Inhaled ambient-level traffic-derived particulates decrease cardiac vagal influence and baroreflexes and increase arrhythmia in a rat model of metabolic syndrome.

BACKGROUND: Epidemiological studies have linked exposures to ambient fine particulate matter (PM2.5) and traffic with autonomic nervous system imbalance (ANS) and cardiac pathophysiology, especially in individuals with preexisting disease. It is unclear whether metabolic syndrome (MetS) increases susceptibility to the effects of PM2.5. We hypothesized that exposure to traffic-derived primary and secondary organic aerosols (P + SOA) at ambient levels would cause autonomic and cardiovascular dysfunction in rats exhibiting features of MetS. Male Sprague Dawley (SD) rats were fed a high-fructose diet (HFrD) to induce MetS, and exposed to P + SOA (20.4 ± 0.9 µg/m3) for 12 days with time-matched comparison to filtered-air (FA) exposed MetS rats; normal diet (ND) SD rats were separately exposed to FA or P + SOA (56.3 ± 1.2 µg/m3). RESULTS: In MetS rats, P + SOA exposure decreased HRV, QTc, PR, and expiratory time overall (mean effect across the entirety of exposure), increased breathing rate overall, decreased baroreflex sensitivity (BRS) on three exposure days, and increased spontaneous atrioventricular (AV) block Mobitz Type II arrhythmia on exposure day 4 relative to FA-exposed animals receiving the same diet. Among ND rats, P + SOA decreased HRV only on day 1 and did not significantly alter BRS despite overall hypertensive responses relative to FA. Correlations between HRV, ECG, BRS, and breathing parameters suggested a role for autonomic imbalance in the pathophysiologic effects of P + SOA among MetS rats. Autonomic cardiovascular responses to P + SOA at ambient PM2.5 levels were pronounced among MetS rats and indicated blunted vagal influence over cardiovascular physiology. CONCLUSIONS: Results support epidemiologic findings that MetS increases susceptibility to the adverse cardiac effects of ambient-level PM2.5, potentially through ANS imbalance.

Non-pegylated liposomal doxorubicin in lymphoma: patterns of toxicity and outcome in a large observational trial.

The anthracycline doxorubicin plays a major role in the treatment of lymphoproliferative disorders. However, its use is often limited due to cardiac toxicity, which seems to be much less in the liposomal non-pegylated formulation (Myocet®). The aim of this study was the evaluation of efficacy and toxicity of Myocet®-containing treatment regimens, with a focus on cardiotoxicity during treatment in lymphoma patients. A total of 326 consecutive patients, treated between March 2008 and December 2013 in 11 Austrian and 1 Italian cancer centers, were retrospectively assessed. Patients' baseline and treatment-related parameters were obtained by reviewing hospital records. Median age was 74 years (range 26-93). The most common histology was DLBCL (60 %), followed by FL (13 %) and MCL (8 %). At least one cardiovascular comorbidity was present in 72 % of patients. Most common grade 3/4 toxicities were hematologic, namely, leukopenia, neutropenia, thrombocytopenia, and febrile neutropenia in 44, 40, 17, and 16 %. Overall, 43 patients suffered a cardiac event (any grade) with most patients developing congestive heart failure. Parameters significantly associated with severe cardiac events (grades 3-5) were the presence of cardiovascular comorbidities, chronic obstructive pulmonary disease, and elevated baseline NT-proBNP. Treatment response after first line Myocet®-containing therapy was ≥58 % among all entities (range 58-86 %) and therefore comparable to those of conventional therapeutic regimens. Herein, we provide a detailed toxicity profile of Myocet®-containing chemotherapy regimens. Despite the high rate of patients with preexisting comorbidities, the number of adverse events was encouraging. However, these results need to be confirmed in a prospective randomized trial.

Anticoagulation Patterns Among Community-Dwelling Older Adults With Atrial Fibrillation.

