Barriers and facilitators influencing the management of academic detailing programs: A descriptive analysis of four programs.

BACKGROUND: Educating prescribers is a key strategy to reduce inappropriate prescribing in selection, dose, type, timing, and duration. Academic detailing (AD) is a form of continuing medical education to educate prescribers. AD programs have been established in Canada, Australia, the United States, and other countries. Each program operates uniquely to reflect its local context and resources. It remains unclear how AD programs in universal health care systems differ from each other in their program components and experiences. OBJECTIVES: To compare AD programs focusing on components of resources, activities, and services and to identify factors influencing program efficiency during the processes of program management, topic development, and service delivery among the selected Canadian and international AD programs. METHODS: We adopted a process evaluation methodology with semistructured interviews and documents. We selected 4 well-established AD programs through an iterative discussion with the BC Ministry of Health: three provincial AD programs in the Canadian provinces of British Columbia, Ontario, and Saskatchewan, and an Australian program based in the State of South Australia. We invited one leader from each program to attend a 1-hour teleconferencing interview. RESULTS: The 4 programs shared similarities of public government funding while differed in their operation models (centralized vs. decentralized), employment of detailers (part-time vs. full-time; hired by AD programs vs. hired by partnered multidisciplinary primary care teams) and staff who developed topics (detailers vs. nondetailers). The most common barriers were funding and reaching new participants, followed by team connection, detailer training resources, summarizing skills, and AD session scheduling. The most common facilitators were participant retention, participant recruitment through partnership, and easy access sessions. CONCLUSION: AD programs can potentially guide a prescriber's choice of drug. A program's operation can be impacted by its access to resources and participants, activities, and service design.

Methods of sample size calculation in descriptive retrospective burden of illness studies.

BACKGROUND: Observational burden of illness studies are used in pharmacoepidemiology to address a variety of objectives, including contextualizing the current treatment setting, identifying important treatment gaps, and providing estimates to parameterize economic models. Methodologies such as retrospective chart review may be utilized in settings for which existing datasets are not available or do not include sufficient clinical detail. While specifying the number of charts to be extracted and/or determining whether the number that can feasibly extracted will be clinically meaningful is an important study design consideration, there is a lack of rigorous methods available for sample size calculation in this setting. The objective of this study was to develop recommended sample size calculations for use in such studies. METHODS: Calculations for identifying the optimal feasible sample size calculations were derived, for studies characterizing treatment patterns and medical costs, based on the ability to comprehensively observe treatments and maximize precision of resulting 95% confidence intervals. For cost outcomes, if the standard deviation is not known, the coefficient of variation cv can be used as an alternative. A case study of a chart review of advanced melanoma (MELODY) was used to characterize plausible values for cv in a real-world example. RESULTS: Across sample sizes, any treatment given with greater than 1% frequency has a high likelihood of being observed. For a sample of size 200, and a treatment given to 5% of the population, the precision of a 95% confidence interval (CI) is expected to be ±0.03. For cost outcomes, for the median cv value observed in the MELODY study (0.72), a sample size of approximately 200 would be required to generate a 95% CI precise to within ±10% of the mean. CONCLUSION: This study presents a formal guidance on sample size calculations for retrospective burden of illness studies. The approach presented here is methodologically rigorous and designed for practical application in real-world retrospective chart review studies.

The clinical and economic burden among caregivers of patients with Alzheimer's disease in Canada.

OBJECTIVE: To estimate the clinical and direct medical economic burden among Alzheimer disease (AD) caregivers using real-world, longitudinal patient-level data in Canada. METHODS/DESIGN: This retrospective observational study assessed the clinical and direct medical economic burden among individuals who cohabitate with AD patients ("AD caregiver cohort") compared with older adults who were cohabiting with another adult without dementia ("comparison cohort") using real-world data from the Southwestern Ontario database, a representative Canadian electronic health record (EHR) longitudinal EHR. RESULTS: The AD caregiver cohort (n = 2749; mild AD: n = 2254, moderate AD: n = 302, and severe AD, n = 193) had a similar or higher level of clinical and economic burden than the comparison cohort (n = 12 152). The overall AD cohort and caregivers of patients with mild AD had a similar clinical burden to the comparison cohort. Those caregiving for more severely affected AD patients had an increased risk of comorbidities and required more medication, physician attention, and hospital encounters compared with caregivers of less severe AD patients and the comparison cohort. Mean annual costs were higher among the AD caregiver cohort than the comparison cohort, and those caregiving for moderate and severe AD patients incurred the highest costs. Overall mortality was higher in the AD caregiver cohort compared with the comparison cohort. CONCLUSIONS: Caregivers of patients with mild AD had a similar clinical and direct economic burden to older adults who were not dementia caregivers, whereas the burden among caregivers of moderate and severe AD patients was much greater.

