Uniform multidrug therapy for leprosy patients in Brazil (U-MDT/CT-BR): Results of an open label, randomized and controlled clinical trial, among multibacillary patients.

BACKGROUND: Leprosy control is based on early diagnosis and multidrug therapy. For treatment purposes, leprosy patients can be classified as paucibacillary (PB) or multibacillary (MB), according to the number of skin lesions. Studies regarding a uniform treatment regimen (U-MDT) for all leprosy patients have been encouraged by the WHO, rendering disease classification unnecessary. METHODOLOGY AND FINDINGS: An independent, randomized, controlled clinical trial conducted from 2007 to 2015 in Brazil, compared main outcomes (frequency of reactions, bacilloscopic index trend, disability progression and relapse rates) among MB patients treated with a uniform regimen/U-MDT (dapsone+rifampicin+clofazimine for six months) versus WHO regular-MDT/R-MDT (dapsone+rifampicin+clofazimine for 12 months). A total of 613 newly diagnosed, untreated MB patients with high bacterial load were included. There was no statistically significant difference in Kaplan-Meyer survival function regarding reaction or disability progression among patients in the U-MDT and R-MDT groups, with more than 25% disability progression in both groups. The full mixed effects model adjusted for the bacilloscopic index average trend in time showed no statistically significant difference for the regression coefficient in both groups and for interaction variables that included treatment group. During active follow up, four patients in U-MDT group relapsed representing a relapse rate of 2.6 per 1000 patients per year of active follow up (95% CI [0·81, 6·2] per 1000). During passive follow up three patients relapsed in U-MDT and one in R-MTD. As this period corresponds to passive follow up, sensitivity analysis estimated the relapse rate for the entire follow up period between 2·9- and 4·5 per 1000 people per year. CONCLUSION: Our results on the first randomized and controlled study on U-MDT together with the results from three previous studies performed in China, India and Bangladesh, support the hypothesis that UMDT is an acceptable option to be adopted in endemic countries to treat leprosy patients in the field worldwide. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00669643.

Uniform multidrug therapy for leprosy patients in Brazil (U-MDT/CT-BR): results of an open label, randomized and controlled clinical trial, among multibacillary patients

BACKGROUND: Leprosy control is based on early diagnosis and multidrug therapy. For treatment purposes, leprosy patients can be classified as paucibacillary (PB) or multibacillary (MB), according to the number of skin lesions. Studies regarding a uniform treatment regimen (U-MDT) for all leprosy patients have been encouraged by the WHO, rendering disease classification unnecessary. METHODOLOGY AND FINDINGS: An independent, randomized, controlled clinical trial conducted from 2007 to 2015 in Brazil, compared main outcomes (frequency of reactions, bacilloscopic index trend, disability progression and relapse rates) among MB patients treated with a uniform regimen/U-MDT (dapsone+rifampicin+clofazimine for six months) versus WHO regular-MDT/R-MDT (dapsone+rifampicin+clofazimine for 12 months). A total of 613 newly diagnosed, untreated MB patients with high bacterial load were included. There was no statistically significant difference in Kaplan-Meyer survival function regarding reaction or disability progression among patients in the U-MDT and R-MDT groups, with more than 25% disability progression in both groups. The full mixed effects model adjusted for the bacilloscopic index average trend in time showed no statistically significant difference for the regression coefficient in both groups and for interaction variables that included treatment group. During active follow up, four patients in U-MDT group relapsed representing a relapse rate of 2.6 per 1000 patients per year of active follow up (95% CI [0·81, 6·2] per 1000). During passive follow up three patients relapsed in U-MDT and one in R-MTD. As this period corresponds to passive follow up, sensitivity analysis estimated the relapse rate for the entire follow up period between 2·9- and 4·5 per 1000 people per year. CONCLUSION: Our results on the first randomized and controlled study on U-MDT together with the results from three previous studies performed in China, India and Bangladesh, support the hypothesis that UMDT is an acceptable option to be adopted in endemic countries to treat leprosy patients in the field worldwide.

Communication training improves patient-centered provider behavior and screening for soldiers' mental health concerns.

