medroxyprogesterone acetate 2.5mg (CEE/MPA) and no therapy. Analysis was conducted within a Markov model with states relating to the presence and absence of vaginal bleeding, menopausal symptoms and hip fracture. Analysis forecasted life expectancy, QALYs and lifetime costs for a 50-year-old menopausal woman. Compliance was modelled related to menopausal symptoms and vaginal bleeding. For the base-case analysis, it was assumed that compliant women would take therapy for up to 5 years. Sensitivity analysis assumed therapy was taken only for 1 year. Results: Compared with both CEE/MPA and no therapy, NA/EE led to an increase in both costs and QALYs, both as a first- and second-line therapy. For first-line therapy, the incremental cost per QALY gained for NA/EE was $2200 Canadian dollars ($Can; 1999 values) [compared with no therapy] and was $Can20 300 (compared with CEE/MPA). For second-line therapy, the incremental cost per QALY gained for NA/EE was $Can900 (compared with no therapy) and was $Can16 400 (compared with CEE/MPA). Results were robust to most sensitivity analyses. Conclusions: NA/EE is a cost-effective therapy for women with menopausal symptoms both as a first-line and second-line therapy.

Rheumatoid arthritis affects ~ 1% of the population. It is associated with pain, deformity, decreased quality of life and disability that in turn affects patients' ability to work. A variety of disease-modifying antirheumatic drugs are available to control the disease activity of rheumatoid arthritis. The goal of treatment is to improve patients' quality of life and prevent joint destruction. This paper reviews both the clinical aspects of frequently prescribed disease-modifying antirheumatic drugs and the available cost-effectiveness information. Clinical evidence supports the effectiveness of methotrexate, etanercept, infliximab, gold, hydroxychloroquine, leflunomide, sulfasalazine, penicillamine, cyclosporin, azathioprine and corticosteroids. The last four of these are associated with greater toxicity and are only used if less toxic drugs are ineffective. The lack of published economic evaluations of disease-modifying antirheumatic drugs highlights the need for such studies to allow efficacious and cost-effective drugs to be used to prevent the long-term complications of uncontrolled rheumatoid arthritis.

Economic analysis of healthcare interventions is increasingly reliant on decision models to estimate the long- term costs and benefits of new therapies. Models permit analysts to take short-term clinical data to forecast long-term costs and benefits. Models should follow certain basic principles and can be appraised in terms of three broad characteristics: clinical relevance, transparency and analytical ability. The purpose of this paper is to explore the role of modelling in the economic analysis of interventions for type 2 diabetes mellitus. A review of existing models for diabetes identified five complex disease models appropriate for economic analysis. These models were broadly similar in structure and in source of input parameters. However, models did vary according to the coverage of relevant disease complications and the complexity of analysis possible. Models could be enhanced by improving their transparency and by using data relevant to type 2 diabetes. In addition, enhancing clinical knowledge through the provision of long-term data on effectiveness may reduce concern relating to the appropriateness of the assumptions currently required within models. The value of such further information must be weighed against the costs of its acquisition.

Recently published clinical trial results have demonstrated that, in patients with type 2 diabetes mellitus, treatment with pioglitazone hydrochloride as a first-line therapy can lead to significant improvements in glycosylated haemoglobin, total cholesterol, high density lipoprotein cholesterol and triglycerides. Given the results of these trials, we assessed the cost effectiveness of the use of pioglitazone as a first-line therapy in Canada.A Markov model was used to determine the health outcomes and economic impact for patients with type 2 diabetes, from the perspective of a provincial ministry of health. The model incorporated six complications of diabetes: hypoglycaemia, acute myocardial infarction, stroke, lower extremity amputation, nephropathy, and retinopathy. Transition probabilities and costs were taken from published literature. Analysis compared treatment strategies with different first-line therapies: pioglitazone, glibenclamide (glyburide), metformin, and diet and exercise.Compared with other strategies, a pioglitazone-based strategy was estimated to reduce the cumulative incidence of severe clinical events and long-term complications by between 23 and 36% and to increase discounted life expectancy by between 0.13 and 0.35 life-years. The discounted incremental cost per life-year gained of a first-line pioglitazone-based strategy was 54,000 Canadian dollars ($Can) compared with metformin, $Can42,000 compared with glibenclamide and $Can27,000 compared with diet and exercise.When compared with other currently funded chronic therapy, these results demonstrate that a treatment strategy employing pioglitazone as a first-line therapy may be cost effective for certain patient strata.