A randomized controlled trial assessing the effect of prescribed patient position changes during colonoscope withdrawal on adenoma detection.

BACKGROUND: High-quality colonoscope withdrawal technique is associated with a higher adenoma detection rate. Position change is routinely used in barium enema and CT colonography to facilitate adequate distension of the colon and promote movement of fluid from the segment of the colon being assessed. OBJECTIVE: To determine whether prescribed position changes during colonoscope withdrawal affect the adenoma detection rate compared with the usual care per endoscopist. DESIGN: Prospective, randomized, controlled trial. SETTING: Tertiary-care, university-affiliated hospital. PATIENTS: Patients referred for outpatient colonoscopy between July 2011 and July 2012 were evaluated for eligibility. Inclusion criteria were outpatient status and age ≥40 years. Exclusion criteria were (1) complete colonoscopy within 1 year before the procedure, (2) inability to provide informed consent, (3) incomplete colonoscopy to the cecum, (4) previous bowel resection, (5) inflammatory bowel disease, (6) colonic polyposis syndrome, (7) inadequate bowel preparation, and (8) musculoskeletal disorder or other mobility issues limiting effective patient position changes during colonoscopy. INTERVENTIONS: Prescribed position changes during colonoscope withdrawal. MAIN OUTCOME MEASUREMENTS: Polyp detection rate (PDR) and adenoma detection rate (ADR). RESULTS: A total of 776 patients were enrolled, with 388 in the dynamic group. There was no difference in PDR (odds ratio [OR] 0.99; P = .93) or ADR (OR 1.17; P = .28). Colonoscope withdrawal time was longer in the dynamic group (median time 466.5 vs 422.5 seconds; P < .0001). LIMITATIONS: Single-center study. Indication for procedure not controlled. Lack of standardized bowel preparation and blinding. CONCLUSION: Prescribed position changes during colonoscope withdrawal do not affect polyp/adenoma detection compared with the usual practice when the baseline ADR is above the recommended standard. ( CLINICAL TRIAL REGISTRATION NUMBER: NCT01395173.).

Diagnostic yield of repeat capsule endoscopy and the effect on subsequent patient management.

BACKGROUND: Capsule endoscopy (CE) has been shown to produce a high diagnostic yield in patients with obscure gastrointestinal bleeding (OGIB); however, in those with negative studies, management is controversial. Very few studies have reported on repeat CE in the same patient; data regarding this diagnostic strategy are limited. OBJECTIVE: To determine the diagnostic yield of repeated CE studies and how this yield affects subsequent patient management. METHODS: A retrospective chart review of all patients who underwent CE at St Paul's Hospital (Vancouver, British Columbia) between December 2001 and June 2009 was conducted. Patients who underwent subsequent repeat CE were identified and divided into one of four subgroups. Findings were classified as positive or negative. RESULTS: Eighty-two of 676 patients underwent more than one CE study. Group 1 (incomplete study) included 22 patients (27%) and yielded 10 positive findings (45%). Group 2 (screening) comprised four patients (5%) and yielded two positive findings (50%). Group 3 (ongoing symptoms despite previous negative study) totalled 26 patients (32%) and yielded 10 positive findings (38%). Group 4 (previous positive study with treatment/investigation) included 30 patients (37%) and yielded 23 positive findings (77%). Overall, the present study found positive findings in 55% (45 of 82) of repeated CE cases, which resulted in a change in management in 39% (n=32) of the patients. CONCLUSION: Due to the high diagnostic yield and noninvasive nature of CE, repeat CE appears to be of benefit and should be considered for specific patients before other types of small bowel studies.

Costs of in-house genomic profiling and implications for economic evaluation: a case example of non-small cell lung cancer (NSCLC).