OBJECTIVE: To evaluate the effectiveness of patient-centered communication training for military providers who conduct post-deployment health screening. The half-day interactive workshop included simulated Soldier patients using video technology. METHODS: Using a quasi-experimental design, all health care providers at four military treatment facilities were recruited for data collection during a four- to nine-day site visit (23 trained providers, 28 providers in the control group, and one provider declined to participate). All Soldiers were eligible to participate and were blinded to provider training status. Immediately after screening encounters, providers reported on their identification of mental health concerns and Soldiers reported on provider communication behaviors resulting in 1,400 matched pairs. Electronic health records were also available for 26,005 Soldiers. RESULTS: The workshop was found to increase (1) providers' patient-centered communication behaviors as evaluated by Soldiers; (2) provider identification of Soldier mental health concerns; and (3), related health outcomes including provision of education and referral to a confidential counseling resource. CONCLUSION: Results are promising, but with small effect sizes and study limitations, further research is warranted. PRACTICE IMPLICATIONS: A brief intensive workshop on patient-centered communication tailored to the military screening context is feasible and may improve key outcomes.

Implementing a Measurement Feedback System: A Tale of Two Sites.

A randomized experiment was conducted in two outpatient clinics evaluating a measurement feedback system called contextualized feedback systems. The clinicians of 257 Youth 11-18 received feedback on progress in mental health symptoms and functioning either every 6 months or as soon as the youth's, clinician's or caregiver's data were entered into the system. The ITT analysis showed that only one of the two participating clinics (Clinic R) had an enhanced outcome because of feedback, and only for the clinicians' ratings of youth symptom severity on the SFSS. A dose-response effect was found only for Clinic R for both the client and clinician ratings. Implementation analyses showed that Clinic R had better implementation of the feedback intervention. Clinicians' questionnaire completion rate and feedback viewing at Clinic R were 50 % higher than clinicians at Clinic U. The discussion focused on the differences in implementation at each site and how these differences may have contributed to the different outcomes of the experiment.

Feedback mechanisms of change: How problem alerts reported by youth clients and their caregivers impact clinician-reported session content.

OBJECTIVE: This study explored how clinician-reported content addressed in treatment sessions was predicted by clinician feedback group and multi-informant cumulative problem alerts that appeared in computerized feedback reports for 299 clients aged 11-18 years receiving home-based community mental health treatment. METHOD: Measures included a clinician report of content addressed in sessions and additional measures of treatment progress and process (e.g., therapeutic alliance) completed by clinicians, clients, and their caregivers. Item responses in the top 25th percentile in severity from these measures appeared as "problem alerts" on corresponding computerized feedback reports. Clinicians randomized to the feedback group received feedback weekly while the control group did not. Analyses were conducted using the Cox proportional hazards regression for recurrent events. RESULTS: For all content domains, the results of the survival analyses indicated a robust effect of the feedback group on addressing specific content in sessions, with feedback associated with shorter duration to first occurrence and increased likelihood of addressing or focusing on a topic compared to the non-feedback group. CONCLUSION: There appears to be an important relationship between feedback and cumulative problem alerts reported by multiple informants as they influence session content.

Contact dermatitis to methylisothiazolinone.

Methylisothiazolinone (MI) is a preservative found in cosmetic and industrial products. Contact dermatitis caused by either methylchloroisothiazolinone/methylisothiazolinone (MCI/MI or Kathon CG) or MI has shown increasing frequency. The latter is preferably detected through epicutaneous testing with aqueous MI 2000 ppm, which is not included in the Brazilian standard tray. We describe a series of 23 patients tested using it and our standard tray. A case with negative reaction to MCI/MI and positive to MI is emphasized.

Vigilância à saúde: endemias e epidemias: tuberculose e hanseníase

Este material contempla a disciplina optativa " Vigilância à saúde: endemias e epidemias: tuberculose e hanseníase" do Curso de Especialização Estratégia Saúde da Família (2014). Esta disciplina busca incentivar a equipe multidisciplinar das equipes de Saúde da Família a se organizar para o controle da tuberculose e hanseníase. O conteúdo está distribuído em quatro seções: Seção 1: Fatores determinantes e condicionantes das epidemias e endemias. Seção 2: Abordagem específica de doenças endêmicas e epidêmicas. Seção 3: Situação da tuberculose e da hanseníase. Seção 4: Casos clínicos: tuberculose e hanseníase

Comparative effectiveness of after-school programs to increase physical activity.

BACKGROUND: We conducted a comparative effectiveness analysis to evaluate the difference in the amount of physical activity children engaged in when enrolled in a physical activity-enhanced after-school program based in a community recreation center versus a standard school-based after-school program. METHODS: The study was a natural experiment with 54 elementary school children attending the community ASP and 37 attending the school-based ASP. Accelerometry was used to measure physical activity. Data were collected at baseline, 6 weeks, and 12 weeks, with 91% retention. RESULTS: At baseline, 43% of the multiethnic sample was overweight/obese, and the mean age was 7.9 years (SD = 1.7). Linear latent growth models suggested that the average difference between the two groups of children at Week 12 was 14.7 percentage points in moderate-vigorous physical activity (P < .001). Cost analysis suggested that children attending traditional school-based ASPs-at an average cost of $17.67 per day-would need an additional daily investment of $1.59 per child for 12 weeks to increase their moderate-vigorous physical activity by a model-implied 14.7 percentage points. CONCLUSIONS: A low-cost, alternative after-school program featuring adult-led physical activities in a community recreation center was associated with increased physical activity compared to standard-of-care school-based after-school program.

