Cost-Effectiveness of Canagliflozin Added to Standard of Care for Treating Diabetic Kidney Disease (DKD) in Patients with Type 2 Diabetes Mellitus (T2DM) in England: Estimates Using the CREDEM-DKD Model.

Introduction: On the basis of reductions in diabetic kidney disease (DKD) progression and major adverse cardiovascular events observed in the landmark CREDENCE trial, canagliflozin 100 mg received an extension to its EU marketing authorisation in July 2020 to include the treatment of DKD in people with type 2 diabetes mellitus (T2DM) making it the first pharmacological therapy to receive regulatory authorisation for treatment of DKD since the RENAAL and IDNT trials in nearly 20 years. Efficient allocation of limited healthcare resources requires evaluation not only of clinical safety and efficacy but also economic consequences. The study aim was to estimate the cost-effectiveness of canagliflozin when added to current standard of care (SoC) versus SoC alone from the perspective of the NHS in England.

CANadian CAnagliflozin REgistry: Patient-Reported Outcomes of Canagliflozin in the Treatment of Type 2 Diabetes Mellitus in Canadian Clinical Practice.

Objectives: To describe patient-reported outcomes (PROs) after initiation of treatment with canagliflozin (CANA) for type 2 diabetes mellitus (T2DM) in a real-world Canadian setting.

Methods: CANadian CAnagliflozin REgistry (CanCARE) is a prospective, observational, single-arm, real-world Canadian study of the effectiveness and safety of CANA for the treatment of T2DM in 527 subjects. PRO measures were collected in CanCARE using the Current Health Satisfaction Questionnaire (CHES-Q) at baseline and after 3, 6 and 12 months of CANA treatment to examine patient satisfaction regarding weight and overall health.

A call to action to inform patient-centred approaches to obesity management: Development of a disease-illness model.

Patient-centred care is an essential component of high-quality health care, shown to improve clinical outcomes and patient satisfaction, and reduce costs. While there are several authoritative models of obesity pathophysiology and treatment algorithms, a truly patient-centred model is lacking. We describe the development of a patient-centric obesity model.

CANadian CAnagliflozin REgistry: Effectiveness and safety of canagliflozin in the treatment of type 2 diabetes mellitus in Canadian clinical practice.

Aim: There is limited information concerning the effects of canagliflozin (CANA), a sodium-glucose co-transporter 2 inhibitor (SGLT2i) in a real-world clinical setting in Canada. CanCARE is a 12-month, prospective, observational analysis to demonstrate the effectiveness and safety of CANA in usual clinical practice in Canada.

Materials And Methods: SGLT2i-naïve adult patients with type 2 diabetes mellitus (T2DM) (n = 527) on a stable antihyperglycemic agent (AHA) regimen with glycated hemoglobin (A1C) ≥ 7%, an estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.

Impact of Canagliflozin Treatment on Health-Related Quality of Life among People with Type 2 Diabetes Mellitus: A Pooled Analysis of Patient-Reported Outcomes from Randomized Controlled Trials.

Background: Evidence from patient-reported outcomes in clinical trials may explain health-related behaviors observed in the real world.

Objective: The purpose of this analysis was to evaluate the effect of treatment with canagliflozin, a sodium glucose co-transporter 2 inhibitor, compared with placebo or sitagliptin on health-related quality-of-life outcomes in participants with type 2 diabetes mellitus from the clinical development program.

Methods: Patient-reported outcomes data from four randomized controlled trials of canagliflozin (n = 2536) were pooled and analyzed to evaluate participants' interest in continuing study medication; satisfaction with weight; and physical, mental, and emotional health after 26-52 weeks of treatment with canagliflozin vs.

Improvement of fatigue, physical functioning, and well-being among patients with severe impairment at baseline receiving ibrutinib in combination with bendamustine and rituximab for relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma in the HELIOS study.

Health-related quality of life (HRQoL) is an important endpoint, especially in clinical trials for malignancies with a long course of disease, such as chronic lymphocytic leukemia (CLL). Patient-reported outcomes were examined in the randomized, double-blind, placebo-controlled HELIOS study to assess the impact of treatment with the Bruton's tyrosine kinase inhibitor ibrutinib, added to bendamustine plus rituximab (BR) background therapy. Measures included FACIT-Fatigue, EORTC QLQ-C30, QLQ-CLL16, and EQ-5D-5L.

