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1.  Empowering pharmacists in asthma management through interactive SMS (EmPhAsIS): study protocol for a randomized controlled trial 
Trials  2014;15(1):488.
Medication regimens for asthma are particularly vulnerable to adherence problems because of the requirement for long-term use and periods of symptom remission experienced by patients. Pharmacists are suited to impact medication adherence given their training, skills, and frequent contact with patients. The Empowering pharmacists in asthma management through interactive SMS (EmPhAsIS) trial involves an intervention leveraging mobile health (mHealth) technology to support community pharmacy practice with the hypothesis of improved medication adherence in asthma.
This study is a pragmatic pharmacy-based, cluster, randomized controlled trial with 12 months of intervention delivery and follow-up. Pharmacies (the clusters) will be randomized at a 1:1 ratio to provide intervention or usual care. The EmPhAsIS intervention consists of patient asthma education, short message service (SMS)-based monthly assessment of adherence, and follow-up of non-adherent individuals by community pharmacists. There are no inclusion or exclusion criteria for pharmacies. Patients are eligible if they: are 14 years of age or older, fill a prescription for inhaled corticosteroid (either monotherapy or in a combination inhaler with long-acting beta-agonists), have been diagnosed with asthma, possess a mobile phone with SMS capabilities, and have no communication difficulties such as inability to communicate in English, or significant impairment in vision, hearing, or speech. The primary outcome is adherence to inhaled corticosteroids ascertained by the medication possession ratio, the ratio of the days of medication supplied to days in a given time interval. This study will also evaluate secondary outcomes including: asthma control, asthma-related quality of life, asthma-related hospital admissions, and use of reliever medications during the follow-up period. A nested economic evaluation using a probabilistic decision-analytic model will be used to perform a cost-effectiveness analysis from the societal perspective of the intervention compared with usual care over a 10-year time horizon.
Considering the prevalence of asthma, the extent of the non-adherence problem in this disease, and the availability of effective treatments, there is a tremendous potential to reduce the burden of asthma through improving adherence. This is the first study of an intervention based on mobile communication technology involving community pharmacists in asthma management.
Trial registration identifier: NCT02170883; date of registration: 19 June 2014.
PMCID: PMC4301403  PMID: 25494702
Asthma; Medication adherence; Inhaled corticosteroids; Cluster randomized controlled trial; Community pharmacy; Pharmacy practice research
2.  Heterogeneity's ruses: the neglected role of between-individual variability in longitudinal studies of COPD exacerbations 
Thorax  2014;69(11):1043-1044.
Studying the causal and temporal association between past and future exacerbations in COPD is an active area of research. Standard survival analysis techniques often used in such studies typically produce results that pertain to the overall population, whereas the greatest interest is in the study of associations within individuals. A factor that can lead to profound discrepancies between population-level and individual-level survival patterns is the between-individual heterogeneity in the rate of exacerbations. We briefly review two studies that, while reporting valid results for the overall population, drew conclusions at the individual level that could not be supported by the observations. We caution on the distinction between population and individual-level associations in survival analysis, and recommend accounting for heterogeneity in future studies.
PMCID: PMC4215271  PMID: 24550058
COPD Exacerbations
4.  Incorporating external evidence in trial-based cost-effectiveness analyses: the use of resampling methods 
Trials  2014;15:201.
Cost-effectiveness analyses (CEAs) that use patient-specific data from a randomized controlled trial (RCT) are popular, yet such CEAs are criticized because they neglect to incorporate evidence external to the trial. A popular method for quantifying uncertainty in a RCT-based CEA is the bootstrap. The objective of the present study was to further expand the bootstrap method of RCT-based CEA for the incorporation of external evidence.
We utilize the Bayesian interpretation of the bootstrap and derive the distribution for the cost and effectiveness outcomes after observing the current RCT data and the external evidence. We propose simple modifications of the bootstrap for sampling from such posterior distributions.
In a proof-of-concept case study, we use data from a clinical trial and incorporate external evidence on the effect size of treatments to illustrate the method in action. Compared to the parametric models of evidence synthesis, the proposed approach requires fewer distributional assumptions, does not require explicit modeling of the relation between external evidence and outcomes of interest, and is generally easier to implement. A drawback of this approach is potential computational inefficiency compared to the parametric Bayesian methods.
