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BACKGROUND: Despite rising hepatitis C virus (HCV) prevalence among pregnant individuals in the United States, HCV testing among exposed infants remains low. Although recent guidelines recommend early RNA testing for HCV-exposed children to help improve testing rates, national studies describing factors associated with HCV testing and type of testing completed are lacking. METHODS: In this retrospective national study, we characterized HCV testing and care among HCV-exposed infants born 2010-2020 captured in the electronic health record-based TriNetX Research Network. We analyzed factors associated with appropriate HCV testing completion (negative or positive HCV RNA testing or negative HCV antibody testing at any age through study end in 2022) and with RNA compared with antibody testing, using univariable and multivariable logistic regression with clustered standard errors by healthcare organization. RESULTS: Of 8,516 HCV-exposed children, 45.8% completed any HCV testing and 42.1% completed appropriate testing (25% of whom had RNA testing only). 182 (5.1% of appropriately tested children) had evidence of HCV infection. Of 104 treatment-eligible children, 14.4% were treated. Black (OR 0.38, 95% CI 0.26-0.55), Asian/Pacific Islander (OR 0.06, 95% CI 0.03-0.11), and Hispanic/Latinx children (OR 0.56, 95% CI 0.36-0.88) had lower odds of appropriate testing compared with White and non-Hispanic/Latinx children, respectively. CONCLUSIONS: Fewer than half of HCV-exposed children in this national sample were tested for HCV, with lower testing odds among Black, Asian/Pacific Islander, and Hispanic/Latinx children. Substantial work to increase testing and treatment and decrease disparities in testing among HCV-exposed children is needed to help reach US HCV elimination goals.
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Importance: Prevalence of chronic hepatitis C virus (HCV) infection among pregnant people is increasing in the US. HCV is transmitted vertically in 7% to 8% of births. Direct-acting antiviral (DAA) therapy was recently approved for children with HCV who are 3 years or older. The clinical and economic impacts of early DAA therapy for young children with HCV, compared with treating at older ages, are unknown. Objective: To develop a state-transition model to project clinical and economic outcomes for children with perinatally acquired HCV to investigate the cost-effectiveness of treating at various ages. Design, Setting, and Participants: The study team modeled the natural history of perinatally acquired HCV to simulate disease progression and costs of a simulated a cohort of 1000 US children with HCV from 3 years old through death. Added data were analyzed January 5, 2021, through July 1, 2022. Interventions: The study compared strategies offering 8 weeks of DAA therapy at 3, 6, 12, or 18 years old, as well as a comparator of never treating HCV. Main Outcomes and Measures: Outcomes of interest include life expectancy from 3 years and average lifetime per-person health care costs. Other clinical outcomes include cases of cirrhosis, decompensated cirrhosis, and hepatocellular carcinoma (HCC). Results: The study team projected that treating HCV at 3 years old was associated with lower mean lifetime per-person health care costs ($148â¯162) than deferring treatment until 6 years old ($164â¯292), 12 years old ($171â¯909), or 18 years old ($195â¯374). Projected life expectancy was longest when treating at 3 years old (78.36 life years [LYs]) and decreased with treatment deferral until 6 years old (76.10 LYs), 12 years old (75.99 LYs), and 18 years old (75.46 LYs). In a cohort of 1000 children with perinatally acquired HCV, treating at 3 years old prevented 89 projected cases of cirrhosis, 27 cases of HCC, and 74 liver-related deaths compared with deferring treatment until 6 years old. In sensitivity analyses, increasing loss to follow-up led to even greater clinical benefits and cost savings with earlier treatment. Conclusions and Relevance: These study results showed that DAA therapy for 3-year-old children was projected to reduce health care costs and increase survival compared with deferral until age 6 years or older. Measures to increase DAA access for young children will be important to realizing these benefits.
