[Show abstract][Hide abstract] ABSTRACT: Randomized controlled trials are considered the "gold standard" for scientific rigor in the assessment of benefits and harms of interventions in healthcare. They may not always be feasible, however, when evaluating quality improvement interventions in real-world healthcare settings. Non-randomized controlled trials (NCTs) are designed to answer questions of effectiveness of interventions in routine clinical practice to inform a decision or process. The on-off NCT design is a relatively new design where participant allocation is by alternation. In alternation, eligible patients are allocated to the intervention "on" or control "off " groups in time series dependent sequential clusters.
We used two quality improvement studies undertaken in a Canadian primary care setting to illustrate the features of the on-off design. We also explored the perceptions and experiences of healthcare providers tasked with implementing the on-off study design.
The on-off design successfully allocated patients to intervention and control groups. Imbalances between baseline variables were attributed to chance, with no detectable biases. However, healthcare providers' perspectives and experiences with the design in practice reveal some conflict. Specifically, providers described the process of allocating patients to the off group as unethical and immoral, feeling it was in direct conflict with their professional principle of providing care for all. The degree of dissatisfaction seemed exacerbated by: 1) the patient population involved (e.g., patient population viewed as high-risk (e.g., depressed or suicidal)), 2) conducting assessments without taking action (e.g., administering the PHQ-9 and not acting on the results), and 3) the (non-blinded) allocation process.
Alternation, as in the on-off design, is a credible form of allocation. The conflict reported by healthcare providers in implementing the design, while not unique to the on-off design, may be alleviated by greater emphasis on the purpose of the research and having research assistants allocate patients and collect data instead of the healthcare providers implementing the trial. In addition, consultation with front-line staff implementing the trials with an on-off design on appropriateness to the setting (e.g., alignment with professional values and the patient population served) may be beneficial.
Health Eating and Active Living with Diabetes: ClinicalTrials.gov identifier: NCT00991380 Date registered: 7 October 2009. Controlled trial of a collaborative primary care team model for patients with diabetes and depression: Clintrials.gov Identifier: NCT01328639 Date registered: 30 March 2011.
[Show abstract][Hide abstract] ABSTRACT: Seasonality in health outcomes has long been recognized in conditions such as colds and flu's. This study sought to determine if hospitalizations of acute complications of type 1 diabetes vary by month and season.
We performed an observational study of national administrative health data. Hospitalizations for acute complications in adults (age ≥ 18 years old) with type 1 diabetes were identified using ICD-10 CA codes between 2004 and 2010. Monthly and seasonal counts per year were determined for the study period. For each acute complication, a ratio of the number of observed hospitalizations divided by the expected number of hospitalizations was calculated for each month and season per year, adjusting for varied lengths of month, season, and year.
There were a total of 21,568 hospitalizations for diabetic ketoacidosis and 5,349 hospitalizations for hypoglycemia in the study period. December demonstrated higher than expected hospitalizations for diabetic ketoacidosis and March demonstrated higher than expected hospitalizations for hypoglycemia. There did not appear to be variation for either diabetic ketoacidosis or hypoglycemia hospitalizations by season.
This study suggests temporal variation in hospitalizations for diabetic ketoacidosis and hypoglycemia, and therefore signals important times of patient vulnerability. Potential mechanisms underlying this pattern warrant further examination. Prevention strategies and resources for patients with type 1 diabetes may need to be increased at specific times during the year. This article is protected by copyright. All rights reserved.
This article is protected by copyright. All rights reserved.
Journal of Diabetes 08/2015; DOI:10.1111/1753-0407.12336 · 1.93 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: OBJECTIVE:
To examine the prevalence and predictors of foot disease, self-care and clinical monitoring in adults with type 2 diabetes in Alberta, Canada.
Baseline data from a prospective cohort of adults with type 2 diabetes were used. Assessment of foot disease included self-reported peripheral neuropathy, peripheral vasculopathy, foot or leg ulcer/infection or gangrene/amputation. Foot self-care was assessed using the Summary of Diabetes Self-Care Activities, and clinical monitoring using patients' reports of having feet checked for lesions or sensory loss.
