Integrated antibody and cellular immunity monitoring are required for assessment of the long term protection that will be essential for effective next generation vaccine development.

The COVID pandemic exposed the critical role T cells play in initial immunity, the establishment and maintenance of long term protection, and of durable responsiveness against novel viral variants. A growing body of evidence indicates that adding measures of cellular immunity will fill an important knowledge gap in vaccine clinical trials, likely leading to improvements in the effectiveness of the next generation vaccines against current and emerging variants. In depth cellular immune monitoring in Phase II trials, particularly for high risk populations such as the elderly or immune compromised, should result in better understanding of the dynamics and requirements for establishing effective long term protection. Such analyses can result in cellular immunity correlates that can then be deployed in Phase III studies using appropriate, scalable technologies. Measures of cellular immunity are less established than antibodies as correlates of clinical immunity, and some misconceptions persist about cellular immune monitoring usefulness, cost, complexity, feasibility, and scalability. We outline the currently available cellular immunity assays, review their readiness for use in clinical trials, their logistical requirements, and the type of information each assay generates. The objective is to provide a reliable source of information that could be leveraged to develop a rational approach for comprehensive immune monitoring during vaccine development.

Cellular Immunity Is Critical for Assessing COVID-19 Vaccine Effectiveness in Immunocompromised Individuals.

COVID-19 vaccine clinical development was conducted with unprecedented speed. Immunity measurements were concentrated on the antibody response which left significant gaps in our understanding how robust and long-lasting immune protection develops. Better understanding the cellular immune response will fill those gaps, especially in the elderly and immunocompromised populations which not only have the highest risk for severe infection, but also frequently have inadequate antibody responses. Although cellular immunity measurements are more logistically complex to conduct for clinical trials compared to antibody measurements, the feasibility and benefit of doing them in clinical trials has been demonstrated and so should be more widely adopted. Adding significant cellular response metrics will provide a deeper understanding of the overall immune response to COVID-19 vaccination, which will significantly inform vaccination strategies for the most vulnerable populations. Better monitoring of overall immunity will also substantially benefit other vaccine development efforts, and indeed any therapies that involve the immune system as part of the therapeutic strategy.

Embedded emergency department physical therapy versus usual care for acute low back pain: a protocol for the NEED-PT randomised trial.

INTRODUCTION: Low back pain is a common problem and a substantial source of morbidity and disability worldwide. Patients frequently visit the emergency department (ED) for low back pain, but many experience persistent symptoms at 3 months despite frequent receipt of opioids. Although physical therapy interventions have been demonstrated to improve patient functioning in the outpatient setting, no randomised trial has yet to evaluate physical therapy in the ED setting. METHODS AND ANALYSIS: This is a single-centre cluster-randomised trial of an embedded ED physical therapy intervention for acute low back pain. We used a covariate-constrained approach to randomise individual physicians (clusters) at an urban academic ED in Chicago, Illinois, USA, to receive, or not receive, an embedded physical therapist on their primary treatment team to evaluate all patients with low back pain. We will then enrol individual ED patients with acute low back pain and allocate them to the embedded physical therapy or usual care study arms, depending on the randomisation assignment of their treating physician. We will follow patients to a primary endpoint of 3 months and compare a primary outcome of change in PROMIS-Pain Interference score and secondary outcomes of change in modified Oswestry Disability Index score and patient-reported opioid use. Our primary approach will be a modified intention-to-treat analysis, whereby all participants who complete at least one follow-up data time point will be included in analyses, regardless of their or their physicians' adherence to their assigned study arm. ETHICS AND DISSEMINATION: This trial is funded by the US Agency for Healthcare Research and Quality (R01HS027426) and was approved by the Northwestern University Institutional Review Board. All physician and patient participants will give written informed consent to study participation. Trial results will be submitted for presentation at scientific meetings and for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov (NCT04921449).

Latent Class Analysis of Prescribing Behavior of Primary Care Physicians in the Veterans Health Administration.

