Evaluation of an experiential training program in patient-centered outcomes and comparative effectiveness research for diverse researcher communities and health care organizations.

Background/Objective: The goal of the Patient-Centered Outcomes Research Partnership was to prepare health care professionals and researchers to conduct patient-centered outcomes and comparative effectiveness research (CER). Substantial evidence gaps, heterogeneous health care systems, and decision-making challenges in the USA underscore the need for evidence-based strategies. Methods: We engaged five community-based health care organizations that serve diverse and underrepresented patient populations from Hawai'i to Minnesota. Each partner nominated two in-house scholars to participate in the 2-year program. The program focused on seven competencies pertinent to patient-centered outcomes and CER. It combined in-person and experiential learning with asynchronous, online education, and created adaptive, pragmatic learning opportunities and a Summer Institute. Metrics included the Clinical Research Appraisal Inventory (CRAI), a tool designed to assess research self-efficacy and clinical research skills across 10 domains. Results: We trained 31 scholars in 3 cohorts. Mean scores in nine domains of the CRAI improved; greater improvement was observed from the beginning to the midpoint than from the midpoint to conclusion of the program. Across all three cohorts, mean scores on 52 items (100%) increased (p ≤ 0.01), and 91% of scholars reported the program improved their skills moderately/significantly. Satisfaction with the program was high (91%). Conclusions: Investigators that conduct patient-centered outcomes and CER must know how to collaborate with regional health care systems to identify priorities; pose questions; design, conduct, and disseminate observational and experimental research; and transform knowledge into practical clinical applications. Training programs such as ours can facilitate such collaborations.

Reliability of the conditioned pain modulation paradigm across three anatomical sites.

Background and aims Conditioned Pain Modulation (CPM) is a measure of pain inhibition-facilitation in humans that may elucidate pain mechanisms and potentially serve as a diagnostic test. In laboratory settings, the difference between two pain measures [painful test stimulus (TS) without and with the conditioning stimulus (CS) application] reflects the CPM magnitude. Before the CPM test can be used as a diagnostic tool, its reliability on the same day (intra-session) and across multiple days (inter-session) needs to be known. Furthermore, it is important to determine the most reliable anatomical sites for both the TS and the CS. This study aimed to measure the intra-session and inter-session reliability of the CPM test paradigm in healthy subjects with the TS (pressure pain threshold-PPT) applied to three test sites: the face, hand, and dorsum of the foot, and the CS (cold pressor test-CPT) applied to the contralateral hand. Methods Sixty healthy participants aged 18-65 were tested by the same examiner on 3 separate days, with an interval of 2-7 days. On each day, testing was comprised of two identical experimental sessions in which the PPT test was performed on each of the three dominant anatomical sites in randomized order followed by the CPM test (repeating the PPT with CPT on the non-dominant hand). CPM magnitude was calculated as the percent change in PPT. The Intraclass Correlation Coefficient (ICC), Coefficient of Variation (CV), and Bland-Altman analyses were used to assess reliability. Results PPT relative reliability ranged from good to excellent at all three sites; the hand showed an intra-session ICC of 0.90 (0.84, 0.94) before CPT and ICC of 0.89 (0.83, 0.92) during CPT. The PPT absolute reliability was also high, showing a low bias and small variability when performed on all three sites; for example, CV of the hand intra-session was 8.0 before CPT and 8.1 during CPT. The relative reliability of the CPM test, although only fair, was most reliable when performed during the intra-session visits on the hand; ICC of 0.57 (0.37, 0.71) vs. 0.20 (0.03, 0.39) for the face, and 0.22 (0.01, 0.46) for the foot. The inter-session reliability was lower in all three anatomical sites, with the best reliability on the hand with an ICC of 0.40 (0.23, 0.55). The pattern of absolute reliability of CPM was similar to the relative reliability findings, with the reliability best on the hand, showing lower intra-session and inter-session variability (CV% = 43.5 and 51.5, vs. 70.1 and 73.1 for the face, and 75.9 and 78.9 for the foot). The CPM test was more reliable in women than in men, and in older vs. younger participants. Discussion The CPM test was most reliable when the TS was applied to the dominant hand and CS performed on the contralateral hand. These data indicate that using the CS and TS in the same but contralateral dermatome in CPM testing may create the most reliable results.

