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Leading professional health bodies have called for the wider adoption of Patient Reported Outcome Measures, such as quality of life, in research and clinical practice as a means for understanding why the global burden of depression continues to climb despite increased rates of treatment use. Here, we examined whether anhedonia-an often recalcitrant and impairing symptom of depression-along with its neural correlates, was associated with longitudinal changes in patient-reported quality of life among individuals seeking treatment for mood disorders. We recruited 112 participants, including n = 80 individuals with mood disorders (58 unipolar, 22 bipolar) and n = 32 healthy controls (63.4% female). We assessed anhedonia severity along with two electroencephalographic markers of neural reward responsiveness (scalp-level 'Reward Positivity' amplitude and source-localized reward-related activation in the dorsal anterior cingulate cortex), and assessed quality of life at baseline, 3- and 6-month follow-up. Anhedonia emerged as a robust correlate of quality of life cross-sectionally and longitudinally among individuals with mood disorders. Furthermore, increased neural reward responsiveness at baseline was associated with greater improvements in quality of life over time, and this improvement was mediated by longitudinal improvements in anhedonia severity. Finally, differences in quality of life observed between individuals with unipolar and bipolar mood disorders were mediated by differences in anhedonia severity. Our findings indicate that anhedonia and its reward-related neural correlates are linked to variability in quality of life over time in individuals with mood disorders. Treatments capable of improving anhedonia and normalizing brain reward function may be necessary for improving broader health outcomes for individuals seeking treatment for depression.ClinicalTrials.gov identifier: NCT01976975.
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In many psychometric applications, the relationship between the mean of an outcome and a quantitative covariate is too complex to be described by simple parametric functions; instead, flexible nonlinear relationships can be incorporated using penalized splines. Penalized splines can be conveniently represented as a linear mixed effects model (LMM), where the coefficients of the spline basis functions are random effects. The LMM representation of penalized splines makes the extension to multivariate outcomes relatively straightforward. In the LMM, no effect of the quantitative covariate on the outcome corresponds to the null hypothesis that a fixed effect and a variance component are both zero. Under the null, the usual asymptotic chi-square distribution of the likelihood ratio test for the variance component does not hold. Therefore, we propose three permutation tests for the likelihood ratio test statistic: one based on permuting the quantitative covariate, the other two based on permuting residuals. We compare via simulation the Type I error rate and power of the three permutation tests obtained from joint models for multiple outcomes, as well as a commonly used parametric test. The tests are illustrated using data from a stimulant use disorder psychosocial clinical trial.
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Modelos Lineales , Simulación por Computador , Funciones de Verosimilitud , Distribución de Chi-CuadradoRESUMEN
There is a great need for statistical methods for analyzing skewed responses in complex sample surveys. Quantile regression is a logical option in addressing this problem but is often accompanied by incorrect variance estimation. We show how the variance can be estimated correctly by including the survey design in the variance estimation process. In a simulation study, we illustrate that the variance of the median regression estimator has a very small relative bias with appropriate coverage probability. The motivation for our work stems from the National Health and Nutrition Examination Survey where we demonstrate the impact of our results on iodine deficiency in females compared with males adjusting for other covariates.
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Yodo , Sesgo , Simulación por Computador , Femenino , Humanos , Masculino , Encuestas Nutricionales , Encuestas y CuestionariosRESUMEN
BACKGROUND: Causal mediation analysis addresses mechanistic questions by decomposing and quantifying effects operating through different pathways. Because most individual studies are underpowered to detect mediating effects, we outlined a parametric approach to meta-analyzing causal mediation and interaction analyses with multiple mediators, compared it with a bootstrap-based alternative, and discussed its limitations. METHODS: We employed fixed- and random-effects multivariate meta-analyses to integrate evidence on treatment-mediators and mediators-outcome associations across trials. We estimated path-specific effects as functions of meta-analyzed regression coefficients; we obtained standard errors using the delta method. We evaluated the performance of this approach in simulations and applied it to assess the mediating roles of positive symptoms of schizophrenia and weight gain in the treatment effect of paliperidone ER on negative symptoms across four efficacy trials. RESULTS: Both simulations and the application showed that the meta-analytic approaches increased statistical power. In the application, we observed substantial mediating effects of positive symptoms (proportions mediated from fixed-effects meta-analysis: (Equation is included in full-text article.)). Weight gain may have beneficial mediating effects; however, such benefit may disappear at high doses when metabolic side effects were excessive. CONCLUSIONS: Meta-analyzing causal mediation analysis combines evidence from multiple sources and improves power. Targeting positive symptoms may be an effective way to reduce negative symptoms that are challenging to treat. Future work should focus on extending the existing methods to allow for more flexible modeling of mediation.