BACKGROUND: Benzodiazepines, opioids, proton-pump inhibitors (PPIs), and antibiotics are frequently prescribed inappropriately by primary care physicians (PCPs), without sufficient consideration of alternative options or adverse effects. We hypothesized that distinct groups of PCPs could be identified based on their propensity to prescribe these medications. OBJECTIVE: To identify PCP groups based on their propensity to prescribe benzodiazepines, opioids, PPIs, and antibiotics, and patient and PCP characteristics associated with identified prescribing patterns. DESIGN: Retrospective cohort study using VA data and latent class regression analyses to identify prescribing patterns among PCPs and examine the association of patient and PCP characteristics with class membership. PARTICIPANTS: A total of 2524 full-time PCPs and their patient panels (n = 2,939,636 patients), from January 1, 2017, to December 31, 2018. MAIN MEASURES: We categorized PCPs based on prescribing volume quartiles for the four drug classes, based on total days' supply dispensed of each medication by the PCP to their patients (expressed as days' supply per 1000 panel patient-days). We used latent class analysis to group PCPs based on prescribing and used multinomial logistic regression to examine patient and PCP characteristics associated with latent class membership. KEY RESULTS: PCPs were categorized into four groups (latent classes): low intensity (23% of cohort), medium-intensity overall/high-intensity PPI (36%), medium-intensity overall/high-intensity opioid (20%), and high intensity (21%). PCPs in the high-intensity group were predominantly in the highest quartile of prescribers for all four drugs (68% in the highest quartile for benzodiazepine, 86% opioids, 64% PPIs, 62% antibiotics). High-intensity PCPs (vs. low intensity) were substantially less likely to be female (OR: 0.30, 95% CI: 0.21-0.42) or practice in the northeast versus other census regions (OR: 0.10, 95% CI: 0.06-0.17). CONCLUSIONS: VA PCPs can be classified into four clearly differentiated groups based on their prescribing of benzodiazepines, opioids, PPIs, and antibiotics, suggesting an underlying typology of prescribing. High-intensity PCPs were more likely to be male.

Indication alerts to improve problem list documentation.

BACKGROUND: Problem lists represent an integral component of high-quality care. However, they are often inaccurate and incomplete. We studied the effects of alerts integrated into the inpatient and outpatient computerized provider order entry systems to assist in adding problems to the problem list when ordering medications that lacked a corresponding indication. METHODS: We analyzed medication orders from 2 healthcare systems that used an innovative indication alert. We collected data at site 1 between December 2018 and January 2020, and at site 2 between May and June 2021. We reviewed random samples of 100 charts from each site that had problems added in response to the alert. Outcomes were: (1) alert yield, the proportion of triggered alerts that led to a problem added and (2) problem accuracy, the proportion of problems placed that were accurate by chart review. RESULTS: Alerts were triggered 131 134, and 6178 times at sites 1 and 2, respectively, resulting in a yield of 109 055 (83.2%) and 2874 (46.5%), P< .001. Orders were abandoned, for example, not completed, in 11.1% and 9.6% of orders, respectively, P<.001. Of the 100 sample problems, reviewers deemed 88% ± 3% and 91% ± 3% to be accurate, respectively, P = .65, with a mean of 90% ± 2%. CONCLUSIONS: Indication alerts triggered by medication orders initiated in the absence of a justifying diagnosis were useful for populating problem lists, with yields of 83.2% and 46.5% at 2 healthcare systems. Problems were placed with a reasonable level of accuracy, with 90% ± 2% of problems deemed accurate based on chart review.

Opioid-related emergency department visits and hospitalizations among patients with chronic gastrointestinal symptoms and disorders dually enrolled in the Department of Veterans Affairs and Medicare Part D.

