RESUMEN
OBJECTIVE: The Graded Chronic Pain Scale (GCPS) is frequently used in pain research and treatment to classify mild, bothersome, and high impact chronic pain. This study's objective was to validate the revised version of the GCPS (GCPS-R) in a US Veterans Affairs (VA) healthcare sample to support its use in this high-risk population. METHODS: Data were collected from Veterans (n = 794) via self-report (GCPS-R and relevant health questionnaires) and electronic health record extraction (demographics and opioid prescriptions). Logistic regression, adjusting for age and gender, was used to test for differences in health indicators by pain grade. Adjusted odds ratio (AOR) with 95% confidence intervals (CIs) were reported with CIs not including an AOR of 1 indicating that the difference exceeded chance. RESULTS: In this population, the prevalence of chronic pain (pain present most or every day, prior 3 months) was 49.3%: 7.1% with mild chronic pain (mild pain intensity and lower interference with activities); 23.3% bothersome chronic pain (moderate to severe pain intensity with lower interference); and 21.1% high impact chronic pain (higher interference). Results of this study mirrored findings in the non-VA validation study; differences between bothersome and high impact were consistent for activity limitations and present but not fully consistent for psychological variables. Those with bothersome chronic pain or high impact chronic pain were more likely to receive long-term opioid therapy compared to those with no/mild chronic pain. CONCLUSIONS: Findings highlight categorical differences captured with the GCPS-R, and convergent validity supports use of the GCPS-R in US Veterans.
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Dolor Crónico , Veteranos , Humanos , Estados Unidos , Dolor Crónico/diagnóstico , Dolor Crónico/tratamiento farmacológico , Veteranos/psicología , Analgésicos Opioides , Dimensión del Dolor , Encuestas y Cuestionarios , United States Department of Veterans AffairsRESUMEN
BACKGROUND: Multisite chronic pain (MSCP) is associated with increased chronic pain impact, but methods for identifying MSCP for epidemiological research have not been evaluated. OBJECTIVE: We assessed the validity of identifying MSCP using electronic health care data compared with survey questionnaires. METHODS: Stratified random samples of adults served by Kaiser Permanente Northwest and Washington (N = 2,059) were drawn for a survey, oversampling persons with frequent use of health care for pain. MSCP and single-site chronic pain were identified by two methods, with electronic health care data and with self-report of common chronic pain conditions by survey questionnaire. Analyses were weighted to adjust for stratified sampling. RESULTS: MSCP was somewhat less common when ascertained by electronic health records (14.7% weighted prevalence) than by survey questionnaire (25.9% weighted prevalence). Agreement of the two MSCP classifications was low (kappa agreement statistic of 0.21). Ascertainment of MSCP with electronic health records was 30.9% sensitive, 91.0% specific, and had a positive predictive value of 54.5% relative to MSCP identified by self-report as the standard. After adjusting for age and gender, patients with MSCP identified by either electronic health records or self-report showed higher levels of pain-related disability, pain severity, depressive symptoms, and long-term opioid use than persons with single-site chronic pain identified by the same method. CONCLUSIONS: Identification of MSCP with electronic health care data was insufficiently accurate to be used as a surrogate or screener for MSCP identified by self-report, but both methods identified persons with heightened chronic pain impact.
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Dolor Crónico , Trastornos Relacionados con Opioides , Adulto , Dolor Crónico/diagnóstico , Dolor Crónico/epidemiología , Registros Electrónicos de Salud , Humanos , Encuestas y Cuestionarios , Washingtón/epidemiologíaRESUMEN
Wrist actigraphy has been used to assess sleep in older adult populations for nearly half a century. Over the years, the continuous raw activity data derived from actigraphy has been used for the characterization of factors beyond sleep/wake such as physical activity patterns and circadian rhythms. Behavioral activity rhythms (BAR) are useful to describe individual daily behavioral patterns beyond sleep and wake, which represent important and meaningful clinical outcomes. This paper reviews common rhythmometric approaches and summarizes the available data from the use of these different approaches in older adult populations. We further consider a new approach developed in our laboratory designed to provide graphical characterization of BAR for the observed behavioral phenomenon of activity patterns across time. We illustrate the application of this new approach using actigraphy data collected from a well-characterized sample of older adults (age 60+) with osteoarthritis (OA) pain and insomnia. Generalized additive models (GAM) were implemented to fit smoothed nonlinear curves to log-transformed aggregated actigraphy-derived activity measurements. This approach demonstrated an overall strong model fit (R2 = 0.82, SD = 0.09) and was able to provide meaningful outcome measures allowing for graphical and parameterized characterization of the observed activity patterns within this sample.