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Antivirales , Análisis Costo-Beneficio , Hepatitis C Crónica , Humanos , Antivirales/uso terapéutico , Antivirales/economía , Niño , Preescolar , Femenino , Hepatitis C Crónica/tratamiento farmacológico , Hepatitis C Crónica/economía , Adolescente , Masculino , Transmisión Vertical de Enfermedad Infecciosa/prevención & control , Embarazo , Estados Unidos/epidemiología , Esperanza de VidaRESUMEN
BACKGROUND AND AIMS: International Classification of Diseases (ICD) diagnosis codes are often used in research to identify patients with opioid use disorder (OUD), but their accuracy for this purpose is not fully evaluated. This study describes application of ICD-10 diagnosis codes for opioid use, dependence and abuse from an electronic health record (EHR) data extraction using data from the clinics' OUD patient registries and clinician/staff EHR entries. DESIGN: Cross-sectional observational study. SETTING: Four rural primary care clinics in Washington and Idaho, USA. PARTICIPANTS: 307 patients. MEASUREMENTS: This study used three data sources from each clinic: (1) a limited dataset extracted from the EHR, (2) a clinic-based registry of patients with OUD and (3) the clinician/staff interface of the EHR (e.g. progress notes, problem list). Data source one included records with six commonly applied ICD-10 codes for opioid use, dependence and abuse: F11.10 (opioid abuse, uncomplicated), F11.20 (opioid dependence, uncomplicated), F11.21 (opioid dependence, in remission), F11.23 (opioid dependence with withdrawal), F11.90 (opioid use, unspecified, uncomplicated) and F11.99 (opioid use, unspecified with unspecified opioid-induced disorder). Care coordinators used data sources two and three to categorize each patient identified in data source one: (1) confirmed OUD diagnosis, (2) may have OUD but no confirmed OUD diagnosis, (3) chronic pain with no evidence of OUD and (4) no evidence for OUD or chronic pain. FINDINGS: F11.10, F11.21 and F11.99 were applied most frequently to patients who had clinical diagnoses of OUD (64%, 89% and 79%, respectively). F11.20, F11.23 and F11.90 were applied to patients who had a diagnostic mix of OUD and chronic pain without OUD. The four clinics applied codes inconsistently. CONCLUSIONS: Lack of uniform application of ICD diagnosis codes make it challenging to use diagnosis code data from EHR to identify a research population of persons with opioid use disorder.
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Dolor Crónico , Trastornos Relacionados con Opioides , Humanos , Analgésicos Opioides/uso terapéutico , Clasificación Internacional de Enfermedades , Dolor Crónico/diagnóstico , Dolor Crónico/tratamiento farmacológico , Estudios Transversales , Trastornos Relacionados con Opioides/diagnóstico , Trastornos Relacionados con Opioides/epidemiología , Trastornos Relacionados con Opioides/tratamiento farmacológicoRESUMEN
INTRODUCTION: Opioid overdose deaths are increasing rapidly in the United States. Medications for opioid use disorder (MOUD) are effective and can be delivered in primary care, but uptake has been limited in rural communities. Referral to and coordination with an external telemedicine (TM) vendor by rural primary care clinics for MOUD (TM-MOUD) may increase MOUD access for rural patients, but we know little about perspectives on this model among key stakeholders. As part of a TM-MOUD feasibility study, we explored TM-MOUD acceptability and feasibility among personnel and patients from seven rural primary care clinics and a TM-MOUD vendor. METHODS: We conducted virtual interviews or focus groups with clinic administrators (n = 7 interviews), clinic primary care and behavioral health providers (8 groups, n = 30), other clinic staff (9 groups, n = 37), patients receiving MOUD (n = 16 interviews), TM-MOUD vendor staff (n = 4 interviews), and vendor-affiliated behavioral health and prescribing providers (n = 17 interviews). We asked about experiences with and acceptability of MOUD (primarily buprenorphine) and telemedicine (TM) and a TM-MOUD referral and coordination model. We conducted content analysis to identify themes and participants quantitatively rated acceptability of TM-MOUD elements on a 4-item scale. RESULTS: Perceived benefits of vendor-based TM-MOUD included reduced logistical barriers, more privacy and less stigma, and access to services not available locally (e.g., counseling, pain management). Barriers included lack of internet or poor connectivity in patients' homes, limited communication and trust between TM-MOUD and clinic providers, and questions about the value to the clinic of TM-MOUD referral to external vendor. Acceptability ratings for TM-MOUD were generally high; they were lowest among frontline staff. CONCLUSIONS: Rural primary care clinic personnel, TM-MOUD vendor personnel, and patients generally perceived referral from primary care to a TM-MOUD vendor to hold potential for increasing access to MOUD in rural communities. Increasing TM-MOUD uptake requires buy-in and understanding among staff of the TM-MOUD workflow, TM services offered, requirements for patients, advantages over clinic-based or TM services from clinic providers, and identification of appropriate patients. Poverty, along with patient hesitation to initiate treatment, creates substantial barriers to MOUD treatment generally; insufficient internet availability creates a substantial barrier to TM-MOUD.
