Primary Care Women's Health Screening: A Case Study of a Community Engaged Human Centered Design Approach to Enhancing the Screening Process.

PURPOSE: To apply a Human Centered Design (HCD) approach to co-designing a comprehensive women's health screening tool with community partners. DESCRIPTION: Evidenced-based health screenings for behaviors and risks are important tools in primary health care and disease prevention, especially for women. However, numerous barriers limit the effective implementation of comprehensive health screenings, and often lead to excluding important risks such as intimate partner violence (IPV). Utilizing a human centered design approach (HCD), Mountain Area Health Education Center (MAHEC, NC USA) developed a community co-designed 9-topic health screening for women. Key end-users were recruited to participate in the design process, including women who identified IPV as a health issue in their community, Spanish speaking women, domestic violence program organizers, and MAHEC staff. ASSESSMENT: A total of 21 participants collaborated during three design sessions on two specific goals: 1) creating a comprehensive women's health screening tool from the existing tools that were in use in our clinics at the time, and 2) incorporating IPV screening. Through the HCD sessions, participants highlighted the impact of what they termed "Triple T: time, trust and talk" on the effectiveness of women's health screening. CONCLUSION: Our co-designed women's health screening tool is a first step towards addressing screening barriers from both primary care provider's and community women's perspectives. Future research will explore the facilitators of and barriers to implementing the tools in different primary care settings. Future work should also more systematically examine whether and how screening processes may reinforce or contribute to women's feelings of being stereotyped, and how screening processes can be designed to avoid stereotype threat, which has the potential to reduce the effectiveness of screenings intended to promote women's health.

A checklist for ascertaining study cohorts in oncology health services research using secondary data: report of the ISPOR oncology good outcomes research practices working group.

OBJECTIVES: The ISPOR Oncology Special Interest Group formed a working group at the end of 2010 to develop standards for conducting oncology health services research using secondary data. The first mission of the group was to develop a checklist focused on issues specific to selection of a sample of oncology patients using a secondary data source. METHODS: A systematic review of the published literature from 2006 to 2010 was conducted to characterize the use of secondary data sources in oncology and inform the leadership of the working group prior to the construction of the checklist. A draft checklist was subsequently presented to the ISPOR membership in 2011 with subsequent feedback from the larger Oncology Special Interest Group also incorporated into the final checklist. RESULTS: The checklist includes six elements: identification of the cancer to be studied, selection of an appropriate data source, evaluation of the applicability of published algorithms, development of custom algorithms (if needed), validation of the custom algorithm, and reporting and discussions of the ascertainment criteria. The checklist was intended to be applicable to various types of secondary data sources, including cancer registries, claims databases, electronic medical records, and others. CONCLUSIONS: This checklist makes two important contributions to oncology health services research. First, it can assist decision makers and reviewers in evaluating the quality of studies using secondary data. Second, it highlights methodological issues to be considered when researchers are constructing a study cohort from a secondary data source.

Comparative effectiveness research for prostate cancer radiation therapy: current status and future directions.

Comparative effectiveness research aims to help clinicians, patients and policymakers make informed treatment decisions under real-world conditions. Prostate cancer patients have multiple treatment options, including active surveillance, androgen deprivation therapy, surgery and multiple modalities of radiation therapy. Technological innovations in radiation therapy for prostate cancer have been rapidly adopted into clinical practice despite relatively limited evidence for effectiveness showing the benefit for one modality over another. Comparative effectiveness research has become an essential component of prostate cancer research to help define the benefits, risks and effectiveness of the different radiation therapy modalities currently in use for prostate cancer treatment.

Exploration of the Effects of Rural Obstetric Unit Closures on Birth Outcomes in North Carolina.

