Quality assessment of clinical practice guidelines on treatments for oral cancer.

BACKGROUND: The applicability of clinical practice guidelines (CPGs) on treatments for oral cancer remains unknown since there are no systematic assessments of their quality. Thus, the objective of this study is to identify and assess the quality of them. METHODS: We conducted a systematic search to identify CPGs that provided recommendations on treatments for oral cancer. The quality of each included CPG was determined using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) instrument, by four appraisers independently. The inter-appraisers agreement was assessed. RESULTS: Twelve CPGs met the eligibility criteria. Overall agreement among appraisers was very good (ICC: 0.865; 95% CI: 0.835-0.889). The mean scores for each AGREE domain were the following: "scope and purpose" 88.4%±12.4%; "stakeholder involvement" 60.4%±25%; "rigor of development" 60.9%±25.3%; "clarity of presentation" 76.5%±19.8%; "applicability" 32.2%±30.7%; and "editorial independence" 61.6%±35.5%. Three CPGs were rated as "recommended"; six as "recommended with modifications"; and three as "not recommended". CONCLUSIONS: Overall, the quality of CPGs on treatments for oral cancer is suboptimal. These findings highlight the need to improve CPG development processes and their applicability in this field. Thus, increased efforts are required to enable the development of high-quality evidence-based CPGs for oral cancer.

Fixed-dose combinations of drugs versus single-drug formulations for treating pulmonary tuberculosis.

BACKGROUND: People who are newly diagnosed with pulmonary tuberculosis (TB) typically receive a standard first-line treatment regimen that consists of two months of isoniazid, rifampicin, pyrazinamide, and ethambutol followed by four months of isoniazid and rifampicin. Fixed-dose combinations (FDCs) of these drugs are widely recommended. OBJECTIVES: To compare the efficacy, safety, and acceptability of anti-tuberculosis regimens given as fixed-dose combinations compared to single-drug formulations for treating people with newly diagnosed pulmonary tuberculosis. SEARCH METHODS: We searched the Cochrane Infectious Disease Group Specialized Register; the Cochrane Central Register of Controlled Trials (CENTRAL, published in the Cochrane Library, Issue 11 2015); MEDLINE (1966 to 20 November 2015); EMBASE (1980 to 20 November 2015); LILACS (1982 to 20 November 2015); the metaRegister of Controlled Trials; and the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP), without language restrictions, up to 20 November 2015. SELECTION CRITERIA: Randomized controlled trials that compared the use of FDCs with single-drug formulations in adults (aged 15 years or more) newly diagnosed with pulmonary TB. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed studies for inclusion, and assessed the risk of bias and extracted data from the included trials. We used risk ratios (RRs) for dichotomous data and mean differences (MDs) for continuous data with 95% confidence intervals (CIs). We attempted to assess the effect of treatment for time-to-event measures with hazard ratios and their 95% CIs. We used the Cochrane 'Risk of bias' assessment tool to determine the risk of bias in included trials. We used the fixed-effect model when there was little heterogeneity and the random-effects model with moderate heterogeneity. We used an I² statistic value of 75% or greater to denote significant heterogeneity, in which case we did not perform a meta-analysis. We assessed the quality of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. MAIN RESULTS: We included 13 randomized controlled trials (RCTs) in the review, which enrolled 5824 participants. Trials were published between 1987 and 2015 and included participants in treatment with newly diagnosed pulmonary TB in countries with high TB prevalence. Only two trials reported the HIV status of included participants.Overall there is little or no difference detected between FDCs and single-drug formulations for most outcomes reported. We did not detect a difference in treatment failure between FDCs compared with single-drug formulations (RR 1.28, 95% CI 0.82 to 2.00; 3606 participants, seven trials, moderate quality evidence). Relapse may be more frequent in people treated with FDCs compared to single-drug formulations, although the confidence interval (CI) includes no difference (RR 1.28, 95% CI 1.00 to 1.64; 3621 participants, 10 trials, low quality evidence). We did not detect any difference in death between fixed-dose and single-drug formulation groups (RR 0.96, 95% CI 0.67 to 1.39; 4800 participants, 11 trials, moderate quality evidence).When we compared FDCs with single-drug formulations we found little or no difference for sputum smear or culture conversion at the end of treatment (RR 0.99, 95% CI 0.96 to 1.02; 2319 participants, seven trials, high quality evidence), for serious adverse events (RR 1.45, 95% CI 0.90 to 2.33; 3388 participants, six trials, moderate quality evidence), and for adverse events that led to discontinuation of therapy (RR 0.96, 95% CI 0.56 to 1.66; 5530 participants, 13 trials, low quality evidence).We conducted a sensitivity analysis excluding studies at high risk of bias and this did not alter the review findings. AUTHORS' CONCLUSIONS: Fixed-dose combinations and single-drug formulations probably have similar effects for treating people with newly diagnosed pulmonary TB.

