Vitamin D for the Prevention of Disease: An Endocrine Society Clinical Practice Guideline.

BACKGROUND: Numerous studies demonstrate associations between serum concentrations of 25-hydroxyvitamin D (25[OH]D) and a variety of common disorders, including musculoskeletal, metabolic, cardiovascular, malignant, autoimmune, and infectious diseases. Although a causal link between serum 25(OH)D concentrations and many disorders has not been clearly established, these associations have led to widespread supplementation with vitamin D and increased laboratory testing for 25(OH)D in the general population. The benefit-risk ratio of this increase in vitamin D use is not clear, and the optimal vitamin D intake and the role of testing for 25(OH)D for disease prevention remain uncertain. OBJECTIVE: To develop clinical guidelines for the use of vitamin D (cholecalciferol [vitamin D3] or ergocalciferol [vitamin D2]) to lower the risk of disease in individuals without established indications for vitamin D treatment or 25(OH)D testing. METHODS: A multidisciplinary panel of clinical experts, along with experts in guideline methodology and systematic literature review, identified and prioritized 14 clinically relevant questions related to the use of vitamin D and 25(OH)D testing to lower the risk of disease. The panel prioritized randomized placebo-controlled trials in general populations (without an established indication for vitamin D treatment or 25[OH]D testing), evaluating the effects of empiric vitamin D administration throughout the lifespan, as well as in select conditions (pregnancy and prediabetes). The panel defined "empiric supplementation" as vitamin D intake that (a) exceeds the Dietary Reference Intakes (DRI) and (b) is implemented without testing for 25(OH)D. Systematic reviews queried electronic databases for publications related to these 14 clinical questions. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) methodology was used to assess the certainty of evidence and guide recommendations. The approach incorporated perspectives from a patient representative and considered patient values, costs and resources required, acceptability and feasibility, and impact on health equity of the proposed recommendations. The process to develop this clinical guideline did not use a risk assessment framework and was not designed to replace current DRI for vitamin D. RESULTS: The panel suggests empiric vitamin D supplementation for children and adolescents aged 1 to 18 years to prevent nutritional rickets and because of its potential to lower the risk of respiratory tract infections; for those aged 75 years and older because of its potential to lower the risk of mortality; for those who are pregnant because of its potential to lower the risk of preeclampsia, intra-uterine mortality, preterm birth, small-for-gestational-age birth, and neonatal mortality; and for those with high-risk prediabetes because of its potential to reduce progression to diabetes. Because the vitamin D doses in the included clinical trials varied considerably and many trial participants were allowed to continue their own vitamin D-containing supplements, the optimal doses for empiric vitamin D supplementation remain unclear for the populations considered. For nonpregnant people older than 50 years for whom vitamin D is indicated, the panel suggests supplementation via daily administration of vitamin D, rather than intermittent use of high doses. The panel suggests against empiric vitamin D supplementation above the current DRI to lower the risk of disease in healthy adults younger than 75 years. No clinical trial evidence was found to support routine screening for 25(OH)D in the general population, nor in those with obesity or dark complexion, and there was no clear evidence defining the optimal target level of 25(OH)D required for disease prevention in the populations considered; thus, the panel suggests against routine 25(OH)D testing in all populations considered. The panel judged that, in most situations, empiric vitamin D supplementation is inexpensive, feasible, acceptable to both healthy individuals and health care professionals, and has no negative effect on health equity. CONCLUSION: The panel suggests empiric vitamin D for those aged 1 to 18 years and adults over 75 years of age, those who are pregnant, and those with high-risk prediabetes. Due to the scarcity of natural food sources rich in vitamin D, empiric supplementation can be achieved through a combination of fortified foods and supplements that contain vitamin D. Based on the absence of supportive clinical trial evidence, the panel suggests against routine 25(OH)D testing in the absence of established indications. These recommendations are not meant to replace the current DRIs for vitamin D, nor do they apply to people with established indications for vitamin D treatment or 25(OH)D testing. Further research is needed to determine optimal 25(OH)D levels for specific health benefits.

The electronic health record Risk of Alzheimer's and Dementia Assessment Rule (eRADAR) Brain Health Trial: Protocol for an embedded, pragmatic clinical trial of a low-cost dementia detection algorithm.

