Reprint of: Psychosocial factors associated with pharmacists' antidepressant drug treatment monitoring.

OBJECTIVE: Patients undergoing antidepressant drug treatment (ADT) may face challenges regarding its adverse effects, adherence, and efficacy. Community pharmacists are well positioned to manage ADT-related problems. Little is known about the factors influencing pharmacists' ADT monitoring. This study aimed to identify the psychosocial factors associated with pharmacists' intention to perform systematic ADT monitoring and report on this monitoring. DESIGN: Cross-sectional study based on the Theory of Planned Behavior (TPB). SETTING AND PARTICIPANTS: Community pharmacists in the province of Quebec, Canada. OUTCOME MEASURES: Pharmacists completed a questionnaire on their performance of ADT monitoring, TPB constructs (intention; attitude; subjective norm; perceived behavioral control; and attitudinal, normative, and control beliefs), and professional identity. Systematic ADT monitoring was defined as pharmacists' reporting 4 or more consultations with each patient during the first year of ADT to address adverse effects, adherence, and efficacy. Hierarchical linear regression models were used to identify the factors associated with the intention and reporting of systematic ADT monitoring and Poisson working models to identify the beliefs associated with intention. RESULTS: A total of 1609 pharmacists completed the questionnaire (participation = 29.6%). Systematic ADT monitoring was not widely reported (mean score = 2.0 out of 5.0), and intention was moderate (mean = 3.2). Pharmacists' intention was the sole psychosocial factor associated with reporting systematic ADT monitoring (P < 0.0001; R2 = 0.370). All TPB constructs and professional identity were associated with intention (P < 0.0001; R2 = 0.611). Perceived behavioral control had the strongest association. CONCLUSION: Interventions to promote systematic ADT monitoring should focus on developing a strong intention among pharmacists, which could, in turn, influence their practice. To influence intention, priority should be given to ensuring that pharmacists feel capable of performing this monitoring. The main barriers to overcome were the presence of only 1 pharmacist at work and limited time. Other factors identified offer complementary intervention targets.

Psychosocial factors associated with pharmacists' antidepressant drug treatment monitoring.

OBJECTIVE: Patients undergoing antidepressant drug treatment (ADT) may face challenges regarding its adverse effects, adherence, and efficacy. Community pharmacists are well positioned to manage ADT-related problems. Little is known about the factors influencing pharmacists' ADT monitoring. This study aimed to identify the psychosocial factors associated with pharmacists' intention to perform systematic ADT monitoring and report on this monitoring. DESIGN: Cross-sectional study based on the Theory of Planned Behavior (TPB). SETTING AND PARTICIPANTS: Community pharmacists in the province of Quebec, Canada. OUTCOME MEASURES: Pharmacists completed a questionnaire on their performance of ADT monitoring, TPB constructs (intention; attitude; subjective norm; perceived behavioral control; and attitudinal, normative, and control beliefs), and professional identity. Systematic ADT monitoring was defined as pharmacists' reporting 4 or more consultations with each patient during the first year of ADT to address adverse effects, adherence, and efficacy. Hierarchical linear regression models were used to identify the factors associated with the intention and reporting of systematic ADT monitoring and Poisson working models to identify the beliefs associated with intention. RESULTS: A total of 1609 pharmacists completed the questionnaire (participation = 29.6%). Systematic ADT monitoring was not widely reported (mean score = 2.0 out of 5.0), and intention was moderate (mean = 3.2). Pharmacists' intention was the sole psychosocial factor associated with reporting systematic ADT monitoring (P < 0.0001; R2 = 0.370). All TPB constructs and professional identity were associated with intention (P < 0.0001; R2 = 0.611). Perceived behavioral control had the strongest association. CONCLUSION: Interventions to promote systematic ADT monitoring should focus on developing a strong intention among pharmacists, which could, in turn, influence their practice. To influence intention, priority should be given to ensuring that pharmacists feel capable of performing this monitoring. The main barriers to overcome were the presence of only 1 pharmacist at work and limited time. Other factors identified offer complementary intervention targets.

Risk of pulmonary toxicity of bleomycin and filgrastim.

