Re-examining the factor structure of the Insomnia Severity Index (ISI) and defining the meaningful within-individual change (MWIC) for subjects with insomnia disorder in two phase III clinical trials of the efficacy of lemborexant.

Background: The Insomnia Severity Index (ISI) is a widely used measure of insomnia severity. Various ISI research findings suggest different factor solutions and meaningful within-individual change (MWIC) to detect treatment response in patients with insomnia. This study examined an ISI factor solution and psychometric indices to define MWIC in a robust patient sample from clinical trial settings.

Disease landscape of advanced HER2-breast cancer patients by treatment line in three EU countries and USA.

To report treatment patterns and quality of life (QoL) in HER2-negative advanced breast cancer patients. Data were drawn from a cross-sectional survey in Europe and USA. Hormone plus targeted therapy was the most frequent first-line (1L, 62%) and second-line (2L, 45%) treatment for HR+/HER2-patients.

Development of a community pharmacy-based intervention for patients with uncontrolled asthma.

Background: Achieving asthma control is often difficult, despite the availability of effective medications. Because of their expertise, regular contact with patients, and accessibility, community pharmacists can play an important role in helping patients manage uncontrolled asthma.

Objective: To develop a community pharmacy-based intervention for improving asthma control in patients with uncontrolled moderate to severe asthma.

Cyclin-dependent kinase 4/6 inhibitor treatment use in women treated for advanced breast cancer: Integrating ASCO/NCODA patient-centered standards in a community pharmacy.

Background: Outpatients treated with oral anti-cancer drugs, including selective cyclin-dependent kinase 4/6 inhibitors (CDK4/6i), may benefit from a pharmacy practice setting adapted to support proper oral anti-cancer drug monitoring. This real-world study aimed to characterize patient-centered pharmacy practice aligned with American Society of Clinical Oncology (ASCO)/National Community Oncology Dispensing Association (NCODA) standards and to describe its impact on CDK4/6i treatment use.

Methods: This retrospective study included women with confirmed hormone receptor-positive/human epidermal growth factor 2 negative locally advanced or metastatic breast cancer treated with either palbociclib, abemaciclib or ribociclib combined with letrozole or fulvestrant.

Understanding the unmet needs in insomnia treatment: a systematic literature review of real-world evidence.

Study Objective: The objective of this study was to define and characterize the unmet needs in the pharmacological management of insomnia.

Methods: A systematic literature review was conducted to identify relevant literature reporting real-world evidence in insomnia, published from January 2009 to April 2020. Pharmacological treatments - both prescription (benzodiazepines, 'Z-drugs' and suvorexant) and off-label (antidepressants, antipsychotics, and antihistamines) - were considered.

A Pre-Phase III Efficacy Trial of the Spermicide/Contraceptive Effect of the Invisible Condom, a Non-Hormonal Vaginal Gel, in Women from Canada.

Objectives: To evaluate the spermicidal efficacy of non-hormonal vaginal gel in vitro and in a post-coital test, and to evaluate its contraceptive efficacy in Canadian women of childbearing age.

Methods: We conducted single-centre trial to assess spermicidal and contraceptive efficacy of vaginal gel. Participants were healthy, sexually active women aged 18-49 years and their regular male sexual partners (30 couples).

Network meta-analysis of eribulin versus other chemotherapies used as second- or later-line treatment in locally advanced or metastatic breast cancer.

Background: Eribulin mesylate (ERI; Halaven®) is a microtubule inhibitor approved in the United States for metastatic breast cancer patients with at least two prior chemotherapy regimens for metastatic breast cancer, and in the European Union in locally advanced breast cancer or metastatic breast cancer patients who progressed after at least one chemotherapy for advanced disease. This network meta-analysis compared the efficacy and safety of ERI versus other chemotherapies in this setting.

Methods: Systematic searches conducted in MEDLINE, Embase, and the Cochrane Central Register of Clinical Trials identified randomized controlled trials of locally advanced breast cancer/metastatic breast cancer chemotherapies in second- or later-line settings.

