Real-world Compliance With Percutaneous Tibial Nerve Stimulation Maintenance Therapy in an American Population.

OBJECTIVE: To evaluate percutaneous tibial nerve stimulation (PTNS) maintenance therapy dropout rates and identify factors associated with compliance in an American population. METHODS: We retrospectively queried our PTNS database for patients from 2014-2019. Demographic, relevant clinical, and visit data were collected. Maintenance therapy was patient-driven and frequency of sessions was tapered based on symptomology. Upon completion of 12 initial sessions, we assessed dropout from maintenance at 3, 6, 9, and 12 months. Multiple variables were tested for correlation with dropout in patients continuing maintenance therapy for 1 year vs those who dropped out. RESULTS: One hundred and sixty-three PTNS patients were identified, of which 104 completed initial therapy and 81 proceeded with maintenance therapy. At 3, 6, 9, and 12 months, maintenance continuation rates were 77.8% (63/81), 58.0% (47/81), 45.6% (37/81), and 39.5% (32/41), respectively. Primary reasons for dropout were worsening of urinary symptoms/lack of efficacy (n = 21), time commitment (n = 9), loss of insurance (n = 5), medical comorbidities (n = 4), request for alternative OAB treatment (n = 2), and unknown (n = 8). On both univariate and multivariate analysis, perceived symptom improvement (P<.01; HR = 0.02, P< .01) was associated with continuing maintenance therapy. On only univariate analysis, neurological history (P = .02) and multiple sclerosis history (0.02) were associated with continuing therapy. CONCLUSION: Only 39.5% of patients continue to undergo maintenance PTNS therapy after 1 year. Future studies are required to understand and ameliorate factors for low compliance in PTNS maintenance therapy.

Electronic Patient Portal Use in Orthopaedic Surgery Is Associated with Disparities, Improved Satisfaction, and Lower No-Show Rates.

BACKGROUND: Electronic patient portal (EPP) use has been associated with a number of benefits in the internal medicine setting. Few studies have examined the disparities in and the benefits of EPP utilization among surgical patients. The purposes of this study were to examine factors associated with EPP use among patients undergoing an orthopaedic surgical procedure and to determine if EPP use is associated with improved outcomes or satisfaction after orthopaedic surgical procedures. METHODS: We queried all patients undergoing an orthopaedic surgical procedure from May 2015 to December 2018 at 2 academic medical centers in an integrated hospital system. Patient demographic characteristics, operative characteristics, satisfaction scores, and patient-reported outcome measures (PROMs) were collected. Multivariable logistic regression was used to identify disparities in EPP use. Adjusted logistic and linear regressions were then used to assess the association between EPP use and the various outcome metrics while controlling for confounders identified in the previous analysis. RESULTS: Numerous demographic factors were independently associated with EPP use among patients undergoing an orthopaedic surgical procedure, including English speakers compared with non-English speakers (odds ratio [OR], 2.37 [95% confidence interval (CI), 2.01 to 2.79]); African-American or black race (OR, 0.42 [95% CI, 0.36 to 0.48]) and Hispanic race (OR, 0.52 [95% CI, 0.44 to 0.61]) compared with white race; college education compared with high school education (OR, 2.30 [95% CI, 2.12 to 2.49]); and a surgical procedure for orthopaedic trauma compared with that for the hand or upper extremity (OR, 0.51 [95% CI, 0.45 to 0.58]) (p < 0.001 for all), among others. EPP use was independently associated with the increased likelihood of completing a PROM (OR, 1.57 [95% CI, 1.45 to 1.7]) and a satisfaction survey (OR, 2.38 [95% CI, 2.17 to 2.61]) and improved overall patient satisfaction (mean difference, 2.61 points [95% CI, 1.79 to 3.43 points]) (p < 0.001 for all). Finally, EPP use was independently associated with lower mean no-show rates (6.8% [95% CI, 6.4% to 7.2%] compared with 9.3% [95% CI, 8.9% to 9.7%]). The lower no-show rate for EPP users corresponded to an estimated $218,225 in savings for our institution within the first postoperative year. CONCLUSIONS: This study identified significant disparities in EPP use among patients undergoing an orthopaedic surgical procedure. Given that EPP use was independently associated with lower no-show rates and improved patient satisfaction among patients undergoing an orthopaedic procedure, efforts to reduce these disparities are warranted. CLINICAL RELEVANCE: EPPs are increasingly being used by health-care systems to improve communication between providers and patients; however, providers should be aware of and strive to eliminate disparities in EPP utilization among orthopaedic patients. Within orthopaedic surgery, EPPs are associated with a number of benefits, including lower no-show rates and increased patient satisfaction.

A Systematic Review of Intensive Empirically Supported Treatments for Posttraumatic Stress Disorder.

Various clinical practice guidelines for the treatment of posttraumatic stress disorder (PTSD) have consistently identified two frontline evidence-based psychotherapies (EBPs)-prolonged exposure (PE) and cognitive processing therapy (CPT)-as well as other empirically supported treatments (EST), such as eye movement desensitization and reprocessing (EMDR) and cognitive therapy for PTSD (CT for PTSD). However, researchers and clinicians continue to be concerned with rates of symptom improvement and patient dropout within these treatments. Recent attempts to address these issues have resulted in intensive, or "massed," treatments for PTSD. Due to variability among intensive treatments, including treatment delivery format, fidelity to the EST, and the population studied, we conducted a systematic review to summarize and integrate the literature on the impact of intensive treatments on PTSD symptoms. A review of four major databases, with no restrictions regarding publication date, yielded 11 studies that met all inclusion criteria. The individual study findings denoted a large impact of treatment on reduction of PTSD symptoms, ds = 1.15-2.93, and random-effects modeling revealed a large weighted mean effect of treatment, d = 1.57, 95% CI [1.24, 1.91]. Results from intensive treatments also noted high rates of treatment completion (i.e., 0%-13.6% dropout; 5.51% pooled dropout rate across studies). The findings suggest that intensive delivery of these treatments can be an effective alternative to standard delivery and contribute to improved treatment response and reduced treatment dropout.

Shock wave therapy for rotator cuff disease with or without calcification.