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Esquizofrenia , Interpretación Estadística de Datos , Humanos , Análisis Multivariante , Esquizofrenia/tratamiento farmacológico , Aumento de PesoRESUMEN
We conducted a novel pilot randomized controlled trial of the Treatment Ambassador Program (TAP), an 8-session, peer-based, behavioral intervention for people with HIV (PWH) in South Africa not on antiretroviral therapy (ART). PWH (43 intervention, 41 controls) completed baseline, 3- and 6-month assessments. TAP was highly feasible (90% completion), with peer counselors demonstrating good intervention fidelity. Post-intervention interviews showed high acceptability of TAP and counselors, who supported autonomy, assisted with clinical navigation, and provided psychosocial support. Intention-to-treat analyses indicated increased ART initiation by 3 months in the intervention vs. control arm (12.2% [5/41] vs. 2.3% [1/43], Fisher exact p-value = 0.105; Cohen's h = 0.41). Among those previously on ART (off for > 6 months), 33.3% initiated ART by 3 months in the intervention vs. 14.3% in the control arm (Cohen's h = 0.45). Results suggest that TAP was highly acceptable and feasible among PWH not on ART.
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Fármacos Anti-VIH , Infecciones por VIH , Fármacos Anti-VIH/uso terapéutico , Infecciones por VIH/tratamiento farmacológico , Humanos , Grupo Paritario , Sudáfrica , Factores de TiempoRESUMEN
BACKGROUND: Nearly 800,000 suicides occur worldwide annually and suicide rates are increasing faster than population growth. Unfortunately, the pathophysiology of suicide remains poorly understood, which has hindered suicide prevention efforts. However, mechanistic clues may be found by studying effects of seasonality on suicide and other mortality causes. Suicides tend to peak in spring-summer periods and nadir in fall-winter periods while circulatory system disease-related mortality tends to exhibit the opposite temporal trends. This study aimed to determine for the first time whether monthly temporal cross-correlations exist between suicide and circulatory system disease-related mortality at the population level. If so and if common biological factors moderate risks for both mortality types, such factors may be discoverable and utilized to improve suicide prevention. METHODS: We conducted time series analyses of monthly mortality data from northern (England and Wales, South Korea, United States) and southern (Australia, Brazil) hemisphere countries during the period 2009-2018 (N = 41.8 million all-cause mortality cases). We used a Poisson regression variant of the standard cosinor model to determine peak months of mortality. We also estimated cross-correlations between monthly mortality counts from suicide and from circulatory system diseases. RESULTS: Suicide and circulatory disease-related mortality temporal patterns were negatively correlated in Australia (- 0.32), Brazil (- 0.57), South Korea (- 0.32), and in the United States (- 0.66), but no temporal correlation was discernable in England and Wales. CONCLUSIONS: The negative temporal cross-correlations between these mortality types we found in 4 of 5 countries studied suggest that seasonal factors broadly and inversely moderate risks for circulatory disease-related mortality and suicide, but not in all regions, indicating that the effect is not uniform. Since the seasonal factors of temperature and light exert opposite effects on suicide and circulatory disease-related mortality in several countries, we propose that physiologically-adaptive circulatory system responses to heat and light may increase risk for suicide and should be studied to determine whether they affect suicide risk. For example, heat and light increase production and release of the bioactive gas nitric oxide and reduce circulatory system disease by relaxing blood vessel tone, while elevated nitric oxide levels are associated with suicidal behavior, inverse effects that parallel the inverse temporal mortality patterns we detected.