OBJECTIVES: To estimate the relative risk of pulmonary toxicity in patients exposed to a bleomycin-based chemotherapy including filgrastim compared to a similar chemotherapy without filgrastim. METHODS: We conducted a nested case-control study of patients treated with BEP (bleomycin, etoposide and cisplatin) for germ cell cancer or with ABVD (doxorubicin, bleomycin, vinblastine and dacarbazine) for Hodgkin's lymphoma at the Hôtel-Dieu de Lévis Hospital between 31 October 2000 and 30 June 2016. The relative risk was estimated by an adjusted odds ratio (aOR) using a propensity score-adjusted regression analysis. RESULTS: Thirteen cases of pulmonary toxicity, representing 14.7% of the 88 patients included in the study, were matched with 65 controls. A higher proportion of women (31.8%) than men (11.3%) developed pulmonary toxicity although the difference was not statistically significant (P = 0.08). Within the cohort, two deaths related to lung toxicity were observed among cases where no filgrastim was used. The risk of pulmonary toxicity associated with the addition of filgrastim was not statistically significant (aOR = 2.48 95% CI = 0.50 to 12.19). CONCLUSION: The results add further evidence that the concomitant use of filgrastim might not increase the risk of pulmonary toxicity of bleomycin. It also suggests that female patients might be more likely to develop this adverse effect. A clinical trial would be needed to confirm this result.

Factors associated with adherence to asthma treatment with inhaled corticosteroids: A cross-sectional exploratory study.

BACKGROUND: Understanding factors at the patient, provider or organizational level associated with inhaled corticosteroids (ICSs) adherence is important when planning adherence-enhancing interventions. OBJECTIVE: To explore factors associated with adherence to ICS among patients with asthma aged 12-45 years. METHODS: A cross-sectional study was conducted among patients with asthma reporting ICS prescription during the baseline interview of an intervention study. Three methods were used to measure ICS adherence: a 4-item self-report questionnaire, a single question (SQ) measuring past 7-day exposure to ICS and a medication possession ratio (MPR, i.e., the sum of ICS days of supply/365). We assessed 46 potential factors of ICS adherence derived from the Predisposing, Reinforcing and Enabling Constructs in Educational Diagnosis and Evaluation (PRECEDE) model. Their association with ICS adherence was measured using multivariate logistic regressions. RESULTS: Among the 319 participants included, 16.0% were deemed adherent according to the 4-item questionnaire. This proportion was 43.0% and 9.1% for the SQ and the MPR method, respectively. Ten factors were associated with good ICS adherence. Among these factors, four were associated with adherence through one of the measuring methods: a low family income level, a high number of asthma drugs used, a good knowledge of asthma pathophysiology and the perception that following the ICS prescription was easy. Two factors emerged through more than one measure: perceiving asthma severity as moderate to very severe and perceiving a high risk of death if ICSs are not taken as prescribed. CONCLUSION: ICS adherence was poor in those individuals with asthma. Future adherence-enhancing interventions could target the identified modifiable risk factors. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT02093013.

Appropriateness of Ticagrelor Use at Initiation: A Population-Based Cohort Study.

PURPOSE: Ticagrelor is recommended following an acute coronary syndrome if used appropriately. Its use has not yet been well described in the context of ambulatory clinical practice. The objective of this study was to assess the proportion of ticagrelor new users who initiated this medication appropriately and explore associated factors. METHODS: A retrospective population-based inception cohort study was conducted using Quebec administrative databases. The study population included all Quebec residents aged ≥18 years who had a first ticagrelor prescription claim between 1 January, 2012, and 31 March, 2015, and had been continuously eligible in the Quebec public drug plan during the 365 days preceding the first ticagrelor claim. The initial ticagrelor prescription was considered appropriate if:1) it met the indication for use criterion, 2) the prescribed daily dose was 90 mg twice a day, and 3) there was a concomitant use of acetylsalicylic acid (ASA) 80-81 mg daily. Factors potentially associated with the ticagrelor appropriateness of use were included in a logistic log-binomial regression model. RESULTS: A total of 7,073 patients were included in the study, 6,013 (85.0%) had an appropriate indication, 6,895 (97.5%) were prescribed ticagrelor 90 mg twice a day, and 6,385 (90.3%) had a concomitant prescription of ASA. A total of 5,371 (75.9%) patients were prescribed ticagrelor in accordance with all criteria. Twelve factors were associated with prescription appropriateness. CONCLUSIONS: A large majority of patients initiated ticagrelor appropriately. Further improvement in appropriateness may come at targeting indication for use.

Neighbourhood Material and Social Deprivation and Exposure to Antidepressant Drug Treatment: A Cohort Study Using Administrative Data.