Health-related quality of life in pediatric patients with partial onset seizures or primary generalized tonic-clonic seizures receiving adjunctive perampanel.

Rationale: Study 311 (E2007-G000-311; NCT02849626) was a Phase 3, multicenter, open-label single-arm study of adjunctive perampanel oral suspension in pediatric patients (aged 4 to <12 years) with partial-onset seizures (POS) (with/without secondarily generalized tonic-clonic seizures [SGTCS]) or primary generalized tonic-clonic seizures (PGTCS). Health-related quality of life (HRQoL) was an exploratory endpoint initially analyzed through simple descriptive summaries. The aim of this post hoc analysis was to provide a more thorough assessment of HRQoL.

Systematic review of Real-World effectiveness of eribulin for locally advanced or metastatic breast cancer.

Background: Eribulin mesylate (eribulin) is indicated for patients with metastatic breast cancer (MBC) who have previously received at least two chemotherapies in the US and for patients with locally advanced breast cancer (LABC) or MBC who have progressed after at least one chemotherapy in the European Union (EU). In both indications, prior therapy should include an anthracycline and a taxane in adjuvant or metastatic setting. Numerous studies evaluated eribulin in real-world (RW) breast cancer populations to reinforce its consistent effectiveness beyond registration randomized controlled trials (RCTs) that reported median overall survival (OS) of 13.

The initial state of the human gut microbiome determines its reshaping by antibiotics.

Microbiome studies have demonstrated the high inter-individual diversity of the gut microbiota. However, how the initial composition of the microbiome affects the impact of antibiotics on microbial communities is relatively unexplored. To specifically address this question, we administered a second-generation cephalosporin, cefprozil, to healthy volunteers.

Evolution of health technology assessment: best practices of the pan-Canadian Oncology Drug Review.

Background: In 2007, Canada chose to develop a separate and distinct path for oncology drug health technology assessment (HTA). In 2013, the decision was made to transfer the pan-Canadian Oncology Drug Review (pCODR) to the Canadian Agency for Drugs and Technologies in Health (CADTH), to align the pCODR and CADTH Common Drug Review processes while building on the best practices of both. The objective of this research was to conduct an examination of the best practices established by the pCODR.

Oncology drug health technology assessment recommendations: Canadian versus UK experiences.

Background: CANADA HAS TWO HEALTH TECHNOLOGY ASSESSMENT (HTA) AGENCIES RESPONSIBLE FOR ONCOLOGY DRUG FUNDING RECOMMENDATIONS: the Institut National d'Excellence en Santé et Services Sociaux (INESSS) for the province of Québec and the pan-Canadian Oncology Drug Review for the rest of Canada. The objective of the research was to review and compare the recommendations of these two agencies alongside an international comparator - the National Institute for Health and Care Excellence (NICE) in the United Kingdom - with respect to their recommendations records and the influence of clinical and cost-effectiveness evidence on the recommendations.

Methods: Recommendations were identified from the three agencies from January 1, 2002 to June 1, 2013.

How do cost-effectiveness analyses inform reimbursement decisions for oncology medicines in Canada? The example of sunitinib for first-line treatment of metastatic renal cell carcinoma.

Background: Canadian oncology decision-makers have reimbursed cancer drugs at incremental cost-effectiveness ratios (ICER) higher than those considered acceptable in other therapeutic areas. Sunitinib is a multitargeted receptor tyrosine kinase inhibitor, indicated for metastatic renal-cell carcinoma (MRCC) of clear cell histology. Canadian decision-makers evaluated sunitinib funding in the presence of important data limitations (including interim analysis of a surrogate outcome) and in the context of a high ICER.

The challenge of conducting pharmacoeconomic evaluations in oncology using crossover trials: the example of sunitinib for gastrointestinal stromal tumour.

This paper examines the challenge of conducting economic evaluations to support patient access to cancer therapies when the cost-effectiveness estimation is hampered by crossover trial design. To demonstrate these limitations, we present the submission to the Canadian Drug Review (CDR) of a cost-effectiveness evaluation of sunitinib versus best supportive care (BSC) for the treatment of gastrointestinal stromal tumour in patients intolerant or resistant to imatinib. The economic model generated an incremental cost-effectiveness ratio for sunitinib versus BSC of dollars 79,884/quality-adjusted life-year gained.