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Suicidio , Australia , Brasil , Inglaterra , Humanos , República de Corea/epidemiología , Estaciones del Año , Estados Unidos/epidemiología , GalesRESUMEN
Borderline personality disorder (BPD) is a serious psychiatric illness, and it is often associated with dissociative symptoms. The purpose of this study was to assess the course of depersonalization and derealization symptoms in recovered and non-recovered borderline patients over 20 years of prospective follow-up. The Dysphoric Affect Scale (DAS) - a 50-item self-report measure was administered to 290 borderline inpatients at baseline, and the remaining participants (85%) at 10 follow-up interviews conducted over 20 years. The level of depersonalization and derealization experienced by borderline patients was assessed using three items (feeling unreal, feeling completely numb, and feeling like people and things aren't real) from the DAS. The patients who recovered from BPD reported significantly lower scores in all three inner states (62 - 63%) at baseline compared to those patients who did not recover. Furthermore, scores of recovered and non-recovered groups decreased significantly in all three inner states studied over 20 years of prospective follow-up. Overall, these results suggest that the severity of depersonalization and derealization symptoms decreased significantly over 20 years of prospective follow-up and had a strong association with BPD recovery status.
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Trastorno de Personalidad Limítrofe/psicología , Despersonalización/psicología , Adolescente , Adulto , Femenino , Estudios de Seguimiento , Humanos , Estudios Longitudinales , Masculino , Estudios Prospectivos , Escalas de Valoración Psiquiátrica , Índice de Severidad de la EnfermedadRESUMEN
OBJECTIVE: We examined whether eating disorder (ED) outcome trajectories during residential treatment differed for patients screening positive for comorbid borderline personality disorder (BPD) and/or substance use disorders (SUDs) than those who do not. METHOD: We examined data from patients in a residential ED treatment program. Patients completed validated self-report surveys to screen for SUDs and BPD on admission, and the ED Examination-Questionnaire (EDE-Q) on admission and every 2 weeks until discharge (N = 479 females). RESULTS: Fifty-four percent screened positive for at least one co-occurring condition. At admission, patients screening positive for SUD and/or BPD had significantly greater eating pathology than patients screening negative for both (t[477] = 8.23, p < .001). Patients screening positive for SUD (independent of BPD screening status) had a significantly faster rate of symptom improvement during the initial 4 weeks than patients screening positive for BPD only and those with no comorbidities. DISCUSSION: Screening positive for SUD and/or BPD was common in residential ED treatment, and associated with more severe ED symptoms. Screening positive for SUD was associated with faster ED symptom improvement than screening positive for BPD. These findings suggest that intensive ED treatment, even in the absence of intensive SUD treatment, may enhance patient outcomes for those with SUDs.
