Title-plus-abstract versus title-only first-level screening approach: a case study using a systematic review of dietary patterns and sarcopenia risk to compare screening performance.

BACKGROUND: Conducting a systematic review is a time- and resource-intensive multi-step process. Enhancing efficiency without sacrificing accuracy and rigor during the screening phase of a systematic review is of interest among the scientific community. METHODS: This case study compares the screening performance of a title-only (Ti/O) screening approach to the more conventional title-plus-abstract (Ti + Ab) screening approach. Both Ti/O and Ti + Ab screening approaches were performed simultaneously during first-level screening of a systematic review investigating the relationship between dietary patterns and risk factors and incidence of sarcopenia. The qualitative and quantitative performance of each screening approach was compared against the final results of studies included in the systematic review, published elsewhere, which used the standard Ti + Ab approach. A statistical analysis was conducted, and contingency tables were used to compare each screening approach in terms of false inclusions and false exclusions and subsequent sensitivity, specificity, accuracy, and positive predictive power. RESULTS: Thirty-eight citations were included in the final analysis, published elsewhere. The current case study found that the Ti/O first-level screening approach correctly identified 22 citations and falsely excluded 16 citations, most often due to titles lacking a clear indicator of study design or outcomes relevant to the systematic review eligibility criteria. The Ti + Ab approach correctly identified 36 citations and falsely excluded 2 citations due to limited population and intervention descriptions in the abstract. Our analysis revealed that the performance of the Ti + Ab first-level screening was statistically different compared to the average performance of both approaches (Chi-squared: 5.21, p value 0.0225) while the Ti/O approach was not (chi-squared: 2.92, p value 0.0874). The predictive power of the first-level screening was 14.3% and 25.5% for the Ti/O and Ti + Ab approaches, respectively. In terms of sensitivity, 57.9% of studies were correctly identified at the first-level screening stage using the Ti/O approach versus 94.7% by the Ti + Ab approach. CONCLUSIONS: In the current case study comparing two screening approaches, the Ti + Ab screening approach captured more relevant studies compared to the Ti/O approach by including a higher number of accurately eligible citations. Ti/O screening may increase the likelihood of missing evidence leading to evidence selection bias. SYSTEMATIC REVIEW REGISTRATION: PROSPERO Protocol Number: CRD42020172655.

Dietary Patterns and the Risk of Sarcopenia: A Systematic Review and Meta-Analysis.

The purpose of this systematic review is to examine the relationship between dietary patterns and sarcopenia using a protocol developed for use by the 2020 Dietary Guidelines Advisory Committee, and to conduct a meta-analysis to summarize the evidence. Multiple electronic databases were searched for studies investigating sarcopenia risk factors or risk of sarcopenia and dietary patterns. Eligible studies were 1) peer-reviewed controlled trials or observational trials, 2) involving adult or older-adult human subjects who were healthy and/or at risk for chronic disease, 3) comparing the effect of consumption or adherence to dietary patterns (measured as an index/score, factor or cluster analysis; reduced rank regression; or a macronutrient distribution), and 4) reported on measures of skeletal muscle mass, muscle strength, muscle performance, and/or risk of sarcopenia. Thirty-eight publications met all inclusion criteria for qualitative synthesis. Thirteen observational studies met inclusion criteria for meta-analysis. Higher adherence to a healthy dietary pattern was associated with a decreased risk of gait speed reduction (OR = 0.58; 95% CI: 0.18, 0.97). The association between healthy dietary pattern adherence and other intermediate markers or risk of sarcopenia was not statistically significant. The majority of individual studies were judged as "serious" risk of bias and analysis of the collective evidence base was suggestive of publication bias. Studies suggest a significant association between healthy dietary patterns and maintenance of gait speed with age, an intermediate marker of sarcopenia risk, but the evidence base is limited by serious risk of bias, within and between studies. Further research is needed to understand the association between healthy dietary patterns and risk of sarcopenia.

A collaborative care intervention to improve opioid prescribing among providers caring for persons with HIV: Impact on satisfaction, confidence, and trust.