PURPOSE: Closures of rural labor and delivery (L/D) units have prompted national and state-based efforts to assess the impact on birth outcomes. This study explores local effects of L/D closures in rural areas of North Carolina (NC). METHODS: This is a retrospective cohort study of birth outcomes of 4,065 women in 5 rural areas of NC with L/D unit closures between 2013 and 2017. Outcomes were abstracted from birth certificate data from the NC Vital Statistics Reporting System. Localized outcomes 1 year prior to L/D unit closure were compared with outcomes 1 and 2 years post closure, including: (1) birth location and demographics, (2) change in travel patterns for birth, and (3) birth outcomes, including rates of labor induction, cesarean deliveries, maternal morbidity, and neonatal outcomes. FINDINGS: Before closures, 25%-56% of deliveries occurred outside county of residence. Commercially insured and college-educated women were more likely to deliver out-of-area. Closures increased travel distance to delivery hospital an average of 7-27 miles. In 2 areas, cesarean delivery rates decreased despite an increase in labor inductions. There was also variability between areas in prenatal care adequacy and breastfeeding. CONCLUSIONS: We found that L/D unit closures in rural NC disproportionately affected women on Medicaid. The impact showed area-specific variability, highlighting effects potentially masked by statewide or national analyses. Implications for future L/D closures would be eased by regional coordination and planning to mitigate negative effects, and state and national policies should address the excess burden placed on vulnerable populations.

Subtypes of sleep disturbance: associations among symptoms, comorbidities, treatment, and medical costs.

Medical claims and survey data were used to evaluate patients with sleep disturbance lasting 1 year or more, and to identify subtypes of sleep disturbance using latent class analysis. Four subtypes were identified from the 1,374 patients. Subtypes differed on the number of sleep disturbance symptoms, presence of non-restorative sleep and comorbidities, degree of daytime impairment, and insomnia severity. The results from this study suggest that patient-reported symptoms of sleep disturbance, the frequency of symptoms, functional impairment, and comorbid conditions are important elements in distinguishing among groups of patients with varying degrees of sleep problems. These data provide evidence that the Insomnia Severity Index (ISI) varies accordingly with the frequency and resulting impairment of symptoms captured in the 4 clusters.

The Value of Treating Opioid Use Disorder in Family Medicine: From the Patient Perspective.

INTRODUCTION: Despite evidence demonstrating that medications for opioid use disorder (OUD) reduce morbidity and mortality, the majority of patients do not receive treatment. The National Academies of Science call for more research exploring the patient's perspective of treatment modalities to increase access to individualized, patient-centered care. We aim to build on existing literature by describing patient experiences treated for OUD in a rural family medicine setting. METHODS: We employed a convenience sampling methodology to complete brief, structured interviews with thematic data analysis for 30 of 57 eligible patients receiving office-based opioid treatment (OBOT) in the primary care setting. RESULTS: Participants' experiences with OBOT were generally positive and shaped by societal structures and institutions, their life before treatment, their treatment history, and the kind of care they received in OBOT. Patients identified accessibility and privacy as advantages to receiving OBOT in primary care. DISCUSSION: This research identifies ways providers can provide individualized and effective OUD treatment within the family medicine setting.

The North Carolina Community Preceptor Experience: Third Study of Trends Over 12 Years.

PURPOSE: To measure community-based preceptors' overall satisfaction and motivations, the influence of students on preceptors' practices, and compare with 2005 and 2011 studies. METHOD: North Carolina primary care preceptors across disciplines (physicians, pharmacists, advanced practice nurses, physician assistants) received survey invitations via e-mail, fax, postcard, and/or full paper survey. Most questions in 2017 were the same as questions used in prior years, including satisfaction with precepting, likelihood to continue precepting, perceived influence of teaching students in their practice, and incentives for precepting. A brief survey or phone interview was conducted with 62 nonresponders. Chi-square tests were used to examine differences across discipline groups and to compare group responses over time. RESULTS: Of the 2,786 preceptors contacted, 893 (32.1%) completed questionnaires. Satisfaction (816/890; 91.7%) and likelihood of continuing to precept (778/890; 87.4%) remained unchanged from 2005 and 2011. However, more preceptors reported a negative influence for patient flow (422/888; 47.5%) in 2017 than in 2011 (452/1,266; 35.7%) and 2005 (496/1,379; 36.0%) (P < .0001), and work hours (392/889; 44.1%) in 2017 than in 2011 (416/1,268; 32.8%) and 2005 (463/1,392; 33.3%) (P < .0001). Importance of receiving payment for teaching increased from 32.2% (371/1,152) in 2011 to 46.4% (366/789) in 2017 (P < .0001). CONCLUSIONS: This 2017 survey suggests preceptor satisfaction and likelihood to continue precepting have remained unchanged from prior years. However, increased reporting of negative influence of students on practice and growing value of receiving payment highlight growing concerns about preceptors' time and finances and present a call to action.