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Actigrafía/métodos , Ritmo Circadiano/fisiología , Actividades Humanas , Procesamiento de Señales Asistido por Computador , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Sueño/fisiologíaRESUMEN
CONTEXT: To address risks associated with prescription opioid medications, guidelines recommend lower dose, shorter duration of use, and avoidance of concurrent sedatives. Monitoring opioid-prescribing practices is critical for assessing guideline impact, comparing populations, and targeting interventions to reduce risks. OBJECTIVE: To describe development of Washington (WA) State opioid-prescribing metrics, provide purpose and definitions, and apply metrics to prescription data for WA health care organizations. DESIGN: We describe the development and testing of opioid-prescribing metrics by the WA State Bree Collaborative opioid work group. SETTING: Washington State. PARTICIPANTS: Kaiser Permanente of Washington (KPW) Integrated Group Practice, KPW-contracted care providers, and WA Medicaid. MAIN OUTCOME MEASURES: Set of 6 strategic metrics tested across 3 different health systems adopted by WA State in 2017 for uniform tracking of opioid-prescribing guidelines and state policies. These metrics include (1) overall prevalence of any opioid use, (2) chronic use, (3) high-dose chronic use, (4) concurrent chronic sedative use, (5) days' supply of new prescriptions, and (6) transition from acute to chronic use. RESULTS: In the first quarter of 2010, 10% to 12% of KPW and 14% of Medicaid patients received at least 1 opioid prescription. Among opioid users, 22% to 24% of KPW and 36% of Medicaid patients received chronic opioids. Among patients receiving chronic opioids, 16% to 22% of KPW and 32% of Medicaid patients received high doses (≥90 morphine-equivalent dose per day) and 20% to 23% of KPW and 33% of Medicaid patients received concurrent chronic sedatives. Five percent of Medicaid and 2% to 3% of KPW patients receiving new opioid prescriptions transitioned to chronic opioid use. CONCLUSIONS: The metrics are relatively easy to calculate from electronic health care data and yield meaningful comparisons between populations or health plans. These metrics can be used to display trends over time and to evaluate the impact of opioid-prescribing policy interventions.
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Analgésicos Opioides/efectos adversos , Pautas de la Práctica en Medicina/normas , Programas de Monitoreo de Medicamentos Recetados/instrumentación , Analgésicos Opioides/administración & dosificación , Sobredosis de Droga/epidemiología , Humanos , Pautas de la Práctica en Medicina/estadística & datos numéricos , Programas de Monitoreo de Medicamentos Recetados/estadística & datos numéricos , Salud Pública/instrumentación , Salud Pública/estadística & datos numéricos , Washingtón/epidemiologíaRESUMEN
PURPOSE: Six key elements of opioid medication management redesign in primary care have been previously identified. Here, we examine the effect of implementing these Six Building Blocks on opioid-prescribing practices. METHODS: Six rural-serving organizations with 20 clinic locations received support for 15 months during the period October 2015 to May 2017 to implement the Six Building Blocks. Patients undergoing long-term opioid therapy (LtOT) at these study sites were compared with patients undergoing LtOT enrolled in a regional health plan who did not receive care at the study sites but who resided in the same primary care service areas (control group). Outcomes were monthly trend in the proportion of patients undergoing LtOT prescribed a ≥100 morphine equivalent dose (MED) of opioids daily and the total number of patients receiving an opioid prescription. An interrupted time series using difference-indifference analysis was used for tests of significance. RESULTS: The proportion of patients prescribed a ≥100 MED of opioids daily decreased 2.2% (11.8% to 9.6%) among patients at the intervention clinics and 1.3% (14.0% to 12.7%) among patients in the control group. The rate of decrease was significantly greater among study patients than among patients in the control group (P = .018). The rate of decrease in the number of patients on LtOT at intervention clinics increased during the intervention period compared with the preintervention period (P <.001). CONCLUSIONS: Efforts to redesign opioid medication management in primary care resulted in a significant decrease in opioid prescribing. Future research is needed to determine if these results are generalizable to other settings and to assess implications for patient-reported outcomes.