BACKGROUND: HIV clinicians report low confidence and satisfaction prescribing chronic opioid therapy (COT). We hypothesized that the Targeting Effective Analgesia in Clinics for HIV (TEACH) intervention [a system-level improvement to increase guideline concordant care for COT] would improve satisfaction, confidence, and trust among PWH and their clinicians. METHODS: We conducted a two-arm, unblinded cluster randomized controlled trial (RCT) to assess the TEACH intervention. Clinicians were randomized in a 1:1 ratio to receive either the TEACH intervention (an IT-enabled nurse care manager, opioid education, academic detailing, and access to addiction specialists) or usual care. Outcomes were the following: clinician satisfaction (primary); confidence prescribing COT; patient satisfaction with COT; and trust in clinician. Intention-to-treat analyses were conducted using linear and logistic regression models. RESULTS: Clinicians (n = 41) were randomized and their 114 patients assessed. At 12 months, the adjusted mean difference in satisfaction with COT was 1.11 points for intervention vs control clinicians (Scale 1-10; 95% confidence interval [CI]: -0.04 to 2.26, p = 0.06). The adjusted mean confidence with prescribing COT was 1.01 points higher among intervention clinicians (Scale 1-10; 95% CI: 0.05-1.96, p = 0.04). There were no significant differences in patient satisfaction with COT (adjusted odds ratio (AOR) 1.17, 95% CI: 0.50-2.76, p = 0.72) or trust in provider (AOR 1.63, 95% CI: 0.65-4.09, p = 0.30). CONCLUSIONS: TEACH did not significantly affect prescriber satisfaction, patient satisfaction with pain management or patient trust; however, it did improve prescriber confidence. TEACH is a promising strategy to improve provider prescribing of COT for PWH without adverse patient satisfaction or trust in provider.

Prevalence and Correlates of Positive Follow-up Screens in Primary Care for Unhealthy Alcohol and Other Drug Use After a Negative Screen.

OBJECTIVE: To determine the proportion and characteristics of adults in primary care (PC) who screen positive for unhealthy substance use (SU) (alcohol and/or other drug) 1 year or more after screening negative. METHODS: Screening consisted of single-item questions for unhealthy use of alcohol and other drugs (illicit drugs and prescription medications). Health educators conducted in-person screening of patients presenting for a PC appointment. SU severity (low, moderate, high) was assessed with the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST). Multivariate logistic regression models estimated predictors of a positive follow-up screen. RESULTS: Among 9215 patients who previously screened negative, 237 (2.6%) screened positive for unhealthy SU (42% alcohol only, 43% other drug only, 15% alcohol and other drug). The mean interval between screens was 19 months. Most alcohol use was low risk (ASSIST score ≤10) (81%), whereas most drug use was moderate risk (ASSIST score 4-26) (77%). Patients between ages of 18 to 25 had a higher proportion of positive follow-up screens (7.4% [33/ 443]) as well as those with a self-identified history of SU problems (9.4% [40/421]). Patients with a higher odds of a positive follow-up screen were male (adjusted odds ratio [AOR] 2.64; 95% CI: 2.02-3.45), used tobacco (AOR 2.38; 95% CI: 1.75-3.23), had a longer interval between screenings (AOR 3.26; 95% CI: 1.84-5.75). CONCLUSIONS: Screening for unhealthy SU 1 year or more after screening negative identified additional patients at-risk. These findings highlight the need to empirically determine the incremental benefits of screening all PC patients annually.

Opioid analgesic use after ambulatory surgery: a descriptive prospective cohort study of factors associated with quantities prescribed and consumed.

OBJECTIVES: To prospectively characterise: (1) postoperative opioid analgesic prescribing practices; (2) experience of patients undergoing elective ambulatory surgeries and (3) impact of patient risk for medication misuse on postoperative pain management. DESIGN: Longitudinal survey of patients 7 days before and 7-14 days after surgery. SETTING: Academic urban safety-net hospital. PARTICIPANTS: 181 participants recruited, 18 surgeons, follow-up data from 149 participants (82% retention); 54% women; mean age: 49 years. INTERVENTIONS: None. PRIMARY AND SECONDARY OUTCOME MEASURES: Total morphine equivalent dose (MED) prescribed and consumed, percentage of unused opioids. RESULTS: Surgeons postoperatively prescribed a mean of 242 total MED per patient, equivalent to 32 oxycodone (5 mg) pills. Participants used a mean of 116 MEDs (48%), equivalent to 18 oxycodone (5 mg) pills (~145 mg of oxycodone remaining per patient). A 10-year increase in patient age was associated with 12 (95% CI (-2.05 to -0.35)) total MED fewer prescribed opioids. Each one-point increase in the preoperative Graded Chronic Pain Scale was associated with an 18 (6.84 to 29.60) total MED increase in opioid consumption, and 5% (-0.09% to -0.005%) fewer unused opioids. Prior opioid prescription was associated with a 55 (5.38 to -104.82) total MED increase in opioid consumption, and 19% (-0.35% to -0.02%) fewer unused opioids. High-risk drug use was associated with 9% (-0.19% to 0.002%) fewer unused opioids. Pain severity in previous 3 months, high-risk alcohol, use and prior opioid prescription were not associated with postoperative prescribing practices. CONCLUSIONS: Participants with a preoperative history of chronic pain, prior opioid prescription, and high-risk drug use were more likely to consume higher amounts of opioid medications postoperatively. Additionally, surgeons did not incorporate key patient-level factors (eg, substance use, preoperative pain) into opioid prescribing practices. Opportunities to improve postoperative opioid prescribing include system changes among surgical specialties, and patient education and monitoring.

