ARTICLEThe psychosocial and economic burden of genital warts among women assisted in six sexual and reproductive health clinics in Brazil

A carga psicossocial e econômica de verrugas genitais em mulheres atendidas em seis clínicas de saúde sexual e reprodutiva no Brasil

Mônica Gomes de Almeida 1, Antônio Márcio Tavares Thomé 2, José Berilo Lima Filho 3

2013
Vol. 25 - Nº.04
Pag.196 – 201

ABSTRACT

Introduction:

World Health Organization estimates that 291 million women worldwide will have a human papillomavirus infection. Treatment for genital warts brings discomfort and may be stressful.

Objective:

The objectives are to estimate the psychological burden of genital warts and to estimate its economic burden in six reproductive health clinics in Brazil.

Methods:

Women visiting BEMFAM's clinics from January 2012 until March 2013 filled a self-administered questionnaire based on psychometric scale. The economic burden was measured with a retrospective study of medical chart review of patients assisted form January 2009 to December 2010.

Conclusão:

Houve relação entre a carga econômica e a carga psicossocial das VG. O maior uso de serviços de saúde após um episódio de verruga genital deve ser analisado em estudos sobre a carga econômica das VG. O presente estudo reforça a importância da análise dos custos indiretos, considerando o número de visitas por episódio de VG. Estudos adicionais podem fortalecer os esforços para programas abrangentes de prevenção no Brasil.

Keywords

reproductive health
health and costs
genital warts

Palavras-chave

saúde reprodutiva
saúde e custos
verrugas genitais

INTRODUCTION

The World Health Organization estimates that 291 million women worldwide will have a human papillomavirus (HPV) infection at any given point in their lifetime1. Cervical cancer is related to oncogenic types of HPV infection and constitutes a public health issue in Brazil. According to the Brazilian National Cancer Institute 15.590 new cases and a rate of 15,33 cases per 100.000 women are estimated for 20142.

Although cervical cancer is the most important public health issue related to HPV infection in women, genital warts (GW), a benign condition related to non oncogenic HPV subtypes, cannot be neglected. In 2008, the Brazilian Ministry of Health published a study on sexually transmitted infections (STI) prevalence in selected populations (pregnant women, men working in industry and people seeking care in STI clinics) in five regions of the country3. Genital warts were diagnosed in 5.7% of pregnant women, and 6.5% reported previous episodes. Among women who seek STI clinics, 21% had a GW diagnosis, and 25% reported previous episodes.

Genital warts usually cause stress to the affected individuals. The treatment options bring some kind of discomfort, such as burning sensation and pain. Besides, as a sexually transmitted infection, it may be associated with feelings of shame, anxiety and problems in the relationship with the partner.

Zhu et al.4 developed a psychometric scale to assess the psychological burden of HPV. The self-administered questionnaire consists of 29 questions designed to capture a wide range of psychosocial consequences of HPV disease, including both cervical cancer precursors and genital warts. The results were sensitive to differences in the psychosocial impact of various HPV-related diseases.

There are studies about costs of GW treatment in many countries; some of them consider only direct costs5,6 and others include indirect costs such as sick leave7,8,9. Considering the importance of HPV and related diseases in Brazil and the lack of studies about both the psychosocial and the economic burden of these diseases, Bem Estar Familiar no Brasil (BEMFAM - Family Wellbeing in Brazil) carried out a study to measure the psychosocial and economic burden of genital warts among two samples of women attending its six reproductive health clinics. BEMFAM is a Brazilian non-governmental organization that provides sexual and reproductive health (SRH) services and technical support to local governments.

OBJECTIVE

There are two objectives in this paper: (i) to estimate the psychological burden of genital warts (GW); and (ii) to estimate the economic burden of GW in six reproductive health clinics in Brazil.

METHODS

The study design comprises two objectives and groups of women assisted in the six BEMFAM's SRH clinics in the Brazilian Northeast States of Maranhão, Paraíba, Rio Grande do Norte, Pernambuco, Ceará and the Southeast State of Rio de Janeiro. All the clinics are located in urban areas of the State capital cities, provide outpatient care and assist both individuals who pay out-of-pocket or with private health plans. All the individuals were assisted by gynecologists. The psychosocial burden was measured by a self-administered questionnaire at the time of the visit and the economic burden was measured with a retrospective study of medical chart review analysis.

Women who visited the six BEMFAM's clinics from January 31st, 2012 until March 1st, 2013 were invited to participate in the study. Inclusion criteria were women aged 18-45 years, who had a Pap smear in the preceding 90 days or were diagnosed with genital warts during physical examination, in good health. Women who self-reported to be positive for Human Immunodefficiency Virus (HIV) serology, undergoing antiretroviral treatment, illiterate or pregnant were excluded.

