Search

Adrian R Levy,1,2 Robert M Perkins,3 Karissa M Johnston,2 Sean D Sullivan,4 Vipan C Sood,5 Wendy Agnese,5 Mark A Schnitzler61Department of Community Health and Epidemiology, Dalhousie University, Halifax, NS, Canada; 2Oxford Outcomes Ltd, Vancouver, BC, Canada; 3Center for Health Research and Division of Nephrology, Geisinger Health System, Danville, PA, USA; 4School of Pharmacy, University of Washington, Seattle, WA, USA; 5Mitsubishi Tanabe Pharma America, Jersey City, NJ, USA; 6Departments of Internal Medicine and Community Health, Saint Louis University, St Louis, MO, USAPurpose: Predicting the timing and number of end-stage renal disease (ESRD) cases from a population of individuals with pre-ESRD chronic kidney disease (CKD) has not previously been reported. The objective is to predict the timing and number of cases of ESRD occurring over the lifetime of a cohort of hypothetical CKD patients in the US based on a range of baseline estimated glomerular filtration rate (eGFR) values and varying rates of eGFR decline.Methods: A three-state Markov model – functioning kidney, ESRD, and death – with an annual cycle length is used to project changes in baseline eGFR on long-term health outcomes in a hypothetical cohort of CKD patients. Using published eGFR-specific risk equations and adjusting for predictive characteristics, the probability of ESRD (eGFR

The regeneration of periodontal structures lost to inflammatory disease is an elusive yet attainable goal of periodontal therapy. This article reports the successful treatment of a large periodontal defect using a combination of demineralized freeze-dried bone allograft (DFDBA) and guided tissue regeneration (GTR). The case presents endodontic and mucogingival complications in the combined GTR osseous graft technique. The combined techniques used in this 27-year-old patient achieved a reduction in probing depth, radiographic evidence of bone fill, and a reduction in clinical mobility. [ABSTRACT FROM AUTHOR]

Abstract Background: Cetuximab (Erbitux * *Erbitux is a registered trade name of Bristol-Myers Squibb, Princeton, NJ, USA. ) is the only new medical therapy for locally and regionally advanced SCCHN to be licensed in industrialized countries in the past 15 years and presents an alternative to cisplatin which is the current therapeutic standard. In the absence of a published head-to-head trial, we estimated the relative benefit of cetuximab and cisplatin using an indirect comparison methodology. Methods: We performed a systematic review of the Medline and Embase databases between 1998 and 2008 to find published trials of cisplatin plus radiotherapy vs. radiotherapy alone and synthesized the information with meta-analysis. Those results were combined with trial-based results of cetuximab plus radiotherapy vs. radiotherapy alone. Inclusion criteria stipulated that cisplatin be administered concurrently with radiation, the radiation protocol be comparable to the registration trial for cisplatin (once-daily, twice-daily, or concomitant boost) and cisplatin dosing be comparable to that in common use (i.e. day 1, 22 and 43 of treatment). Endpoints were locoregional control and overall survival. Two reviewers examined 269 abstracts which yielded four trials meeting the inclusion criteria. Results: There was little evidence of superiority of either platinum-based radiotherapy or cetuximab-based radiotherapy. All estimated hazard ratios were near 1.0 (equivalence), all confidence intervals spanned the null value (1.0), and no consistent pattern was observed regarding the direction of the effect. The results remained robust in sensitivity analysis. Conclusion: This is the first quantitative analysis allowing formal comparison between cetuximab and radiotherapy versus cisplatin and radiotherapy. Based on state-of-the-art methodology for indirect comparisons, it was not possible to identify either treatment regimen as superior in prolonging either locoregional control or overall survival. Until the publication of more studies, and particularly a head-to-head comparison, the two treatments may be considered equally efficacious when given alongside radiotherapy. The choice of treatment may focus on the toxicity profile of the medications. [ABSTRACT FROM AUTHOR]