Improving the Delivery of Chronic Opioid Therapy Among People Living With Human Immunodeficiency Virus: A Cluster Randomized Clinical Trial.

BACKGROUND: Chronic pain is prevalent among people living with human immunodeficiency virus (PLWH); managing pain with chronic opioid therapy (COT) is common. Human immunodeficiency virus (HIV) providers often diverge from prescribing guidelines. METHODS: This 2-arm, unblinded, cluster-randomized clinical trial assessed whether the Targeting Effective Analgesia in Clinics for HIV (TEACH) intervention improves guideline-concordant care compared to usual care for PLWH on COT. The trial was implemented from 2015 to 2018 with 12-month follow-up at safety-net hospital-based HIV clinics in Boston and Atlanta. We enrolled 41 providers and their 187 patients on COT. Prescribers were randomized 1:1 to either a 12-month intervention consisting of a nurse care manager with an interactive electronic registry, opioid education, academic detailing, and access to addiction specialists or a control condition consisting of usual care. Two primary outcomes were assessed through electronic medical records: ≥2 urine drug tests and any early COT refills by 12 months. Other outcomes included possible adverse consequences. RESULTS: At 12 months, the TEACH intervention arm had higher odds of ≥2 urine drug tests than the usual care arm (71% vs 20%; adjusted odds ratio [AOR], 13.38 [95% confidence interval {CI}, 5.85-30.60]; P < .0001). We did not detect a statistically significant difference in early refills (22% vs 30%; AOR, 0.55 [95% CI, .26-1.15]; P = .11), pain severity (6.30 vs 5.76; adjusted mean difference, 0.10 [95% CI, -1.56 to 1.75]; P = .91), or HIV viral load suppression (86.9% vs 82.1%; AOR, 1.21 [95% CI, .47-3.09]; P = .69). CONCLUSIONS: TEACH is a promising intervention to improve adherence to COT guidelines without evident adverse consequences.

Inadequate calcium and vitamin D intake and osteoporosis risk in older Americans living in poverty with food insecurities.

Poverty may be a barrier to acquiring adequate nutrient levels for the prevention of osteoporosis. Age and nutritional intake are major factors that contribute to osteoporosis prevalence. This study examined the relationship between markers of poverty with calcium / vitamin D intake and osteoporosis. A cross-sectional analysis of the United States population was performed using National Health and Nutrition Examination Survey (NHANES) data from 2007-2010 and 2013-2014 for older US adults (n = 3,901 participants, 50 years old and older). Odds of inadequate calcium / vitamin D intake and dietary supplement use and risk of probable osteoporosis were calculated in order to determine the relative difference and possible associations between household income, the Family Monthly Poverty Level Index, food security, and participation in the Supplemental Nutrition Assistance Program (SNAP). A sub-analysis of ethnic disparities and biological sex was also performed. In general, women age 50 and older consistently have inadequate calcium intake, regardless of economic level including poverty. While inadequate calcium intake has a larger prevalence among women, markers of poverty increased the risk of inadequate calcium intake in all men and risk of osteoporosis among some subgroups, with the exception of SNAP program participation. Over one fourth of Non-Hispanic black men in the US are below the poverty line. Approximately half of this population has inadequate calcium (58.9%) and vitamin D (46.7%) intake. Typically, osteoporosis risk is relatively low for Non-Hispanic Black males, however considering poverty status, risk is significantly increased (Relative Risk Ratio [RR]: 2.057 ± 0.012) for those with low income suggesting that calcium and vitamin D supplementation may be of benefit for this population.

Developing a clinical decision support for opioid use disorders: a NIDA center for the clinical trials network working group report.

