This methodological longitudinal study was conducted in the Department of Prevention and Oncological Gynaecology of the Barretos Cancer Hospital, Barretos, state of São Paulo, Brazil. A total of 439 women were eligible, including 329 women with a histopathological diagnosis of CIN (low or high grade) without treatment and 110 women not diagnosed with the disease. The participants attended the Department of Prevention for screening via a cervical cytology examination (Papanicolaou test). Illiterate women and women known to have psychological or psychiatric disorders that could hinder the understanding of the questionnaire and the informed consent form were excluded.
After formal agreement to participate in the study, the participants answered the questionnaires, which were applied using interviews by a single interviewer. Sociodemographic and clinical data were initially collected. Then, the FACIT-CD, EORTC QLQ-CX24, and SF-12 (version 2) questionnaires were applied; this step was considered the first stage of the study.
Among the 329 women diagnosed with CIN, the first 112 were selected to answer the FACIT-CD questionnaire a second time to assess the reproducibility of the instrument. Interviews were conducted in a second consultation 30 days after the first interview to inform the test results. Of the 112 women selected, 87 (77.7%) returned on the expected date and answered the questionnaire.
The responsiveness and sensitivity of the FACIT-CD questionnaire were evaluated in 228 participants with a medical indication for surgical treatment using the loop electrosurgical excisional procedure (LEEP). Of this total, 179 (78.5%) returned after treatment during the stipulated period (4–6 months) and answered the FACIT-CD questionnaire a second time and the first question of the SF-12 questionnaire (“In general, would you say your health is:”). The responses obtained to this question at baseline and after treatment allowed the creation of groups and the classification of women as having improved health, worsened health, or no change in health. Among the other participants who underwent LEEP (49 women), 7 presented with invasive carcinoma and were forwarded to the Department of Oncological Gynaecology, 12 women returned outside the period stipulated for re-application of the questionnaire, and the remaining participants did not return on the previously scheduled date.
The FACIT-CD instrument in Brazilian Portuguese is a specific instrument to assess the HRQoL of women with CIN and comprises 37 questions divided into five scales to assess aspects related to physical well-being (9 questions), treatment satisfaction (4 questions), general perception (7 questions), emotional well-being (11 questions), and relationships (6 questions). The scores were calculated using the specific guidelines provided by the FACIT . The responses were based on experiences from the last 7 days. The answer scale is Likert, with scores ranging between 0 and 4 (a little bit to very much). A score was assigned to each scale, and the scores were summed to obtain a single value. The total score of the questionnaire ranged from 0 to 136. A higher score indicated a better HRQoL.
EORTC QLQ-CX24 questionnaire
The EORTC QLQ-CX24 questionnaire was developed and validated cross-culturally by the European Organization for Research and Treatment of Cancer and was used for the assessment of HRQoL in patients with cervical cancer . This instrument consists of 24 questions divided into three scales of multiple items and six scales of single items, including 11 questions on symptoms (questions 31 to 37, 39, and 41 to 43), 3 questions on body image (questions 45 to 47), 4 questions on sexual/vaginal function (questions 50 to 53), 1 question on lymphedema (question 38), 1 question on peripheral neuropathy (question 40), 1 question on menopause symptoms (question 44), 1 question on sexual worry (question 48), 1 question on sexual activity (question 49), and 1 question on sexual enjoyment (question 54). The scores were calculated separately for each scale of the multiple and single items to allow the evaluation of sexuality using the questions on sexual/vaginal function, sexual activity, and sexual enjoyment .
The SF-12 questionnaire is a generic instrument for the assessment of HRQoL. This questionnaire is considered a smaller version of the Medical Outcomes Study 36 – Item Short-Form Health Survey (SF-36). The main goal of developing an instrument with a reduced number of items was to provide a questionnaire that could be answered quickly and easily, which is a good option for population-based studies and health screening . The questionnaire consists of 12 questions derived from the SF-36 questionnaire. In Brazil, the SF-36 questionnaire was translated into Brazilian Portuguese and validated by Ciconelli et al. in 1999 . The scores were calculated using specific software provided by the Medical Outcomes Health Survey.
Analysis of psychometric properties
The classical psychometric properties of the FACIT-CD questionnaire were tested by assessing the internal consistency, reproducibility, structural validity, convergent and divergent validity, known-group validity, sensitivity, and responsiveness.
Cronbach’s alpha coefficient was used to test the internal consistency of the instrument, with values equal to or higher than 0.70 considered appropriate . The reproducibility of the FACIT-CD was evaluated by comparing the scores obtained in the questionnaire during the first and second interviews. For this purpose, the intraclass correlation coefficient (ICC) was used. Structural validity was assessed using a confirmatory factor analysis. The oblique rotation method was used for principal component analysis, and a five-factor solution was forced, as presented in the original questionnaire. For the analysis of convergent and divergent validity, the scores generated by the FACIT-CD questionnaire were correlated with the scores generated by the SF-12 questionnaire and the scores of the scales that assessed sexuality in the EORTC QLQ-CX24 questionnaire. The Spearman correlation coefficient was used to calculate the correlations, with values higher than 0.40 considered appropriate . The assumptions of correlations between the FACIT-CD, SF-12, and EORTC QLQ-CX24 scales were established a priori.
To assess the known-group validity, women without the disease were compared with women diagnosed with CIN using the Mann-Whitney test. These two groups were also assessed based on the answers to the first question of the SF-12 (“In general, would you say your health is:”). The responses were classified as excellent/very good, good, and poor/very poor and were compared using the Kruskal-Wallis test.
Sensitivity was evaluated by calculating the magnitude of the effect using the Cohen’s D, standardized response mean (SRM), and relative efficiency tests . The tests were applied to the groups before and after treatment.
Responsiveness was analysed using hypotheses established a priori. For this purpose, the study groups were compared before and after treatment (LEEP). The reference statistical method most commonly used to measure the magnitude of changes in HRQoL scores is the assessment of the effect size (ES) and the SRM [27, 28], which provide useful data concerning significant changes in clinical practice . The ES and SRM are defined using Cohen’s criteria, in which values up to 0.20 indicate low responsiveness, values up to 0.50 indicate moderate responsiveness, and values higher than 0.80 indicate high responsiveness [26, 30]. The level of significance was 5% in all statistical tests.
This study was approved by the Research Ethics Committee of the Barretos Cancer Hospital under CAAE No. 36619714.9.0000.5432, and all the women who agreed to participate in the study signed an informed consent form.