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Trastorno de Personalidad Limítrofe/complicaciones , Trastornos de Alimentación y de la Ingestión de Alimentos/complicaciones , Trastornos Relacionados con Sustancias/complicaciones , Adolescente , Trastorno de Personalidad Limítrofe/epidemiología , Comorbilidad , Femenino , Humanos , Masculino , Tamizaje Masivo , Tratamiento Domiciliario , Trastornos Relacionados con Sustancias/epidemiología , Encuestas y Cuestionarios , Resultado del TratamientoRESUMEN
BACKGROUND: Treatment of ovarian cancer often requires extensive surgical resection. The transversus abdominis plane (TAP) block has been utilized in benign gynecologic surgery to decrease post-operative pain and opioid use. We hypothesized that TAP blocks would decrease total opioid use in the first 24 hours and decrease length of stay following staging and cytoreductive surgery for ovarian cancer compared with either no local anesthetic or local wound infiltration alone. METHODS: All patients undergoing surgery for ovarian cancer from November 2016 to June 2017 were included in this retrospective cohort study. Median opioid use at 24, 48, and 72 hours post-operatively, as well as length of stay, were assessed. Multivariate median regression analysis was performed to adjust for potential confounders: post-operative non-steroidal anti-inflammatory drug (NSAID) usage, pre-operative opioid consumption, and extent of cytoreductive surgery. Length of stay was compared using Cox regression analysis. RESULTS: One-hundred-and-twenty patients were included in the analysis. Eighty-two patients had a TAP block, while 38 did not. After adjusting for potential confounders there was no difference in median 24 hours opioid consumption (p=0.29) or length of stay (HR 0.95, p=0.78) between patients receiving TAP block compared with those without. After adjusting for potential confounders, patients receiving scheduled NSAIDs had a 2.6-fold greater likelihood of being discharged (p<0.0005) and a significant reduction in median opioid use at 24 hours (23.5 vs 14.5 mg) (p=0.017) compared with those patients without NSAIDs. DISCUSSION: Post-operative administration of NSAIDs, but not TAP block, was associated with a decrease in post-operative opioid use and length of stay following surgery for ovarian cancer. Further investigation into alternative regional anesthetics for Enhanced Recovery after Surgery (ERAS) protocols is warranted.
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Analgésicos Opioides/administración & dosificación , Antiinflamatorios no Esteroideos/administración & dosificación , Bloqueo Nervioso/métodos , Neoplasias Ováricas/cirugía , Dolor Postoperatorio/prevención & control , Músculos Abdominales/inervación , Estudios de Cohortes , Procedimientos Quirúrgicos de Citorreducción/métodos , Recuperación Mejorada Después de la Cirugía , Femenino , Humanos , Persona de Mediana Edad , Dolor Postoperatorio/tratamiento farmacológico , Estudios RetrospectivosRESUMEN
OBJECTIVE: Electroconvulsive therapy (ECT) is a highly efficacious, well-tolerated treatment in adults. Little is known, however, about its effectiveness in adolescents and young adults. Our objectives were to assess clinical outcomes after acute phase ECT in adolescents and young adults and determine whether screening positive or negative for a substance use disorder (SUD) is associated with differences in treatment outcomes. METHODS: Study sample consisted of all patients 16 to 25 years old who received ECT from May 2011 to August 2016 and who completed self-reported SUD screens and the Behavior and Symptom Identification Scale-24 (BASIS-24) initially and completed the BASIS-24 again after the fifth ECT treatment. For 5 BASIS-24 domains, longitudinal changes in mean domain scores were assessed; mean changes by SUD screening status were also examined using linear mixed models. RESULTS: One hundred ninety adolescents and young adults, with mean age 21.0 ± 2.6 years, met inclusion criteria. Electroconvulsive therapy was associated with significant clinical improvement (score decreases) in all 5 BASIS-24 domains during the acute phase treatment (P < 0.001). Sixty-four percent (122/190) screened positive for SUD. Compared with adolescents and young adults screening negative for SUD, those screening positive for co-occurring SUD had greater improvement in depression/functioning (-0.37 ± 0.14, P = 0.009), interpersonal relationships (-0.27 ± 0.13, P = 0.045), and emotional lability (-0.27 ± 0.14, P = 0.044) domains after the fifth ECT treatment. CONCLUSIONS: Electroconvulsive therapy in adolescents and young adults was associated with significantly improved clinical outcomes during acute phase treatment. Adolescents and young adults screening positive for SUD had better acute phase ECT outcomes in self-reported depression/functioning, interpersonal relationships, and emotional lability than those screening negative. More research is needed to clarify adolescents and young adult patient characteristics that may be associated with differential ECT outcomes.