A case-control evaluation of fungiform papillae density in burning mouth syndrome.

HYPOTHESIS: It has been hypothesized that high fungiform papillae density may be a risk factor for developing the taste and pain alterations characteristic of burning mouth syndrome. OBJECTIVE: Evaluate whether fungiform papillae density, taste sensitivity, and mechanical pain sensitivity differ between burning mouth syndrome cases and controls. STUDY DESIGN: This case-control study compared cases diagnosed with primary burning mouth syndrome with pain-free controls. METHODS: Participants (17 female cases and 23 female controls) rated the intensity of sucrose, sodium chloride, citric acid, and quinine applied separately to each side of the anterior tongue and sampled whole mouth. Mechanical pain sensitivity was assessed separately for each side of the tongue using weighted pins. Digital photographs of participants' tongues were used to count fungiform papillae. RESULTS: Burning mouth syndrome cases had increased whole mouth taste intensity. Cases also had increased sensitivity to quinine on the anterior tongue, as well as increased mechanical pain sensitivity on the anterior tongue. Fungiform papillae density did not differ significantly between cases and controls. Fungiform papillae density on the left and right sides of the tongue were correlated in controls; however, there was no left/right side correlation in cases. CONCLUSION: Cases had increased pain and taste perception on the anterior tongue. The lack of correlation between left and right fungiform papillae density in cases may be an indication of asymmetrical lingual innervation in these patients. LEVEL OF EVIDENCE: 3b. Laryngoscope, 128:841-846, 2018.

A longitudinal study of depression among middle-aged and senior patients initiating chronic opioid therapy.

BACKGROUND: Improved understanding how depressive symptoms change with sustained opioid use is needed. METHODS: We prospectively assessed patients 45 years or older initiating chronic opioid therapy (COT) at baseline and at 4 and 12 months, differentiating recent COT initiators (n=748) and continuing users (n=468). Level of opioid use before 12-month follow-up was classified as regular/higher-dose, intermittent/lower-dose, or minimal/no use. Depressive symptoms were assessed using the Patient Health Questionnaire-8 (PHQ-8). RESULTS: Depressive symptoms decreased, on average, from baseline to 12 months regardless of level of opioid use. COT patients with regular/higher-dose compared to those with intermittent/lower-dose opioid use (who had similar pain outcomes) did not differ in PHQ-8 scores at 12 months (adjusted mean difference -0.14, 95% CI, -1.07, 0.78 for COT initiators). At 12 months, COT patients with intermittent/lower-dose use had higher adjusted PHQ-8 scores than did those with minimal/no opioid use (adjusted mean difference 0.77, 95% CI, 0.03-1.52 for COT initiators). However, 77% of patients who discontinued opioids cited improved pain as a reason for discontinuation, while 21% cited negative emotional effects of opioids as a reason for discontinuation. Discontinuation was more common among persons who, at baseline, attributed 3 or more depressive symptoms to opioid use. LIMITATIONS: Results are relevant to older COT patients receiving low to moderate opioid doses. CONCLUSIONS: Depressive symptoms did not increase with sustained opioid use. Depressive symptoms were not higher with regular/higher-dose compared to intermittent/lower-dose use. Persons who perceived negative effects of opioids on emotions more often discontinued their use.

A Prospective Study of Predictors of Long-term Opioid Use Among Patients With Chronic Noncancer Pain.