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Analgésicos Opioides/administración & dosificación , Dolor Crónico/tratamiento farmacológico , Pautas de la Práctica en Medicina , Atención Primaria de Salud/organización & administración , Adolescente , Adulto , Estudios de Casos y Controles , Femenino , Humanos , Análisis de Series de Tiempo Interrumpido , Masculino , Persona de Mediana Edad , Trastornos Relacionados con Opioides/prevención & control , Atención Dirigida al Paciente , Mejoramiento de la Calidad , Población Rural/estadística & datos numéricos , Adulto JovenRESUMEN
PURPOSE: The purpose of the study is to determine whether initiatives to improve the safety of opioid prescribing decreased injuries in people using chronic opioid therapy (COT). METHODS: We conducted an interrupted time series analysis using data from Group Health (GH), an integrated health care delivery system in the United States. In 2007, GH implemented initiatives which substantially reduced daily opioid dose and increased patient monitoring. Among GH members age 18 or older receiving COT between 2006 and 2014, we compared injury rates for patients in GH's integrated group practice (IGP; exposed to the initiatives) vs patients cared for by contracted providers (not exposed). Injuries were identified using a validated algorithm. We calculated injury incidence during the baseline (preintervention) period from 2006 to 2007; the dose reduction period, 2008 to 2010; and the risk stratification and monitoring period, 2010 to 2014. Using modified Poisson regression, we estimated adjusted relative risks (RRs) representing the relative change per year in injury rates. RESULTS: Among 21 853 people receiving COT in the IGP and 8260 in contracted care, there were 2679 injuries during follow-up. The baseline injury rate was 1.0% per calendar quarter in the IGP and 0.9% in contracted care. Risk reduction initiatives did not decrease injury rates: Within the IGP, the RR in the dose reduction period was 1.01 (95% CI, 0.95-1.07) and in the risk stratification and monitoring period, 0.99 (95% CI, 0.95-1.04). Injury trends did not differ between the two care settings. CONCLUSIONS: Risk reduction initiatives did not decrease injuries in people using COT.
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Analgésicos Opioides/efectos adversos , Dolor Crónico/tratamiento farmacológico , Traumatismos Craneocerebrales/epidemiología , Prestación Integrada de Atención de Salud/normas , Pautas de la Práctica en Medicina/normas , Adulto , Anciano , Traumatismos Craneocerebrales/etiología , Prestación Integrada de Atención de Salud/organización & administración , Prescripciones de Medicamentos/normas , Prescripciones de Medicamentos/estadística & datos numéricos , Femenino , Estudios de Seguimiento , Implementación de Plan de Salud , Humanos , Incidencia , Análisis de Series de Tiempo Interrumpido , Masculino , Persona de Mediana Edad , Guías de Práctica Clínica como Asunto , Pautas de la Práctica en Medicina/estadística & datos numéricos , Evaluación de Programas y Proyectos de Salud , Estados UnidosRESUMEN
OBJECTIVE: Chronic musculoskeletal pain (CMSP) disorders are among the most prevalent and disabling conditions worldwide. It would be advantageous to have common outcome measures when comparing results across different CMSP research studies. METHODS: The Veterans Health Administration appointed a work group to recommend core outcome measures for assessing pain intensity and interference as well as important secondary domains in clinical research. The work group used three streams of data to inform their recommendations: 1) literature synthesis augmented by three recently completed trials; 2) review and comparison of measures recommended by other expert groups; 3) two Delphi surveys of work group members. RESULTS: The single-item numerical rating scale and seven-item Brief Pain Inventory interference scale emerged as the recommended measures for assessing pain intensity and interference, respectively. The secondary domains ranked most important included physical functioning and depression, followed by sleep, anxiety, and patient-reported global impression of change (PGIC). For these domains, the work group recommended the Patient-Reported Outcome Information System four-item physical function and sleep scales, the Patient Health Questionnaire two-item depression scale, the Generalized Anxiety Disorder two-item anxiety scale, and the single-item PGIC. Finally, a single-item National Health Interview Survey item was favored for defining chronic pain. CONCLUSIONS: Two scales comprising eight items are recommended as core outcome measures for pain intensity and interference in all studies of chronic musculoskeletal pain, and brief scales comprising 13 additional items can be added when possible to assess important secondary domains.
