Randomized study of early hospital discharge following autologous blood SCT: medical outcomes and hospital costs.

We report the first randomized study comparing early hospital discharge with standard hospital-based follow-up after high-dose chemotherapy (HDCT) and PBSCT. Patients aged 18-65 years, with an indication of PBSCT for non-leukemic malignant diseases were randomly assigned between two arms. Arm A consisted of early hospital discharge (HDCT during hospitalization, discharge at day 0, home stay with a caregiver, outpatient clinic follow-up). In arm B patients were followed up as inpatients. In total 131 patients were analyzed (66 in arm A and 65 in arm B). Patient characteristics and hematological reconstitution were comparable between the two groups. In arm A, 26 patients were actually discharged early. Patients in group A spent fewer days in hospital (11 vs 12 days, P=0.006). This strategy resulted in a 6% mean cost reduction per patient when compared with the conventional hospital-based group. The early discharge approach within the French health system, while safe and feasible, is highly dependent on social criteria (caregiver availability and home to hospital distance). It is almost always associated with conventional hospital readmission during the aplasia phase, and limits cost savings when considering the whole population of patients benefiting from HDCT in routine clinical practice.

Does cancer survivors' health-related quality of life depend on cancer type? Findings from a large French national sample 2 years after cancer diagnosis.

We investigated whether health-related quality of life (HRQL) depends on cancer type, after adjustment for demographic and medical variables. A French national population-based survey was conducted between November and December 2004 to assess surviving cancer patients' HRQL 2 years after diagnosis. HRQL was measured by the 36-Item Short Form Survey scale. The sample included 3900 persons. All cancer diagnoses were entered in the study. We demonstrated that medical and treatment variables have an impact on patients' physical HRQL but not on mental HRQL. Cancer type impacted on physical HRQL, with those suffering from upper aerodigestive tract /lung cancers and haematological malignancies being affected to a greater degree. Disturbing side effects impacted both HRQL domains. Socio-demographic variables had statistically significant effects but not clinically meaningful ones. Socio-economic variables led to potentially clinically meaningful differences for cancer patients' HRQL and represented a socio-economic gradient in HRQL among cancer survivors. From our results, we may assert that cancer survivors, 2 years after cancer diagnosis, share a similar pattern of psychological morbidity, independent of cancer type. Patients disproportionately affected by cancer, such as those with lower educational levels and income, need to be identified and targeted and interventions which address their unique needs and concerns need to be developed.

Disclosure of prognosis to terminally ill patients: attitudes and practices among French physicians.

BACKGROUND: Disclosure of the prognosis to terminally ill patients is a strong prerequisite for integrating the physical, psychological, spiritual, and social aspects of end-of-life care. OBJECTIVE: This study aimed to assess French physicians' general attitudes and effective practices (with patients followed up to death recently) toward such disclosure. DESIGN/SUBJECTS: We used data from a cross-sectional survey conducted among a national sample of 917 French general practitioners, oncologists, and neurologists. RESULTS: A majority of respondents opted for prognosis disclosure only at patients' request, very few opted for systematic disclosure without patient's request, and a significant minority opted for systematic concealment. Concerning deceased patients described by respondents, 44.5% of competent patients were informed of prognosis by their physician, 27.3% were informed by someone else, 9.0% refused to be informed, and 19.2% were simply not informed. Concealment was more frequent for older patients, and physicians involved in a nongovernmental organization (NGO) for patients' support were more likely to disclose the prognosis, even without patient's request. CONCLUSIONS: Disclosure of the prognosis to terminally ill patients is still far from systematic in France. Further research is needed to better understand the motivations of French physicians' disclosure practices, which are probably culturally shaped.

Attitudes toward palliative care, conceptions of euthanasia and opinions about its legalization among French physicians.

We assume that actors of the professionalization process of palliative care make a special effort to demarcate it from euthanasia, and that such an effort has a significant impact on beliefs and attitudes toward euthanasia among the whole medical profession. We investigated concurrently attitudes toward palliative care, conceptions of euthanasia and opinion toward its legalization among a sample of 883 French general practitioners, oncologists and neurologists. We found four contrasted profiles of attitudes toward palliative care, which were closely correlated with being in touch with palliative care providers. Attitudes toward palliative care were closely correlated with beliefs about which medical practices should be labelled euthanasia, and these beliefs were in turn strongly associated with opinions toward euthanasia legalization. Our results suggest that the relationship between palliative care and euthanasia mixes semantic and strategic aspects, beyond cognitive and conative ones.

