European journal of cancer : official journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)
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In 1977, Zelen proposed a new design for clinical trials with the aim of increasing recruitment by avoiding some of the problems associated with obtaining informed consent. These 'randomised consent' designs have proved controversial, and have not often been used. ⋯ All identified published cancer treatment trials using a randomised consent design are considered in some detail. Reasons for and against the use of these designs are summarised.
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The understanding and treatment of pain is one of the oldest challenges for physicians, scientists and philosophers. Much of our present rationale of pain control is based on the Cartesian idea that pain mostly originates from external or internal noxious stimuli, which are transmitted to and interpreted in the brain. Consequently, removal (blocking) of the stimuli and modification of cerebral awareness have been the prime targets of analgesic interventions. ⋯ The current preoccupation with quality assurance in healthcare is directed, ultimately, to the delivery of a better quality of care, which should also be more cost-effective, for large populations. An important intermediate step towards that ideal is the collection of data on pain and other symptoms, but also validated quality of life parameters on well-defined groups. Only by widening the scope of analgesic studies to include these dimensions can we hope to define appropriate strategies for more rational healthcare.
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Quality of care and quality of life are patient-centred, whereas medical education tends to be disease-centred. More patient-centred models will be necessary to optimise the quality of care for cancer patients. This demands new priorities in medical education, new concepts for structuring and organising responsibilities in medical care, and new complementary task definitions for the players involved. ⋯ Quality of life measuring instruments should be adapted to the priorities of the clinical situation and implemented in basic practice routines. There is no single objective quality of life level or score, and measuring instruments must take into account different quality of life options. Multidisciplinarity and multimedia education means the appropriate learning instruments at the appropriate time for all those concerned.
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Review Randomized Controlled Trial Clinical Trial
Scalp cooling has no place in the prevention of alopecia in adjuvant chemotherapy for breast cancer.
35 patients were studied to determine the effectiveness of scalp hypothermia in the prevention of alopecia caused by adjuvant chemotherapy for breast cancer. Scalp hypothermia was induced by the newly developed Theracool cooling machine. The chemotherapeutic regimen consisted of one perioperative course of doxorubicin 50 mg/m2, cyclophosphamide 600 mg/m2 and 5-fluorouracil 600 mg/m2 (EORTC protocol 10854). ⋯ No scalp metastases were observed after scalp cooling. These results and a review of the literature suggest that scalp hypothermia to prevent alopecia may only be effective in a cytotoxic regimen containing an anthracycline as the sole alopecia-inducing agent. With current adjuvant chemotherapy for breast cancer, in which a combination of cyclophosphamide and an anthracycline is often used, there is no place for scalp hypothermia.
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Proton beams are already being employed for radiation therapy in 15 centres worldwide and over a dozen more are planned. Good clinical results have been reported in uveal melanomas and in sarcomas of the skull base. Calculated dose distributions for the treatment of brain, lung, head and neck and pelvic tumours predict an improvement relative to multiple-field or conformal photon radiotherapy. Protons may well provide high-precision radiotherapy that will lead to improved treatment of certain tumours in specific anatomical locations.