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Terapia Electroconvulsiva/métodos , Resultado del Tratamiento , Adolescente , Síntomas Afectivos/psicología , Síntomas Afectivos/terapia , Depresión/psicología , Depresión/terapia , Femenino , Humanos , Relaciones Interpersonales , Masculino , Trastornos Mentales/psicología , Trastornos Mentales/terapia , Pruebas Neuropsicológicas , Trastornos Psicóticos/psicología , Trastornos Psicóticos/terapia , Autoinforme , Trastornos Relacionados con Sustancias/complicaciones , Trastornos Relacionados con Sustancias/psicología , Adulto JovenRESUMEN
This study assessed longitudinal associations between bullying and intimate partner violence (IPV) among adolescents and young adults in a U.S.-based cohort study. Participants (N = 5,279) reported past-year bullying when they were 14-20 years old and reported lifetime experiences of IPV when they were 20-27 years old. The results indicate that participants reporting being bullied more than twice were at elevated risk of IPV victimization compared to participants reporting no bullying victimization, adjusting for bullying perpetration and covariates. Participants reporting bullying others once or more were at elevated risk of IPV perpetration compared to participants reporting no bullying perpetration, adjusting for bullying victimization and covariates. There was no evidence that the associations differed by gender. Results suggest that adolescents carry forward behaviors from their peer relationships to their dating relationships. Findings may have implications for school-based programs, which should explicitly integrate IPV prevention into bullying prevention efforts.
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Conducta del Adolescente , Acoso Escolar/psicología , Víctimas de Crimen , Violencia de Pareja , Adolescente , Acoso Escolar/prevención & control , Estudios de Cohortes , Femenino , Humanos , Relaciones Interpersonales , Masculino , Adulto JovenRESUMEN
OBJECTIVES: We compared the IQ and academic achievement of the young adult offspring of parents malnourished in infancy and those of a healthy control group in order to test the hypothesis that the offspring of previously malnourished individuals would show IQ and academic deficits that could be related to reduced parental socioeconomic status. METHODS: We conducted a group comparison study based on a community sample in Barbados (Barbados Nutrition Study). Participants were adult children ≥16 years of age whose parents had been malnourished during the first year of life (n = 64; Mean age 19.3 years; 42% male) or whose parents were healthy community controls (n = 50; Mean age 19.7 years; 48% male). The primary outcome was estimated IQ (Wechsler Abbreviated Scale of Intelligence); a secondary outcome was academic achievement (Wide Range Achievement Test - Third Edition). Data were analyzed using PROC MIXED with and without adjusting for parental socioeconomic status (Hollingshead Index of Social Position). RESULTS: IQ was reduced in the offspring of previously malnourished parents relative to the offspring of controls (9.8 point deficit; P < 0.01), but this difference was not explained by parental socioeconomic status or parental IQ. The magnitude of the group difference was smaller for basic academic skills and did not meet criteria for statistical significance. DISCUSSION: The deleterious impact of infant malnutrition on cognitive function may be transmitted to the next generation; however, this intergenerational effect does not appear to be explained by the reduced socioeconomic status or IQ of the parent generation.
