The Influence of Education and Depression on Autonomy of Women with Chronic Pelvic Pain: A Cross-sectional Study

Abstract Objective Patient autonomy has great importance for a valid informed consent in clinical practice. Our objectives were to quantify the domains of patient autonomy and to evaluate the variables that can affect patient autonomy in women with chronic pelvic pain. Methods This study is a cross sectional survey performed in a tertiary care University Hospital. Fifty-two consecutive women scheduled for laparoscopic management of chronic pelvic were included. Three major components of autonomy (competence, information or freedom) were evaluated using a Likert scale with 24 validated affirmatives. Results Competence scores (0.85 vs 0.92; p = 0.006) and information scores (0.90 vs 0.93; p = 0.02) were low for women with less than eight years of school attendance. Information scores were low in the presence of anxiety (0.91 vs 0.93; p = 0.05) or depression (0.90 vs 0.93; p = 0.01). Conclusions Our data show that systematic evaluation of patient autonomy can provide clinical relevant information in gynecology. Low educational level, anxiety and depression might reduce the patient autonomy in women with chronic pelvic pain.


Introduction
Informed consent is an integral part of medical decisionmaking for a patient accepting a specific treatment. 1 For an informed consent to be valid, the patient has to be informed about potential effects and side effects of the treatment. The final decision whether to recommend or not the treatment should take in account the patient autonomy. Autonomy implies competence to consent, understanding of risks and benefits, and freedom to decide. 2 Competence to consent refers to the ability to understand the information. The risks, benefits and alternatives available have to be informed in an accessible language. Finally, the patient has to feel free to decide in being submitted or not to the proposed procedure. According to the autonomy principle, all patients are entitled to decide on the issues related to their own life. 3 With medical care moving toward patient centered approach, to understand the various aspects involved in autonomy has great importance for achieving optimal care in reproductive medicine. However, in clinical practice, a systematic evaluation of patient's autonomy is not done routinely. For women with chronic pelvic pain (CPP), the laparoscopic investigation can led to additional diagnostic procedures or treatment in 28.8% and discard unnecessary diagnostic procedures in 13% of cases. The rates of minor complications are around 2% and major complications 0.1%. 4 Despite the benefits of laparoscopy in the management of selected patients with CPP, the informed consent is mandatory before the surgical intervention. In this proof of principle study, we systematically evaluated the autonomy in a consecutive series of women with CPP scheduled for diagnostic laparoscopy.

Study Design and Participants
Fifty-two consecutive patients with chronic pelvic pain scheduled to diagnostic laparoscopy were included in this crosssectional survey study. The Institutional Ethics Committee for Research provided ethical approval for this study registration number: 3973/2008) and all participants gave specific written consent before being interviewed for this study.
The inclusion criterion was: pain in pelvic region persistent for at least six months requiring laparoscopy for diagnosis and/or treatment. Women who had history of abdominal cancer or pelvic cancer were not included. The informed consents for laparoscopic procedures were obtained by the consultant gynecologist, and the application of the questionnaires for this study was conducted by one of the authors of this study. All patients had given consent to be submitted to laparoscopy by the time the questionnaires were applied. This manuscript was written based on STROBE Statement.

Measures
The questionnaire for autonomy characterization was based on five-level Likert scale and included 24 affirmations (►Table 1). The questionnaire was applied in Portuguese and the contents had been previously validated by six experts who evaluated whether test items assess the proposed autonomy domains. 5 The affirmations were divided in three categories: information (11 affirmations), competence (6 affirmations) and freedom (7 affirmations). Each statement was followed by a visual analogue scale with the following alternatives and their corresponding values: strongly disagree (1), disagree (2), neither agree nor disagree (3), agree (4) and strongly agree (5). The statements were presented randomly, with positive and negative propositions. For negative propositions, the values were adjusted for the analysis. The scores for competence, information, and freedom were calculated by dividing the score obtained by the maximum possible value in the category.
Data on age, educational attainment, marital status and family monthly income, were obtained at the time of questionnaire application. Pain duration was recorded in months as informed by the patient. The current pain intensity was based on a 100 mm visual analogue scale: moderate pain (45-74 mm) and severe pain (75-100 mm). 6 Anxiety and depression symptoms were evaluated using the Hospital Anxiety and Depression Scale (HADS). The HADS is a fourteen item scale that generates ordinal data. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from zero to three. 7 In this study we used the cut-off value of 8/21 for anxiety or depression. 8
autonomy components was calculated using the Pearson product-moment correlation coefficient. Univariate analyses were conducted using Student t-test.