The relationship between change in therapeutic alliance ratings and improvement in youth symptom severity: whose ratings matter the most?

This paper presents the psychometric evaluation of brief measures of therapeutic alliance (TA) for youths, clinicians and caregivers and a longitudinal analysis of relationships between changes in TA and changes in youth symptom and functioning severity. Psychometric analyses using methods from Classical Test Theory, Item Response Theory, and Factor Analysis indicate that the measures of TA used in this study offer something new for both practice and research. The measures have variability, sensitivity to change over time, brevity and can be used with multiple parties through parallel forms. The longitudinal analyses, employing hierarchical linear modeling with time-varying covariates, found that TA ratings of the clinician correlated with symptom improvement as rated by the clinician, caregiver and youth. Additional analyses showed that decreases in clinician-rated youth TA was most important in predicting a lower rate of youth improvement. Implications for future research and clinical practice are discussed.

Measurement Quality of the Caregiver Strain Questionnaire-Short Form 7 (CGSQ-SF7).

This study examined the measurement quality of an abbreviated version of the Caregiver Strain Questionnaire. The CGSQ-Short Form 7 (CGSQ-SF7) is practical for routine assessment of objective and subjective internalized caregiver strain. The subjective externalized subscale is not included in the CGSQ-SF7. Findings indicate that the reliability and validity of the shortened objective and subjective internalized subscales are comparable to the original. Examination of construct validity suggested that caregiver, youth, and clinician ratings of child clinical severity were related to objective caregiver strain. However, youth and clinician ratings of child clinical severity were not related to subjective internalized caregiver strain.

The Session Report Form (SRF): are clinicians addressing concerns reported by youth and caregivers?

This study explores the relationship between clinician-reported content addressed in sessions, measured with the Session Report Form (SRF), and multi-informant problem alerts stemming from a larger battery of treatment process and progress measures. Multilevel Multinomial Logit Models were conducted with 133 clinicians and 299 youths receiving home-based treatment (N = 3,143 sessions). Results indicate a strong relationship between session content and problems related to youth symptoms and functioning as reported by clinicians in the same session. Session content was related to emotional, family, and friend/peer problems reported by youth and youth behavioral problems reported by caregivers. High-risk problems (alcohol/substance use, harm to self or others) were strongly related to session content regardless of informant. Session content was not related to problem alerts associated with the treatment process, caregiver strain, or client/caregiver strengths. The SRF appears to be a useful measure for assessing common themes addressed in routine mental health settings.

Endemias e epidemias: tuberculose e hanseníase

Este módulo integra a disciplina optativa " Vigilância à saúde: endemias e epidemias: tuberculose e hanseníase" do Curso de Especialização Estratégia Saúde da Família (2014). Esta disciplina busca incentivar a equipe multidisciplinar das equipes de Saúde da Família a se organizar para o controle da tuberculose e hanseníase. O conteúdo está distribuído em quatro seções: Seção 1: Fatores determinantes e condicionantes das epidemias e endemias. Seção 2: Abordagem específica de doenças endêmicas e epidêmicas. Seção 3: Situação da tuberculose e da hanseníase. Seção 4: Casos clínicos: tuberculose e hanseníase

Effects of routine feedback to clinicians on mental health outcomes of youths: results of a randomized trial.

OBJECTIVE: A randomized cluster controlled trial tested the hypothesis that weekly feedback to clinicians would improve the effectiveness of home-based mental health treatment received by youths in community settings. METHODS: Youths, caregivers, and clinicians at 28 sites in ten states completed assessments of the youths' symptoms and functioning every other week. Clinicians at 13 sites were provided with weekly feedback about the assessments, and clinicians at 15 sites received feedback every 90 days. Data were collected from June 1, 2006, through December 31, 2008. Intent-to-treat analyses were conducted with hierarchical linear modeling of data provided by youths, caregivers, and clinicians. RESULTS: Assessments by youths, caregivers, and clinicians indicated that youths (N=173) treated at sites where clinicians could receive weekly feedback improved faster than youths (N=167) treated at sites where clinicians did not receive weekly feedback. A dose-response analysis showed even stronger effects when clinicians viewed more feedback reports. CONCLUSIONS: Routine measurement and feedback can be used to improve outcomes for youths who receive typical home-based services in the community.