OBJECTIVE: To assess whether neighbourhood deprivation is associated with exposure to an antidepressant drug treatment (ADT) and its quality among individuals diagnosed with unipolar depression and insured by the Quebec public drug plan. METHOD: We conducted an administrative database cohort study of adults covered by the Quebec public drug plan who were diagnosed with a new episode of unipolar depression. We assessed material and social deprivation using an area-based index. We considered exposure to an ADT as having ≥1 claim for an ADT within the 365 days following depression diagnosis. Among those exposed to ADT, ADT quality was assessed with 3 indicators: first-line recommended ADT, persistence with the ADT, and compliance with the ADT. Generalized linear models were used to estimate adjusted prevalence ratios (aPR) and 95% confidence intervals (95% CI). RESULTS: Of 100,432 individuals with unipolar depression, 65,436 (65%) were exposed to an ADT in the year following the diagnosis. Individuals living in the most materially deprived areas were slightly more likely to be exposed to an ADT than those living in the least deprived areas (aPR, 1.04; 95% CI, 1.03 to 1.06). The likelihoods of being exposed to a first-line ADT, persisting for the minimum recommended duration and complying with the ADT were independent of the deprivation levels. CONCLUSIONS: Neighbourhood deprivation was not associated with ADT quality among individuals insured by the Quebec public drug plan. It might be partly attributable to the public drug plan whose goal is to provide equitable access to prescription drugs regardless of income.

Patient perspectives on the role of community pharmacists for antidepressant treatment: A qualitative study.

OBJECTIVES: Patients prescribed antidepressant drug treatment (ADT) for major depression report several needs in relation to their treatment, and a large proportion of these patients will end ADT prematurely. Community pharmacists may play an important role in monitoring ADT and supporting these patients. However, little is known about patient experiences of the services provided in community pharmacies. The objectives of this study were to 1) explore patients' experiences with the services community pharmacists provide for ADT and 2) identify potential avenues for improvement of pharmacists' services within the context of ADT. METHODS: A qualitative descriptive exploratory study was conducted among individuals diagnosed with major depression who had initiated ADT at some point in the 12 months prior to their participation in the study. A total of 14 persons recruited in a local health centre and a community-based organization participated in individual interviews. A thematic analysis of the interview transcripts was conducted. RESULTS: Pharmacists tend to concentrate their involvement in treatment at initiation and at the first refill when questions, uncertainties and side effects are major issues. Patients felt that the pharmacists' contributions consisted of providing information and reassurance; in these respects, their needs were met. Participants had few ideas as to what additional services pharmacists could implement to improve patients' experience with ADT. Patients' sole expectations were that pharmacists extend this information role to the whole length of the treatment and enhance the confidentiality of discussions in pharmacy. CONCLUSION: Pharmacists should provide counselling throughout the entire treatment rather than passively waiting for patients to ask their questions. However, facilitation of open discussions may not be achieved unless confidentiality at pharmacies is secured.

The Association between Depression and Medication Nonpersistence in New Users of Antidiabetic Drugs.

OBJECTIVES: To measure the association between depression and nonpersistence with antidiabetic drugs (ADs) among new users of oral ADs and to estimate factors associated with nonpersistence among these new users with depression. METHODS: We used administrative claims data to identify an adult cohort (≥18 years) of new oral AD users who were free of depression. We followed the patients from AD initiation until either discontinuation, ineligibility for the public drug plan, death, or the end of the study. A proportional hazard Cox regression model with depression as a time-dependent variable was used to compute the adjusted hazard ratio of nonpersistence. A proportional hazard Cox regression model was also used to identify factors associated with nonpersistence in the subcohort of patients with depression. RESULTS: We identified 114,366 new oral AD users, of whom 4,808 were diagnosed with depression during the follow-up. A greater proportion (55.4%) of patients with depression (vs. 42.5% without depression) discontinued their treatment during the follow-up. The adjusted hazard ratio of nonpersistence with ADs was 1.52 (95% confidence interval 1.41-1.63). Among patients with depression, independent factors associated with nonpersistence included younger age at oral AD initiation (<45 years) and starting treatment with drugs other than metformin (especially polytherapy with insulin). CONCLUSIONS: Patients with depression are more likely to discontinue their treatment. Health care professionals should pay attention to patients on AD therapy who also suffer from depression, especially if the patients are young or are using insulin because these patients are at an increased risk of nonpersistence.