Characteristics of patients initiating raloxifene compared to those initiating bisphosphonates.

BACKGROUND: Both raloxifene and bisphosphonates are indicated for the prevention and treatment of postmenopausal osteoporosis, however these medications have different efficacy and safety profiles. It is plausible that physicians would prescribe these agents to optimize the benefit/risk profile for individual patients. The objective of this study was to compare demographic and clinical characteristics of patients initiating raloxifene with those of patients initiating bisphosphonates for the prevention and treatment of osteoporosis. METHODS: This study was conducted using a retrospective cohort design. Female beneficiaries (45 years and older) with at least one claim for raloxifene or a bisphosphonate in 2003 through 2005 and continuous enrollment in the previous 12 months and subsequent 6 months were identified using a collection of large national commercial, Medicare supplemental, and Medicaid administrative claims databases (MarketScan). Patients were divided into two cohorts, a combined commercial/Medicare cohort and a Medicaid cohort. Within each cohort, characteristics (demographic, clinical, and resource utilization) of patients initiating raloxifene were compared to those of patients initiating bisphosphonate therapy. Group comparisons were made using chi-square tests for proportions of categorical measures and Wilcoxon rank-sum tests for continuous variables. Logistic regression was used to simultaneously examine factors independently associated with initiation of raloxifene versus a bisphosphonate. RESULTS: Within both the commercial/Medicare and Medicaid cohorts, raloxifene patients were younger, had fewer comorbid conditions, and fewer pre-existing fractures than bisphosphonate patients. Raloxifene patients in both cohorts were less likely to have had a bone mineral density (BMD) screening in the previous year than were bisphosphonate patients, and were also more likely to have used estrogen or estrogen/progestin therapy in the previous 12 months. These differences remained statistically significant in the multivariate model. CONCLUSION: In this sample of patients enrolled in commercial, Medicare, and Medicaid plans, patients who initiated raloxifene treatment differed from those initiating bisphosphonates. Raloxifene patients were younger, had better overall health status and appeared to be less likely to have risk factors for new osteoporotic fractures than bisphosphonate patients. Differences in the clinical profiles of these agents may impact prescribing decisions. Investigators using observational data to make comparisons of treatment outcomes associated with these medications should take these important differences in patient characteristics into consideration.

Time to pain freedom and onset of pain relief with rizatriptan 10 mg and prescription usual-care oral medications in the acute treatment of migraine headaches: a multicenter, prospective, open-label, two-attack, crossover study.

