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Biomedical subjects

S Schraub

Publications and source records attributed to S Schraub.

At least 19 recordsLinked to original sources
PubMed2006

Determinants of patient satisfaction in oncology settings from European and Asian countries: preliminary results based on the EORTC IN-PATSAT32 questionnaire.

The aim of this study was to identify factors associated significantly with hospitalised cancer patients' satisfaction with care. Patients were recruited from four geographical/cultural groups, including five European countries and Taiwan. They rated their level of satisfaction by completing the EORTC IN-PATSAT32 questionnaire at home. Additionally, data were collected on the sociodemographic and clinical characteristics and the quality of life of the patients, as well as on institutional characteristics. Of 762 patients recruited, 647 (85%) returned a completed questionnaire. The number of nurses and doctors per bed, institution size, geo-cultural origin, ward setting, teaching/non-teaching setting, treatment toxicity, global health status, participation in clinical trials and education level were all associated significantly at the multivariate level with satisfaction with doctor and nurse interpersonal skills, information provision, availability, and/or overall satisfaction. A number of patient-, institutional- and culture-related factors are associated with the perceived quality of cancer care. Future studies, with appropriate sampling frames and stratification procedures, are needed to better understand cross-national and cross-cultural differences in cancer patient satisfaction.

Adult↗
PubMed2006

[Multisite validation study of questionnaire assessing out-patient satisfaction with care questionnaire in ambulatory chemotherapy or radiotherapy treatment].

Patient satisfaction is now recognised as an important quality of care outcome which is particularly relevant in oncology. Adapted from the EORTC In-Patsat32, the Out-Patsat35 is a 35-item satisfaction with care questionnaire measuring cancer outpatients' perception of hospital doctors and nurses, as well as aspects of care organisation and services. This study assessed the psychometric properties of this scale. Patients undergoing ambulatory chemotherapy (CT) or radiotherapy (RT) in 7 cancer centres in France were invited to complete at home the Out-Patsat35 as well as EORTC QLQ-C30 for psychometric testing. Of 416 eligible patients recruited, 96% returned the questionnaire. Most patients (71% in CT; 69% in RT) completed this scale within 15 minutes and the mean rate of item omission was only 4.4%. Confirmatory analyses revealed good convergent validity and excellent internal consistency, although some subscales within the Out-Patsat35 were relatively highly correlated. Items and subscales of the Out-Patsat35 and of the QLQ-C30 were not significantly correlated, underlying that the two questionnaires are assessing quite distinct concepts. The subscales of the Out-Patsat35 were not related to age, gender and education, suggesting a cultural evolution in French cancer patients towards a greater homogeneity in their opinion toward care. This study supports the acceptability to patients, and the psychometric properties of the EORTC Out-Patsat35 questionnaire.

Ambulatory Care↗
PubMed2005

An international prospective study of the EORTC cancer in-patient satisfaction with care measure (EORTC IN-PATSAT32).

Little is known about patients' satisfaction with care in oncology hospitals across cultural contexts. Within the EORTC, we developed a 32-item satisfaction with care questionnaire to measure patients' appraisal of hospital doctors and nurses, as well as aspects of care organisation and services. This study assessed the psychometric characteristics of the questionnaire, the EORTC IN-PATSAT32, in a large, international sample of patients with cancer. Patients discharged from a surgery or medical oncology ward in nine countries were invited to complete at home the EORTC IN-PATSAT32 as well as other instruments for psychometric testing. Of 762 eligible patients recruited, 15% failed to return the questionnaire. Of the 647 compliant patients, 63% completed the questionnaires within 15 min and 82% required no help in its completion. Multitrait scaling analysis revealed excellent internal consistency and convergent validity, although some scales within the IN-PATSAT32 were relatively highly correlated. Test-retest data on 113 patients showed high reliability for most scales. Scales of the IN-PATSAT32 and of the QLQ-C30 were not significantly correlated, suggesting that the two questionnaires are assessing quite distinct concepts. The scales of the IN-PATSAT32 were able to discriminate clearly between patients with differing care expectations and differing intentions to recommend their hospital to others. This study supports the acceptability to patients, and the psychometric robustness of the EORTC IN-PATSAT32 questionnaire. Further studies are needed to assess the responsiveness of the questionnaire to changes in the structure and process of care over time.