Higher risk of neutropenia associated with piperacillin-tazobactam compared with ticarcillin-clavulanate in children.

BACKGROUND: A series of cases of piperacillin-tazobactam (P/T)-associated neutropenia has been observed recently in children in our center. Because neutropenia was seldom observed in children treated with ticarcillin-clavulanic acid (T/C), we conducted a study to determine if there is an increased risk of neutropenia in children exposed to P/T in comparison with T/C. METHODS: Medical records of subjects aged <18 years who received at least 1 dose of P/T or T/C between 1 January 2008 and 30 June 2011 were reviewed. RESULTS: Two hundred ninety-nine episodes of treatment (65 P/T, 234 T/C) met inclusion criteria. Among those episodes, 213 had data allowing complete white blood cell count analysis and were included in the final analysis. Thirteen cases of neutropenia were observed during the study period. The average time to onset was 17.6 days and all patients were aged <13 years. Seven cases (10.8%) occurred in the P/T group and 6 (2.6%) in the T/C group (unadjusted odds ratio, 4.59; 95% confidence interval, 1.48-14.17). Although a statistically significant correlation was observed between age, treatment duration, and total dose and the development of neutropenia (r = -0.121, P = .037; r = 0.267, P < .001; r = 0.260, P < .001, respectively), this was not the case for sex, indications, neutrophil count at initiation, and concomitant drug treatments. CONCLUSIONS: Although our results need to be confirmed, they suggest that children receiving long courses of therapy (>2 weeks) with P/T may be at increased risk of neutropenia, compared with T/C.

Effectiveness and Content Analysis of Interventions to Enhance Oral Antidiabetic Drug Adherence in Adults with Type 2 Diabetes: Systematic Review and Meta-Analysis.

OBJECTIVES: To estimate the pooled effect size of oral antidiabetic drug (OAD) adherence-enhancing interventions and to explore which of the behavior change techniques (BCTs) applied in the intervention groups modified this pooled intervention effect size. METHODS: We searched relevant studies published until September 3, 2013, on MEDLINE, Embase, PsycInfo, the Cochrane Library, CINAHL, Current Contents Connect, and Web of Science. Selected studies were qualitatively synthesized, and those of at least medium quality were included in the meta-analysis. A random-effects model was used to pool effectiveness (Hedges's g) and to examine heterogeneity (Higgins I(2)). We also explored the influence on the pooled effectiveness of unique intervention BCTs (those delivered to the intervention groups but not control groups in a trial) by estimating their modifying effects. RESULTS: Fourteen studies were selected for the qualitative synthesis and 10 were included in the meta-analysis. The pooled effectiveness of the interventions was 0.21 (95% confidence interval -0.05 to 0.47; I(2) = 82%). Eight unique BCTs were analyzed. "Cope with side effects" (P = 0.003) and "general intention formation" (P = 0.006) had a modifying effect on the pooled effectiveness. The pooled effectiveness of the interventions in which "cope with side effects" was applied was moderate (0.64; 95% confidence interval 0.31-0.96; I(2) = 56%). CONCLUSIONS: The overall effectiveness of OAD adherence-enhancing interventions that have been tested is small. Helping patients cope with side effects or formulate desired treatment outcomes could have an impact on the effectiveness of OAD adherence-enhancing interventions. Only those interventions that include helping patients to cope with side effects appear to be particularly effective in improving OAD adherence.

Effectiveness of an asthma integrated care program on asthma control and adherence to inhaled corticosteroids.

OBJECTIVE: To measure the effectiveness of an integrated care program for individuals with asthma aged 12-45 years, on asthma control and adherence to inhaled corticosteroids (ICS). METHODS: Researchers used a theoretical model to develop the program and assessed effectiveness at 12 months, using a pragmatic controlled clinical trial design. Forty-two community pharmacists in Quebec, Canada recruited participants with either uncontrolled or mild-to-severe asthma. One group was exposed to the program; another received usual care. Asthma control was measured with the Asthma Control Questionnaire; ICS adherence was assessed with the Morisky medication adherence scale and the medication possession ratio. Program effectiveness was assessed with an intention-to-treat approach using multivariate generalized estimating equation models. RESULTS: Among 108 exposed and 241 non-exposed, 52.2% had controlled asthma at baseline. At 12-months, asthma control had improved in both groups but the interaction between study groups and time was not significant (p = 0.09). The proportion of participants with good ICS adherence was low at baseline. Exposed participants showed improvement in adherence and the interaction between study groups and time was significant (p = 0.02). CONCLUSION: An integrated intervention, with healthcare professionals collaborating to optimize asthma control, can improve ICS adherence.