BACKGROUND: Patients and physicians consider rapid onset of pain relief and pain freedom among the most important attributes of migraine therapy. OBJECTIVE: This study compared the effectiveness of rizatriptan 10 mg and usual-care oral migraine medications in everyday clinical practice settings. METHODS: This was a multicenter, prospective, open-label study. Adult patients treated 2 sequential migraine attacks with rizatriptan 10 mg and a usual-care prescription migraine medication in a crossover manner. Patients chose which medication to take first. They recorded the treatment outcomes using a stopwatch and a treatment diary. End points included time to pain freedom (length of time from dosing to no pain) and time to onset of pain relief (mean time to onset of pain relief and proportion of patients reporting onset of pain relief at 30 minutes), satisfaction with treatment, and medication preference. Information on adverse events was collected through the normal post-marketing reporting mechanism. Comparisons were made using the paired t test and McNemar test for continuous and categorical variables, respectively. A mixed model, accounting for multiple observations per patient, was fitted for the time to pain freedom, controlling for age, sex, treatment period, medication, and headache severity. RESULTS: Of 2346 enrolled patients, 1489 treated 2 migraines in a crossover manner and were included in the analysis (86.8% women, 13.2% men; mean age, 41.7 years). A majority of patients (80.6%) treated both migraines with oral triptans. The most commonly used nontriptans were NSAIDs (5.4%), butalbital-containing combinations (4.3%), and isometheptene (3.4%). Over-the-counter medications were used by 22.3% of patients during rizatriptan-treated attacks and by 28.9% of patients during attacks treated with usual-care medications. The mean time to pain freedom was significantly shorter when an attack was treated with rizatriptan compared with usual-care medications (222 vs 298 minutes, respectively; P<0.001), and the onset of pain relief was significantly more rapid (85 vs 107 minutes; P=0.003), with significant differences noted as early as 15 minutes after dosing (P<0.001). The findings remained similar after adjustment for potential confounding factors. No significant sequence effect was detected. Significantly more patients reported being very satisfied or satisfied with rizatriptan compared with usual-care medications (65.4% vs 57.7%; P<0.001) and preferred rizatriptan (58.0% vs 42.0%; P<0.001). One female patient reported having hives and itchy skin the day after taking rizatriptan; the symptoms subsided after treatment with methylprednisolone. CONCLUSIONS: In this selected population, treatment of a migraine attack with rizatriptan 10 mg was associated with a faster time to pain freedom and onset of pain relief compared with treatment with usual-care oral migraine medications. Patients reported greater satisfaction with and preference for rizatriptan.

Development and Validation of an Algorithm to Identify Patients with Multiple Myeloma Using Administrative Claims Data.

PURPOSE: The objective was to expand on prior work by developing and validating a new algorithm to identify multiple myeloma (MM) patients in administrative claims. METHODS: Two files were constructed to select MM cases from MarketScan Oncology Electronic Medical Records (EMR) and controls from the MarketScan Primary Care EMR during January 1, 2000-March 31, 2014. Patients were linked to MarketScan claims databases, and files were merged. Eligible cases were age ≥18, had a diagnosis and visit for MM in the Oncology EMR, and were continuously enrolled in claims for ≥90 days preceding and ≥30 days after diagnosis. Controls were age ≥18, had ≥12 months of overlap in claims enrollment (observation period) in the Primary Care EMR and ≥1 claim with an ICD-9-CM diagnosis code of MM (203.0×) during that time. Controls were excluded if they had chemotherapy; stem cell transplant; or text documentation of MM in the EMR during the observation period. A split sample was used to develop and validate algorithms. A maximum of 180 days prior to and following each MM diagnosis was used to identify events in the diagnostic process. Of 20 algorithms explored, the baseline algorithm of 2 MM diagnoses and the 3 best performing were validated. Values for sensitivity, specificity, and positive predictive value (PPV) were calculated. CONCLUSION: Three claims-based algorithms were validated with ~10% improvement in PPV (87-94%) over prior work (81%) and the baseline algorithm (76%) and can be considered for future research. Consistent with prior work, it was found that MM diagnoses before and after tests were needed.

Trends in lipid management among patients with coronary artery disease: has diabetes received the attention it deserves?

OBJECTIVE: To examine lipid management trends for coronary artery disease (CAD) patients with and without diabetes in order to determine whether those with diabetes are beginning to receive aggressive lipid management consistent with their elevated risk. RESEARCH DESIGN AND METHODS: We used outpatient medical record data from 47,813 CAD patients seen at 295 medical practices participating in the Quality Assurance Program II between 1996 and 1998. Lipid testing rates, lipid treatment rates, and serum lipid concentrations are described for CAD patients with and without diabetes within strata of office visit date. RESULTS: Lipid testing and treatment rates increased and mean lipid levels decreased markedly over time. Those with diabetes were 26% less likely to have a lipid profile and 17% less likely to receive a lipid-lowering medication than their nondiabetic counterparts, and this disparity did not diminish over time. Among treated patients, mean non-HDL cholesterol (non-HDL-C) and LDL cholesterol (LDL-C) declined less rapidly over time for patients with than without diabetes. CONCLUSIONS: Although impressive progress was made in the outpatient lipid management of CAD patients, lipid management for CAD patients with diabetes improved no more rapidly, and in some cases less rapidly, than for nondiabetic patients. Given their higher risk, more effort is needed to ensure that CAD patients with diabetes receive aggressive lipid management.