Women who accepted to be a volunteer signed an informed consent and answered a socio-demographic questionnaire and a psychometric scale test applied by nurses. Both questionnaires were pretested through in-depth interviews with clients, to evaluate easy of understanding and adequacy of translations.

All volunteers received written information and an educational counseling session about prevention and treatment of HPV after filling the self-administered questionnaire. Women belonging to the groups with cervical intraepithelial neoplasia (CIN) 1 and CIN 2-3, also had a colposcopy and/or biopsy free-of-charge.

Medical chart review

In order to identify patients with GW, medical records of women who consulted from January 2009 to December 2010 and had undergone one of the procedures that could be related to GW treatment were analyzed. The procedures were provider-applied modalities to treat vulvovaginal or anal lesions. Criteria for enrollment in the study comprise women aged 18 to 45 years, with a GW diagnosis in the preceding twelve months and in good health. Pregnant women, those infected with HIV, women with only vestibular micropapilomatosis and with abnormal Pap smear were excluded.

The individuals were classified as (1) newly diagnosed (never having been diagnosed before with GW); (2) recurrent (those who had previous episodes of GW but who had been free of lesions for at least 12 months); and (3) resistant (those who had previous episodes of GW that remained despite treatment).

All the visits, exams and treatment information were collected by nurses using a checklist form and then sent to the medical department for data review. Cost analysis was carried out considering treatment costs from the payer's perspective. Exams not specific to GW, but performed during the episodes to investigate other HPV related lesions, such as Pap smear and colposcopy were included. Indirect costs were not included. Unit costs for visits and treatments were used to estimate the cost per episode of care, which is defined as the period between the first and the last clinic visit for GW treatment. Costs were based on BEMFAM and private health plans prices in 2013. All costs were converted to US dollars at an exchange rate of 1 US$= R$ 2.3 (Brazilian reais).

Sample size and statistical analysis

A target sample size of 120 cases for the psychological scale and 100 cases for the medical records review was set. The study aimed at recruiting 30 cases each in the eligibility groups of normal Pap test, CIN 1, 2-3 and GW, for the sample on psychological burden. Due to the low number of cases CIN 1 and 2-3 were regrouped in one single group for analysis. Also, data from all clinical centers was regrouped in one dataset due to small numbers. No systematic differences on samples recruited in the different centers were expected.

RESULTS

Sample characteristics are displayed in Table 1.

Characteristics of participants in the study.

(*) Age at first genital warts diagnostic for medical records.

Mean age was similar for both samples, with a slightly younger population for the sample under medical record review (25.8 versus 27.6). Most of the sample enrolled for the psychometric part of the study was married, earning a family income of less than US 11 a day, with one living children and was revisiting BEMFAM clinics. They used modern contraception in larger proportions than women under medical record review (82.8 versus 75%). Prevalent methods among the first were pills (43%) and condoms (34%) against pill (35%), condom (29%) and sterilizations (13%), for the second. Fifty three cases were enrolled from the normal Pap smear group, 29 with CIN 1, 6 cases with CIN 2 or 3 and 34 cases with GW. For the psychometric scales, cases with CIN 1, 2 and 3 were regrouped, totaling 35 cases. The sample for medical review had the first intercourse at 17.8 years old in average, were experiencing their first GW episode for 90.2% of the total sample, with 2.0% being recurrent and 7.8% resistant cases. In average, women from the medical record sample had 0.18 normal deliveries, 0.16 cesarean sections and 0.22 abortions. Treatment payment with money out-of-pocket represented 95.1%.

The psychometric scale met with asymmetric results, with skewness above 1 for several item scales, as depicted in Chart 1. Scale items with skewness above the threshold of 1 were not retained for analysis. Overall, there were very few missing cases to observation.

Four factors were regrouped during exploratory factor analysis (varimax rotation) and are displayed in Table 2.

Psychological burden exploratory factors

(*) Significantly different at 95% confidence interval (bootstrap)

Women with normal Pap smear presented lower scores of worries and concerns about their gynecological health (fear of test results, implications for fertility, fear of no cure for abnormal Pap smear or for cervical cancer, risks of infecting the partner or herself during sexual relations) than the group with CIN or GW. However, there was no significant difference in worries between the groups with CIN and GW. Scores of satisfaction with sexual life (feeling their bodies sexually attractive, satisfied with their sex life, relaxed after last gynecological exam and not disgusted with tests or exams) were also higher for women with normal Pap smear than for the other two groups. Again, differences in feelings about sexual life were not statistically different for women with CIN and GW. Feelings of anxiety and surprise (felt anxious or surprised with last exam or were concerned about GW) were higher for GW group than for the CIN and normal Pap smear group, in that order. All differences for the anxiety and surprise factor were statistically significant. Finally, there were no statistically significant differences in the factor of distress and shame (feeling ashamed, not in control of everyday life or of own health) among the groups.