Adherence to anti-estrogen therapy in seniors with breast cancer: how well are we doing?

A third of breast cancers (BC) occur in women ≥65 years (seniors). Anti-estrogen therapy (AET) significantly reduces BC recurrence and death. This study characterizes determinants of adherence to AET in seniors with BC. Provincial cancer registry and administrative claims data were accessed for all non-metastatic BC diagnosed in Quebec (1998-2005) to identify seniors treated for 5 years with AET. Multivariate linear regression was used to assess the association with patient, disease, and physician characteristics and the 5-year medication possession ratio (MPR) for each patient. 4,715 women were included (mean age: 72.9). Mean MPR was 83.5%, 79% of patients reached a 5-year MPR of ≥80%, and 34% discontinued AET at some point during treatment. The cumulative probability of discontinuation was 33.8% (mean time to discontinuation 2.3 years). The MPR decreased with increasing age and non-BC related hospitalizations, p < 0.05. Each new medication added during the 5-years decreased the MPR by 0.3% (p < 0.05). Women with in situ disease, on antidepressants at baseline, or treated with Tamoxifen had a lower MPR by 6.5% (p = 0.0002), 4.7% (p = 0.003) and 6% (p = 0.001), respectively. Switching AET type was associated with a lower MPR by 5.3% (p = 0.002) if the switch occurred during the first year. Optimal 5-year adherence to AET in seniors with BC remained a challenge and medication discontinuation rates were high. Advanced age, increasing number of hospitalizations, in situ disease, baseline use of antidepressants, Tamoxifen (versus aromatase inhibitors), early switches of AET type, and newly added medications significantly reduced the MPR.

Disentangling the influence of neighborhood and individual characteristics on early residential mobility among newly diagnosed patients with schizophrenia: a multilevel analysis.

PURPOSE: Early residential mobility of schizophrenic patients may relate to discontinuity of treatment and adverse outcome. However, factors influencing early residential mobility of these patients are still poorly examined. The aim of this study was to disentangle the influence of individual and neighborhood characteristics on early residential mobility of schizophrenic patients. METHODS: The study used administrative data of 13, 400 individuals newly diagnosed with schizophrenia in Quebec between 2001 and 2002. These individuals were nested in 163 different health territories. Multilevel analyses were used to assess the contribution of individual and neighborhood characteristics on early residential mobility. RESULTS: The final model indicates that at the individual level, being men, wonder patients and physical comorbidity increased the likelihood of early residential mobility whereas older patients were less likely to migrate earlier. The health territory level explains about 7 % of the variation of early residential mobility and variables influencing residential mobility at this level are the fourth and the third quartiles of the population density. CONCLUSIONS: Factors influencing early residential mobility of schizophrenic patients are located at both individual and neighborhood levels. This suggests that policies targeting only one-level factors are unlikely to significantly delays early residential mobility.

Treatment prevalence and incidence of schizophrenia in Quebec using a population health services perspective: different algorithms, different estimates.

PURPOSE: Using a population health services perspective, this article defines and assesses an efficient criteria-based algorithm to identify treatment prevalent and incident cases of schizophrenia. We refer here "treatment" prevalence and incidence since its evaluation depends on a patient receiving a health care service with a diagnosis of schizophrenia. METHODS: A population-based cohort study was conducted among all adults having a hospital discharge or a physician claim for schizophrenia in the public health plan databases between January 1996 and December 2006. Four algorithms to characterize patients with schizophrenia were defined. To identify treatment incident cases in 2006, we removed from the treatment prevalent pool patients with a previous record of schizophrenia between 1996 and 2006 (10-year clearance period). Using this 10-year period as reference, Kappa coefficients (KC) and positive predictive values (PPV) were calculated to determine the "optimal" length of clearance period to identify incident cases. RESULTS: The lifetime treatment prevalence and incidence of schizophrenia varied from 0.59 to 1.46% and from 42 to 94 per 100,000, respectively. When compared to the 10-year clearance period, the KC is excellent in a clearance period of 6-7 years. To achieve a PPV of 90%, a clearance period of 7-8 years would be necessary. CONCLUSIONS: With an appropriate algorithm, treatment prevalence and incidence of schizophrenia can be conveniently estimated using administrative data. These estimates are a vital step toward appropriate planning of services for schizophrenia.