BACKGROUND: Chronic pain patients at increased risk of unfavorable pain and opioid misuse outcomes may be those most likely to use opioids long-term, but this has not been evaluated prospectively. OBJECTIVES: To ascertain whether pain prognostic risk, problem opioid use risk, and depression predict opioid use 1 year later among patients recently initiating opioid therapy with a moderate likelihood of long-term opioid use. MATERIALS AND METHODS: Self-report and electronic health record data were collected from patients aged 45+ years who recently initiated opioid therapy (N=762), in an integrated health care system. Logistic regression models tested whether baseline patient chronic pain prognostic risk, problem opioid use risk, depression, and expectations concerning continued opioid use independently predicted continuing use at 1 year (≥30 d supply in the prior 4 mo). RESULTS: At 1 year, 46% of participants continued to use opioids. Baseline problem opioid use risk score (adjusted odds ratio, 1.15; 95% confidence interval, 1.04-1.26) and expectations about continuing opioid use, but not pain prognostic risk score or depression, were significant predictors of 1-year opioid use. Compared with patients who thought continued opioid use unlikely, those who thought it was extremely or very likely had 4 times the odds of opioid use at 1 year (adjusted odds ratio, 4.05; 95% confidence interval, 2.59-6.31). DISCUSSION: The strongest predictors of long-term opioid use were not patient-related or medication-related factors, but expectations about using opioids in the future. Asking about such expectations may be the easiest way to identify patients likely to continue opioid use long-term.

Comprehensive systematic review of long-term opioids in women with chronic noncancer pain and associated reproductive dysfunction (hypothalamic-pituitary-gonadal axis disruption).

A comprehensive systematic literature review of reproductive side effects in women aged 18 to 55 years treated with opioids for 1 month or longer for chronic noncancer pain. A search of 7 databases including EMBASE and Medline was undertaken (October 2014 and a limited rerun April 2016). The search contained key words for opioids (generic and specific drug names) and side effects (generic and specific reproductive). Titles were screened using predefined criteria by a single reviewer and abstracts and full texts by 2 independent reviewers. A total of 10,684 articles were identified and 12 full texts (cohort [n = 1], case-control [n = 4], cross-sectional [n = 4], case series [n = 1], and case report [n = 2] with a maximum of 41 cases in 1 article) were included covering 3 different modes of administration: oral (n = 6), intrathecal (n = 5), and transdermal (n = 1). Amenorrhoea occurred in 23% to 71% of those receiving oral or intrathecal opioids. Decreased libido was seen in 61% to 100%. Of the 10 studies that undertook hormonal assays, only 2 studies showed a statistically significant decrease in hormone levels. This review supports the view that there is a potential relationship between the use of long-term opioids in women and reproductive side effects. The evidence is however weak and the mode of administration, duration, type, and dose of opioid might influence associations. Although hormone levels were statistically significant in only 2 studies, women exhibited clinically important symptoms (decreased libido and altered menstrual cycle). Further investigation is required with larger cohorts and analysis of different delivery methods.

Does association of opioid use with pain and function differ by fibromyalgia or widespread pain status?

Many consider chronic opioid therapy (COT) to be ineffective for fibromyalgia, but empirical evidence is limited. Among patients identified as initiating COT, we examined whether fibromyalgia was associated with different relationships of opioid use to pain and activity interference outcomes 12 months later. We obtained electronic data on diagnoses and opioid prescriptions. We obtained patient self-report data, including pain and activity interference measures, at baseline, 4 months, and 12 months. Among 1218 patients, 429 (35%) met our definition of fibromyalgia. Patients with and without fibromyalgia who had intermittent/lower-dose or regular/higher-dose opioid use at 12 months had similar 12-month pain intensity scores. However, among patients with minimal/no opioid use at 12 months, 12-month pain intensity was greater for those with fibromyalgia (adjusted mean = 5.15 [95% confidence interval, 4.80-5.51]; 0-10 scale) than for those without (4.44 [4.15-4.72]). Similar patterns were observed for 12-month activity interference. Among patients who discontinued opioids by 12 months, those with fibromyalgia were more likely to report bothersome side effects and less likely to report pain improvement as important reasons for discontinuation (P < 0.05). In sum, at 12 months, among patients who had discontinued opioids or used them minimally, those with fibromyalgia had worse outcomes and were less likely to have discontinued because of pain improvement. Among patients continuing COT, pain and activity interference outcomes were worse than those of patients with minimal/no opioid use and did not differ for those with fibromyalgia vs those with diverse other chronic pain conditions.