Medical records analysis showed that each GW episode last in average 132 days (Table 1) and cost US$139 with private health plan and US$ 105 with BEMFAM's clinics subsidized tariffs. Cost figures per episode of GW, number of encounters (visits) and cost per procedure are depicted in Table 3. Regarding the medical procedures, in 95 episodes, the provider applied trichloroacetic acid as the only treatment. It was also associated with electrosurgery in one episode, with excision and imiquimod in six episodes each. Excision was the only treatment in four episodes. Other procedures described were consultations, Pap smear and colposcopy.

DISCUSSION

The results of this research are consistent with findings from other studies showing a high psychological and economic burden of the disease. However, the average number of visits per episode is higher than reported elsewhere8,9,10,11,12. According to the analysis of medical records, home treatment with imiquimod was also ­prescribed less often than reported by other studies7,8,9,10,11,11. Most cases of GW were treated with provider-applied trichloroacetic acid that is cheaper than patient applied imiquimod, which is neither provided by public sector nor by private health plans. This probably explains the higher number of mean visits in our study.

Average costs per episode (US$105) might also appear low when compared to other countries but it is not when compared with an average monthly income for 91.2% of women enrolled in our study, that is under US$ 480. For this population, about one-week wages is necessary to provide for treatment, indirect and social costs not included.

Woodhall et al.13) wrote that concerns over future recurrence and transmission to new partners could impair the quality of life of subjects after completion of an episode. In our study the results from the psychosocial scale suggest that the psychological burden of GW is at least as distressful and heavy as for the CIN diagnosis and much heavier than for the normal Pap smear group. All the negative feelings associated to GW may lead to sexual dysfunction, low self-steem, risky behavior and the need to use additional health services, increasing the GW related costs.

Those results prompt for practical implications and future research directions. Free access to public healthcare is a constitutional right for all Brazilian citizens. Nevertheless, there are 50.7 million users of private health plans in the country14, which means that almost 25% of the population is resorting to complementary or substitute sources of healthcare. Low income citizens constitute the majority of users of public primary health care services. Those who cannot afford a private health plan but prefer private assistance pay for low fee private health services, as the clients enrolled in this study did.

HPV is the most common viral reproductive tract infection. Primary prevention includes vaccination, sexuality education and condom promotion15. According to the International Federation of Gynecology and Obstetrics16, all randomized controlled clinical trials provide evidence of a safety profile for the two vaccines against HPV: the bivalent Cervarix (GlaxoSmithKline) and the quadrivalent Gardasil (Merck, Co., Inc.). In Brazil both vaccines are available in the private market and the Ministry of Health included the quadrivalent vaccine in the national vaccination programme since March 2014, for 11-13 year-old girls.

A national study about knowledge, attitudes and practice in the Brazilian population17, revealed that 26.8% of those who reported at least one sexual intercourse in the last twelve months had had sexual debut before the age of 15. This national study also revealed that only 24.6% of women had free access to condoms in the past year. A survey on adolescent sexual behavior in a public Brazilian high school showed that at the age of 14, 39% boys and 8,5% girls declared being sexually active18. Advocacy efforts for the scaling up of the government vaccination program in order to include boys and to expand the age range for the target population of the public vaccination campaigns should be considered. Promoting condom access and use and sexual education cannot be neglected. In addition, the use of imiquimod for treatment should be encouraged and provided through public sector channels. Besides, as the private health plans serve almost 25% of Brazilian population, their contribution to vaccine access should be encouraged.

Despite the relevant results of our study, which shows an excessive psychological and economic burden of GW among the clinics surveyed, there are some limitations to the study that open venues for new research. The main limitations of this study are the analysis of only part of the economic burden of the disease, from the payers' perspective and the fact that the sample is not representative of the country but of BEMFAM's clinics. A comprehensive cost analysis should also include social costs that emerge from the conflict between sexual partners and domestic violence19. Finally, the asymmetry in the scales prevented us from analyzing different psychological burdens of the disease due to the non-validation of some scale items in this study. The expansion of the sample for confirmatory factor analysis is also suggested.

CONCLUSION

Our study shows that the economic burden of GW is closely related to psychosocial burden of disease, and health service use after a GW episode should be considered in next studies. The study of indirect costs is also important, considering the mean number of visits per episode of GW. Additional studies about both the psychological and the economic burden of GW are needed and can help the advocacy efforts for a comprehensive primary prevention program in Brazil, with the participation of the private health sector.

Conflict of interests

Conflict of interest: The study has received funding from Merck Investigator Studies Program.

Affiliation

1 MD, MSc, Medical Director, Bem Estar Familiar no Brasil ­(BEMFAM) - Rio de Janeiro (RJ), Brazil.
2 DSc, Evaluation Director, Evaluation and Statistics Department, ­BEMFAM - Rio de Janeiro (RJ), Brazil.
3 Statistician, Evaluation and Statistics, BEMFAM - Rio de Janeiro (RJ), Brazil.

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