BACKGROUND: Shock wave therapy has seen widespread use since the 1990s to treat various musculoskeletal disorders including rotator cuff disease, but evidence of its efficacy remains equivocal. OBJECTIVES: To determine the benefits and harms of shock wave therapy for rotator cuff disease, with or without calcification, and to establish its usefulness in the context of other available treatment options. SEARCH METHODS: We searched Ovid MEDLINE, Ovid Embase, CENTRAL, ClinicalTrials.gov and the WHO ICTRP up to November 2019, with no restrictions on language. We reviewed the reference lists of retrieved trials to identify potentially relevant trials. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and controlled clinical trials (CCTs) that used quasi-randomised methods to allocate participants, investigating participants with rotator cuff disease with or without calcific deposits. We included trials of comparisons of extracorporeal or radial shock wave therapy versus any other intervention. Major outcomes were pain relief greater than 30%, mean pain score, function, patient-reported global assessment of treatment success, quality of life, number of participants experiencing adverse events and number of withdrawals due to adverse events. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies for inclusion, extracted data and assessed the certainty of evidence using GRADE. The primary comparison was shock wave therapy compared to placebo. MAIN RESULTS: Thirty-two trials (2281 participants) met our inclusion criteria. Most trials (25) included participants with rotator cuff disease and calcific deposits, five trials included participants with rotator cuff disease and no calcific deposits, and two trials included a mixed population of participants with and without calcific deposits. Twelve trials compared shock wave therapy to placebo, 11 trials compared high-dose shock wave therapy (0.2 mJ/mm² to 0.4 mJ/mm² and above) to low-dose shock wave therapy. Single trials compared shock wave therapy to ultrasound-guided glucocorticoid needling, ultrasound-guided hyaluronic acid injection, transcutaneous electric nerve stimulation (TENS), no treatment or exercise; dual session shock wave therapy to single session therapy; and different delivery methods of shock wave therapy. Our main comparison was shock wave therapy versus placebo and results are reported for the 3 month follow up. All trials were susceptible to bias; including selection (74%), performance (62%), detection (62%), and selective reporting (45%) biases. No trial measured participant-reported pain relief of 30%. However, in one trial (74 participants), at 3 months follow up, 14/34 participants reported pain relief of 50% or greater with shock wave therapy compared with 15/40 with placebo (risk ratio (RR) 1.10, 95% confidence interval (CI) 0.62 to 1.94); low-quality evidence (downgraded for bias and imprecision). Mean pain (0 to 10 scale, higher scores indicate more pain) was 3.02 points in the placebo group and 0.78 points better (0.17 better to 1.4 better; clinically important change was 1.5 points) with shock wave therapy (9 trials, 608 participants), moderate-quality evidence (downgraded for bias). Mean function (scale 0 to 100, higher scores indicate better function) was 66 points with placebo and 7.9 points better (1.6 better to 14 better, clinically important difference 10 points) with shock wave therapy (9 trials, 612 participants), moderate-quality evidence (downgraded for bias). Participant-reported success was reported by 58/150 people in shock wave therapy group compared with 35/137 people in placebo group (RR 1.59, 95% CI 0.87 to 2.91; 6 trials, 287 participants), low-quality evidence (downgraded for bias and imprecision). None of the trials measured quality of life. Withdrawal rate or adverse event rates may not differ between extracorporeal shock wave therapy and placebo, but we are uncertain due to the small number of events. There were 11/34 withdrawals in the extracorporeal shock wave therapy group compared with 13/40 withdrawals in the placebo group (RR 0.75, 95% CI 0.43 to 1.31; 7 trials, 581 participants) low-quality evidence (downgraded for bias and imprecision); and 41/156 adverse events with extracorporeal shock wave therapy compared with 10/139 adverse events in the placebo group (RR 3.61, 95% CI 2.00 to 6.52; 5 trials, 295 participants) low-quality evidence (downgraded for bias and imprecision). Subgroup analyses indicated that there were no between-group differences in pain and function outcomes in participants who did or did not have calcific deposits in the rotator cuff. AUTHORS' CONCLUSIONS: Based upon the currently available low- to moderate-certainty evidence, there were very few clinically important benefits of shock wave therapy, and uncertainty regarding its safety. Wide clinical diversity and varying treatment protocols means that we do not know whether or not some trials tested subtherapeutic doses, possibly underestimating any potential benefits. Further trials of extracorporeal shock wave therapy for rotator cuff disease should be based upon a strong rationale and consideration of whether or not they would alter the conclusions of this review. A standard dose and treatment protocol should be decided upon before further research is conducted. Development of a core set of outcomes for trials of rotator cuff disease and other shoulder disorders would also facilitate our ability to synthesise the evidence.

Six-month retention and changes in quality of life and substance use from a low-threshold methadone maintenance therapy programme in Durban, South Africa.

BACKGROUND: Emerging data points to a potential heroin use epidemic in South Africa. Despite this, access to methadone maintenance therapy and other evidence-based treatment options remains negligible. We aimed to assess retention, changes in substance use and quality of life after 6 months on methadone maintenance therapy provided through a low-threshold service in Durban, South Africa. METHODS: We enrolled a cohort of 54 people with an opioid use disorder into the study. We reviewed and described baseline socio-demographic characteristics. Baseline and 6-month substance use was assessed using the World Health Organization's Alcohol Smoking and Substance Use Involvement Screening Test (ASSIST) and quality of life, using the SF-12. We compared changes at 6 months on methadone to baseline using the Wilcoxon signed rank test and paired-tests for the ASSIST and SF-12 scores, respectively. McNemar's test was used for comparisons between paired results of categorical variables relating to injecting frequency. RESULTS: The majority of the participants were young, Black African males, with a history of drug use spanning over 10 years. Retention after 6 months was 81%. After 6 months, the median heroin ASSIST score decreased from 37 to 9 (p < 0.0001) and the cannabis ASSIST score increased from 12.5 to 21 (p = 0.0003). The median mental health composite score of the SF-12 increased from 41.4 to 48.7 (p = 0.0254). CONCLUSIONS: Interim findings suggest high retention, significant reductions in heroin use and improvements in mental health among participants retained on methadone maintenance therapy for 6 months. Further research into longer term outcomes and the reasons contributing to these changes would strengthen recommendations for the scale-up of methadone maintenance therapy in South Africa.

Dropout rates in clinical trials of smartphone apps for depressive symptoms: A systematic review and meta-analysis.

BACKGROUND: Low engagement and attrition from app interventions is an increasingly recognized challenge for interpreting and translating the findings from digital health research. Focusing on randomized controlled trials (RCTs) of smartphone apps for depressive symptoms, we aimed to establish overall dropout rates, and how this differed between different types of apps. METHODS: A systematic review of RCTs of apps targeting depressive symptoms in adults was conducted in May 2019. Random-effects meta-analysis were applied to calculate the pooled dropout rates in intervention and control conditions. Trim-and-fill analyses were used to adjust estimates after accounting for publication bias. RESULTS: The systematic search retrieved 2,326 results. 18 independent studies were eligible for inclusion, using data from 3,336 participants randomized to either smartphone interventions for depression (n = 1,786) or control conditions (n = 1,550). The pooled dropout rate was 26.2%. This increased to 47.8% when adjusting for publication bias. Study retention rates did not differ between depression vs. placebo apps, clinically-diagnosed vs. self-reported depression, paid vs. unpaid assessments, CBT vs. non-CBT apps, or mindfulness vs. non-mindfulness app studies. Dropout rates were higher in studies with large samples, but lower in studies offering human feedback and in-app mood monitoring. DISCUSSION: High dropout rates present a threat to the validity of RCTs of mental health apps. Strategies to improve retention may include providing human feedback, and enabling in-app mood monitoring. However, it critical to consider bias when interpreting results of apps for depressive symptoms, especially given the strong indication of publication bias, and the higher attrition in larger studies.

[Maintaining a Strong Therapeutic Alliance: Initial Experiences with the Alliance-Focused Training (AFT) in Germany]. / Umgang mit Spannungen und Krisen in der therapeutischen Beziehung: Erste Erfahrungen mit einem handlungsorientierten Ausbildungs- und Supervisionskonzept.

AIMS: Alliance Focused Training (AFT) 1 aims at enhancing therapists' competences in resolving ruptures in the therapeutic alliance using video recordings and role-plays. This pilot study funded by the Heigl Foundation aimed at presenting initial results and clinical experiences with AFT in Germany, and to prepare a subsequent RCT. METHODS: 7 trainee therapists participated. Therapies of 15 patients with depressive disorder were analyzed. RESULTS AND CONCLUSION: Trainees experienced AFT as very helpful for their professional development and for dealing with alliance ruptures. The therapeutic competence significantly improved both in self and in observer ratings. The results indicate that AFT is a promising approach to improve psychotherapy training, emphasizing the relevance of the planned proof of concept RCT.