The bootstrap method of RCT-based CEA can be extended to incorporate external evidence, while preserving its appealing features such as no requirement for parametric modeling of cost and effectiveness outcomes.
PMCID: PMC4055939  PMID: 24888356
Cost-benefit analysis; Bayes theorem; Clinical trial; Statistics-nonparametric
5.  The effect of weekly text-message communication on treatment completion among patients with latent tuberculosis infection: study protocol for a randomised controlled trial (WelTel LTBI) 
BMJ Open  2014;4(4):e004362.
Interventions to improve adherence to treatment for latent tuberculosis infection (LTBI) are necessary to improve treatment completion rates and optimise tuberculosis (TB) control efforts. The high prevalence of cell phone use presents opportunities to develop innovative ways to engage patients in care. A randomised controlled trial (RCT), WelTel Kenya1, demonstrated that weekly text messages improved antiretroviral adherence and clinical outcomes among patients initiating HIV treatment. The aim of this study is to determine whether the WelTel intervention can improve treatment completion among patients with LTBI and to evaluate the intervention's cost-effectiveness.
Methods and analysis
This open, two-site, parallel RCT (WelTel LTBI) will be conducted at TB clinics in Vancouver and New Westminster, British Columbia, Canada. Over 2 years, we aim to recruit 350 individuals initiating a 9-month isoniazid regimen. Participants will be randomly allocated to an intervention or control (standard care) arm in a 1:1 ratio. Intervention arm participants will receive a weekly text-message ‘check-in’ to which they will be asked to respond within 48 h. A TB clinician will follow-up instances of non-response and problems that are identified. Participants will be followed until treatment completion (up to 12 months) or discontinuation. The primary outcome is self-reported treatment completion (taking ≥80% of doses within 12 months). Secondary outcomes include daily adherence (percentage of days participants used medication as prescribed) and time to treatment completion. Patient satisfaction with the intervention will be evaluated, and the intervention's cost-effectiveness will be analysed through decision-analytic modelling.
Ethics and dissemination
Ethical approval has been obtained from the University of British Columbia. This trial will test the efficacy and cost-effectiveness of the WelTel intervention to improve treatment completion among patients with LTBI. Trial results and economic evaluation will help inform policy and practice on the use of WelTel in this population.
Trial registration number NCT01549457.
PMCID: PMC3987735  PMID: 24719431
6.  The impact of incorporating Bayesian network meta-analysis in cost-effectiveness analysis - a case study of pharmacotherapies for moderate to severe COPD 
To evaluate the impact of using network meta-analysis (NMA) versus pair wise meta-analyses (PMA) for evidence synthesis on key outputs of cost-effectiveness analysis (CEA).
We conducted Bayesian NMA of randomized clinical trials providing head-to-head and placebo comparisons of the effect of pharmacotherapies on the exacerbation rate in chronic obstructive pulmonary disease (COPD). Separately, the subset of placebo–comparison trials was used in a Bayesian PMA. The pooled rate ratios (RR) were used to populate a decision-analytic model of COPD treatment to predict 10-year outcomes.
Efficacy estimates from the NMA and PMA were similar, but the NMA provided estimates with higher precision. This resulted in similar incremental cost-effectiveness ratios (ICER). Probabilities of being cost-effective at willingness-to-pay thresholds (WTPs) between $25,000 and $100,000 per quality adjusted life year (QALY) varied considerably between the PMA- and NMA-based approaches. The largest difference in the probabilities of being cost-effective was observed at a WTP of approximately $40,000/QALY. At this threshold, with the PMA-based analysis, ICS, LAMA and placebo had a 43%, 30, and 18% probability of being the most cost-effective. By contrast, with the NMA based approach, ICS, LAMA, and placebo had a 56%, 19%, and 21% probability of being cost-effective. For larger WTP thresholds the probability of LAMA being the most cost-effective became higher than that of ICS. Under the PMA-based analyses the cross-over occurred at a WTP threshold between $60,000/QALY-$65,000/QALY, whereas under the NMA-based approach, the cross-over occurred between $85,000/QALY-$90,000/QALY.
