Clinical practice guidelines.

Transferring results of research into clinical practice and their effective use for decisions in health care have become a major concern and are pivotal to quality improvement. Among the tools that have been developed are clinical practice guidelines (CPG). Developing reliable and valid recommendations requires a rigorous methodological approach that combines a systematic review of the results of clinical research with expert, pondered and explicit judgment. Guaranteeing applicability and implementation of these recommendations implies asking the question of how acceptable the recommendations are for the patient, the availability of the procedure and the expertise necessary in the specific context as well as identification of the organizational impact when put into action. CPG are a source of information not only for physicians but also for policy makers, insurance institutions, continued education programs and production of information for high quality decision making for patients.

[The patient's role in evidence-based medicine]. / La place du patient dans la médecine factuelle.

Medical practice has undergone a significant evolution over the last decade due to two important factors: (1) the theory and practice of Evidence-Based Medicine (EBM) has become widely established; (2) the relationship between health-care professionals and patients or clients has been profoundly modified. In this review, we discuss the heterogeneity and variability of patient preference and the need to develop a doctor-patient relationship, which facilitates shared decision-making in preference to previous models based on patient information without choice and paternalistic attitudes. Thus, this modern concept of care based on EBM shifts the focus of interest from the disease entity itself to that of the patient suffering from a disease. The patient has a right to information concerning his illness; this information helps the patient to participate in medical decisions through the laying out of clinical practice guidelines. These aspects of the patient's role in care management are illustrated by a national program in the field of oncology which empower the patient in the decisions arrived at by a multi-disciplinary oncology team.

[Standards and Options for the use of radiation therapy in the management of patients with osteosarcoma. Update 2004]. / Recommandations pour la pratique clinique: Standards et Options 2004 pour la prise en charge par radiothérapie des patients atteints d'ostéosarcome. Mise à jour.

CONTEXT: The "Standards, Options and Recommendations" (SOR) project, started in 1993, is a collaboration between the Federation of French Cancer Centres (FNCLCC), the 20 French regional cancer centres, and specialists from French public universities, general hospitals and private clinics. The main objective is the development of clinical practice guidelines to improve the quality of health care and the outcome of cancer patients. The methodology is based on a literature review and critical appraisal by a multidisciplinary group of experts, with feedback from specialists in cancer care delivery. OBJECTIVE: To update the SOR recommendations for the use of radiation therapy in the management of patients with osteosarcoma. This work was performed in collaboration with the French society against cancers in children and adolescent (SFCE). METHODS: Data have been identified by literature search using Medline (from January 1992 to October 2003). In addition several Internet sites were searched in October 2003. RESULTS: The 3 mains standards are: 1) local and exclusive curative irradiation is not indicated as primary treatment for osteosarcoma or for local and operable recurrence, except for lesion in inaccessible sites or if the patient refuses surgery; 2) local and prophylactic adjuvant irradiation is not indicated for the treatment of osteosarcoma after chemotherapy (neoadjuvant and/or adjuvant) and complete macro or microscopic surgery, except for non-operable R1 or R2 surgical resection; 3) whole-lung prophylactic irradiation is not indicated in non-metastatic osteosarcoma. Systemic metabolic radiotherapy for pain treatment, using samarium-153 ethylenediaminetetramethylene phosphonic acid (Sm-153-EDTMP) can be offered to patients with painful metastatic osteosarcoma or in case of recurrent bone sites inaccessible to local therapies (surgery, external irradiation).

[Standards, options, and recommendation for external radiotherapy of prostatic cancer: evaluation of the effect of dosage]. / Standards, Options et Recommandations pour la radiothérapie externe des patients atteints de cancer de la prostate: évaluation de l'effet dose.

