Health related quality of life outcomes in cancer clinical trials.

Over the last decade, health related quality of life (HRQOL) investigations have become an increasingly important part of many cancer clinical trial research programs. This paper presents a review of all HRQOL studies published by the European Organisation for Research and Treatment of Cancer (EORTC), one of the largest clinical trials organisations in Europe. The findings highlight 24 clinical trials that have been published to date, enrolling over 9000 patients. HRQOL is fully integrated into EORTC phase III trials. In many trials, HRQOL provides a valuable source of additional information useful to both clinician and patient when making treatment decisions. Furthermore, several trials have found that the combined use of clinical information along with HRQOL data has led to the development of new standards of care in several different cancer sites. With more than 40 ongoing HRQOL studies in the EORTC, we expect HRQOL to play an even greater role over the coming decade in helping establish the optimal treatment and care approach for cancer patients.

The challenges and achievements involved in implementing Quality of Life research in cancer clinical trials.

Over the last decade, Quality of Life (QOL) research has become an important aspect of cancer clinical trials. A dramatically increasing number of published studies, both randomised and non-randomised, report QOL outcomes. There is increasing evidence that QOL results impact on both future research and treatment decisions for clinicians. The rising number of studies with QOL components is mirrored within the European Organization for Research and Treatment of Cancer (EORTC), one of the largest cancer clinical trial organisations in Europe. Clinical trial groups have frequently reported on the difficulties and challenges of implementing QOL research. In the following paper, we therefore examine past experience in EORTC QOL studies, with a focus on the challenges presented and the improved approaches that are being implemented to obtain more meaningful outcomes.

Methodological issues in assessing health-related quality of life of colorectal cancer patients in randomised controlled trials.

Although health-related quality of life (HRQOL) is increasingly reported as an important endpoint in cancer clinical trials, questions still remain about the quality of its reporting. The aim of this study was to evaluate the level of reporting of HRQOL in randomised controlled trials (RCTs) of colorectal cancer (CRC). A systematic literature search from 1980 to March 2003 was undertaken on a number of databases. Identified eligible studies were selected and then evaluated on a broad set of HRQOL predetermined criteria by four reviewers. Thirty-one randomised controlled trials involving 9683 colorectal cancer patients were identified. Nearly all studies dealt with metastatic patients and principally compared different chemotherapy regimens. The HRQOL tool most often used was the European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), which was used in 48% of the studies. Some methodological limitations were identified: 39% of the RCTs did not report HRQOL compliance at baseline and 52% did not give details on missing data. A rationale for using a specific HRQOL measure was given in only 10% of the studies. Whilst HRQOL assessment is a potential valuable source of information in understanding the impact of colorectal cancer, a number of methodological shortcomings have to be further addressed in future studies.

Management of skin reactions during radiotherapy: a study of nursing practice.

The aim of this study was to investigate the consensus of skin care advice given by nurses during radiotherapy. Sixty-seven nurses, identified through nine Belgian radiotherapy departments, responded to a questionnaire survey consisting of 58 items regarding prevention and management of erythema, dry desquamation and moist desquamation. Consensus for a given advice was categorized as small if less than 50% of the nurses gave the same answer, as moderate if between 50% and 75% and as large when more than 75%. Overall, 33% of the items showed small consensus, 29% showed moderate consensus and 38% showed large consensus. The highest consensus was seen for advice in cases of moist and dry desquamation. There was less agreement in the case of erythema and it decreased further for preventive advice. Some skin care techniques that were frequently used by the nurses cannot be supported by the literature. Also, some techniques recommended by the literature are not frequently used. Further, few differences (P < 0.05) between nurses working in a university hospital and the ones working in a non-university hospital were found in terms of advice given to patients. To increase consensus on skin care issues more conclusive research is needed. Of equal importance is the translation of existing research results into daily clinical practice.