Fairview Health Services

BACKGROUND: Coronavirus disease 2019 (Covid-19) occurs after exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). For persons who are exposed, the standard of care is observation and quarantine. Whether hydroxychloroquine can prevent symptomatic infection after SARS-CoV-2 exposure is unknown. METHODS: We conducted a randomized, double-blind, placebo-controlled trial across the United States and parts of Canada testing hydroxychloroquine as postexposure prophylaxis. We enrolled adults who had household or occupational exposure to someone with confirmed Covid-19 at a distance of less than 6 ft for more than 10 minutes while wearing neither a face mask nor an eye shield (high-risk exposure) or while wearing a face mask but no eye shield (moderate-risk exposure). Within 4 days after exposure, we randomly assigned participants to receive either placebo or hydroxychloroquine (800 mg once, followed by 600 mg in 6 to 8 hours, then 600 mg daily for 4 additional days). The primary outcome was the incidence of either laboratory-confirmed Covid-19 or illness compatible with Covid-19 within 14 days. RESULTS: We enrolled 821 asymptomatic participants. Overall, 87.6% of the participants (719 of 821) reported a high-risk exposure to a confirmed Covid-19 contact. The incidence of new illness compatible with Covid-19 did not differ significantly between participants receiving hydroxychloroquine (49 of 414 [11.8%]) and those receiving placebo (58 of 407 [14.3%]); the absolute difference was -2.4 percentage points (95% confidence interval, -7.0 to 2.2; P = 0.35). Side effects were more common with hydroxychloroquine than with placebo (40.1% vs. 16.8%), but no serious adverse reactions were reported. CONCLUSIONS: After high-risk or moderate-risk exposure to Covid-19, hydroxychloroquine did not prevent illness compatible with Covid-19 or confirmed infection when used as postexposure prophylaxis within 4 days after exposure. (Funded by David Baszucki and Jan Ellison Baszucki and others; ClinicalTrials.gov number, NCT04308668.).

This consensus statement presents a comprehensive and evidence-based set of guidelines for the care of postoperative nausea and vomiting (PONV) in both adult and pediatric populations. The guidelines are established by an international panel of experts under the auspices of the American Society of Enhanced Recovery and Society for Ambulatory Anesthesia based on a comprehensive search and review of literature up to September 2019. The guidelines provide recommendation on identifying high-risk patients, managing baseline PONV risks, choices for prophylaxis, and rescue treatment of PONV as well as recommendations for the institutional implementation of a PONV protocol. In addition, the current guidelines focus on the evidence for newer drugs (eg, second-generation 5-hydroxytryptamine 3 [5-HT3] receptor antagonists, neurokinin 1 (NK1) receptor antagonists, and dopamine antagonists), discussion regarding the use of general multimodal PONV prophylaxis, and PONV management as part of enhanced recovery pathways. This set of guidelines have been endorsed by 23 professional societies and organizations from different disciplines (Appendix 1).Guidelines currently available include the 3 iterations of the consensus guideline we previously published, which was last updated 6 years ago; a guideline published by American Society of Health System Pharmacists in 1999; a brief discussion on PONV management as part of a comprehensive postoperative care guidelines; focused guidelines published by the Society of Obstetricians and Gynecologists of Canada, the Association of Paediatric Anaesthetists of Great Britain & Ireland and the Association of Perianesthesia Nursing; and several guidelines published in other languages.The current guideline was developed to provide perioperative practitioners with a comprehensive and up-to-date, evidence-based guidance on the risk stratification, prevention, and treatment of PONV in both adults and children. The guideline also provides guidance on the management of PONV within enhanced recovery pathways.The previous consensus guideline was published 6 years ago with a literature search updated to October 2011. Several guidelines, which have been published since, are either limited to a specific populations or do not address all aspects of PONV management. The current guideline was developed based on a systematic review of the literature published up through September 2019. This includes recent studies of newer pharmacological agents such as the second-generation 5-hydroxytryptamine 3 (5-HT3) receptor antagonists, a dopamine antagonist, neurokinin 1 (NK1) receptor antagonists as well as several novel combination therapies. In addition, it also contains an evidence-based discussion on the management of PONV in enhanced recovery pathways. We have also discussed the implementation of a general multimodal PONV prophylaxis in all at-risk surgical patients based on the consensus of the expert panel.