There is an urgent need for strategies to address the US epidemic of prescription opioid, heroin and fentanyl-related overdoses, misuse, addiction, and diversion. Evidence-based treatment such as medications for opioid use disorder (MOUD) are available but lack numbers of providers offering these services to meet the demands. Availability of electronic health record (EHR) systems has greatly increased and led to innovative quality improvement initiatives but this has not yet been optimized to address the opioid epidemic or to treat opioid use disorder (OUD). This report from a clinical decision support (CDS) working group convened by the NIDA Center for the Clinical Trials Network aims to converge electronic technology in the EHR with the urgent need to improve screening, identification, and treatment of OUD in primary care settings through the development of a CDS algorithm that could be implemented as a tool in the EHR. This aim is consistent with federal, state and local government and private sector efforts to improve access and quality of MOUD treatment for OUD, existing clinical quality and HEDIS measures for OUD or drug and alcohol use disorders, and with a recent draft grade B recommendation from the US Preventative Services Task Force (USPSTF) for screening for illicit drug use in adults when appropriate diagnosis, treatment and care services can be offered or referred. Through a face-to-face expert panel meeting and multiple follow-up conference calls, the working group drafted CDS algorithms for clinical care felt to be essential for screening, diagnosis, and management of OUD in primary care. The CDS algorithm was reviewed by addiction specialists and primary care providers and revised based on their input. A clinical decision support tool for OUD screening, assessment, and treatment within primary care systems may help improve healthcare delivery to help address the current epidemic of opioid misuse and overdose that has outpaced the capacity of specialized treatment settings. A semi-structured outline of clinical decision support for OUD was developed to facilitate implementation within the EHR. Further work for adaptation at specific sites and for testing is needed.

Study protocol for the targeting effective analgesia in clinics for HIV (TEACH) study - a cluster randomized controlled trial and parallel cohort to increase guideline concordant care for long-term opioid therapy among people living with HIV.

Background: People living with HIV (PLWH) frequently experience chronic pain and receive long-term opioid therapy (LTOT). Adherence to opioid prescribing guidelines among their providers is suboptimal. Objective: This paper describes the protocol of a cluster randomized trial, targeting effective analgesia in clinics for HIV (TEACH), which tested a collaborative care intervention to increase guideline-concordant care for LTOT among PLWH. Methods: HIV physicians and advanced practice providers (n = 41) were recruited from September 2015 to December 2016 from two HIV clinics in Boston and Atlanta. Patients receiving LTOT from participating providers were enrolled through a waiver of informed consent (n = 187). After baseline assessment, providers were randomized to the control group or the year-long TEACH intervention involving: (1) a nurse care manager and electronic registry to assist with patient management; (2) opioid education and academic detailing; and (3) facilitated access to addiction specialists. Randomization was stratified by site and LTOT patient volume. Primary outcomes (≥2 urine drug tests, early refills, provider satisfaction) were collected at 12 months. In parallel, PLWH receiving LTOT (n = 170) were recruited into a longitudinal cohort at both clinics and underwent baseline and 12-month assessments. Secondary outcomes were obtained through patient self-report among participants enrolled in both the cohort and the RCT (n = 117). Conclusions: TEACH will report the effects of an intervention on opioid prescribing for chronic pain on both provider and patient-level outcomes. The results may inform delivery of care for PLWH on LTOT for chronic pain at a time when opioid practices are being questioned in the US.

Cost-benefit analysis of calcium and vitamin D supplements.

If all adults with osteoporosis in the European Union (EU) and United States (US) used calcium and vitamin D supplements, it could prevent more than 500,000 fractures/year in the EU and more than 300,000/year in the US and save approximately €5.7 billion and US $3.3 billion annually. PURPOSE: Evaluate the cost-effectiveness of calcium/vitamin D supplementation for preventing osteoporotic fractures. METHODS: A cost-benefit analysis tool was used to estimate the net cost savings from reduced fracture-related hospital expenses if adults with osteoporosis in the EU and US used calcium/vitamin D supplements. A 14% relative risk reduction of fracture with calcium/vitamin D supplementation from a recent systematic review and meta-analysis of randomized, controlled trials was used as the basis for the benefit estimate. Other model inputs were informed by epidemiologic, clinical, and cost data (2016-2017) obtained via the medical literature or public databases. Analyses estimated the total number of avoided fractures and associated cost savings with supplement use. Net cost benefit was calculated by subtracting the supplements' market costs from those savings. RESULTS: The > 30 million persons in the EU and nearly 11 million in US with osteoporosis experience about 3.9 million and 2.3 million fractures/year and have annual hospital costs exceeding €50 billion and $28 billion. If all persons with osteoporosis used calcium and vitamin D supplements, there would be an estimated 544,687 fewer fractures/year in the EU and 323,566 fewer in the US, saving over €6.9 billion and $3.9 billion; the net cost benefit would be €5,710,277,330 and $3,312,236,252, respectively. CONCLUSIONS: Calcium and vitamin D supplements are highly cost-effective, and expanded use could considerably reduce fractures and related costs. Although these analyses included individuals aged ≥ 50 years, the observed effects are likely driven by benefits observed in those aged ≥ 65 years.

Provider opioid prescribing practices and the belief that opioids keep people living with HIV engaged in care: a cross-sectional study.