PURPOSE: We examined the prevalence of, and factors associated with, serious opioid-related adverse drug events (ORADEs) that led to an emergency department (ED) visit or hospitalization among patients with chronic gastrointestinal (GI) symptoms and disorders dually enrolled in the Department of Veterans Affairs (VA) and Medicare Part D. METHODS: In this retrospective cohort study, we used linked national patient-level data (April 1, 2011, to October 31, 2014) from the VA and Centers for Medicare and Medicaid Services to identify serious ORADEs among dually enrolled veterans with a chronic GI symptom or disorder. Outcome measures included serious ORADEs, defined as an ED visit attributed to an ORADE or a hospitalization where the principal or secondary reason for admission involved an opioid. We used multiple logistic regression models to determine factors independently associated with a serious ORADE. RESULTS: We identified 3,430 veterans who had a chronic GI symptom or disorder; were dually enrolled in the VA and Medicare Part D; and had a serious ORADE that led to an ED visit, hospitalization, or both. The period prevalence of having a serious ORADE was 2.4% overall and 4.4% among veterans with chronic opioid use (≥90 consecutive days). Veterans with serious ORADEs were more likely to be less than 40 years old, male, white, and to have chronic abdominal pain, functional GI disorders, chronic pancreatitis, or Crohn's disease. They were also more likely to have used opioids chronically and at higher daily doses. CONCLUSION: There may be a considerable burden of serious ORADEs among patients with chronic GI symptoms and disorders. Future quality improvement efforts should target this vulnerable population.

Characteristics of Opioid Prescriptions to Veterans With Chronic Gastrointestinal Symptoms and Disorders Dually Enrolled in the Department of Veterans Affairs and Medicare Part D.

INTRODUCTION: Gastrointestinal (GI) symptoms and disorders affect an increasingly large group of veterans. Opioid use may be rising in this population, but this is concerning from a patient safety perspective, given the risk of dependence and lack of evidence supporting opioid use to manage chronic pain. We examined the characteristics of opioid prescriptions and factors associated with chronic opioid use among chronic GI patients dually enrolled in the DVA and Medicare Part D. MATERIALS AND METHODS: In this retrospective cohort study, we used linked, national patient-level data (from April 1, 2011, to December 31, 2014) from the VA and Centers for Medicare & Medicaid Services to identify chronic GI patients and observe opioid use. Veterans who had a chronic GI symptom or disorder were dually enrolled in VA and Part D and received ≥1 opioid prescription dispensed through the VA, Part D, or both. Chronic GI symptoms and disorders included chronic abdominal pain, chronic pancreatitis, inflammatory bowel diseases, and functional GI disorders. Key outcome measures were outpatient opioid prescription dispensing overall and chronic opioid use, defined as ≥90 consecutive days of opioid receipt over 12 months. We described patient characteristics and opioid use measures using descriptive statistics. Using multiple logistic regression modeling, we generated adjusted odds ratios and 95% CIs to determine variables independently associated with chronic opioid use. The final model included variables outlined in the literature and our conceptual framework. RESULTS: We identified 141,805 veterans who had a chronic GI symptom or disorder, were dually enrolled in VA and Part D, and received ≥1 opioid prescription dispensed from the VA, Part D, or both. Twenty-six percent received opioids from the VA only, 69% received opioids from Medicare Part D only, and 5% were "dual users," receiving opioids through both VA and Part D. Compared to veterans who received opioids from the VA or Part D only, dual users had a greater likelihood of potentially unsafe opioid use outcomes, including greater number of days on opioids, higher daily doses, and higher odds of chronic use. CONCLUSIONS: Chronic GI patients in the VA may be frequent users of opioids and may have a unique set of risk factors for unsafe opioid use. Careful monitoring of opioid use among chronic GI patients may help to begin risk stratifying this group. and develop tailored approaches to minimize chronic use. The findings underscore potential nuances within the opioid epidemic and suggest that components of the VA's Opioid Safety Initiative may need to be adapted around veterans at a higher risk of opioid-related adverse events.

High-Dose Opioid Use Among Veterans with Unexplained Gastrointestinal Symptoms Versus Structural Gastrointestinal Diagnoses.

