Opioid-Induced Constipation Among Patients with Chronic Noncancer Pain in the United States, Canada, Germany, and the United Kingdom: Laxative Use, Response, and Symptom Burden Over Time.

PURPOSE: Estimate rate of laxative inadequate response (LIR) over time among patients with chronic noncancer pain with opioid-induced constipation (OIC). METHODS: A prospective longitudinal study was conducted in United States, Canada, Germany, and United Kingdom. Patients on opioid therapy for ≥4 weeks for chronic noncancer pain and OIC completed an Internet-based survey at Baseline and Weeks 2, 4, 6, 8, 12, 16, 20, and 24. 1xLIR was defined as sufficient laxative use (≥1 laxative ≥ 4 times in past 2 weeks) and inadequate response (<3 bowel movements or ≥ 1 constipation symptom rated Moderate or greater). 2xLIR was sufficient laxative use of ≥2 laxatives from different drug classes and inadequate response. Descriptive statistics and logistic regressions were performed. RESULTS: 489 patients (62% female; 85% white) completed Baseline; 27% reported no laxative use; 25% had insufficient laxative use; 48% had sufficient laxative use. During follow-up, 21-28% of patients had no or insufficient laxative use. Prevalence of 1xLIR was 93% at Baseline and ranged from 59-81% across follow-up; 26% met criteria for 2xLIR (follow-up range: 11-20%). CONCLUSIONS: OIC among noncancer pain patients is a persistent and significant condition with varying utilization and response to laxatives thus increasing the ongoing burden of chronic pain. © 2014 Wiley Periodicals, Inc.

Transfusions and patient burden in chemotherapy-induced anaemia in France.

OBJECTIVES: To estimate the patient burden in terms of the time spent on outpatient red blood cell (RBC) transfusions indicated for chemotherapy induced-anaemia (CIA) in patients with cancer in France. METHODS: A retrospective chart review of patients with cancer receiving an outpatient RBC transfusion was conducted at seven treatment centres in France. Total treatment time for one transfusion visit per patient was measured as the elapsed time between pre- and post-transfusion vital sign assessment, including time from transfusion start to stop. Elapsed time from haemoglobin (Hb) level testing to transfusion start and from blood draw for compatibility testing to transfusion start were recorded. In addition, estimated travel time and distance to the transfusion centre, and clinical and demographic information were collected. RESULTS: A total of 103 patients [63.1% men; mean age 66.2 years, standard deviation (SD) 11.9] were enrolled in the study (1 August 2010-31 October 2010). The four most frequent diagnoses were lung cancer (31.1%), urological cancer (15.5%), gynecological cancer (14.6%) and gastrointestinal/colorectal cancer (14.6%). Mean elapsed time between prevital and postvital sign assessment was 4.0 h [95% confidence interval (CI) 1.9-6.1], including a mean of 3.4 h (95% CI 2.5-4.2) for the transfusion itself. Hb level testing (mean pre-transfusion Hb level 8.0 g/dl, SD 0.8) and blood draw for compatibility testing were completed in a mean of 28.8 h (95% CI 1.3-56.2) and 9.4 h (95% CI 0-21.4) prior to transfusion respectively. Patients' one-way mean travel time to the transfusion centre was 32.9 min (95% CI 28.5-37.4) and mean distance travelled was 25.4 km (95% CI 11.6-39.3). CONCLUSION: In France, CIA treatment with RBC transfusion is a time-consuming activity for patients that includes multiple trips to a medical facility, blood testing and the transfusion procedure itself. This burden is important to consider in the context of optimizing proactive monitoring and planning for supportive oncology care.

The International Burden of Migraine Study (IBMS): study design, methodology, and baseline cohort characteristics.

OBJECTIVE: To describe a survey methodology to evaluate headache characteristics and burden and to present baseline characteristics for the international cohort of survey participants. METHODS: A targeted, web-based methodology was used to recruit and survey subjects with migraine in 10 countries. Based on reported symptoms, subjects meeting ICHD-2 criteria for migraine were included; eligible subjects were classified as chronic (≥ 15 headache days per month) or episodic (< 15 headache days per month). Outcomes included sociodemographic and clinical characteristics, resource utilization, disability, health-related quality of life, anxiety, depression and productivity. RESULTS: Of 23,312 survey respondents, 11,897 were eligible and 9715 (81.7%) completed the survey; subjects were 81.5% female; 5.7% (n = 555) had chronic migraine. CONCLUSIONS: This is the first large international cohort of persons with chronic and episodic migraine studied using a web-based approach, a methodology well suited to the study of the burden of migraines.

Increasing Access to Cognitive-Behavioural Therapy (CBT) for the Treatment of Mental Illness in Canada: A Research Framework and Call for Action.

International studies suggest that cognitive-behavioural therapy (CBT) for the treatment of mental disorders results in improved clinical and economic outcomes. In Canada, however, publicly funded CBT is scarce, representing an inequity in service delivery. A research framework to evaluate the Canadian health economic impact of increasing access to CBT is proposed. Canadian data related to the epidemiology of mental disorders, patterns of usual care, CBT effectiveness, resource allocation and costs of care will be required and methodologies should be transparent and outcomes meaningful to Canadian decision-makers. Findings should be delivered by multidisciplinary teams of researchers and health professionals. Barriers to funding reform must be identified and knowledge translation strategies delineated and implemented. Canadian clinical and economic outcomes data are essential for those seeking to provide decision-makers with the evidence they need to evaluate whether CBT represents value for mental health dollars spent.

Iron chelation therapy: clinical effectiveness, economic burden and quality of life in patients with iron overload.