We describe HIV providers' opioid prescribing practices and assess whether belief that chronic opioid therapy (COT) keeps people living with HIV (PLWH) engaged in care is associated with differences in these practices among providers from two HIV clinics. We conducted logistic regression to evaluate the association between the belief that COT keeps PLWH engaged in care and at least one component of guideline-recommended care (i.e., urine drug tests, treatment agreements, and/or prescription monitoring program use). The sample included 41 providers with a median age of 42 years, 63% female, 37% non-white. Routine adherence to guideline-recommended practices was: 34% urine drug tests, 27% treatment agreements, and 17% prescription monitoring program. Over half [54%] agreed that COT keeps PLWH engaged in care. There was no significant association between belief that COT keeps PLWH engaged in care and routinely providing any recommended COT care component (aOR 2.38; 95% CI 0.65-8.73). Most HIV providers do not routinely follow guidelines for opioid prescribing. We observed a positive association between belief that COT keeps PLWH engaged in care and following any guideline-recommended prescribing practices, although the result was not statistically significant. Interventions are needed to improve guideline-concordant care for COT by HIV providers.

Communication between nurse care managers and patients who take opioids for chronic pain: Strategies for exploring aberrant behavior.

OBJECTIVE: One approach to potential misuse of prescription opioids by patients with chronic pain is team-based collaborative primary care, with primary care visits complemented by frequent visits with nurse care managers (NCMs) specializing in addiction care. However, little is known about the communication strategies NCMs employ in these visits. This study aimed to describe strategies NCMs used with patients when discussing aberrancies encountered during opioid monitoring. DESIGN: Observational study of NCM-patient interactions. Patients' primary care providers had been randomized to the treatment arm of a study evaluating an intervention, of which NCM visits were part, to change opioid prescribing patterns. The overall intervention was found to be successful. SETTING: Four primary care settings. PARTICIPANTS: Two NCMs and 41 patients. MAIN OUTCOME MEASURE: Forty one interactions between two NCMs and 41 unique patients were directly observed, and the detailed field notes coded for strategies using conventional content analysis. RESULTS: Five themes describing strategies that NCMs use to navigate aberrant patient behavior emerged: (1) NCM develops therapeutic relationship with patient; (2) NCM encourages adherence to monitoring strategies by contextualizing intensive opioid management for patient; (3) NCM inquires into discrepancies between patient's narrative and objective data to further understand aberrancy; (4) NCM assesses patient's medication use and pain to obtain more information about aberrancy and determine risk for opioid misuse; and (5) NCM educates patient and makes recommendations to guide appropriate medication use. CONCLUSIONS: These findings provide a potential model for the replication of intensive care management strategies utilizing NCMs in primary care.

Improving Adherence to Long-term Opioid Therapy Guidelines to Reduce Opioid Misuse in Primary Care: A Cluster-Randomized Clinical Trial.

Importance: Prescription opioid misuse is a national crisis. Few interventions have improved adherence to opioid-prescribing guidelines. Objective: To determine whether a multicomponent intervention, Transforming Opioid Prescribing in Primary Care (TOPCARE; http://mytopcare.org/), improves guideline adherence while decreasing opioid misuse risk. Design, Setting, and Participants: Cluster-randomized clinical trial among 53 primary care clinicians (PCCs) and their 985 patients receiving long-term opioid therapy for pain. The study was conducted from January 2014 to March 2016 in 4 safety-net primary care practices. Interventions: Intervention PCCs received nurse care management, an electronic registry, 1-on-1 academic detailing, and electronic decision tools for safe opioid prescribing. Control PCCs received electronic decision tools only. Main Outcomes and Measures: Primary outcomes included documentation of guideline-concordant care (both a patient-PCC agreement in the electronic health record and at least 1 urine drug test [UDT]) over 12 months and 2 or more early opioid refills. Secondary outcomes included opioid dose reduction (ie, 10% decrease in morphine-equivalent daily dose [MEDD] at trial end) and opioid treatment discontinuation. Adjusted outcomes controlled for differing baseline patient characteristics: substance use diagnosis, mental health diagnoses, and language. Results: Of the 985 participating patients, 519 were men, and 466 were women (mean [SD] patient age, 54.7 [11.5] years). Patients received a mean (SD) MEDD of 57.8 (78.5) mg. At 1 year, intervention patients were more likely than controls to receive guideline-concordant care (65.9% vs 37.8%; P < .001; adjusted odds ratio [AOR], 6.0; 95% CI, 3.6-10.2), to have a patient-PCC agreement (of the 376 without an agreement at baseline, 53.8% vs 6.0%; P < .001; AOR, 11.9; 95% CI, 4.4-32.2), and to undergo at least 1 UDT (74.6% vs 57.9%; P < .001; AOR, 3.0; 95% CI, 1.8-5.0). There was no difference in odds of early refill receipt between groups (20.7% vs 20.1%; AOR, 1.1; 95% CI, 0.7-1.8). Intervention patients were more likely than controls to have either a 10% dose reduction or opioid treatment discontinuation (AOR, 1.6; 95% CI, 1.3-2.1; P < .001). In adjusted analyses, intervention patients had a mean (SE) MEDD 6.8 (1.6) mg lower than controls (P < .001). Conclusions and Relevance: A multicomponent intervention improved guideline-concordant care but did not decrease early opioid refills. Trial Registration: clinicaltrials.gov Identifier: NCT01909076.

