ABSTRACT
BACKGROUND: The lack of uniformity in the outcomes reported in clinical studies of the treatment of cutaneous squamous cell carcinoma (cSCC) complicates efforts to compare treatment effectiveness across trials. OBJECTIVES: To develop a core outcome set (COS), a minimum set of agreed-upon outcomes to be measured in all clinical trials of a given disease or outcome, for the treatment of cSCC. METHODS: One hundred and nine outcomes were identified via a systematic literature review and interviews with 28 stakeholders. After consolidation of this long list, 55 candidate outcomes were rated by 19 physician and 10 patient stakeholders, in two rounds of Delphi exercises. Outcomes scored 'critically important' (score of 7, 8 or 9) by ≥ 70% of patients and ≥ 70% of physicians were provisionally included. At the consensus meeting, after discussion and voting of 44 international experts and patients, the provisional list was reduced to a final core set, for which consensus was achieved among all meeting participants. RESULTS: A core set of seven outcomes was finalized at the consensus meeting: (i) serious or persistent adverse events, (ii) patient-reported quality of life, (iii) complete response, (iv) partial response, (v) recurrence-free survival, (vi) progression-free survival and (vii) disease-specific survival. CONCLUSIONS: In order to increase the comparability of results across trials and to reduce selective reporting bias, cSCC researchers should consider reporting these core outcomes. Further work needs to be performed to identify the measures that should be reported for each of these outcomes.
Subject(s)
Carcinoma, Squamous Cell , Skin Neoplasms , Carcinoma, Squamous Cell/therapy , Delphi Technique , Humans , Quality of Life , Research Design , Skin Neoplasms/therapy , Treatment OutcomeABSTRACT
BACKGROUND: Anti-HER2 therapy-related cardiotoxicity is well described in the context of clinical trials, particularly in the setting of early stage disease, but there is more limited data in advanced breast cancer and in the real world setting. MATERIAL AND METHODS: A prospectively-maintained registry database with 312 consecutive patients diagnosed with HER2 positive advanced breast cancer in Australia was analysed. RESULTS: 287 patients (92%) received anti-HER2 therapy, 17 (6%) experienced anti-HER2 therapy-related cardiotoxicity. Patients who experienced cardiotoxicity were more likely to have ≥2 risk factors for cardiotoxicity (OR 3.9 95% CI 1.4-11.3 p = 0.01). A prior diagnosis of cardiovascular disease was significantly associated with cardiotoxicity (OR 7.1 95% CI 1.3-39.5). Cardiotoxicity resolved on imaging in 65% of patients; there was no association between severity and resolution. 11 patients (65%) received cardiologist input. Of the patients who developed cardiotoxicity, 12 patients (71%) received further anti-HER2 therapy in the first- or second-line setting without recurrent cardiotoxicity. DISCUSSION AND CONCLUSION: Therapy-related cardiotoxicity is an uncommon complication of anti-HER2 therapy in the real world setting. Cardiac toxicity resolved in the majority of affected patients, and further anti-HER2 therapy was administered without recurrence of cardiac issues. Our data suggests anti-HER2 therapy can be safely given in routine care, even in patients with risk factors for toxicity.