Spurred by a desire to improve quality of care and to understand the relative value of medical treatments, there has been a recent surge of interest in publicly funded comparative effectiveness research (CER) in the US. As health technology assessment (HTA) shares some of the same goals as CER, and publicly funded HTA has been a feature within other industrialized countries for many years, a review of HTA activities in some of these countries can be a helpful source of information for the US debate. Informed by a literature review, and in two cases augmented by informant interviews, we reviewed the organization of HTA activities in five jurisdictions: Canada, Sweden, Scotland, the Netherlands and Australia. We provide a summary description of the healthcare system in each country as well as a description of the key features of their HTA bodies, with a particular focus on the processes of HTA for listing medications on public formularies. Four of the committees evaluating medications for formulary inclusion are funded by, but remain at arm's length from, the government (Canada, Australia, Sweden and Scotland), while the process is fully embedded within the government in the Netherlands. Each of these jurisdictions has a stated preference for comparative outcomes evidence from randomized controlled trials, but will, under certain circumstances, accept randomized evidence using surrogate markers, other comparators that are not directly relevant or non-randomized evidence. Health technology evaluation committees largely comprise health professionals, with public representatives included in the Canadian, Australian and Scottish committees. Scotland is the only one of the five jurisdictions reviewed to have industry representation on the evaluation committee. We identified seven characteristics that are shared across the jurisdictions reviewed and that potentially serve as insights for development of CER in the US: (i) the process must be responsive to stakeholders' interests, in that the turn-around time for assessments must be minimized, transparency must be maximized, the process must be considered fair using universally agreed standards and the process must be modifiable based on stakeholders' requirements; (ii) the assessment of medical technologies other than drugs may present different challenges and is managed separately in other HTA organizations; (iii) because of the link between HTA and reimbursement decisions, completion of the HTA process following regulatory approval can delay market access to new technologies, thus closer integration between regulatory approval and HTA processes is being explored internationally; (iv) there is a direct or indirect link to reimbursement in the jurisdictions explored - without this link the role of CER in the US will remain advisory; (v) each jurisdiction reviewed benefits from a single payer that is informed by the process - given the diverse multipayer environment in the US, CER in the US may usefully focus on generating comparative effectiveness evidence; (vi) a common metric for assessing intended and unintended effects of treatment allows comparison across different technologies; and (vii) one stated focus of CER is on therapeutic benefit among 'high-priority populations', including specific demographic groups (the elderly and children, racial and ethnic minorities) and individuals with disabilities, multiple chronic conditions and specific genomic factors. This will be difficult to achieve because epidemiological evidence of differences in therapeutic benefit among subgroups is detected through effect modification, or more specifically, statistical evidence of effect measure modification, typically on relative measures of effect. Few randomized trials have enough power to detect effect modification and these have been uncommon in the scientific literature. As consideration is given to the development of a publicly funded CER body in the US, much can be learned from the international experience. Nevertheless, there are some distinctive features of the US healthcare system that must be taken into account when assessing the transferability of these insights. [ABSTRACT FROM AUTHOR]

Background: Published decision analyses show that screening for colorectal cancer is cost-effective. However, because of the number of tests available, the optimal screening strategy in Canada is unknown. We estimated the incremental cost-effectiveness of 10 strategies for colorectal cancer screening, as well as no screening, incorporating quality of life, noncompliance and data on the costs and benefits of chemotherapy.Methods: We used a probabilistic Markov model to estimate the costs and quality-adjusted life expectancy of 50-year-old average-risk Canadians without screening and with screening by each test. We populated the model with data from the published literature. We calculated costs from the perspective of a third-party payer, with inflation to 2007 Canadian dollars.Results: Of the 10 strategies considered, we focused on three tests currently being used for population screening in some Canadian provinces: low-sensitivity guaiac fecal occult blood test, performed annually; fecal immunochemical test, performed annually; and colonoscopy, performed every 10 years. These strategies reduced the incidence of colorectal cancer by 44%, 65% and 81%, and mortality by 55%, 74% and 83%, respectively, compared with no screening. These strategies generated incremental cost-effectiveness ratios of $9159, $611 and $6133 per quality-adjusted life year, respectively. The findings were robust to probabilistic sensitivity analysis. Colonoscopy every 10 years yielded the greatest net health benefit.Interpretation: Screening for colorectal cancer is cost-effective over conventional levels of willingness to pay. Annual high-sensitivity fecal occult blood testing, such as a fecal immunochemical test, or colonoscopy every 10 years offer the best value for the money in Canada. [ABSTRACT FROM AUTHOR]