What do providers want to know about opioid prescribing? A qualitative analysis of their questions.

BACKGROUND: In 2012, the US Food and Drug Administration (FDA) responded to the opioid crisis with a Risk Evaluation and Mitigation Strategy, requiring manufacturers of extended-release/long-acting opioids to fund continuing medical education based on the "FDA Blueprint for Prescriber Education." Topics in the Blueprint are "Assessing Patients for Treatment," "Initiating Therapy, Modifying Dosing, and Discontinuing Use," "Managing Therapy," "Counseling Patients and Caregivers about Safe Use," "General Drug Information," and "Specific Drug Information." Based on the FDA Blueprint, Boston University School of Medicine's "Safe and Competent Opioid Prescribing Education" (SCOPE of Pain) offers live trainings for physicians and other prescribers. During trainings, participants submit written questions about the curriculum and/or their clinical experiences. METHODS: The objective was to compare themes that arose from questions asked by SCOPE of Pain participants with content of the FDA Blueprint in order to evaluate how well the Blueprint answers prescribers' concerns. The authors conducted qualitative analyses of all 1309 questions submitted by participants in 29 trainings across 16 states from May 2013 to May 2015, using conventional content analysis to code the questions. Themes that emerged from participants' questions were then compared with the Blueprint. RESULTS: Most themes fell into the topic categories of the Blueprint. Five main themes diverged: Participants sought information on (1) safe alternatives to opioids, (2) overcoming barriers to safe opioid prescribing, (3) government regulations of opioid prescribing, (4) the role of marijuana in opioid prescribing, and (5) maintaining a positive provider-patient relationship while prescribing opioids. CONCLUSIONS: In addition to learning the mechanics of safe opioid prescribing, providers want to understand government regulations and effective patient communication skills. Aware of the limitations of opioids in managing chronic pain, providers seek advice on alternatives therapies. Future updates to the FDA Blueprint and other educational guidelines on opioid prescribing should address providers' additional questions.

A Multicomponent Intervention to Improve Primary Care Provider Adherence to Chronic Opioid Therapy Guidelines and Reduce Opioid Misuse: A Cluster Randomized Controlled Trial Protocol.

BACKGROUND: Prescription opioid misuse is a significant public health problem as well as a patient safety concern. Primary care providers (PCPs) are the leading prescribers of opioids for chronic pain, yet few PCPs follow standard practice guidelines regarding assessment and monitoring. This cluster randomized controlled trial will determine whether four implementation strategies; nurse care management, use of a patient registry, academic detailing, and electronic tools, will increase PCP adherence to chronic opioid therapy guidelines and reduce opioid misuse among patients, relative to electronic tools alone. The implementation strategies and intervention content are based on the chronic care model. METHODS: We include 53 PCPs from three Boston-area community health centers and one urban safety-net hospital-based primary care practice who have at least four patients meeting the following inclusion criteria: 1) age≥18; 2) one or more completed visits to the primary care practice in the past year; 3) long-term opioid treatment defined as three or more opioid prescriptions written at least 21days apart within 6months and 4) an inpatient or outpatient ICD-9-CM diagnosis for musculoskeletal or neuropathic pain. We consider PCPs to be study subjects, and obtained a waiver of informed consent for patients because the study is promoting an established standard of care. We enrolled participants (PCPs) from December 2012 through March 2015. PCPs were randomized to receive the intervention, which includes four components: 1) nurse care management, 2) use of a patient registry, 3) academic detailing, and 4) electronic tools, or a control condition, which includes only the use of the electronic tools. The intervention PCPs receive the services of a nurse-managed registry for planning individual patient care and conducting population-based care for patients receiving opioids for chronic pain. In academic detailing visits, trained co-investigators provide intervention PCPs with individualized education to change prescribing practice. Electronic tools, located on a web site external to the EMR, www.mytopcare.org, include validated instruments to assess patient status, and management resources to facilitate PCP adherence to suggested monitoring. Electronic tools are available to PCPs in both study arms. The primary outcomes are PCP adherence to chronic opioid therapy guidelines and patient opioid misuse. Secondary outcomes include measures of substance abuse, possible opioid diversion, and level of opioid risk among patients. We will follow PCPs and their estimated 1200 chronic pain patients for 1year after study enrollment. To determine whether the intervention condition achieves greater adherence to guidelines and reduced opioid misuse after 1year compared to the control condition, we will compare the baseline and follow-up measures of the individual patients, stratifying by intervention status and noting differences that are statistically significant at the p=0.05 level. Analyses will be based on intent-to-treat. RESULTS: Randomization resulted in groups with similar baseline characteristics. The ages of PCPs are evenly distributed, with inclusion of both PCPs who have recently completed training and those who have been in practice for more than 20years. Two-thirds of enrolled PCPs are women, and one-third are non-white. DISCUSSION: The study will determine the impact of this multicomponent intervention on improving PCP adherence to guidelines and reducing opioid misuse among patients.

