Compliance with ethical standards
This study was approved by the Institutional Review Board (IRB) at Indiana Wesleyan University (IWU). Women participated only after providing informed written consent, and all procedures performed in this study were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Participants
For this study, 120 women between the ages of 17 to 42 years of age enrolled in a 2nd year psychology course at Indiana Wesleyan University were given the option to participate in our study for academic extra credit. If they agreed to participate by signing a written consent form explaining the study, they completed the Foley Polycystic Ovarian Syndrome (FPCOS) screening scale for symptoms of PCOS. Their score on this instrument determined if they were in the “screen negative” or “screen positive” group in the present study. Screen positive women were offered a subsequent medical appointment that was offered along with a medical follow-up evaluation. IWU women students scoring high on the Foley PCOS screening assessment were individually interviewed by Steven A. Foley (SAF) and recruited into the study through the IWU health center if confirmed to have PCOS following analysis of a blood draw for insulin resistance markers, blood androgen levels, as well as elevated cholesterol and triglyceride level (N = 11, PCOS-confirmed group). Eight of the IWU psychology students scored high enough on the Foley PCOS screening questionnaire for medical follow-up but declined to participate and remained in the “screen positive” group in the present study. Five women scored negative on the PCOS screening measure but did not attend their appointments for completing the other study assessments and were not included in this study.
Instruments
Foley polycystic ovarian syndrome screening scale (FPCOS)
The PCOS Foley Screening Instrument was developed by SAF to assess the medical risk for PCOS. Using the most significant factor loadings for medical items from Cronin et al., (1998) Foley devised a 12-item screening questionnaire for PCOS for use in the medical women’s health clinical setting [19]. At the time, the Cronin et al. (1998) medical PCOS quality of life questionnaire was the most cited instrument in evaluating these domains with PCOS patients [7, 23, 24]. Likewise, at the time of this study, the 2018 International Guidelines for the assessment and management of PCOS had not yet been released, so women’s health practitioners used a variety of medical symptoms to try to screen for and diagnose PCOS in the healthcare setting [20,21,22].
The FPCOS screening items were selected by SAF as medically strategic in diagnosing the symptomology of PCOS on the basis of an authoritative medical book written by Samuel S. Thatcher (2000) [25]. On a scale from 0 (no history of problems) to 10 (consistent history of problem), so that the higher the score the poorer the health and quality of life self-evaluation by the respondent. The FPCOS has a question dedicated to each of the following 12 items: high cholesterol, high triglycerides, problems with weight loss, cravings for sweets, muscular weakness, excessive body hair, acne problems, father had excessive hair, sudden weight gain, difficulties conceiving children, history of miscarriages, and significant menstruation discomfort.
The rating for all 12 items is totaled and a scored of greater than 40 indicates a significant risk for PCOS, necessitating follow-up medical evaluation if the participant is agreeable. Medical confirmation of PCOS was made with ultrasound imaging evidence of cysts on the ovaries, significantly high levels of low-density lipoprotein (LDL) and high-density lipoprotein (HDL) cholesterol and triglyceride levels from lipid blood panels, along with a high body mass index (BMI) – all of which are risk factors of metabolic syndrome women. These clinical criteria, described in detail by Thatcher (2000), served as diagnostic measures were used by SAF to identify the medically “confirmed PCOS” women in the present study [25]. The FPCOS has only been used by SAF only in his medical practice specializing in women’s health issues and has not been evaluated for sensitivity or specificity as a screening measure. The present study is the first time that it has been evaluated for its utility as a screening instrument for PCOS. The principal PCOS quality of life (QoL) measure is correlated to the FPCOS measure. The PCOS QoL measure is described next.
The PCOS Quality-of-Life Scale was devised by researchers at Brigham and Women’s Hospital, Boston, MA and validated with a sample of 100 clinically diagnosed PCOS women [19]. As described above, the present version consists of 26 items provided a composite total PCOS QoL score as an overall item average on a scale from 1 to 10, with a higher score indicating a better QoL.
Zung self-rating depression scale [26]
Used by our group in a previous women’s health study in this study setting pertaining to breast cancer treatment [27], this is a 20-item self-administered questionnaire that takes only a few minutes to complete. It includes a variety of statements associated with depressed moods and is a helpful tool to assess depression in individuals in a general medical setting [28]. The inventory looks at various symptoms of depression such as insomnia, poor appetite, fatigue, suicidal thoughts, anhedonia, and dysphoria. The 20 items are based on a Likert scale and the four possible responses range from “None or little of the time” to “Most or all of the time.” The higher the subject scores on the Zung scale, the more at risk a respondent is for depression.
