Physical, functional, emotional well-being, and total scores, improved significantly between baseline and six months. In all cases, there was no effect of group and no interaction between group and time, indicating that the women were not affected by the method of data collection. There were also no significant effects of group even when there was no change in the scores over time (social well-being, fatigue). The one significant interaction effect was observed with the social well-being domain, which appeared due to a high baseline score in the CP group. At baseline, the CP group was the same as the CC group (they all used the computer) so it is not clear why there would be a high baseline score in the group that would use a paper version six months later. It is possible that with the number of tests conducted, one spurious finding would be obtained. The trend across all the tests is very strong, however. There are clear and significant changes with time but not with the method of obtaining the data.
Given the choice between using the computer version and the paper version, a small number of women chose the paper version. Of the 238 total measurements, the paper version was used a total of 53 times (22%). Reasons for not using the computer included not wanting to come in to the physician's office at all and patient preference but also instances beyond the patients' control such as scheduling complications and researcher unavailability on a small number of occasions. Designing strategies to increase computer availability may result in further reductions in patient use of the paper versions. If patients can log onto the computer using a unique identifier and complete the questionnaires on their own in the waiting room, the number of women who have to take questionnaires home or forgo completing them should decrease even further.
The second assessment occurred six months following major surgery for all women. The majority of women with ovarian cancer received chemotherapy, but were not receiving it at six months. This time point therefore allows a relatively stable point to assess changes in QoL relative to pre-operative scores in these groups of women. It is possible that differences in method of data collection would be obtained if women were acutely ill at the time of measurement, however the time frame of seven days used in the FACT-G reduces the likelihood that a separation in time of a day or two between using the computer in the office or the paper version at home will result in different responses. The time frame used in the FACT-G, and the relatively stable time point chosen may therefore contribute to the lack of measurement effect obtained in these groups of women.
A limitation of this study is the lack of minority representation which may reduce the generalizability of these results. Additionally, 19% of patients refused to participate in the study. Of the patients who did participate, 21% did not complete the second assessment, although this figure includes 16 women with a benign adnexal mass who may have returned to their referring physician, and women with cancer who moved or transferred their care. Nonetheless, the women who remained on study may differ from those who did not agree to participate or who did not complete the second assessment. They may, for example, have a greater degree of commitment to the research process.
A second limitation is that women were not randomly assigned to use either the computer or the paper versions. This is a preliminary examination of existing data to determine whether there appeared to be a selection bias, or major effect, of using the paper version. Women with QoL scores that differed markedly from the norm, for example, might have chosen to take the paper version home. This did not appear to be the case, however, as highly significant effects of time were observed, but group and interaction effects were markedly non-significant. Related limitations include the remote, but possible, explanation that the first method of administration had an effect on participants at the second time point. Additionally, patient choice itself may have had an unmeasured effect. For example, women with benign adnexal mass were more likely to forego the second office visit and complete the questionnaire at home. Disease and questionnaire administration are therefore confounded. These limitations may have influenced group choice, as well as responses on the second measurement.
These exploratory data suggest that women are responding to questionnaires presented on a computer in the same manner as questionnaires on paper. This study therefore differed somewhat from studies that found differences in method of administration [12
]. An important consideration may be maintaining the same format of the questions in the two methods of administration. In this study, each domain was presented on one large screen so that all questions were listed together. The similarity of the format may have contributed to the finding that modes of administration are interchangeable, however larger scale studies, which include randomization and assessing women at different stages of treatment, should be conducted to verify these findings.