INTRODUCTION: This study of UK patients examines clinical, health-related quality of life (HRQOL) and economic outcomes associated with iron chelation therapy (ICT). Desferrioxamine (DFO) (Desferal; Novartis, Switzerland) and Deferiprone (Ferriprox; Apotex, Canada) are ICTs used to treat iron overload. DFO requires 8-to 12-hour infusions a minimum of five times per week. Deferiprone is administered in an oral daily regimen. Although pharmacologically efficacious, clinical effectiveness of ICT within the real-world setting is yet to be fully elucidated. METHODS: A naturalistic cohort study of 60 patients (beta-thalassaemia, n=40; sickle cell disease, n=14; myelodysplastic syndromes, n=6; 63% female) receiving ICT in four UK treatment centres was conducted. Serum ferritin level data were abstracted from medical charts. Compliance, HRQOL, satisfaction and resource utilisation data were collected from interviews. Maximum ICT costs were estimated using the resource utilisation data associated with DFO. RESULTS: Mean serum ferritin levels, generally, remained elevated despite ICT. Compliance was suboptimal and HRQOL scores were lower than population norms. The total estimated mean weighted annual per-patient cost of DFO treatment was approximately pound19,000. DFO-related equipment, DFO drug, and home healthcare were estimated to account for 43%, 19% and 24% of costs, respectively. Other more minor components of total annual costs were for in-patient infusions, ICT home delivery services and monitoring costs. CONCLUSION: Generally, patients are not achieving target serum ferritin thresholds despite chronic treatment for iron overload. ICT appears to negatively impact HRQOL; compliance with ICT is poor; and, in the case of DFO, treatment costs well exceed the cost of DFO alone. These results suggest that current ICT in the real-world setting is suboptimal with respect to various clinical, HRQOL and economic outcomes.

Clinical and economic burden of infused iron chelation therapy in the United States.

BACKGROUND: Patients requiring chronic blood transfusions are at risk for iron overload, which, if not treated by iron chelation therapy (ICT), can create serious organ damage and reduce life expectancy. Current ICT requires burdensome 8- to 12-hour infusions five to seven times per week. STUDY DESIGN AND METHODS: A naturalistic study of the burden of infused ICT was conducted in four US centers. Data from the initial and most recent years of ICT were collected from medical charts of consenting thalassemia (n = 40) and sickle cell disease (n = 9) patients. Quality of life (QoL), treatment satisfaction, and ICT-related resource utilization data were also collected from a patient interview. RESULTS: Mean serum ferritin levels during the initial (2519 +/- 1382 ng/mL) and most recent (2741 +/- 2532 ng/mL) years remained unacceptably high and increased over time (306 +/- 2200 ng/mL; mean of 20+/- years of therapy). Within 30 days before interview, 55 percent of patients suffered at least one ICT-related adverse event; 76 percent missed at least one dose. QoL, measured by the SF-36, and treatment satisfaction appear compromised in this cohort. Although total annual costs of ICT were estimated at USD $30,000 to $35,000, drug accounted for only 50 to 60 percent of this amount. CONCLUSIONS: Infused ICT may not provide adequate effectiveness in the real world. High ferritin levels seem to be associated with ICT noncompliance, likely in relation to the bothersome mode of administration and side effects. The total cost of ICT appears to well exceed that of drug alone.

Evaluating the true cost of hypertension management: evidence from actual practice.

Hypertension is a prevalent and costly disease and drug cost is the most significant driver of total expense. Therefore, medications such as diuretics, with lower acquisition costs, and equal or better trial-based efficacy versus other classes of antihypertensives, are currently recommended as first-line therapy. However, observational data from actual practice suggest that antihypertensive drug acquisition costs alone are a poor predictor of total treatment cost. This review explores other important determinants of cost which must be considered, such as therapeutic turbulence and persistence on therapy, which cannot be measured with validity within a clinical trial environment. Actual practice data reveal that greater turbulence and poorer persistence is associated with older agents such as diuretics, versus newer, more tolerable medications. On the basis of observational evidence, the gap in total treatment cost associated with older versus newer antihypertensives is significantly less than that which is commonly reported and used as an argument for first-line treatment with diuretics. Continued constructive debate over the implications of observational data for the selection of a first-line antihypertensive therapy is warranted.

Long term cost-of-illness in stroke: an international review.

An international review of the costs of stroke was conducted to explore data sources, and cost variables as well as to compare estimates of the annual aggregated cost (prevalence-based) and total per patient long-term cost (incidence-based) of care. Dutch, English, French, German, Italian and Spanish literature was searched using the keywords stroke, ischaemic stroke, haemorrhagic stroke, cerebrovascular accident, cerebral infarction, cost(s), economics, and cost analysis. Criteria for study inclusion were: provides estimates of direct and/or indirect costs of stroke, published after 1989, methods described in adequate detail, and for studies of long-term costs, estimates based on a minimum 5 years of care following the event. Cost estimates are presented in original currencies and US dollars. Among studies representing Australia, New Zealand, Western Europe and North America, six prevalence studies reported total annual aggregated costs of US dollars 7,975 (1988 values) to US dollars 54,546 (1993 values) per patient; eight incidence-based studies reported total long-term per patient costs of US dollars 18,538 (1991 values) to US dollars 228,038 (1990 values). Identifiable factors underlying variation included: perspective employed, cost variables considered, and exclusion of comorbidities. Although lack of uniformity hampers inter-study comparisons, it is evident that stroke poses a significant economic burden. Consensus on standard cost variables and methods for projections of resource use and survival over time are clearly warranted.