CONTEXT: The "Standards, Options and Recommendations" (SOR) collaborative project was initiated in 1993 by the Federation of the French Cancer Centres (FNCLCC), with the 20 French Regional Cancer Centres, several French public university and general hospitals, as well as private clinics and medical speciality societies. Its main objective is the development of serviceable clinical practice guidelines in order to improve the quality of health care and the outcome of cancer patients. The methodology is based on a literature review, followed by critical appraisal by a multidisciplinary group of experts. Draft guidelines are produced, then validated by specialists in cancer care delivery. OBJECTIVES: Produce clinical practice guidelines for the radiotherapy of prostate cancer using the methodology developed by the Standards, Options and Recommendations project. METHODS: The FNCLCC and the French Urology Association (AFU) designated the multidisciplinary group of experts. Available data were collected by a search of Medline and lists selected by experts in the group. A first draft of the guidelines was written, they validated by independent reviewers. RESULTS: The main recommendations are: 1/ a minimal dose of 70 Gy must be used, whatever the prognostic factors; 2/ it appeared that patients with favourable prognostic indicators (stage T1-2, PSA < or = 10 micrograms/L and Gleason score < or = 6) do not benefit from a dose escalation effect for doses over 70-74 Gy; 3/ patients with intermediate prognosis are the ones who benefit most from the dose escalation effect over 74 Gy, provided they receive exclusive radiation therapy; 4/ whenever possible, patients should be included in controlled trials designed to assess the effects of dose escalation and hormonotherapy.

[Standards, options and recommendations: Good clinical practice in the dietetic management of cancer patients: hospital catering]. / Standards, options et recommandations: Bonnes practiques de diététique en cancérologie: la prestation alimentaire.

CONTEXT: The "Standards, Options and Recommendations" (SOR) project, started in 1993, involves a collaboration between the Federation of the French Cancer Centres (FNCLCC), the 20 French Regional Cancer Centres, some French public university and general hospitals and private Clinics and medical scientific societies. Its main objective is the development of clinical practice guidelines to improve the quality of health care and outcome for cancer patients. The methodology is based on a literature review followed by a critical appraisal by a multidisciplinary group of experts to produce the draft guidelines which are then validated by specialists in cancer care delivery. OBJECTIVES: To develop clinical practice guidelines for hospital catering for cancer patient using the methodology developed by the Standards, Options and Recommendations project. METHODS: Data were identified by a literature search of Medline and the reference lists of experts in the groups. After the guidelines were drafted, they were validated by independent reviewers. RESULTS: The main recommendations are: 1) While taking into consideration the specific needs of cancer patients, the dietician is responsible for the hygiene, the sanitary quality of alimentation, the equilibrium and nutritional quality of the hospital catering. 2) Ordering and distribution of meals, and clearing up afterwards contribute to the quality of hospital catering and the personnel who do this should have time and be willing to listen to the patients. 3) The ordering of meals should be adapted to individual patient's requirements and must take into account the patient's medication. 4) The method of transporting the food chosen by the institution (cold or warm method) should be respected. The personnel responsible should receive regular and specific training to use the method correctly. 5) The intake of patients with nutritional follow-up should be reliably and reproducibly evaluated by the personnel after every meal. 6) Patient satisfaction should be assessed once a year and the results of this assessment used to improve the quality of hospital catering. 7) The dietician is the interface between the accounts department, the medical wards, the hospital catering department and the patients.

Treatment strategies for metastatic Ewing's sarcoma.

Therapy in metastatic Ewing's sarcoma is reviewed using the methodology recommended by the guidelines project of the Federation of French Cancer Centres (FNCLCC) Standards, Options and Recommendation (SOR) Group. Twelve articles relating to conventional dose therapy and seven articles related to high-dose therapy were judged suitable for detailed appraisal. Rates of complete response (CR) at metastatic sites and local control were high using combinations of vincristine, actinomycin, cyclophosphamide and doxorubicin with radiation or surgery. With more recent regimens, including increased doses of alkylating agents and anthracyclines the relapse-free survival has increased from <15 to 20-30%. 'Megatherapy' regimens with haematopoietic stem cell rescue are tolerable in this patient group, but to date there is little evidence of any benefit. It appears that patients with isolated lung metastases do significantly better (approximately 40% EFS) than those presenting with combined sites such as bone, bone marrow and lung. The use of lung irradiation in children with lung metastases is associated with a reduced incidence of subsequent lung recurrence and a consistently better overall relapse-free survival (RFS).

[Standards, options, and recommendations for the radiotherapy of patients with endometrial cancer. FNCLCC (National Federation of Cancer Campaign Centers) and CRLCC (Regional Cancer Campaign Centers)]. / Standards, Options et Recommandations pour la radiothérapie des patientes atteintes de cancer de l'endomètre.