BACKGROUND: About half of people living with dementia have not received a diagnosis, delaying access to treatment, education, and support. We previously developed a tool, eRADAR, which uses information in the electronic health record (EHR) to identify patients who may have undiagnosed dementia. This paper provides the protocol for an embedded, pragmatic clinical trial (ePCT) implementing eRADAR in two healthcare systems to determine whether an intervention using eRADAR increases dementia diagnosis rates and to examine the benefits and harms experienced by patients and other stakeholders. METHODS: We will conduct an ePCT within an integrated healthcare system and replicate it in an urban academic medical center. At primary care clinics serving about 27,000 patients age 65 and above, we will randomize primary care providers (PCPs) to have their patients with high eRADAR scores receive targeted outreach (intervention) or usual care. Intervention patients will be offered a "brain health" assessment visit with a clinical research interventionist mirroring existing roles within the healthcare systems. The interventionist will make follow-up recommendations to PCPs and offer support to newly-diagnosed patients. Patients with high eRADAR scores in both study arms will be followed to identify new diagnoses of dementia in the EHR (primary outcome). Secondary outcomes include healthcare utilization from the EHR and patient, family member and clinician satisfaction assessed through surveys and interviews. CONCLUSION: If this pragmatic trial is successful, the eRADAR tool and intervention could be adopted by other healthcare systems, potentially improving dementia detection, patient care and quality of life.

LungCARE: Encouraging Shared Decision-Making in Lung Cancer Screening-a Randomized Trial.

BACKGROUND: Lung cancer screening (LCS) is recommended for individuals at high risk due to age and smoking history after a shared decision-making conversation. However, little is known about best strategies for incorporating shared decision-making, especially in a busy primary care setting. OBJECTIVE: To develop a novel tool, Lung Cancer Assessment of Risk and Education (LungCARE) to guide LCS decisions among eligible primary care patients. DESIGN: Pilot cluster randomized controlled trial of LungCARE versus usual care. PARTICIPANTS: Patients of providers in a university primary care clinic, who met criteria for LCS. INTERVENTION: Providers were randomized to LungCARE intervention or control. LungCARE participants completed a computer tablet-based video assessment of lung cancer educational needs in the waiting room prior to a primary care visit. Patient and provider both received a summary handout of patient concerns and responses. MAIN MEASURES: All eligible patients completed baseline interviews by telephone. One week after the index visit, participants completed a follow-up telephone survey that assessed patient-physician discussion of LCS, referral to and scheduling of LCS, as well as LCS knowledge and acceptability of LungCARE. Two months after index visit, we reviewed patients' electronic health records (EHRs) for evidence of a shared decision-making conversation and referral to and receipt of LCS. KEY RESULTS: A total of 66 participants completed baseline and follow-up visits (34: LungCARE; 32: usual care). Mean age was 65.9 (± 6.0). Based on EHR review, compared to usual care, LungCARE participants were more likely to have discussed LCS with their physicians (56% vs 25%; p = 0.04) and to be referred to LCS (44% vs 13%; p < 0.02). Intervention participants were also more likely to complete LCS (32% vs 13%; p < 0.01) and had higher knowledge scores (mean score 6.5 (± 1.7) vs 5.5 (± 1.4; p < 0.01). CONCLUSIONS: LungCARE increased discussion, referral, and completion of LCS and improved LCS knowledge. CLINICAL TRIAL REGISTRATION: NCT03862001.

Efficacy of a Primary Care-Based Mobile Application to Increase Hepatitis C Screening Among Asian Americans: A Secondary Analysis of a Randomized Clinical Trial.

