Kathleen Saunders

A chronic disease score from automated pharmacy data

Using population-based automated pharmacy data, patterns of use of selected prescription medications during a 1 year time period identified by a consensus judgement process were used to construct a measure of chronic disease status (Chronic Disease Score). This score was evaluated in terms of its stability over time and its association with other health status measures. In a pilot test sample of high utilizers of ambulatory health care well known to their physicians (n = 219), Chronic Disease Score (CDS) was correlated with physician ratings of physical disease severity (r = 0.57). In a second random sample of patients (n = 722), its correlation with physician-rated disease severity was 0.46. In a total population analysis (n = 122,911), it was found to predict hospitalization and mortality in the following year after controlling for age, gender and health care visits. In a population sample (n = 790), CDS showed high year to year stability (r = 0.74). Based on health survey data, CDS showed a moderate association with self rated health status and self reported disability. Unlike self-rated health status and health care utilization, CDS was not associated with depression or anxiety. We conclude that scoring automated pharmacy data can provide a stable measure of chronic disease status that, after controlling for health care utilization, is associated with physician-rated disease severity, patient-rated health status, and predicts subsequent mortality and hospitalization rates. Specific methods of scoring automated pharmacy data to measure global chronic disease status may require adaptation to local prescribing practices. Scoring might be improved by empirical estimation of weighting factors to optimize prediction of mortality and other health status measures.

Opioid Prescriptions for Chronic Pain and Overdose: A Cohort Study

BACKGROUND Long-term opioid therapy for chronic noncancer pain is becoming increasingly common in community practice. Concomitant with this change in practice, rates of fatal opioid overdose have increased. The extent to which overdose risks are elevated among patients receiving medically prescribed long-term opioid therapy is unknown. OBJECTIVE To estimate rates of opioid overdose and their association with an average prescribed daily opioid dose among patients receiving medically prescribed, long-term opioid therapy. DESIGN Cox proportional hazards models were used to estimate overdose risk as a function of average daily opioid dose (morphine equivalents) received at the time of overdose. SETTING HMO. PATIENTS 9940 persons who received 3 or more opioid prescriptions within 90 days for chronic noncancer pain between 1997 and 2005. MEASUREMENTS Average daily opioid dose over the previous 90 days from automated pharmacy data. Primary outcomes--nonfatal and fatal overdoses--were identified through diagnostic codes from inpatient and outpatient care and death certificates and were confirmed by medical record review. RESULTS 51 opioid-related overdoses were identified, including 6 deaths. Compared with patients receiving 1 to 20 mg/d of opioids (0.2% annual overdose rate), patients receiving 50 to 99 mg/d had a 3.7-fold increase in overdose risk (95% CI, 1.5 to 9.5) and a 0.7% annual overdose rate. Patients receiving 100 mg/d or more had an 8.9-fold increase in overdose risk (CI, 4.0 to 19.7) and a 1.8% annual overdose rate. LIMITATIONS Increased overdose risk among patients receiving higher dose regimens may be due to confounding by patient differences and by use of opioids in ways not intended by prescribing physicians. The small number of overdoses in the study cohort is also a limitation. CONCLUSION Patients receiving higher doses of prescribed opioids are at increased risk for overdose, which underscores the need for close supervision of these patients. PRIMARY FUNDING SOURCE National Institute of Drug Abuse.

Chronic spinal pain and physical-mental comorbidity in the United States: Results from the national comorbidity survey replication

This paper investigates comorbidity between chronic back and neck pain and other physical and mental disorders in the US population, and assesses the contributions of chronic spinal pain and comorbid conditions to role disability. A probability sample of US adults (n=5692) was interviewed. Chronic spinal pain, other chronic pain conditions and selected chronic physical conditions were ascertained by self‐report. Mood, anxiety and substance use disorders were ascertained with the Composite International Diagnostic Interview (CIDI). Role disability was assessed with questions about days out of role and with impaired role functioning. The 1 year prevalence of chronic spinal pain was 19.0%. The vast majority (87.1%) of people with chronic spinal pain reported at least one other comorbid condition, including other chronic pain conditions (68.6%), chronic physical conditions (55.3%), and mental disorders (35.0%). Anxiety disorders showed as strong an association with chronic spinal pain as did mood disorders. Common conditions not significantly comorbid with chronic spinal pain were diabetes, heart disease, cancer, and drug abuse. Chronic spinal pain was significantly associated with role disability after controlling for demographic variables and for comorbidities. However, comorbid conditions explained about one‐third of the gross association of chronic spinal pain with role disability. We conclude that chronic spinal pain is highly comorbid with other pain conditions, chronic diseases, and mental disorders, and that comorbidity plays a significant role in role disability associated with chronic spinal pain. The societal burdens of chronic spinal pain need to be understood and managed within the context of comorbid conditions.