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Hijos Adultos , Trastornos del Conocimiento/etiología , Salud de la Familia , Fenómenos Fisiológicos Nutricionales del Lactante , Desnutrición/fisiopatología , Estado Nutricional , Padres , Adolescente , Adulto , Hijos Adultos/etnología , Barbados , Trastornos del Conocimiento/etnología , Estudios de Cohortes , Países en Desarrollo , Escolaridad , Salud de la Familia/etnología , Femenino , Estudios de Seguimiento , Humanos , Lactante , Fenómenos Fisiológicos Nutricionales del Lactante/etnología , Pruebas de Inteligencia , Masculino , Desnutrición/etnología , Estado Nutricional/etnología , Índice de Severidad de la Enfermedad , Adulto JovenRESUMEN
BACKGROUND: South Africa has undergone multiple expansions in antiretroviral therapy (ART) eligibility from an initial CD4+ threshold of ≤200 cells/µl to providing ART for all people living with HIV (PLWH) as of September 2016. We evaluated the association of programmatic changes in ART eligibility with loss from care, both prior to ART initiation and within the first 16 weeks of starting treatment, during a period of programmatic expansion to ART treatment at CD4+ ≤ 350 cells/µl. METHODS AND FINDINGS: We performed a retrospective cohort study of 4,025 treatment-eligible, non-pregnant PLWH accessing care in a community health center in Gugulethu Township affiliated with the Desmond Tutu HIV Centre in Cape Town. The median age of participants was 34 years (IQR 28-41 years), almost 62% were female, and the median CD4+ count was 173 cells/µl (IQR 92-254 cells/µl). Participants were stratified into 2 cohorts: an early cohort, enrolled into care at the health center from 1 January 2009 to 31 August 2011, when guidelines mandated that ART initiation required CD4+ ≤ 200 cells/µl, pregnancy, advanced clinical symptoms (World Health Organization [WHO] stage 4), or comorbidity (active tuberculosis); and a later cohort, enrolled into care from 1 September 2011 to 31 December 2013, when the treatment threshold had been expanded to CD4+ ≤ 350 cells/µl. Demographic and clinical factors were compared before and after the policy change using chi-squared tests to identify potentially confounding covariates, and logistic regression models were used to estimate the risk of pre-treatment (pre-ART) loss from care and early loss within the first 16 weeks on treatment, adjusting for age, baseline CD4+, and WHO stage. Compared with participants in the later cohort, participants in the earlier cohort had significantly more advanced disease: median CD4+ 146 cells/µl versus 214 cells/µl (p < 0.001), 61.1% WHO stage 3/4 disease versus 42.8% (p < 0.001), and pre-ART mortality of 34.2% versus 16.7% (p < 0.001). In total, 385 ART-eligible PLWH (9.6%) failed to initiate ART, of whom 25.7% died before ever starting treatment. Of the 3,640 people who started treatment, 58 (1.6%) died within the first 16 weeks in care, and an additional 644 (17.7%) were lost from care within 16 weeks of starting ART. PLWH who did start treatment in the later cohort were significantly more likely to discontinue care in <16 weeks (19.8% versus 15.8%, p = 0.002). After controlling for baseline CD4+, WHO stage, and age, this effect remained significant (adjusted odds ratio [aOR] = 1.30, 95% CI 1.09-1.55). As such, it remains unclear if early attrition from care was due to a "healthy cohort" effect or to overcrowding as programs expanded to accommodate the broader guidelines for treatment. Our findings were limited by a lack of generalizability (given that these data were from a single high-volume site where testing and treatment were available) and an inability to formally investigate the effect of crowding on the main outcome. CONCLUSIONS: Over one-quarter of this ART-eligible cohort did not achieve the long-term benefits of treatment due to early mortality, ART non-initiation, or early ART discontinuation. Those who started treatment in the later cohort appeared to be more likely to discontinue care early, and this outcome appeared to be independent of CD4+ count or WHO stage. Future interventions should focus on those most at risk for early loss from care as programs continue to expand in South Africa.
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Antirretrovirales/uso terapéutico , Terapia Antirretroviral Altamente Activa/mortalidad , Infecciones por VIH/tratamiento farmacológico , Infecciones por VIH/mortalidad , Atención al Paciente/mortalidad , Guías de Práctica Clínica como Asunto , Adulto , Terapia Antirretroviral Altamente Activa/tendencias , Estudios de Cohortes , Centros Comunitarios de Salud/tendencias , Femenino , VIH-1/efectos de los fármacos , Humanos , Masculino , Atención al Paciente/normas , Atención al Paciente/tendencias , Guías de Práctica Clínica como Asunto/normas , Estudios Retrospectivos , Sudáfrica/epidemiología , Resultado del TratamientoRESUMEN
BackgroundAlthough childhood adversity is a strong determinant of psychopathology, it remains unclear whether there are 'sensitive periods' when a first episode of adversity is most harmful.AimsTo examine whether variation in the developmental timing of a first episode of interpersonal violence (up to age 18) associates with risk for psychopathology.MethodUsing cross-sectional data, we examined the association between age at first exposure to four types of interpersonal violence (physical abuse by parents, physical abuse by others, rape, and sexual assault/molestation) and onset of four classes of DSM-IV disorders (distress, fear, behaviour, substance use) (n = 9984). Age at exposure was defined as: early childhood (ages 0-5), middle childhood (ages 6-10) and adolescence (ages 11-18).ResultsExposure to interpersonal violence at any age period about doubled the risk of a psychiatric disorder (odds ratios (ORs) = 1.51-2.52). However, few differences in risk were observed based on the timing of first exposure. After conducting 20 tests of association, only three significant differences in risk were observed based on the timing of exposure; these results suggested an elevated risk of behaviour disorder among youth first exposed to any type of interpersonal violence during adolescence (OR = 2.37, 95% CI 1.69-3.34), especially being beaten by another person (OR = 2.44; 95% CI 1.57-3.79), and an elevated risk of substance use disorder among youth beaten by someone during adolescence (OR = 2.77, 95% CI 1.94-3.96).ConclusionsChildren exposed to interpersonal violence had an elevated risk of psychiatric disorder. However, age at first episode of exposure was largely unassociated with psychopathology risk.