Use of NMAs in CEAs is feasible and, as our case study showed, can decrease uncertainty around key cost-effectiveness measures compared with the use of PMAs. The approval process of health technologies in many jurisdictions requires estimates of comparative efficacy and cost-effectiveness. NMAs play an increasingly important role in providing estimates of comparative efficacy. Their use in the CEAs therefore results in methodological consistency and reduced uncertainty.
PMCID: PMC4007707  PMID: 24625208
Meta-analysis; Multiple treatment comparison; Bayesian analysis; Cost-effectiveness
7.  Post-hospital syndrome in adults with asthma: a case-crossover study 
Post-hospital syndrome refers to the period of generalized risk of adverse health outcomes among patients who are recently discharged from hospital. This period is associated with a short-term increased risk of readmission which may not be related to the original condition. While the majority of studies of post-hospital syndrome have focused on all-cause readmissions, whether and to what extent such a phenomenon exists within discrete medical conditions is not yet known.
To investigate whether the risk of admission due to asthma is increased in individuals who are discharged following any-cause hospital admission.
Using administrative health data for the period 1997 to 2007 from the province of British Columbia, Canada, we created a cohort of adults with asthma. Using a case-crossover design, we assessed the association between discharge from a hospital (exposure) within 30 days before an asthma-related hospitalization (the outcome), using two 30-day control periods within the same subject. Conditional logistic regression was performed to calculate the relative risk (RR) of the outcome in association with exposure. We performed several sensitivity and subgroup analyses.
The final cohort included 3,852 patients experiencing 6,333 instances of the outcome. Mean age at the time of the outcome was 43.7 (SD 14.2), 69.0% of such outcomes belonged to females. The RR of the outcome within the next 30 days of a previous any-cause discharge was 1.40 (95% CI 1.22 - 1.59). However, the association was mainly caused by discharge from asthma-related admission [RR = 1.99 (95% CI 1.65 - 2.39)]. The RR associated with non-asthma-related discharge was 0.88 (95% CI 0.74 - 1.04) and was not statistically significant. Similar results were obtained in a range of sensitivity analyses.
Our results indicate that in patients with asthma, the 30-day risk of asthma-related admission is increased after an episode of asthma-related hospitalization, but not after an episode of non-asthma-related hospitalization.
PMCID: PMC3880050  PMID: 24364886
8.  Complementary and alternative asthma treatments and their association with asthma control: a population-based study 
BMJ Open  2013;3(9):e003360.
Many patients with asthma spend time and resources consuming complementary and alternative medicines (CAMs). This study explores whether CAM utilisation is associated with asthma control and the intake of asthma controller medications.
Population-based, prospective cross-sectional study.
General population residing in two census areas in the province of British Columbia, Canada. Recruitment was based on random-digit dialling of both landlines and cell phones.
486 patients with self-reported physician diagnosis of asthma (mean age 52 years; 67.3% woman).
Primary and secondary outcome measures
We assessed CAM use over the previous 12 months, level of asthma control as defined by the Global Initiative for Asthma and the self-reported intake of controller medications. Multivariate logistic regression was performed to study the relationship between any usage of CAMs (outcome), asthma control and controller medication usage, adjusted for potential confounders.
A total of 179 (36.8%) of the sample reported CAM usage in the past 12 months. Breathing exercises (17.7%), herbal medicines (10.1%) and vitamins (9.7%) were the most popular CAMs reported. After adjustment, female sex (OR 1.66; 95% CI 1.09 to 2.52) and uncontrolled asthma (vs controlled asthma, OR 2.25, 95% CI 1.30 to 3.89) were associated with a higher likelihood of using any CAMs in the past 12 months. Controller medication use was not associated with CAM usage in general and in the subgroups defined by asthma control.
Clinicians and policy makers need to be aware of the high prevalence of CAM use in patients with asthma and its association with lack of asthma control.
PMCID: PMC3773646  PMID: 24005131
Complementary Medicine
9.  Correction: Trends in Asthma-Related Direct Medical Costs from 2002 to 2007 in British Columbia, Canada: A Population Based-Cohort Study 
PLoS ONE  2013;8(6):10.1371/annotation/a3275f00-6d75-4430-a0d6-5b4397ba501a.