CONTEXT: Laboratory and epidemiological data suggest that folic acid may have an antineoplastic effect in the large intestine. OBJECTIVE: To assess the safety and efficacy of folic acid supplementation for preventing colorectal adenomas. DESIGN, SETTING, AND PARTICIPANTS: A double-blind, placebo-controlled, 2-factor, phase 3, randomized clinical trial conducted at 9 clinical centers between July 6, 1994, and October 1, 2004. Participants included 1021 men and women with a recent history of colorectal adenomas and no previous invasive large intestine carcinoma. INTERVENTION: Participants were randomly assigned in a 1:1 ratio to receive 1 mg/d of folic acid (n = 516) or placebo (n = 505), and were separately randomized to receive aspirin (81 or 325 mg/d) or placebo. Follow-up consisted of 2 colonoscopic surveillance cycles (the first interval was at 3 years and the second at 3 or 5 years later). MAIN OUTCOME MEASURES: The primary outcome measure was occurrence of at least 1 colorectal adenoma. Secondary outcomes were the occurrence of advanced lesions (> or =25% villous features, high-grade dysplasia, size > or =1 cm, or invasive cancer) and adenoma multiplicity (0, 1-2, or > or =3 adenomas). RESULTS: During the first 3 years, 987 participants (96.7%) underwent colonoscopic follow-up, and the incidence of at least 1 colorectal adenoma was 44.1% for folic acid (n = 221) and 42.4% for placebo (n = 206) (unadjusted risk ratio [RR], 1.04; 95% confidence interval [CI], 0.90-1.20; P = .58). Incidence of at least 1 advanced lesion was 11.4% for folic acid (n = 57) and 8.6% for placebo (n = 42) (unadjusted RR, 1.32; 95% CI, 0.90-1.92; P = .15). A total of 607 participants (59.5%) underwent a second follow-up, and the incidence of at least 1 colorectal adenoma was 41.9% for folic acid (n = 127) and 37.2% for placebo (n = 113) (unadjusted RR, 1.13; 95% CI, 0.93-1.37; P = .23); and incidence of at least 1 advanced lesion was 11.6% for folic acid (n = 35) and 6.9% for placebo (n = 21) (unadjusted RR, 1.67; 95% CI, 1.00-2.80; P = .05). Folic acid was associated with higher risks of having 3 or more adenomas and of noncolorectal cancers. There was no significant effect modification by sex, age, smoking, alcohol use, body mass index, baseline plasma folate, or aspirin allocation. CONCLUSIONS: Folic acid at 1 mg/d does not reduce colorectal adenoma risk. Further research is needed to investigate the possibility that folic acid supplementation might increase the risk of colorectal neoplasia. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00272324.

