The association of financial difficulties with clinical outcomes in cancer patients: secondary analysis of 16 academic prospective clinical trials conducted in Italy.

BACKGROUND: Cancer may cause financial difficulties, but its impact in countries with public health systems is unknown. We evaluated the association of financial difficulties with clinical outcomes of cancer patients enrolled in academic clinical trials performed within the Italian public health system. PATIENTS AND METHODS: Data were pooled from 16 prospective multicentre trials in lung, breast or ovarian cancer, using the EORTC quality of life (QOL) C30 questionnaire. Question 28 scores financial difficulties related to disease or treatment in four categories from 'not at all' to 'very much'. We defined financial burden (FB) as any financial difficulty reported at baseline questionnaire, and financial toxicity (FT) as score worsening in a subsequent questionnaire. We investigated (i) the association of FB with clinical outcomes (survival, global QOL response [questions 29/30] and severe toxicity), and (ii) the association of FT with survival. Multivariable analyses were performed using logistic regression models or the Cox model adjusting for trial, gender, age, region and period of enrolment, baseline global QOL and, where appropriate, FB and global QOL response. Results are reported as odds ratio (OR) or hazard ratio (HR) with 95% confidence intervals (CI). RESULTS: At baseline 26% of the 3670 study patients reported FB, significantly correlated with worse baseline global QOL. FB was not associated with risks of death (HR 0.94, 95% CI 0.85-1.04, P = 0.23) and severe toxicity (OR 0.90, 95% CI 0.76-1.06, P = 0.19) but was predictive of a higher chance of worse global QOL response (OR 1.35, 95% CI 1.08-1.70, P = 0.009). During treatment, 2735 (74.5%) patients filled in subsequent questionnaires and 616 (22.5%) developed FT that was significantly associated with an increased risk of death (HR 1.20, 95% CI 1.05-1.37, P = 0.007). Several sensitivity analyses confirmed these findings. CONCLUSION: Even in a public health system, financial difficulties are associated with relevant cancer patients outcomes like QOL and survival. CLINICAL TRIALS NUMBER: Any registered clinical trial number should be indicated after the abstract.

To be or not to be translational.

Translational Research means different things to different people, but it seems crucial to almost everyone. This discipline, although defined differently in academia, regulatory institutions, and industry, shares the fundamental vision of Translational Medicine, which efficiently and effectively translates basic scientific findings relevant to human disease into knowledge that benefits patients. In the present perspective, we collected commentaries and descriptions about Translational Medicine to stimulate discussion and better understand what Translational Medicine is.

Quality improvement of medical records in a teaching hospital.

INTRODUCTION: The aim of this study was to evaluate the quality of the MR compilation in some Operative Units of the "Azienda Ospedaliera Universitaria--II Università di Napoli" (AOU- SUN)-Italy, before and after an intervention of quality improvement, underlining the potential differences in the behaviour of different specialists (physicians vs. surgeons). METHODS: Two random samples of 660 MRs were reviewed. A four-step program was developed: (1) first assessment of the MR; (2) implementation of the MR quality, sending a letter with the purpose of the study, the results obtained in the first step from that ward, the guidelines to correctly fill out the MR; (3) follow-up step four months later; (4) comparison of the data before and after the distribution of the guidelines using indicators of completeness of all sections of MR, clarity of handwriting and presence and clarity of signature. RESULTS: The main concerns were related to the signature of the duty physician (present in 2.0% and legible in only 15.4%), the presence of the letter of discharge (18.0%) and the clarity of the days of hospital stay (32.0%). After the intervention the improvement of the quality of compilation was modest and regarded mainly medical rather than surgical wards. DISCUSSION AND CONCLUSIONS: The improvement was not satisfying since from a medical and a legal point of view the indicators should reach 100% of clarity and completeness. A further study is being carried out to improve the involvement of health care professional, so that such requirements will be perceived as a common goal, not as mere bureaucratic initiatives.

Hip fractures in Italy: 2000-2005 extension study.

SUMMARY: A total of 507,671 people > or =65 experienced hip fractures between 2000 and 2005. In 2005, 94,471 people > or =65 were hospitalized due to hip fractures, corresponding to a 28.5% increase over 6 years. Most fractures occurred in patients > or =75 (82.9%; n = 420,890; +16% across 6 years), particularly in women (78.2%; n = 396,967). INTRODUCTION: We aimed to analyze incidence and costs of hip fractures in Italy over the last 6 years. METHODS: We analyzed the national hospitalization and DRG databases concerning fractures occurred in people > or =65 between 2000 and 2005. RESULTS: A total of 507,671 people > or =65 experienced hip fractures across 6 years, resulting in about 120,000 deaths. In year 2005 94,471 people aged > or =65 were hospitalized due to hip fractures, corresponding to a 28.5% increase over 6 years. The majority of hip fractures occurred in patients > or =75 (82.9%; n = 420,890; +16% across 6 years) and particularly in women (78.2%; n = 396,967). Among women, 84.2% of fractures (n = 334,223; +28.0% over 6 years) were experienced by patients > or =75, which is known to be the age group with the highest prevalence of osteoporosis, accounting for 68.6% of the overall observed increase in the total number of fractures. Hip fractures in men > or =75 increased by 33.1% (up to 16,540). Hospitalization costs increased across the six examined years (+36.1%) reaching 467 million euros in 2005, while rehabilitation costs rose up to 531 million in the same year. CONCLUSIONS: Hip fractures of the elderly are increasing and represent a major health problem in industrialized countries such as Italy.