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Dolor Crónico/fisiopatología , Dolor Musculoesquelético/fisiopatología , Evaluación de Resultado en la Atención de Salud , Ansiedad , Investigación Biomédica , Dolor Crónico/psicología , Dolor Crónico/terapia , Técnica Delphi , Depresión , Humanos , Dolor Musculoesquelético/psicología , Dolor Musculoesquelético/terapia , Manejo del Dolor , Dimensión del Dolor , Cuestionario de Salud del Paciente , Medición de Resultados Informados por el Paciente , Rendimiento Físico Funcional , Psicometría , Sueño , Estados Unidos , United States Department of Veterans AffairsRESUMEN
BACKGROUND: Determinants of prescribing psychoactive medications for symptom management in older adults remain underexamined despite known risks and cautions concerning these medications. OBJECTIVE: To examine independent and combined effects of pain, concurrent insomnia and depression symptoms on psychoactive medications supplied to older adults with osteoarthritis (OA). RESEARCH DESIGN: Survey data on pain, insomnia, and depression obtained from OA patients screened for a randomized controlled trial were used to identify predictors of psychoactive medication supply [opioids, sedatives, tricyclic antidepressants (TCAs), and non-TCAs] over a 4-year period. SUBJECTS: Group Health Cooperative patients with a diagnosis of OA (N=2976). MEASURES: Survey data on pain (Graded Chronic Pain Scale), insomnia (Insomnia Severity Index), and depression (Patient Health Questionnaire-8); and medications supply assessed from electronic medical records. RESULTS: In negative binomial models, pain [incidence rate ratio (IRR), 2.8-3.5; P<0.001], insomnia (IRR, 2.0; P<0.001), and depression (IRR, 1.5; P<0.05) each independently predicted opioid supply. Insomnia (IRR, 3.2; P<0.001) and depression (IRR, 3.0; P<0.001) each independently predicted sedative supply. Pain (IRR, 2.1; P<0.05) and insomnia (IRR, 2.0; P<0.05) independently predicted TCA supply, whereas only depression (IRR, 2.2; P<0.001) independently predicted non-TCA supply. Combined effects of pain and insomnia/depression on these medications were additive and increased the rate of medication supply 1.5-7.5 times. Combined effects increased with insomnia or depression severity. CONCLUSIONS: Concurrent insomnia and depressive symptoms predicted increased supply of opioids, sedatives, and antidepressants after accounting for pain, indicating the importance of sleep and mood disorders as factors increasing supply of these medications.
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Dolor Crónico/tratamiento farmacológico , Comorbilidad , Depresión/tratamiento farmacológico , Osteoartritis/terapia , Psicotrópicos/provisión & distribución , Psicotrópicos/uso terapéutico , Trastornos del Inicio y del Mantenimiento del Sueño/tratamiento farmacológico , Anciano , Registros Electrónicos de Salud , Femenino , Humanos , Masculino , Dimensión del Dolor , Estudios Retrospectivos , Encuestas y CuestionariosRESUMEN
Chronic pain, one of the most common reasons adults seek medical care (1), has been linked to restrictions in mobility and daily activities (2,3), dependence on opioids (4), anxiety and depression (2), and poor perceived health or reduced quality of life (2,3). Population-based estimates of chronic pain among U.S. adults range from 11% to 40% (5), with considerable population subgroup variation. As a result, the 2016 National Pain Strategy called for more precise prevalence estimates of chronic pain and high-impact chronic pain (i.e., chronic pain that frequently limits life or work activities) to reliably establish the prevalence of chronic pain and aid in the development and implementation of population-wide pain interventions (5). National estimates of high-impact chronic pain can help differentiate persons with limitations in major life domains, including work, social, recreational, and self-care activities from those who maintain normal life activities despite chronic pain, providing a better understanding of the population in need of pain services. To estimate the prevalence of chronic pain and high-impact chronic pain in the United States, CDC analyzed 2016 National Health Interview Survey (NHIS) data. An estimated 20.4% (50.0 million) of U.S. adults had chronic pain and 8.0% of U.S. adults (19.6 million) had high-impact chronic pain, with higher prevalences of both chronic pain and high-impact chronic pain reported among women, older adults, previously but not currently employed adults, adults living in poverty, adults with public health insurance, and rural residents. These findings could be used to target pain management interventions.