Adult↗
PubMed2005

Methodological quality and reporting of ethical requirements in phase III cancer trials.

BACKGROUND: The approval of a research ethics committee (REC) and obtaining informed consent from patients (ICP) could be considered the main issues in the ethics of research with human beings. The aim of this study was to assess both methodological quality and ethical quality, and also to assess the relationship between these two qualities in randomised phase III cancer trials. METHOD: Methodological quality (Jadad score) and ethical quality (Berdeu score) were assessed for all randomised controlled trials (RCTs) published in 10 international journals between 1999 and 2001 (n = 231). RESULTS: The mean Jadad score was 9.86 +/- 1.117. The methodological quality was poor in 75 RCTs (Jadad score <9). The mean Berdeu score was 0.42 +/- 0.133. The mean ethical quality score for poor methodological quality RCTs (n = 75) was 0.39 +/- 0.133; it was 0.43 +/- 0.133 for good (n = 156) methodological quality RCTs (p = 0.07). There was improvement in ethical quality according to the year of commencement of the trials (p < 0.001). There was no correlation between methodological quality and the number of participating patients (R2 = 0.003, p = 0.78), between ethical quality and the number of participating patients (R2 = 0.003, p = 0.76 ), or between ethical quality and methodological quality (R2 = 0.012, p = 0.1). ICP and REC approval were not obtained for 21 and 77 trials respectively. CONCLUSION: The association between methodological quality and the reporting of ethical requirements probably reflects the respect shown for patients during the whole research process. These results suggest that closer attention to the conduct of clinical research, as well as the reporting of its ethical aspects, is needed.

Clinical Trials, Phase III as Topic↗
PubMed2004

French version of FACT-G: validation and comparison with other cancer-specific instruments.

The aim of this study was to assess the validity of the French version of the Functional Assessment of Cancer Therapy - General (FACT-G), and to compare its psychometric properties with those of two other cancer-specific quality of life questionnaires, European Organisation for Research and Treatment of Cancer Quality of Life - Core 30 (EORTC QLQ-C30) and Functional Living Index - Cancer (FLIC). Two hundred and twenty three patients with breast or colorectal cancer completed the FACT-G questionnaire in French followed by (in random order) the QLQ-C30 and FLIC. An additional 87 patients with head and neck (H&N) cancer completed the FACT-H&N followed by the QLQ-C30 and H&N-Besançon. The French version of FACT-G was internally consistent, and its reproducibility was excellent. FACT-G Physical Well-Being and global scores correlated with all QLQ-C30 subscales. There was evidence of discriminant validity. Compared with the other tools, FACT-G included a statistically significantly higher proportion of items patients considered to be confusing or upsetting. Patients with breast or colorectal cancer expressed a preference for QLQ-C30. Use of the specific H&N additional items increased the responsiveness to change of FACT-G. The French version of FACT-G is valid and has psychometric properties similar to those of FLIC and QLQ-C30.

Aged↗
PubMed2001

Alternative medicine use worldwide: the International Union Against Cancer survey.

BACKGROUND: In the current study, the authors attempted to surmount the deficiencies of previous surveys and elicit information regarding the use of alternative treatments of cancer worldwide. METHODS: The International Union Against Cancer (UICC), an international, nongovernment volunteer organization, E-mailed a questionnaire concerning alternative therapy use to its members. RESULTS: A total of 83 responses from 33 countries were received. Descriptive analyses of this dataset were conducted, indicating the existence of a large and heterogeneous group of unproved remedies used to treat cancer in both developed and developing countries around the world. CONCLUSIONS: Improved public education concerning the importance of early medical attention and the value of documented cancer therapies, the wider availability of useful cancer treatments, and public policies that are sensitive to the patient's need to play a meaningful role in his or her own care are required.

Complementary Therapies↗
PubMed2001

A comprehensive assessment of satisfaction with care: preliminary psychometric analysis in French, Polish, Swedish and Italian oncology patients.

