Methodological study to evaluate the psychometric properties of FACIT-CD in a sample of Brazilian women with cervical intraepithelial neoplasia

Human papillomavirus (HPV) infection is the most prevalent sexually transmitted disease worldwide [1]. Approximately 440 million people are estimated to have genital HPV infections worldwide [2], and approximately 10% of women will carry HPV at some point in their life [3].

Approximately 40 types of HPV can invade the mucous membranes of the upper aerodigestive tract and anogenital region of humans; these HPV types are classified as low and high risk according to their carcinogenic potential [4]. Low-grade intraepithelial lesions spontaneously regress in 60% of cases, and only 10% of cases progress to high-grade lesions. Even cervical carcinoma in situ (CIN 3) may undergo spontaneous regression to normality in one-third of women [4]. The period from HPV infection to the onset of invasive cervical cancer is estimated to extend 10 to 20 years, which makes this disease preventable using well-structured screening strategies [5].

The occurrence of cervical intraepithelial neoplasia is associated with changes in health-related quality of life (HRQoL), including psychological factors, such as fear and shame, and changes in sexuality and sexual satisfaction, such as decreased sexual desire and decreased frequency of sexual intercourse [6–8]. Such problems tend to sustain for a period of time after the treatment [9]. Anxiety, distress, concern with fertility, changes in family dynamics and work-related changes are also negative effects of CIN diagnosis and treatment [10–13]. Because this disease is sexually transmitted, many women tend to blame their partner for transmission [13, 14].

Despite the availability of instruments to objectively assess HRQoL, few instruments have investigated the impact of HPV infection in the female genital tract. The number of studies on aspects related to HRQoL in women diagnosed with cervical cancer has significantly increased. This increased interest can be justified by the magnitude of the disease, which predominantly affects young women who will live the rest of their lives with the consequences of the disease and treatment [15–18]. However, little is known about the impact of diagnosis and treatment on HRQoL in women diagnosed with precursor lesions of cervical cancer.

In 2010, Rao et al. [6] developed a tool that was designated the Functional Assessment of Chronic Illness Therapy – Cervical Dysplasia (FACIT-CD) to assess the functional, physical, and psychological characteristics of women with CIN. The questionnaire has recently been translated and adapted to Brazilian Portuguese.

The FACIT system questionnaires are easy to apply (self-applied or using interviews), require little time to complete, have adequate validity and sensitivity to detect changes, and are designed to reach a population with a level of education corresponding to the fourth year of primary school (9–10-year-old age group) [19].

The aim of this study was to evaluate the psychometric properties of the FACIT-CD questionnaire in Brazilian women diagnosed with CIN.

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.

Among women without changes in health between the assessments, the average scores remained unchanged (8.6–8.8; p = 0.021) and had low responsiveness (ES = 0.009; SEM = 0.10) only in the relationship scale (1/5 scales). In the other scales, the HRQoL scores improved with the exception of the general perception scale, which maintained the tendency of worsening after treatment.

Different results were found in the group of women who reported worsening of health between assessments. The decrease in the HRQoL scores was evident on the scales that assessed physical well-being and general perceptions (2/5 scale). There were no differences in the relationship scale and the total FACIT-CD score. However, the treatment satisfaction and emotional well-being scales improved.

To the best of our knowledge, this study is the first to validate a questionnaire (translated into Brazilian Portuguese) that measures the quality of life of women diagnosed with cervical intraepithelial neoplasia. The FACIT-CD questionnaire was developed by Rao et al. [6] in 2010. To date, no other studies have evaluated the psychometric properties of this instrument, which means that some comparisons are only exploratory.

The first test assessed the reliability of the questionnaire by analysing the internal consistency using Cronbach’s alpha coefficient. Results higher than 0.70 indicate that the items on the scales or domains are homogeneous or that they measure the same attribute. In this study, the value on the relationship scale was lower than expected (0.66). However, other authors support the hypothesis that Cronbach’s alpha values ​​higher than 0.60 could be acceptable [31]. Despite this assumption, we believe that a value of 0.70 ​​would be more desirable, and thus, we considered that the relationship scale did not achieve adequate internal consistency. Therefore, these results suggest that the relationship scale does not measure the same attribute because it addresses questions about the emotional support that women receive from their partner and family combined with questions about their relationships with friends and support in case of need [8]. We believe that further studies with other populations are necessary to compare the results and to determine whether the problems will be repeated.

The second stage of the study evaluated the reproducibility of the FACIT-CD questionnaire (i.e., the consistency of the results after repetition of the measurements). Most of the studies that assessed reproducibility used a period of 14 ± 5 days [32–34]. Despite this recommendation, the treatment of intraepithelial lesions is not related to sudden changes in health status. Therefore, the period between assessments used in this study was 30 days because this time frame represented the interval between the colposcopy examination and the second medical consultation. The lower limit of the 95% CI of the ICC on the treatment satisfaction scale was lower than 0.40, indicating low reproducibility (i.e., the variability in treatment satisfaction was greater than desired). Some factors reported by the study participants could justify this variability. The consultations were conducted by different physicians from the same team, which might lead to dissatisfaction or conversely a better evaluation in another consultation. The impact on the emotional factors of the patient might also influence this variable (e.g., whether the consultation was scheduled only to perform follow-up tests such as colposcopy or whether it was scheduled to inform the result of a test that would define a course of action). Emotional factors in these different instances (consultation for examination and consultation to receive laboratory test results) may explain this variability.