IMPORTANCE: Blood transfusion is one of the most frequently used therapies worldwide and is associated with benefits, risks, and costs. OBJECTIVE: To develop a set of evidence-based recommendations for patient blood management (PBM) and for research. EVIDENCE REVIEW: The scientific committee developed 17 Population/Intervention/Comparison/Outcome (PICO) questions for red blood cell (RBC) transfusion in adult patients in 3 areas: preoperative anemia (3 questions), RBC transfusion thresholds (11 questions), and implementation of PBM programs (3 questions). These questions guided the literature search in 4 biomedical databases (MEDLINE, EMBASE, Cochrane Library, Transfusion Evidence Library), searched from inception to January 2018. Meta-analyses were conducted with the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) methodology and the Evidence-to-Decision framework by 3 panels including clinical and scientific experts, nurses, patient representatives, and methodologists, to develop clinical recommendations during a consensus conference in Frankfurt/Main, Germany, in April 2018. FINDINGS: From 17 607 literature citations associated with the 17 PICO questions, 145 studies, including 63 randomized clinical trials with 23 143 patients and 82 observational studies with more than 4 million patients, were analyzed. For preoperative anemia, 4 clinical and 3 research recommendations were developed, including the strong recommendation to detect and manage anemia sufficiently early before major elective surgery. For RBC transfusion thresholds, 4 clinical and 6 research recommendations were developed, including 2 strong clinical recommendations for critically ill but clinically stable intensive care patients with or without septic shock (recommended threshold for RBC transfusion, hemoglobin concentration <7 g/dL) as well as for patients undergoing cardiac surgery (recommended threshold for RBC transfusion, hemoglobin concentration <7.5 g/dL). For implementation of PBM programs, 2 clinical and 3 research recommendations were developed, including recommendations to implement comprehensive PBM programs and to use electronic decision support systems (both conditional recommendations) to improve appropriate RBC utilization. CONCLUSIONS AND RELEVANCE: The 2018 PBM International Consensus Conference defined the current status of the PBM evidence base for practice and research purposes and established 10 clinical recommendations and 12 research recommendations for preoperative anemia, RBC transfusion thresholds for adults, and implementation of PBM programs. The relative paucity of strong evidence to answer many of the PICO questions supports the need for additional research and an international consensus for accepted definitions and hemoglobin thresholds, as well as clinically meaningful end points for multicenter trials.

Patient engagement has become a major focus of health reform. However, there is limited evidence showing that increases in patient engagement are associated with improved health outcomes or lower costs. We examined the extent to which a single assessment of engagement, the Patient Activation Measure, was associated with health outcomes and costs over time, and whether changes in assessed activation were related to expected changes in outcomes and costs. We used data on adult primary care patients from a single large health care system where the Patient Activation Measure is routinely used. We found that results indicating higher activation in 2010 were associated with nine out of thirteen better health outcomes-including better clinical indicators, more healthy behaviors, and greater use of women's preventive screening tests-as well as with lower costs two years later. Changes in activation level were associated with changes in over half of the health outcomes examined, as well as costs, in the expected directions. These findings suggest that efforts to increase patient activation may help achieve key goals of health reform and that further research is warranted to examine whether the observed associations are causal.

A series of 34 patients with Bulimia is presented. The patients were young females who usually experienced the onset of eating problems by early adulthood. Most had binge eating episodes on a daily basis, frequently followed by vomiting. Although the majority had never had active anorexia nervosa, all of these patients demonstrated characteristics often described in anorectic patients including a preoccupation with food and an exaggerated fear of becoming obese. Many appeared to be clinically depressed. The association between stealing behavior, chemical abuse and bulimia suggests problems with impulse control in this population.

BACKGROUND: No effective oral therapy exists for early coronavirus disease 2019 (COVID-19). OBJECTIVE: To investigate whether hydroxychloroquine could reduce COVID-19 severity in adult outpatients. DESIGN: Randomized, double-blind, placebo-controlled trial conducted from 22 March through 20 May 2020. (ClinicalTrials.gov: NCT04308668). SETTING: Internet-based trial across the United States and Canada (40 states and 3 provinces). PARTICIPANTS: Symptomatic, nonhospitalized adults with laboratory-confirmed COVID-19 or probable COVID-19 and high-risk exposure within 4 days of symptom onset. INTERVENTION: Oral hydroxychloroquine (800 mg once, followed by 600 mg in 6 to 8 hours, then 600 mg daily for 4 more days) or masked placebo. MEASUREMENTS: Symptoms and severity at baseline and then at days 3, 5, 10, and 14 using a 10-point visual analogue scale. The primary end point was change in overall symptom severity over 14 days. RESULTS: = 0.29). LIMITATION: Only 58% of participants received SARS-CoV-2 testing because of severe U.S. testing shortages. CONCLUSION: Hydroxychloroquine did not substantially reduce symptom severity in outpatients with early, mild COVID-19. PRIMARY FUNDING SOURCE: Private donors.