Satisfaction with care may be closely related to quality of life in cancer patients. This evaluation is especially relevant when quality of care is considered. The present study assessed whether equivalent scaling properties could be found in a comprehensive assessment of satisfaction with care (CASC) administered in cancer patients from French, Polish and Swedish oncology settings, in comparison to the scaling properties previously evidenced in the CASC with an Italian sample. A total of 140, 186 and 133 oncology patients were approached in France, Poland and Sweden, respectively. Specific items in the CASC were identified as consistently omitted across country samples. Multitrait scaling analysis on an item-grouping adapted for the French, Polish, Swedish and Italian samples provided excellent internal consistencies and convergent validity estimates. Discriminant validity proved less satisfactory, evidencing overlap between hypothesised care dimensions across country samples. The identification of omitted or overlapping items will lead to the design of a revised CASC version to further test in larger cross-cultural samples.

Adult↗
PubMed2001

Results of a phase III prospective, randomised trial, comparing mitoxantrone and vinorelbine (MV) in combination with standard FAC/FEC in front-line therapy of metastatic breast cancer.

This comparative phase III trial of mitoxantrone+vinorelbine (MV) versus 5-fluorouracil+cyclophosphamide+either doxorubicin or epirubicin (FAC/FEC) in the treatment of metastatic breast cancer was conducted to determine whether MV would produce equivalent efficacy, while resulting in an improved tolerance in relation to alopecia and nausea/vomiting. This multicentre study recruited and randomised 281 patients with metastatic breast cancer; 280 were evaluable for response survival and toxicity (138 received FAC/FEC, 142 received MV). Patient characteristics were matched in each arm and stratification for prior exposure to adjuvant therapy was made prospectively. The overall response rate (ORR) was equivalent in the two arms (33.3% for FAC/FEC versus 34.5% for MV), but MV was more effective in patients who had received prior adjuvant therapy (13% (95% confidence interval (CI) 3-23) for FAC/FEC versus 33% (95% CI 20-47) for MV P=0.025) with a better progression-free survival (PFS) (5 months (range 1-18 months) versus 8 months (range 1-27 months); P=0.0007 for FAC/FEC versus MV, respectively) while FAC/FEC was more effective in previously untreated patients (ORR 43% (95% CI 33-53) versus 35% (95% CI 25-45), P=0.26; PFS 9 months (range 0-29 months) versus 6 months (range 0-26 months) P=0.014). Toxicity was monitored through the initial six cycles of therapy; febrile neutropenia and delayed haematological recovery was more frequent for MV (P=0.001), while nausea/vomiting of grades 3-4 was greater for FAC/FEC (P=0.031), as was alopecia (P=0.0001), cardiotoxicity was the same for the two regimens. MV represents a chemotherapy combination with equivalent efficacy to standard FAC/FEC and improved results for patients who have previously received adjuvant chemotherapy. Toxicity must be balanced to allow for increased haematological suppression and risk of febrile neutropenia with MV compared with a higher risk of subjectively unpleasant side-effects such as nausea/vomiting and alopecia with FAC/FEC.

Adolescent↗
PubMed2001

[Conservative treatment of choroidal melanoma using iodine-125 brachytherapy, technique and preliminary analysis of 78 patients].

PURPOSE: Iodine 125 curietherapy is one of the conservative treatments of uveal melanoma. The technique used to achieve these results was simplified through the physical characteristics of the radioelement and the optimized-dosimetry program employed. PATIENTS AND METHODS: 78 patients with choroidal melanoma were treated with iodine 125. About 100 Gy were delivered to the superior pole of the tumour. The minimal length of follow-up was 17 months and the average, 67 months. RESULTS: There was 88% local control, leading to lowered visual acuity in 76% of the cases. Radiation retinopathy, directly related to proximity to the macula, is the principle etiology. Seven patients died of hepatic metastasis, five patients were enucleated. Four patients were further treated with protontherapy to make up for noncontrol locally. CONCLUSION: One dose of 100 Gy to the superior pole of the tumor seemed to lead to good local control, with the exception of complications related to proximity to the macula and the optic nerve. In this attempt to optimize irradiation, the time lapse between any benefit in local control derived from irradiation and posttherapeutic complications observed remains insufficient to evaluate any relationship.

Adult↗
PubMed2001

Systematic esophageal endoscopy screening in patients previously treated for head and neck squamous-cell carcinoma.