Determinants of patients' choice of reconstruction with mastectomy for primary breast cancer.

BACKGROUND: The aim of the study was to measure women's decisions about breast reconstruction (BR) after mastectomy and to assess the factors contributing to their decisions, in a context involving shared decision-making and maximum patient autonomy. METHODS: Women who were about to undergo mastectomy for primary breast cancer were systematically offered choices concerning BR and time of reconstruction (intervention always covered by the French National Insurance System). Self-administered questionnaires were used prior to the operation. RESULTS: Among the 181 respondents, 81% opted for BR and 19% for mastectomy alone. In comparison with those who chose mastectomy alone, those opting for BR more frequently recognized the importance of discussing these matters with the surgeon and their partner (adjusted odds ratio [OR(adj)] = 13.45 and 3.59, respectively; P <.05) and realized that their body image was important (OR(adj) = 10.55, P <.01); fears about surgery prevented some of the women from opting for BR (OR(adj) = 0.688, P <.05). Among the women opting for BR, 83% chose immediate breast reconstruction (IBR) and 17% chose delayed breast reconstruction (DBR). The preference for IBR was mainly attributable to the fact that these women had benefited more frequently from doctor-patient discussions (OR(adj) = 3.49, P <.05) but was also attributable to the patients' physical and functional characteristics: they were in a poorer state of health (P <.05). The surgeons predicted their patients' preferences fairly accurately. CONCLUSIONS: In a context of maximum autonomy, the great majority of the women chose IBR. The patients' choices were explained mainly by their psychosocial characteristics. The indication for BR should be properly discussed between patients and surgeons before mastectomy.

[Advanced rectal cancer: attitudes of French surgeons]. / Cancer avancé du rectum: attitudes des chirurgiens français.

PURPOSE: French guidelines recommended the treatment of locally advanced rectal cancers. Our aim was first to describe therapeutic decision of digestive surgeons related to clinical cases and then to measure their knowledge of french guidelines. METHODS: Two vignettes were mailed to 183 french surgeons, randomly selected. The first one dealt with a man, 46-years-old, with a rectal cancer T3N0M0. The second one dealt with a woman, 50-years-old, with a rectal cancer complicated by a rectovaginal fistula. Questions covered the decision modality and the therapeutic choice. RESULTS: We received back 124 responses (67%). The decision modality was multidisciplinary for half of the surgeons. For the former case, the therapeutic choice fits with guidelines--radiotherapy followed by conservative surgery--for 69% of surgeons. For the latter case, more than half of the surgeons chose an association of radiotherapy-surgery-chemotherapy. Age appeared to be a limiting factor for a curative surgery. Surgeons therapeutics attitudes meet with changes in practice already observed in 1990, but 1/3 of surgeons still did not follow the guidelines. Chemotherapy was chosen while its efficacy has not been demonstrated. CONCLUSION: There is few overlapping between attitudes, and optimal surgical practices. Quality of surgery, in the art of debate, may improve thanks to the rulemaking of therapeutic decisions and thanks to the evolution of the state-of-the-art among multidisciplinary committees or professional networks.

[Women's preferences for early discharge after conservative breast surgery: feasibility, patient profile and satisfaction]. / Préférences des femmes pour une réduction de l'hospitalisation après chirurgie conservatrice pour tumeur mammaire: faisabilité, profil et satisfaction des patientes.

PURPOSE: Ours aims were to assess the feasibility of short stay after conservative breast surgery when giving the choice to women, to identify women characteristics associated to short (less than 48 hours) or conventional stay and to confront satisfaction and anxiety of the two groups. METHODS: Women were able to choice the length of stay immediately after surgery. Afterwards they completed a questionnaire measuring pain, anxiety and satisfaction. Clinical data concerning surgery were also collected. RESULTS: The hospital stay was short for 114 women (75.5%) and conventional for 37 women (24.5%). Length of stay was related to education level (P = 0,021), general health status (ASA score) (P = 0,003), breast pain (P = 0,001), the number of wound drains (P = 0,005), cancer (P = 0,001) and satisfaction about hospitalisation (P = 0,022). Post-surgical morbidity was similar between groups, except prolonged axillary drainage more frequent in conventional stay group. CONCLUSION: Women often chose a short stay after breast conservative surgery. This procedure is feasible routinely without heavy complication. Women preference for a short stay is real and could be improved by a better organisation, which ensure the continuity of care between hospital and home, with satisfaction assessment.