In the era of highly active antiretroviral therapy (HAART), hospitalization as a measure of morbidity has become of increasing interest. The objectives of this study were to determine clinical predictors of hospitalization among HIV-infected persons initiating HAART and to explore the impact of gender and drug use on hospitalization. The analysis was based on a cohort of HIV-positive individuals initiating HAART between 1996 and 2001. Information on hospitalizations was obtained through data linkage with the BC Ministry of Health. Cox-proportional hazard models were used to assess variables associated with time to hospitalization. A total of 1,605 people were eligible and 672 (42%) were hospitalized for one or more days. The final multivariate model indicated that there was an increased risk of hospitalization among those with high baseline HIV RNA (HR for > 100,000 copies/mL: 1.26; 95%CI: 1.16-1.59) or low CD4 cell counts (HR [95% CI] compared to >/= 200 cells/mm3: 1.62 [1.28-2.06] and 1.29 [1.07-1.56] for < 50 and 50-199 cells/mm(3), respectively). Other factors, including adherence, previous hospitalization, gender and injection drug use remained predictive of hospitalization. These findings highlight the importance of closely monitoring patients starting therapy with low CD4 cell counts in order to mediate or prevent outcomes requiring hospitalization. [ABSTRACT FROM AUTHOR]

After a patient presents with symptoms of illness and undergoes treatment, there are three features of care that require assessment: the impact of delivering care on the patient, the benefits and harms of treatment, and the functioning of the health care system. This formulation leads to three types of outcomes of care delivery that require assessment: 1) patient outcomes, which reflect the impact on patients of undergoing care; 2) treatment outcomes, which reflect the intended and unintended medical consequences of undergoing therapy; and 3) system outcomes, which reflect the impact on the system of delivering health care to a group of patients. In this paper, examples of these three types of outcomes are presented, with particular reference to coronary artery bypass graft surgery. It is argued that the current focus of computer simulation models on system outcomes should be expanded to include patient and treatment outcomes. [ABSTRACT FROM AUTHOR]

Purpose: The objective was to determine whether the year and medical school of graduation, the medical specialty and the sex of the treating physician was associated with prescribing beta-blockers after hospital discharge among survivors of myocardial infarction (MI), after adjusting for patient characteristics.Methods: We carried out a dynamic retrospective cohort study using data from a longitudinal database that contained information on Quebec residents over the age of 65 years sent home from hospital after MI between 1990 and 1993. The outcome was a beta-blocker being dispensed after hospital discharge. Logistic regression was used to estimate the association between training characteristics and beta-blocker dispensation and clustering of patients within physicians was accounted for using Generalized Estimating Equations.Results: The cohort consisted of 14,334 MI survivors who were treated by 3209 physicians, yielding a mean of about 4.5 patients per physician [standard deviation (SD) = 8.2]. Beta-blockers were prescribed to approximately one-third of subjects. After adjusting for patients' demographic characteristics, comorbid medical conditions, and markers of MI severity, physicians who were more likely to prescribe a beta-blocker included cardiologists and the most recent graduates (graduating after 1989). Systematic differences were also observed between graduates of different medical schools.Conclusions: After adjusting for differences between patients', the sex of the physician was largely unrelated to prescribing beta-blockers for secondary prevention of MI. However, prescribing differed by training characteristics such as medical specialty and year and medical school of graduation. [ABSTRACT FROM AUTHOR]

Background: Currently there are no direct estimates of mortality reduction afforded by coronary-artery bypass grafting (CABG) that take into account the deaths among patients for whom coronary revascularization was indicated but who did not undergo the treatment. The objective of this analysis was to compare survival after the treatment decision between patients who underwent CABG and those who remained untreated.Methods: We used a population-based registry to identify patients with established coronary artery disease who were to undergo first-time isolated CABG. We measured the effect of surgical revascularization on survival after the treatment decision in two cohorts of patients categorized by symptoms, coronary anatomy, and left ventricular function.Results: One in 10 patients died during the five years after treatment decision. The hazard of death among patients who underwent CABG was 51 percent of that for the untreated group, the adjusted hazard ratio was 0.51 (95 percent confidence interval, 0.43 to 0.61). The effect was stronger when CABG was performed within the recommended time: adjusted hazard ratios were 0.43 (95 percent confidence interval, 0.35 to 0.53) and 0.58 (95 percent confidence interval, 0.48 to 0.70) for early and late intervention, respectively; chi-square for the difference between hazard ratios was 12.2 (P < 0.001).Conclusion: Estimates that account for patients who died before they could undergo a required CABG indicate a significant survival benefit of performing early surgical revascularization even for patients registered to undergo the operation on the non-urgent basis. [ABSTRACT FROM AUTHOR]