Abandonment of therapy in multidrug-resistant tuberculosis: Associated factors in a region with a high burden of the disease in Perú / Abandono del tratamiento en tuberculosis multirresistente: factores asociados en una región con alta carga de la enfermedad en Perú

Introduction: In the context of multidrug-resistant tuberculosis, abandonment of therapy represents a serious public health problem that affects the quality of life of patients, families, and communities. Managing this phenomenon places a burden on health systems since it causes free sources of transmission in the community, thereby increasing prevalence and mortality. Thus, there is a need to study factors associated with this problem. Objective: This study sought to identify risk factors associated with the abandonment of therapy by patients with multidrug-resistant tuberculosis in the Peruvian region of Callao. Materials and methods: We conducted an analytical case-control study (cases=80; controls=180) in patients under treatment from January 1st, 2010, to December 31, 2012. Risk factors were identified using logistic regression; odds ratios (OR) and 95% confidence intervals (CI) were calculated. Results: The multivariate analysis identified the following risk factors: Being unaware of the disease (OR=23.10; 95% CI 3.6-36.79; p=0.002); not believing in healing (OR=117.34; 95% CI 13.57-124.6; p=0.000); not having social support (OR=19.16; 95% CI 1.32-27.77; p=0.030); considering the hours of attention to be inadequate (OR=78.13; 95% CI 4.84-125.97; p=0.002), and not receiving laboratory reports (OR=46.13; 95% CI 2.85-74.77; p=0.007). Conclusion: Health services must focus on the early detection of conditions that may represent risk factors to proactively implement effective, rapid and high-impact interventions.

Introducción. En la tuberculosis multirresistente, el abandono del tratamiento constituye un grave problema de salud pública que afecta la calidad de vida de los pacientes, sus familias y la comunidad. El enfrentarlo supone una carga para los sistemas sanitarios debido a que provoca fuentes de transmisión libre en la comunidad e incrementa la prevalencia y la mortalidad. De ahí, la necesidad de investigar los factores asociados con esta situación. Objetivo. Determinar los factores de riesgo asociados con el abandono del tratamiento en pacientes con tuberculosis multirresistente en la región de Callao (Perú). Materiales y métodos. Se hizo un estudio analítico de casos y controles (80 casos y 180 controles) en tratamiento entre el 1° enero del 2010 y el 31 diciembre del 2012. Los factores se determinaron mediante regresión logística, y se calcularon los odds ratios (OR) y los intervalos de confianza (IC) del 95 %. Resultados. En el análisis multivariado se determinaron los siguientes factores de riesgo: no tener conocimiento de la enfermedad (OR=23,10; IC95%: 3,6-36,79; p=0,002); no creer en la curación (OR=117,34; IC95%: 13,57-124,6; p=0,000); no tener apoyo social (OR=19,16; IC95%: 1,32-27,77; p=0,030); no considerar adecuado el horario de atención (OR=78,13; IC95%: 4,84-125,97; p=0,002), y no recibir los resultados de laboratorio (OR=46,13; IC95%: 2,85-74,77; p=0,007). Conclusión. Los servicios de salud deben esforzarse en la determinación precoz de las condiciones que podrían convertirse en factores de riesgo, lo cual ayudaría a implementar preventivamente intervenciones efectivas, rápidas y de alto impacto.

Moment-by-Moment in Women's Recovery (MMWR): Mindfulness-based intervention effects on residential substance use disorder treatment retention in a randomized controlled trial.

In this study we test the efficacy of Moment-by-Moment in Women's Recovery (MMWR), a mindfulness-based intervention adapted to support women with substance use disorder (SUD) while in residential treatment. We use a parallel-group randomized controlled trial with a time-matched psychoeducation control to test MMWR effects on residential treatment retention. We used clinical staff-determined residential site discharge status and discharge date from the SUD treatment site record to determine retention. We tested for study group differences in retention defined as time to treatment non-completion without improvement (i.e., patient left treatment before completion of the treatment plan and made little or no progress toward achieving treatment goals based on clinical team determination), as well as differences in self-report of study intervention mechanisms of action (i.e., mindfulness, perceived stress, distress tolerance, emotion regulation, distress, affect, and drug and alcohol craving). The analytic timeframe for the survival analysis was from study intervention start date to 150 days later. The sample (N = 200) was female, majority amphetamine/methamphetamine users (76%), Hispanic (58%), with a history of incarceration (62%). By the 150-day analytic endpoint, the sample had 74 (37%) treatment Completers, 42 (21%) still In-residence, 26 (13%) Non-completers with satisfactory progress, and 58 (29%) Non-completers without satisfactory progress. Survival analysis of the intent-to-treat sample showed the risk of non-completion without improvement was lower in MMWR as compared to the control group (adjusted hazard ratio = 0.42, 95% CI: 0.16-1.08, p = .07). Both groups improved on select self-reported mechanism measure scores at immediate post-intervention, but only in the MMWR group did class attendance (dosage) have a large-size correlation with improved mindfulness (r = .61, p < .01), distress tolerance (r = 0.55, p < .01) and positive affect (r = 0.52, p < .01) scores. The hazard ratio for retention was of medium-to-large effect size, suggesting the clinical relevance of adding MMWR to an all-women's, ethnoracially diverse, SUD residential treatment center. An extended curriculum may be helpful considering the protective benefits of class attendance on psychological health indicators.

[Tuberculosis in indigenous children and adolescents in Brazil: factors associated with death and treatment dropout]. / Tuberculose entre crianças e adolescentes indígenas no Brasil: fatores associados ao óbito e ao abandono do tratamento.

The study aimed to describe clinical and sociodemographic characteristics, estimate incidence, and analyze factors associated with dropout and death during treatment of TB cases reported in indigenous children and adolescents in Brazil from 2006 to 2016. A historical case series was performed on incidence according to age bracket and major geographic region, and multinomial logistic regression was used to explain factors associated with treatment dropout and death. Of the 2,096 reported cases, 88.2% evolved to cure, 7.2% dropped out of treatment, and 4.6% evolved to death. There was a predominance of cases in boys 15-19 years of age and a higher proportion of deaths (55.7%) in children < 4 years. Considering indigenous children and adolescents with TB in Brazil as a whole, mean incidence was 49.1/100,000, ranging from 21.5/100,000 to 97.6/100,000 in the Northeast and Central, respectively. Cases with insufficient and irregular follow-up showed higher odds of dropout (OR = 11.1; 95%CI: 5.2-24.8/OR = 4.4; 95%CI: 1.9-10.3) and death (OR = 20.3; 95%CI: 4.9-84.9/OR = 5.1; 95%CI: 1.2-22.7). Cases in retreatment (OR = 2.4; 95%CI: 2.08-8.55) and with HIV coinfection (OR = 8.2; 95%CI: 2.2-30.9) were also associated with dropout. Extrapulmonary (OR = 1.8; 95%CI: 1.1-3.3) and mixed clinical forms (OR = 5.6; 95%CI: 2.8-11.4), age < 4 years (OR = 3.1; 95%CI: 1.5-6.4), and cases from the North (OR = 2.8; 95%CI: 1.1-7.1) and Central (OR = 2.8; 95%CI: 1.1-7.0) were associated with death. TB control in indigenous children and adolescents cannot be achieved without investments in research and development and without reducing social inequalities.

O objetivo deste estudo foi descrever características clínicas e sociodemográficas, estimar a incidência da tuberculose (TB), além de analisar fatores associados ao abandono e ao óbito na vigência do tratamento dos casos de TB notificados entre crianças e adolescentes indígenas, no Brasil, entre 2006-2016. Realizou-se análise da série histórica de incidência, segundo faixa etária e macrorregião e utilizou-se regressão logística multinomial para elucidar fatores associados ao abandono e ao óbito. Do total de 2.096 casos notificados, 88,2% tiveram cura, 7,2% abandonaram o tratamento e 4,6% evoluíram para óbito. Houve predomínio de casos em meninos de 15-19 anos e maior proporção de óbitos (55,7%) em < 4 anos. Considerando o conjunto de crianças e adolescentes indígenas com TB no Brasil, a incidência média foi 49,1/100 mil, variando de 21,5/100 mil a 97,6/100 mil nas regiões Nordeste e Centro-oeste, respectivamente. Os casos com acompanhamento insuficiente e regular tiveram maiores chances de abandono (OR = 11,1; IC95%: 5,2-24,8/OR = 4,4; IC95%: 1,9-10,3) e óbito (OR = 20,3; IC95%: 4,9-84,9/OR = 5,1; IC95%: 1,2-22,7). Os casos em retratamento (OR = 2,4; IC95%: 2,08-8,55) e com anti-HIV positivo (OR = 8,2; IC95%: 2,2-30,9) também mostraram-se associados ao abandono. As formas clínicas extrapulmonar (OR = 1,8; IC95%: 1,1-3,3) e mista (OR = 5,6; IC95%: 2,8-11,4), os casos em < 4 anos (OR = 3,1; IC95%: 1,5-6,4) e os casos provenientes das regiões Norte (OR = 2,8; IC95%: 1,1-7,1) e Centro-oeste (OR = 2,8; IC95%: 1,1-7,0) mostraram-se associados ao óbito. Acreditamos que o controle da TB em crianças e adolescentes indígenas não poderá ser alcançado sem investimentos em pesquisa e desenvolvimento e sem a redução das desigualdades sociais.