Subject(s)
Breast Neoplasms/complications , Cardiotoxicity/etiology , Receptor, ErbB-2/antagonists & inhibitors , Adult , Aged , Aged, 80 and over , Breast Neoplasms/drug therapy , Female , Humans , Middle Aged , Prospective StudiesABSTRACT
ABSTRACT Objective: To evaluate the adequacy of the documentation of referral forms for sexually abused females aged 13-19 years directed to the Sexual Assault Follow-up and Evaluation (SAFE) Clinic at the Agape Family Medicine Clinic, Nassau, The Bahamas, for interim management. Methods: An approved review was performed on 123 referral forms regarding sexually abused females aged 13-19 years who attended the SAFE Clinic from 2011 to 2015. The exercise focussed on documentation adequacy based on a scoring system developed by the researchers (> 50% was assessed to be adequate; records of the referee's disposition of the patient, the date of the incident and evidence of sexually transmitted infection (STI) screening were considered vital for adequacy). Descriptive and inferential statistics were calculated. Results: The median age of the participants was 14 years (interquartile range: 13-15). Of the 63.4% (78) with documented nationality, 88.5% (69) were Bahamian and 11.5% (9) Haitian. Documentation status did not differ statistically significantly by nationality. Regarding documentation, 74% (91) recorded the name of the patient's school, 59.3% (73) recorded that the patient knew the assailant and 17.9% (22) indicated that the patient did not know the assailant, while 22.8% (28) did not document this latter information. Type of sexual penetration was indicated by 65.9% (81). Of the vital variables, 18.7% (23) recorded the referee's disposition of the patient, 29.8% (36) the date of the incident and 60.2% (74) evidence of STI screening; 7.3% (9) documented all three and 22.8% (28) two. The mean percentage of documentation for vital variables was 49.3% (± 3.6) for the Accident and Emergency (A&E) Department, Princess Margaret Hospital, Nassau, versus 30.5% (± 4.0) for public health clinics (PHCs) (p = 0.001). Overall, 69.9% (86 of 123) of the referral forms were deemed inadequate: 64.7% (33 of 51) from the A&E Department versus 73.4% (47 of 64) from PHCs among the 115 patients who provided referral information. Conclusion: Documentation deficiencies of the sexual abuse referral forms demand reform. Complete and consistent documentation is required.
RESUMEN Objetivo: Evaluar la idoneidad de la documentación de los formularios de remisión para mujeres de 13 a 19 años sexualmente abusadas, dirigidas a la Clínica de Evaluación y Seguimiento de Agresiones Sexuales (ESAS) en la Clínica Ágape de Medicina Familiar, Nassau, Bahamas, para la administración interina. Métodos: Se aprobó una revisión para examinar 123 formularios de remisión con respecto a las mujeres de 13 a 19 años sexualmente abusadas, que asistieron a la clínica de ESAS de 2011 a 2015. El ejercicio se centró en la idoneidad de la documentación basada en un sistema de puntuación desarrollado por los investigadores (50% fue adecuado según la valoración; los registros de la disposición de la paciente en el arbitraje, la fecha del incidente y la evidencia del tamizaje de la infección de transmisión sexual (ITS), fueron todos vitales a la hora de determinar la idoneidad). Se calcularon las estadísticas descriptivas e inferenciales. Resultados: La edad promedio de las participantes fue 14 años (rango intercuartil: 13-15). De 63.4% (78) con nacionalidad documentada, el 88.5% (69) fueron bahameñas y el 11.5% (9) haitianas. El estado de la documentación en término de las estadísticas no difirió significativamente por nacionalidad. Con respecto a la documentación, el 74% (91) registró el nombre de la escuela de la paciente, 59.3% (73) registró que la paciente conocía al agresor, y el 17.9% (22) indicó que la paciente no conocía al agresor, mientras que el 22.8% (28) no documentó esta última información. El tipo de penetración sexual fue indicado por 65.9% (81). De las variables vitales, 18.7% (23) registró la disposición de la paciente en el arbitraje, 29.8% (36) la fecha del incidente, y el 60.2% (74) evidencia del tamizaje de las ITS; 7.3% (9) documentó tres de ellas y 2.8% (28) dos. El porcentaje medio de documentación de las variables vitales fue 49.3% (± 3.6) para el Departamento de Accidentes y Emergencias (A&E), Hospital Princess Margaret, Nassau, frente al 30.5% (± 4.0) de las clínicas de salud pública (CSP) (p = 0.001). En general, el 69.9% (86 de 123) de los formularios de referencia se consideró inadecuado: 64.7% (33 de 51) del Departamento de A&E frente al 73.4% (47 de 64) de las CSP entre las 115 pacientes que proporcionaron la información de la remisión. Conclusión: Las deficiencias de la documentación de los formularios de remisión de abuso sexual exigen reformas. Se requiere una documentación completa y consistente.