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Sobredosis de Opiáceos , Trastornos Relacionados con Opioides , Humanos , Población Rural , Trastornos Relacionados con Opioides/tratamiento farmacológico , Personal Administrativo , Atención Primaria de SaludRESUMEN
PURPOSE: The use of telemedicine (TM) has accelerated in recent years, yet research on the implementation and effectiveness of TM-delivered medication treatment for opioid use disorder (MOUD) has been limited. This study investigated the feasibility of implementing a care coordination model involving MOUD delivered via an external TM provider for the purpose of expanding access to MOUD for patients in rural settings. METHODS: The study tested a care coordination model in 6 rural primary care sites by establishing referral and coordination between the clinic and a TM company for MOUD. The intervention spanned approximately 6 months from July/August 2020 to January 2021, coinciding with the peak of the COVID-19 pandemic. Each clinic tracked patients with OUD in a registry during the intervention period. A pre-/post-intervention design (N = 6) was used to assess the clinic-level outcome as patient-days on MOUD based on patient electronic health records. FINDINGS: All clinics implemented critical components of the intervention, with an overall TM referral rate of 11.7% among patients in the registry. Five of the 6 sites showed an increase in patient-days on MOUD during the intervention period compared to the 6-month period before the intervention (mean increase per 1,000 patients: 132 days, P = .08, Cohen's d = 0.55). The largest increases occurred in clinics that lacked MOUD capacity or had a greater number of patients initiating MOUD during the intervention period. CONCLUSIONS: To expand access to MOUD in rural settings, the care coordination model is most effective when implemented in clinics that have negligible or limited MOUD capacity.
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COVID-19 , Trastornos Relacionados con Opioides , Telemedicina , Humanos , COVID-19/epidemiología , Estudios de Factibilidad , Pandemias , Trastornos Relacionados con Opioides/tratamiento farmacológico , Atención Primaria de SaludRESUMEN
PURPOSE OF REVIEW: In the context of the opioid epidemic, hepatitis C virus (HCV) infection prevalence is increasing among women of reproductive age. Pregnant people with HIV/HCV coinfection may be at increased risk of adverse pregnancy and neonatal outcomes, although research in this key population is lacking. RECENT FINDINGS: Treatment with directly acting antivirals (DAAs) has transformed the clinical care for most patients with HCV. However, pregnant people were excluded from trials of these medications. A recent phase I study has shown promise with excellent safety profile for ledipasvir-sofosbuvir; demonstrating no episodes of perinatal transmission, 100% sustained virologic response, and no safety concerns. Pregnancy represents a time of maximal interaction with the healthcare system and therefore an ideal window of opportunity to cure HCV. Current observational data regarding pregnant people who are co-infected with HCV and HIV suggest poor outcomes such as increased risk of preterm birth; however, there are no prospective and well-controlled studies to fully understand the impact of HIV/HCV coinfection on pregnancy. Phase 1 studies suggest that DAAs are well-tolerated and effective during pregnancy. Only through large, prospective clinical trials will we be able to understand the interaction of HCV and HIV during pregnancy and to evaluate safety and efficacy of DAAs in this key population.