OBJECTIVES: To assess clinicians' prescribing practices for anticoagulation in older adults with atrial fibrillation or atrial flutter (AF/F) and determine factors common among those without anticoagulation. METHODS: We performed a community-based retrospective cohort study of adults aged 65 years and older with a history of nonvalvular AF/F to determine the rate of oral anticoagulation utilization. We also assessed for associations between anticoagulation use and comorbid conditions and common geriatric syndromes. RESULTS: A total of 3832 patients with a diagnosis of nonvalvular AF/F were included (mean [SD] age, 79.9 [8.4] years), 2693 (70.3%) of whom were receiving anticoagulation (51.7%, a vitamin K antagonist; 48.1%, a direct-acting oral anticoagulant). Patients with higher Elderly Risk Assessment index (ERA) scores, a surrogate for health vulnerability, received anticoagulation less often than patients with lower scores. The percentage of patients with a history of falling was higher among those who did not receive anticoagulation than among those who did (44.4% vs 32.8%; P < .001). Similarly, a diagnosis of dementia was more common in the no-anticoagulation group than the anticoagulation group (18.5% vs 12.7%; P < .001). CONCLUSIONS: A substantial proportion of older adults with AF/F do not receive anticoagulation. Those without anticoagulation had higher risk of health deterioration based on higher ERA scores and had a higher incidence of dementia and fall history. This suggests that the presence of geriatric syndromes may influence the decision to withhold anticoagulation.

Hyaluronic Acid-based Fillers for Facial Rehabilitation in Inherited Neuropath.

Charcot-Marie-Tooth (CMT) disease is the most prevalent inherited neuromuscular disorder. It commonly leads to various musculoskeletal deformities, profoundly impacting the quality of life. The present case report explores the often under-recognized body image dissatisfaction in CMT, highlighting the potential benefits of a multidisciplinary approach to enhance aesthetic satisfaction. We present a case of a 54-year-old woman with CMT, who experienced chronic facial asymmetry, significantly impairing her quality of life. Seeking cosmetic enhancement, she underwent two sessions of facial treatment using hyaluronic acid-based fillers. The first session focused on correcting right mandibular hypoplasia and other facial asymmetries, whereas the second session focused on enhancing perioral aesthetics. The treatment resulted in significant aesthetic improvements, as demonstrated by high ratings in both the Physician Global Aesthetic Improvement Scale and the Subject Global Aesthetic Improvement Scale. Besides, there was a marked reduction in lip corner asymmetry, the patient's primary concern. The role of hyaluronic acid fillers in facial aesthetic enhancement is well established, and their application in the context of CMT is a promising under-investigated field, to our knowledge. This case study highlights the importance of considering body image in CMT patients and suggests that minimally invasive aesthetic procedures can be a valuable addition to the multidisciplinary care of patients with inherited neurological disorders. Despite being a single-case study, the significant improvement in the patient's aesthetic satisfaction requires further research in this field.

Extended evaluation of a longitudinal medical school evidence-based medicine curriculum.

BACKGROUND: Evidence-based medicine (EBM) is an important element of medical education. However, limited information is available on effective curricula. OBJECTIVE: To evaluate a longitudinal medical school EBM curriculum using validated instruments. DESIGN, PARTICIPANTS, MEASUREMENTS: We evaluated EBM attitudes and knowledge of medical students as they progressed through an EBM curriculum. The first component of the curriculum was an EBM "short course" with didactic and small-group sessions occurring at the end of the second year. The second component integrated EBM assignments with third-year clinical rotations. The 15-point Berlin Questionnaire was administered before the course in 2006 and 2007, after the short course, and at the end of the third year. The 212-point Fresno Test was administered before the course in 2007 and 2008, after the short course, and at the end of the third year. Self-reported knowledge and attitudes were also assessed in all three classes of medical students. RESULTS: EBM knowledge scores on the 15-point Berlin Questionnaire increased from baseline by 3.0 points (20.0%) at the end of the second year portion of the course (p < 001) and by 3.4 points (22.7%) at the end of the third year (p < 001). EBM knowledge scores on the 212-point Fresno Test increased from baseline by 39.7 points (18.7%) at the end of the second year portion of the course (p < 001) and by 54.6 points (25.8%) at the end of the third year (p < 001). On a 5-point scale, self-rated EBM knowledge increased from baseline by 1.0 and 1.4 points, respectively (both p < 001). EBM was felt to be of high importance for medical education and clinical practice at all time points, with increases noted after both components of the curriculum. CONCLUSIONS: A longitudinal medical school EBM was associated with markedly increased EBM knowledge on two validated instruments. Both components of the curriculum were associated with gains in knowledge. The curriculum was also associated with increased perceptions of the importance of EBM for medical education and clinical practice.