BACKGROUND: In a cohort of Veterans dually enrolled in the Department of Veterans Affairs (VA) and Medicare Part D, we sought to describe high-dose daily opioid use among Veterans with unexplained gastrointestinal (GI) symptoms and structural GI diagnoses and examine factors associated with high-dose use. METHODS: We used linked national patient-level data from the VA and Centers for Medicare and Medicaid Services (CMS). We grouped patients into 3 subsets: those with unexplained GI symptoms (e.g., chronic abdominal pain); structural GI diagnoses (e.g., chronic pancreatitis); and those with a concurrent unexplained GI symptom and structural GI diagnosis. High-dose daily opioid use levels were examined as a binary variable [≥ 100 morphine milligram equivalents (MME)/day] and as an ordinal variable (50-99 MME/day, 100-119 MME/day, or ≥ 120 MME/day). RESULTS: We identified 141,805 chronic GI patients dually enrolled in VA and Part D. High-dose opioid use was present in 11% of Veterans with unexplained GI symptoms, 10% of Veterans with structural GI diagnoses, and 15% of Veterans in the concurrent GI group. Compared to Veterans with only an unexplained GI symptom or structural diagnosis, concurrent GI patients were more likely to have higher daily opioid doses, more opioid days ≥ 100 MME, and higher risk of chronic use. Factors associated with high-dose use included opioid receipt from both VA and Part D, younger age, and benzodiazepine use. CONCLUSIONS: A significant subset of chronic GI patients in the VA are high-dose opioid users. Efforts are needed to reduce high-dose use among Veterans with concurrent GI symptoms and diagnoses.

Interpretability of the audiogram by audiologists and physician non-specialists.

OBJECTIVE: The audiogram is frequently used by hearing specialists communicate test results to non-specialists, such as physicians. However, it relies on uncommon terminology and interpreting unusual graphical elements to extract information. In this study, we examine whether the audiogram can be accurately interpreted by specialists and non-specialists. DESIGN: We used an online questionnaire to assess the interpretability of an audiogram by audiologists and primary-care physicians. Participants viewed a sample audiogram and submitted their answers via an online survey system. STUDY SAMPLE: We recruited actively practicing primary care physicians (n = 100) and actively practicing audiologists (n = 67). We only accepted respondents from the United States. RESULTS: The audiogram was not easily interpreted by physicians, with a median score of 4/9. Fewer than 25% could accurately report a threshold correctly. Audiologists were more accurate than physicians (median score 7/9, Wilcoxon two-sample p < 0.001, r = 0.648). CONCLUSIONS: The audiogram is difficult for non-specialists to interpret. Clinicians are advised to supplement or supplant the audiogram in interprofessional communication. The development of tools to facilitate interprofessional communication between audiologists and physicians could have positive effects on physician awareness of hearing loss, and even downstream influences on patient behaviour and outcomes.

A Prospective Observational Study of Emergency Department-Initiated Physical Therapy for Acute Low Back Pain.

OBJECTIVE: Low back pain accounts for nearly 4 million emergency department (ED) visits annually and is a significant source of disability. Physical therapy has been suggested as a potentially effective nonopioid treatment for low back pain; however, no studies to our knowledge have yet evaluated the emerging resource of ED-initiated physical therapy. The study objective was to compare patient-reported outcomes in patients receiving ED-initiated physical therapy and patients receiving usual care for acute low back pain. METHODS: This was a prospective observational study of ED patients receiving either physical therapy or usual care for acute low back pain from May 1, 2018, to May 24, 2019, at a single academic ED (>91,000 annual visits). The primary outcome was pain-related functioning, assessed with Oswestry Disability Index (ODI) and Patient-Reported Outcomes Measurement Information System pain interference (PROMIS-PI) scores. The secondary outcome was use of high-risk medications (opioids, benzodiazepines, and skeletal muscle relaxants). Outcomes were compared over 3 months using adjusted linear mixed and generalized estimating equation models. RESULTS: For 101 participants (43 receiving ED-initiated physical therapy and 58 receiving usual care), the median age was 40.5 years and 59% were women. Baseline outcome scores in the ED-initiated physical therapy group were higher than those in the usual care group (ODI = 51.1 vs 36.0; PROMIS-PI = 67.6 vs 62.7). Patients receiving ED-initiated physical therapy had greater improvements in both ODI and PROMIS-PI scores at the 3-month follow-up (ODI = -14.4 [95% CI = -23.0 to -5.7]; PROMIS-PI = -5.1 [95% CI = -9.9 to -0.4]) and lower use of high-risk medications (odds ratio = 0.05 [95% CI = 0.01 to 0.58]). CONCLUSION: In this single-center observational study, ED-initiated physical therapy for acute low back pain was associated with improvements in functioning and lower use of high-risk medications compared with usual care; the causality of these relationships remains to be explored. IMPACT: ED-initiated physical therapy is a promising therapy for acute low back pain that may reduce reliance on high-risk medications while improving patient-reported outcomes. LAY SUMMARY: Emergency department-initiated physical therapy for low back pain was associated with greater improvement in functioning and lower use of high-risk medications over 3 months.