Background: Hepatitis C virus (HCV) screening remains suboptimal. We assessed the efficacy of a mobile application and provider alert in enhancing HCV screening among Asian Americans. Methods: A secondary analysis of a cluster-randomized clinical trial was performed during the birth cohort screening era to assess the efficacy of a Hepatitis App (intervention), a multilingual mobile application delivering interactive video education on viral hepatitis and creating a Provider Alert printout, at primary care clinics within 2 healthcare systems in San Francisco from 2015 to 2017. A comparison group received usual care and a similar intervention on nutrition and physical activity. The outcome was electronic health record (EHR) documentation of HCV screening along with patient-provider communication about testing and test ordering. Results: Four hundred fifty-two participants (mean age 57 years, 36% male, 80% foreign-born) were randomized by provider clusters to the intervention (n = 270) or comparison groups (n = 182). At 3-month follow up, the intervention group was more likely than the comparison group to be aware of HCV (75% vs 59%, P = .006), to discuss HCV testing with their providers (63% vs 13%, P < .001), to have HCV testing ordered (39% vs 10%, P < .001), and to have EHR-verified HCV testing (30% vs 6%, P < .001). Within the intervention group, being born between 1945 and 1965 (odds ratio, 3.15; 95% confidence interval, 1.35-7.32) was associated with increased HCV testing. Conclusions: The Hepatitis App delivered in primary care settings was effective in increasing HCV screening in a socioeconomically diverse Asian American cohort. This highlights the importance of mobile technology as a patient-centered strategy to address gaps in HCV care.

Women's health update: A literature review impacting primary care.

The authors review studies on key issues in women's health with potential impact on internal medicine practice. The reviewed articles discuss cardiovascular disease risks, bone health, breast cancer genetics, cervical cancer prevention, depression in the peripartum period, pelvic pain, and emergency contraception.

Barriers and Facilitators to Lung Cancer Screening: A Physician Survey.

PURPOSE: To describe barriers to lung cancer screening (LCS) among family medicine and general internal medicine primary care physicians (PCPs) and assess the association of barriers with discussion and referral for screening. DESIGN: Cross-sectional survey. SUBJECTS AND SETTINGS: Random sample of primary care physicians (PCPs) in California. MEASURES: PCP practices for discussion and referral for LCS and ratings of LCS barriers. ANALYSIS: We performed exploratory factor analysis to identify four barrier constructs: (1) Physician Visit-Level Barriers to screening referral; (2) Physician System and Evidence Barriers; (3) Patient Cost Barrier; and (4) Other Patient Barriers. We then performed multivariable logistic regression adjusted for physician and practice characteristics to assess the association between the physician-reported barriers and whether PCPs discussed or referred for LCS. RESULTS: 368 physicians responded (response rate 42%). Most worked in large metropolitan areas (80%) and large health systems (59%). After adjusting for physician and practice characteristics, we found that physician-reporting of System and Evidence Barriers was associated with lower odds of discussion or referral for LDCT (aOR .18, 95% CI 0.09-0.37), while physician-reported Visit-Level Barriers were associated with increased odds discussion or referral (aOR 2.65, 95% CI 1.30-5.04). CONCLUSIONS: While physicians reported numerous barriers to LCS, we found that barriers were differentially associated with discussion or referral for screening. As new LCS guidelines broaden screening eligibility, it is critical to address these barriers to achieve higher rates of evidence-based LCS.

Health Within Reach-a Patient-Centered Intervention to Increase Hepatitis B Screening Among Asian Americans: a Randomized Clinical Trial.

BACKGROUND: There are few studies to date of interventions to increase viral hepatitis screening among Asian Americans, who have high rates of chronic hepatitis B (HBV) infection. OBJECTIVE: To develop, implement, and test the efficacy of a mobile application (Hepatitis App) delivered in four languages to increase HBV screening among Asian Americans. DESIGN: Cluster-randomized clinical trial. PARTICIPANTS: Four hundred fifty-two Asian American patients ≥ 18 years of age, who had no prior HBV testing, and received primary care within two healthcare systems in San Francisco, CA. INTERVENTIONS: The intervention group received the Hepatitis App, delivering interactive video education on viral hepatitis in English, Cantonese, Mandarin, or Vietnamese and a provider printout (Provider Alert) and Provider Panel Notification. The comparison group received a mobile application delivering nutrition and physical activity education and Provider Panel Notification. MAIN MEASURES: Primary outcomes were patient-provider discussion about HBV and documentation of a HBV screening test within 3 months post-intervention. Secondary outcome was documentation of an order for a HBV screening test. KEY RESULTS: Participants had a mean age of 57 years and were 64% female, 80% foreign-born, and 44% with limited English fluency. At post-visit, over 80% of intervention participants reported they liked using the Hepatitis App. At 3-month follow-up, the intervention group was more likely than the comparison group (all P < 0.001) to have discussed HBV with their provider (70% vs.16%), have a HBV test ordered (44% vs.10%), and receive a HBV test (38% vs.8%). In multivariable analyses, the intervention odds ratio for HBV test ordering was 7.6 (95% CI: 3.9, 14.8) and test receipt was 7.5 (95% CI: 3.6, 15.5). CONCLUSIONS: A multi-lingual educational intervention using a mobile application in primary care clinics was well received by Asian American patients, enhanced patient-provider communication about HBV, and increased HBV screening. Technology can improve healthcare quality among Asian Americans. TRIAL REGISTRATION: ClinicalTrials.gov NCT02139722 ( https://clinicaltrials.gov/ct2/show/NCT02139722 ).