The mean age of respondents (N=2040) was 64 (SD 10.7) years; 45% were female, and 91% were Caucasian. Peripheral neuropathy was reported by 18% of the respondents, peripheral vasculopathy by 28%, ulcer/infection by 6% and gangrene/amputation by 1.4%. Only 14% of respondents performed foot self-care behaviours ≥6 days per week, and only 41% and 34% had their feet clinically checked for lesions or sensory loss, respectively. Predictors of foot disease included longer duration of diabetes, smoking, depressive symptoms, low self-efficacy and a history of cardiovascular diseases. Predictors of good self-care included older age, female sex, longer duration of diabetes and no report of hyperlipidemia. Predictors of clinical monitoring included female sex, current smoking, residing in urban areas, longer duration of diabetes, and histories of heart disease or hyperlipidemia.
Peripheral neuropathy and vasculopathy were the most common reported foot problems in this population. Foot self-care is generally infrequent, and clinical monitoring is performed for less than half of these patients, with significant variations by patient demographics and clinical presentation.
Canadian Journal of Diabetes 08/2015; · 2.00 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The EuroQol Valuation Technology (EQ-VT) uses traditional time trade-off (tTTO) for health states better than dead and lead-time TTO (LT-TTO) for states worse than dead to elicit a value (-1.0 to +1.0) for each health state. In the Canadian EQ-5D-5L Valuation study which used the EQVT platform, we observed an unexpected peak in frequency of "0" values and few negative values, particularly in the range of 0 to -0.5. To better understand this finding, we sought to explore respondents' thought processes while valuing a health state, and their understanding of the tTTO and LT-TTO exercises.
Qualitative semi-structured interviews were conducted with EQVT task respondents. Questions focused on valuations of health states as: (a) Same as dead in tTTO, (b) Worse than dead in tTTO but changed to same as dead in LT-TTO, (c) Worse than dead in LT-TTO, and (d) Worse than dead in LT-TTO with trading off all 10 years. Data were analyzed using content and thematic analysis.
Mean age of participants (N = 70) was 40 ± 18.1 years, 60 % female, and 76 % Caucasian. Participants provided similar reasons for valuing a health state same as or worse than dead. Many participants expressed confusion about worse than dead valuations, distinction between same as and worse than dead, and the transition from tTTO to LT-TTO. A few indicated that the addition of 10 years of full health in the LT-TTO influenced their valuations.
The transition from tTTO to LT-TTO in the EQVT was confusing to participants, whereby some health state valuations around this transition appeared to be arbitrary.
Quality of Life Research 07/2015; DOI:10.1007/s11136-015-1073-9 · 2.49 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: We evaluated the implementation of an efficacious collaborative care model for patients with diabetes and depression in a controlled trial in 4 community-based primary care networks (PCNs) in Alberta, Canada. Similar to previous randomized trials, the nurse care manager-led TeamCare intervention demonstrated statistically significant improvements in depressive symptoms compared with usual care. We contextualized TeamCare’s effectiveness by describing implementation fidelity at the organizational and patient levels.
[Show abstract][Hide abstract] ABSTRACT: To identify which activities produced a significant improvement in blood pressure control in patients with type 2 diabetes when pharmacists were added to primary care teams.
This prespecified, secondary analysis evaluated medication management data from a randomized controlled trial. The primary outcome was a change in treatment, defined as addition, dosage increase, or switching of an antihypertensive medication during the 1-year study period. The secondary outcome was a change in antihypertensive medication adherence using the medication possession ratio (MPR).
The 200 evaluable trial patients had a mean age of 59 (SD, 11) years, 44% were men, and mean blood pressure was 130 (SD, 16)/74 (SD, 10) mm Hg at baseline. Treatment changes occurred in 45 (42%) of 107 patients in the intervention group and 24 (26%) of 93 patients in the control group (RR, 1.63; 95% CI, 1.08-2.46). Addition of a new medication was the most common type of change, occurring in 34 (32%) patients in the intervention group and 17 (18%) patients in the control group (P = 0.029). Adherence to antihypertensive medication was high at baseline (MPR, 93%). Although medication adherence improved in the intervention group (MPR, 97%) and declined in the control group (MPR, 91%), the difference between groups was not significant (P = 0.21).