Effect of drug utilization reviews on the quality of in-hospital prescribing: a quasi-experimental study.

Background: Drug utilization review (DUR) programs are being conducted in Canadian hospitals with the aim of improving the appropriateness of prescriptions. However, there is little evidence of their effectiveness. The objective of this study was to assess the impact of both a retrospective and a concurrent DUR programs on the quality of in-hospital prescribing.

Retrospective analysis of utilization patterns and cost implications of coxibs among seniors in Quebec, Canada: what is the potential impact of the withdrawal of rofecoxib?

Objective: In September 2004, the manufacturer of rofecoxib announced a voluntary worldwide withdrawal of the drug. The impact of this withdrawal on drug budgets is unclear. This study evaluated average daily doses and costs of rofecoxib and celecoxib and concomitant use of gastroprotective agents (GPAs) in elderly patients with osteoarthritis (OA) or rheumatoid arthritis (RA) in Quebec, prior to the rofecoxib withdrawal.

Treatment persistence with leukotriene receptor antagonists and inhaled corticosteroids.

Background: Leukotriene receptor antagonists (LTRAs) and inhaled corticosteroids (ICSs) must be taken continuously to control persistent asthma. We compared the use of LTRAs and ICSs in patients with similar level of asthma control at treatment initiation with particular attention to treatment persistence.

Methods: Two cohorts of 15 to 45 year old patients with asthma were selected from the Quebec Health Insurance Plan Database between January 1, 1998, and December 31, 2000.

Quality of life in hypertension: the SF-12 compared to the SF-36.

Background: The SF-36 has frequently been used to measure health related quality of life (HRQOL) in hypertension. Recently, the SF-12, a shorter form of the SF-36, has been proposed. However, the validity of the SF-12 in hypertension has not yet been assessed.

Losartan reduces the costs associated with nephropathy and end-stage renal disease from type 2 diabetes: Economic evaluation of the RENAAL study from a Canadian perspective.

Background: The Reduction of Endpoints in NIDDM [non-insulin-dependent diabetes mellitus] with the Angiotensin II Antagonist Losartan (RENAAL) study demonstrated the renoprotective effects of losartan in patients with nephropathy from type 2 diabetes.

Objective: To perform an economic evaluation of the costs associated with end-stage renal disease (ESRD) from a Canadian public health perspective, based on the clinical outcomes reported in the RENAAL study.

Methods: ESRD-related costs were determined by estimating the mean number of days with ESRD multiplied by the daily cost of ESRD (140 dollars); mean days with ESRD were calculated by subtracting the area under the Kaplan-Meier survival curve for time to the first event of ESRD or all-cause mortality from the area under the curve for all-cause mortality.

The societal value of universal childhood vaccination.

Availability of new vaccines preventing infectious diseases in healthy children populations is increasing worldwide. In Canada, despite the current recommendation of the National Advisory Committee on Immunization to include recent vaccines in routine schedule, only a few provinces have incorporated some of the newer vaccines in routine vaccination programs. A review was undertaken of economic evaluations of childhood vaccination strategies performed from the societal point of view in industrialized countries, to gain perspective on their global benefits.

Pharmacist intervention program for control of hypertension.

Background: Pharmaceutical care programs have been shown to improve outcomes in hypertension. However, most programs required direct access to patient medical chart and patient consultation sessions by appointment.

Objective: To follow the current practice of community pharmacy, exploring the effect of an intervention program on blood pressure (BP) and factors affecting BP.

A pharmacy-based health promotion programme in hypertension: cost-benefit analysis.

Objective: To weigh the costs and benefits of a pharmacy-based health promotion programme implemented in four pharmacies of the Quebec City area, Canada. This programme was developed to improve blood pressure control through activities aimed at improving the quality of prescribing and the adherence to treatment.

Design: Nine pharmacies in Quebec City were included, of which four pharmacies were assigned to the implementation of the health promotion programme.