Exploring the black box: measuring youth treatment process and progress in usual care.

The session report form (SRF) is a 25-item self-report measure scheduled to be completed by clinicians at the end of each session. This study addresses the utility of the SRF for describing session content by exploring patterns of self-reported behavior of 235 clinicians in 7,058 sessions with 600 clients. Results indicate that the SRF has a distinct subscale of treatment process and provides an adequate range of topics related to session content while also discriminating between client and clinician influences on patterns of topics addressed. The SRF is a promising measure meeting a significant need in describing session content in usual care.

The influence of ML Flow test in leprosy classification.

This is a descriptive, exploratory study correlating ML Flow, bacilloscopy and classification of paucibacillary (PB) and multibacillary (MB), involving 1,041 new leprosy cases in 13 municipalities of Minas Gerais State, from October 2002 to March 2004. Agreement between ML Flow and the classification of the number of skin lesions and bacilloscopy was moderate (K:0.51 and K:0.48, respectively); and substantial for final classification (K:0.77). From January 2000 to March 2004, the proportion of new MB cases in Minas Gerais decreased from 78.1 to 65.8%. The reduction in the percentage of MB cases was higher in health centers that participated in the ML Flow study (73.1% to 53.3%). The difference between PB and MB in the participating and non-participating health centers from January to March 2004 was statistically significant. Implementation of the ML Flow test influenced the classification of patients, suggesting a direct and beneficial impact on patient treatment and the control of the leprosy endemic in Minas Gerais, Brazil.

Risk factors for ML Flow seropositivity in leprosy patients.

The early diagnosis of leprosy, its correct classification and the risk factors related to seropositivity have become important for patient treatment and disease control, especially where the responsibility for treatment has been transferred to basic health care centers. This descriptive, exploratory study using logistic regression was undertaken to evaluate the association between the variables of sex, age, mode of detection, number of skin lesions and affected nerves, disability grade and bacilloscopy with the results of the ML Flow serological test in 1,072 new leprosy cases in 13 municipalities in Minas Gerais State. Seropositivity (50.7%) was statistically associated with patients 15 years-old or over (OR:2.6) and those with more than five skin lesions (OR:7.5), more than one affected nerve (OR:2.4) and a positive bacilloscopic index (OR:5.5 for 0or=2), thus contributing to the appropriate classification and treatment of patients.

Seroprevalence of ML Flow test in leprosy contacts from State of Minas Gerais, Brazil.

Leprosy is a public health problem in Brazil. Epidemiological control actions are based on the diagnosis and treatment of leprosy patients and household contact surveillance. Serological tests for leprosy could identify from among the contacts those at greater risk of developing leprosy in the future. ML Flow was administered to 2,840 household contacts of new leprosy cases diagnosed from October 2002 to March 2004, in State of Minas Gerais. ML Flow was positive in 20.5% of leprosy contacts, with high seropositivity among males (22.4%), individuals aged over 15 years-old (21.7%) and individuals in contact with multibacillary cases (23.9%). The chances of a household contact presenting a seropositive test was related to household contact with a multibacillary index case (OR=1.75), age over 15 years-old (OR=1.38) and male gender (OR=1.25). Follow-up of these contacts is necessary to evaluate the real role of seropositivity in the development of leprosy disease.

A influência do teste sorológico ML Flow na classificação da hanseníase / The influence of ML Flow test in leprosy classification

Estudo descritivo e exploratório correlacionando o ML Flow, a baciloscopia e a classificação em paucibacilar (PB) e multibacilar (MB), envolveu 1.041 casos novos com hanseníase em 13 municípios de Minas Gerais, de outubro de 2002 a março de 2004. A concordância entre o ML Flow e a classificação pelo número de lesões cutâneas e a baciloscopia foi moderada (Kappa:0,51 e 0,48, respectivamente) e, substancial (Kappa:0,77) com a classificação final. De janeiro de 2000 a março de 2004, a proporção de casos novos MB no Estado, passou de 78,1 para 65,8%. A queda no percentual de MB foi maior nos serviços participantes da pesquisa ML Flow (73,1 para 53,3%). A diferença de PB e MB nos serviços participantes e não participantes, de janeiro a março de 2004, foi estatisticamente significativa, indicando implicação direta e benéfica no tratamento e no controle da endemia em Minas Gerais.