BACKGROUND: An attempt was made to improve metachronous oesophageal cancer prognosis through bi-annual systematic esophageal endoscopy screening in patients treated for head and neck cancer. PATIENTS AND METHODS: Bi-annual esophageal endoscopy, without a staining procedure, was performed in 1560 patients from 1987 to 1997. The distribution of previous head and neck cancer was oral cavity (20%), oropharynx (30%), hypopharynx (34%), and larynx (16%). All patients had initial panendoscopic inspection before HNSCC treatment. Esophageal tumors were considered to be second synchronous primaries when discovered within the first six months of initial tumor diagnosis. RESULTS: Fifty metachronous esophageal asymptomatic cancers (42 T1 and 7 in situ carcinomas) were diagnosed by endoscopy. The median time between the HNC and the esophageal carcinoma was 43 months (7-137 months). Metachronous esophageal carcinoma was discovered in 2.6% of patients with oral cavity tumor, 5.7% of patients with oropharynx tumor, 2.3% of patients with hypopharynx tumor, and 1.7% of patients with larynx tumor. Causes of death were: 41.1% related to esophageal tumor with tumor progression, metastatic evolution, or treatment toxicity; 28.9% related to non malignant causes; 26.6% related to a cancer that was not of esophageal origin. CONCLUSIONS: Over a 10-year period, systematic bi-annual esophageal endoscopy uncovered metachronous esophageal tumors in 3.2% of 1560 patients originally treated for head and neck carcinoma, developing in a median time of 47 months. Patients with initial oropharyngeal tumors had a significantly higher risk of metachronous esophageal SCC, compared to the other tumor sites (P < 0.02 with Fisher exact test). Given the elevated death rate not related to the esophageal cancer and the median survival of 16 months, any potential benefit from this time-consuming procedure is debatable.

Adult↗
PubMed2000

[Quality of life measure in cancerology].

CONCEPT: Quality of life assessment in cardiology has become an important point in the overall evaluation of anticancer treatments. Quality of life is a multidimensional subjective concept usually assessed by self-administered questionnaires with a linear analogous design. Multiple choice questions can also be used to explore several dimensions of quality of life. QUESTIONNAIRES: No one questionnaire is ideal. Two appear to be most widely used worldwide. The main body of these modular questionnaires is completed by specific sections dealing as needed with designated organs or treatment toxicity. Data interpretation is particularly difficult and must take into consideration the fact that most currently used questionnaires measure health in general rather than the philosophical concept of quality of life. CLINICAL APPLICATION: Use of quality of life questionnaires varies greatly. These tools can be used to estimate the impact of public health measures or treatments in general. They are most widely used to date as assessment tools for therapeutic trials or to provide secondary criteria in trials where survival is the main outcome criteria. In this case, they provide a means of comparing symptomatic treatment and anticancer treatments or two different anticancer treatments. Studies are under way to use quality of life scales in everyday patient care. PERSPECTIVES: Certain authors have attempted to combine quality and quantity of life in a single tool in order to obtain a global index which could be used to compare large groups of patients. Different tools are still in the development phase.

Humans↗
PubMed2000

Unproven methods in cancer: a worldwide problem.

Questionable or unproven methods are used by cancer patients throughout the world. Treatments include drugs, vitamins, herbs, diets, healing, "psychological" treatments, folk medicines, and homeopathy. The exact frequency of questionable methods in cancer is difficult to evaluate because of the variety of methods, some being used as complementary treatments to conventional ones (and often not mentioned by patients) and others, as curative treatment (alternative treatment). In Europe, data are available for the Nordic countries, Switzerland, Germany, Austria, United Kingdom, The Netherlands, France and Italy. High frequencies of use are observed in German-speaking countries (52-65%). In North America, many publications give frequencies of between 7% and 54%. In Mexico, the frequency is 50%, higher than in Argentina (17%). In Australia, 22% have used complementary medicines. In Asia, some data are available from India, Taiwan and Japan. In Tunisia (northern Africa), the results of 59 interviews also show the use of questionable methods among Arabic patients. There is a lack of data from countries in Africa and in Asia. While some products are used all over the world (e.g. mistletoe, vitamins), others are country specific (Moerman diet in The Netherlands). Some traditional medicines are also country specific (e.g., Chinese medicine, Ayurvedic medicine in India). Both alternative and complementary unproven methods are prescribed either according to classical concepts of cancer treatment or according to a new concept of the world and of life.