United States National Pain Strategy for Population Research: Concepts, Definitions, and Pilot Data.

UNLABELLED: National Pain Strategy population research objectives include: estimating chronic pain prevalence, studying pain treatment with electronic health care data, and developing metrics to assess progress in reducing chronic pain impact. In this article, the National Pain Strategy Population Research Workgroup reviews concepts relevant to achieving these aims. High-impact chronic pain was defined as persistent pain with substantial restriction of life activities lasting 6 months or more. In pilot work, we tested a brief assessment of high-impact chronic pain, and used electronic health records data to describe pain-related health care. A mail survey of adult health plan enrollees (N = 770) reported that 14% had high-impact chronic pain. Relative to persons with lower-impact chronic pain, those with high-impact chronic pain were more often frequent users of health care for pain, reported lower quality of life, greater pain-related interference with activities, and more often reported pain at multiple anatomic locations. Analyses of health care data (N = 289,464) reported that pain patients had higher health care costs compared with others and that pain services were typically delivered in primary care. These results support the feasibility of developing data on chronic pain through national health interview surveys and large electronic health care databases. PERSPECTIVE: Pilot analyses supported the feasibility of brief chronic pain assessments suitable for national health surveys and use of electronic health care databases to develop data regarding trends in the delivery of pain treatments, costs, and effectiveness. These methods are relevant to achieving the aims of the US National Pain Strategy.

Timeliness of Care Planning upon Initiation of Chronic Opioid Therapy for Chronic Pain.

BACKGROUND: Chronic opioid therapy (COT) guidelines recommend developing a COT care plan at the initiation of COT. OBJECTIVE: Assess the timeliness of care planning upon initiation of COT. DESIGN: Observational cohort study in a setting incentivizing and tracking documentation of COT care plans in electronic health records (EHRs). PARTICIPANTS: Study participants (N = 896) were aged 45 years or older, had initiated an episode of opioid use within the prior 6 months, and reported regular use of prescription analgesics when screened for a baseline interview about 3 months after an index opioid prescription MEASURES: A timely care plan was defined by an EHR documented care plan prior to or within 4 months after the index opioid prescription. RESULTS: Among COT initiators, 30% had a timely COT care plan documented in the EHR within 4 months following index prescription, while 51% had a documented COT care plan within 12 months following index prescription. Among those interviewed at 1 year follow-up (N = 735), 252 (34.2%) reported opioid use on 7 or more days in the prior 2 weeks. Less than half (45.6%) of the 252 individuals who sustained regular opioid use at 1 year had predicted at baseline that it was somewhat, very, or extremely likely they would be using opioids regularly in 1 year. CONCLUSIONS: Patients initiating COT were unlikely to have timely COT care plans. Many who sustained regular opioid use at 1 year had not anticipated using opioids long term.

Association of levels of opioid use with pain and activity interference among patients initiating chronic opioid therapy: a longitudinal study.

Little is known about long-term pain and function outcomes among patients with chronic noncancer pain initiating chronic opioid therapy (COT). In the Middle-Aged/Seniors Chronic Opioid Therapy study of patients identified through electronic pharmacy records as initiating COT for chronic noncancer pain, we examined the relationships between level of opioid use (over the 120 days before outcome assessment) and pain and activity interference outcomes at 4- and 12-month follow-ups. Patients aged 45+ years (N = 1477) completed a baseline interview; 1311 and 1157 of these comprised the 4- and 12-month analysis samples, respectively. Opioid use was classified based on self-report and electronic pharmacy records for the 120 days before the 4- and 12-month outcome assessments. Controlling for patient characteristics that predict sustained COT and pain outcomes, patients who had used opioids minimally or not at all, compared with those with intermittent/lower-dose and regular/higher-dose opioid use, had better pain intensity and activity interference outcomes. Adjusted mean (95% confidence interval) pain intensity (0-10 scale) at 12 months was 4.91 (4.68-5.13) for the minimal/no use group and 5.71 (5.50-5.92) and 5.72 (5.51-5.93) for the intermittent/lower-dose and regular/higher-dose groups, respectively. A similar pattern was observed for pain intensity at 4 months and for activity interference at both time points. Better outcomes in the minimal/no use group could reflect pain improvement leading to opioid discontinuation. The similarity in outcomes of regular/higher-dose and intermittent/lower-dose opioid users suggests that intermittent and/or lower-dose use vs higher-dose use may confer risk reduction without reducing benefits.