Prospective validation on a new set of patients is an essential test of a new decision rule. However, many clinical decision rules are not prospectively assessed to determine their accuracy, reliability, clinical sensibility, or potential impact on practice. This validation process is important because many statistically derived rules or guidelines do not perform well when tested in a new population. The methodologic standards for a validation study are similar to those described in the article on phase I for derivation studies in the August 2001 issue of Annals of Emergency Medicine. The goal of phase II is to prospectively assess the accuracy, reliability, and acceptability of the decision rule in a new set of patients with minor head injury. This will determine the clinical utility of the rule and is essential if such a rule is to be widely adopted into clinical practice.

Objective: To assess the cost effectiveness of nasal calcitonin (Miacalcin®) compared with no therapy, alendronate or etidronate in the treatment of postmenopausal women with previous osteoporotic fracture. Design and setting: Meta-analysis followed by economic analysis. Perspective: A Canadian provincial Ministry of Health. Methods: The meta-analysis of randomised controlled clinical trials was based on the recommendations of the Cochrane Collaboration. Economic analysis was conducted within a Markov model using probabilities and costs derived from Canadian sources. Results: The meta-analysis found evidence of the positive effect of both nasal calcitonin and alendronate in reducing the risks of hip, wrist and vertebral fractures in postmenopausal women. However, there was a lack of evidence of the effect of etidronate on hip and wrist fractures. For a 65-year-old woman, with 5 years’ therapy, the incremental cost per quality-adjusted life-year (QALY) gained for nasal calcitonin was 46 500 Canadian dollars ($Can) compared with no therapy and $Can32 600 compared with etidronate (1998 values). Comparison with alendronate was highly sensitive to the inclusion of one specific trial. Conclusions: Given the results of the analysis, based on current evidence, nasal calcitonin can be considered at themargins of being cost effectiv ewhen compared with no therapy. Compared with active therapy, nasal calcitonin can be considered more cost effective than etidronate, but its cost effectiveness versus alendronate is inconclusive.

Introduction Cigarette smoking causes many chronic diseases that are costly and result in frequent hospitalisation. Hospital-initiated smoking cessation interventions increase the likelihood that patients will become smoke-free. We modelled the cost-effectiveness of the Ottawa Model for Smoking Cessation (OMSC), an intervention that includes in-hospital counselling, pharmacotherapy and posthospital follow-up, compared to usual care among smokers hospitalised with acute myocardial infarction (AMI), unstable angina (UA), heart failure (HF), and chronic obstructive pulmonary disease (COPD). Methods We completed a cost-effectiveness analysis based on a decision-analytic model to assess smokers hospitalised in Ontario, Canada for AMI, UA, HF, and COPD, their risk of continuing to smoke and the effects of quitting on re-hospitalisation and mortality over a 1-year period. We calculated short-term and long-term cost-effectiveness ratios. Our primary outcome was 1-year cost per quality-adjusted life year (QALY) gained. Results From the hospital payer’s perspective, delivery of the OMSC can be considered cost effective with 1-year cost per QALY gained of $C1386, and lifetime cost per QALY gained of $C68. In the first year, we calculated that provision of the OMSC to 15 326 smokers would generate 4689 quitters, and would prevent 116 rehospitalisations, 923 hospital days, and 119 deaths. Results were robust within numerous sensitivity analyses. Discussion The OMSC appears to be cost-effective from the hospital payer perspective. Important consideration is the relatively low intervention cost compared to the reduction in costs related to readmissions for illnesses associated with continued smoking.

Effect of hemoglobin levels in hemodialysis patients with asymptomatic cardiomyopathy. Background Hemoglobin levels below 10 g/dL lead to left ventricular (LV) hypertrophy, LV dilation, a lower quality of life, higher cardiac morbidity, and a higher mortality rate in end-stage renal disease. The benefits and risks of normalizing hemoglobin levels in hemodialysis patients without symptomatic cardiac disease are unknown. Methods One hundred forty-six hemodialysis patients with either concentric LV hypertrophy or LV dilation were randomly assigned to receive doses of epoetin α designed to achieve hemoglobin levels of 10 or 13.5 g/dL. The study duration was 48 weeks. The primary outcomes were the change in LV mass index in those with concentric LV hypertrophy and the change in cavity volume index in those with LV dilation. Results In patients with concentric LV hypertrophy, the changes in LV mass index were similar in the normal and low target hemoglobin groups. The changes in cavity volume index were similar in both targets in the LV dilation group. Treatment-received analysis of the concentric LV hypertrophy group showed no correlation between the change in mass index and a correlation between the change in LV volume index and mean hemoglobin level achieved (8 mL/m 2 per 1 g/dL hemoglobin decrement, P = 0.009). Mean hemoglobin levels and the changes in LV mass and cavity volume index were not correlated in patients with LV dilation. Normalization of hemoglobin led to improvements in fatigue ( P = 0.009), depression ( P = 0.02), and relationships ( P = 0.004). Conclusions Normalization of hemoglobin does not lead to regression of established concentric LV hypertrophy or LV dilation. It may, however, prevent the development of LV dilation, and it leads to improved quality of life.