Evaluating the sustainability of a cancer screening intervention through a PRISM: The PreView experience.

Although many trials of cancer screening interventions evaluate efficacy and effectiveness, less research focuses on how to sustain interventions in non-research settings, which limit the potential reach of these interventions. Identifying the factors that influence the potential for sustainability is critical. We evaluate the factors influencing sustainability of PreView, a Cancer Screening Intervention, within the context of the Practical, Robust Implementation and Sustainability Model (PRISM). PRISM includes organizational and patient perspectives of the intervention as well as characteristics of the organizational and patient recipients. It considers how the program or intervention design, external environment, implementation, and sustainability infrastructure and the recipients influence program adoption, implementation, and maintenance. We evaluate the attempts at sustainability of PreView within the constructs of PRISM. Encouraging patients to use PreView was more difficult outside of a clinical trial. Organizational perspectives on how the intervention fit in with other goals, patient perspectives on how the intervention is individualized (i.e. being able to choose which cancer screening to address) and focused on barriers, patient characteristics (i.e. having multiple comorbidities making cancer screening less of a priority), organizational characteristics (i.e. middle managers having competing responsibilities), external environment influences (i.e. reimbursement for achieving certain cancer screening goals), and sustainability infrastructure all affect the likelihood of PreView being sustained in clinical practice. Despite advance planning for sustainability, adapting interventions to achieve sustainability is difficult. Lessons learned from evaluating PreView within the PRISM model can inform future sustainability efforts.

An Exploration of New Graduate Nurses' Transition to Specialty Practice.

New graduates' adjustment to high-acuity specialty areas was evaluated using qualitative methods in a hospital system that uses the Versant New Graduate Residency Program. Subjects were interviewed at baseline in person, answered interview questions at 6 months via computer, and were interviewed at 12 months in person. Twelve themes emerged from the interviews, reflecting intrinsic and extrinsic factors affecting new graduate nurse adjustment. Study results were used to evaluate the program and improve the program implementation.

Nursing attitudes and practices for routine I.V. catheter resiting.

PURPOSE: To understand nursing perceptions of hospital requirements for routine resiting of short peripheral catheters (SPCs). METHODS: This exploratory research project at the authors' medium-sized regional referral and trauma center utilized an online survey to assess the perceived efficacy and patient disruption related to SPC resiting among acute care nurses. RESULTS: Out of 203 eligible nurses, 81 participated. The survey results support the perception that SPC insertions and resiting can be time-consuming and disruptive to the flow of care. The strongest correlation occurred between patients who had requested no SPC resiting and the reported disruption from SPC resiting. CONCLUSION: Based on the survey results, a formal recommendation was made within the hospital system to amend the existing policy and remove the requirement for SPC resiting after 96 hours in favor of the nurses' best clinical judgment.

The Effectiveness and Value of Oral Immunotherapy and Viaskin Peanut for Peanut Allergy.