PMCID: PMC3731367
10.  Trends in Asthma-Related Direct Medical Costs from 2002 to 2007 in British Columbia, Canada: A Population Based-Cohort Study 
PLoS ONE  2012;7(12):e50949.
Asthma-related health resource use and costs may be influenced by increasing asthma prevalence, changes to asthma management guidelines, and new medications over the last decade. The objective of this work was to analyze direct asthma-related medical costs, and trends in total and per-patient costs of hospitalizations, physician visits, and medications.
A cohort of asthma patients from British Columbia (BC), Canada, was created. Asthma patients were identified using a validated case definition. Costs for hospitalizations, physician visits, and medications were calculated from billing records (in 2008 Canadian dollars). Trends in total and per-patient costs over the study period were analyzed using Generalized Linear Models.
398,235 patients satisfied the asthma case definition (mid-point prevalence 8.0%). Patients consumed $315.9 million (M) in direct asthma-related health resources between 2002 and 2007. Hospitalizations, physician visits, and medication costs accounted for 16.0%, 15.7% and 68.2% of total costs, respectively. Cost of asthma increased from $49.4 M in 2002 to $54.7 M in 2007. Total annual costs attributable to hospitalizations and physician visits decreased (−39.8% and −25.5%, respectively; p<0.001), while medication costs increased (+38.7%; p<0.001).
This population-based analysis shows that the total direct cost of asthma in BC has increased since 2002, mainly due to a rise in asthma prevalence and cost of medication. Combination therapy with inhaled corticosteroids/long-acting beta-agonists has become a significant component of the cost of asthma. Although billing records capture only a fraction of the true burden of asthma, the simultaneous increase in medication costs and reductions in hospitalization and physician visit costs provides valuable insight for policy makers into the shifts in asthma-related resource use.
PMCID: PMC3515523  PMID: 23227222
11.  Future Impact of Various Interventions on the Burden of COPD in Canada: A Dynamic Population Model 
PLoS ONE  2012;7(10):e46746.
Chronic obstructive pulmonary disease (COPD) is a growing economic burden worldwide. Smoking cessation is thought to be the single most effective way of reducing the economic burden of COPD. The impact of other strategies such as interventions that predict risk of disease, reduce progression of disease, or reduce exacerbations has not been systematically studied.
We estimated the economic and clinical burden of COPD over the next 25 years in Canada and the impact of three potential interventions (screening test for predisposition to COPD, new drugs to avoid progression into more severe disease stages, and predictive test for exacerbations) on COPD burden.
Using a dynamic simulation model, we projected the total burden of COPD (cost, morbidity, and mortality) from 2011 to 2035 using the population of Canada as a case study. The model stratified population based on sex, age, smoking status, respiratory symptoms, and their COPD stage. The cost and quality adjusted life years (QALYs) associated with each intervention were estimated.
The model indicates that annual societal cost of COPD is $4.52 billion (B) Canadian dollars in 2011 and will reach $3.61B ($7.33B undiscounted) per year in 2035. Over the next 25 years, COPD will be responsible for approximately $101.4B in societal costs ($147.5B undiscounted) and 12.9 million QALYs lost (19.0 million undiscounted). Our results suggested that the best strategy to reduce the financial burden of COPD is by reducing exacerbations. Smoking cessation, while it is the cornerstone of COPD prevention, has only a modest effect in attenuating the financial burden of COPD over the next 25 years in Western countries such as Canada.
Our data suggest that any intervention that can reduce the number of exacerbations has a substantial impact on morbidity and costs of COPD and should be considered in conjunction with the ongoing efforts to reduce smoking rates.
PMCID: PMC3469627  PMID: 23071626
12.  Direct health care costs associated with asthma in British Columbia 
A better understanding of health care costs associated with asthma would enable the estimation of the economic burden of this increasingly common disease.
To determine the direct medical costs of asthma-related health care in British Columbia (BC).