Results
The baseline data are presented in ►Table 2. Patients' age varied from 19 to 58 years with median of 33 years. Nineteen (37%) reported moderate pain and 33 (63%) severe pain according to VAS classification. Twenty-six patients (50%) had pain duration between 6 months and 2 years and 26 (50%) patients had pain duration longer than 2 years. Thirtythree (63%) patients presented anxiety symptoms and 18 (35%) presented depression symptoms. Twenty-six (50%) women did not complete the fundamental compulsory education time (8 years). Forty-three (83%) had family income lower than US$ 1,000.00 a month. Thirteen (25%) women were single.
Autonomy scores varied from 0.60 to 1.00 (mean ¼ 0.92) for competence, from 0.6 to 1.0 (mean ¼ 0.92) for information and from 0.80 to 1.00 (mean ¼ 0.92) for freedom. Competence and information scores were significantly correlated (r ¼ 0.34, p ¼ 0.01). However, the freedom scores were not correlated with competence or information scores (►Table 3).
Associations between autonomy scores and patients characteristics are presented in the ►Table 4. Two parameters were significantly associated with reduction of autonomy to consent in undergoing to laparoscopic diagnosis procedure: educational attainment and symptoms of depression. Women who did not complete the fundamental level of compulsory education had low competence score (0.85 vs 0.92; p ¼ 0.006) and low information score (0.90 vs 0.93; p ¼ 0.02). The information score was low for women with symptoms of anxiety (0.91 vs 0.93; p ¼ 0.05) or depression had low information score (0.90 vs 0.93; p ¼ 0.02).

Discussion
Shared decision making is becoming dominant in gynecology. This approach has ethical and clinical benefits, 9 however its implementation is challenging. One important factor in this process is patient autonomy. In this study we evaluated a questionnaire, previously used for quantifying patient au-tonomy in deciding about aesthetic procedures, 5 to quantify patient autonomy in women with CPP scheduled for diagnostic laparoscopy. Our results showed that the quantification of patient autonomy can provide details about the domains of autonomy: competence, information and freedom. We were also able to identify variables that can affect these domains. Educational level can affect many aspects of the decision process in health care. In the current study, patients were predominantly from low income population (83%). However, there were social inequalities even among them. Fifty percent of the patients did not complete the compulsory fundamental educational level. In clinical trials the comprehension of informed consent is impaired by low educational level. 10 At the time of deciding to undergo hysterectomy for treating benign gynecologic disease, the unjustified fear of cancer is more common among less educated women. 11 Men from underserved communities are at higher risk of misunderstanding medical terms associated with diagnosis and treatment of prostate cancer. 12 Our quantitative analysis showed that the scores for competence and information were lower among less educated women. Although limited by the study design, a cross-sectional survey, our data provided evidence that usual care might not warrant autonomy for women with low educational level. Strategies based on decision aids are needed to improve the shared decision making for those patients. 13 The presence of symptoms of depression among women with CPP is high. While the prevalence of depression is around 21% among women in general population 14 , among patients with gynecological pain it is up to 35%. 15 In our study, 34.6% of patients presented symptoms of depression. In this group the score for information were significantly lower. Some studies in clinical ethics have demonstrated that depression can impair the ability to appreciate significance of information about the illness and the consequences of treatment options. 16 Our data reinforce the need of screening psychiatric disorders in women with CPP. In the presence of signs of depression, the patient should be properly evaluated before the decision about invasive diagnostic procedures.
In conclusion, we were to show that systematic evaluation of patient autonomy can provide clinical relevant information in gynecology. The quantification of the domains of patient autonomy might also be important for research on factors affecting the validity of informed consent in patients with low educational level or symptoms of anxiety and depression. FAEPA had no involvement in study design; in the collection, analysis and interpretation of data; in the writing of the report; and in the decision to submit the article for publication.