DISCLOSURES: Funding for this summary was contributed by Arnold Ventures, Commonwealth Fund, California Health Care Foundation, National Institute for Health Care Management (NIHCM), New England States Consortium Systems Organization, Blue Cross Blue Shield of Massachusetts, Harvard Pilgrim Health Care, Kaiser Foundation Health Plan, and Partners HealthCare to the Institute for Clinical and Economic Review (ICER), an independent organization that evaluates the evidence on the value of health care interventions. ICER's annual policy summit is supported by dues from Aetna, America's Health Insurance Plans, Anthem, Allergan, Alnylam, AstraZeneca, Biogen, Blue Shield of CA, Cambia Health Services, CVS, Editas, Express Scripts, Genentech/Roche, GlaxoSmithKline, Harvard Pilgrim, Health Care Service Corporation, Health Partners, Johnson & Johnson (Janssen), Kaiser Permanente, LEO Pharma, Mallinckrodt, Merck, Novartis, National Pharmaceutical Council, Premera, Prime Therapeutics, Regeneron, Sanofi, Spark Therapeutics, and United Healthcare. Herron-Smith and Pearson are employed by ICER, which has a contract with the University of California, San Francisco, to perform work for these analyses. Segal was employed by ICER at the time of this review. Tice and Walsh are employed by the University of California, San Francisco. Gazauskas and Hansen have nothing to disclose.

PreView: a Randomized Trial of a Multi-site Intervention in Diverse Primary Care to Increase Rates of Age-Appropriate Cancer Screening.

BACKGROUND: Women aged 50-70 should receive breast, cervical (until age 65), and colorectal cancer (CRC) screening; men aged 50-70 should receive CRC screening and should discuss prostate cancer screening (PSA). PreView, an interactive, individually tailored Video Doctor Plus Provider Alert Intervention, adresses all cancers for which average risk 50-70-year-old individuals are due for screening or screening discussion. METHODS: We conducted a randomized controlled trial in 6 clinical sites. Participants were randomized to PreView or a video about healthy lifestyle. Intervention group participants completed PreView before their appointment and their clinicians received a "Provider Alert." Primary outcomes were receipt of mammography, Pap tests (with or without HPV testing), CRC screening (FIT in last year or colonoscopy in last 10 years), and PSA screening discussion. Additional outcomes included breast, cervical, and CRC screening discussion. RESULTS: A total of 508 individuals participated, 257 in the control group and 251 in the intervention group. Screening rates were relatively high at baseline. Compared with baseline screening rates, there was no significant increase in mammography or Pap smear screening, and a nonsignificant increase (18% vs 12%) in CRC screening. Intervention participants reported a higher rate of PSA discussion than did control participants (58% vs 36%: P < 0.01). Similar increases were seen in discussions about mammography, cervical cancer, and CRC screening. CONCLUSION: In clinics with relatively high overall screening rates at baseline, PreView did not result in significant increases in breast, cervical, or CRC screening. PreView led to an increase in PSA screening discussion. Clinician-patient discussion of all cancer screenings significantly increased, suggesting that interventions like PreView may be most useful when discussion of the pros and cons of screening is recommended and/or with patients reluctant to undergo screening. Future research should investigate PreView's impact on those who are hesitant or reluctant to undergo screening. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02264782.

Informing New Mothers about Newborn Screening Bloodspot Repositories during Postpartum Hospitalization.

PURPOSE: The primary goals of the study were to assess maternal knowledge and attitudes about the newborn screening bloodspot repository program in Texas and to evaluate the effect of a video about the bloodspot repository on the rate of parental permission to store infant bloodspots. DESIGN: This descriptive, comparative study used descriptive statistics, nonparametric tests, and multivariable analyses to describe the sample, compare groups, and determine associations between factors that influenced parents' decisions to permit state storage of infant bloodspots. RESULTS: There were 465 mothers in the study. Maternal knowledge about basic genetics and risks of genetic testing was poor, but mothers reported strong trust in the state to make good decisions about using genetic material for research. Race, ethnicity, and attitude toward research significantly influenced decisions to opt-in to the bloodspot storage program. Postpartum nurses provided the bulk of information about newborn screening and dried bloodspots, although 2/3 of respondents would have preferred to obtain this information prior to birth. CLINICAL IMPLICATIONS: Although postpartum nurses are the most common source of information about newborn screening, genuine informed consent for bloodspot storage is questionable. Information about newborn screening and bloodspot storage needs to be addressed in community venues prior to birth.

Through the Lens of Postcolonial Theory: Establishing Global North-South Partnerships.