Onychomatricoma with Onychomycosis: A Case Report and Review of the Literature.

Onychomatricoma is a primary benign neoplasm of the nail matrix. Currently, a limited number of cases have been reported, so it is still considered a rare neoplasia. However, it is debatable if this condition is underdiagnosed and underreported. Onychomycosis is an important differential diagnosis of onychomatricoma, and sometimes, both these conditions may even coexist in the same nail. As the tumor grows, tissue microenvironment is more vulnerable to dermatophytes. Probably, the altered keratin appears to be susceptible to fungal invasion. Careful clinical assessment and dermoscopic evaluation help nailing the diagnosis. Usually, total nail avulsion is the preferred therapeutic approach when they coexist. Herein, we present a case of a middle-aged woman with onychomycosis and onychomatricoma affecting a single fingernail. The proposed therapy was oral terbinafine for 6 months followed by a conservative surgery. There were dramatic changes in dermoscopic features after fungal treatment, which, to our knowledge, have not been previously reported.

Olaratumab plus anthracyline in advanced/metastatic soft tissue sarcoma : Data of real-world utilization in Austria.

BACKGROUND: Olaratumab is a humanized monoclonal antiplatelet-derived growth factor receptor alpha antibody that has been approved in combination with doxorubicin for the treatment of patients with metastatic soft tissue sarcoma (STS). The purpose of this retrospective study was to assess the clinical efficacy in STS patients treated with olaratumab in a real-world setting in Austria. METHODS: Retrospectively collected longitudinal data from patients treated between November 2016 and September 2018 at 9 Austrian centers were obtained from the respective medical charts. All patients who received at least one dose of olaratumab were eligible. Parameters of most interest were response rates, progression-free survival (PFS) and overall survival (OS). RESULTS: Altogether 55 patients were included in the analysis. The median age was 58 years. In total, 65.5% (n = 36), 21.8% (n = 12) and 12.7% (n = 7) received olaratumab as first, second or ≥third line treatment, respectively. Olaratumab was administered either in combination with doxorubicin (81.8%, n = 45) or liposomal doxorubicin (16.4%, n = 9); one patient received olaratumab as upfront monotherapy. The median PFS and OS were 2.6 and 11.4 months, respectively. The objective response rate was 11.4% and the disease control rate was 40.9%. CONCLUSION: In this real-world analysis the outcome was less pronounced compared to the results of both the phase Ib/II approval trial and the confirmatory phase III trial. The latter failed to show an improvement in OS and PFS for the doxorubicin/olaratumab combination. As such, olaratumab should not be used anymore in patients with STS.

In-home Compared With In-Clinic Warfarin Therapy Monitoring in Mechanical Heart Valves: A Population-Based Study.

OBJECTIVE: To evaluate differences in time in therapeutic range (TTR), major bleeding, thromboembolism, and survival comparing in-home and in-clinic international normalized ratio monitoring for patients with mechanical heart valves receiving warfarin anticoagulation. PATIENTS AND METHODS: An observational population-based study of 383 patients (mean ± SD age, 61.5±14.1 years; 38.6% female) with mechanical heart valves (aortic, 77.8%; mitral, 31.1%; tricuspid, 1%; pulmonic 0.2%; and multiple, 9.7%) was performed from January 1, 2012, through December 31, 2017. The target international normalized ratio was 2.5 for 199 patients (52.0%) and 3.0 for 184 (48.0). Of these patients, 37.9% (n=145) were managed by in-home monitoring (cases) and 62.1% (n=238) were monitored in the clinic (controls). RESULTS: During median follow-up of 3.1 years, mean ± SD TTR was similar between in-home (66.6%±19.2%) and in-clinic (67.2%±19.8%) monitoring (P=.76). There were no differences between the in-home and in-clinic groups regarding survival to major bleeding (5.7% per person-year vs 6.7% per person-year; P=.66) or thrombotic complications (2.3% vs 1.8%; P=.56). In-home monitoring was associated with reduced all-cause mortality (hazard ratio, 0.40; 95% CI, 0.19 to 0.83; P=.01) on univariate analysis; however, this was no longer apparent when controlling for age and baseline left ventricular ejection fraction. CONCLUSION: In this real-world population-based study of patients with mechanical heart valves, in-home monitoring was equivalent to in-clinic monitoring regarding TTR and important clinical outcomes.