The course of back pain in primary care.

Study Design Review paper of outcome studies among primary care back pain patients. Objectives To determine the short‐term and long‐term pain and functional outcomes of patients with back pain who are seeking treatment in primary care settings. Summary of Background Data Back pain has been viewed as running either an acute or a chronic course, but most patients experience recurrent back pain. This review summarizes outcome studies in light of the episodic course of back pain. Methods Studies reporting pain and functional outcome data for consecutive primary care patients with back pain were reviewed. Results Back pain among primary care patients typically is a recurrent condition for which definitions of acute and chronic pain based on a single episode are inadequate. Because a majority of patients experience recurrences, describing only the outcome of the initial back pain episode may convey a more favorable picture of long‐term outcome than warranted. For the short‐term follow‐up evaluation, most patients improve considerably during the first 4 weeks after seeking treatment. Sixty‐six percent to 75% continue to experience at least mild back pain 1 month after seeking care. At 1 month, approximately 33% report continuing pain of at least moderate intensity, whereas 20‐25% report substantial activity limitations. For the long‐term follow‐up (1 year or more) period, approximately 33% report intermittent or persistent pain of at least moderate intensity, one in seven continue to report back pain of severe intensity, and one in five report substantial activity limitations. Conclusion Results from existing studies suggest that back pain among primary care patients typically runs a recurrent course characterized by variation and change, rather than an acute, self‐limiting course.

Trends in long-term opioid therapy for chronic non-cancer pain

To report trends and characteristics of long‐term opioid use for non‐cancer pain.

Use of exogenous hormones and risk of temporomandibular disorder pain.

Abstract Temporomandibular disorders (TMD) are common pain conditions that have their highest prevalence among women of reproductive age. The higher prevalence of TMD pain among women, pattern of onset after puberty and lowered prevalence rates in the post‐menopausal years suggest that female reproductive hormones may play an etiologic role in TMD. Two epidemiologic studies were designed to assess whether use of exogenous hormones is associated with increased risk of TMD pain. Both used data from automated pharmacy records of women enrolled in a large health maintenance organization to identify prescriptions filled for post‐menopausal hormone replacement therapies (Study 1) or for oral contraceptives (OCs) (Study 2). Study 1 employed an age‐matched case‐control design to compare post‐menopausal hormone use among 1291 women over age 40 referred for TMD treatment and 5164 controls not referred. After controlling for health services use, the odds of being a TMD case were approximately 30% higher among those receiving estrogen compared to those not exposed (P=0.002); a clear dose‐response relationship was evident. The relationship of progestin use to TMD was not statistically significant. Study 2 used a similar design to examine the relationship of OC use to referral for TMD care, drawing on data from 1473 cases and 5892 controls aged 15–35. Use of OCs was also associated with referral for TMD care, with an increased risk of TMD of approximately 20% for OC users, after controlling for health services use (P<0.05). These results suggest that female reproductive hormones may play an etiologic role in orofacial pain. This relationship warrants further investigation through epidemiologic, clinical and basic research.

Treatment costs, cost offset, and cost-effectiveness of collaborative management of depression

Objective This report estimates the treatment costs, cost-offset effects, and cost-effectiveness of Collaborative Care of depressive illness in primary care. Study Design Treatment costs, cost-offset effects, and cost-effectiveness were assessed in two randomized, controlled trials. In the first randomized trial (N = 217), consulting psychiatrists provided enhanced management of pharmacotherapy and brief psychoeducational interventions to enhance adherence. In the second randomized trial (N = 153), Collaborative Care was implemented through brief cognitive-behavioral therapy and enhanced patient education. Consulting psychologists provided brief psychotherapy supplemented by educational materials and enhanced pharmacotherapy management. Results Collaborative Care increased the costs of treating depression largely because of the extra visits required to provide the interventions. There was a modest cost offset due to reduced use of specialty mental health services among Collaborative Care patients, but costs of ambulatory medical care services did not differ significantly between the intervention and control groups. Among patients with major depression there was a modest increase in cost-effectiveness. The cost per patient successfully treated was lower for Collaborative Care than for Usual Care patients. For patients with minor depression, Collaborative Care was more costly and not more cost-effective than Usual Care. Conclusions Collaborative Care increased depression treatment costs and improved the cost-effectiveness of treatment for patients with major depression. A cost offset in specialty mental health costs, but not medical care costs, was observed. Collaborative Care may provide a means of increasing the value of treatment services for major depression.