El objetivo de este estudio fue describir características clínicas y sociodemográficas, estimar la incidencia de la tuberculosis (TB), además de analizar factores asociados al abandono y al óbito en la vigencia del tratamiento de los casos de TB, notificados entre niños y adolescentes indígenas, en Brasil entre 2006-2016. Se realizó un análisis de la serie histórica de incidencia, según la franja de edad y macrorregión y se utilizó la regresión logística multinomial para elucidar factores asociados al abandono y al óbito. Del total de 2.096 casos notificados, un 88,2% tuvieron cura, un 7,2% abandonaron el tratamiento y un 4,6% evolucionaron hacia óbito. Hubo un predominio de casos en chicos de 15-19 años y mayor proporción de óbitos (55,7%) en < 4 años. Considerando el conjunto de niños y adolescentes indígenas con TB en Brasil, la incidencia media fue 49,1/100.000, variando de 21,5/100.000 a 97,6/100.000 en las regiones Nordeste y Centro-oeste, respectivamente. Los casos con un seguimiento insuficiente y regular tuvieron mayores oportunidades de abandono (OR = 11,1; IC95%: 5,2-24,8/OR = 4,4; IC95%: 1,9-10,3) y óbito (OR = 20,3; IC95%: 4,9-84,9/OR = 5,1; IC95%: 1,2-22,7). Los casos de retorno al tratamiento (OR = 2,4; IC95%: 2,08-8,55) y con anti-VIH positivo (OR = 8,2; IC95%: 2,2-30,9) también se mostraron asociados al abandono. Las formas clínicas extrapulmonares (OR = 1,8; IC95%: 1,1-3,3) y mixta (OR = 5,6; IC95%: 2,8-11,4), los casos en < 4 años (OR = 3,1; IC95%: 1,5-6,4) y los casos procedentes de las regiones Norte (OR = 2,8; IC95%: 1,1-7,1) y Centro-oeste (OR = 2,8; IC95%: 1,1-7,0) se mostraron asociados al óbito. Creemos que el control de la TB en niños y adolescentes indígenas no se podrá alcanzar sin inversiones en investigación y desarrollo y sin la reducción de las desigualdades sociales.

Abandono del tratamiento en tuberculosis multirresistente: factores asociados en una región con alta carga de la enfermedad en Perú / Abandonment of therapy in multidrug-resistant tuberculosis: Associated factors in a region with a high burden of the disease in Perú

Resumen Introducción. En la tuberculosis multirresistente, el abandono del tratamiento constituye un grave problema de salud pública que afecta la calidad de vida de los pacientes, sus familias y la comunidad. El enfrentarlo supone una carga para los sistemas sanitarios debido a que provoca fuentes de transmisión libre en la comunidad e incrementa la prevalencia y la mortalidad. De ahí, la necesidad de investigar los factores asociados con esta situación. Objetivo. Determinar los factores de riesgo asociados con el abandono del tratamiento en pacientes con tuberculosis multirresistente en la región de Callao (Perú). Materiales y métodos. Se hizo un estudio analítico de casos y controles (80 casos y 180 controles) en tratamiento entre el 1° enero del 2010 y el 31 diciembre del 2012. Los factores se determinaron mediante regresión logística, y se calcularon los odds ratios (OR) y los intervalos de confianza (IC) del 95 %. Resultados. En el análisis multivariado se determinaron los siguientes factores de riesgo: no tener conocimiento de la enfermedad (OR=23,10; IC95%: 3,6-36,79; p=0,002); no creer en la curación (OR=117,34; IC95%: 13,57-124,6; p=0,000); no tener apoyo social (OR=19,16; IC95%: 1,32-27,77; p=0,030); no considerar adecuado el horario de atención (OR=78,13; IC95%: 4,84-125,97; p=0,002), y no recibir los resultados de laboratorio (OR=46,13; IC95%: 2,85-74,77; p=0,007). Conclusión. Los servicios de salud deben esforzarse en la determinación precoz de las condiciones que podrían convertirse en factores de riesgo, lo cual ayudaría a implementar preventivamente intervenciones efectivas, rápidas y de alto impacto.

Abstract Introduction: In the context of multidrug-resistant tuberculosis, abandonment of therapy represents a serious public health problem that affects the quality of life of patients, families, and communities. Managing this phenomenon places a burden on health systems since it causes free sources of transmission in the community, thereby increasing prevalence and mortality. Thus, there is a need to study factors associated with this problem. Objective: This study sought to identify risk factors associated with the abandonment of therapy by patients with multidrug-resistant tuberculosis in the Peruvian region of Callao. Materials and methods: We conducted an analytical case-control study (cases=80; controls=180) in patients under treatment from January 1st, 2010, to December 31, 2012. Risk factors were identified using logistic regression; odds ratios (OR) and 95% confidence intervals (CI) were calculated. Results: The multivariate analysis identified the following risk factors: Being unaware of the disease (OR=23.10; 95% CI 3.6-36.79; p=0.002); not believing in healing (OR=117.34; 95% CI 13.57-124.6; p=0.000); not having social support (OR=19.16; 95% CI 1.32-27.77; p=0.030); considering the hours of attention to be inadequate (OR=78.13; 95% CI 4.84-125.97; p=0.002), and not receiving laboratory reports (OR=46.13; 95% CI 2.85-74.77; p=0.007). Conclusion: Health services must focus on the early detection of conditions that may represent risk factors to proactively implement effective, rapid and high-impact interventions.

Development, implementation, and effects of a cancer center's exercise-oncology program.

BACKGROUND: National and international bodies acknowledge the benefit of exercise for people with cancer, yet limited accessibility to related programing remains. Given their involvement in managing the disease, cancer centers can play a central role in delivering exercise-oncology services. The authors developed and implemented a clinically integrated exercise-oncology program at a major cancer center and evaluated its effectiveness and participant experience. METHODS: A hospital-based program with prescribed at-home exercise was developed and accepted referrals over a 42-month period (3.5 years). Implementation was conducted in 2 phases: a pilot phase for women with breast cancer and men with genitourinary cancer and a roll-out phase for all patients with cancer. Enrolled patients were assessed and received an exercise prescription as well as a program manual, resistance bands, and a stability ball from a kinesiologist. Program participation and effectiveness were evaluated up to 48 weeks after the baseline assessment using intention-to-treat analyses. Participants in the roll-out phase were asked to complete a program experience questionnaire at the completion of the 48-week follow-up. RESULTS: In total, 112 participants enrolled in the pilot, and 150 enrolled in the roll-out phase. Program attrition to 48 weeks was 48% and 65% in the pilot and roll-out phases, respectively. In participants who consented to research evaluation of their performance, objective and patient-reported measures of functional capacity improved significantly from baseline in both phases. Participants were highly satisfied with the program. CONCLUSIONS: Despite significant drop-out to program endpoints, our cancer-exercise program demonstrated clinically relevant improvement in functional outcomes and was highly appreciated by participants.