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Coinfección , Infecciones por VIH , Hepatitis C Crónica , Hepatitis C , Nacimiento Prematuro , Embarazo , Humanos , Femenino , Recién Nacido , Hepacivirus , Infecciones por VIH/complicaciones , Infecciones por VIH/tratamiento farmacológico , Hepatitis C Crónica/tratamiento farmacológico , Coinfección/tratamiento farmacológico , Transmisión Vertical de Enfermedad Infecciosa/prevención & control , Nacimiento Prematuro/inducido químicamente , Nacimiento Prematuro/tratamiento farmacológico , Hepatitis C/complicaciones , Hepatitis C/tratamiento farmacológico , Antivirales/uso terapéuticoRESUMEN
Background and Objectives: Patients taking opioids are at risk of developing dependence and possibly abuse. Given the role of the mesolimbic dopamine system in opioid reward, blocking dopamine D2 receptors should limit the abuse liability of opioid analgesics. This pilot study evaluates the analgesic efficacy of oxycodone combined with an atypical antipsychotic (dopamine D2 receptor antagonist). Methods: A randomized, double-blind, within-subjects, controlled trial in healthy volunteers was conducted at UT Health SA Pain Clinic. Fifteen volunteers with previous medical exposure to opioids were enrolled. Risperidone (2 mg) or ziprasidone (80 mg) in combination with oxycodone (5, 10, 15 mg) was administered. Pain intensity using the cold pressor test, Current Opioid Misuse Measure (COMM), Addiction Research Center Inventory (ARCI, opioid subscale), Drug likability with drug effects questionnaire (DEQ) were assessed. Results: Oxycodone produced dose dependent increases in thermal analgesia on the cold pressor test that was significant at 10 and 15 mg (t = 3.087, P = 0.017). The combination did not significantly alter thermal analgesia. There was no significant effect of the combination on the ARCI or the POMS. Discussion and Conclusion: The combination of an atypical antipsychotic with oxycodone does not alter analgesic response or increase the incidence of adverse effects when compared to oxycodone alone. Such information is critical for the development of drug combinations for the treatment of pain and provide the foundation for future studies of abuse potential in drug users. Scientific Significance: This intervention in chronic pain patients is unique because it utilizes FDA approved drugs in combination to reduce abuse liability. The first step, and aim of this study, is to confirm the drug combination does not interfere with analgesic efficacy. The next step is to examine the combination in recreational drug users to assess the potential to block the euphoric effects of oxycodone. Ultimately, if this combination is effective, this approach could be beneficial in management of chronic pain.
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BACKGROUND AND AIM: There is no gold-standard and considerable heterogeneity in outcome measures used to evaluate treatments for opioid use disorder (OUD) along the opioid treatment cascade. The aim of this study was to develop the US National Institute on Drug Abuse (NIDA) National Drug Abuse Treatment Clinical Trials Network (CTN) opioid use disorder core outcomes set (OUD-COS). DESIGN: Four-round, e-Delphi expert panel consensus study and plenary research group discussion and targeted consultation. SETTING: United States. PARTICIPANTS: A panel of 25 members including clinical practitioners, clinical researchers and administrative staff from the CTN, the network's affiliated clinical and community sites and the NIDA Centre for the CTN. MEASUREMENTS: From a pool of 24 candidate items in four domains (biomedical/disease status; behaviors, symptoms and functioning; opioid treatment cascade; and morbidity and mortality), the panel completed an on-line questionnaire to rank items with defined specification on a 9-point scale for importance, with a standard 70% consensus criterion. FINDINGS: After the fourth round of the questionnaire and subsequent discussion, consensus was reached for five outcomes: two patient-reported (global impression of improvement and incident non-fatal overdose); one clinician-reported (illicit/non-medical drug toxicology); and two from administrative records (duration of treatment and fatal opioid poisoning). CONCLUSIONS: An e-Delphi consensus study has produced the US National Institute on Drug Abuse (NIDA) National Drug Abuse Treatment Clinical Trials Network opioid use disorder core outcomes set (version 1) for opioid use disorder treatment efficacy and effectiveness research.
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Analgésicos Opioides , Trastornos Relacionados con Opioides , Consenso , Técnica Delphi , Humanos , Trastornos Relacionados con Opioides/terapia , Evaluación de Resultado en la Atención de Salud , Proyectos de Investigación , Estados UnidosRESUMEN
OBJECTIVES: Sexually transmitted infections (STIs) cause significant morbidity among women with HIV and increase HIV transmission. We estimated the prevalence of four STIs among women with HIV in sub-Saharan Africa (SSA) and compared prevalence among women with and without HIV. DESIGN: Systematic review and meta-analysis. METHODS: We searched for studies published 1 January 1999 to 19 December 2019 reporting prevalence of gonorrhea, chlamydia, trichomoniasis, or Mycoplasma genitalium among women with HIV in SSA. We excluded studies conducted in high-risk groups (e.g. female sex workers). We extracted data on laboratory-confirmed STIs among women with HIV, and when included, among women without HIV. We estimated pooled prevalence for each STI among women with HIV using inverse variance heterogeneity meta-analysis, compared prevalence to women without HIV, and examined the influences of region, clinical setting, and pregnancy status in subgroup analyses. RESULTS: We identified 3756 unique records; 67 studies were included in the meta-analysis. Prevalence of gonorrhea, chlamydia, trichomoniasis, and M. genitalium was 3.5, 4, 15.6, and 10.2%, respectively. Chlamydia prevalence was lower in Eastern (2.8%) than in Southern (12.5%) and West/Central (19.1%) Africa combined. Prevalence of chlamydia and trichomoniasis was higher among pregnant (8.1%, 17.6%) than nonpregnant (1.7%, 12.3%) women. All STIs were more prevalent among women with than without HIV (relative risks ranging 1.54-1.89). CONCLUSION: STIs are common among women with HIV in SSA, and more common among women with than without HIV. Integrated STI and HIV care could substantially impact STI burden among women with HIV, with potential downstream impacts on HIV transmission.