An Indirect Comparison of Changes in the Impact of Weight on Quality of Life Among Subjects with Type 2 Diabetes Treated with Antihyperglycemic Agents in Dual Therapy with Metformin.

Introduction: It is important to capture the patient experience with a diabetes treatment in clinical trials; however, use of instruments to assess patient-reported outcomes (PROs) in diabetes trials is inconsistent and results may not be reported alongside primary efficacy data. In lieu of head-to-head data, indirect comparisons can be used to compare competing interventions. In this study, we used indirect comparison methods to assess differences in PRO score changes between canagliflozin and other antihyperglycemic agents as add-on to metformin.

Health-related quality of life data from a phase 3, international, randomized, open-label, multicenter study in patients with previously treated mantle cell lymphoma treated with ibrutinib versus temsirolimus.

Mantle cell lymphoma (MCL) is a rare, aggressive, incurable B-cell malignancy. Ibrutinib has been shown to be highly active for patients with relapsed/refractory (R/R) MCL. The RAY trial (MCL3001) was a phase 3, randomized, open-label, multicenter study that compared ibrutinib with temsirolimus in patients with R/R MCL.

The Effect of Canagliflozin, a Sodium Glucose Cotransporter 2 Inhibitor, on Glycemic End Points Assessed by Continuous Glucose Monitoring and Patient-Reported Outcomes Among People With Type 1 Diabetes.

Objective: To assess the effects of canagliflozin, a sodium glucose cotransporter 2 inhibitor, on glycemic parameters and measures of glucose variability assessed by a 9-point self-monitoring blood glucose (SMBG) and continuous glucose monitoring (CGM) profiles, and patient-reported outcomes as an add-on to insulin among participants with type 1 diabetes.

Research Design And Methods: In this randomized, double-blind study, 351 participants received canagliflozin 100 or 300 mg or placebo for 18 weeks. Change from baseline in daily mean glucose and SD was measured using a 9-point SMBG profile.

The Diabetes Intention, Attitude, and Behavior Questionnaire: evaluation of a brief questionnaire to measure physical activity, dietary control, maintenance of a healthy weight, and psychological antecedents.

Background: This study assessed measurement properties of the 17-item Diabetes Intention, Attitude, and Behavior Questionnaire (DIAB-Q), which measures intention to engage in self-care behaviors, including following a diabetes diet and engaging in appropriate physical activity.

Methods: The DIAB-Q includes questions based on the Theory of Planned Behavior. Items were developed using published literature, input from health care professionals, and qualitative research findings in patients with and without type 2 diabetes mellitus (T2DM).

Demystifying "patient-centered" care in type 2 diabetes: the role of systematic measurement.

Questionnaires are noninvasive, inexpensive measures that can identify key elements of the patient perspective that are important for the achievement of better outcomes in diabetes care.

Ibrutinib versus temsirolimus in patients with relapsed or refractory mantle-cell lymphoma: an international, randomised, open-label, phase 3 study.

Background: Mantle-cell lymphoma is an aggressive B-cell lymphoma with a poor prognosis. Both ibrutinib and temsirolimus have shown single-agent activity in patients with relapsed or refractory mantle-cell lymphoma. We undertook a phase 3 study to assess the efficacy and safety of ibrutinib versus temsirolimus in relapsed or refractory mantle-cell lymphoma.

The Importance of Weight Change Experiences for Performance of Diabetes Self-Care: A Patient-Centered Approach to Evaluating Clinical Outcomes in Type 2 Diabetes.

Introduction: The aim of this study was to examine the influence of weight change experiences over time on motivation to perform diabetes self-care behaviors using data from a study of canagliflozin (an agent that inhibits sodium glucose co-transporter 2) versus glimepiride in dual therapy with metformin and background diet/exercise.

Methods: Weight and motivation for performing healthy behaviors were collected at baseline and over time. The motivation questionnaire enabled categorization into two groups: those performing or not performing health behaviors.

Pragmatic measurement of health satisfaction in people with type 2 diabetes mellitus using the Current Health Satisfaction Questionnaire.