[Transanal irrigations in patients with constipation and fecal incontinence: results, indications and follow up in our center]. / Irrigación transanal en pacientes con estreñimiento e incontinencia orgánica refractaria. Resultados, indicaciones y seguimiento en nuestro centro.

AIM OF THE STUDY: To present our results with transanal irrigation (TAI) for management of fecal incontinence and fecal constipation without response to other treatments. METHODS: Retrospective study of patients with fecal constipation and/or fecal incontinence treated with TAI between 2013 and 2017. A Rintala questionnaire(1) was carried out comparing pre and post-treatment results. This study was approved by the ethical committee. MAIN RESULTS: Twenty-five patients were included with a median age of 13 years old (range 6-44 years). Nineteen patients had spinal pathology (76%), four colorectal surgery (16%) and two functional constipation (8%). They presented fecal incontinence in 20% of cases, 12% of fecal constipation and 68% both conditions. After a mean follow-up of 1.5 years (1 month-4 years), 52% of the patients abandoned the treatment. The mean Rintala score was 6.8±4 before treatment, and after, resulted to 11.42±2.75 (p=0.001). The main complications throughout the treatment were pain (68%) and balloon leaks (28%). The patients declared as cause of treatment cessation: reduced mobility (15%), fear or misinformation (32%) and pain (76%). All patients with reduced mobility (n=3) left treatment, versus 45% (n=12) of the patients that had full mobility (p=0.17, OR 8.3 [IC95% 0.3-38]). Complementary treatments such as laxatives, enemas or digital extraction were abandoned in 55% of the patients. CONCLUSIONS: Using TAI seems to improve quality of life in patients with fecal constipation and fecal incontinence refractory compared to other treatments. Our abandonment rate was higher than expected, so we believe it is necessary to create a support group to improve follow-ups.

OBJETIVOS: Presentar nuestros resultados con el uso del irrigador transanal (IT) en el manejo intestinal de pacientes con incontinencia fecal o estreñimiento sin respuesta a otros tratamientos. METODOS: Estudio retrospectivo de pacientes con estreñimiento y/o incontinencia fecal refractaria tratados con IT (2013-2017) con el sistema Peristeen® (Coloplast). Se realizó cuestionario Rintala(1), comparando resultados pre y postratamiento. La realización del estudio fue aprobada por el comité de investigación clínica. RESULTADOS: Fueron incluidos en el estudio veinticinco pacientes, mediana de edad 13 años (6-44 años), cuatro no localizables. Diecinueve presentaban patología medular (76%), cuatro cirugías colorrectales (16%) y dos estreñimiento funcional (8%). El 20% aquejaba incontinencia, 12% estreñimiento y 68% ambas condiciones. Tras una mediana de seguimiento de 1,5 años (1 mes-4 años), el 52% abandonó el tratamiento. La puntuación media pretratamiento fue 6,8±4, frente a 11,42±2,75 tras su empleo (p=0,001), disminuyendo el número de escapes con repercusión positiva en actividades diarias. Las complicaciones principales fueron dolor (68%) y expulsión del balón (28%). Refirieron como causa de abandono: dificultad de uso por movilidad reducida (15%), miedo o desinformación (32%) y dolor (76%). El 100% de pacientes con movilidad reducida (n=3) abandonó el tratamiento, frente al 45% (n=12) en el resto (p=0,17, OR 8.3 [IC95% 0,3-38]). El 55% de los pacientes dejaron de utilizar laxantes, enemas o extracción digital. CONCLUSIONES: El uso de IT parece mejorar la calidad de vida en pacientes con estreñimiento e incontinencia de causa orgánica refractaria. La tasa de abandono fue mayor de la esperada, por lo que creemos necesaria la creación de un grupo de apoyo que mejore el seguimiento.

HOPON (Hyperbaric Oxygen for the Prevention of Osteoradionecrosis): A Randomized Controlled Trial of Hyperbaric Oxygen to Prevent Osteoradionecrosis of the Irradiated Mandible After Dentoalveolar Surgery.

PURPOSE: Hyperbaric oxygen (HBO) has been advocated in the prevention and treatment of osteoradionecrosis (ORN) of the jaw after head and neck radiation therapy, but supporting evidence is weak. The aim of this randomized trial was to establish the benefit of HBO in the prevention of ORN after high-risk surgical procedures to the irradiated mandible. METHODS AND MATERIALS: HOPON was a randomized, controlled, phase 3 trial. Participants who required dental extractions or implant placement in the mandible with prior radiation therapy >50 Gy were recruited. Eligible patients were randomly assigned 1:1 to receive or not receive HBO. All patients received chlorhexidine mouthwash and antibiotics. For patients in the HBO arm, oxygen was administered in 30 daily dives at 100% oxygen to a pressure of 2.4 atmospheres absolute for 80 to 90 minutes. The primary outcome measure was the diagnosis of ORN 6 months after surgery, as determined by a blinded central review of clinical photographs and radiographs. The secondary endpoints included grade of ORN, ORN at other time points, acute symptoms, pain, and quality of life. RESULTS: A total of 144 patients were randomized, and data from 100 patients were analyzed for the primary endpoint. The incidence of ORN at 6 months was 6.4% and 5.7% for the HBO and control groups, respectively (odds ratio, 1.13; 95% confidence interval, 0.14-8.92; P = 1). Patients in the hyperbaric arm had fewer acute symptoms but no significant differences in late pain or quality of life. Dropout was higher in the HBO arm, but the baseline characteristics of the groups that completed the trial were comparable between the 2 arms. CONCLUSIONS: The low incidence of ORN makes recommending HBO for dental extractions or implant placement in the irradiated mandible unnecessary. These findings are in contrast with a recently published Cochrane review and previous trials reporting rates of ORN (non-HBO) of 14% to 30% and challenge a long-established standard of care.

Efficacy, acceptability and tolerability of antipsychotics in patients with schizophrenia and comorbid substance use. A systematic review and meta-analysis.

Patients with schizophrenia and substance related comorbidity or substance induced psychotic disorder are difficult to treat. Although the prevalence of a comorbid substance use is approximately 40% in schizophrenia, such patients are usually excluded from clinical trials. We therefore performed a random-effects meta-analysis of all randomized controlled antipsychotic drug trials in this patient subgroup. We searched multiple databases up to May, 2018. The primary outcome was the reduction of substance user; secondary outcomes were craving, mean reduction of substance use, overall change in schizophrenia symptoms, positive and negative symptoms, response, dropouts, quality of life, social functioning, weight gain, sedation, prolactin, extrapyramidal side effects and use of antiparkinsonian medication. We identified 27 references from 19 RCTs published from 1999 to March 2017 including 1742 participants. The most frequent types of substance abuse were cannabis (8 studies) and cocaine (6 studies) use/dependence. Clozapine was superior to other antipsychotics for reduction of substance use and risperidone to olanzapine for craving. Olanzapine, clozapine and risperidone showed superiority for symptom reduction compared to some other drugs. When reported, results of side-effects followed known patterns. The evidence-base is considerable (19 RCTs), however, firm conclusions cannot be drawn due to small sample sizes of individual studies and insufficient reporting.

