A protocol on Information-Motivation-Behavioural Skills Risk of Intensive Phase Treatment Interruption Among Pulmonary Tuberculosis Patients in Urban Districts, Selangor

@# Despite advancement of treatment modalities, Tuberculosis (TB) treatment interruption rate has globally accelerating, calling for greater framework shifting towards psychosocial intervention. Similarly, Selangor state had reported the perturbing TB treatment interruption rate, which was figured persistently above 10% in the interval year of 2014 to 2018, thus signifies an empirical assessment on Information-Motivation-Behavioural skills (IMB) determinants of TB intensive phase treatment. This study aims to determine the time to intensive phase TB treatment interruption and its prognostic factors among newly diagnosed pulmonary Tuberculosis (PTB) smear positive patients in urban district Selangor. Methods: A multi-centric prospective cohort study will recruit 695 newly diagnosed PTB smear positive patients at treatment centres in urban districts, Selangor. This study will utilize validated self-administered questionnaire and standardised data collection form (PROFORMA). At baseline, we will elicit information on IMB models constructs, additionally on socio-demographics, health service factors and clinical characteristics. Meanwhile, four points follow up will be executed to retrieve information on treatment status and time varying effects of body weight, treatment side effects, symptoms improvement and internalised stigma. Finally, survival analysis will be computed to identify the time to intensive phase treatment interruption and its prognostic factors. Conclusion: This study will enlighten IMB model determinants of intensive phase treatment interruption, hence to endeavour psychosocial elements in designing time relevant public health strategies in TB case management. Tuberculosis; Treatment interruption; Survival; Time to event analysis; IMB model

Treatment interruption of biological drugs and tofacitinib in rheumatoid arthritis: A systematic review of case reports

The aim of this study was to evaluate interruption of treatment with biological drugs and tofacitinib due to adverse events in patients with rheumatoid arthritis. A systematic review was performed in the electronic databases MEDLINE, Cochrane, Scopus, CRD, IPA, Lilacs and Scielo. Case reports addressing interruption of treatment due to any adverse event related to abatacept (ABA), adalimumab (ADA), anakinra (ANA), certolizumab pegol (CER), etanercept (ETA), golimumab (GOL), infliximab (IFX), rituximab (RTX), secukinumab (SEC), tocilizumab (TCZ), tofacitinib (TOF) or ustekinumab (UST) in rheumatoid arthritis patients were evaluated. Baseline data, patient profile, previous and current treatments, cause of discontinuation and information on reintroduction of treatment were extracted from the case reports. One hundred and fifty-four studies (154 patients) reported 162 discontinuations of rheumatoid arthritis treatment due to adverse events (ETA = 57; IFX = 46; ADA = 32; TCZ = 13; RTX = 5; ANA = 3; GOL = 2; ABA = 2; TOF = 1; CER = 1; SEC = 0 and UST = 0). The mean age of patients was 56 (± 12.1) years and 82% were female. Seventy-four adverse events were confirmed (related to used drug), and 138 were observed in patients using anti-TNF. The most common adverse events were infections (21%), skin disease (15%), autoimmune disease (13%) and hematological disorders (9%). Case reports are important in the detection of rare adverse events and should be considered in the choice of appropriate therapy for patients.

Predictors of early treatment discontinuation and severe anemia in a Brazilian cohort of hepatitis C patients treated with first-generation protease inhibitors