Antibiotic residues in final effluents of European wastewater treatment plants and their impact on the aquatic environment.

A comprehensive monitoring of a broad set of antibiotics in the final effluent of wastewater treatment plants (WWTPs) of 7 European countries (Portugal, Spain, Ireland, Cyprus, Germany, Finland, and Norway) was carried out in two consecutive years (2015 and 2016). This is the first study of this kind performed at an international level. Within the 53 antibiotics monitored 17 were detected at least once in the final effluent of the WWTPs, i.e.: ciprofloxacin, ofloxacin, enrofloxacin, orbifloxacin, azithromycin, clarithromycin, sulfapyridine, sulfamethoxazole, trimethoprim, nalidixic acid, pipemidic acid, oxolinic acid, cefalexin, clindamycin, metronidazole, ampicillin, and tetracycline. The countries exhibiting the highest effluent average concentrations of antibiotics were Ireland and the southern countries Portugal and Spain, whereas the northern countries (Norway, Finland and Germany) and Cyprus exhibited lower total concentration. The antibiotic occurrence data in the final effluents were used for the assessment of their impact on the aquatic environment. Both, environmental predicted no effect concentration (PNEC-ENVs) and the PNECs based on minimal inhibitory concentrations (PNEC-MICs) were considered for the evaluation of the impact on microbial communities in aquatic systems and on the evolution of antibiotic resistance, respectively. Based on this analysis, three compounds, ciprofloxacin, azithromycin and cefalexin are proposed as markers of antibiotic pollution, as they could occasionally pose a risk to the environment. Integrated studies like this are crucial to map the impact of antibiotic pollution and to provide the basis for designing water quality and environmental risk in regular water monitoring programs.

Time-driven activity-based cost analysis for outpatient anticoagulation therapy: direct costs in a primary care setting with optimal performance.

OBJECTIVES: To determine how overall cost of anticoagulation therapy for warfarin compares with that of Novel Oral Anticoagulants (NOACs). Also, to demonstrate a scientific, comprehensive, and an analytical approach to estimate direct costs involved in monitoring and management of anticoagulation therapy for outpatients in an academic primary care clinic setting, post-initiation of therapy. METHODS: A population-based cross-sectional study was conducted in conjunction with observations of patient care processes between August 2014 and January 2015. The study was conducted in an academic primary care outpatient setting at Mayo Clinic's warfarin anticoagulation clinic, Rochester, MN. The anticoagulation clinic serves patients 18 years of age or older in Warfarin therapy management, for any indication, after referral from the patient's primary care provider. The study included anticoagulation clinic enrollment data on a population of 5,526 patients. Time-Driven Activity-Based Costing (TDABC) technique was applied. Detailed process flow maps which showed process steps for all the anticoagulation program components and care continuum phases were created. Staff roles associated with each of the process steps were identified and displayed on the maps. Process times and costs were captured and analyzed. The main outcome was direct cost of monitoring and management of anticoagulation therapy, post-initiation of therapy. RESULTS: The cost of warfarin management for patients who display unstable International Normalized Ratio (INR) is more than three times those who display stable INR over time. (Comparator to distinguish stability: Frequency of point-of-care visits needed by patients.) For complex anticoagulation patients, total cost of medication and monitoring for warfarin anticoagulation therapy is similar to that for NOACs. CONCLUSION: Despite warfarin being significantly less expensive to purchase than NOACs, overall warfarin management incurs higher costs due to laboratory monitoring and provider time than NOACs. NOAC treatment, therefore, may not be more expensive than warfarin therapy management for complex anticoagulation patients.

Antibiotic resistance in European wastewater treatment plants mirrors the pattern of clinical antibiotic resistance prevalence.