Tuberculose entre crianças e adolescentes indígenas no Brasil: fatores associados ao óbito e ao abandono do tratamento / Tuberculosis in indigenous children and adolescents in Brazil: factors associated with death and treatment dropout / Tuberculosis entre niños y adolescentes indígenas en Brasil: factores asociados al óbito y al abandono del tratamiento

Resumo: O objetivo deste estudo foi descrever características clínicas e sociodemográficas, estimar a incidência da tuberculose (TB), além de analisar fatores associados ao abandono e ao óbito na vigência do tratamento dos casos de TB notificados entre crianças e adolescentes indígenas, no Brasil, entre 2006-2016. Realizou-se análise da série histórica de incidência, segundo faixa etária e macrorregião e utilizou-se regressão logística multinomial para elucidar fatores associados ao abandono e ao óbito. Do total de 2.096 casos notificados, 88,2% tiveram cura, 7,2% abandonaram o tratamento e 4,6% evoluíram para óbito. Houve predomínio de casos em meninos de 15-19 anos e maior proporção de óbitos (55,7%) em < 4 anos. Considerando o conjunto de crianças e adolescentes indígenas com TB no Brasil, a incidência média foi 49,1/100 mil, variando de 21,5/100 mil a 97,6/100 mil nas regiões Nordeste e Centro-oeste, respectivamente. Os casos com acompanhamento insuficiente e regular tiveram maiores chances de abandono (OR = 11,1; IC95%: 5,2-24,8/OR = 4,4; IC95%: 1,9-10,3) e óbito (OR = 20,3; IC95%: 4,9-84,9/OR = 5,1; IC95%: 1,2-22,7). Os casos em retratamento (OR = 2,4; IC95%: 2,08-8,55) e com anti-HIV positivo (OR = 8,2; IC95%: 2,2-30,9) também mostraram-se associados ao abandono. As formas clínicas extrapulmonar (OR = 1,8; IC95%: 1,1-3,3) e mista (OR = 5,6; IC95%: 2,8-11,4), os casos em < 4 anos (OR = 3,1; IC95%: 1,5-6,4) e os casos provenientes das regiões Norte (OR = 2,8; IC95%: 1,1-7,1) e Centro-oeste (OR = 2,8; IC95%: 1,1-7,0) mostraram-se associados ao óbito. Acreditamos que o controle da TB em crianças e adolescentes indígenas não poderá ser alcançado sem investimentos em pesquisa e desenvolvimento e sem a redução das desigualdades sociais.

Abstract: The study aimed to describe clinical and sociodemographic characteristics, estimate incidence, and analyze factors associated with dropout and death during treatment of TB cases reported in indigenous children and adolescents in Brazil from 2006 to 2016. A historical case series was performed on incidence according to age bracket and major geographic region, and multinomial logistic regression was used to explain factors associated with treatment dropout and death. Of the 2,096 reported cases, 88.2% evolved to cure, 7.2% dropped out of treatment, and 4.6% evolved to death. There was a predominance of cases in boys 15-19 years of age and a higher proportion of deaths (55.7%) in children < 4 years. Considering indigenous children and adolescents with TB in Brazil as a whole, mean incidence was 49.1/100,000, ranging from 21.5/100,000 to 97.6/100,000 in the Northeast and Central, respectively. Cases with insufficient and irregular follow-up showed higher odds of dropout (OR = 11.1; 95%CI: 5.2-24.8/OR = 4.4; 95%CI: 1.9-10.3) and death (OR = 20.3; 95%CI: 4.9-84.9/OR = 5.1; 95%CI: 1.2-22.7). Cases in retreatment (OR = 2.4; 95%CI: 2.08-8.55) and with HIV coinfection (OR = 8.2; 95%CI: 2.2-30.9) were also associated with dropout. Extrapulmonary (OR = 1.8; 95%CI: 1.1-3.3) and mixed clinical forms (OR = 5.6; 95%CI: 2.8-11.4), age < 4 years (OR = 3.1; 95%CI: 1.5-6.4), and cases from the North (OR = 2.8; 95%CI: 1.1-7.1) and Central (OR = 2.8; 95%CI: 1.1-7.0) were associated with death. TB control in indigenous children and adolescents cannot be achieved without investments in research and development and without reducing social inequalities.

Resumen: El objetivo de este estudio fue describir características clínicas y sociodemográficas, estimar la incidencia de la tuberculosis (TB), además de analizar factores asociados al abandono y al óbito en la vigencia del tratamiento de los casos de TB, notificados entre niños y adolescentes indígenas, en Brasil entre 2006-2016. Se realizó un análisis de la serie histórica de incidencia, según la franja de edad y macrorregión y se utilizó la regresión logística multinomial para elucidar factores asociados al abandono y al óbito. Del total de 2.096 casos notificados, un 88,2% tuvieron cura, un 7,2% abandonaron el tratamiento y un 4,6% evolucionaron hacia óbito. Hubo un predominio de casos en chicos de 15-19 años y mayor proporción de óbitos (55,7%) en < 4 años. Considerando el conjunto de niños y adolescentes indígenas con TB en Brasil, la incidencia media fue 49,1/100.000, variando de 21,5/100.000 a 97,6/100.000 en las regiones Nordeste y Centro-oeste, respectivamente. Los casos con un seguimiento insuficiente y regular tuvieron mayores oportunidades de abandono (OR = 11,1; IC95%: 5,2-24,8/OR = 4,4; IC95%: 1,9-10,3) y óbito (OR = 20,3; IC95%: 4,9-84,9/OR = 5,1; IC95%: 1,2-22,7). Los casos de retorno al tratamiento (OR = 2,4; IC95%: 2,08-8,55) y con anti-VIH positivo (OR = 8,2; IC95%: 2,2-30,9) también se mostraron asociados al abandono. Las formas clínicas extrapulmonares (OR = 1,8; IC95%: 1,1-3,3) y mixta (OR = 5,6; IC95%: 2,8-11,4), los casos en < 4 años (OR = 3,1; IC95%: 1,5-6,4) y los casos procedentes de las regiones Norte (OR = 2,8; IC95%: 1,1-7,1) y Centro-oeste (OR = 2,8; IC95%: 1,1-7,0) se mostraron asociados al óbito. Creemos que el control de la TB en niños y adolescentes indígenas no se podrá alcanzar sin inversiones en investigación y desarrollo y sin la reducción de las desigualdades sociales.

Cannabis for the treatment of ulcerative colitis.