Population implications of changes in lipid management in patients with coronary heart disease.

Pharmacologic treatment and goal attainment rates from published literature indicate that lipid management has generally improved for patients with coronary heart disease. The population implications of these changes in lipid management are examined, suggesting that the challenge of lipid management may be shifting from a problem of no treatment to one of undertreatment.

Disparities in lipid management for African Americans and Caucasians with coronary artery disease: a national cross-sectional study.

BACKGROUND: Individuals with coronary artery disease are at high risk for adverse health outcomes. This risk can be diminished by aggressive lipid management, but adherence to lipid management guidelines is far from ideal and substantial racial disparities in care have been reported. Lipid treatment and goal attainment information is not readily available for large patient populations seen in the fee-for-service setting. As a result, national programs to improve lipid management in this setting may focus on lipid testing as an indicator of lipid management. We describe the detection, treatment, and control of dyslipdemia for African Americans and Caucasians with coronary artery disease to evaluate whether public health programs focusing on lipid testing can eliminate racial disparities in lipid management. METHODS: Physicians and medical practices with high numbers of prescriptions for coronary artery disease medications were invited to participate in the Quality Assurance Program. Medical records were reviewed from a random sample of patients with coronary artery disease seen from 1995 through 1998. Data related to the detection, treatment, and control of dyslipidemia were abstracted from the medical record and evaluated in cross-sectional stratified and logistic regression analyses using generalized estimation equations. RESULTS: Data from the medical records of 1,046 African Americans and 22,077 Caucasians seen in outpatient medical practices in 23 states were analyzed. African-American patients were younger, more likely to be women and to have diabetes, heart failure, and hypertension. The low density lipoprotein cholesterol (LDL-C) testing rate for Caucasian men was over 1.4 times higher than that for African-American women and about 1.3 times higher than that for African-American men. Almost 60% of tested Caucasian men and less than half of tested African Americans were prescribed lipid-lowering drugs. Tested and treated Caucasian men had the highest LDL-C goal attainment (35%) and African-American men the lowest (21%). CONCLUSIONS: Although increased lipid testing is clearly needed for African Americans, improvements in treatment and control are also necessary to eliminate racial disparities in lipid management. Disparities in treatment and goal attainment must be better understood and reflected in policy to improve the health of underserved populations.

Utilization patterns of cyclooxygenase-2 inhibitors among patients with arthritis in a managed care setting.

When anti-inflammatory/analgesic agents are not well tolerated, patients with arthritis may be prescribed a cyclooxygenase-2 (COX-2) inhibitor. Since these patients often require daily treatment and COX-2 inhibitors are more expensive than nonselective nonsteroidal anti-inflammatory agents, it is important to assess their patterns of use. In this retrospective study, rofecoxib and celecoxib were compared, in a managed care population with arthritis, in terms of average daily medication consumption and cost. Celecoxib was found to be significantly more costly than rofecoxib, and certain factors, such as the treating physician's specialty, correlated with prescribing patterns. Given the high prevalence of arthritic conditions, these results suggest that the selection of a COX-2 inhibitor may substantially affect health care costs.

Current challenges in health economic modeling of cancer therapies: a research inquiry.