This is a descriptive, exploratory study correlating ML Flow, bacilloscopy and classification of paucibacillary (PB) and multibacillary (MB), involving 1,041 new leprosy cases in 13 municipalities of Minas Gerais State, from October 2002 to March 2004. Agreement between ML Flow and the classification of the number of skin lesions and bacilloscopy was moderate (K:0.51 and K:0.48, respectively); and substantial for final classification (K:0.77). From January 2000 to March 2004, the proportion of new MB cases in Minas Gerais decreased from 78.1 to 65.8%. The reduction in the percentage of MB cases was higher in health centers that participated in the ML Flow study (73.1% to 53.3%). The difference between PB and MB in the participating and non-participating health centers from January to March 2004 was statistically significant. Implementation of the ML Flow test influenced the classification of patients, suggesting a direct and beneficial impact on patient treatment and the control of the leprosy endemic in Minas Gerais, Brazil.

Fatores de risco para a soropositividade do ML Flow em pacientes com hanseníase / Risk factors for ML Flow seropositivity in leprosy patients

O diagnóstico precoce da hanseníase, a correta classificação e o estudo dos fatores de risco relacionados à soropositividade, tornam-se importantes para o tratamento do doente e controle da endemia, especialmente, quando a responsabilidade pelo atendimento desses pacientes está sendo absorvida pelos serviços de atenção básica. Estudo descritivo e exploratório utilizando regressão logística avaliou a associação das variáveis: sexo, idade, modo de detecção, número de lesões cutâneas e de nervos acometidos, grau de incapacidade, baciloscopia, com o resultado do teste sorológico ML Flow, em 1.072 casos novos com hanseníase em 13 municípios de Minas Gerais. A soropositividade (50,7%) estava estatisticamente associada aos pacientes com 15 anos ou mais de idade (OR:2,6), mais de cinco lesões cutâneas (OR:7,5), mais de um nervo acometido (OR:2,4) e com baciloscopia positiva (OR:5,5 para IB<2 e OR:191,2 para IB>2), colaborando, assim, com a classificação e o tratamento adequados dos doentes.

The early diagnosis of leprosy, its correct classification and the risk factors related to seropositivity have become important for patient treatment and disease control, especially where the responsibility for treatment has been transferred to basic health care centers. This descriptive, exploratory study using logistic regression was undertaken to evaluate the association between the variables of sex, age, mode of detection, number of skin lesions and affected nerves, disability grade and bacilloscopy with the results of the ML Flow serological test in 1,072 new leprosy cases in 13 municipalities in Minas Gerais State. Seropositivity (50.7%) was statistically associated with patients 15 years-old or over (OR:2.6) and those with more than five skin lesions (OR:7.5), more than one affected nerve (OR:2.4) and a positive bacilloscopic index (OR:5.5 for 02), thus contributing to the appropriate classification and treatment of patients.

Soroprevalência do teste ML Flow em contatos de hanseníase de Minas Gerais / Seroprevalence of ML Flow test in leprosy contacts from State of Minas Gerais, Brazil

A hanseníase é um problema de saúde pública no Brasil. As ações de controle estão baseadas no diagnóstico e tratamento dos indivíduos doentes e na vigilância de seus contatos. Os testes sorológicos permitem identificar, entre os contatos, aqueles com maior risco de desenvolver hanseníase. O ML Flow foi utilizado em 2.840 contatos intradomiciliares de casos novos de hanseníase, diagnosticados entre outubro de 2002 e março de 2004, em Minas Gerais. O ML Flow foi positivo em 20,5% dos contatos de hanseníase, sendo maior nos contatos do sexo masculino (22,4%), nos maiores de 15 anos (21,7%), nos contatos de doentes multibacilares (23,9%). A chance de um contato ser soropositivo foi maior se convivia com caso multibacilar (OR=1,75), idade superior a 15 anos (OR=1,38) e sexo masculino (OR=1,25). O acompanhamento desses contatos permitirá, no futuro, avaliar o risco que a soropositividade representa no desenvolvimento de hanseníase.

Leprosy is a public health problem in Brazil. Epidemiological control actions are based on the diagnosis and treatment of leprosy patients and household contact surveillance. Serological tests for leprosy could identify from among the contacts those at greater risk of developing leprosy in the future. ML Flow was administered to 2,840 household contacts of new leprosy cases diagnosed from October 2002 to March 2004, in State of Minas Gerais. ML Flow was positive in 20.5% of leprosy contacts, with high seropositivity among males (22.4%), individuals aged over 15 years-old (21.7%) and individuals in contact with multibacillary cases (23.9%). The chances of a household contact presenting a seropositive test was related to household contact with a multibacillary index case (OR=1.75), age over 15 years-old (OR=1.38) and male gender (OR=1.25). Follow-up of these contacts is necessary to evaluate the real role of seropositivity in the development of leprosy disease.