The prescription of opioid analgesics to terminal cancer patients: impact of physicians' general attitudes and contextual factors.

OBJECTIVE: This study aimed to examine factors associated with the prescription of opioid analgesics to terminal cancer patients, including physicians' general attitudes toward morphine and contextual factors. METHODS: A survey was conducted among a sample of French general practitioners (GPs) and oncologists. Respondents were asked to describe the last three terminally ill patients they had followed up to death. RESULTS: Overall, 526 GPs and oncologists (global response rate: 57%) described 1,082 cancer patients, among whom 85.4% received opioid analgesics. Among other significant predictors (patient age, cancer type, family assistance), this prescription was less frequent for female patients followed by male physicians (OR = 0.53), and more frequent for patients followed by physicians trained in palliative care (OR = 2.70). On the other hand, physicians' attitudes toward morphine were not associated with prescription of morphine and other opioid analgesics. SIGNIFICANCE OF RESULTS: Although nonprescription of opioid analgesics is only a crude proxy measure for undertreatment of cancer pain, our findings suggest the need to develop training in palliative care in order to standardize practices among GPs and specialists. Our results also highlight the necessity to study pain assessment as an interaction between the physician and the patient, and to consider patients' and physicians' respective genders as a key variable within this interaction.

Quality of life of breast cancer patients receiving high-dose-intensity chemotherapy: impact of length of cycles.

This study was designed to measure treatment side-effects and quality of life (QL) of 47 nonmetastatic breast cancer patients subjected to a dose-intensity increase while receiving a sequential high dose chemotherapy (doxorubicin+cyclophosphamide - 4 cycles). The dose-intensity increase was obtained by shortening the length of cycles from 21 to 14 days. Treatment side-effects were self-assessed in terms of frequency and associated distress in cycles 1 and 3 by using a specific side-effect self-report questionnaire (19 items). Multidimensional QL measurement was performed at inclusion and before the start of cycles 2 and 4, by using the EORTC QLQ-C30. Pain was evaluated by patients on a visual analogue scale at the same times as QL evaluation. Patients' self-ratings indicated that the total number of symptoms, the number of symptoms rated by patients as quite or very distressing, and symptom frequency were comparable whatever the length of cycle. Overall, although underestimating most patients' symptoms, physicians' reports provided similar results. However, analysis of multidimensional QL showed that, in comparison to standard administration of 4 cycles of 21 days, there was a more significant deterioration of the QLQ-C30 global QL score ( P=0.01) at the second cycle of chemotherapy and of the physical functioning score ( P=0.02) at the fourth cycle when the cycle length was reduced. This study, although limited by a small patient cohort, has shown that shortening cycles to increase dose intensity had relatively few consequences on adverse treatment effects but a highly negative impact on patients' quality of life.

Healthy sibling donor anxiety and pain during bone marrow or peripheral blood stem cell harvesting for allogeneic transplantation: results of a randomised study.

This study reports the first comparison of healthy donor subjective well-being during two alternative procedures of hematopoietic stem cells harvesting for allogeneic transplantation. Among the 105 donors included between September 1996 and October 1998 in the SFGM French randomised trial aiming to compare allogeneic bone marrow (BM) transplantation and blood cell (BC) transplantation, 64 donors (33 in BC and 31 in BM groups) were relevant for the analysis. They had received a set of self-administered questionnaires to complete during the collection process, aiming to measure anxiety (assessed using the Spielberger's State-Trait Anxiety Inventory) and pain induced by the procedure (evaluated using a visual analogical scale). Results showed that no harvest procedure is free from pain even if none was more painful than the other. Levels of anxiety before the collection procedure were high in both groups and significantly so for BC donors. Although BC collection induces at least similar levels of pain and anxiety as does BM collection, they were of a different kind, and the short-term impact of G-CSF stimulation on the well-being of BC donors has to be taken into account in improving quality of care in the allogeneic setting.

[Economic evaluation of blood stem-cells autologous transplantation]. / L'évaluation économique de l'autogreffe de cellules souches du sang périphérique.

Economic evaluation of autologous peripheral blood stem cell (PBSC) transplantation certainly played a role in the very fast substitution from bone marrow to BC autograft. Economic evaluation is still ongoing about the optimization of the procedure by assessing the cost-effectiveness ratio of each new improvement of the technique. Among these improvements we present the administration of high dose CD34+ cells, the delayed administration of G-CSF and the outpatient management of post-graft follow-up. It is still very rare in the field of health economics to notice such an early and ongoing economic evaluation of an innovation.