Integrated antibiotic resistance (AR) surveillance is one of the objectives of the World Health Organization global action plan on antimicrobial resistance. Urban wastewater treatment plants (UWTPs) are among the most important receptors and sources of environmental AR. On the basis of the consistent observation of an increasing north-to-south clinical AR prevalence in Europe, this study compared the influent and final effluent of 12 UWTPs located in seven countries (Portugal, Spain, Ireland, Cyprus, Germany, Finland, and Norway). Using highly parallel quantitative polymerase chain reaction, we analyzed 229 resistance genes and 25 mobile genetic elements. This first trans-Europe surveillance showed that UWTP AR profiles mirror the AR gradient observed in clinics. Antibiotic use, environmental temperature, and UWTP size were important factors related with resistance persistence and spread in the environment. These results highlight the need to implement regular surveillance and control measures, which may need to be appropriate for the geographic regions.

Inappropriate use of symptom-triggered therapy for alcohol withdrawal in the general hospital.

OBJECTIVE: To determine if hospitalized medical and surgical patients were placed inappropriately on symptom-triggered therapy (STT) for alcohol withdrawal syndrome (AWS) and if certain conditions were more likely to be associated with inappropriate STT use or adverse events. PATIENTS AND METHODS: We randomly selected 124 (25%) of the 495 Mayo Clinic inpatients who received STT according to the Revised Clinical Institute for Withdrawal Assessment for Alcohol (CIWA-Ar) protocol in 2003 and assessed them for STT appropriateness, defined as having both intact verbal communication and recent alcohol use. Adverse events, including delirium tremens, seizures, or death, were correlated with CIWA-Ar appropriateness. RESULTS: Of the 124 randomly selected patients, only 60 (48%) met both inclusion criteria. Of the remaining 64 patients, 9 (14%) were drinkers but could not communicate, and 35 (55%) could communicate but had not been drinking. Twenty (31%) met neither criterion. Univariate analysis identified a significant association between inappropriate initiation and chronic heart failure, postoperative status (POS), liver disease (LD), nonmetastatic cancer, and chemical dependency consultation. On multivariate analysis, only LD (P equals .02) and POS (P equals .01) retained significance, with LD more and POS less likely to predict appropriateness. Seven of 11 patients who experienced adverse events had received STT according to the CIWA-Ar protocol (P equals .05). Univariate analysis identified a significant association between adverse events and a history of alcohol dependence or AWS. Multivariate analysis showed significance only for a history of alcohol dependence (P equals .049). CONCLUSION: Fewer than half of the randomly selected patients met both of the inclusion criteria for the CIWA-Ar instrument, leading us to conclude that more stringent evaluation is needed. Particularly postoperatively, alternative explanations for putative AWS should be sought. Health care professionals should more aggressively seek information on recent alcohol use from medical records, family members, and patients themselves.

Stability and Agreement of a Microtransducer and an Air-Filled Balloon Esophageal Catheter in the Monitoring of Esophageal Pressure.

BACKGROUND: The use of esophageal catheters with microtransducer promises advantages over traditional catheters with air-filled balloons. However, performance comparisons between these 2 types of catheters are scarce and incomplete. METHODS: A catheter with a 9.5-cm air-filled balloon at the distal tip and a catheter with a microtransducer mounted within a flexible silicone rubber were tested in vitro and in vivo. In vitro, the response times of both catheters were compared, and the drift of the baseline pressure of the microtransducer catheter was evaluated over a 6-h period. In vivo, 11 healthy volunteers had both catheters inserted, and the drift of the baseline esophageal pressure was measured over a 3-h period. Also, the correlation and agreement of the baseline and changes in the esophageal pressure of both catheters were evaluated. RESULTS: In vitro, the microtransducer catheter had a response time significantly higher (262 × 114 Hz, P < .01) and a good pressure stability, with a mean baseline pressure drift of 1.4 cm H2O. In vivo, both catheters presented a small and similar baseline esophageal pressure drift (P = 0.08). For measurements of baseline and changes in esophageal pressure, the correlation and agreement between the catheters were poor, with a large bias between them. CONCLUSIONS: The catheter with the microtransducer had a small baseline pressure drift, similar to the air-filled balloon catheter. The low agreement between the catheters does not allow the microtransducer catheter to be used as a surrogate for the traditional air-filled balloon catheter.