OBJECTIVES: Genomic profiling in oncology is vital for determining eligible patients for mutation-specific targeted therapies. Use of commercial genomic testing has the potential to improve patient outcomes. Economic evaluations of in-house genomic profiling typically only include material costs while external commercial services include many other factors. Using non-small cell lung cancer (NSCLC) as an example, this study sought to characterize the unique challenges of costing testing services and their impact on results of economic evaluations. METHODS: Structured interviews with Canadian oncologists, pathologists, and laboratory directors were conducted to identify material and non-material costs associated with genomic-testing laboratories to allow estimation of a more complete cost of in-house testing, with NSCLC cost-per-test calculated using annual operational costs and NSCLC-specific testing volume. A health and budget impact model of in-house versus external commercial profiling services was used to compare the impact of non-material costs on results. RESULTS: In-house testing costs, limited to materials, was $133/single-gene test and $1,400/panel. For a laboratory running 1,300 in-house tests/year, total annual non-material costs included equipment maintenance ($6,842), labor ($502,313; technicians, administrative, and medical staff), shipping/reporting and software updates ($146,050), for an additional $519/test. The combined cost of $652/single-gene and $1,919/panel was compared to a cost of $6,194 for a commercial external test. Based on current Canadian testing patterns and anticipated utilization of external testing, inclusion of in-house non-material costs reduced the estimated 3-year budget impact by 12%. CONCLUSION: When conducting economic evaluation to assess the value of introducing external tests, it is critical that non-material costs of standard testing strategies be measured and incorporated.

Characterizing the Health-Related Quality of Life Burden of Overactive Bladder Using Disease-Specific Patient-Reported Outcome Measures: A Systematic Literature Review.

INTRODUCTION: The objective was to identify the most commonly used patient-reported outcome (PRO) instruments for overactive bladder (OAB), determine which are the most useful for measuring burden in OAB and characterize the findings of recent studies that have employed PRO instruments to assess OAB symptoms and the effects of treatment. METHODS: A systematic search of OAB literature published between January 2006 and November 2017 using Medline/PubMed and EMBASE databases. RESULTS: Of 3425 abstracts and 500 full-text articles reviewed, 58 studies (both clinical trials and observational studies) were included in the review. The most commonly used PRO instruments were the OAB Questionnaire (OAB-q; 64%), followed by the King's Health Questionnaire (KHQ; 31%) and the Patient Perception of Bladder Condition (PCBC; 21%). Synthesis of data from studies using the OAB-q showed that OAB treatment with antimuscarinics, mirabegron and onabotulinumtoxinA all improve health-related quality of life (HRQoL) and symptoms beyond the benefits observed with placebo. The OAB-q could detect dose-response relationships in some studies and demonstrated there were no significant differences across therapies from different drug classes. CONCLUSION: The HRQoL burden of OAB and response to treatment can be reliably measured by PRO instruments, and the OAB-q is the most commonly used instrument in OAB, particularly in clinical trials of OAB interventions. These data will be useful to provide benchmarks of burden levels for PRO scores obtained among those on contemporary therapies for comparison with outcomes from patients managed with emerging treatments. FUNDING: Astellas Pharma Global Development, Inc.

Factors associated with incomplete small bowel capsule endoscopy studies.

AIM: To identify patient risk factors associated with incomplete small bowel capsule endoscopy (CE) studies. METHODS: Data from all CE procedures performed at St. Paul's Hospital in Vancouver, British Columbia, Canada, between December 2001 and June 2008 were collected and analyzed on a retrospective basis. Data collection for complete and incomplete CE study groups included patient demographics as well as a number of potential risk factors for incomplete CE including indication for the procedure, hospitalization, diabetes mellitus with or without end organ damage, limitations in mobility, renal insufficiency, past history of bowel obstruction, abdominal surgery, abdominal radiation therapy and opiate use. Risk factors were analyzed using a univariable and multivariable logistic regression model. RESULTS: From a total of 535 CE procedures performed, 158 were incomplete (29.5%). The univariable analysis showed that CE procedures performed for overt gastrointestinal bleeding (P = 0.002), and for patients with a prior history of abdominal surgery (P = 0.023) or bowel obstruction (P = 0.023) were significantly associated with incomplete CE studies. Patients on opiate medications (P = 0.094) as well as hospitalized patients (P = 0.054) were not statistically significant, but did show a trend towards incomplete CE. The multivariable analysis showed that independent risk factors for an incomplete CE procedure include prior history of bowel obstruction [odds ratios (OR) 2.77, P = 0.02, 95% confidence intervals (CI): 1.17-6.56] and procedures performed for gastrointestinal bleeding (Occult OR 2.04, P = 0.037, 95% CI: 1.04-4.02 and Overt OR 2.69, P = 0.002, 95% CI: 1.44-5.05). Patients with a prior history of abdominal surgery (OR 1.46, P = 0.068, 95% CI: 0.97-2.19), those taking opiate medications (OR 1.54, P = 0.15, 95% CI: 0.86-2.76) and hospitalized patients (OR 1.82, P = 0.124, 95% CI: 0.85-3.93) showed a trend towards statistical significance. CONCLUSION: We have identified a number of risk factors for incomplete CE procedures that can be used to risk-stratify patients and guide interventions to improve completion rates.