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Infecciones por Chlamydia , Gonorrea , Infecciones por VIH , Trabajadores Sexuales , Enfermedades de Transmisión Sexual , Tricomoniasis , África del Sur del Sahara/epidemiología , Infecciones por Chlamydia/complicaciones , Infecciones por Chlamydia/epidemiología , Femenino , Gonorrea/complicaciones , Gonorrea/epidemiología , Infecciones por VIH/complicaciones , Infecciones por VIH/epidemiología , Humanos , Masculino , Embarazo , Prevalencia , Enfermedades de Transmisión Sexual/epidemiologíaRESUMEN
PURPOSE: To examine characteristics associated with disparities in digital access (i.e., access to high-speed Internet via a computer or smartphone) in American rural and urban households given that digital access has a direct impact on access to telemedicine-based services. METHODS: Using the 2019 American Community Survey, we analyzed the proportions of geographic area, race/ethnicity, and socioeconomic status according to device and high-speed Internet access. Maximum likelihood logit estimators estimated how these factors influenced device and high-speed Internet access. FINDINGS: Of 105,312,959 households, 32.29% were without a desktop or laptop computer with high-speed Internet (WDW), 21.51% were without a smartphone with a data plan for wireless Internet (WSW), and 14.02% were without any digital access (WDA). Nonmetropolitan households were significantly more likely to be WDA than metropolitan households (odds ratio [OR] = 1.87; 95% confidence interval [CI]: 1.83-1.91). Relative to non-Hispanic Whites, non-Hispanic Blacks (OR = 1.60; 95% CI: 1.56-1.64), American Indian or Alaska natives (OR = 2.00; 95% CI: 1.82-2.19), or Hispanics (OR = 1.70; 95% CI: 1.66-1.74) were significantly more likely to be WDA. When compared to households with private health insurance coverage, households WDA were significantly more likely to have no insurance (OR = 2.44; 95% CI: 2.36-2.53) or public insurance coverage (OR = 3.78; 95% CI: 3.70-3.86). Households with any digital access reported higher income and more family members living at home. Using the same predictors, similar findings were reported for households WDW or WSW. CONCLUSIONS: Significant disparities in digital access exist among nonmetropolitan households, racial/ethnic minority households, and lower-income households. The lack of digital access has implications for the accessibility of health care services via telemedicine and thus could exacerbate health disparities.
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Etnicidad , Telemedicina , Accesibilidad a los Servicios de Salud , Disparidades en Atención de Salud , Hispánicos o Latinos , Humanos , Grupos Minoritarios , Estados Unidos , Población BlancaRESUMEN
BACKGROUND: Individuals treated for opioid use disorder (OUD) have high rates of psychiatric disorders potentially diminishing treatment outcomes. We examined long-term treatment experiences and outcomes by type of psychiatric disorder among participants who participated in the Starting Treatment with Agonist Replacement Therapies (START) study and its follow-up study. METHODS: We categorized the 593 participants who completed the Mini-International Neuropsychiatric Interview (MINI) during the START follow-up study into four mutually exclusive groups to indicate current psychiatric diagnosis: 1) bipolar disorder (BPD; n = 51), 2) major depressive disorder (MDD; n = 85), 3) anxiety disorder (AXD; n = 121), and 4) no comorbid mental disorder (NMD; n = 336). We compared participants' baseline characteristics and treatment outcomes. RESULTS: Groups with mental disorders had worse substance use outcomes and poorer psychosocial functioning than the NMD group. Participants with BPD had significantly more self-reported days using opioids (Mean: 8.6 for BPD vs. 3.4 days for NMD, p < 0.01) and heroin (Mean: 6.4 for BPD vs. 2.0 for MDD, 3.1 days for NMD, p < 0.05) in the 30 days prior to the final interview. Compared to patients without mental disorders, patients with MDD spent more time engaged with OUD pharmacotherapy during the â¼16-month period between MINI and final interview (mean: 71.6 % vs. 50.6 %; p < 0.001). CONCLUSIONS: Our results show that treatment outcomes in individuals with OUD vary by psychiatric comorbidity groups, which supports the need for mental health assessment and treatment for psychiatric conditions in the context of pharmacotherapy for patients with OUD.