Nurse-based telephone protocol versus usual care for management of URI and acute sinusitis: a controlled trial.

Two hundred and twelve patients with upper-respiratory-tract infection (URI) or sinusitis were treated using a nurse-based telephone protocol. This study evaluated the clinical outcomes and satisfaction of the patients compared with patients receiving usual care. For patients with URI, the rate of antibiotic administration was lower in the nurse-based telephone-treatment group (28% vs. 34%; P = .46), and for those with sinusitis, a greater proportion of the telephone treatment group received first-line antibiotics for the infection, compared with the usual care group (81% vs. 53%; P = .01). A guideline-based nurse telephone treatment protocol may decrease inappropriate use of antibiotics for URI and can result in a greater use of first-line antibiotics for patients with sinus infection with similar clinical outcomes.

Prevalence of calreticulin exon 9 indel mutations in vascular risk patients.

INTRODUCTION: Acquired JAK2 as well as calreticulin (CALR) mutations are involved in the development of Philadelphia-negative myeloproliferative neoplasms (MPN). We previously showed that the JAK2 V617F mutation could also been found in coronary patients and in patients with peripheral arterial disease (PAD). However, prevalence of CALR mutations is unknown in vascular risk patients and its evaluation subject of the present study. MATERIALS AND METHODS: We determined the prevalence of CALR exon 9 indel mutations in a cohort of 1052 angiographied coronary patients, including 141 patients with PAD, and, additionally, 86 patients with PAD, but without coronary angiography. CALR mutation analysis was performed using PCR fragment analysis and JAK2 V617F mutation analysis with allele-specific real-time PCR. RESULTS: From included 1138 patients, 18 individuals were tested positive for the JAK2 V617F mutation. CALR exon 9 mutations were not detected in any of our patients. CONCLUSIONS: We conclude that CALR exon 9 mutations are infrequent in vascular risk patients. Routine testing for the presence of CALR mutations is not recommended for unselected patients with vascular disease. Future studies are warranted to define a putative pathologic role of CALR mutations in patients without MPN.

Improved resident physician confidence with advance care planning after an ambulatory clinic intervention.

Many primary care providers feel uncomfortable discussing end-of-life care. The aim of this intervention was to assess internal medicine residents' advance care planning (ACP) practices and improve residents' ACP confidence. Residents participated in a facilitated ACP quality improvement workshop, which included an interactive presentation and chart audit of their own patients. Pre- and postintervention surveys assessed resident ACP-related confidence. Only 24% of the audited patients had an advance directive (AD), and 28% of the ACP-documentation was of no clinical utility. Terminally ill patients (odds ratio 2.8, P < .001) were more likely to have an AD. Patients requiring an interpreter were less likely to have participated in ACP. Residents reported significantly improved confidence with ACP and identified important training gaps. Future studies examining the impact on ACP quality are needed.

Resident physician perspectives on outpatient continuity of care.

BACKGROUND: The outpatient continuity clinic is an essential component of internal medicine residency programs, yet continuity of patient care in these clinics is suboptimal. Reasons for this discontinuity have been inadequately explored. OBJECTIVE: We sought to assess perceived factors contributing to discontinuity in trainee ambulatory clinics. METHODS: The study encompassed 112 internal medicine residents at a large academic medical center in the Midwest. We conducted 2 hours of facilitated discussion with 18 small groups of residents. Residents were asked to reflect on factors that pose barriers to continuity in their ambulatory practice and potential mechanisms to reduce these barriers. Resident comments were transcribed and inductive analysis was performed to develop themes. We used these themes to derive recommendations for improving continuity of care in a resident ambulatory clinic. RESULTS: Key themes included an imbalance of clinic scheduling that favors access for patients with acute symptoms over continuity, clinic triage scripts that deemphasize continuity, inadequate communication among residents and faculty regarding shared patients, residents' inefficient use of nonphysician care resources, and a lack of shared values between patients and providers regarding continuity of care. CONCLUSIONS: The results offer important information that may be applied in iterative program changes to enhance continuity of care in resident clinics.