Background: Many health care systems now use priority wait lists for scheduling elective coronary artery bypass grafting (CABG) surgery, but there have not yet been any direct estimates of reductions in in-hospital mortality rate afforded by ensuring that the operation is performed within recommended time periods. Methods: We used a population-based registry to identify patients with established coronary artery disease who underwent isolated CABG in British Columbia, Canada. We studied whether postoperative survival during hospital admission for CABG differed significantly among patients who waited for surgery longer than the recommended time, 6 weeks for patients needing semi-urgent surgery and 12 weeks for those needing non-urgent surgery. Results: Among 7316 patients who underwent CABG, 97 died during the same hospital admission, for a province-wide death rate at discharge of 1.3%. The observed proportion of patients who died during the same admission was 1.0% (27 deaths among 2675 patients) for patients treated within the recommended time and 1.5% (70 among 4641) for whom CABG was delayed. After adjustment for age, sex, anatomy, comorbidity, calendar period, hospital, and mode of admission, patients with early CABG were only 2/3 as likely as those for whom CABG was delayed to experience in-hospital death (odds ratio 0.61; 95% confidence interval [CI] 0.39 to 0.96). There was a linear trend of 5% increase in the odds of in-hospital death for every additional month of delay before surgery, adjusted OR = 1.05 (95% CI 1.00 to 1.11). Conclusion: We found a significant survival benefit from performing surgical revascularization within the time deemed acceptable to consultant surgeons for patients requiring the treatment on a semi-urgent or non-urgent basis. [ABSTRACT FROM AUTHOR]

Background and Aim: Cancer related fatigue significantly impairs the ability to undertake sustained physical activity across the domains of daily living, work and recreation. The purpose of this study is to monitor cancer related fatigue and the factors affected or caused by it for 12 months in head and neck cancer patients following their diagnosis. Their perceptions of how fatigue might affect their activity levels in addition to identifying avenues to improve engagement with physical activity will be also explored., Methods: A single centre longitudinal mixed-methods study will be conducted. Forty head and neck cancer patients will be recruited over 6 months following the confirmation of their treatment plan, after which fatigue and physical activity will be assessed at four time points over 12 months. Additionally, other factors which influence fatigue such as body composition, blood counts, systemic inflammation levels, haemoglobin concentration, thyroid function, sleep quality, cardiorespiratory fitness and upper and lower extremity strength will be measured to understand how the multifactorial problem of fatigue may evolve over time and influence physical activity levels. Semi-structured interviews will be conducted after treatment completion and at end of twelve months which will analyse the participants fatigue experiences, understand how their perceived fatigue may have impacted physical activity and report the factors which may improve engagement with physical activity during cancer. Quantitative data will be analysed and reported using standard descriptive statistics and post-hoc pairwise comparisons. The changes in outcome measures across time will be analysed using the MIXED procedure in SPSS software. Statistical significance will be accepted at p<0.05. Qualitative data will be analysed using the Interpretative Phenomenological Approach using the NVivo software., Discussion: The results from this study may help inform the planning and delivery of appropriately timed interventions for the management of cancer related fatigue., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Narasimhan et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Ranitidine was the most prescribed histamine-2 receptor antagonist (H 2 RA) in Canada when recalled in 2019 because of potential carcinogenicity. We sought to compare geographic and temporal patterns in use of prescription ranitidine and 3 other HRAs and estimated population exposure to ranitidine in 6 provinces between 1996 and 2019., Methods: This population-based serial cross-sectional study used prescription claims for H 2 RAs dispensed from community pharmacies in Nova Scotia, Ontario, Manitoba, Saskatchewan, Alberta and British Columbia. We estimated the period prevalence of ranitidine use per 100 population by province, age category and sex. We estimated exposure to ranitidine between 2015 and 2019 using defined daily doses (DDDs)., Results: Overall, 2.4 million ranitidine prescriptions were dispensed to patients aged 65 years and older, and 1.7 million were dispensed to younger adults. Among older adults, the median period prevalence of ranitidine use among females was 16% (interquartile range [IQR] 13%-27%) higher than among males. Among younger adults, the median prevalence was 50% (IQR 37%-70%) higher among females. Among older adults, between 1996 and 1999, use was highest in Nova Scotia (33%) and Ontario (30%), lower in the prairies (Manitoba [18%], Saskatchewan [26%], Alberta [17%]) and lowest in BC (11%). By 2015-2019, use of ranitidine among older adults dropped by at least 50% in all provinces except BC. We estimate that at least 142 million DDDs of prescribed ranitidine were consumed annually in 6 provinces (2015-2019)., Interpretation: Over the 24-year period in 6 provinces, patients aged 65 years and older were dispensed 2.4 million prescriptions of ranitidine and younger adults were dispensed 1.7 million prescriptions of ranitidine. These estimates of ranitidine exposure can be used for planning studies of cancer risk and identifying target populations for cancer surveillance., Competing Interests: Competing interests: Laura Targownik has served on advisory boards or created educational materials for Janssen AbbVie Canada, Takeda Canada, Merck Canada, Pfizer Canada, Janssen Canada, Roche Canada, Sandoz Canada, JAMP Pharmaceuticals and Celltrion Pharmaceuticals. No other competing interests were declared., (© 2023 CMA Impact Inc. or its licensors.)