A new theory of the mechanism of percutaneous arterial angioplasty is advanced. For this study, abdominal aortas and coronary, renal, superior mesenteric, and iliac arteries were obtained from cadavers. In addition, the iliac arteries of dogs were dilated and studied. No evidence of significant compression or redistribution of plaques could be found, supporting the theory that atheromatous material is incompressible. Cracking of the intima and separation of it from the media were histologically demonstrated following angioplasty. It is proposed that the stretched media distends following dilatation, carrying with the intima and atheromatous material. Once the media is freed from the encasing effect of the intima, it adapts to the circulatory needs of the body. Beyond a certain point, the arterial widening becomes permanent, due to an overstretching of the muscle fibers, which is demonstrated by a corkscrew deformity of the muscle cell nuclei.

OBJECTIVE: To evaluate cerebrospinal fluid (CSF) levels of amyloid beta protein ending at amino acid 42 (Abeta42) and tau as markers for Alzheimer disease (AD) and to determine whether clinical variables influence these levels. DESIGN: Cohort study. SETTING: Six academic research centers with expertise in dementia. SUBJECTS: Eighty-two patients with probable AD, including 24 with very mild dementia (Mini-Mental State Examination score >23/30) (AD group); 60 cognitively normal elderly control subjects (NC group); and 74 subjects with neurological disorders, including dementia (ND group). MAIN OUTCOME MEASURES: Levels of Abeta42 and tau were compared among AD, NC, and ND groups. Relationships of age, sex, Mini-Mental State Examination score, and apolipoprotein E (Apo E) genotype with these levels were examined using multiple linear regression. Classification tree models were developed to optimize distinguishing AD from NC groups. RESULTS: Levels of Abeta42 were significantly lower, and levels of tau were significantly higher, in the AD group than in the NC or ND group. In the AD group, Abeta42 level was inversely associated with Apo E epsilon4 allele dose and weakly related to Mini-Mental State Examination score; tau level was associated with male sex and 1 Apo E epsilon4 allele. Classification tree analysis, comparing the AD and NC subjects, was 90% sensitive and 80% specific. With specificity set at greater than 90%, the tree was 77% sensitive for AD. This tree classified 26 of 74 members of the ND group as having AD. They had diagnoses difficult to distinguish from AD clinically and a high Apo E epsilon4 allele frequency. Markers in CSF were used to correctly classify 12 of 13 patients who later underwent autopsy, including 1 with AD not diagnosed clinically. CONCLUSIONS: Levels of CSF Abeta42 decrease and levels of CSF tau increase in AD. Apolipoprotein E epsilon4 had a dose-dependent relationship with CSF levels of Abeta42, but not tau. Other covariates influenced CSF markers minimally. Combined analysis of CSF Abeta42 and tau levels discriminated patients with AD, including patients with mild dementia, from the NC group, supporting use of these proteins to identify AD and to distinguish early AD from aging. In subjects in the ND group with an AD CSF profile, autopsy follow-up will be required to decide whether CSF results are false positive, or whether AD is a primary or concomitant cause of dementia.

Patient activation is a term that describes the skills and confidence that equip patients to become actively engaged in their health care. Health care delivery systems are turning to patient activation as yet another tool to help them and their patients improve outcomes and influence costs. In this article we examine the relationship between patient activation levels and billed care costs. In an analysis of 33,163 patients of Fairview Health Services, a large health care delivery system in Minnesota, we found that patients with the lowest activation levels had predicted average costs that were 8 percent higher in the base year and 21 percent higher in the first half of the next year than the costs of patients with the highest activation levels, both significant differences. What's more, patient activation was a significant predictor of cost even after adjustment for a commonly used "risk score" specifically designed to predict future costs. As health care delivery systems move toward assuming greater accountability for costs and outcomes for defined patient populations, knowing patients' ability and willingness to manage their health will be a relevant piece of information integral to health care providers' ability to improve outcomes and lower costs.