BACKGROUND: Cannabis and cannabinoids are often promoted as treatment for many illnesses and are widely used among patients with ulcerative colitis (UC). Few studies have evaluated the use of these agents in UC. Further, cannabis has potential for adverse events and the long-term consequences of cannabis and cannabinoid use in UC are unknown. OBJECTIVES: To assess the efficacy and safety of cannabis and cannabinoids for the treatment of patients with UC. SEARCH METHODS: We searched MEDLINE, Embase, WHO ICTRP, AMED, PsychINFO, the Cochrane IBD Group Specialized Register, CENTRAL, ClinicalTrials.Gov and the European Clinical Trials Register from inception to 2 January 2018. Conference abstracts and references were searched to identify additional studies. SELECTION CRITERIA: Randomized controlled trials (RCTs) comparing any form or dose of cannabis or its cannabinoid derivatives (natural or synthetic) to placebo or an active therapy for adults (> 18 years) with UC were included. DATA COLLECTION AND ANALYSIS: Two authors independently screened search results, extracted data and assessed bias using the Cochrane risk of bias tool. The primary outcomes were clinical remission and relapse (as defined by the primary studies). Secondary outcomes included clinical response, endoscopic remission, endoscopic response, histological response, quality of life, C-reactive protein (CRP) and fecal calprotectin measurements, symptom improvement, adverse events, serious adverse events, withdrawal due to adverse events, psychotropic adverse events, and cannabis dependence and withdrawal effects. We calculated the risk ratio (RR) and corresponding 95% confidence interval for dichotomous outcomes. For continuous outcomes, we calculated the mean difference (MD) and corresponding 95% CI. Data were pooled for analysis when the interventions, patient groups and outcomes were sufficiently similar (determined by consensus). Data were analyzed on an intention-to-treat basis. GRADE was used to evaluate the overall certainty of evidence. MAIN RESULTS: Two RCTs (92 participants) met the inclusion criteria. One study (N = 60) compared 10 weeks of cannabidiol capsules with up to 4.7% D9-tetrahydrocannabinol (THC) with placebo capsules in participants with mild to moderate UC. The starting dose of cannabidiol was 50 mg twice daily increasing to 250 mg twice daily if tolerated. Another study (N = 32) compared 8 weeks of therapy with two cannabis cigarettes per day containing 0.5 g of cannabis, corresponding to 23 mg THC/day to placebo cigarettes in participants with UC who did not respond to conventional medical treatment. No studies were identified that assessed cannabis therapy in quiescent UC. The first study was rated as low risk of bias and the second study (published as an abstract) was rated as high risk of bias for blinding of participants and personnel. The studies were not pooled due to differences in the interventional drug.The effect of cannabidiol capsules (100 mg to 500 mg daily) compared to placebo on clinical remission and response is uncertain. Clinical remission at 10 weeks was achieved by 24% (7/29) of the cannabidiol group compared to 26% (8/31) in the placebo group (RR 0.94, 95% CI 0.39 to 2.25; low certainty evidence). Clinical response at 10 weeks was achieved in 31% (9/29) of cannabidiol participants compared to 22% (7/31) of placebo patients (RR 1.37, 95% CI 0.59 to 3.21; low certainty evidence). Serum CRP levels were similar in both groups after 10 weeks of therapy. The mean CRP in the cannabidiol group was 9.428 mg/L compared to 7.638 mg/L in the placebo group (MD 1.79, 95% CI -5.67 to 9.25; moderate certainty evidence). There may be a clinically meaningful improvement in quality of life at 10 weeks, measured with the IBDQ scale (MD 17.4, 95% CI -3.45 to 38.25; moderate certainty evidence). Adverse events were more frequent in cannabidiol participants compared to placebo. One hundred per cent (29/29) of cannabidiol participants had an adverse event, compared to 77% (24/31) of placebo participants (RR 1.28, 95% CI 1.05 to1.56; moderate certainty evidence). However, these adverse events were considered to be mild or moderate in severity. Common adverse events included dizziness, disturbance in attention, headache, nausea and fatigue. None (0/29) of the cannabidiol participants had a serious adverse event compared to 13% (4/31) of placebo participants (RR 0.12, 95% CI 0.01 to 2.11; low certainty evidence). Serious adverse events in the placebo group included worsening of UC and one complicated pregnancy. These serious adverse events were thought to be unrelated to the study drug. More participants in the cannabidiol group withdrew due to an adverse event than placebo participants. Thirty-four per cent (10/29) of cannabidiol participants withdrew due to an adverse event compared to 16% (5/31) of placebo participants (RR 2.14, 95% CI 0.83 to 5.51; low certainty evidence). Withdrawls in the cannabidiol group were mostly due to dizziness. Withdrawals in the placebo group were due to worsening UC.The effect of cannabis cigarettes (23 mg THC/day) compared to placebo on mean disease activity, CRP levels and mean fecal calprotectin levels is uncertain. After 8 weeks, the mean disease activity index score in cannabis participants was 4 compared with 8 in placebo participants (MD -4.00, 95% CI -5.98 to -2.02). After 8 weeks, the mean change in CRP levels was similar in both groups (MD -0.30, 95% CI -1.35 to 0.75; low certainty evidence). The mean fecal calprotectin level in cannabis participants was 115 mg/dl compared to 229 mg/dl in placebo participants (MD -114.00, 95% CI -246.01 to 18.01). No serious adverse events were observed. This study did not report on clinical remission, clinical response, quality of life, adverse events or withdrawal due to adverse events. AUTHORS' CONCLUSIONS: The effects of cannabis and cannabidiol on UC are uncertain, thus no firm conclusions regarding the efficacy and safety of cannabis or cannabidiol in adults with active UC can be drawn.There is no evidence for cannabis or cannabinoid use for maintenance of remission in UC. Further studies with a larger number of patients are required to assess the effects of cannabis in UC patients with active and quiescent disease. Different doses of cannabis and routes of administration should be investigated. Lastly, follow-up is needed to assess the long term safety outcomes of frequent cannabis use.

Migrant patients living with HIV/AIDS in Japan: Review of factors associated with high dropout rate in a leading medical institution in Japan.

The present study aimed to identify factors associated with retention in HIV/AIDS care among migrant patients who visited the outpatient clinic of the AIDS Clinical Center, National Center for Global Health and Medicine in Tokyo, Japan. We reviewed the records of 551 selected (78 non-Japanese and 473 Japanese) patients who started visiting our clinic between 2011 and 2014. A total of 390 patients (70.8%: 38 non-Japanese and 352 Japanese) continued their visits during the study: from the date of their first visit to the end of 2015. The difference in retention rate was not significant (Incidence Rate Ratio (IRR) = 0.89, p = 0.27), but the loss-to-follow-up cases were considerably high among non-Japanese patients (n = 13, Incidence rate (IR) = 24.6 per 100,000 person-days, IRR = 3.65, p<0.01 after adjusting for time since diagnosis). The results showed, nevertheless, that there was no apparent association between retention and factors peculiar to non-Japanese. Twelve out of thirteen lost-to-follow-up non-Japanese patients held legal status to reside in Japan and were eligible for public health services. Nine had limited fluency in Japanese language, and six used alternative verbal communication. Further studies are needed to identify the factors responsible for the high dropout rate and to improve the care of migrant patients living with HIV/AIDS.

Mindfulness-based stress reduction for family carers of people with dementia.

BACKGROUND: Caring for people with dementia is highly challenging, and family carers are recognised as being at increased risk of physical and mental ill-health. Most current interventions have limited success in reducing stress among carers of people with dementia. Mindfulness-based stress reduction (MBSR) draws on a range of practices and may be a promising approach to helping carers of people with dementia. OBJECTIVES: To assess the effectiveness of MBSR in reducing the stress of family carers of people with dementia. SEARCH METHODS: We searched ALOIS - the Cochrane Dementia and Cognitive Improvement Group's Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (all years to Issue 9 of 12, 2017), MEDLINE (Ovid SP 1950 to September 2017), Embase (Ovid SP 1974 to Sepetmber 2017), Web of Science (ISI Web of Science 1945 to September 2017), PsycINFO (Ovid SP 1806 to September 2017), CINAHL (all dates to September 2017), LILACS (all dates to September 2017), World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP), ClinicalTrials.gov, and Dissertation Abstracts International (DAI) up to 6 September 2017, with no language restrictions. SELECTION CRITERIA: Randomised controlled trials (RCTs) of MBSR for family carers of people with dementia. DATA COLLECTION AND ANALYSIS: Two review authors independently screened references for inclusion criteria, extracted data, assessed the risk of bias of trials with the Cochrane 'Risk of bias' tool, and evaluated the quality of the evidence using the GRADE instrument. We contacted study authors for additional information, then conducted meta-analyses, or reported results narratively in the case of insufficient data. We used standard methodological procedures expected by Cochrane. MAIN RESULTS: We included five RCTs involving 201 carers assessing the effectiveness of MBSR. Controls used in included studies varied in structure and content. Mindfulness-based stress reduction programmes were compared with either active controls (those matched for time and attention with MBSR, i.e. education, social support, or progressive muscle relaxation), or inactive controls (those not matched for time and attention with MBSR, i.e. self help education or respite care). One trial used both active and inactive comparisons with MBSR. All studies were at high risk of bias in terms of blinding of outcome assessment. Most studies provided no information about selective reporting, incomplete outcome data, or allocation concealment.1. Compared with active controls, MBSR may reduce depressive symptoms of carers at the end of the intervention (3 trials, 135 participants; standardised mean difference (SMD) -0.63, 95% confidence interval (CI) -0.98 to -0.28; P<0.001; low-quality evidence). We could not be certain of any effect on clinically significant depressive symptoms (very low-quality evidence).Mindfulness-based stress reduction compared with active control may decrease carer anxiety at the end of the intervention (1 trial, 78 participants; mean difference (MD) -7.50, 95% CI -13.11 to -1.89; P<0.001; low-quality evidence) and may slightly increase carer burden (3 trials, 135 participants; SMD 0.24, 95% CI -0.11 to 0.58; P=0.18; low-quality evidence), although both results were imprecise, and we could not exclude little or no effect. Due to the very low quality of the evidence, we could not be sure of any effect on carers' coping style, nor could we determine whether carers were more or less likely to drop out of treatment.2. Compared with inactive controls, MBSR showed no clear evidence of any effect on depressive symptoms (2 trials, 50 participants; MD -1.97, 95% CI -6.89 to 2.95; P=0.43; low-quality evidence). We could not be certain of any effect on clinically significant depressive symptoms (very low-quality evidence).In this comparison, MBSR may also reduce carer anxiety at the end of the intervention (1 trial, 33 participants; MD -7.27, 95% CI -14.92 to 0.38; P=0.06; low-quality evidence), although we were unable to exclude little or no effect. Due to the very low quality of the evidence, we could not be certain of any effects of MBSR on carer burden, the use of positive coping strategies, or dropout rates.We found no studies that looked at quality of life of carers or care-recipients, or institutionalisation.Only one included study reported on adverse events, noting a single adverse event related to yoga practices at home AUTHORS' CONCLUSIONS: After accounting for non-specific effects of the intervention (i.e. comparing it with an active control), low-quality evidence suggests that MBSR may reduce carers' depressive symptoms and anxiety, at least in the short term.There are significant limitations to the evidence base on MBSR in this population. Our GRADE assessment of the evidence was low to very low quality. We downgraded the quality of the evidence primarily because of high risk of detection or performance bias, and imprecision.In conclusion, MBSR has the potential to meet some important needs of the carer, but more high-quality studies in this field are needed to confirm its efficacy.