OBJECTIVES: To develop clinical practice guidelines according to the definitions of the Standards, Options and Recommendations project for the radiotherapy of carcinoma of the endometrium. METHODS: Data were identified by searching Medline and personal reference lists of members of the expert groups. Once the guidelines were defined, the document was submitted for review to independent reviewers, and to the medical committees of the 20 French Cancer Centres. RESULTS: The main recommendations for the radiotherapy of carcinoma of the endometrium are: 1) For grade 1 and 2 stage IA tumours, follow-up alone is standard as additional treatment. For grade 1 and 2 stage IB tumours, vaginal brachytherapy or follow-up alone are options. For grade 3, stage IB tumours and stage IC disease, there are two treatment options: external pelvic radiotherapy with a brachytherapy boost or vaginal brachytherapy. 2) Treatment for stage II disease can be preoperative when stage II disease has been suggested by a positive endometrial curettage. Postoperative vaginal brachytherapy is given for stage IIA tumours if the penetration of the myometrium is less than 50% or if the tumour is grade 1 or 2. In the case of deep penetration, or higher grade disease, or for stage IIB external radiotherapy with brachytherapy boosting must be undertaken routinely. 3) After surgery, for stage IIIA disease, either external pelvic radiotherapy or abdomino-pelvic radiotherapy is indicated, along with medical treatment in certain patients. For stage IIIB tumours, postoperative external radiotherapy with brachytherapy (if possible) should be undertaken. For stage IIIC tumours, standard treatment is external (pelvic or pelvic and para-aortic) radiotherapy followed or not by a brachytherapy boost. In case of extrauterine sites involved abdomino-pelvic irradiation is recommended. 4) Standard treatment for inoperable stage I and II disease is external radiotherapy and brachytherapy. For patients with inoperable stage III or IV disease, treatment is often symptomatic, combining external radiotherapy and medical treatment.

[Standards, Options and Recommendations for the surgical management of carcinoma of the endometrium]. / Standards, Options et Recommandations pour la prise en charge chirurgicale des patientes atteintes de cancer de l'endomètre.

CONTEXT: The "Standards, Options and Recommendations" (SOR) project, started in 1993, is a collaboration between the Federation of the French Cancer Centres (FNCLCC), the 20 French Cancer Centres and specialists from French Public Universities, General Hospitals and Private Clinics. The main objective is the development of clinical practice guidelines to improve the quality of health care and outcome for cancer patients. The methodology is based on literature review and critical appraisal by a multidisciplinary group of experts, with feedback from specialists in cancer care delivery. OBJECTIVES: To develop clinical practice guidelines according to the definitions of the Standards, Options and Recommendations project for the surgical management of carcinoma of the endometrium. METHODS: Data were identified by searching Medline and personal reference lists of members of the expert groups. Once the guidelines were defined, the document was submitted for review to independent reviewers, and to the medical committees of the 20 French Cancer Centres. RESULTS: The main recommendations for the surgical management of carcinoma of the endometrium are: 1) where-ever possible, surgery is the primary treatment of both localised and advanced disease; 2) surgery is performed according to the stage of the cancer and the status of the patient; 3) surgery for stages I and II disease entails total abdominal hysterectomy and bilateral salpingo-oophorectomy. A modified radical hysterectomy is undertaken in cases of macroscopic cervical involvement. An omenectomy is recommended for serous papillary types. Pelvic lymphadenectomy for the purposes of precise staging is undertaken if the patient is of good performance status and without bad pronostic factors. Para-aortic lymphadenectomy can be undertaken to determine involvement of para-aortic nodes; 4) surgery for stages III and IV: radical surgery must be undertaken if at all possible with additional treatment as indicated. In the case of advanced disease, debulking surgery is indicated.

[Standards, Options, and Recommendations for brachytherapy in patients with prostate cancer: efficacy and toxicity]. / Standards, Options et Recommandations pour la curiethérapie des patients atteints de cancer de la prostate: efficacité et toxicité.