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Dolor Crónico/epidemiología , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Encuestas Epidemiológicas , Humanos , Masculino , Persona de Mediana Edad , Prevalencia , Estados Unidos/epidemiología , Adulto JovenRESUMEN
Objective: We aimed to determine if opioid risk reduction initiatives including dose reduction and risk mitigation strategies for chronic noncancer pain patients receiving chronic opioid therapy (COT) had a differential impact on average daily opioid doses of COT patients at higher risk for opioid-related adverse outcomes compared with lower-risk patients. Design: Interrupted time series. Setting: Group Health Cooperative (GH), a health care delivery system and insurance within Washington State, between 2006 and 2014. Population: GH enrollees on COT defined as receiving a supply of 70 or more days of opioids within 90 days using electronic pharmacy data for filled prescriptions. Methods: We compared the average daily morphine equivalent doses (MED) of COT patients with and without each of the following higher-risk characteristics: mental disorders, substance use disorders, sedative use, and male gender. Results: In all four pairwise comparisons, the higher-risk subgroup had a higher average daily MED than the lower-risk subgroup across the study period. Adjusted for covariates, modest differences in the annual rate of reduction in average daily MED were noted between higher- and lower-risk subgroups in three pairwise comparisons: those with mental disorders vs without (-8.2 mg/y vs -5.2 mg/y, P = 0.005), with sedative use vs without (-9.2 mg/y vs -5.8 mg/y, P = 0.004); mg), in men vs women (-8.8 mg/y vs -5.9 mg/y, P = 0.01). Conclusion: Using clinical policy initiatives in a health care system, dose reductions were achieved among COT patients at higher risk for opioid-related adverse outcomes that were at least as large as those among lower-risk patients.
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Analgésicos Opioides/uso terapéutico , Dolor Crónico/tratamiento farmacológico , Hipnóticos y Sedantes/uso terapéutico , Trastornos Relacionados con Opioides/tratamiento farmacológico , Adulto , Anciano , Anciano de 80 o más Años , Analgésicos Opioides/efectos adversos , Protocolos Clínicos , Femenino , Humanos , Hipnóticos y Sedantes/efectos adversos , Análisis de Series de Tiempo Interrumpido , Masculino , Persona de Mediana Edad , Riesgo , Factores de Riesgo , Resultado del TratamientoRESUMEN
PURPOSE: Although prescription opioids have been associated with higher motor vehicle crash (MVC) risk, it is unknown whether health system initiatives to better manage chronic opioid therapy (COT) can reduce MVC risk at the population level. METHODS: We conducted an interrupted time series population-level cohort study at Group Health (GH), between January 2006 and September 2014, comparing MVC risk among COT patients who were GH members receiving care in either group practice or contracted care settings. Group practice COT risk reduction initiatives were implemented in two phases: (1) altered prescribing expectations and (2) multifaceted initiatives. These initiatives did not exist in the contracted care network. We compared the adjusted quarterly rate of MVC between group practice and contracted care patients over time using a modified Poisson regression model for a binary outcome. RESULTS: A total of 32 691 COT patients (27.4% from contracted care) met eligibility criteria and experienced a total of 1956 MVCs during study follow-up (mean, 8.1 quarters per person), of which 810 were serious injury crashes. Crash rates were not significantly different between the patient groups within any of the time periods. Analyses stratified by concurrent prescription of a sedative hypnotic or benzodiazepine found no significant difference between the group practice and contracted care patients. There was a modest elevation of MVC risk for high-dose patients relative to former COT patients who stopped receiving opioids. CONCLUSIONS: The risk of MVC was not mitigated in a large cohort of COT patients exposed to a health plan policy initiative that substantially lowered mean opioid dose. Copyright © 2016 John Wiley & Sons, Ltd.