From Science to Finance-A Tool for Deriving Economic Implications from the Results of Dietary Supplement Clinical Studies.

This article examines evidence showing that the use of key dietary supplements can reduce overall disease treatment-related hospital utilization costs associated with coronary heart disease (CHD) in the United States among those at a high risk of experiencing a costly, disease-related event. Results show that the potential avoided hospital utilization costs related to the use of omega-3 supplements at preventive intake levels among the target population can be as much as $2.06 billion on average per year from 2013 to 2020. The potential net savings in avoided CHD-related hospital utilization costs after accounting for the cost of omega-3 dietary supplements at preventive daily intake levels would be more than $3.88 billion in cumulative health care cost savings from 2013 to 2020. Furthermore, the use of folic acid, B6, and B12 among the target population at preventive intake levels could yield avoided CHD-related hospital utilization costs savings of an average savings of $1.52 billion per year from 2013 to 2020. The potential net savings in avoided CHD-related health care costs after accounting for the cost of folic acid, B6, and B12 utilization at preventive daily intake levels would be more than $5.23 billion in cumulative health care cost net savings during the same period. Thus, targeted dietary supplement regimens are recommended as a means to help control rising societal health care costs, and as a means for high-risk individuals to minimize the chance of having to deal with potentially costly events and to invest in increased quality of life.

Assessing the potential adoption and usefulness of concurrent, action-oriented, electronic adverse drug event triggers designed for the outpatient setting.

BACKGROUND: Adverse drug event (ADE) detection is an important priority for patient safety research. Trigger tools have been developed to help identify ADEs. In previous work we developed seven concurrent, action-oriented, electronic trigger algorithms designed to prompt clinicians to address ADEs in outpatient care. OBJECTIVES: We assessed the potential adoption and usefulness of the seven triggers by testing the positive predictive validity and obtaining stakeholder input. METHODS: We adapted ADE triggers, "bone marrow toxin-white blood cell count (BMT-WBC)," "bone marrow toxin - platelet (BMT-platelet)," "potassium raisers," "potassium reducers," "creatinine," "warfarin," and "sedative hypnotics," with logic to suppress flagging events with evidence of clinical intervention and applied the triggers to 50,145 patients from three large health care systems. Four pharmacists assessed trigger positive predictive value (PPV) with respect to ADE detection (conservatively excluding ADEs occurring during clinically appropriate care) and clinical usefulness (i.e., whether the trigger alert could change care to prevent harm). We measured agreement between raters using the free kappa and assessed positive PPV for the trigger's detection of harm, clinical usefulness, and both. Stakeholders from the participating health care systems rated the likelihood of trigger adoption and the perceived ease of implementation. FINDINGS: Agreement between pharmacist raters was moderately high for each ADE trigger (kappa free > 0.60). Trigger PPVs for harm ranged from 0 (Creatinine, BMT-WBC) to 17 percent (potassium raisers), while PPV for care change ranged from 0 (WBC) to 60 percent (Creatinine). Fifteen stakeholders rated the triggers. Our assessment identified five of the seven triggers as good candidates for implementation: Creatinine, BMT-Platelet, Potassium Raisers, Potassium Reducers, and Warfarin. CONCLUSIONS: At least five outpatient ADE triggers performed well and merit further evaluation in outpatient clinical care. When used in real time, these triggers may promote care changes to ameliorate patient harm.

Clinical Operations Variables are Associated With Blood Pressure Outcomes.