Background and Aim: Attempts at personalisation of exercise programmes in head and neck cancer (HaNC) have been limited. The main aim of the present study is to investigate the feasibility and acceptability of introducing a remotely delivered, fully personalised, collaborative, and flexible approach to prescribing and delivering exercise programmes into the HaNC usual care pathway., Methods: This is a single arm, feasibility study. Seventy patients diagnosed with HaNC will be recruited from two regional HaNC centres in the United Kingdom. Patients will undertake an 8-week exercise programme designed and delivered by cancer exercise specialists. The exercise programme will start any time between the time of diagnosis and up to 8 weeks after completing treatment, depending on patient preference. The content of the exercise programme will be primarily based on patient needs, preferences, and goals, but guided by current physical activity guidelines for people with cancer. The primary outcome measure is retention to the study. Secondary quantitative outcomes are uptake to the exercise programme, different measures of exercise adherence, pre- and post-intervention assessments of fatigue (Multidimensional Fatigue Symptom Inventory-Short Form), quality of life (SF-36), physical activity levels (International Physical Activity Questionnaire-Short Form), and various components of physical fitness. The outcomes of the nested qualitative study are acceptability and feasibility of the intervention evaluated via interviews with patients, health care professionals, and the cancer exercise specialists. Intervention and participant fidelity will be determined using checklists and scrutiny of each patient's logbook and the cancer exercise specialists' meeting notes. Analysis of quantitative data will be via standard summary statistics. Qualitative data will be analysed using thematic analysis., Expected Results: This feasibility study will inform the design and conduct of a future randomised controlled trial. Success will be defined according to a traffic light system for identifying the appropriateness of progression to a randomised controlled trial., Trial Registration: International Standard Randomised Controlled Trial Number registry (ISRCTN82505455)., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Midgley et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Purpose: Assess safety and feasibility of the cardiopulmonary exercise test (CPET) for evaluating head and neck cancer (HaNC) survivors. Also compare their cardiorespiratory fitness to age and sex-matched norms and establish current physical activity levels., Methods: Fifty HaNC survivors [29 male; mean (SD) age, 62 (8) years], who had completed treatment up to 1 year previously, were recruited. Participants performed a CPET on a cycle ergometer to symptom-limited tolerance. Participants completed a questionnaire to report contributory factors they perceived as influencing test termination. Physical activity levels were determined using a self-reported physical activity questionnaire., Results: Three participants did not complete the CPET because (1) poor fitting mouthpiece and naso-oral mask due to facial disfiguration from surgery; (2) knee pain elicited by cycling; and (3) early CPET termination due to electrocardiogram artefacts. Participants reached a mean peak oxygen uptake that was 34% lower than predicted and the mean (SD) CPET duration of 7:52 (2:29) min:s was significantly lower than the target test duration of 10 min (p < 0.001). Leg muscle aches and/or breathing discomfort were major contributory factors influencing test termination for 78% of participants, compared to 13% for dry mouth/throat and/or drainage in the mouth/throat. No major adverse events occurred. Participants were categorised as 26% active, 8% moderately active, and 66% insufficiently active., Conclusion: These preliminary data suggest the CPET appears safe and feasible for most HaNC survivors when strict exclusion criteria are applied; however, low levels of cardiorespiratory fitness should be considered when calculating an appropriate ramp rate., (© 2022 The Authors. Clinical Physiology and Functional Imaging published by John Wiley & Sons Ltd on behalf of Scandinavian Society of Clinical Physiology and Nuclear Medicine.)