Women's attitudes toward preventive strategies for hereditary breast or ovarian carcinoma differ from one country to another: differences among English, French, and Canadian women.

BACKGROUND: The authors investigated the acceptability to women of the preventive strategies available for dealing with hereditary breast/ovarian carcinoma in France, the United Kingdom, and Canada, countries selected because of their cultural differences. The authors aimed to discover the existence of specific factors that may affect acceptability of these preventative measures. METHODS: A cross-sectional, multicenter survey was conducted in Marseilles, France (n = 141), in Manchester, England (n = 130), and in Montreal, Quebec (n = 84). All of the women attending cancer genetic clinics for the first time because of a family history of breast-ovarian carcinoma completed a self-administered questionnaire before their clinic consultation. RESULTS: Variations in responses to different preventative options presented on the questionnaire were seen within the sample of patients considered as a whole. The highest levels of acceptability were obtained for mammographic screening (87%) and chemoprevention (58%). In contrast, prophylactic oophorectomy and prophylactic mastectomy were thought to be acceptable at an early age (before 35 years), an age associated with the highest prophylactic efficacy, by only 19% and 16% of the respondents, respectively. After multivariate adjustment, the statistical data showed that the British respondents were more in favor of oophorectomy (P < 0.0001) and more in favor of chemoprevention than the French (P < 0.001) and the Canadian respondents (P < 0.001). The British (overall adjusted response [OR(adj)] = 3.9; P < 0.001) and Canadian respondents (OR(adj) = 3; P < 0.01) were more in favor of prophylactic mastectomy than the French. The cumulated acceptability of mammography before the age of 40 years was found to be greater in the French (OR(adj) = 2.8; P < 0.01) and Canadian (OR(adj) = 3.1; P < 0.05) samples than in the British sample. CONCLUSION: These results demonstrated the existence of international variations in the acceptability of the preventive strategies available for women at risk for hereditary breast/ovarian carcinoma. Therefore, these results suggested that when establishing medical recommendations or planning public health interventions, physicians must integrate the population's perception of advantages and drawbacks with the patient's individual decision making.

[Interest in and limitations of economic assessment applied to the evaluation of medical strategies: examples in oncological hematology]. / Intérêt et limites du calcul économique appliqué à l'évaluation des stratégies médicales: exemples en onco-hématologie.

Using examples of economic assessment of medical innovations in the field of oncology, haematology and safety of blood products, the article shows that most of these innovations follow a law of diminishing returns: increasing levels of resources must be devoted in order to obtain an additional unit of health benefit (such as a life-year saved by a medical intervention). The article argues that, in such a context, cost-benefit analysis, a standard method in public economics, can be a useful tool to determine the 'optimal' level of resources that should be allocated by society for various medical interventions. In some instances, cost-benefit analysis can help to identify barriers to optimal diffusion of medical innovations that are due to inappropriate incentives and constraints in the management of the healthcare system.

Comparison of physicians' and cancer prone women's attitudes about breast/ovarian prophylactic surgery. Results from two national surveys.

Prophylactic surgery is a major issue for breast/ovarian cancer prone women. Bio-clinical data to help in the decision-making are not sufficient. In this context of uncertainty, physicians' and women's attitudes to prophylactic surgery is information of great value. The physicians' attitudes were assessed by a randomised national sample of practitioners involved in breast and ovarian cancer management. The patients' attitudes were appraised with a pre-consultation self- administered questionnaire presented during a one-year period to all women in five cancer genetic clinics chosen, for their representative geographical locations and their activity level. Consent to prophylactic surgery is higher among physicians than among patients (p < 0.0001). Acceptability of mastectomy is lower than that of oophorectomy in both patients and physicians (p < 0.0001 in both groups). In addition, age at which the intervention is proposed to be performed is a key determinant for both mastectomy and oophorectomy acceptability, in both physicians and patients (p < 0.001 for each comparison). Particularly, the age of 40 years seems to be a critical threshold for the acceptability of prophylactic oophorectomy. In contrast, respondents' age at the time of the survey has no significant effect on the acceptability rate. The higher acceptability rate of prophylactic oophorectomy compared to that of mastectomy observed in the physicians' survey is paradoxical because a more substantial medical impact on life expectancy was expected from the latter. Our results indicate that assumed reduced mortality is not the main criterion steering acceptability. It was anticipated that prophylactic mastectomy should be rarely performed in France.