BACKGROUND: Uncontrolled blood pressure (BP), among patients diagnosed and treated for the condition, remains an important clinical challenge; aspects of clinical operations could potentially be adjusted if they were associated with better outcomes. OBJECTIVES: To assess clinical operations factors' effects on normalization of uncontrolled BP. RESEARCH DESIGN: Observational cohort study. SUBJECTS: Patients diagnosed with hypertension from a large urban clinical practice (2005-2009). MEASURES: We obtained clinical data on BP, organized by person-month, and administrative data on primary care provider (PCP) staffing. We assessed the resolution of an episode of uncontrolled BP as a function of time-varying covariates including practice-level appointment volume, individual clinicians' appointment volume, overall practice-level PCP staffing, and number of unique PCPs. RESULTS: Among the 7409 unique patients representing 50,403 person-months, normalization was less likely for the patients in whom the episode starts during months when the number of unique PCPs were high [the top quintile of unique PCPs was associated with a 9 percentage point lower probability of normalization (P<0.01) than the lowest quintile]. Practice appointment volume negatively affected the likelihood of normalization [episodes starting in months with the most appointments were associated with a 6 percentage point reduction in the probability of normalization (P=0.01)]. Neither clinician appointment volume nor practice clinician staffing levels were significantly associated with the probability of normalization. CONCLUSIONS: Findings suggest that clinical operations factors can affect clinical outcomes like BP normalization, and point to the importance of considering outcome effects when organizing clinical care.

Variability in opioid prescription monitoring and evidence of aberrant medication taking behaviors in urban safety-net clinics.

Little is known about variability in primary care providers' (PCPs) adherence to opioid-monitoring guidelines for patients. We examined variability of adherence to monitoring guidelines among PCPs and ascertained the relationship between PCP adherence and opioid misuse by their patients. We included primary care patients receiving long-term opioids (≥3 prescriptions within 6 months) for chronic noncancer pain and PCPs with ≥4 eligible patients. We examined guideline adherence using: (1) electronic health record documentation of opioid treatment agreement, (2) past-year urine drug screen (UDS), and (3) evidence of misuse through early refills (≥2 opioid prescriptions written 7-25 days after the previous prescription). Covariates included morphine equivalent daily opioid medication dose (MED, >50 mg/d vs ≤50mg/d). Multilevel regression models assessed variability among PCPs, and odds ratios examined associations among patient-level binary outcomes. Sixty-seven PCPs prescribed opioids to 1546 patients. Significant variability was found between PCPs in use of agreement (variance = 1.27, P < 0.001), UDS (variance = 1.75, P < 0.001), and early refills (variance = 0.29, P = 0.002). Primary care providers had a mean of 48% of patients with agreement (range, 9%-84%), 56% with ≥1 UDS (range, 7%-91%) and 36% with early refills (range, 19%-60%). High MED among patients was associated with increased odds of agreement (1.93, confidence interval [CI], 1.53-2.44), UDS (2.65, CI: 2.06-3.41), and early refill (2.92, CI: 2.30-3.70). Primary care providers varied significantly in adherence to opioid prescription guidelines. Increased patient risk was associated with increased monitoring and with greater misuse. Future work should study system-level interventions to enable clinical monitoring and support opioid guideline adherence.

Adherence to prescription opioid monitoring guidelines among residents and attending physicians in the primary care setting.

OBJECTIVE: The aim of this study was to compare adherence to opioid prescribing guidelines and potential opioid misuse in patients of resident vs attending physicians. DESIGN: Retrospective cross-sectional study. SETTING: Large primary care practice at a safety net hospital in New England. SUBJECTS: Patients 18-89 years old, with at least one visit to the primary care clinic within the past year and were prescribed long-term opioid treatment for chronic noncancer pain. METHODS: Data were abstracted from the electronic medical record by a trained data analyst through a clinical data warehouse. The primary outcomes were adherence to any one of two American Pain Society Guidelines: (1) documentation of at least one opioid agreement (contract) ever and (2) any urine drug testing in the past year, and evidence of potential prescription misuse defined as ≥2 early refills. We employed logistic regression analysis to assess whether patients' physician status predicts guideline adherence and/or potential opioid misuse. RESULTS: Similar proportions of resident and attending patients had a controlled substance agreement (45.1% of resident patients vs. 42.4% of attending patient, P = 0.47) or urine drug testing (58.6% of resident patients vs. 63.6% of attending patients, P = 0.16). Resident patients were more likely to have two or more early refills in the past year relative to attending patients (42.8% vs. 32.5%; P = 0.004). In the adjusted regression analysis, resident patients were more likely to receive early refills (odds ratio 1.82, 95% confidence interval 1.26-2.62) than attending patients. CONCLUSIONS: With some variability, residents and attending physicians were only partly compliant with national guidelines. Residents were more likely to manage patients with a higher likelihood of opioid misuse.