The clinical and economic burden of osteoporosis is high and has resulted in increasing interest in assessing the costs and benefits associated with strategies to reduce the incidence of fracture. In this article, we aim to summarize the major issues related to conducting economic evaluations of therapies for osteoporosis. We identify the principal data parameters (baseline clinical probabilities, effectiveness, costs, and utilities) and economic model characteristics (patient age, compliance, and duration of therapy). We highlight these issues by referring to previous studies identified in a systematic review and to current work in the area. Further discussion provides an overview of the results of the existing economic evaluations of therapies for osteoporosis and a brief summary of ongoing research in Canada. In conclusion, there appears to be a consensus in the literature that under most circumstances hormone replacement therapy is cost-effective in the treatment of osteoporosis. Further research is required before definitive conclusions on the cost-effectiveness of other therapies can be made. Drug Dev. Res. 49:135–140, 2000. © 2000 Wiley-Liss, Inc.

2. Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88 2.1. Description of the centre . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88 2.2. Allocation of expenditures to the radiation program . . . . . . . . . . . . . . . . . . . . . 88 2.2.1. Direct treatment-related costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88 2.2.2. Non-treatment related direct costs. . . . . . . . . . . . . . . . . . . . . . . . . . . 89 2.3. Cost allocation within the radiation program to treatment function . . . . . . . . . . . . 89 2.4. Computation of activity costs (cost per fraction) . . . . . . . . . . . . . . . . . . . . . . . 90 2.5. Sensitivity analyses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90

An increasing number of economic evaluations are being conducted alongside clinical trials. While this practice offers the prospect of collecting comprehensive and accurate cost data, it requires considerable time and effort. In the case of clinical data, key analytic decisions such as which data to collect and sample size are often made with reference to smaller (pilot) trials. However, this approach is not normally followed in the case of economic evaluation.This study was based on a recently completed health technology assessment comparing conventional radiotherapy with continuous hyperfractionated accelerated radiotherapy (CHART) for patients with head and neck cancer or carcinoma of the bronchus. In the full health technology assessment, cost data were available for 526 head and neck patients (314 CHART and 212 conventional therapy) and 286 bronchus patients (175 CHART and 109 conventional therapy). In order to simulate a pilot study, data were extracted for the patients recruited to both trials in the first 3 months. These were then compared with the full data set in order to assess whether such a pilot study would have given useful guidance on: a) the usefulness of undertaking a full study; b) the sample size required; and c) the important resource items for which comprehensive data collection would be required.Pilot studies can be helpful in determining the likely advantages of undertaking full economic evaluations and in identifying important resource items. Therefore, it is important that clinical researchers and research funding bodies create the necessary time window to enable such studies to take place. However, formal sample size calculations are more difficult to perform on limited data, since they also require knowledge of the unit cost (or prices) to be attached to the resource items and the correlation between costs and clinical effects.

Decisions relating to designing and implementing economic evaluations alongside clinical trials are dependent on a number of issues. Initial consideration should focus on whether an economic evaluation is appropriate, whether a randomized controlled trial (RCT) is a suitable vehicle, and whether the design of the specific RCT is appropriate for integration of economic evaluation. If an economic evaluation is appropriate, decisions are required on how economic data are to be collected and analyzed. This paper discusses these and other issues and, where appropriate, provides recommendations for future studies.

The increasing number of economic evaluations of healthcare interventions and of drug therapies in particular has been well documented. Surveys of the quality of studies have demonstrated that standards of conduct of such studies have not similarly increased. Concerns over the standards have led to increased calls that economic analyses be more closely linked to randomised controlled clinical trials (RCT). Seven potential threats to the external validity of results limit the generalisability of studies based on RCTs. One such threat is the existence of protocol driven costs. There are two main types of protocol driven costs. Protocol prescribed costs arise as a result of resource use mandated by the clinical trial design. Protocol derived costs occur when increased clinical investigations mandated by trial protocols lead to atypical disease management. Methods to control for protocol driven costs within pharmacoeconomic study designs are available. Modelling studies can be based on data within clinical trials combined with observational data representing more typical resource use. The adoption of pragmatic clinical trial designs provide greater external validity though reduced internal validity. Refinements to explanatory clinical trials can also lead to reduced protocol driven costs. The extent that current studies control for such costs is unclear due to the lack of transparency in the reporting of study methods. A review of published studies found little consideration of protocol driven costs although in several studies there was evidence of their existence. Future studies conducted alongside RCTs should explicitly address how the issue of protocol driven costs was handled within the study framework.