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Maltrato a los Niños/estadística & datos numéricos , Trastornos de la Conducta Infantil/epidemiología , Abuso Físico/estadística & datos numéricos , Violación/estadística & datos numéricos , Trastornos Relacionados con Sustancias/epidemiología , Adolescente , Factores de Edad , Abuso Sexual Infantil/estadística & datos numéricos , Trastornos de la Conducta Infantil/etiología , Estudios Transversales , Femenino , Humanos , Masculino , Padres , Riesgo , Trastornos Relacionados con Sustancias/etiología , Estados Unidos/epidemiologíaRESUMEN
BACKGROUND AND OBJECTIVES: We assessed the safety, tolerability, and preliminary efficacy of nabilone, a cannabinoid agonist, to treat cannabis dependence. METHODS: Eighteen adults with DSM-IV cannabis dependence were randomized to receive either 2 mg/day of nabilone (n = 10) or placebo (n = 8) for 10 weeks in addition to medication management. Twelve participants, six in each group, completed treatment. The safety and tolerability of nabilone was assessed at each visit. Any side effects from nabilone or the placebo were documented. Cannabis use outcomes were assessed via self-report of days of use and twice-weekly urine cannabinoid tests; secondary outcomes included cannabis craving and anxiety. RESULTS: We assessed safety and tolerability at each study visit. A total of eight adverse events, all mild or moderate, were reported in two participants in the nabilone group, and six events were reported in four participants in the placebo group during study treatment. A total of eight adverse events were reported in two participants in the nabilone group and six events were reported in four participants in the placebo group during study treatment. All reported adverse events were rated mild-to-moderate. There were no side effects deemed serious enough to be classified as an FDA-defined serious adverse event. In general, participants in both groups reported reduced cannabis use according to self-report over the course of the study, although these reductions were not statistically discernible. Moreover, there was no difference in cannabis use between the nabilone group and the placebo group as measured by self-report. DISCUSSION AND CONCLUSIONS: Nabilone pharmacotherapy was safe and well-tolerated in participants with cannabis dependence. Future studies might evaluate a higher dose of nabilone to determine its effects on cannabis use outcomes in participants with cannabis dependence. SCIENTIFIC SIGNIFICANCE: There remains a clear need for additional pharmacotherapy trials for cannabis dependence, and nabilone remains a candidate for such trials. (Am J Addict 2017;26:795-801).