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Buprenorfina , Trastorno Depresivo Mayor , Trastornos Relacionados con Opioides , Analgésicos Opioides/uso terapéutico , Buprenorfina/uso terapéutico , Combinación Buprenorfina y Naloxona/uso terapéutico , Comorbilidad , Estudios de Seguimiento , Humanos , Metadona/uso terapéutico , Tratamiento de Sustitución de Opiáceos , Trastornos Relacionados con Opioides/complicaciones , Trastornos Relacionados con Opioides/tratamiento farmacológico , Trastornos Relacionados con Opioides/epidemiología , Resultado del TratamientoRESUMEN
Telemedicine (TM) enabled by digital health technologies to provide medical services has been considered a key solution to increasing health care access in rural communities. With the immediate need for remote care due to the COVID-19 pandemic, many health care systems have rapidly incorporated digital technologies to support the delivery of remote care options, including medication treatment for individuals with opioid use disorder (OUD). In responding to the opioid crisis and the COVID-19 pandemic, public health officials and scientific communities strongly support and advocate for greater use of TM-based medication treatment for opioid use disorder (MOUD) to improve access to care and have suggested that broad use of TM during the pandemic should be sustained. Nevertheless, research on the implementation and effectiveness of TM-based MOUD has been limited. To address this knowledge gap, the National Drug Abuse Treatment Clinical Trials Network (CTN) funded (via the NIH HEAL Initiative) a study on Rural Expansion of Medication Treatment for Opioid Use Disorder (Rural MOUD; CTN-0102) to investigate the implementation and effectiveness of adding TM-based MOUD to rural primary care for expanding access to MOUD. In preparation for this large-scale, randomized controlled trial incorporating TM in rural primary care, a feasibility study is being conducted to develop and pilot test implementation procedures. In this commentary, we share some of our experiences, which include several challenges, during the initial two-month period of the feasibility study phase. While these challenges could be due, at least in part, to adjusting to the COVID-19 pandemic and new workflows to accommodate the study, they are notable and could have a substantial impact on the larger, planned pragmatic trial and on TM-based MOUD more broadly. Challenges include low rates of identification of risk for OUD from screening, low rates of referral to TM, digital device and internet access issues, workflow and capacity barriers, and insurance coverage. These challenges also highlight the lack of empirical guidance for best TM practice and quality remote care models. With TM expanding rapidly, understanding implementation and demonstrating what TM approaches are effective are critical for ensuring the best care for persons with OUD.
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COVID-19/epidemiología , Accesibilidad a los Servicios de Salud/organización & administración , Tratamiento de Sustitución de Opiáceos/estadística & datos numéricos , Trastornos Relacionados con Opioides/terapia , Población Rural/estadística & datos numéricos , Telemedicina/organización & administración , Estudios de Factibilidad , HumanosRESUMEN
BACKGROUND: A lack of consensus on the optimal outcome measures to assess the efficacy and effectiveness of interventions for the treatment of opioid use disorder (OUD) has hampered the pooling of research data for evidence synthesis and clinical guidelines. A core outcome set (COS) is a minimum set of outcome measures that are recommended for all studies of a particular condition. The National Drug Abuse Treatment Clinical Trials Network (CTN) Core Outcome Set for OUD (COS-OUD) is a development study to identify core constructs, meaningful outcomes, and their optimal measurement for all efficacy and effectiveness studies of OUD treatment and service delivery. METHODS/DESIGN: Overseen by an expert workgroup, a modified, stepwise, e-Delphi methodology will be used to gain consensus among a panel of clinical practitioners and researchers involved in the treatment of OUD, who are members of the CTN. Sequential rounds of anonymous, online questionnaires will be used to identify, rate the importance of, and refine a core outcome set. A consensus threshold will be achieved if at least 70% of the panel rate the measure as critical for inclusion in the COS-OUD. Where consensus is not reached or there are suggestions for new measures, these will be brought forward to a further round of review prior to a consensus meeting. Products from this study will be communicated via peer-reviewed scientific journals and conferences. DISCUSSION: This initiative will develop a COS for OUD intervention trials, treatment studies, and service delivery and will support the pooling of research and clinical practice data and efforts to develop measurement-based care within the OUD treatment cascade. TRIAL REGISTRATION: http://www.comet-initiative.org/Studies/Details/1579.