BACKGROUND: The role of chronic medical conditions in elderly persons' loss of functional abilities is intuitively important but not well defined. This analysis was designed to identify chronic medical conditions that lead to the development of severe functional limitation. METHODS: Functionally intact members of a multistage probability sample (n = 6,862) of all noninstitutionalized U.S. civilians age 70 years or older were interviewed in 1984. Based on data from the National Death Index and from follow-up telephone interviews in 1988 with survivors, subjects were classified as functionally intact, functionally limited (unable to perform one or more of seven essential activities), or decreased. RESULTS: After adjusting for the effects of exercise habits and demographic, socioeconomic, and psychosocial factors, we found that the best predictors of the development of functional limitation were cerebrovascular disease (OR = 2.14; 95% CL = 1.16, 3.98) and arthritis (OR = 1.51; 95% CL = 1.08, 2.11). The contribution of coronary artery disease also approached statistical significance (OR = 1.49; 95% CL = 0.99, 2.27). CONCLUSION: In the future, the primary prevention or effective treatment of cerebrovascular disease, arthritis, and possibly coronary artery disease may produce a modest reduction in the incidence of severe functional limitation.

Background: Left atrial appendage (LAA) occlusion provides an alternative to oral anticoagulation for thromboembolic risk reduction in patients with nonvalvular atrial fibrillation. Since regulatory approval in 2015, the WATCHMAN device has been the only LAA closure device available for clinical use in the United States. The PINNACLE FLX study (Protection Against Embolism for Nonvalvular AF Patients: Investigational Device Evaluation of the Watchman FLX LAA Closure Technology) evaluated the safety and effectiveness of the next-generation WATCHMAN FLX LAA closure device in patients with nonvalvular atrial fibrillation in whom oral anticoagulation is indicated, but who have an appropriate rationale to seek a nonpharmaceutical alternative. Methods: This was a prospective, nonrandomized, multicenter US Food and Drug Administration study. The primary safety end point was the occurrence of one of the following events within 7 days after the procedure or by hospital discharge, whichever was later: death, ischemic stroke, systemic embolism, or device- or procedure-related events requiring cardiac surgery. The primary effectiveness end point was the incidence of effective LAA closure (peri-device flow ≤5 mm), as assessed by the echocardiography core laboratory at 12-month follow-up. Results: A total of 400 patients were enrolled. The mean age was 73.8±8.6 years and the mean CHA 2 DS 2 -VASc score was 4.2±1.5. The incidence of the primary safety end point was 0.5% with a 1-sided 95% upper CI of 1.6%, meeting the performance goal of 4.2% ( P &lt;0.0001). The incidence of the primary effectiveness end point was 100%, with a 1-sided 95% lower CI of 99.1%, again meeting the performance goal of 97.0% ( P &lt;0.0001). Device-related thrombus was reported in 7 patients, no patients experienced pericardial effusion requiring open cardiac surgery, and there were no device embolizations. Conclusions: LAA closure with this next-generation LAA closure device was associated with a low incidence of adverse events and a high incidence of anatomic closure. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02702271.

BACKGROUND: The assessment of real-world effectiveness of immunomodulatory medications for multisystem inflammatory syndrome in children (MIS-C) may guide therapy. METHODS: We analyzed surveillance data on inpatients younger than 21 years of age who had MIS-C and were admitted to 1 of 58 U.S. hospitals between March 15 and October 31, 2020. The effectiveness of initial immunomodulatory therapy (day 0, indicating the first day any such therapy for MIS-C was given) with intravenous immune globulin (IVIG) plus glucocorticoids, as compared with IVIG alone, was evaluated with propensity-score matching and inverse probability weighting, with adjustment for baseline MIS-C severity and demographic characteristics. The primary outcome was cardiovascular dysfunction (a composite of left ventricular dysfunction or shock resulting in the use of vasopressors) on or after day 2. Secondary outcomes included the components of the primary outcome, the receipt of adjunctive treatment (glucocorticoids in patients not already receiving glucocorticoids on day 0, a biologic, or a second dose of IVIG) on or after day 1, and persistent or recurrent fever on or after day 2. RESULTS: A total of 518 patients with MIS-C (median age, 8.7 years) received at least one immunomodulatory therapy; 75% had been previously healthy, and 9 died. In the propensity-score-matched analysis, initial treatment with IVIG plus glucocorticoids (103 patients) was associated with a lower risk of cardiovascular dysfunction on or after day 2 than IVIG alone (103 patients) (17% vs. 31%; risk ratio, 0.56; 95% confidence interval [CI], 0.34 to 0.94). The risks of the components of the composite outcome were also lower among those who received IVIG plus glucocorticoids: left ventricular dysfunction occurred in 8% and 17% of the patients, respectively (risk ratio, 0.46; 95% CI, 0.19 to 1.15), and shock resulting in vasopressor use in 13% and 24% (risk ratio, 0.54; 95% CI, 0.29 to 1.00). The use of adjunctive therapy was lower among patients who received IVIG plus glucocorticoids than among those who received IVIG alone (34% vs. 70%; risk ratio, 0.49; 95% CI, 0.36 to 0.65), but the risk of fever was unaffected (31% and 40%, respectively; risk ratio, 0.78; 95% CI, 0.53 to 1.13). The inverse-probability-weighted analysis confirmed the results of the propensity-score-matched analysis. CONCLUSIONS: Among children and adolescents with MIS-C, initial treatment with IVIG plus glucocorticoids was associated with a lower risk of new or persistent cardiovascular dysfunction than IVIG alone. (Funded by the Centers for Disease Control and Prevention.).