CONTEXT: The "Standards, Options and Recommendations" (SOR) collaborative project was initiated in 1993 by the Federation of the French Cancer Centres (FNCLCC), with the 20 French Regional Cancer Centres, several French public university and general hospitals, as well as private clinics and medical specialty societies. Its main objective is the development of serviceable clinical practice guidelines in order to improve the quality of health care and the outcome of cancer patients. The methodology is based on a literature review, followed by a critical appraisal by a multidisciplinary group of experts. Draft guidelines are produced, then validated by specialists in cancer care delivery. OBJECTIVES: Produce clinical practice guidelines for the brachytherapy of prostate cancer using the methodology developed by the Standards, Options and Recommendations project. METHODS: The FNCLCC and the French Urology Association (AFU) first designated the multidisciplinary group of experts. Available data were collected by a search of Medline and lists selected by experts in the group. A first draft of the guidelines was written, they validated by independent reviewers. RESULTS: The main recommendations are: 1/Brachytherapy with permanent seeds alone is a possible curative treatment for prostate cancer patients with the following prognosis factors: tumour stage T1 or T2a (TNM 1992), Gleason score < or = 6 and PSA < 10 micrograms/L. 2/Combined treatment with brachytherapy and hormonal therapy could be more efficient than brachytherapy alone for prostate cancer patients with Gleason score > 7 and/or PSA > 10.3/Combination of brachytherapy and external beam radiation therapy can be proposed to prostate cancer patients with intermediate prognosis. 4/Before and after seed implantation, risks of infection must be prevented by appropriate antibiotic therapy (recommendation). 5/Brachytherapy must not be performed within 2 months of transurethral prostate resection. 6/The height of the urethra receiving more than 200% of the prescribed dose must be reported. The portion of the rectum receiving 100 and 120% of the prescribed dose must be limited to 10 and 5 mm length, respectively.

[Concomitant radiochemotherapy for cancer of the cervix: critical analysis based on the Standards, Options and Recommendations methodology]. / Radiochimiothérapie concomitante dans les cancers du col de l'utérus: analyse critique des données et mise à jour des Standards, Options et Recommandations.

INTRODUCTION: The "Standards, Options and Recommendations" (SOR) project, started in 1993, is a collaboration between the National Federation of the French Cancer Centres (FNCLCC), the 20 French Cancer Centres (CRLCC) and specialists from French public universities, general hospitals and private clinics. The main objective is the development of clinical practice guidelines to improve the quality of health care and outcome for cancer patients. The methodology is based on literature review and critical appraisal by a multidisciplinary group of experts, with feedback from specialists in cancer care delivery. OBJECTIVES: To update, according to the methodology of SOR, the Standards, Options and Recommendations for the management of patients with cancer of the cervix, and in particular, the place of concomitant radiochemotherapy. METHODS: Data have been identified by a literature search using Medline (to April 1999) and the personal reference lists of experts. Once the guidelines were defined, the document was submitted for review to independent national and international reviewers and to the medical committees of the CRCC. RESULTS: The principle recommendations concerning the place of radiochemotherapy in the treatment of cancer of the cervix are 1/ the available data shows a significant increase in local control (level of evidence A) and of overall survival (level of evidence B1) following concomitant radiochemotherapy as compared to radiotherapy alone or the combination of radiotherapy-hydroxyurea. For stages IB, IIA, proximal IIB with bad prognostic factors (tumour size greater than 4 cm and/or invasion of pelvic nodes and/or microscopic invasion of the parametrium) and without lumbo-aortic nodal invasion, concomitant radiochemotherapy can be considered as standard treatment. This benefit is less clear for stages distal IIB, III and IVA without para-aortic nodal invasion (level of evidence C) and must be confirmed (expert agreement). 2/ the toxicity of radiochemotherapy is essentially haematologic and gastrointestinal (level of evidence B1) and is greater than that of radiotherapy alone (level of evidence B1). 3/ these results have been obtained by the combination of chemotherapy based oncisplatin alone, or in combination with 5-FU. Although of equal benefit, the toxicity of the cisplatin/5-FU/ hydroxyurea combination was greater than that of cisplatin alone in a trial comparing the two protocols. A significantly longer survival have also been obtained by the combination of chemoradiation and adjuvant chemotherapy with epirubicin (level of evidence C). These results must be confirmed. 4/ the exact means of delivering the chemotherapy has not been clearly established. In fact, in these trials, some protocols use cisplatin weekly at a dose of 40 mg/m2 and others every three or four weeks at doses ranging from 50 to 75 mg/m2. Subsequent randomised studies are likely to establish optimal schema for the delivery of chemotherapy when combined with external radiotherapy and brachytherapy.