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Accidentes de Tránsito/estadística & datos numéricos , Analgésicos Opioides/administración & dosificación , Dolor Crónico/tratamiento farmacológico , Pautas de la Práctica en Medicina/estadística & datos numéricos , Accidentes de Tránsito/prevención & control , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Analgésicos Opioides/efectos adversos , Estudios de Cohortes , Relación Dosis-Respuesta a Droga , Femenino , Estudios de Seguimiento , Humanos , Análisis de Series de Tiempo Interrumpido , Masculino , Persona de Mediana Edad , Distribución de Poisson , Estudios Retrospectivos , Conducta de Reducción del Riesgo , Adulto JovenRESUMEN
OBJECTIVE: To better identify individuals on chronic opioid therapy (COT) at high risk for aberrant-drug related behavior (ADRB). We examine whether patients with low level alcohol and drug use have similar characteristics to those with alcohol and drug disorders. We then examined the relationship of alcohol and drug use to ADRBs among COT patients. METHODS: The sample was 972 randomly selected COT patients (age 21-80 years old) from a large health system in Northern California, USA, and interviewed in 2009. Logistic regression models were used to model the dependent variables of: alcohol use, illicit drug use, alcohol disorders, illicit drug disorders, and ADRBs. RESULTS: The odds of daily/weekly alcohol use were lower for those with a high daily opioid dose (120+ mg/day vs. <20 mg/day) (OR = 0.32, p < 0.010). Illicit drug disorders were associated with depression (OR = 2.31, p < .001) and being on a high daily opioid dose (OR = 5.51, p < .01). Participants with illicit drug use had higher odds of giving (OR = 2.57, p < 0.01) and receiving opioids from friends or family (OR = 3.25, p < 0.001), but disorder diagnoses were not associated with ADRBs. CONCLUSIONS: Findings reinforce that illicit drug use should be of high concern to clinicians prescribing opioids, and suggest it should be considered separately from alcohol use and alcohol disorders in the evaluation of ADRBs. Frequent alcohol use is low, but not uncommon, and suggests a need to discuss specific issues regarding safe use of opioids among persons who use alcohol that may differ from their risk of drug use.
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Consumo de Bebidas Alcohólicas/epidemiología , Analgésicos Opioides/efectos adversos , Consumidores de Drogas/estadística & datos numéricos , Trastornos Relacionados con Sustancias/epidemiología , Adulto , Anciano , Anciano de 80 o más Años , Analgésicos Opioides/uso terapéutico , California/epidemiología , Dolor Crónico/tratamiento farmacológico , Femenino , Humanos , Masculino , Persona de Mediana Edad , Adulto JovenRESUMEN
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.
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Analgésicos Opioides/administración & dosificación , Dolor Crónico/tratamiento farmacológico , Dolor Crónico/epidemiología , Planificación de Atención al Paciente , Anciano , Estudios de Cohortes , Esquema de Medicación , Femenino , Estudios de Seguimiento , Humanos , Entrevistas como Asunto/métodos , Masculino , Persona de Mediana Edad , Factores de Tiempo , Washingtón/epidemiologíaRESUMEN
IMPORTANCE: Survivors of sepsis face long-term sequelae that diminish health-related quality of life and result in increased care needs in the primary care setting, such as medication, physiotherapy, or mental health care. OBJECTIVE: To examine if a primary care-based intervention improves mental health-related quality of life. DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial conducted between February 2011 and December 2014, enrolling 291 patients 18 years or older who survived sepsis (including septic shock), recruited from 9 intensive care units (ICUs) across Germany. INTERVENTIONS: Participants were randomized to usual care (n = 143) or to a 12-month intervention (n = 148). Usual care was provided by their primary care physician (PCP) and included periodic contacts, referrals to specialists, and prescription of medication, other treatment, or both. The intervention additionally included PCP and patient training, case management provided by trained nurses, and clinical decision support for PCPs by consulting physicians. MAIN OUTCOMES AND MEASURES: The primary outcome was change in mental health-related quality of life between ICU discharge and 6 months after ICU discharge using the Mental Component Summary (MCS) of the 36-Item Short-Form Health Survey (SF-36 [range, 0-100; higher ratings indicate lower impairment; minimal clinically important difference, 5 score points]). RESULTS: The mean age of the 291 patients was 61.6 years (SD, 14.4); 66.2% (n = 192) were men, and 84.4% (n = 244) required mechanical ventilation during their ICU stay (median duration of ventilation, 12 days [range, 0-134]). At 6 and 12 months after ICU discharge, 75.3% (n = 219 [112 intervention, 107 control]) and 69.4% (n = 202 [107 intervention, 95 control]), respectively, completed follow-up. Overall mortality was 13.7% at 6 months (40 deaths [21 intervention, 19 control]) and 18.2% at 12 months (53 deaths [27 intervention, 26 control]). Among patients in the intervention group, 104 (70.3%) received the intervention at high levels of integrity. There was no significant difference in change of mean MCS scores (intervention group mean at baseline, 49.1; at 6 months, 52.9; change, 3.79 score points [95% CI, 1.05 to 6.54] vs control group mean at baseline, 49.3; at 6 months, 51.0; change, 1.64 score points [95% CI, -1.22 to 4.51]; mean treatment effect, 2.15 [95% CI, -1.79 to 6.09]; P = .28). CONCLUSIONS AND RELEVANCE: Among survivors of sepsis and septic shock, the use of a primary care-focused team-based intervention, compared with usual care, did not improve mental health-related quality of life 6 months after ICU discharge. Further research is needed to determine if modified approaches to primary care management may be more effective. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN61744782.
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Manejo de Caso , Sistemas de Apoyo a Decisiones Clínicas , Salud Mental , Atención Primaria de Salud/métodos , Calidad de Vida , Sepsis/psicología , Adulto , Anciano , Femenino , Humanos , Unidades de Cuidados Intensivos , Masculino , Persona de Mediana Edad , Alta del Paciente , Médicos de Atención Primaria , Derivación y Consulta , Sepsis/rehabilitación , SobrevivientesRESUMEN
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.
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Toma de Decisiones , Diagnóstico , Pronóstico , Errores Diagnósticos , Humanos , Práctica ProfesionalRESUMEN
OBJECTIVE: Posttraumatic stress disorder (PTSD) is associated with high medical morbidity, but the nature of this association remains unclear. Among responders to the World Trade Center (WTC) disaster, PTSD is highly comorbid with lower respiratory symptoms (LRS), which cannot be explained by exposure alone. We sought to examine this association longitudinally to establish the direction of the effects and evaluate potential pathways to comorbidity. METHODS: 18,896 responders (8466 police and 10,430 nontraditional responders) participating in the WTC-Health Program were first evaluated between 2002 and 2010 and assessed again 2.5 years later. LRS were ascertained by medical staff, abnormal pulmonary function by spirometry, and probable WTC-related PTSD with a symptom inventory. RESULTS: In both groups of responders, initial PTSD (standardized regression coefficient: ß = 0.20 and 0.23) and abnormal pulmonary function (ß = 0.12 and 0.12) predicted LRS 2.5 years later after controlling for initial LRS and covariates. At follow-up, LRS onset was 2.0 times more likely and remission 1.8 times less likely in responders with initial PTSD than in responders without. Moreover, PTSD mediated, in part, the association between WTC exposures and development of LRS (p < .0001). Initial LRS and abnormal pulmonary function did not consistently predict PTSD onset. CONCLUSIONS: These analyses provide further evidence that PTSD is a risk factor for respiratory symptoms and are consistent with evidence implicating physiological dysregulation associated with PTSD in the development of medical conditions. If these effects are verified experimentally, treatment of PTSD may prove helpful in managing physical and mental health of disaster responders.
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Socorristas/estadística & datos numéricos , Trastornos Respiratorios/epidemiología , Trastornos por Estrés Postraumático/epidemiología , Adulto , Comorbilidad , Humanos , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Policia/estadística & datos numéricos , Trastornos Respiratorios/etiología , Riesgo , Ataques Terroristas del 11 de Septiembre , Trastornos por Estrés Postraumático/etiologíaRESUMEN
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.