Electronic Health Records to Evaluate and Account for Non-response Bias: A Survey of Patients Using Chronic Opioid Therapy.

BACKGROUND: In observational studies concerning drug use and misuse, persons misusing drugs may be less likely to respond to surveys. However, little is known about differences in drug use and drug misuse risk factors between survey respondents and nonrespondents. METHODS: Using electronic health record (EHR) data, we compared respondents and non-respondents in a telephone survey of middle-aged and older chronic opioid therapy patients to assess predictors of interview nonresponse. We compared general patient characteristics, specific opioid misuse risk factors, and patterns of opioid use associated with increased risk of opioid misuse. Inverse probability weights were calculated to account for nonresponse bias by EHR-measured covariates. EHR-measured covariate distributions for the full sample (nonrespondents and respondents), the unweighted respondent sample, and the inverse probability weighted respondent sample are reported. We present weighted and unweighted prevalence of self-reported opioid misuse risk factors. RESULTS: Among 2489 potentially eligible patients, 1477 (59.3%) completed interviews. Response rates differed with age (45-54 years, 51.8%; 55-64 years, 58.7%; 65-74 years, 67.9%; and 75 years or older, 59.9%). Tobacco users had lower response rates than did nonusers (53.5% versus 60.9%). Charlson comorbidity score was also related to response rates. Individuals with a Charlson score of 2 had the highest response rate at 65.6%; response rates were lower amoung patients with the lowest (the patients with the fewest health conditions had response rates of 56.7-60.0%) and the highest Charlson scores (patients with the most health conditions had response rates of 52.2-56.0%). These bivariate relationships persisted in adjusted multivariable logistic regression models predicting survey response. Response rates of persons with and without specific opioid misuse risk factors were similar (e.g., 58.7% for persons with substance abuse diagnoses, 59.4% for those without). Opioid use patterns associated with opioid misuse did not predict response rates (e.g., 60.6% versus 59.2% for those receiving versus not receiving opioids from 3 or more physicians outside their primary care clinic). Very few patient characteristics predicted non-response; thus, inverse probability weights accounting for nonresponse had little impact on the distributions of EHR-measured covariates or self-reported measures related to opioid use and misuse. CONCLUSIONS: Response rates differed by characteristics that predict nonresponse in general health surveys (age, tobacco use), but did not appear to differ by specific patient or drug use risk factors for prescription opioid misuse among middle- and older-aged chronic opioid therapy patients. When observational studies are conducted in health plan populations, electronic health records may be used to evaluate nonresponse bias and to adjust for variables predicting interview nonresponse, complementing other research uses of EHR data in observational studies.

Sex and Age Differences in Global Pain Status Among Patients Using Opioids Long Term for Chronic Noncancer Pain.

BACKGROUND: The use of chronic opioid therapy (COT) has risen dramatically in recent years, especially among women. However, little is known about factors influencing overall pain and function (global pain status) among COT users. Characterizing the typical experiences of COT patients by age-sex group could help clinicians and patients better weigh the risks and benefits of COT. Thus, we sought to characterize global pain status among COT users in community practice by age and sex. METHODS: Telephone survey of 2,163 health plan members aged 21-80 years using COT. We assessed average/usual pain (0-10 scale); pain-related interference (0-10); activity limitation days, last 3 months; and pain impact, last 2 weeks (0-11). Status on each indicator was classified as low (better pain/function), moderate, or high (worse pain/function). Global pain status was categorized as favorable if 2-4 indicators were low and 0-1 was high and unfavorable if 2-4 indicators were high and 0-1 was low. RESULTS: Among female COT patients, 15% (vs. 26% of males) had favorable global pain status and 59% (vs. 42% of males) had unfavorable status. Under age 65 years, women fared more poorly than men on every indicator. Among 65- to 80-year-olds, women and men had similar global pain status. CONCLUSIONS: Although pain and function among COT users vary considerably, only one in five reported low pain levels and high levels of function. Young and middle-aged women seem to be at particularly high risk for unfavorable global pain status. More research is needed about how to best manage pain in this group.

