Background: Health related quality of life (HRQOL) is routinely measured in cancer trials alongside traditional endpoints, and is particularly important where survival rates can be small such as in ovarian carcinoma. However, questions still remain regarding the methodological quality and impact value of HRQOL assessment in some randomised controlled trials (RCTs). Objectives: To systematically assess methodological quality of patient reported HRQOL outcomes in RCTs of therapeutic regimens in ovarian carcinoma. Methods: The Cochrane Central Register of Controlled Trials, MEDLINE and EMBASE were searched for RCTs of surgical procedures, radiotherapy or chemotherapy in patients with ovarian carcinoma, reporting a primary or secondary HRQOL endpoint. Searches were conducted from 1980 to 2007 and restricted to English language publications. Two reviewers independently assessed trials to evaluate their HRQOL methodological quality on predetermined criteria. Results: Twenty RCTs enrolling 8031 ovarian carcinoma patients were identified. Nearly all trials compared different chemotherapy regimens in first to third line treatment. All trials assessed HRQOL as a secondary endpoint, with the cancer specific European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-Core 30 (EORTC QLQ-30), used either alone or in conjunction with the site specific ovarian-28 module in 75% of trials. Methodological constraints included lack of a priori hypotheses regarding HRQOL differences between treatment arms, and only 70% of trials reported pre-determined methods of statistical analysis for HRQOL data. Additionally, only sub-samples of randomised patients were included in the HRQOL assessment, and reporting of baseline compliance rates was variable. Rates of attrition ranged markedly from 0% to >70% at different time points, with most trials experiencing moderate attrition rates, but robustness of results to assumptions regarding patient withdrawal was only tested in one trial (5%). Seven trials (35%) reported statistically significant differences in HRQOL between treatment groups, but clinical significance of changes in HRQOL was examined in only four (20%). Conclusions: HRQOL data can provide a valuable source of information in understanding the impact of ovarian carcinoma and effects of different therapeutic regimens. However, methodological shortcomings in its assessment and analysis, may limit its utility in treatment decision making.