Psychological therapies for the treatment of mental disorders in low- and middle-income countries affected by humanitarian crises.

BACKGROUND: People living in humanitarian settings in low- and middle-income countries (LMICs) are exposed to a constellation of stressors that make them vulnerable to developing mental disorders. Mental disorders with a higher prevalence in these settings include post-traumatic stress disorder (PTSD) and major depressive, anxiety, somatoform (e.g. medically unexplained physical symptoms (MUPS)), and related disorders. A range of psychological therapies are used to manage symptoms of mental disorders in this population. OBJECTIVES: To compare the effectiveness and acceptability of psychological therapies versus control conditions (wait list, treatment as usual, attention placebo, psychological placebo, or no treatment) aimed at treating people with mental disorders (PTSD and major depressive, anxiety, somatoform, and related disorders) living in LMICs affected by humanitarian crises. SEARCH METHODS: We searched the Cochrane Common Mental Disorders Controlled Trials Register (CCMDCTR), the Cochrane Central Register of Controlled Trials (Wiley), MEDLINE (OVID), Embase (OVID), and PsycINFO (OVID), with results incorporated from searches to 3 February 2016. We also searched the World Health Organization (WHO) trials portal (ICTRP) and ClinicalTrials.gov to identify any unpublished or ongoing studies. We checked the reference lists of relevant studies and reviews. SELECTION CRITERIA: All randomised controlled trials (RCTs) comparing psychological therapies versus control conditions (including no treatment, usual care, wait list, attention placebo, and psychological placebo) to treat adults and children with mental disorders living in LMICs affected by humanitarian crises. DATA COLLECTION AND ANALYSIS: We used standard Cochrane procedures for collecting data and evaluating risk of bias. We calculated standardised mean differences for continuous outcomes and risk ratios for dichotomous data, using a random-effects model. We analysed data at endpoint (zero to four weeks after therapy); at medium term (one to four months after therapy); and at long term (six months or longer). GRADE (Grades of Recommendation, Assessment, Development, and Evaluation) was used to assess the quality of evidence for post-traumatic stress disorder (PTSD), depression, anxiety and withdrawal outcomes. MAIN RESULTS: We included 36 studies (33 RCTs) with a total of 3523 participants. Included studies were conducted in sub-Saharan Africa, the Middle East and North Africa, and Asia. Studies were implemented in response to armed conflicts; disasters triggered by natural hazards; and other types of humanitarian crises. Together, the 33 RCTs compared eight psychological treatments against a control comparator.Four studies included children and adolescents between 5 and 18 years of age. Three studies included mixed populations (two studies included participants between 12 and 25 years of age, and one study included participants between 16 and 65 years of age). Remaining studies included adult populations (18 years of age or older).Included trials compared a psychological therapy versus a control intervention (wait list in most studies; no treatment; treatment as usual). Psychological therapies were categorised mainly as cognitive-behavioural therapy (CBT) in 23 comparisons (including seven comparisons focused on narrative exposure therapy (NET), two focused on common elements treatment approach (CETA), and one focused on brief behavioural activation treatment (BA)); eye movement desensitisation and reprocessing (EMDR) in two comparisons; interpersonal psychotherapy (IPT) in three comparisons; thought field therapy (TFT) in three comparisons; and trauma or general supportive counselling in two comparisons. Although interventions were described under these categories, several psychotherapeutic elements were common to a range of therapies (i.e. psychoeducation, coping skills).In adults, psychological therapies may substantially reduce endpoint PTSD symptoms compared to control conditions (standardised mean difference (SMD) -1.07, 95% confidence interval (CI) -1.34 to -0.79; 1272 participants; 16 studies; low-quality evidence). The effect is smaller at one to four months (SMD -0.49, 95% CI -0.68 to -0.31; 1660 participants; 18 studies) and at six months (SMD -0.37, 95% CI -0.61 to -0.14; 400 participants; five studies). Psychological therapies may also substantially reduce endpoint depression symptoms compared to control conditions (SMD -0.86, 95% CI -1.06 to -0.67; 1254 participants; 14 studies; low-quality evidence). Similar to PTSD symptoms, follow-up data at one to four months showed a smaller effect on depression (SMD -0.42, 95% CI -0.63 to -0.21; 1386 participants; 16 studies). Psychological therapies may moderately reduce anxiety at endpoint (SMD -0.74, 95% CI -0.98 to -0.49; 694 participants; five studies; low-quality evidence) and at one to four months' follow-up after treatment (SMD -0.53, 95% CI -0.66 to -0.39; 969 participants; seven studies). Dropout rates are probably similar between study conditions (19.5% with control versus 19.1% with psychological therapy (RR 0.98 95% CI 0.82 to 1.16; 2930 participants; 23 studies, moderate quality evidence)).In children and adolescents, we found very low quality evidence for lower endpoint PTSD symptoms scores in psychotherapy conditions (CBT) compared to control conditions, although the confidence interval is wide (SMD -1.56, 95% CI -3.13 to 0.01; 130 participants; three studies;). No RCTs provided data on major depression or anxiety in children. The effect on withdrawal was uncertain (RR 1.87 95% CI 0.47 to 7.47; 138 participants; 3 studies, low quality evidence).We did not identify any studies that evaluated psychological treatments on (symptoms of) somatoform disorders or MUPS in LMIC humanitarian settings. AUTHORS' CONCLUSIONS: There is low quality evidence that psychological therapies have large or moderate effects in reducing PTSD, depressive, and anxiety symptoms in adults living in humanitarian settings in LMICs. By one to four month and six month follow-up assessments treatment effects were smaller. Fewer trials were focused on children and adolescents and they provide very low quality evidence of a beneficial effect of psychological therapies in reducing PTSD symptoms at endpoint. Confidence in these findings is influenced by the risk of bias in the studies and by substantial levels of heterogeneity. More research evidence is needed, particularly for children and adolescents over longer periods of follow-up.