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Dronabinol/análogos & derivados , Abuso de Marihuana/rehabilitación , Adulto , Terapia Conductista , Terapia Combinada , Ansia/efectos de los fármacos , Dronabinol/efectos adversos , Dronabinol/uso terapéutico , Femenino , Humanos , Masculino , Proyectos Piloto , Estudios Prospectivos , Adulto JovenRESUMEN
The ready availability of public-use data from various large national complex surveys has immense potential for the assessment of population characteristics using regression models. Complex surveys can be used to identify risk factors for important diseases such as cancer. Existing statistical methods based on estimating equations and/or utilizing resampling methods are often not valid with survey data due to complex survey design features. That is, stratification, multistage sampling, and weighting. In this article, we accommodate these design features in the analysis of highly skewed response variables arising from large complex surveys. Specifically, we propose a double-transform-both-sides (DTBS)'based estimating equations approach to estimate the median regression parameters of the highly skewed response; the DTBS approach applies the same Box-Cox type transformation twice to both the outcome and regression function. The usual sandwich variance estimate can be used in our approach, whereas a resampling approach would be needed for a pseudo-likelihood based on minimizing absolute deviations (MAD). Furthermore, the approach is relatively robust to the true underlying distribution, and has much smaller mean square error than a MAD approach. The method is motivated by an analysis of laboratory data on urinary iodine (UI) concentration from the National Health and Nutrition Examination Survey.
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Modelos Estadísticos , Análisis de Regresión , Encuestas y Cuestionarios , Servicios de Laboratorio Clínico/estadística & datos numéricos , Humanos , Yodo/orinaRESUMEN
BACKGROUND AND OBJECTIVES: Grit is an emerging concept in positive psychology, defined as the ability to be persistent and focused in pursuit of long-term goals. This concept has received a great deal of interest recently because of its robust ability to predict success and well-being across a wide variety of domains. The study aim was to examine the clinical relevance of the construct of grit among patients with substance use disorders. METHODS: Inpatients on a detoxification unit were enrolled from September 2013 to August 2015 (N = 673). Psychometric properties of the Short Grit Scale (Grit-S) were reported. We then examined sociodemographic and clinical variables that might be associated with grit in this population. RESULTS: In this sample of patients with substance use disorders, the total Grit-S demonstrated strong psychometric properties. Grit-S scores were higher among older patients and those who were employed; scores were lower among those never married, diagnosed with a co-occurring psychiatric disorder, or who had used heroin during the past month, according to bivariate analyses. Grit-S scores remained associated with age, employment, and presence of a co-occurring psychiatric disorder in adjusted analysis. CONCLUSIONS AND SCIENTIFIC SIGNIFICANCE: This study provides initial support for the utility of the Grit-S among those with substance use disorders; this novel measure has not been previously reported in clinical populations. Research examining grit prospectively is needed to determine whether the links between grit and outcomes observed in other populations apply to patients with substance use disorders. (Am J Addict 2016;25:652-658).
RESUMEN
BACKGROUND AND OBJECTIVES: A Stage II, two-site randomized clinical trial compared the manualized, single-gender Women's Recovery Group (WRG) to mixed-gender group therapy (Group Drug Counseling; GDC) and demonstrated efficacy. Enhanced affiliation and support in the WRG is a hypothesized mechanism of efficacy. This study sought to extend results of the previous small Stage I trial that showed the rate of supportive affiliative statements occurred more frequently in WRG than GDC. METHODS: Participants (N = 158; 100 women, 58 men) were 18 years or older, substance dependent, and had used substances within the past 60 days. Women were randomized to WRG (n = 52) or GDC (n = 48). Group therapy videos were coded by two independent raters; Rater 1 coded 20% of videos (n = 74); Rater 2 coded 25% of videos coded by Rater 1 (n = 19). RESULTS: The number of affiliative statements made in WRG was 66% higher than in GDC. Three of eight affiliative statement categories occurred more frequently in WRG than GDC: supportive, shared experience, and strategy statements. DISCUSSION AND CONCLUSIONS: This larger Stage II trial provided a greater number of group therapy tapes available for analysis. Results extended our previous findings, demonstrating both greater frequency of all affiliative statements, as well as specific categories of statements, made in single-gender WRG than mixed-gender GDC. SCIENTIFIC SIGNIFICANCE: Greater frequency of affiliative statements among group members may be one mechanism of enhanced support and efficacy in women-only WRG compared with standard mixed-gender group therapy for substance use disorders. (Am J Addict 2016;25:573-580).