BACKGROUND: The demand for economic models that evaluate cancer treatments is increasing, as healthcare decision makers struggle for ways to manage their budgets while providing the best care possible to patients with cancer. Yet, after nearly 2 decades of cultivating and refining techniques for modeling the cost-effectiveness and budget impact of cancer therapies, serious methodologic and policy challenges have emerged that question the adequacy of economic modeling as a sound decision-making tool in oncology. OBJECTIVES: We sought to explore some of the contentious issues associated with the development and use of oncology economic models as informative tools in current healthcare decision-making. Our objective was to draw attention to these complex pharmacoeconomic concerns and to promote discussion within the oncology and health economics research communities. METHODS: Using our combined expertise in health economics research and economic modeling, we structured our inquiry around the following 4 questions: (1) Are economic models adequately addressing questions relevant to oncology decision makers; (2) What are the methodologic limitations of oncology economic models; (3) What guidelines are followed for developing oncology economic models; and (4) Is the evolution of oncology economic modeling keeping pace with treatment innovation? Within the context of each of these questions, we discuss issues related to the technical limitations of oncology modeling, the availability of adequate data for developing models, and the problems with how modeling analyses and results are presented and interpreted. DISCUSSION: There is general acceptance that economic models are good, essential tools for decision-making, but the practice of oncology and its rapidly evolving technologies present unique challenges that make assessing and demonstrating value especially complex. There is wide latitude for improvement in oncology modeling methodologies and how model results are presented and interpreted. CONCLUSION: Complex technical and data availability issues with oncology economic modeling pose serious concerns that need to be addressed. It is our hope that this article will provide a framework to guide future discourse on this important topic.

Evidence-to-policy gap on hepatitis A vaccine adoption in 6 countries: Literature vs. policymakers' beliefs.

BACKGROUND: National vaccine adoption decisions may be better understood by linking multiple data sources. When examining countries' decisions to adopt the hepatitis A vaccine, applying multiple research methods can facilitate assessments of gaps between evidence and policy. We conducted a literature review on hepatitis A and stakeholder interviews about decisions to adopt the vaccine in six countries (Chile, India, South Korea, Mexico, Russia, and Taiwan). METHODS: A systematic literature review was conducted across five literature databases. The review identified and abstracted 340 articles, supplemented by internet search. In addition, we interviewed 62 experts and opinion leaders on hepatitis A and/or vaccines. Data from the two sources were analyzed to identify gaps around epidemiologic data, economic data, and barriers/facilitators of hepatitis A vaccine adoption. RESULTS: Epidemiologic data gaps were found in Chile and Russia, where stakeholders believed data to be more solid than the literature documented. Economic data on hepatitis A was found to be weak across all countries despite stakeholders' agreement on its importance. Barriers and facilitators of vaccine adoption such as political will, prioritization among vaccines, and global or local recommendations were discussed more by stakeholders than the literature. Stakeholders in India and Mexico were not concerned with the lack of data, despite growing recognition in the literature of the epidemiological transition and threat of outbreaks. CONCLUSIONS: Triangulation of results from two methods captured a richer story behind vaccine adoption decisions for hepatitis A. The discrepancy between policymakers' beliefs and existing data suggest a decline in priority of hepatitis A or weak investment in data collection. Filling the confirmed data gaps in seroprevalence or economic data is important to help guide policy decisions. Greater communication of the risk of hepatitis A and the benefits of the vaccine may help countries undergoing the epidemiologic transition.

Physician beliefs and practices for adjuvant and salvage radiation therapy after prostatectomy.