Abstract This study examined the development of shared mental models in software development teams over time. Contrary to predictions, team members' mental models about the group's work and each other's expertise did not become more similar over time. Structural equation modelling revealed that as role differentiation increased in these teams, it led to a decrease in interaction and a corresponding decline in shared mental models. Implications for research on shared cognition and team development are explored. Copyright © 2001 John Wiley &amp; Sons, Ltd.

We studied the effect of acute renal allograft rejection and its timing on the development of chronic rejection and subsequent graft loss. Between January 1, 1987 and April 30, 1991, 424 patients at the University of Minnesota received a primary kidney transplant (minimum follow-up, 1 year). Patients were subdivided by donor source, presence or absence of acute rejection, and the timing of acute rejection onset (early, < or = 60 days vs. late, > 60 days post-transplant). For living donor (LD) transplant recipients (n = 219), the incidence of chronic rejection is 0.8% in those who had no acute rejection (n = 130), 20% in those with acute rejection < or = 60 days (n = 59) (P < 0.001 vs. no acute rejection), and 43% in those with acute rejection > 60 days (n = 30) (P < 0.001 vs. no acute rejection, P = 0.04 vs. early acute rejection). For cadaver (CAD) transplant recipients (n = 205), the incidence of chronic rejection is 0% in those who had no acute rejection (n = 109), 36% in those with acute rejection < or = 60 days (n = 69) (P < 0.001 vs. no acute rejection), and 63% in those with acute rejection > 60 days (n = 27) (P < 0.001 vs. no acute rejection, P = 0.03 vs. early acute rejection). For both LD and CAD recipients, no grafts have been lost to chronic rejection among those who did not first have at least 1 acute rejection episode. In contrast, 23 patients with acute rejection have had graft loss to chronic rejection. For both LD and CAD recipients, those with > 1 acute rejection episode had significantly more chronic rejection than those with only 1 rejection (P < 0.05). There was no significant difference in the incidence of chronic rejection based on whether the first acute rejection episode was steroid resistant or steroid responsive. We conclude that acute rejection is strongly related to the development of biopsy-proven chronic rejection and subsequent graft loss. Patients undergoing their first acute rejection episode > 60 days (vs. < or = 60 days) have an increased incidence of chronic rejection.

BACKGROUND: Burden of treatment refers to the workload of health care as well as its impact on patient functioning and well-being. We set out to build a conceptual framework of issues descriptive of burden of treatment from the perspective of the complex patient, as a first step in the development of a new patient-reported measure. METHODS: We conducted semistructured interviews with patients seeking medication therapy management services at a large, academic medical center. All patients had a complex regimen of self-care (including polypharmacy), and were coping with one or more chronic health conditions. We used framework analysis to identify and code themes and subthemes. A conceptual framework of burden of treatment was outlined from emergent themes and subthemes. RESULTS: Thirty-two patients (20 female, 12 male, age 26-85 years) were interviewed. Three broad themes of burden of treatment emerged including: the work patients must do to care for their health; problem-focused strategies and tools to facilitate the work of self-care; and factors that exacerbate the burden felt. The latter theme encompasses six subthemes including challenges with taking medication, emotional problems with others, role and activity limitations, financial challenges, confusion about medical information, and health care delivery obstacles. CONCLUSION: We identified several key domains and issues of burden of treatment amenable to future measurement and organized them into a conceptual framework. Further development work on this conceptual framework will inform the derivation of a patient-reported measure of burden of treatment.