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Consenso , Técnica Delphi , National Institute on Drug Abuse (U.S.)/normas , Trastornos Relacionados con Opioides/terapia , Proyectos de Investigación/normas , Adolescente , Adulto , Anciano , Determinación de Punto Final/normas , Femenino , Humanos , Masculino , Persona de Mediana Edad , Trastornos Relacionados con Opioides/diagnóstico , Resultado del Tratamiento , Estados Unidos , Adulto JovenRESUMEN
BACKGROUND: Amid the ongoing U.S. opioid crisis, achieving safe and effective chronic pain management while reducing opioid-related morbidity and mortality is likely to require multi-level efforts across health systems, including the Military Health System (MHS), Department of Veterans Affairs (VA), and civilian sectors. OBJECTIVE: We conducted a series of qualitative panel discussions with national experts to identify core challenges and elicit recommendations toward improving the safety of opioid prescribing in the U.S. DESIGN: We invited national experts to participate in qualitative panel discussions regarding challenges in opioid risk mitigation and how best to support providers in delivery of safe and effective opioid prescribing across MHS, VA, and civilian health systems. PARTICIPANTS: Eighteen experts representing primary care, emergency medicine, psychology, pharmacy, and public health/policy participated. APPROACH: Six qualitative panel discussions were conducted via teleconference with experts. Transcripts were coded using team-based qualitative content analysis to identify key challenges and recommendations in opioid risk mitigation. KEY RESULTS: Panelists provided insight into challenges across multiple levels of the U.S. health system, including the technical complexity of treating chronic pain, the fraught national climate around opioids, the need to integrate surveillance data across a fragmented U.S. health system, a lack of access to non-pharmacological options for chronic pain care, and difficulties in provider and patient communication. Participating experts identified recommendations for multi-level change efforts spanning policy, research, education, and the organization of healthcare delivery. CONCLUSIONS: Reducing opioid risk while ensuring safe and effective pain management, according to participating experts, is likely to require multi-level efforts spanning military, veteran, and civilian health systems. Efforts to implement risk mitigation strategies at the patient level should be accompanied by efforts to increase education for patients and providers, increase access to non-pharmacological pain care, and support use of existing clinical decision support, including state-level prescription drug monitoring programs.
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Analgésicos Opioides/efectos adversos , Dolor Crónico/terapia , Manejo del Dolor/métodos , Pautas de la Práctica en Medicina/organización & administración , Programas de Monitoreo de Medicamentos Recetados/organización & administración , Analgésicos Opioides/normas , Sistemas de Apoyo a Decisiones Clínicas/organización & administración , Prescripciones de Medicamentos/normas , Femenino , Humanos , Colaboración Intersectorial , Masculino , Servicios de Salud Militares/normas , Epidemia de Opioides , Educación del Paciente como Asunto/organización & administración , Pautas de la Práctica en Medicina/normas , Mal Uso de Medicamentos de Venta con Receta/prevención & control , Programas de Monitoreo de Medicamentos Recetados/normas , Atención Primaria de Salud/organización & administración , Atención Primaria de Salud/normas , Investigación Cualitativa , Estados Unidos/epidemiología , United States Department of Veterans Affairs/organización & administración , United States Department of Veterans Affairs/normasRESUMEN
We provide a brief description of the development of the Trauma and Suicide Potential Index-5 (TSPI-5) and report on the psychometric properties of scores from the new instrument. The TSPI-5 is designed to assess an individual's desire to attempt suicide due to experiencing a trauma. We examined the structure of the instrument in two independent undergraduate samples. Study 1 (N = 415) examined the structure of the TSPI-5 using exploratory structural equation modeling. Study 2 (N = 538) reexamined the instrument structure using the same modeling strategy and also examined other validity estimates. Study 1 demonstrated an adequate fit to the sample data (χ2 [1, N = 415] = 215.99, p < .001, comparative fit index (CFI ) = .969, Tucker-Lewis non-normed fit index (TLI) = .939, root mean squared error of approximation (RMSEA) = .319 [90% confidence interval (CI) = .283, .356], p < .001) and suggested evidence for unidimensionality. Study 2 confirmed the unidimensionality of the TSPI-5 as shown by acceptable fit estimates to the sample data, χ2 (5, N = 538) = 80.45, p < .001, CFI = .996, TLI = .99, RMSEA = .17 (90% CI = .140, .200), p < .001. Scale reliability estimates for the TSPI-5 were good in Study 1 (omega = .94) and Study 2 (omega = .96). The TSPI-5 is a brief unidimensional instrument and its scores demonstrated good reliability and validity for assessing suicide-related behaviors due to experiencing a trauma in undergraduate samples.