[Economic analysis versus the principle of guaranteed safety in blood transfusion]. / L'analyse économique face au principe de la garantie de sécurité en transfusion sanguine.

This article shows that policies aimed at reducing risks of infectious agents transmissible through blood unfortunately follow a law of 'diminishing returns': increasing marginal costs have to be devoted for limited reductions in the risks of contamination through blood donations. Therefore, the economic cost-effectiveness analysis is appropriate to identify screening strategies which may minimize costs to reach a certain level of safety. Moreover, economic analysis can contribute to public debates about the level of residual risk that society is willing to accept. Empirical results from French studies about screening for hepatitis C virus (HCV) in individuals who have received blood transfusions and in blood donations are presented to illustrate these points.

Physicians' attitudes towards mammography and prophylactic surgery for hereditary breast/ovarian cancer risk and subsequently published guidelines.

After a BRCA mutation has been identified in the context of hereditary breast/ovarian cancer (HBOC), mammographic screening and prophylactic surgery are two of the main options available to those responsible for the clinical management of healthy women. The aim of this study was to describe the attitudes of specialists towards the clinical management of women with an HBOC risk: this information was collected prior to the publication of the recent French guidelines. A random national sample of 1169 French surgeons, gynaecologists and obstetricians was surveyed using a mailed questionnaire, to which 700 of these physicians (60%) responded. When dealing with a BRCA mutated woman, 88.6% of the respondents said they would recommend mammographic screening, but only 27.1% would recommend that it should be carried out annually from the age of 30 years onwards, as recommended in the French guidelines; 10.9% would find it acceptable to propose prophylactic mastectomy from the age of 30 years, and 22.9% would find it acceptable to propose prophylactic oophorectomy from the age of 35 years. The specialists who agreed with recommending breast/ovarian cancer genetic testing also had more positive attitudes towards prophylactic mastectomy (adj OR = 3.4, 95% CI = 1.4-8.2), as did those who had previously recommended prophylactic mastectomy when gene testing was not yet available (adj OR = 2.06, 95% CI = 1.23-3.44). The respondents' attitudes towards prophylactic oophorectomy and mastectomy were significantly associated (adj OR = 3.9; 95% CI = 2.3-6.5). Previous recommendation of prophylactic mastectomy was associated (P < 0.01) with a higher level of knowledge of breast/ovarian cancer genetics and with medical practice in this field. French physicians' attitudes towards mammographic screening and prophylactic surgery were not in complete agreement with the subsequently published French guidelines, the impact of which has now to be considered. Constantly evolving knowledge about the efficacy of preventive intervention will give practitioners new elements to integrate into their counselling.

Randomized trial of bone marrow versus lenograstim-primed blood cell allogeneic transplantation in patients with early-stage leukemia: a report from the Société Française de Greffe de Moelle.

PURPOSE: To compare hematologic recovery in patients receiving allogeneic blood cell transplantation (BCT) with those receiving allogeneic bone marrow transplantation (BMT). PATIENTS AND METHODS: One hundred eleven patients with leukemia in the early stages and with HLA-matched sibling donors were randomized in this study. One hundred one underwent transplantation. Standard procedures for collection and transplantation were used. Patients did not receive prophylactic granulocyte colony-stimulating factor after undergoing transplantation. In addition to clinical end points being established, a prospective and comparative economic evaluation of the first 6 months after transplantation was performed. RESULTS: Groups were balanced for patient, donor, and transplant characteristics. Blood cell collection led to the collection of a higher number of CD34(+) and CD3(+) cells than did bone marrow collection (P < 10(-6)) without reported side effects for the donor. Patients in the BCT group reached platelet counts of 25 and 50 x 10(9) platelets/L 8 and 11 days earlier than did the BMT group (P < 10(-4) and P < 10(-5)), respectively. This resulted in fewer platelet transfusions during the first 180 days after transplantation (P =.002) for the former group. The time to reach neutrophil counts of 0.5 and 1 x 10(9) neutrophils/L was 6 and 7 days shorter, respectively, in the BCT group than in the BMT group (P < 10(-5)). This quicker hematologic recovery was associated with a shorter length of hospitalization and a decrease in total cost of procedure during the first 6 months. CONCLUSION: This study establishes that allogeneic BCT results in quicker hematologic recovery but is associated with a higher occurrence of chronic graft-versus-host disease.