PURPOSE: Despite results of randomized trials that support adjuvant radiation therapy (RT) after radical prostatectomy (RP) for prostate cancer with adverse pathologic features (APF), many clinicians favor selective use of salvage RT. This survey was conducted to evaluate the beliefs and practices of radiation oncologists (RO) and urologists (U) regarding RT after RP. METHODS AND MATERIALS: We designed a Web-based survey of post-RP RT beliefs and policies. Survey invitations were e-mailed to a list of 926 RO and 591 U. APF were defined as extracapsular extension, seminal vesicle invasion, or positive surgical margin. Differences between U and RO in adjuvant RT recommendations were evaluated by comparative statistics. Multivariate analyses were performed to evaluate factors predictive of adjuvant RT recommendation. RESULTS: Analyzable surveys were completed by 218 RO and 92 U (overallresponse rate, 20%). Adjuvant RT was recommended based on APF by 68% of respondents (78% RO, 44% U, p <0.001). U were less likely than RO to agree that adjuvant RT improves survival and/or biochemical control (p < 0.0001). PSA thresholds for salvage RT were higher among U than RO (p < 0.001). Predicted rates of erectile dysfunction due to RT were higher among U than RO (p <0.001). On multivariate analysis, respondent specialty was the only predictor of adjuvant RT recommendations. CONCLUSIONS: U are less likely than RO to recommend adjuvant RT. Future research efforts should focus on defining the toxicities of post-RP RT and on identifying the subgroups of patients who will benefit from adjuvant vs. selective salvage RT.

Role of quality improvement in prevention of inappropriate transfusions.

PURPOSE: Many different methods are used to manage surgical bleeding and reduce transfusion. Techniques vary by institution, resulting in inconsistent outcomes. We reviewed the current literature on the quality and costs of transfusions, focusing on prevention and management of transfusions during surgery, and provide recommendations on future directions for quality improvement (QI). DATA SOURCES: Ovid, PubMed, and Scopus. STUDY SELECTION: Key words included QI, blood loss, transfusion, hemostasis, and costs. Inclusion criteria were English language, publication between 1999 and 2010, and primary end points of blood loss, transfusion, or hemostasis. DATA EXTRACTION: A total of 1331 abstracts were reviewed; 43 met the inclusion criteria. RESULTS: A variety of bleeding management (BM) techniques were identified, with multiple studies suggesting that algorithms combining pre-, peri-, and postoperative interventions have the greatest potential to minimize transfusions. Most studies assessing the economic impact of BM interventions excluded resources beyond blood acquisition cost and longer-term complications, which may underestimate transfusion costs and bias estimates of the cost-effectiveness of interventions. Despite consensus on avoiding inappropriate transfusions, little agreement exists on optimal use of interventions. CONCLUSIONS: Multifaceted algorithms show promising results. Future QI should focus on reducing practice variation via evidence-based guidelines for effective use of BM interventions.

Medical devices: adapting to the comparative effectiveness landscape.

Outcomes research for medical devices has always lagged, with good reason. Comparative effectiveness initiatives, though, will soon spur demand for more and better data, and that means more and better outcomes research training.

Associations of nonrestorative sleep with insomnia, depression, and daytime function.

STUDY OBJECTIVES: Nonrestorative sleep (NRS) complaints are common but associations with insomnia, daytime function or depressive symptoms are not well-established. This study aims to (1) describe insomnia related symptoms and sleep quality in those with NRS compared to those with no NRS; (2) identify the independent associations between NRS, insomnia severity, and depression; and (3) identify the association between NRS and daytime function independent of insomnia severity and depression. DESIGN: Cross sectional survey of enrollees at a health plan in the Midwestern United States. MEASUREMENT: Respondents were surveyed about the presence and frequency of NRS complaints, depression, insomnia severity and related symptoms. Multivariate regression was used to examine the study's three research aims. PARTICIPANTS: Study sample consisted of 541 subjects with NRS and 717 who reported never experiencing any NRS symptoms. RESULTS: We found a statistically significant interaction between NRS and total sleep duration such that the association between sleep duration and sleep quality was attenuated in those with NRS compared to those without NRS (b=-0.26, SE=0.07, p<0.0001). In multivariate analysis, subthreshold, moderate and severe insomnia were associated with NRS (OR [95%CI]=5.93 [4.24-8.31], 9.22 [6.15-13.83] and 6.10 [3.34-11.14], respectively). NRS was independently associated with daytime physical function, cognitive function and emotional function OR [95%CI]=2.21 [1.59-3.08], 1.90 [1.37-2.64] and 1.71 [1.23-2.36], respectively. CONCLUSION: NRS is a complex concept that should be further defined and studied in the larger context of sleep quality, other insomnia related symptoms, daytime function and depression.