Factores asociados a la adherencia en el tratamiento de la infección tuberculosa / Factors associated with treatment adherence for tuberculosis infection

OBJETIVO: Analizar la adherencia al tratamiento de la infección tuberculosa (TIT) e identificar los factores de riesgo para su cumplimiento. DISEÑO: Estudio observacional de cohortes históricas. Emplazamiento: Hospital Universitari Sant Joan d'Alacant (Alicante). Participantes: Todos los sujetos con una prueba de tuberculina (PT) realizada durante el estudio de contactos (EC) de tuberculosis durante 6 años. RESULTADOS: Se incluyeron en el análisis 764 contactos. El 59,7% de los 566 pacientes que terminaron el EC presentaron infección tuberculosa (IT). De los pacientes con IT, el 45,6% no iniciaron tratamiento y los factores asociados fueron: edad (36-65 años; RR: 5,8; IC 95%: 1,2-27,5 y > 65 años; RR: 11,3; IC 95%: 2,0-64,0), relación social con el caso índice de tuberculosis (RR: 2,2; IC 95%: 1,2-3,8) e induración de la PT (≥ 15 mm; RR: 0,5; IC 95%: 0,3-0,9). La tasa de cumplimiento fue del 80,4% entre los que comenzaron el TIT. La pauta de tratamiento 7-9H se asoció con mayor cumplimiento del TIT (RR: 12,7; IC 95%: 1,5-107,3). CONCLUSIONES: La tasa de cumplimiento del TIT fue elevada entre los que iniciaron tratamiento. Casi la mitad de los contactos con IT no iniciaron tratamiento y los factores asociados fueron: edad, relación social e induración de la PT. La pauta de tratamiento se asoció con mayor cumplimiento. Debemos conocer con precisión los factores asociados a la adherencia al tratamiento de la IT en cada área de salud y actuar sobre los grupos de riesgo, y de esta manera aproximar el control global de la tuberculosis

OBJECTIVE: To analyze adherence to treatment of tuberculosis infection and to identify risk factors for its compliance. DESIGN: An observational historical cohort study. Setting: Hospital Universitari Sant Joan d'Alacant (Alicante). Participants: All patients with a tuberculin skin test (TST) done during tuberculosis contact tracing during 6 years. RESULTS: We included 764 tuberculosis contacts in the analysis. 59.7% of the 566 patients who completed the contact tracing, had tuberculosis infection (TI). Of the patients with TI, 45.6%had not started treatment for tuberculosis infection (TTBI). Factors associated with not starting TTBI were: age (36-65 years, RR: 5.8; 95% CI: 1.2-27.5, and > 65 years, RR: 11.3; 95% CI: 2.0-64.0), the social relationship with TB case (RR: 2.2; 95% CI 1.2-3.8), and the TST reaction (≥15 mm; RR: 0.5; 95% CI: 0.3-0.9). The completion rate for TTBI was 80.4% among people who started therapy. The treatment regimen was associated with greater compliance to TTBT (7-9H, RR: 12.7; 95% CI: 1.5-107.3). CONCLUSIONS: The treatment compliance rate of Tuberculosis infection was high among people who started therapy. Almost a half of the contacts with TI did not start treatment, and associated factors were: age, social relationship, and the TST reaction. The treatment regimen was associated with greater compliance. It is important to know the factors associated with adherence to treatment of TI in each health area, and focus efforts on risk groups; thereby approaching the global control of tuberculosis

[Factors associated with treatment adherence for tuberculosis infection]. / Factores asociados a la adherencia en el tratamiento de la infección tuberculosa.

OBJECTIVE: To analyze adherence to treatment of tuberculosis infection and to identify risk factors for its compliance. DESIGN: An observational historical cohort study. SETTING: Hospital Universitari Sant Joan d'Alacant (Alicante). PARTICIPANTS: All patients with a tuberculin skin test (TST) done during tuberculosis contact tracing during 6 years. RESULTS: We included 764 tuberculosis contacts in the analysis. 59.7% of the 566 patients who completed the contact tracing, had tuberculosis infection (TI). Of the patients with TI, 45.6% had not started treatment for tuberculosis infection (TTBI). Factors associated with not starting TTBI were: age (36-65 years, RR: 5.8; 95% CI: 1.2-27.5, and > 65 years, RR: 11.3; 95% CI: 2.0-64.0), the social relationship with TB case (RR: 2.2; 95% CI 1.2-3.8), and the TST reaction (≥ 15mm; RR: 0.5; 95% CI: 0.3-0.9). The completion rate for TTBI was 80.4% among people who started therapy. The treatment regimen was associated with greater compliance to TTBT (7-9H, RR: 12.7; 95% CI: 1.5-107.3). CONCLUSIONS: The treatment compliance rate of Tuberculosis infection was high among people who started therapy. Almost a half of the contacts with TI did not start treatment, and associated factors were: age, social relationship, and the TST reaction. The treatment regimen was associated with greater compliance. It is important to know the factors associated with adherence to treatment of TI in each health area, and focus efforts on risk groups; thereby approaching the global control of tuberculosis.