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Analgésicos Opioides/orina , Trastornos Relacionados con Opioides/diagnóstico , Atención Primaria de Salud/métodos , Detección de Abuso de Sustancias/métodos , Adulto , Anciano , Analgésicos Opioides/administración & dosificación , Dolor Crónico/tratamiento farmacológico , Esquema de Medicación , Monitoreo de Drogas/métodos , Monitoreo de Drogas/estadística & datos numéricos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Guías de Práctica Clínica como Asunto , Atención Primaria de Salud/estadística & datos numéricos , Detección de Abuso de Sustancias/estadística & datos numéricos , Washingtón , Adulto JovenRESUMEN
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.
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Analgésicos Opioides/administración & dosificación , Trastornos Relacionados con Opioides/diagnóstico , Trastornos Relacionados con Opioides/orina , Conducta de Reducción del Riesgo , Detección de Abuso de Sustancias/tendencias , Urinálisis/tendencias , Adulto , Anciano , Analgésicos Opioides/efectos adversos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Detección de Abuso de Sustancias/normas , Urinálisis/normasRESUMEN
OBJECTIVE: Despite rapidly increasing intervention, functional disability due to chronic low back pain (cLBP) has increased in recent decades. We often cannot identify mechanisms to explain the major negative impact cLBP has on patients' lives. Such cLBP is often termed non-specific, and may be due to multiple biologic and behavioral etiologies. Researchers use varied inclusion criteria, definitions, baseline assessments, and outcome measures, which impede comparisons and consensus. DESIGN: Expert panel and preliminary evaluation of key recommendations. METHODS: The NIH Pain Consortium charged a Research Task Force (RTF) to draft standards for research on cLBP. The resulting multidisciplinary panel developed a 3-stage process, each with a 2-day meeting. RESULTS: The panel recommended using 2 questions to define cLBP; classifying cLBP by its impact (defined by pain intensity, pain interference, and physical function); use of a minimal data set to describe research subjects (drawing heavily on the PROMIS methodology); reporting "responder analyses" in addition to mean outcome scores; and suggestions for future research and dissemination. The Pain Consortium has approved the recommendations, which investigators should incorporate into NIH grant proposals. CONCLUSION: The RTF believes these recommendations will advance the field, help to resolve controversies, and facilitate future research addressing the genomic, neurologic, and other mechanistic substrates of chronic low back pain. Greater consistency in reporting should facilitate comparisons among studies and the development of phenotypes. We expect the RTF recommendations will become a dynamic document, and undergo continual improvement. PERSPECTIVE: A task force was convened by the NIH Pain Consortium with the goal of developing research standards for chronic low back pain. The results included recommendations for definitions, a minimum dataset, reporting outcomes, and future research. Greater consistency in reporting should facilitate comparisons among studies and the development of phenotypes.
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Comités Consultivos , Dolor de la Región Lumbar , National Institutes of Health (U.S.) , Proyectos de Investigación/normas , Humanos , Estados UnidosRESUMEN
UNLABELLED: Despite rapidly increasing intervention, functional disability due to chronic low back pain (cLBP) has increased in recent decades. We often cannot identify mechanisms to explain the major negative impact cLBP has on patients' lives. Such cLBP is often termed non-specific and may be due to multiple biologic and behavioral etiologies. Researchers use varied inclusion criteria, definitions, baseline assessments, and outcome measures, which impede comparisons and consensus. Therefore, NIH Pain Consortium charged a Research Task Force (RTF) to draft standards for research on cLBP. The resulting multidisciplinary panel recommended using 2 questions to define cLBP; classifying cLBP by its impact (defined by pain intensity, pain interference, and physical function); use of a minimum dataset to describe research participants (drawing heavily on the PROMIS methodology); reporting "responder analyses" in addition to mean outcome scores; and suggestions for future research and dissemination. The Pain Consortium has approved the recommendations, which investigators should incorporate into NIH grant proposals. The RTF believes that these recommendations will advance the field, help to resolve controversies, and facilitate future research addressing the genomic, neurologic, and other mechanistic substrates of chronic low back pain. We expect that the RTF recommendations will become a dynamic document and undergo continual improvement. PERSPECTIVE: A task force was convened by the NIH Pain Consortium with the goal of developing research standards for chronic low back pain. The results included recommendations for definitions, a minimum dataset, reporting outcomes, and future research. Greater consistency in reporting should facilitate comparisons among studies and the development of phenotypes.