Automated detection of wrong-drug prescribing errors.

BACKGROUND: To assess the specificity of an algorithm designed to detect look-alike/sound-alike (LASA) medication prescribing errors in electronic health record (EHR) data. SETTING: Urban, academic medical centre, comprising a 495-bed hospital and outpatient clinic running on the Cerner EHR. We extracted 8 years of medication orders and diagnostic claims. We licensed a database of medication indications, refined it and merged it with the medication data. We developed an algorithm that triggered for LASA errors based on name similarity, the frequency with which a patient received a medication and whether the medication was justified by a diagnostic claim. We stratified triggers by similarity. Two clinicians reviewed a sample of charts for the presence of a true error, with disagreements resolved by a third reviewer. We computed specificity, positive predictive value (PPV) and yield. RESULTS: The algorithm analysed 488 481 orders and generated 2404 triggers (0.5% rate). Clinicians reviewed 506 cases and confirmed the presence of 61 errors, for an overall PPV of 12.1% (95% CI 10.7% to 13.5%). It was not possible to measure sensitivity or the false-negative rate. The specificity of the algorithm varied as a function of name similarity and whether the intended and dispensed drugs shared the same route of administration. CONCLUSION: Automated detection of LASA medication errors is feasible and can reveal errors not currently detected by other means. Real-time error detection is not possible with the current system, the main barrier being the real-time availability of accurate diagnostic information. Further development should replicate this analysis in other health systems and on a larger set of medications and should decrease clinician time spent reviewing false-positive triggers by increasing specificity.

How often do prescribers include indications in drug orders? Analysis of 4 million outpatient prescriptions.

PURPOSE: To examine the extent to which outpatient clinicians currently document drug indications in prescription instructions. METHODS: Free-text sigs were extracted from all outpatient prescriptions generated by the computerized prescriber order entry system of a major academic institution during a 5-year period. Natural language processing was used to identify drug indications. The data set was analyzed to determine the rates at which prescribers included indications. It was stratified by provider specialty, drug class, and specific medications, to determine how often these indications were in prescriptions for as-needed (PRN) versus non-PRN medications. RESULTS: During the study period, 4,356,086 prescriptions were ordered. Indications were included in 322,961 orders (7.41%). From these orders, 249,262 indications (77.18%) were written for PRN orders. Although internal medicine prescribers generated the highest number of medication orders, they included indications in only 6.26% of their prescriptions, whereas orthopedic surgery providers had the highest rate of documenting indications (33.41%). Pain was the most common indication, accounting for 30.35% of all documented indications. The drug class with the highest number of sigs-containing indications was narcotic analgesics. Non-PRN chronic medication prescriptions rarely included the indication. CONCLUSION: Prescribers rarely included drug indications in electronic free-text prescription instructions, and, when they did, it was mostly for PRN uses such as pain.

Evaluating the implementation and effectiveness of a multi-component intervention to reduce post-surgical opioid prescribing: study protocol of a mixed-methods design.