Adherence and sustained virologic response among vulnerable people initiating an hepatitis C treatment at a nurse-led clinic: A non-experimental prospective cohort study based on clinical records.

Background: There is a need to develop specific care route for vulnerable people with hepatitis C virus. Objective: At a nurse-led clinic, we aimed to: (1) report the prevalence of patients initiating an hepatitis C treatment who (a) achieved sustained virologic response and (b) were adherent to their treatment; and (2) explore factors associated with adherence and sustained virologic response. Design: A clinical record-based prospective cohort study. Setting: A community-based nurse-led clinic coordinating outreach services for people with hepatitis C virus in Québec City, Québec, Canada. Population: All patients initiating an hepatitis C treatment at the nurse-led clinic from January 1, 2012 to December 31, 2017 (end of data collection). Methods: Patients were followed from the day they initiated their hepatitis C treatment, up to 24 weeks after the end of the treatment. Sustained virologic response was achieved if hepatitis C virus ribonucleic acid (RNA) was undetectable or below the lower limit of quantification at week 12 or later. Patients who reported hepatitis C treatment completion without missing any doses were considered adherent. Factors associated with adherence and sustained virologic response were identified using adjusted prevalence ratios. Results: A total of 171 patients infected with hepatitis C virus (women: n = 51, 30%; criminal record: n = 102, 60%; substance addiction: n = 99, 58%) initiated an hepatitis C treatment at the nurse-led clinic. Overall, 126/171 (74%) patients were adherent. Patients using illicit drugs were less likely to be adherent (adjusted prevalence ratio 0.77, 95% confidence interval 0.67-0.89). Among 156/171 (91%) patients with an hepatitis C virus RNA test post-treatment, 96% (n = 149) achieved sustained virologic response. Patients who were less likely to achieve sustained virologic response were those who were non-adherent (adjusted prevalence ratio 0.81, 95% confidence interval 0.68-0.98) or who had a criminal record (adjusted prevalence ratio 0.87, 95% confidence interval 0.79-0.97). Conclusions: A nurse-led clinic could fill an important gap in hepatitis C health services targeted at vulnerable people in a community setting, to drive adherence and achievement of sustained virologic response.

Persistence patterns with oral antidiabetes drug treatment in newly treated patients--a population-based study.

OBJECTIVE: We assessed persistence patterns with oral antidiabetes drug (OAD) in patients newly dispensed with different OAD classes. METHODS: We conducted a population-based cohort study using Quebec Health Insurance Board data. Patients aged 18 years or more newly dispensed an OAD between January 1, 1998 and December 31, 2003 were included in the study (n=98,940). Persistence was defined as consistently refilling a prescription for the initial OAD within three times the days' supply of the preceding claim. For nonpersistent patients, a second course of therapy was defined as treatment initiation with any OAD after a first discontinuation. Patients were followed from treatment initiation up to December 31, 2004, ineligibility for the drug plan or death, whichever came first, and treatment discontinuation or second course of treatment. Cox regression models were used to compute adjusted hazards ratios (AHR) of persistence and initiation of second courses of therapy. RESULTS: The probability of persisting with the initial OAD over a 12-month period was 65% and 56% for patients initiated on metformin and sylfonylurea, respectively. Compared to metformin, the likelihood of discontinuing the initial OAD over the study period was significantly higher for patients on sulphonylureas (AHR: 1.32; 95% CI 1.29-1.34). Patients started on sulphonylureas were also less likely to start a second course of therapy after a first treatment discontinuation (AHR: 0.91; 95% CI 0.89-0.93). CONCLUSIONS: Compared to diabetic patients initiated on metformin, those initiated on sulphonylureas displayed poorer persistence patterns.

Combining multicriteria decision analysis, ethics and health technology assessment: applying the EVIDEM decision-making framework to growth hormone for Turner syndrome patients.