Administrative health care data from the BC Linked Health Database and PharmaNet database from 1996 to 2000 were analyzed for BC residents five to 55 years of age, including the billing information for physician visits, drug dispensations and hospital discharge records. A unit cost was assigned to physician/emergency department visits, and government reimbursement fees for prescribed medications were applied. The case mix method was used to calculate hospitalization costs. All costs were reported in inflation-adjusted 2006 Canadian dollars.
Asthma resulted in $41,858,610 in annual health care-related costs during the study period ($331 per patient-year). The major cost component was medications, which accounted for 63.9% of total costs, followed by physician visits (18.3%) and hospitalization (17.8%). When broader definitions of asthma-related hospitalizations and physician visits were used, total costs increased to $56,114,574 annually ($444 per patient-year). There was a statistically significant decrease in the annual per patient cost of hospitalizations (P<0.01) over the study period. Asthma was poorly controlled in 63.5% of patients, with this group being responsible for 94% of asthma-related resource use.
The economic burden of asthma is significant in BC, with the majority of the cost attributed to poor asthma control. Policy makers should investigate the reason for lack of proper asthma control and adjust their policies accordingly to improve asthma management.
PMCID: PMC2866215  PMID: 20422063
Asthma; Cost of illness; Health care costs; Retrospective studies
13.  Treatment Outcomes of Multidrug-Resistant Tuberculosis: A Systematic Review and Meta-Analysis 
PLoS ONE  2009;4(9):e6914.
Treatment outcomes for multidrug-resistant Mycobacterium Tuberculosis (MDRTB) are generally poor compared to drug sensitive disease. We sought to estimate treatment outcomes and identify risk factors associated with poor outcomes in patients with MDRTB.
Methodology/Principal Findings
We performed a systematic search (to December 2008) to identify trials describing outcomes of patients treated for MDRTB. We pooled appropriate data to estimate WHO-defined outcomes at the end of treatment and follow-up. Where appropriate, pooled covariates were analyzed to identify factors associated with worse outcomes. Among articles identified, 36 met our inclusion criteria, representing 31 treatment programmes from 21 countries. In a pooled analysis, 62% [95% CI 57–67] of patients had successful outcomes, while 13% [9]–[17] defaulted, 11% [9]–[13] died, and 2% [1]–[4] were transferred out. Factors associated with worse outcome included male gender 0.61 (OR for successful outcome) [0.46–0.82], alcohol abuse 0.49 [0.39–0.63], low BMI 0.41[0.23–0.72], smear positivity at diagnosis 0.53 [0.31–0.91], fluoroquinolone resistance 0.45 [0.22–0.91] and the presence of an XDR resistance pattern 0.57 [0.41–0.80]. Factors associated with successful outcome were surgical intervention 1.91 [1.44–2.53], no previous treatment 1.42 [1.05–1.94], and fluoroquinolone use 2.20 [1.19–4.09].
We have identified several factors associated with poor outcomes where interventions may be targeted. In addition, we have identified high rates of default, which likely contributes to the development and spread of MDRTB.
PMCID: PMC2735675  PMID: 19742330
14.  Obesity and hypertension in an Iranian cohort study; Iranian women experience higher rates of obesity and hypertension than American women 
BMC Public Health  2006;6:158.
Once considered as the main public health problem in developed countries, obesity has become a major problem throughout the world and developing countries, like Iran, are joining the global obesity pandemic. We determined the prevalence of overweight, obesity, and hypertension in a large cohort of Iranians and compared age-adjusted rates with the rates in the US.
Golestan Cohort Study is a population-based study of 8,998 men and women, aged 35-81 years, from urban and rural areas. Anthropometric parameters were measured by interviewers. Prevalence rates were directly adjusted to the 2000 United States standard population.
The age-adjusted prevalence rates of overweight (BMI ≥ 25 kg/m2) and obesity (BMI ≥ 30 kg/m2) in this Iranian population were 62.2% and 28.0%, respectively. Both overweight and obesity were more common in women than men. Age-adjusted prevalence of overweight was significantly higher in Iranian women compared to the American women (68.6% vs. 61.6%), while the age-adjusted prevalence of obesity is closer in these two populations (34.9% vs. 33.2%). Iranian men—compared to American men—had significantly lower age-adjusted prevalence of overweight (53.7% vs. 68.8%) and obesity (16.2% vs. 27.5%). Age-adjusted prevalence of hypertension was higher in Iranian women than American women (35.7% vs. 30.5%). Diabetes mellitus was reported in 6.2% of participants. Mean waist-to-hip ratio (WHR) among women was 0.96. Smoking rates in men and women were 33.2% and 2.2%, respectively.