AIMS To develop a methodology for obtaining the detailed costs of different substance misuse services and illustrate some of the specific problems by means of a case study. DESIGN Data on the resources required, clinical activity, and patient characteristics for one year were combined to provide detailed costs for different types of clinical events and patients. SETTING The clinical services of a publicly funded addiction unit in a large industrial city in the UK. The unit provides for alcohol and other drug misusers mainly on an outpatient basis but with inpatient care. PARTICIPANTS Over 1500 patients were included in the analysis with 75 per cent being male, and 80 per cent aged between 20 and 49. Nearly half of the clients had alcohol as their main drug of misuse with opiate users being the next largest group. MEASUREMENT Detailed costing by event and patient was possible as the staff type and time taken for each event were routinely recorded. A cost for each individual event was estimated and summed for each individual patient to give a cost estimate by patient for the financial year 1992/3. FINDINGS Core treatment outpatient events had an average cost of Pounds 48, with new assessments costing Pounds 87 but these averages hid high variations. The average cost per year for those receiving only outpatient care was Pounds 358; it was Pounds 1857 for those receiving both outpatient and inpatient care. Opiate misusers were on average more costly than alcohol misusers. The costs were skewed with 10 per cent of patients accounting for 56 per cent of the total annual costs. CONCLUSIONS Dealing with costs of non attendance, including all resource use, and coping with large individual variations in costs across individuals and intervention types are the main problems in devising cost figures. Cost data are useful but need to be combined with outcome data if they are to be used to improve patient services.

The objective of this study was to compare the costs of treatment with continuous hyperfractionated accelerated radiotherapy (CHART) and those of conventional radiotherapy for patients with (1) head and neck cancer and (2) carcinoma of the bronchus. The study was conducted concurrently with two multicentre randomized controlled trials. Data were collected on the use of hospital and community service resources and patients' travel for treatment. Data on resource use up to 3 months after entry to the study were available for 526 head and neck patients (314 receiving CHART and 212 conventional therapy) and 284 bronchus patients (175 CHART and 109 conventional therapy). For patients with head and neck cancer, CHART cost Pounds 1092 (P < 0.001; 95% CI 763-1421) more than conventional therapy. For patients with carcinoma of the bronchus, CHART was also more costly, with a cost differential of Pounds 698 (P < 0.001; 95% CI 392-1003). The magnitude of the cost differentials could be reduced if the working hours of radiotherapy departments were rearranged and all hospitals had access to hostel facilities. The results of this cost analysis will help to facilitate a decision about whether the benefits of CHART, as determined by the clinical trials, are worth the additional costs of hospital-based resource use. The collection of detailed patient-specific resource-use data from a number of centres allows the determination of ways for reducing the cost differential between therapies and making CHART a more cost effective treatment alternative.

The increasing number of economic evaluations of healthcare interventions, and of drug therapies in particular, has been well documented. However, surveys have demonstrated that standards of conduct of such studies have not similarly increased. Of particular concern is the lack of development or even consideration of statistical techniques in the reporting of studies. This article addresses issues that must be considered both in the conduct and in the assessment of the quality of studies. Throughout the paper, examples of pharmacoeconomic analyses are used to illustrate the points made. Recommendations for the conduct of future pharmacoeconomic studies are given. Such recommendations specifically relate to the level of testing that is conducted, the choice of statistical tests and the manner in which statistical significance is reported. In addition, existing methods for the statistical analysis of cost-effectiveness ratios and for the determination of sample size in economic evaluations are discussed, and a partial solution to this issue is offered.

Quality of life is increasingly being used as a measure of outcome in comparative cancer clinical trials. Even when quality of life studies are well funded vis-a-vis data collection and processing, it is unlikely that data sets will be 100% complete, leading to problems at the data analysis stage. Missing data can arise as a consequence of whole assessments being missed due to death or other reasons, or as a result of single items being omitted from particular questionnaires. This paper addresses the latter category of missing data and examines the effects on subscale scores of imputing values for missing items from the Hospital Anxiety and Depression Scale and the psychological complaints subscale of the Rotterdam Symptom Checklist.