PURPOSE: To develop a scoring method for brain observations in patients with X-linked adrenoleukodystrophy. METHODS: One hundred seventy-five brain MR scans in 83 male subjects less than 20 years of age with proved biochemical defects were reviewed. A severity score (0 to 34), based on a point system derived from location and extent of disease and the presence of focal and/or global atrophy, was calculated for each exam. RESULTS: Fifty-five of the 83 patients showed MR findings consistent with adrenoleukodystrophy. Two major patterns were observed. A posterior pattern (mean score, 9; range, 0.5 to 25) was present in 80% of patients, and an anterior pattern (mean score, 10; range, 2 to 18) was present in 15% of patients. Serial MR imaging, positive for adrenoleukodystrophy in 34 patients (mean follow-up, 23 months; range, 2 months to 6 years 11 months), showed progressive disease in 52%, progressive disease with subsequent stabilization in 18%, stable disease in 24%, and minimal improvement in 6%. CONCLUSION: The adrenoleukodystrophy MR severity scoring method is a measure that can be used with standard MR images. When used in conjunction with clinical parameters, this scoring method may help define better the natural history of adrenoleukodystrophy and monitor response to developing therapies.

BACKGROUND: Medication therapy management (MTM) was officially recognized by the federal government in the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, which requires Medicare Part D plans that offer prescription drug coverage to establish MTM programs (MTMPs) for eligible beneficiaries. Even though the term "MTM" was first used in 2003, pharmacists have provided similar services since the term "pharmaceutical care" was introduced in 1990. Fairview Health Services, a large integrated health care system, implemented a standardized pharmaceutical care service system in 1998, naming it a pharmaceutical care-based MTM practice in 2006. OBJECTIVE: To present the clinical, economic, and humanistic outcomes of 10 years of delivering MTM services to patients in a health care delivery system. METHODS: Data from MTM services provided to 9,068 patients and documented in electronic therapeutic records were retrospectively analyzed over the 10-year period from September 1998 to September 2008 in 1 health system with 48 primary care clinics. Patients eligible for MTM services were aged 21 years or older and either paid for MTM out of pocket or met their health care payer's criteria for MTM reimbursement; the criteria varied for Medicaid, Medicare, and commercially insured enrollees. All MTM was delivered face to face. Health data extracted from the electronic therapeutic record by the present study's investigators included patient demographics, medication list, medical conditions, drug therapy problems identified and addressed, change in clinical status, and pharmacist-estimated cost savings. The clinical status assessment was a comparison of the first and most recent MTM visit to measure whether the patient achieved the goals of therapy for each medical condition (e.g., the blood pressure of a patient with diabetes and hypertension will be less than 130/80 millimeters mercury [mmHg] in 1 month; the patient with allergic rhinitis will be relieved of his complaints of nasal congestion, runny nose, and eye itching within 5 days). Goals were set according to evidence-based literature and patient-specific targets determined cooperatively by pharmacists, patients, and physicians. Cost-savings calculations represented MTM pharmacists' estimates of medical services (e.g., office visits, laboratory services, urgent care visits, emergency room visits) and lost work time avoided by the intervention. All short-term (3-month) estimated health care savings that resulted from addressing drug therapy problems were analyzed. The expenses of these avoided services were calculated using the health system's contracted rates for services provided in the last quarter of 2008. The return on investment (ROI) was calculated by dividing the pharmacist-estimated savings by the cost of MTM services in 2008 (number of MTM encounters times the average cost of an MTM visit). The humanistic impact of MTM services was assessed using the results from the second patient satisfaction survey administered in 2008 (new patients seen from January through December 2008) for the health system's MTM program. RESULTS: A total of 9,068 patient records were in the documentation system as of September 30, 2008. During the 10-year period, there were 33,706 documented encounters (mean 3.7 encounters per patient). Of 38,631 drug therapy problems identified and addressed by MTM pharmacists, the most frequent were a need for additional drug therapy (n = 10,870, 28.1%) and subtherapeutic dosage (n = 10,100, 26.1%). In the clinical status assessment of the 12,851 medical conditions in 4,849 patients who were not at goal when they enrolled in the program, 7,068 conditions (55.0%) improved, 2,956 (23.0%) were unchanged, and 2,827 (22.0%) worsened during the course of MTM services. Pharmacist-estimated cost savings to the health system over the 10-year period were $2,913,850 ($86 per encounter) and the total cost of MTM was $2,258,302 ($67 per encounter), for an estimated ROI of $1.29 per $1 in MTM administrative costs. In the patient satisfaction survey, 95.3% of respondents agreed or strongly agreed that their overall health and well-being had improved because of MTM. CONCLUSION: Pharmacist estimates of the impact of an MTM program in a large integrated health care system suggest that the program was associated with improved clinical outcomes and cost savings. Patient satisfaction with the program was high. DISCLOSURES: There was no external funding for this manuscript. The 3 authors are employees of Fairview Pharmacy Services. Ramalho de Oliveira had primary responsibility for the concept and design, writing, and revision of the manuscript, with the assistance of Brummel and Miller. Ramalho de Oliveira performed the data collection, and all 3 authors shared equally in data interpretation.