INTRODUCTION: Opioids prescribed after surgery accounted for 5% of the 191 million opioid prescriptions filled in 2017. Approximately 80% of the opioid pills prescribed by surgical care providers remain unused, leaving a substantial number of opioids available for non-medical use. We developed a multi-component intervention to address surgical providers' role in the overprescribing of opioids. Our study will determine effective strategies for reducing post-surgical prescribing while ensuring adequate post-surgery patient-reported pain-related outcomes, and will assess implementation of the strategies. METHODS AND ANALYSIS: The Minimising Opioid Prescribing in Surgery study will implement a multi-component intervention, in an Illinois network of six hospitals (one academical, two large community and three small community hospitals), to decrease opioid analgesics prescribed after surgery. The multi-component intervention involves four domains: (1) patient expectation setting, (2) baseline assessment of opioid use, (3) perioperative pain control optimisation and (4) post-surgical opioid minimisation. Four surgical specialities (general, orthopaedics, urology and gynaecology) at the six hospitals will implement the intervention. A mixed-methods approach will be used to assess the implementation and effectiveness of the intervention. Data from the network's enterprise data warehouse will be used to evaluate the intervention's effect on post-surgical prescriptions and a survey will collect pain-related patient-reported outcomes. Intervention effectiveness will be determined using a triangulation design, mixed-methods approach with staggered speciality-specific implementation for contemporaneous control of opioid prescribing changes over time. The Consolidated Framework for Implementation Research will be used to evaluate the site-specific contextual factors and adaptations to achieve implementation at each site. ETHICS AND DISSEMINATION: The study aims to identify the most effective hospital-type and speciality-specific intervention bundles for rapid dissemination into our 56-hospital learning collaborative and in hospitals throughout the USA. All study activities have been approved by the Northwestern University Institutional Review Board (ID STU00205053).

Effect of Restriction of the Number of Concurrently Open Records in an Electronic Health Record on Wrong-Patient Order Errors: A Randomized Clinical Trial.

Importance: Recommendations in the United States suggest limiting the number of patient records displayed in an electronic health record (EHR) to 1 at a time, although little evidence supports this recommendation. Objective: To assess the risk of wrong-patient orders in an EHR configuration limiting clinicians to 1 record vs allowing up to 4 records opened concurrently. Design, Setting, and Participants: This randomized clinical trial included 3356 clinicians at a large health system in New York and was conducted from October 2015 to April 2017 in emergency department, inpatient, and outpatient settings. Interventions: Clinicians were randomly assigned in a 1:1 ratio to an EHR configuration limiting to 1 patient record open at a time (restricted; n = 1669) or allowing up to 4 records open concurrently (unrestricted; n = 1687). Main Outcomes and Measures: The unit of analysis was the order session, a series of orders placed by a clinician for a single patient. The primary outcome was order sessions that included 1 or more wrong-patient orders identified by the Wrong-Patient Retract-and-Reorder measure (an electronic query that identifies orders placed for a patient, retracted, and then reordered shortly thereafter by the same clinician for a different patient). Results: Among the 3356 clinicians who were randomized (mean [SD] age, 43.1 [12.5] years; mean [SD] experience at study site, 6.5 [6.0] years; 1894 females [56.4%]), all provided order data and were included in the analysis. The study included 12 140 298 orders, in 4 486 631 order sessions, placed for 543 490 patients. There was no significant difference in wrong-patient order sessions per 100 000 in the restricted vs unrestricted group, respectively, overall (90.7 vs 88.0; odds ratio [OR], 1.03 [95% CI, 0.90-1.20]; P = .60) or in any setting (ED: 157.8 vs 161.3, OR, 1.00 [95% CI, 0.83-1.20], P = .96; inpatient: 185.6 vs 185.1, OR, 0.99 [95% CI, 0.89-1.11]; P = .86; or outpatient: 7.9 vs 8.2, OR, 0.94 [95% CI, 0.70-1.28], P = .71). The effect did not differ among settings (P for interaction = .99). In the unrestricted group overall, 66.2% of the order sessions were completed with 1 record open, including 34.5% of ED, 53.7% of inpatient, and 83.4% of outpatient order sessions. Conclusions and Relevance: A strategy that limited clinicians to 1 EHR patient record open compared with a strategy that allowed up to 4 records open concurrently did not reduce the proportion of wrong-patient order errors. However, clinicians in the unrestricted group placed most orders with a single record open, limiting the power of the study to determine whether reducing the number of records open when placing orders reduces the risk of wrong-patient order errors. Trial Registration: clinicaltrials.gov Identifier: NCT02876588.

