Diagnostic efficacy of sentinel node biopsy in oral squamous cell carcinoma : cohort study and meta-analysis

Objectives: To evaluate the efficacy of sentinel node biopsy (SNB) in oral squamous cell carcinoma (OSCC). Design: A prospective study of a cohort of 25 consecutive patients with OSCC anatomopathological confirmation through biopsy, without oncological pre-treatment, in clinical stage T1-T4N0, of these 25 patients 14 were T1-T2N0. The absence of regional disease (N0) was determined by means of clinical exploration and cervical tomography (CT). To establish the overall sensitivity of the technique, a meta-analysis was carried out of 10 series published to February 2005 where SNB had been applied to head and neck cancer, adding our 14 T1-T2N0 cases, thus making a total of 260 patients. Results: Identification by SNB was accurate in 96% of the 25 cases, with a sensitivity of 66.7%. Analyzing only the T1-T2N0 cases (n=14), the accuracy was 100% with a sensitivity of 1 (CI 95%, 0.29-1.00). The overall sensitivity was 93%. The accuracy in identifying the sentinel node varied between 66% and 100%. The SN was identified in 251 of 260 cases, of those, 71 were true positive, 5 false negative and 175 true negative. The overall sensitivity was 93.4% (CI 95%, 85.3-97.8), with a specificity of 100% (CI 95%, 0.98-100). The weighted negative probability quotient was 0.176 (CI 0.103-0.301) and that of positive probability 24.75 (CI 95%, 10.8-56.71). The weighted diagnostic odds ratio was 183.71 (CI 95%, 59.36-568.56). If we accept that the prevalence of hidden regional disease is 30%, a negative sentinel node has 5% possibility of having hidden disease. Conclusions: Our data provide a certain degree of evidence that, due to its high sensitivity, the SNB procedure can be applied to the initial stages of OSCC

Bladder cancer index: cross-cultural adaptation into Spanish and psychometric evaluation

BACKGROUND: The Bladder Cancer Index (BCI) is so far the only instrument applicable across all bladder cancer patients, independent of tumor infiltration or treatment applied. We developed a Spanish version of the BCI, and assessed its acceptability and metric properties. METHODS: For the adaptation into Spanish we used the forward and back-translation method, expert panels, and cognitive debriefing patient interviews. For the assessment of metric properties we used data from 197 bladder cancer patients from a multi-center prospective study. The Spanish BCI and the SF-36 Health Survey were self-administered before and 12 months after treatment. Reliability was estimated by Cronbach's alpha. Construct validity was assessed through the multi-trait multi-method matrix. The magnitude of change was quantified by effect sizes to assess responsiveness. RESULTS: Reliability coefficients ranged 0.75-0.97. The validity analysis confirmed moderate associations between the BCI function and bother subscales for urinary (r = 0.61) and bowel (r = 0.53) domains; conceptual independence among all BCI domains (r ≤ 0.3); and low correlation coefficients with the SF-36 scores, ranging 0.14-0.48. Among patients reporting global improvement at follow-up, pre-post treatment changes were statistically significant for the urinary domain and urinary bother subscale, with effect sizes of 0.38 and 0.53. CONCLUSIONS: The Spanish BCI is well accepted, reliable, valid, responsive, and similar in performance compared to the original instrument. These findings support its use, both in Spanish and international studies, as a valuable and comprehensive tool for assessing quality of life across a wide range of bladder cancer patients

Bladder cancer index : Cross-cultural adaptation into Spanish and psychometric evaluation

Background: The Bladder Cancer Index (BCI) is so far the only instrument applicable across all bladder cancer patients, independent of tumor infiltration or treatment applied. We developed a Spanish version of the BCI, and assessed its acceptability and metric properties. Methods: For the adaptation into Spanish we used the forward and back-translation method, expert panels, and cognitive debriefing patient interviews. For the assessment of metric properties we used data from 197 bladder cancer patients from a multi-center prospective study. The Spanish BCI and the SF-36 Health Survey were self-administered before and 12 months after treatment. Reliability was estimated by Cronbach's alpha. Construct validity was assessed through the multi-trait multi-method matrix. The magnitude of change was quantified by effect sizes to assess responsiveness. Results: Reliability coefficients ranged 0.75-0.97. The validity analysis confirmed moderate associations between the BCI function and bother subscales for urinary (r = 0.61) and bowel (r = 0.53) domains; conceptual independence among all BCI domains (r ≤ 0.3); and low correlation coefficients with the SF-36 scores, ranging 0.14-0.48. Among patients reporting global improvement at follow-up, pre-post treatment changes were statistically significant for the urinary domain and urinary bother subscale, with effect sizes of 0.38 and 0.53. Conclusions: The Spanish BCI is well accepted, reliable, valid, responsive, and similar in performance compared to the original instrument. These findings support its use, both in Spanish and international studies, as a valuable and comprehensive tool for assessing quality of life across a wide range of bladder cancer patients