The authors reviewed 29 cases of spinal tuberculosis treated from 1973 to 1993 with an average follow-up time of 7.4 years. Clinical findings included back pain, paraparesis, kyphosis, fever, sensory disturbance, and bowel and bladder dysfunction. Twenty-two patients (76%) presented with neurological deficit; 12 (41%) were initially misdiagnosed. Sixteen patients (55%) had predominant vertebral body involvement; nine had marked bone collapse with neurological compromise. Eleven individuals (39%) had intraspinal granulomatous tissue causing neurological dysfunction in the absence of bone destruction, and two (7%) had intramedullary tuberculomas. All patients received antituberculous medications: 13 were initially treated with bracing alone, eight underwent laminectomy and debridement of extra- or intradural granulomatous tissue, and eight underwent anterior, posterior, or combined fusion procedures. No patient with neurological deficit recovered or stabilized with nonoperative management. Thirteen patients were readmitted with progression of inadequately treated osteomyelitis; 12 (92%) of these required new or more radical fusion procedures. Anterior fusion failure was associated with marked preoperative kyphosis and multilevel disease requiring a graft that spanned more than two disc spaces. Courses of antibiotic medications shorter than 6 months were invariably associated with disease recurrence. It was concluded that 1) patients should receive at least 12 months of appropriate antituberculous therapy; 2) individuals with neurological deficit should undergo surgical decompression; 3) laminectomy and debridement are adequate for intraspinal granulomatous tissue in the absence of significant bone destruction; 4) when vertebral body involvement has produced wedging and kyphosis, aggressive debridement and fusion are indicated to prevent delayed instability and progression of disease.

OBJECTIVE: The objective of this project was to develop core competencies in pain assessment and management for prelicensure health professional education. Such core pain competencies common to all prelicensure health professionals have not been previously reported. METHODS: An interprofessional executive committee led a consensus-building process to develop the core competencies. An in-depth literature review was conducted followed by engagement of an interprofessional Competency Advisory Committee to critique competencies through an iterative process. A 2-day summit was held so that consensus could be reached. RESULTS: The consensus-derived competencies were categorized within four domains: multidimensional nature of pain, pain assessment and measurement, management of pain, and context of pain management. These domains address the fundamental concepts and complexity of pain; how pain is observed and assessed; collaborative approaches to treatment options; and application of competencies across the life span in the context of various settings, populations, and care team models. A set of values and guiding principles are embedded within each domain. CONCLUSIONS: These competencies can serve as a foundation for developing, defining, and revising curricula and as a resource for the creation of learning activities across health professions designed to advance care that effectively responds to pain.