The observed improvement in blood pressure control when pharmacists were added to primary care teams was likely achieved through antihypertensive treatment changes and not through improvements in antihypertensive medication adherence.
Journal of the American Pharmacists Association 04/2015; 55(3):e301-e304. DOI:10.1331/JAPhA.2015.14225 · 1.24 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: To the Editor: We thank Frans Pouwer for his comments on our study  exploring adherence to glucose-lowering drugs following a cancer diagnosis among individuals with diabetes . Our findings revealed that there was a significant drop in the medication possession ratio at the time of cancer diagnosis, with the largest drops among patients with stage IV disease and gastrointestinal or pulmonary cancers. In his letter, Pouwer describes two potential mechanisms that could explain these results .As Pouwer indicates, weight loss has been associated with improvements in beta cell function and insulin sensitivity among individuals with diabetes. As a result, glucose levels decline, HbA1c values improve and less glucose-lowering drug treatment may be required to obtain optimal metabolic control. While weight loss is common among cancer patients, especially among those with gastrointestinal, lung or advanced cancer, as described by Pouwer, the impact of weight loss on metabolic control a ...
[Show abstract][Hide abstract] ABSTRACT: Inadequate health literacy has been associated with poorer health behaviors and outcomes in individuals with diabetes or depression. This study was conducted to examine the associations between inadequate health literacy and behavioral and cardiometabolic parameters in individuals with type 2 diabetes and to explore whether these associations are affected by concurrent depression. The authors used cross-sectional data from a study of 343 predominantly African Americans with type 2 diabetes. Inadequate health literacy was significantly and modestly associated with diabetes knowledge (r = -0.34) but weakly associated with self-efficacy (r = 0.16) and depressive symptoms (r = 0.24). In multivariate regression models, there were no associations between health literacy and A1c, blood pressure, or body mass index or control of any of these parameters. There was no evidence that depression was an effect-modifier of the associations between health literacy and outcomes. Although inadequate health literacy was modestly associated with worse knowledge and weakly associated with self-efficacy, it was not associated with any of the cardiometabolic parameters the authors studied. Because this study showed no association between health literacy and behavioral and cardiometabolic outcomes, it is unseemly and premature to embark on trials or controlled interventions to improve health literacy for the purposes of improving patient-related outcomes in diabetes.
Journal of Health Communication 03/2015; 20(5):1-8. DOI:10.1080/10810730.2015.1012235 · 1.61 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Adherence to glucose-lowering drug (GLD) treatment regimens is crucial for metabolic control and improving prognosis. Because a diagnosis of cancer might have an impact on adherence to medication, this study explored changes in adherence to GLDs following a cancer diagnosis.
All new users of GLDs between 1998 and 2011 who lived in the Eindhoven Cancer Registry-PHARMO Database Network catchment area were selected. Those with a primary cancer diagnosis during follow-up were considered cases and matched with eligible controls without cancer during follow-up. Medication possession ratio (MPR) was used as indicator for medication adherence. Segmented linear auto-regression analysis with interrupted time series was used to assess changes in MPR for cases compared with controls (i.e. overall trend) due to (any) cancer diagnosis and specific cancer types.
From the 52,228 GLD users selected, 3,281 cases with cancer and 12,891 controls without cancer during follow-up were included in the study. In our analyses, before cancer diagnosis the MPR increased by 0.10% per month (95% CI 0.10, 0.10). Besides a significant drop in MPR at the time of cancer diagnosis of -6.3% (95% CI -6.5, -6.0), there was an ongoing, yet lower, monthly decline in MPR (-0.20%; 95% CI -0.21, -0.20) after cancer diagnosis. The largest drops in MPR at the time of cancer diagnosis, in the range of 11-15%, were seen among patients with stage IV disease and gastrointestinal or pulmonary cancers.