Dieulafoy's lesions are uncommon causes of upper gastrointestinal bleeding (UGIB) that pose a life-threatening risk if not diagnosed promptly and treated appropriately. These lesions are composed of enlarged submucosal blood vessels that bleed despite any gross abnormality. Early intervention with esophagogastroduodenoscopy (EGD) is necessary to avoid more invasive treatment with angiogram embolization or surgical removal. This paper aims to discuss a case regarding a patient with difficult-to-control recurrent bleeding from a Dieulafoy's lesion located in the gastric fundus of a previously healthy 60-year-old female. This case highlights the need for dual therapy and special considerations regarding antiplatelet medications and supplements when treating patients with Dieulafoy's lesions., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2022, Levy et al.)

Summary Statement: Pediatric disaster triage (PDT) is challenging for healthcare personnel. Mistriage can lead to poor resource utilization. In contrast to live simulation, screen-based simulation is more reproducible and less costly. We hypothesized that the screen-based simulation "60 Seconds to Survival" (60S) to learning PDT will be associated with improved triage accuracy for pediatric emergency nursing personnel.During this prospective observational study, 138 nurse participants at 2 tertiary care emergency departments were required to play 60S at least 5 times over 13 weeks. Efficacy was assessed by measuring the learners' triage accuracy, mistriage, and simulated patient outcomes using JumpStart.Triage accuracy improved from a median of 61.1 [interquartile range (IQR) = 48.5-72.0] to 91.7 (IQR = 60.4-95.8, P < 0.0001), whereas mistriage decreased from 38.9 (IQR = 28.0-51.5) to 8.3 (IQR = 4.2-39.6, P < 0.0001), demonstrating a significant improvement in accuracy and decrease in mistriage. Screen-based simulation 60S is an effective modality for learning PDT by pediatric emergency nurses., Competing Interests: The authors declare no conflict of interest., (Copyright © 2021 Society for Simulation in Healthcare.)

This study explores healthcare professionals' experiences of using behavior change interventions in clinical practice. Semi-structured qualitative interviews were conducted with 11 healthcare professionals working in a cardiac and pulmonary rehabilitation National Health Service Trust in the United Kingdom. Interviews were transcribed and analyzed using inductive thematic analysis. Four overarching themes representing healthcare practitioners' perceptions of using behavior change interventions were identified: (1) reliance on experiential learning, (2) knowledge transition, (3) existing professional development programs, and (4) barriers and facilitators for continued professional development. The results are discussed in relation to the implications they may have for behavior change training in clinical healthcare practice. Healthcare professionals require bespoke and formalized training to optimize their delivery of behavior change interventions in cardiac and pulmonary rehabilitation. Doing so will enhance intervention fidelity and implementation that can potentially ameliorate patient rehabilitation outcomes.

Aims: This study compared the aggregate duration of treatment administration of approved eculizumab and ravulizumab treatment regimens and resultant productivity implications for patients with atypical hemolytic uremic syndrome (aHUS) and their caregivers., Methods: The aggregate duration of treatment administration (which includes waiting time for medication preparation and time for infusion, recovery, and travel to and from the clinic) was determined for a hypothetical population of patients with aHUS treated with eculizumab (10 mg/mL) or ravulizumab (10 or 100 mg/mL), in the clinic or at home, for 1 year, in Germany, Italy, the UK, and the US. The data for US patients treated in the clinic was used to extend a previously published cost-minimization model (CMM) to estimate the annual lost productivity associated with treatment administration and to compare the overall annual treatment costs for hypothetical adult and pediatric patients in the US., Results: The aggregate duration of treatment administration associated with ravulizumab 10 mg/mL and 100 mg/mL was reduced by 44-52% and 69-74%, respectively, compared with eculizumab 10 mg/mL, across all four countries. Using the CMM, the adult and pediatric US patient lost productivity costs due to treatment were reduced by 56-60% and 73-76% with ravulizumab 10 mg/mL and 100 mg/mL, respectively, compared with eculizumab 10 mg/mL, and overall discounted annual treatment costs (direct and lost productivity costs owing to treatment) were reduced for ravulizumab (10 mg/mL and 100 mg/mL) vs eculizumab 10 mg/mL for adult and pediatric patients., Limitations: This study was based on hypothetical patients, and assumptions were made regarding caregiver involvement, patient characteristics, and treatment patterns., Conclusions: Compared with eculizumab, ravulizumab reduces the lost productivity costs associated with treatment. This reduction in costs is greater with the ravulizumab 100 mg/mL formulation, compared with ravulizumab 10 mg/mL, owing to shorter infusion times with this more concentrated formulation.