The prevalence of obesity, overweight, and hypertension in Iran is as high as the US. However, Iranian women are more obese than American women and Iranian men are less obese than their American counterparts. This discrepancy might be due to the low rate of smoking among Iranian women. Iranian women have higher mean WHR than what WHO has defined in 19 other populations.
PMCID: PMC1533819  PMID: 16784543
16.  Discordance in diagnosis of osteoporosis using spine and hip bone densitometry 
Diagnostic discordance for osteoporosis is the observation that the T-score of an individual patient varies from one key measurement site to another, falling into two different diagnostic categories identified by the World Health Organization (WHO) classification system. This study was conducted to evaluate the presence and risk factors for this phenomenon in a large sample of Iranian population.
Demographic data, anthropometric measurements, and risk factors for osteoporosis were derived from a database on 4229 patients referred to a community-based outpatient osteoporosis testing center from 2000 to 2003. Dual-energy X-ray absorptiometry (DXA) was performed on L1–L4 lumbar spine and total hip for all cases. Minor discordance was defined as present when the difference between two sites was no more than one WHO diagnostic class. Major discordance was present when one site is osteoporotic and the other is normal. Subjects with incomplete data were excluded.
In 4188 participants (3848 female, mean age 53.4 ± 11.8 years), major discordance, minor discordance, and concordance of T-scores were seen in 2.7%, 38.9% and 58.3%, respectively. In multivariate logistic regression analysis, older age, menopause, obesity, and belated menopause were recognized as risk factors and hormone replacement therapy as a protective factor against T-score discordance.
The high prevalence of T-score discordance may lead to problems in interpretation of the densitometry results for some patients. This phenomenon should be regarded as a real and prevalent finding and physicians should develop a particular strategy approaching to these patients.
PMCID: PMC555556  PMID: 15762986
17.  Frequency of myasthenic crisis in relation to thymectomy in generalized myasthenia gravis: A 17-year experience 
BMC Neurology  2004;4:12.
Myasthenic crisis is the most serious life-threatening event in generalized myasthenia gravis (MG) patients. The objective of this study was to assess the long-term impact of thymectomy on rate and severity of these attacks in Iranian patients.
We reviewed the clinical records from 272 myasthenic patients diagnosed and treated in our neurology clinic during 1985 to 2002. Fifty-three patients were excluded because of unconfirmed diagnosis, ocular form of MG, contraindication to surgery, concomitant diseases and loss to follow-up. The Osserman classification was used to assess the initial severity of the disease. Frequency and severity of the attacks were compared between two groups with appropriate statistical tests according to the nature of variables. Multivariate logistic regression analysis was used to assess the predictors of myasthenic crisis in the group of patients without thymoma.
110 patients were in thymectomy group and the other 109 patients were on medical therapy. These two groups had no significant differences with respect to age at onset, gender, Osserman score in baseline and follow up period. 62 patients (28.3% of all 219 patients) had reported 89 attacks of myasthenic crisis. 20 patients of 62 (32%) were in thymectomy group and 42 (68%) were in the other group. There was significant difference between the two groups in number of patients with crisis (P = 0.001; odds ratio = 2.8 with 95% CI of 1.5 to 5.2). In addition, these attacks were more severe in group of non-thymectomized patients as the duration of ICU admission was longer and they needed more ventilatory support during their attacks. Regression model showed thymectomy and lower age at onset as two predictors of decrement in myasthenic crisis rate in non-thymomatous MG patients.
It is suggested that frequency and severity of myasthenic attacks as important endpoints in evaluation of MG patients. Thymectomy seems to have a preventive role on rate and severity of these attacks.
PMCID: PMC518967  PMID: 15361260

Results 1-17 (17)