Our findings indicate a clear decline in adherence to GLD treatment regimens following a cancer diagnosis. The reason for the decline in MPR needs to be further elucidated.
[Show abstract][Hide abstract] ABSTRACT: Frailty is a multidimensional syndrome characterized by loss of physiologic reserve that gives rise to vulnerability to poor outcomes. We aimed to examine the association between frailty and long-term health-related quality-of-life among survivors of critical illness.
Prospective multicenter observational cohort study.
ICUs in six hospitals from across Alberta, Canada.
Four hundred twenty-one critically ill patients who were 50 years or older.
Frailty was operationalized by a score of more than 4 on the Clinical Frailty Scale. Health-related quality-of-life was measured by the EuroQol Health Questionnaire and Short-Form 12 Physical and Mental Component Scores at 6 and 12 months. Multiple logistic and linear regression with generalized estimating equations was used to explore the association between frailty and health-related quality-of-life. In total, frailty was diagnosed in 33% (95% CI, 28-38). Frail patients were older, had more comorbidities, and higher illness severity. EuroQol-visual analogue scale scores were lower for frail compared with not frail patients at 6 months (52.2 ± 22.5 vs 64.6 ± 19.4; p < 0.001) and 12 months (54.4 ± 23.1 vs 68.0 ± 17.8; p < 0.001). Frail patients reported greater problems with mobility (71% vs 45%; odds ratio, 3.1 [1.6-6.1]; p = 0.001), self-care (49% vs 15%; odds ratio, 5.8 [2.9-11.7]; p < 0.001), usual activities (80% vs 52%; odds ratio, 3.9 [1.8-8.2]; p < 0.001), pain/discomfort (68% vs 47%; odds ratio, 2.0 [1.1-3.8]; p = 0.03), and anxiety/depression (51% vs 27%; odds ratio, 2.8 [1.5-5.3]; p = 0.001) compared with not frail patients. Frail patients described lower health-related quality-of-life on both physical component score (34.7 ± 7.8 vs 37.8 ± 6.7; p = 0.012) and mental component score (33.8 ± 7.0 vs 38.6 ± 7.7; p < 0.001) at 12 months.
Frail survivors of critical illness experienced greater impairment in health-related quality-of-life, functional dependence, and disability compared with those not frail. The systematic assessment of frailty may assist in better informing patients and families on the complexities of survivorship and recovery.
Critical Care Medicine 01/2015; 43(5). DOI:10.1097/CCM.0000000000000860 · 6.31 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The evidence on the association between pioglitazone use and bladder cancer is contradictory, with many studies subject to allocation bias. The aim of our study was to examine the effect of exposure to pioglitazone on bladder cancer risk internationally across several cohorts. The potential for allocation bias was minimised by focusing on the cumulative effect of pioglitazone as the primary endpoint using a time-dependent approach.
Prescription, cancer and mortality data from people with type 2 diabetes were obtained from six populations across the world (British Columbia, Finland, Manchester, Rotterdam, Scotland and the UK Clinical Practice Research Datalink). A discrete time failure analysis using Poisson regression was applied separately to data from each centre to model the effect of cumulative drug exposure on bladder cancer incidence, with time-dependent adjustment for ever use of pioglitazone. These were then pooled using fixed and random effects meta-regression.
Data were collated on 1.01 million persons over 5.9 million person-years. There were 3,248 cases of incident bladder cancer, with 117 exposed cases and a median follow-up duration of 4.0 to 7.4 years. Overall, there was no evidence for any association between cumulative exposure to pioglitazone and bladder cancer in men (rate ratio [RR] per 100 days of cumulative exposure, 1.01; 95% CI 0.97, 1.06) or women (RR 1.04; 95% CI 0.97, 1.11) after adjustment for age, calendar year, diabetes duration, smoking and any ever use of pioglitazone. No association was observed between rosiglitazone and bladder cancer in men (RR 1.01; 95% CI 0.98, 1.03) or women (RR 1.00; 95% CI 0.94, 1.07).
The cumulative use of pioglitazone or rosiglitazone was not associated with the incidence of bladder cancer in this large, pooled multipopulation analysis.