The science of clinical practice: disease diagnosis or patient prognosis? Evidence about "what is likely to happen" should shape clinical practice.

BACKGROUND: Diagnosis is the traditional basis for decision-making in clinical practice. Evidence is often lacking about future benefits and harms of these decisions for patients diagnosed with and without disease. We propose that a model of clinical practice focused on patient prognosis and predicting the likelihood of future outcomes may be more useful. DISCUSSION: Disease diagnosis can provide crucial information for clinical decisions that influence outcome in serious acute illness. However, the central role of diagnosis in clinical practice is challenged by evidence that it does not always benefit patients and that factors other than disease are important in determining patient outcome. The concept of disease as a dichotomous 'yes' or 'no' is challenged by the frequent use of diagnostic indicators with continuous distributions, such as blood sugar, which are better understood as contributing information about the probability of a patient's future outcome. Moreover, many illnesses, such as chronic fatigue, cannot usefully be labelled from a disease-diagnosis perspective. In such cases, a prognostic model provides an alternative framework for clinical practice that extends beyond disease and diagnosis and incorporates a wide range of information to predict future patient outcomes and to guide decisions to improve them. Such information embraces non-disease factors and genetic and other biomarkers which influence outcome. SUMMARY: Patient prognosis can provide the framework for modern clinical practice to integrate information from the expanding biological, social, and clinical database for more effective and efficient care.

Evaluation of Health Plan Interventions to Influence Chronic Opioid Therapy Prescribing.

OBJECTIVES: Evaluate health plan interventions targeting physician chronic opioid therapy (COT) prescribing. MATERIALS AND METHODS: In 2006, Group Health's (GH) Integrated Group Practice (IGP) initiated diverse interventions targeting COT prescriber norms and practices. In 2010, the IGP implemented a COT guideline, including a mandated online course for physicians managing COT. These interventions were not implemented in GH's network practices. We compared trends in GH-IGP and network practices for 2006 to 2012 in the percent of patients receiving COT and their opioid dose. We compared physician beliefs before versus after the mandated course and precourse to postcourse changes in COT dosing for IGP physicians who took the course. RESULTS: From 2006 to 2012, mean (SE) daily opioid dose among IGP COT patients (intervention setting) declined from 74.1 mg (1.9 mg) morphine equivalent dose (MED) to 48.3 mg (1.0 mg) MED. Dose changes among GH network COT patients (control setting) were modest-88.2 mg (5.0 mg) MED in 2006 to 75.7 mg (2.3 mg) MED in 2012. Among physicians taking the mandated course in 2011, we observed precourse to postcourse changes toward more conservative opioid prescribing beliefs. However, COT dosing trends did not change precourse to postcourse. DISCUSSION: Following initiatives implemented to alter physician prescribing practices and norms, mean opioid dose prescribed to COT patients declined more in intervention than control practices. Physicians reported more conservative beliefs regarding opioid prescribing immediately after completing an online course in 2011, but the course was not associated with additional reductions in mean daily opioid dose prescribed by physicians completing the course.

Chronic opioid therapy urine drug testing in primary care: prevalence and predictors of aberrant results.