The best results were observed in the known-group validity analysis. The comparison of the groups of women with and without a diagnosis of CIN indicated significant differences in the scores on all scales. As expected, some scales showed worsening in the HRQoL scores in women without the disease. The reason for this difference was apparent in the items that composed the scales. In the scales that assessed treatment satisfaction and relationships, women without the disease responded “not at all” on various items, thereby decreasing the HRQoL scores as expected because they were not in treatment. The general perception scale evaluated items such as acceptance of infection and whether women could manage things that came up around the infection. A decrease in the HRQoL scores of women without the disease was expected for the items that composed the scale. These factors contributed to the decrease in the HRQoL scores in women without CIN compared with women with CIN based on the FACIT-CD total score. As expected, the scores of the other physical and emotional well-being scales were higher in women without the disease.

In an additional analysis, the test groups were classified based on the health status rating of each participant, with a lower score indicating a worse perception of the HRQoL. In this case, all scales showed significant differences. This analysis confirmed that the FACIT-CD questionnaire could differentiate the groups for which differences were expected.

The structural validity of the questionnaire was tested by confirmatory factor analysis. The results consistently confirmed the structure of the original questionnaire, which contained five factors. The only exception was in the fifth item of the physical well-being scale, which assessed the side effects of treatment. This item showed higher factor loading in the emotional well-being scale. The follow-up and treatment of women diagnosed with CIN have a greater emotional impact than physical impact [8]. Women who seek medical care after the diagnosis of changes in the Papanicolaou test rarely complain of physical changes but often complain of psychological changes [10–12]. This finding suggests that item GP5 ("I am bothered by side effects of treatment") is better allocated in the emotional well-being scale. On the other hand, confirmatory factor analysis is very sensitive to sample size, and its consistency requires a relatively large number of cases [35]. Therefore, an increase in the sample size may help confirm the new positioning of the variable in the model.

Regarding the convergent and divergent validities of the FACIT-CD questionnaire, we expected to find a correlation between the SF-12 and FACIT-CD questionnaire scales. However, no correlation was found, and the values were lower than 0.40. This result may have occurred because the SF-12 is a generic questionnaire that does not specifically address the questions explored in the FACIT-CD; therefore, the purposes of the evaluations were distinct. Another study that used a generic and a specific questionnaire reported the same problem when correlating the questionnaires [33]. This analysis was also conducted using the EORTC QLQ-CX24 questionnaire, which was developed to assess the HRQoL of women with cervical cancer and could easily calculate the scores of the scales and some items separately. Therefore, for this study, only the scales that assessed sexuality were used. The results of the correlation between the scales of the FACIT-CD and EORTC QLQ-CX24 questionnaires were satisfactory. In this case, it was possible to confirm the correlation of the FACIT-CD questionnaire with other dimensions for which a correlation was already expected.

Some of the women who participated in the first stage of the study and were treated surgically (LEEP) were interviewed again 6 months after surgery. In this analysis, improvements in the scale scores were expected after treatment using the SRM and relative efficiency (ES). The goal was achieved for all scales except for the general perception scale. The scale scores improved after surgery, and the sensitivity was considered low to moderate. The general perception scale indicated deterioration in the overall score; however, it was not possible to identify which items worsened. In the present study, we used the classical test theory (CTT), which tests the validity of an instrument (i.e., the ability to measure what it proposed to measure), for the psychometric analysis of the FACIT-CD questionnaire [36]. However, future studies should conduct other analyses using the item response theory (IRT) [37], which investigates items separately. [37] Furthermore, the responsiveness of the FACIT-CD questionnaire was evaluated using the same group in which sensitivity was measured before and after treatment. Other studies have used a methodology similar to ours to evaluate responsiveness [38–40]. However, in this case, the women were divided based on their self-reported health status. After treatment, the participants answered the FACIT-CD questionnaire and the first question of the SF-12 questionnaire (on health rating). Finally, the answers provided to this question before and after treatment were compared to allow the classification of the groups as improved, worsened, or no change in health status. In the group of 83 women who exhibited improved health, we noticed an increase in the scores of the scales, reflecting an improvement in HRQoL. The total score of the FACIT-CD indicated moderate responsiveness. Responsiveness was low in the groups of women who reported health worsening or had no changes in health status. The HRQoL scores improved even among women who reported not having good health. We believe that other health problems may have interfered with the responses and that there is no direct correlation between health worsening and the worsening of signs and symptoms resulting from CIN.

Our results are encouraging and indicate that the FACIT-CD questionnaire is a promising tool for the analysis of HRQoL in women with CIN. Internal consistency and reproducibility were satisfactory. Regarding structural validity, only one item on the physical well-being scale was not kept in the original domain. The questionnaire was able to discriminate the groups according to disease status and self-rating of health. Sensitivity was low for the relationship scale, but moderate for the other scales. Responsiveness varied between the groups that denominate the self-perception of health as no change, improvement or worsening.