Asunto(s)
Trauma Psicológico , Psicometría , Ideación Suicida , Prevención del Suicidio , Suicidio , Evaluación de Síntomas/métodos , Síntomas Conductuales/diagnóstico , Femenino , Humanos , Esperanza de Vida , Masculino , Trauma Psicológico/diagnóstico , Trauma Psicológico/psicología , Psicometría/métodos , Psicometría/normas , Reproducibilidad de los Resultados , Proyectos de Investigación , Estudiantes/psicología , Estudiantes/estadística & datos numéricos , Suicidio/psicología , Adulto JovenRESUMEN
BACKGROUND: We explored pain, psychological flexibility, and continued substance use among 100 adults treated with methadone for opioid use disorder (OUD). All participants had co-occurring chronic pain. METHODS: Participants recruited from a community treatment center between 2009 and 2010 completed an interviewer-facilitated assessment. Chronic pain severity and interference, psychological flexibility (mindfulness, acceptance, values success), past 30-day substance use, and demographics were reported. We modeled a zero-inflated negative binomial regression to examine 1) the probability that an individual does not use illicit substances and 2) illicit substance use frequency among those expected to use. Pain severity and mindfulness were included as predictors in the logit (zero inflated) model. Pain interference, acceptance, and values success were included as predictors in the negative binomial (count) model. We controlled for age and gender in both models. RESULTS: Participants were predominantly (84%) Hispanic, and 64% used an illicit substance least once in the past 30 days. Greater degree of mindfulness significantly predicted the probability that an individual does not continue to use illicit substances (OR = 1.59, p < 0.05). Lower degree of values success significantly predicted greater illicit substance use frequency among those likely to use (IRR = 0.72, p < 0.01). No other variables were associated with continued substance use. CONCLUSIONS: Findings suggest psychological flexibility is associated with continued substance use in this predominantly Hispanic sample of adults treated for OUD with co-occurring chronic pain. Study findings may have implications for how to address the treatment needs of this complex population.
Asunto(s)
Adaptación Psicológica/efectos de los fármacos , Dolor Crónico/tratamiento farmacológico , Metadona/uso terapéutico , Tratamiento de Sustitución de Opiáceos/psicología , Trastornos Relacionados con Opioides/tratamiento farmacológico , Trastornos Relacionados con Opioides/psicología , Adolescente , Adulto , Analgésicos Opioides/uso terapéutico , Dolor Crónico/complicaciones , Estudios Transversales , Femenino , Hispánicos o Latinos , Humanos , Drogas Ilícitas , Masculino , Persona de Mediana Edad , Modelos Psicológicos , Trastornos Relacionados con Opioides/complicaciones , Adulto JovenRESUMEN
OBJECTIVE: To understand the barriers that serodiscordant couples with human immunodeficiency virus (HIV) face in accessing services for risk reduction and infertility using assisted reproductive technology (ART). DESIGN: Two-arm cross-sectional telephone "secret shopper" study. SETTING: Infertility clinics designated by the Society for Assisted Reproductive Technology (SART), 140 from 15 American states with the highest prevalence of heterosexual HIV-infected men. PATIENT(S): Clinical and nonclinical staff at SART-registered clinics. INTERVENTION(S): Standardized telephone calls to SART-registered clinics by investigators in the roles of physician and patient callers. MAIN OUTCOME MEASURE(S): Availability and difference in services offered to callers and the rate of referral if the clinic did not provide these services. RESULT(S): Of the 140 sampled SART clinics across 15 states, callers in both patient and physician roles spoke to a staff member at greater than 90% of targeted clinics (127 clinics total). Of the physician callers 63% were told that the clinic could offer services, as compared to 40% of patient callers. Of the 55 clinics that were unable to provide services to the patient caller, 51% referred to other clinics with confidence that they could offer these services; 67% of clinics would provide services for both prevention and infertility purposes. CONCLUSION(S): Risk reduction services for HIV were more available at the sampled fertility clinics than previously reported in the literature. However, the responses depended on the person calling. The clinics demonstrated low rates of concordance with the American Society for Reproductive Medicine's guidelines, which endorse referral of patients to other facilities from sites unable to offer services.