BACKGROUND: Urine drug tests (UDTs) are recommended for patients on chronic opioid therapy (COT). Knowledge of the risk factors for aberrant UDT results could help optimize their use. OBJECTIVE: To identify primary care COT patient and opioid regimen characteristics associated with aberrant UDT results. DESIGN: Population-based observational. SAMPLE: 5,420 UDTs for Group Health integrated group practice COT patients. MEASURES: Group Health database measures of patient demographics, medical history, COT characteristics, and UDT results. RESULTS: Thirty percent of UDTs had aberrant results, including prescribed opioid non-detection (12.3%), tetrahydrocannabinol (THC; 11.2%), non-prescribed opioid (5.3%), illicit drug (excluding THC; 0.6%), non-prescribed benzodiazepine (1.7%), and dilute (4.8%). Adjusted odds ratios (95% CI) of any aberrant result were higher for males than females (1.24 [1.07, 1.43]), patients with versus without prior substance use disorder diagnoses (1.42 [1.17, 1.72]), and current smokers versus non-smokers (1.50 [1.30, 1.73]). Odds ratios were lower for patients aged 45-64 (0.77 [0.65, 0.92]) and 65+ (0.40 [0.32, 0.50]) versus patients aged 20-44 and for patients on long-acting opioids only (0.72 [0.55, 0.95]) or long-acting plus short-acting (0.67 [0.54, 0.83]) versus short-acting only. Adjusted odds of prescribed opioid non-detection were lower for patients aged 45-64 (0.79 [0.63, 0.998]) and 65+ (0.44 [0.32, 0.59]) versus patients aged 20-44, for those on 40-<120 mg daily morphine-equivalent dose (0.52 [0.39, 0.70]) or 120+ mg (0.22 [0.11, 0.43]) versus <40 mg, and for patients on long-acting (0.35 [0.21, 0.57]) or long-acting plus short-acting (0.35 [0.24, 0.50]) opioids (versus short-acting only); and odds ratios were higher for patients with versus without prior diagnoses of substance use disorder (1.70 [1.31, 2.20]). CONCLUSIONS: In this primary care setting, results were aberrant for 30% of UDTs of COT patients, largely because of prescribed opioid non-detection and THC. Aberrant results of almost all types were more likely among patients under the age of 45. Other risk factors varied across aberrancies, but commonly included current smoking and prior substance use disorder diagnosis.

Chronic opioid therapy risk reduction initiative: impact on urine drug testing rates and results.

BACKGROUND: In response to epidemic levels of prescription opioid overdose, abuse, and diversion, routine urine drug tests (UDTs) are recommended for patients receiving chronic opioid therapy (COT) for chronic pain. However, UDT ordering for COT patients is inconsistent in primary care, and little is known about how to increase UDT ordering or the impact of increased testing on rates of aberrant results. OBJECTIVE: To compare rates and results of UDTs for COT patients before versus after implementation of an opioid risk reduction initiative in a large healthcare system. DESIGN: Pre-post observational study. PATIENTS: Group Health patients on COT October 2008-September 2009 (N = 4,821), October 2009-September 2010 (N = 5,081), and October 2010-September 2011 (N = 5,498). INTERVENTION: Multi-faceted opioid risk reduction initiative. MAIN MEASURES: Annual rates of UDTs and UDT results. KEY RESULTS: Half of COT patients received at least one UDT in the year after the initiative was implemented, compared to only 7 % 2 years prior. The adjusted odds of COT patients having at least one UDT in the first year of the opioid initiative were almost 16 times (adjusted OR = 15.79; 95 % CI: 13.96-17.87) those 2 years prior. The annual rate of UDT detection of marijuana and illicit drugs did not change (12.6 % after initiative implementation), and largely reflected marijuana use (detected in 11.1 % of all UDTs in the year after initiative implementation). In the year after initiative implementation, 10.7 % of UDTs were negative for opioids. CONCLUSIONS: The initiative appeared to dramatically increase urine drug testing of COT patients in the healthcare system without impacting rates of aberrant results. The large majority of aberrant results reflected marijuana use or absence of opioids in the urine. The utility of increased urine drug testing for COT patient safety and prevention of diversion remains uncertain.

Comparison of back pain prognostic risk stratification item sets.