Use of a decision aid to improve treatment decisions in osteoporosis: the osteoporosis choice randomized trial.

OBJECTIVE: Poor adherence to therapy, perhaps related to unaddressed patient preferences, limits the effectiveness of osteoporosis treatment in at-risk women. A parallel patient-level randomized trial in primary care practices was performed. METHODS: Eligible postmenopausal women with bone mineral density T-scores less than -1.0 and not receiving bisphosphonate therapy were included. In addition to usual primary care, intervention patients received a decision aid (a tailored pictographic 10-year fracture risk estimate, absolute risk reduction with bisphosphonates, side effects, and out-of-pocket cost), and control patients received a standard brochure. Knowledge transfer, patient involvement in decision-making, and rates of bisphosphonate start and adherence were studied. Data came from medical records, post-visit written and 6-month phone surveys, video recordings of clinical encounters, and pharmacy prescription profiles. RESULTS: A total of 100 patients (range of 10-year fracture risk, 6%-60%) were allocated randomly to receive the decision aid (n=52) or usual care (n=48). Patients receiving the decision aid were 1.8 times more likely to correctly identify their 10-year fracture risk (49% vs 28%; 95% confidence interval [CI], 1.03-3.2) and 2.7 times more likely to identify their estimated risk reduction with bisphosphonates (43% vs 16%; 95% CI, 1.3-5.7). Patient involvement improved with the decision aid by 23% (95% CI, 13.6-31.4). Bisphosphonates were started by 44% of patients receiving the decision aid and 40% of patients receiving usual care. Adherence at 6 months was similarly high across both groups, but the proportion with more than 80% adherence was higher with the decision aid (n=23 [100%] vs n=14 [74%]; P = .009). CONCLUSION: A decision aid improved the quality of clinical decisions about bisphosphonate therapy in at-risk postmenopausal women, did not affect start rates, and may have improved adherence.

Protocol for the Osteoporosis Choice trial. A pilot randomized trial of a decision aid in primary care practice.

BACKGROUND: Bisphosphonates can reduce fracture risk in patients with osteoporosis, but many at-risk patients do not start or adhere to these medications. The aims of this study are to: (1) preliminarily evaluate the effect of an individualized 10-year osteoporotic fracture risk calculator and decision aid (OSTEOPOROSIS CHOICE) for postmenopausal women at risk for osteoporotic fractures; and (2) assess the feasibility and validity (i.e., absence of contamination) of patient-level randomization (vs. cluster randomization) in pilot trials of decision aid efficacy. METHODS/DESIGN: This is a protocol for a parallel, 2-arm, randomized trial to compare an intervention group receiving OSTEOPOROSIS CHOICE to a control group receiving usual primary care. Postmenopausal women with bone mineral density T-scores of <-1.0, not receiving bisphosphonate therapy, and receiving care at participating primary care practices in and around Rochester, Minnesota, USA will be eligible to participate in the trial. We will measure the effect of OSTEOPOROSIS CHOICE on five outcomes: (a) patient knowledge regarding osteoporosis risk factors and treatment; (b) quality of the decision-making process for both the patient and clinician; (c) patient and clinician acceptability and satisfaction with the decision aid; (d) rate of bisphosphonate use and adherence, and (e) trial processes (e.g., ability to recruit participants, collect patient outcomes). To capture these outcomes, we will use patient and clinician surveys following each visit and video recordings of the clinical encounters. These video recordings will also allow us to determine the extent to which clinicians previously exposed to the decision aid were able to recreate elements of the decision aid with control patients (i.e., contamination). Pharmacy prescription profiles and follow-up phone interviews will assess medication start and adherence at 6 months. DISCUSSION: This pilot trial will provide evidence of feasibility, validity of patient randomization, and preliminary efficacy of a novel approach--decision aids--to improving medication adherence for postmenopausal women at risk of osteoporotic fractures. The results will inform the design of a larger trial that could provide more precise estimates of the efficacy of the decision aid. TRIAL REGISTRATION: Clinical Trials.gov Identifier: NCT00578981.