AIM: This study used postcolonial theory as a critical lens to examine the factors that supported or hindered equitable partnership formation within an innovative international service-learning (ISL) program in nursing education. BACKGROUND: As ISL programs proliferate, ethical concerns have arisen as minimal attention has been given to both the host and visiting partners' experience and perceptions and how these impact partnership development and outcomes. METHOD: A hybrid intrinsic, instrumental, single embedded case study design, including observations, interviews (n = 70), and document analysis, was used to analyze in depth varied partnerships within a US-Kenyan ISL program. RESULTS: Central themes of dispelling assumptions, making connections, revealing privilege, and sharing power emerged and formed a theoretical model, Establishing and Strengthening Partnerships. CONCLUSION: Attention needs to be given to preconceived assumptions, imbalances in privilege, and issues surrounding power and decision-making for equitable, impactful, partnership development. Leadership philosophy, style, and approach make a difference.

Are genetics/genomics competencies essential for all clinical nurses?

In 2006, the American Nurses Association created a set of essential genetics and genomics (G/G) competencies for all RNs, regardless of academic preparation, practice setting, or specialty. However, more than half of the RNs practicing today received no prelicensure education on these G/G competencies. This study describes the current use of G/G nursing competencies in acute care hospitals and how nurses perceive them.

The Effectiveness and Value of Biologic Therapies for the Treatment of Uncontrolled Asthma.

DISCLOSURES: Funding for this summary was contributed by the Laura and John Arnold Foundation, Blue Shield of California, and California Health Care Foundation to the Institute for Clinical and Economic Review (ICER), an independent organization that evaluates the evidence on the value of health care interventions. ICER's annual policy summit is supported by dues from Aetna, AHIP, Anthem, Blue Shield of California, CVS Caremark, Express Scripts, Harvard Pilgrim Health Care, Cambia Health Solutions, United Healthcare, Kaiser Permanente, Premera Blue Cross, AstraZeneca, Genentech, GlaxoSmithKline, Johnson & Johnson, Merck, National Pharmaceutical Council, Prime Therapeutics, Sanofi, Spark Therapeutics, Health Care Service Corporation, Editas, Alnylam, Regeneron, Mallinkrodt, Biogen, HealthPartners, and Novartis. Synnott, Kumar, Adair, Rind, and Pearson are employees of ICER, which provided grants to the University of California, San Francisco, and the University of Colorado to perform work for these analyses. Tice and Walsh are employed by the University of California, San Francisco, and Campbell and Whittington are employed by the University of Colorado.

Beyond fall risk assessment: A case-control study in an Urban Medical Center.

AIMS AND OBJECTIVES: To examine the characteristics of patients that fell and compare them with patients that did not fall and to seek differences between the two groups that might help better predict falls in future patients. BACKGROUND: It has been estimated that between 700,000 and one million inpatient falls occur yearly in hospitals in the United States, which results in an increase in healthcare costs of over $19 billion dollars per year. DESIGN: This was a case-control study employing a retrospective analysis of inpatient electronic health records. It includes records from 160 patients who experienced a fall after the implementation of the Johns Hopkins Fall Risk Assessment Tool, and 160 records of patient with similar fall risk scores that did not fall. METHODS: All fall and nonfall patient data for the database were obtained by one research team member, while systematic random selection of nonfall patient records was performed by three research team members as described below. Each patient was assigned a unique study code number which was entered into the research database. The final sample size was 302 patients. RESULTS: Patients who did not receive lorazepam within 12 hr of the fall risk assessment were less likely to fall than patients who did receive lorazepam. A statistical relationship was also found between toileting at the time of the fall and age. CONCLUSIONS: Better stratification of patient populations combined with astute nursing awareness may result in a further reduction in falls. RELEVANCE TO CLINICAL PRACTICE: The results indicate that the nursing assessment with respect to falls is critical to identifying fall-prone individuals who may score as a low-to-moderate fall risk. In addition, the administration of lorazepam should cue the nurse that fall precautions be implemented regardless of scored risk.

Women's health 2016: An update for internists.

Internists are called upon on a daily basis to address a range of women's health issues. Staying up to date with the evidence in this wide field can be challenging. This article reviews important studies published in 2015 and early 2016 pertinent to urinary tract infection, osteoporosis, ovarian cancer screening, and contraception.