Complementary Therapies↗
PubMed2000

Post-radiation severe xerostomia relieved by pilocarpine: a prospective French cooperative study.

BACKGROUND AND PURPOSE: The aim of the study was: (1) to confirm the action of pilocarpine hydrochloride (Salagen) against xerostomia: (2) to correlate the response to dose/volume radiotherapy parameters. MATERIALS AND METHODS: From June 1995 to February 1996, 156 patients with severe radiation induced xerostomia received pilocarpine hydrochloride orally. IS mg per day with a 5 mg optional increase at S weeks up to a daily dose of 25 mg beyond 9 weeks. RESULTS: One hundred and forty five patients are fully evaluable. Treatment compliance was 75%. Thirty eight patients (26%) stopped treatment before week 12 for acute intolerance (sweating, nausea, vomiting) or no response. No severe complication occurred. Ninety ses en patients (67%) reported a significant relief of symptoms of xerostomia at 12 weeks. Within 12 weeks, the size of the subgroup ith normal food intake almost doubled (13-24 patients) while the size of the subgroup with (nearly) impossible solid food ingestion decreased by 38% (47 vs. 29 patients). The impact on quality of life was considered important or very important by 77% of the responders. CONCLUSIONS: No difference was found according to dose/volume radiotherapy parameters suggesting that oral pilocarpine hydrochloride: (1) acts primarily by stimulating minor salivary glands: (2) can be of benefit to patients suffering of severe xerostomia regardless of radiotherapy dose/volume parameters: (3) all responders are identified at 12 weeks.

Administration, Oral↗
PubMed1998

[Parcours de femmes. Opinion survey carried out among women treated for gynecologic and breast cancers and their medical care teams].

The opinion survey "Parcours de femmes" initiated in partnership with Bristol-Myers Squibb was conducted by la Ligue nationale contre le cancer between November 1993 and May 1995 and by Sofres Institute. The aim of the study was to increase knowledge of experience of feminine cancers, both by patients and by different treatment teams. Two thousand eight hundred and seventy-four women treated for one of these diseases answered anonymously on a form with sixty-eight questions. Eighty-one individual interviews gave the opinion of the general practitioners and specialists concerned, as well as nursing and hospital staff, pharmacists, health leaders in the private or public fields. The results of this opinion survey highlight and confirm needs, deficiencies, and aspirations of everyone involved. The data show the importance of information, explanations and dialogue at every stage of the disease. The data specify the lines of support to be developed: calming distress, stimulating hope and the will to recover. They also indicate a need for psychological support outside the family and the medical environment as well as for treatment teams. The necessity to improve the hospital environment as well as access to maternal aid during and after treatment to make reinsertion easier are also demonstrated. Apart from associations and help services (such as home care), institutionals do not all have the same sensitivity expect to this pathology. Many people consider it has nothing specific in comparison to other pathologies or to other women in difficulties. They reject the idea of implementing specific measures and valorize research and prevention actions.

Adult↗
PubMed1998

The development of a French version of a questionnaire on the quality of life in cancerology (Functional Living Index-Cancer: FLIC).

The quality of life has become an indispensable element in the evaluation of treatments, especially as clinical trials are generally conducted in more than one country. In cancerology, numerous questionnaires have been developed and validated, but most of them are in English. This article presents the stages of translation and validation of the French version of the FLIC (Functional Living Index-Cancer). It applies to a sample of 200 patients, 47% of whom have breast cancer. The acceptability of this questionnaire is good (92.2%). The main psychometric criteria were verified. The Cronbach alpha coefficient, equal to 0.90, shows good reliability. A factor analysis was conducted to examine construct validity; it revealed a 5-factor solution accounting for 62% of the variance. These 5 factors are associated with specific domains; physical, psychological and social functioning, current well-being and disease symptoms. The global scores of the FLIC correlate significantly with those of the different scales of the EORTC QLQ-C30. Moreover, clinical relevance is ensured by its correlation with certain clinical variables (WHO index, location of tumour). The French version of the FLIC can be used to measure the quality of life of patients afflicted with cancer, but further studies are necessary to confirm its reliability.

Adult↗