De Facto Long-term Opioid Therapy for Noncancer Pain

ObjectivesThis paper describes characteristics of opioid use episodes for noncancer pain and defines thresholds for de facto long-term opioid therapy. MethodsCONSORT (CONsortium to Study Opioid Risks and Trends) includes adult members of 2 health plans serving over 1% of the US population. Opioid use episodes beginning in the years 1997 to 2005 were classified as acute, episodic, long-term/lower dose, or long-term/higher dose. ResultsOn the basis of evaluation of the likelihood of opioid use continuing, long-term opioid therapy was defined by episodes lasting longer than 90 days with 10+ opioid prescriptions or 120+ days supply of opioids dispensed. Long-term/higher dose episodes (<1.5% of all opioid use episodes) were characterized by daily or near daily use, a mean duration of about 1000 days, and an average daily dose of about 55 mg. They accounted for more than half the total morphine equivalents dispensed from the years 1997 to 2006. Short-acting, non-Schedule II opioids (eg, hydrocodone with acetaminophen) were, by far, the most commonly prescribed medications for acute, episodic, and long-term episodes. Long-acting (sustained-release) opioids were the predominately prescribed medication in a minority of long-term episodes (6% to 12%). DiscussionLong-term opioid therapy was characterized by the diversity in medications prescribed, dosage levels, and frequency of use. The proposed threshold for long-term opioid therapy provides a checkpoint for physicians to review whether an explicit decision to sustain opioid therapy has been reached, and to ensure that a documented treatment plan and provisions for monitoring medication use and patient outcomes are in place.

A randomized trial of a lay person-led self-management group intervention for back pain patients in primary care.

Study Design. Randomized, controlled trial. Objective. To evaluate a four‐session self‐management group intervention for patients with pain in primary care, led by trained lay persons with back pain. The intervention was designed to reduce patient worries, encourage self‐care, and reduce activity limitations. Background Data. Randomized trials of educational interventions suggest that activating interventions may improve back pain outcomes. Expert opinion increasingly regards effective self‐management of back pain as important in achieving good outcomes. In this study, an educational intervention designed to activate patients and support effective self‐management was evaluated. Methods. Six to 8 weeks after a primary care visit for back pain, patients were invited to participate in an educational program to improve back pain self‐management. Those showing interest by returning a brief questionnaire became eligible for the study. Participants (n = −255) randomly were assigned to either a self‐management group intervention or to a usual care control group. The effect of the intervention, relative to usual care, was assessed 3, 6, and 12 months after randomization, controlling for baseline values. The intervention consisted of a four‐session group applying problem‐solving techniques to back pain self‐management, supplemented by educational materials (book and videos) supporting active management of back pain. The groups were led by lay persons trained to implement a fully structured group protocol. The control group received usual care, supplemented by a book on back pain care. Results. Participants randomly assigned to the self‐management groups reported significantly less worry about back pain and expressed more confidence in self‐care. Roland Disability Questionnaire Scores were significantly lower among participants in the self‐management groups relative to the usual care controls at 6 months (P = 0.007), and this difference was sustained at 12 months at borderline significance levels (P = 0.09). Among self‐management group participants, 48% showed a 50% or greater reduction in Roland Disability Questionnaire Score at 6 months, compared with 33% among the usual care controls. Conclusions. Self‐management groups led by trained lay persons following a structured protocol were more effective than usual care in reducing worries, producing positive attitudes toward self‐care, and reducing activity limitations among patients with back pain in primary care.

A randomized trial of a cognitive-behavioral program for enhancing back pain self care in a primary care setting.

&NA; Back pain is a significant health care problem that has been managed unsatisfactorily in primary care settings. Providers typically address medical issues but do not adequately address patient concerns or functional limitations related to back pain. We evaluated a brief intervention for primary care back pain patients designed to provide accurate information about back pain, instill attitudes favorable towards self care, reduce fears and worries, assist patients in developing personalized action plans to manage their back pain, and improve functional outcomes. Patients enrolled in a large health maintenance organization were invited to participate in an educational program to improve back pain self care skills 6–8 weeks after a primary care back pain visit. Patients (n=226) were randomly assigned to a Self Care intervention or to Usual Care, and were assessed at baseline, 3‐, 6‐, and 12‐months. The intervention involved a two‐session Self Care group and an individual meeting and telephone conversation with the group leader, a psychologist experienced in chronic pain management. The intervention was supplemented by educational materials (book and videos) supporting active management of back pain. The control group received usual care supplemented by a book on back pain care. Participants assigned to the Self Care intervention showed significantly greater reductions in back‐related worry and fear‐avoidance beliefs than the control group. Modest, but statistically significant, effects on pain ratings and interference with activities were also observed.