Drug formulary decision-making: Ethnographic study of 3 pharmacy and therapeutics committees.

PURPOSE: An ethnographic study of 3 pharmacy and therapeutics (P&T) committees was conducted to characterize the process by which evidence is weighted and decisions are made. METHODS: We recorded discussions and conducted an analysis of the transcripts from the 3 P&T committees for a 1-year period. We examined the content and ideas expressed during deliberations and synthesized themes to give a broader picture of the issues arising. Committee discussions were transcribed and the segments of each meeting that addressed any new formulary additions were then analyzed. Using constant comparison method, we generated a series of topic codes to characterize and classify that portion of the discussion. RESULTS: At 26 meetings across the 3 sites, 24 new drug formulary additions were discussed. A total of 1,093 discussion segments were identified and mapped to 7 broad categories related to discussion of evidence of need, efficacy/indications, safety, misuse potential, cost issues, committee decision-making issues, and discussion related to operationalizing use and implementation at the local institution. Overall, the leading category of discussion was efficacy/indications followed by evidence of need, operational issues, and cost issues, with some variation by site. The committees devoted substantially greater portions of their discussion to the logistics of using the drugs in their institutions than they did safety issues. We identified wide variations in specific drugs being considered and the relative amount of time devoted to various issues related to these drugs being discussed. We found discussions generally did not follow a systematic, standardized, rigorous, and reproducible approach. Discussions tended to be more idiosyncratic, individualized, varying from drug to drug, and at times devoted to a variety of tangential issues raised by committee members. CONCLUSION: P&T committee discussions at all 3 sites tended to be idiosyncratic and individualized, varying from drug to drug, and at times devoted to a variety of issues more tangentially raised by committee members. All spent less time talking about drug safety, in each case roughly half the time that they devoted to discussions of efficacy.

A comparison of analgesic prescribing among ED back and neck pain visits receiving physical therapy versus usual care.

OBJECTIVE: Physical therapy (PT) is commonly cited as a non-opioid pain strategy, and previous studies indicate PT reduces opioid utilization in outpatients with back pain. No study has yet examined whether PT is associated with lower analgesic prescribing in the ED setting. METHODS: This was a retrospective cohort study of discharged ED visits with a primary ICD-10 diagnosis relating to back or neck pain from 10/1/15 to 2/21/17 at an urban academic ED. Visits receiving a PT evaluation were matched with same-date visits receiving usual care. We compared the primary outcomes of opioid and benzodiazepine prescribing between the two cohorts using chi-squared test and multivariable logistic regression. RESULTS: 74 ED visits received PT during the study period; these visits were matched with 390 same-date visits receiving usual care. Opioid prescribing among ED-PT visits was not significantly higher compared to usual care visits on both unadjusted analysis (50% vs 42%, p = 0.19) and adjusted analysis (adjOR 1.05, 95% CI 0.48-2.28). However, benzodiazepine prescribing among ED-PT visits was significantly higher than usual care visits on both unadjusted (45% vs 23%, p < 0.001) and adjusted analysis (adjOR 3.65, 95% CI 1.50-8.83). CONCLUSIONS: In this single center study, ED back and neck pain visits receiving PT were no less likely to receive an opioid prescription and were more likely to receive a benzodiazepine than visits receiving usual care. Although prior studies demonstrate that PT may reduce opioid utilization in the subsequent year, these results indicate that analgesic prescribing is not reduced at the initial ED encounter.