OBJECTIVES: To test and further develop a healthcare policy and clinical decision support framework using growth hormone (GH) for Turner syndrome (TS) as a complex case study. METHODS: The EVIDEM framework was further developed to complement the multicriteria decision analysis (MCDA) Value Matrix, that includes 15 quantifiable components of decision clustered in four domains (quality of evidence, disease, intervention and economics), with a qualitative tool including six ethical and health system-related components of decision. An extensive review of the literature was performed to develop a health technology assessment report (HTA) tailored to each component of decision, and content was validated by experts. A panel of representative stakeholders then estimated the MCDA value of GH for TS in Canada by assigning weights and scores to each MCDA component of decision and then considered the impact of non-quantifiable components of decision. RESULTS: Applying the framework revealed significant data gaps and the importance of aligning research questions with data needs to truly inform decision. Panelists estimated the value of GH for TS at 41% of maximum value on the MCDA scale, with good agreement at the individual level (retest value 40%; ICC: 0.687) and large variation across panelists. Main contributors to this panel specific value were "Improvement of efficacy", "Disease severity" and "Quality of evidence". Ethical considerations on utility, efficiency and fairness as well as potential misuse of GH had mixed effects on the perceived value of the treatment. CONCLUSIONS: This framework is proposed as a pragmatic step beyond the current cost-effectiveness model, combining HTA, MCDA, values and ethics. It supports systematic consideration of all components of decision and available evidence for greater transparency. Further testing and validation is needed to build up MCDA approaches combined with pragmatic HTA in healthcare decision-making.

The economic burden of insomnia: direct and indirect costs for individuals with insomnia syndrome, insomnia symptoms, and good sleepers.

BACKGROUND AND PURPOSE: Insomnia is a highly prevalent problem that is associated with increased use of health care services and products, as well as functional impairments. This study estimated from a societal perspective the direct and indirect costs of insomnia. PARTICIPANTS AND METHODS: A randomly selected sample of 948 adults (mean age = 43.7 years old; 60% female) from the province of Quebec, Canada completed questionnaires on sleep, health, use of health-care services and products, accidents, work absences, and reduced productivity. Data were also obtained from the Quebec government administered health insurance board regarding consultations and hospitalizations. Participants were categorized as having insomnia syndrome, insomnia symptoms or as being good sleepers using a standard algorithm. Frequencies of target cost variables were obtained and multiplied by unit costs to generate estimates of total costs for the adult population of the province of Quebec. RESULTS: The total annual cost of insomnia in the province of Quebec was estimated at $6.6 billion (Cdn$). This includes direct costs associated with insomnia-motivated health-care consultations ($191.2 million) and transportation for these consultations ($36.6 million), prescription medications ($16.5 million), over the-counter products ($1.8 million) and alcohol used as a sleep aid ($339.8 million). Annual indirect costs associated with insomnia-related absenteeism were estimated at $970.6 million, with insomnia-related productivity losses estimated at $5.0 billion. The average annual per-person costs (direct and indirect combined) were $5,010 for individuals with insomnia syndrome, $1431 for individuals presenting with symptoms, and $421 for good sleepers. CONCLUSIONS: This study suggests that the economic burden of insomnia is very high, with the largest proportion of all expenses (76%) attributable to insomnia-related work absences and reduced productivity. As the economic burden of untreated insomnia is much higher than that of treating insomnia, future clinical trials should evaluate the cost-benefits, cost-utility, and cost-effectiveness of insomnia therapies.

Initiation of insulin therapy in elderly patients taking oral antidiabetes drugs.

BACKGROUND: We sought to estimate the rate of initiation of insulin therapy among elderly patients using oral anti-diabetes drugs and to identify the factors associated with this initiation. METHODS: We conducted a population-based cohort study involving people aged 66 or more years who were newly dispensed an oral antidiabetes drug. Individuals who had received acarbose or a thiazolidinedione were excluded. The rate of insulin initiation was calculated by use of the Kaplan-Meier method. Factors associated with insulin initiation were identified by multivariable Cox regression analyses. RESULTS: In this cohort of 69,674 new users of oral antidiabetes drugs, insulin was initiated at rate of 9.7 cases per 1000 patient-years. Patients who had initially received an insulin secretagogue (rather than metformin), who were prescribed an oral antidiabetes drug by an endocrinologist or an internist, who received higher initial doses of an oral antidiabetes drug, who received oral corticosteroids, used glucometer strips, or were admitted to hospital in the year before initiation of oral antidiabetes therapy, or who received 16 or more medications were more likely than those without these characteristics to have insulin therapy initiated. In contrast, patients who received thiazides or who used up to 12 medications (v. none) were less likely to have insulin therapy initiated. INTERPRETATION: Several factors related to drugs and health services are associated with the initiation of insulin therapy in elderly patients receiving oral antidiabetes drugs. It is unclear whether these factors predict secondary failure of oral antidiabetes drugs or instead reflect better management of type 2 diabetes.