Background: The concept of diabetes-related health satisfaction encompasses issues specifically related to living with diabetes (eg, blood glucose, blood pressure levels, body weight). Health satisfaction is more specific than overall health-related quality of life because it considers disease-related factors, and is different from diabetes treatment satisfaction because it addresses issues not specifically related to treatment. Low levels of health satisfaction in people with type 2 diabetes mellitus (T2DM) may negatively affect self-care behaviors and treatment outcomes; however, there are currently no instruments available to assess health satisfaction in this population.

The impact of weight loss on weight-related quality of life and health satisfaction: results from a trial comparing canagliflozin with sitagliptin in triple therapy among people with type 2 diabetes.

Type 2 diabetes mellitus (T2DM) is primarily a self-managed disease in which self-care behaviors play an important role in achieving optimal outcomes. Because self-care does not result in immediate tangible or noticeable benefits, adherence to such a regimen can be confusing, difficult, and frustrating. People are more likely to adhere to treatment regimens that offer benefits from the patient perspective, such as convenience, avoidance of hypoglycemic episodes, and weight loss, compared with regimens that do not.

Rapid and sustained improvement in health-related quality of life and utility for 72 weeks in patients with ankylosing spondylitis receiving etanercept.

Objective: To examine the longterm effect of etanercept (ETN) therapy on health-related quality of life (HRQOL) and utility in patients with ankylosing spondylitis.

Methods: Patients completing a 24-week placebo-controlled trial were continued on ETN in a 72-week open-label extension study. Short Form-36 (SF-36), EuroQOL-5D (EQ-5D), and EuroQOL visual analog scale (EQ-VAS) scores were collected at open-label baseline and every 12 weeks thereafter.

Symptoms and treatment burden associated with cancer treatment: results from a cross-sectional national survey in the U.S.

Goals: To examine the prevalence of chemotherapy-or radiotherapy-associated side effects and related treatment burden, and correlates of fatigue and missed work days among cancer patients.

Materials And Methods: A cross-sectional survey was conducted using a dual sampling frame of 63,949 cancer patients (35,751 from an online panel and 28,198 from telephone listings) > or = 18 years receiving chemotherapy and/or radiotherapy at the time of the survey or during the previous 12 months. Data were collected on cancer type, time since diagnosis, treatment side effects, visits, caregiver burden, missed work days, and sociodemographic characteristics.

The complexity of care for patients with rheumatoid arthritis: metrics for better understanding chronic disease care.

Background: Patients with rheumatoid arthritis (RA) provide an important opportunity for understanding care of patients with a serious chronic condition.

Objectives: We sought to characterize the complexity of care for patients with RA, including metrics describing the patient, the disease, and use of the health care system across time and place.

Methods: We undertook a prospective cohort study of 568 community-dwelling patients with RA by using observational data from clinically detailed telephone interviews at baseline and 2 years later in addition to medical record abstraction.

Measuring process of arthritis care: the Arthritis Foundation's quality indicator set for rheumatoid arthritis.

Objective: To describe the scientific evidence that supports each of the explicit process measures in the Arthritis Foundation's Quality Indicator Set for Rheumatoid Arthritis.

Methods: For each of the 27 measures in the Arthritis Foundation's Quality Indicator set, a comprehensive literature review was performed for evidence that linked the process of care defined in the indicator with relevant clinical outcomes and to summarize practice guidelines relevant to the indicators.

Results: Over 7500 titles were identified and reviewed.

Effects of omega-3 fatty acids on cancer risk: a systematic review.

Context: Omega-3 fatty acids are purported to reduce the risk of cancer. Studies have reported mixed results.

Objective: To synthesize published and unpublished evidence to determine estimates of the effect of omega-3 fatty acids on cancer risk in prospective cohort studies.

The efficacy of omega-3 fatty acids on cognitive function in aging and dementia: a systematic review.

We systematically reviewed the published literature on the effects of omega-3 fatty acids on measures of cognitive function in normal aging, incidence and treatment of dementia. Computerized databases were searched for published literature to identify potentially relevant studies with the intent to conduct a meta-analysis. We screened 5,865 titles, reviewed 497 studies of which 49 underwent a detailed review, and found 5 studies that pertained to our objectives.

Telephone reminder calls increased response rates to mailed study consent forms.

Background: This study assessed the impact of follow-up reminder phone calls on response rates to a mailed consent form packet.

Methods: Patients with rheumatoid arthritis were invited to enroll in a study by signing and returning consent forms by mail. Patients not returning completed study consent forms were called and reminded to return the signed consent forms.