Introduction: In Canada, most provinces have established administrative health data repositories to facilitate access to these data for research. Anecdotally, researchers have described delays and substantial inter-provincial variations in the timeliness of data access approvals and receipt of data. Currently, the reasons for these delays and variations in timeliness are not well understood. This paper provides a study protocol for (1) identifying the factors affecting access to administrative health data for research within select Canadian provinces, and (2) comparing factors across provinces to assess whether and how they contribute to inter-provincial variations in access to administrative health data for research., Methods: A qualitative, multiple-case study research design will be used. Three cases will be included, representing three different provinces. For each case, data will be collected from documents and interviews. Specifically, interviews will be carried out with (1) research stakeholders, and (2) regulatory stakeholders (10 individuals/group * 2 groups/province * 3 provinces = 60). During within-case analysis, interview data for each stakeholder group will be analyzed separately using constant comparative analysis. Document analysis will occur iteratively, and will inform interview guide adaptation, and supplement interview data. Cross-case analysis will involve systematic comparison of findings across cases., Discussion: This study represents the first in-depth examination of access to administrative health data in Canada. The main outcome will be an overarching mid-range theory explaining inter-provincial variations in access to administrative health data in Canada. This theory will be strengthened by the inclusion of the perspectives of both researchers and those involved in the regulation of data access. The findings from this study may be used to improve equitable and timely access to administrative health data across provinces, and may be transferable to other jurisdictions where barriers to access to administrative health data have been reported., Competing Interests: Statement on conflicts of interest: The authors have no financial conflicts of interest to disclose. CK, AL, GP, and RU are users of administrative health data for research purposes. CK is a current member of the Data Access Committee at Health Data Nova Scotia. AL is the former Director of Health Data Nova Scotia and financially supports its operation using peer-reviewed funding.

Background: Although the frequency of heart failure makes it among the costliest of illnesses, there are scant Canadian data on annual costs of treatment or the costs as the condition advances. Our objective was to estimate mean prevalence- and incidence-based direct medical costs among older adults discharged alive after a first hospital admission for heart failure., Methods: We conducted a retrospective cohort study using population-based administrative health databases for Nova Scotia. The cohort comprised persons 50 years of age or older with an incident hospital admission for heart failure between 2009 and 2012. We considered the costs (expressed as 2020 Canadian dollars) of hospital admissions, physician visits and, for patients 65 years of age or older, outpatient cardiac medications. We estimated costs for calendar years, longitudinally and in the last 2 years of life. We analyzed costs from the perspective of a third-party public payer., Results: The cohort consisted of 3327 patients (mean age 77.6 yr; 1605 [48.2%] women). Median survival was 2.5 and 2.2 years among men and women, respectively. Annual prevalence-based costs were about $7100. Mean incidence-based costs ranged between $65 000 and $164 000 in the year after diagnosis and decreased by 90% subsequently. Costs were 4 to 7 times higher in the year before death than in the period from 1 to 2 years before death., Interpretation: The direct medical costs of treating patients with heart failure in Nova Scotia displayed a reverse J shape, with costs highest after diagnosis, declining subsequently and then increasing during the final year of life. Strategies designed to improve the quality of care immediately after diagnosis and during more advanced stages of disease might reduce these costs., Competing Interests: Competing interests: Adrian Levy has served as a paid consultant to Broadstreet Health Economics & Outcomes Research and Novartis Pharmaceuticals Canada Inc. Karissa Johnston and Basia Rogula have served as paid consultants to Novartis Pharmaceuticals Canada Inc. Alexia Daoust and Jonathan Fortier are employees and shareholders of Novartis Pharmaceuticals Canada Inc. Paul Oh has participated on advisory boards funded by Amgen, Astra Zeneca and Novartis. No other competing interests were declared., (© 2021 CMA Joule Inc. or its licensors.)