The aim of this study was to determine risk factors for adverse events (AE)-related treatment discontinuation and severe anemia among patients with chronic hepatitis C virus (HCV) genotype 1 infection, treated with first-generation protease inhibitor (PI)-based therapy. We included all patients who initiated treatment with PI-based therapy at a Brazilian university hospital between November 2013 and December 2014. We prospectively collected data from medical records using standardized questionnaires and used Epi Info 6.0 for analysis. Severe anemia was defined as hemoglobin ≤8.5 mg/dL. We included 203 patients: 132 treated with telaprevir (TVR) and 71 treated with boceprevir (BOC). AE-related treatment discontinuation rate was 19.2% and anemia was the main reason (38.5%). Risk factors for treatment discontinuation were higher comorbidity index (OR=1.85, CI=1.05-3.25) for BOC, and higher bilirubin count (OR=1.02, CI=1.01-1.04) and lower BMI (OR=0.98, CI=0.96-0.99) for TVR. Severe anemia occurred in 35 (17.2%) patients. Risk factors for this outcome were lower estimated glomerular filtration rate (eGFR; OR=0.95, CI=0.91-0.98) for patients treated with TVR, and higher comorbidity index (OR=2.21, CI=1.04-4.67) and ribavirin dosage (OR=0.84, CI=0.72-0.99) for those treated with BOC. Fifty-five (57.3%) patients treated with TVR and 15 (27.3%) patients treated with BOC achieved sustained virological response (SVR). Among patients who received TVR and interrupted treatment due to AE (n=19), only 26.3% (n=5) achieved SVR (P=0.003). Higher number of comorbidities, lower eGFR and advanced liver disease are associated with severe anemia and early treatment cessation, which may compromise SVR achievement.

Reasons for interruption of anti-tubercular treatment as reported by patients with tuberculosis admitted in a tertiary care institute.

Setting: Department of Tuberculosis and Chest Diseases, Tertiary Level tuberculosis (TB) institute in Delhi, India. Objective: To study the reasons for interruption of Anti-Tubercular Treatment (ATT) as reported by tuberculosis patients admitted at LRSI. Design: Retrospective cohort-based analysis. Results: A total of 201 patients were enrolled (179 of pulmonary tuberculosis, eight of extra-pulmonary tuberculosis and fourteen of both pulmonary as well as extra-pulmonary tuberculosis); who had interrupted treatment 327 times. Maximum interruptions (72.17%) were found to occur by third month of ATT. More than one reason was often reported for discontinuation of treatment. In all, 366 responses were obtained from 201 patients, in response to reasons for treatment interruption. The rate of treatment interruption was higher in the private health sector (56.27%), as compared to DOTS (34.25%) and other sources of treatment (9.48%). Early improvement (30.05%) and high cost of treatment (16.39%) were found to be the two most common reasons, leading to treatment interruption. Conclusion: Early improvement and high cost of treatment were found to be the two most common reasons, leading to treatment interruption. Continuous health education should be provided to all tubercular patients emphasizing the need to continue treatment despite early improvement in symptoms.

Antihypertensive Drug Treatment and Risk of Cerebral Hemorrhage : Population-Based Case-Control Study / 薬剤疫学

Objective : To examine whether drug treatment for hypertension prevents the first occurrence of cerebral hemorrhage, a population-based case-control study was conducted in Hirara-city, Okinawa Prefecture, Japan.<BR>Methods : Cases were 36 hypertensive persons, 45 to 84 years of age, who had experienced cerebral hemorrhage from 1991 to 1994. Twenty of them were ascertained to be hypertensive by residential mass health examinations before the occurrence of cerebral hemorrhage, and other cases were ascertained by stroke register. Controls were 158 hypertensive persons unaffected by stroke and other life-threatening diseases, who were matched with their corresponding case for sex, age and mean blood pressure. All controls were ascertained as hypertensive by health examinations in 1991. Data on antihypertensive treatment, during the two years before the occurrence for cases and between April 1992 and March 1994 for controls, were collected by claims for medical care cost and medical records. Conditional logistic regression was employed for matched analyses.<BR>Results : Regarding treatment, 16 (44.4%) cases and 36 (23.5%) controls did not receive antihypertensive drug treatment, and 13 (36.1%) cases and 30 (19.6%) controls had interrupted treatment. Compared with continuously treated persons, untreated persons and interrupted persons had odds ratios of 6.27 (95% confidence interval : 2.21 to 17.8) and 4.94 (1.79 to 13.6) for cerebral hemorrhage, respectively. Cases were prescribed antihypertensive drugs for fewer months than controls. By subgroup analyses limited to the cases ascertained as hypertensive by mass health examinations and their matched controls, the same relation was observed.<BR>Conclusion : Among hypertensive persons, non-treatment and interruption of antihypertensive drug treatment were associated with a higher risk of cerebral hemorrhage. Long-term continuous treatment with antihypertensive drug (s) prevents the first occurrence of cerebral hemorrhage.