UNLABELLED: Back pain outcomes may be improved and costs lowered through risk-stratified care, but relative performance of alternative item sets for predicting back pain outcomes has not been well characterized. We compared alternative prognostic item sets based on STarT Back and Chronic Pain Risk screeners in a cohort of patients initiating primary care for back pain. The STarT Back item set was brief and relied on binary responses, whereas the Chronic Pain Risk item set employed scaled responses and assessed pain persistence and diffuse pain. Patients (N = 571) were assessed soon after their initial visit and 502 (88%) were reassessed 4 months later. Items sets based on STarT Back and Chronic Pain Risk prognostic screeners, as well as a combination of items from both, were used to predict Chronic Pain Grade II-IV back pain at 4 months. The area under the receiver operating characteristic curve estimates (95% confidence intervals) were .79 (.74-.83) for items based on the STarT Back, .80 (.75-.83) for items based on Chronic Pain Risk, and .81 (.77-.85) for a composite item set. Differences in prediction were modest. Items from 2 prognostic screeners, and both combined, achieved acceptable and similar prediction of unfavorable back pain outcomes. PERSPECTIVE: Given comparable predictive validity, choice among prognostic item sets should be based on clinical relevance, number of items, ease of administration, and item simplicity.

Do patient-perceived pros and cons of opioids predict sustained higher-dose use?

OBJECTIVES: Chronic opioid therapy (COT) is associated with various adverse outcomes, especially at higher doses, yet little is known about predictors of sustained higher-dose COT. This study aimed to ascertain, among higher-dose COT patients, the association of patient-perceived pros and cons of opioids with continued higher-dose use 1 year later. METHODS: Patients (N=1229) in 2 large health plans prescribed ≥50 mg morphine-equivalent dose (MED) per day for chronic noncancer pain completed a survey assessing opioid benefits and harms. The Prescribed Opioid Difficulties Scale questionnaire assessed psychosocial problems, concerns, benefits, and side effects related to opioid use. Logistic regression models estimated the associations of the reported benefits and problems with higher-dose continuation (≥50 mg MED/d) versus dose reduction (<50 mg MED/d) 1 year later. RESULTS: Over 80% of participants continued higher-dose opioid use at 1 year, regardless of reported problems, concerns, side effects, pain reduction, or perceived helpfulness. Higher scores on the Prescribed Opioid Difficulties Scale Problems subscale (odds ratio=0.79, 95% confidence interval, 0.68-0.92) and Concerns subscale (odds ratio=0.76, 95% confidence interval, 0.65-0.90) were negatively associated with higher-dose use 1 year later. Other baseline measures (opioid helpfulness, reduction in pain, number of side effects, and side effect bothersomeness) were not significantly associated with continued higher-dose use. DISCUSSION: The large majority of patients continued using higher-dose opioids regardless of baseline characteristics. These findings suggest the difficulty of reducing opioid dose among chronic higher-dose opioid users.

Psychophysical tests as predictors of back pain chronicity in primary care.

UNLABELLED: If persons at risk of developing chronic pain could be identified early in a pain episode, treatment could be tailored on the basis of risk. Responses to psychophysical tests differ in persons with chronic pain vs pain-free controls and thus appear promising as indicators of susceptibility to chronic pain. In a cohort of 157 patients making their first primary care visit during a back pain episode, we explored the relationships of psychophysical test responses (pressure pain thresholds at low back and thenar sites, cold pressor pain ratings, conditioned pain modulation, and mechanical temporal summation) to baseline measures of pain and psychological distress and assessed whether test responses predicted clinically significant back pain 4 months later. Examiner-standardized pressure pain thresholds were significantly (P < .05) correlated with baseline back pain severity and diffuseness of bodily pain (Pearson correlations = -.21 to -.35). Lower baseline pressure pain thresholds significantly predicted back pain at 4 months (odds ratio [95% confidence interval]: low back, .66 [.44, .96]; thenar, .62 [.40, .92]); however, after controlling for participant age and sex, these associations were no longer significant. Cold pressor pain, conditioned pain modulation, and mechanical temporal summation were not significant predictors of 4-month back pain in either model. PERSPECTIVE: Some psychophysical test responses have been found to differ in persons with chronic pain vs pain-free controls. In this prospective study, psychophysical test responses had limited utility for predicting which primary care back pain patients would have clinically significant chronic pain 4 months later.