[Standards, Options and Recommendations (SOR): consequences of the SOR guidelines project in terms of liability for French Cancer Centers]. / Standards, Options et Recommandations (SOR): leurs effets juridiques en termes de responsabilité, recommandations et suggestions à l'intention des Centres de lutte contre le cancer.

Context. The "Standards, Options and Recommendations" (SOR) project, started in 1993, is a collaboration between the Federation of the French Cancer Centers (FNCLCC), the 20 French comprehensive Cancer Centers and specialists from French Public Universities, General Hospitals and Private Clinics. The main objective is the development of clinical practice guidelines to improve the quality of health care and outcome for cancer patients. The methodology is based on literature review and critical appraisal by a multidisciplinary group of experts, with feedback from specialists in cancer care delivery. Objectives. To identify consequences in terms of liability of the development of SOR guidelines and to formulate recommendations for the FNCLCC and medical doctors using SOR. Methods. Data have been identified by literature search on legal matters by CNEH's Legal Center JuriSanté, then submitted to a group of 8 experts. Results. The main conclusions of the present study are: 1)The SOR attest a high level of quality and methodological rigor; 2) according to legal considerations and in comparison to the available scientific data, the SOR guidelines can be considered as the state of the art in oncology at time of release; 3) the study identified six quality properties of Standards, Options and Recommendations (SOR): information contained in the SOR must be serious, accurate, reliable, complete, up-to-date and secure. The respect of these quality criteria is essential in the matter of liability; 4) when gathered, they can prevent the actors from being implicated on questions of liability. Specialists who use the SOR may avoid problems of liability, nevertheless evidence and the state of the art may evolve with time; 5) clinicians who do not use the SOR, may appear to be responsible for disasters, except if they can justify their medical decision (evolution of scientific knowledge or specific clinical circumstances, etc.); 6) therefore, SOR developers need to keep in mind these essential properties when SOR are prepared; 7) the SOR steering committee (COSOR) analysed the conclusions of the present legal study and defined a series of actions and procedures to guarantee the respect of the above quality criteria.

[Good clinical practice in the dietetic management of cancer patients]. / Bonnes pratiques pour la prise en charge diététique en cancérologie: la consultation.

CONTEXT: The "Standards, Options and Recommendations" (SOR) project, started in 1993, is a collaboration between the Federation of the French Cancer Centres (FNCL CC), the 20 French Cancer Centres and specialists from French Public Universities, General Hospitals and Private Clinics. The main objective is the development of clinical practice guidelines to improve the quality of health care and outcome for cancer patients. The methodology is based on literature review and critical appraisal by a multidisciplinary group of experts, with feed-back from specialists in cancer care delivery. OBJECTIVES: To develop clinical practice guidelines according to the definitions of Standards, Options and Recommendations for the dietetic consultation for cancer patient. METHODS: Data have been identified by literature search wing Medline and the expert groups personal reference lists. Once the guidelines were defined, the document was submitted for review to 74 independent reviewers, and to the medical committees of the 20 French Cancer Centres. RESULTS: The main recommendations for the referral of cancer patients for dietary advice are: I) in oncology, there are 3 types of dietetic consultation: diagnostic, preventive and therapeutic; 2) the following cancer patients must have a dietetic consultation: i) those with, or at risk of malnutrition, ii) those without malnutrition but in need of counseling and iii) those at risk of treatment-related nutritional side effects; 3) a nutritional assessment is standard at the time of the first dietetic consultation. Patients must be given individualized and written advice; 4) the dietetic opinion and advice should be brought to the attention of medical staff to facilitate a multidisciplinary approach to cancer treatment; 5) patient's relatives should be involved in the dietetic management; 6) the efficacy of dietetic advice can be assessed by monitoring weight, gastrointestinal signs and patient satisfaction.