The use of economic evaluation to assess the costs and consequences of health care technologies has steadily increased in recent years. However, little is known about the influence economic studies have on health care decision makers or policy at local and national level. This paper reports the results of a survey of economic evaluations in EC countries to identify the impact of the results on decision and policy making in health care. Health service researchers in 10 EC countries were identified and asked to participate in the survey. The researchers were asked to locate economic evaluations in their country and complete a standardised questionnaire for each study. The criteria for inclusion in the survey were first, the studies should have been started or reported since 1987, second, the evaluations should include a comparison of the cost and consequences of the technologies assessed and finally, the appraisals should include a comparison of alternative health care technologies or programmes. A total of 66 studies which met the survey criteria were reported. Of these, 27% were thought to have influenced health care decision makers or policy. The results suggested that method of dissemination, source of funding and purpose of the study may be important determinants of whether an economic evaluation will be used in health care policy or decision making. The results of the survey suggest that economic evaluation currently has a relatively low impact on health care policy or decision making.(ABSTRACT TRUNCATED AT 250 WORDS)

Purpose Patients with breast cancer incur out-of-pocket costs when they receive adjuvant radiation. These treatments are administered in dedicated centers on a daily basis over 4 to 5 weeks. We assessed the extent of out-of-pocket costs to access radiotherapy and identified women at risk of experiencing higher costs. Patients and Methods This prospective study was conducted among 800 women from eight Quebec hospitals (participation, 86%), of whom 693 women received adjuvant radiotherapy. Costs to access treatment (transportation, parking, lodging, and meals) were estimated on the basis of information collected by telephone interviews. Generalized linear models were used to identify women at risk of having higher costs. Results Mean and median total costs (including financial aid received) to access radiotherapy were 445 Canadian dollars (Can$; standard deviation, Can$407) and Can$311, respectively. Women who lived at home but far from the radiotherapy center had the highest risk of experiencing weekly costs of at least Can$122 (highest quartile; prevalence ratio [PR], 5.8; 95% CI, 4.7 to 7.1) followed by women who lived away from home and farther from the center (PR, 4.5; 95% CI, 3.4 to 6.0) and by women who lived away from home and closer to the center (PR, 2.14; 95% CI, 1.3 to 3.5). When women stayed at a cancer lodge during treatment, costs were reduced by 80%. Conclusion Considered in and of themselves, out-of-pocket costs for access to radiotherapy appeared relatively modest. Financial assistance initiatives for women who lived away from home during treatments contributed to a substantial reduction of access costs. These efforts should be maintained, but financial assistance should also target patients with cancer who live at home during treatments but have to travel relatively long distances on a daily basis.

Loew L, Brosseau L, Wells GA, Tugwell P, Kenny GP, Reid R, Maetzel A, Huijbregts M, McCullough C, De Angelis G, Coyle D, and the Ottawa Panel. Ottawa Panel evidence-based clinical practice guidelines for aerobic walking programs in the management of osteoarthritis. Objective To update the Evidence-Based Clinical Practice Guidelines (EBCPGs) on aerobic walking programs for the management of osteoarthritis (OA) of the knee. Data Sources A literature search was conducted using the electronic databases MEDLINE, PubMed, and the Cochrane Library for all studies related to aerobic walking programs for OA from 1966 until February 2011. Study Selection The literature search found 719 potential records, and 10 full-text articles were included according to the selection criteria. The Ottawa Methods Group established the inclusion and exclusion criteria regarding the characteristics of the population, by selecting adults of 40 years old and older who were diagnosed with OA of the knee. Data Extraction Two reviewers independently extracted important information from each selected study using standardized data extraction forms, such as the interventions, comparisons, outcomes, time period of the effect measured, and study design. The statistical analysis was reported using the Cochrane collaboration methods. An improvement of 15% or more relative to a control group contributes to the achievement of a statistically significant and clinically relevant progress. A specific grading system for recommendations, created by the Ottawa Panel, used a level system (level I for randomized controlled studies and level II for nonrandomized articles). The strength of the evidence of the recommendations was graded using a system with letters: A, B, C+, C, D, D+, or D–. Data Synthesis Evidence from 7 high-quality studies demonstrated that facility, hospital, and home-based aerobic walking programs with other therapies are effective interventions in the shorter term for the management of patients with OA to improve stiffness, strength, mobility, and endurance. Conclusions The greatest improvements were found in pain, quality of life, and functional status (grades A, B, or C+). A common limitation inherent to the EBCPGs is the heterogeneity of studies included with regards to the characteristics of the population, the interventions, the comparators, the outcomes, the period of time, and the study design. It is strongly recommended to use the Cochrane Risk of Bias Summary assessment to evaluate the methodologic quality of the studies and to consider avenues for future research on how aerobic walking programs would be beneficial in the management of OA of the hip.