The State-Trait Anxiety Inventory(STAI) is a 40-item measure that looks at both state (in the moment" and trait (chronic) anxiety (Spielberger, 1977) [29]. This questionnaire was used by our group in a previous women’s health study pertaining to breast cancer treatment [27]. This instrument has been used effectively to characterize anxiety in adolescent and adult women with PCOS [30, 31]. For the present analysis, we used the trait anxiety measure.
Fatigue symptom inventory (FSI) [32,33,34]
Originally developed for cancer patients and used by our group in a previous women’s health study pertaining to breast cancer treatment, [27] this is a 14-item self-report measure for measuring the intensity, frequency, and impact of symptoms of fatigue on a woman’s quality of life. Higher scores indicate more fatigue symptoms.
Bottomley social support scale (BSS) [35]
This is a seven-item scale originally designed for cancer patients and used by our group in a previous women’s health study pertaining to breast cancer treatmen [27]. This measure was adapted for the present study by removing specific references to “cancer.” It was then used to gauge the social support available to medical patients and the extent to which they utilize available resources in coping with any chronic medical need and its treatment. Each item is rated on a scale between 1 and 5. Women had options to indicate that the item was not applicable or refuse to respond. Total scores range from 7 to 35. Higher scores indicate less perceived social support by our study women.
Spiritual beliefs inventory (SBI) [36]
This is a well-validated 15-item questionnaire that is a brief, yet robust measure of the more universal aspects of religious, spiritual and community social support while coping with a life-threatening illness as well as the subsequent quality of life (QoL) issues, particularly in the context of cancer care [37]. Higher scores indicate a stronger spiritual QoL. This measure of spirituality was used previously by our group in a study pertaining to breast cancer treatment [27].
Automated Neuropsychological Assessment Metric (ANAM) [38] is a computerized neuropsychological assessment developed by Dr. Joe Bleiberg at the National Rehabilitation Hospital in Washington, D.C. for a PC laptop in the hospital or clinic setting. This assessment is used in human performance factor studies (e.g., neuropsychological effects of fatigue, chronic stress, sleeplessness, toxic exposure and was developed by researchers at the Walter Reed Medical Center [38,39,40]. The framework for this assessment is derived from the Halstead-Reitan Neuropsychological Assessment Battery and the Wechsler Adult scales for both intelligence (WAIS) and memory (WMS). Measures such as the Tower of Hanoi Task, Symbolic Logical Relations Test), Sternberg encoding and memory, Sternberg running memory, spatial processing (sequential and simultaneous), and a running memory continuous performance task – provided measures for the neurocognitive domains of executive functioning, problem solving, attention, memory and learning, and processing speed for all of these domains. Although speed, error, and variability are provided for each test in the ANAM, we used the throughput measure (speed by accuracy) for each test as our principal outcome in the present analysis. This was the principal neuropsychological assessment battery used by our group in a previous women’s health study pertaining to breast cancer treatment, where we were able to observe its applicability and validity in that women’s health context [27]. The higher the score, the better the performance.
Bilateral Field Advantage (BFA) task of interhemispheric brain integration is a computerized assessment [41, 42]. Boivin and colleagues have previously used this assessment along with measures of spiritual wellbeing with young adults in the university setting [43]. In previous experimental studies with such students, this test proved sensitive in evaluating the efficiency of right and left hemispheres to process simple visual information, using both a dot (visual-spatial processing) or a letter-matching (verbal processing) task presently tachistoscopically (very rapidly). This is the first time that this experimental neurocognitive performance measure has been used in women’s health research to characterize bilateral field advantage (right or left brain dominant) in neurocognitive performance. We administered a computer-based visual-perceptual asymmetries task (see Fig. 1). The stimuli were generated by computer from its standard character set and briefly displayed tachistoscopically on a 17 by 11-in. computer monitor at a viewing distance of about 15-in.. A letter pair from the grouping, for example, “AaBb”, was presented for each trial (see Fig. 1) [43]. Anywhere from 0 to 3 distractor digits could be presented with the matching or non-matching letter pairs (e.g., Aa, AB or Ab, AA). The letters comprising the pair could also be presented across four different visual fields (left, right, bilateral-top, bilateral-bottom) Fig. 1) [43]. If one member of each letter pair was presented in the left visual field and the other member in the right visual field, then this was considered a bilateral field presentation. For bilateral field presentations, both letters could appear either in the upper portion of the screen (Bilateral Top) or bottom portion (Bilateral Bottom). Letter pairs could also be both presented in the same visual field (left or right); either both in the upper, bottom, or diagonal positions (Fig. 1) [43]. Each condition was presented in a total of five trials during the session, which lasted about 30 min.
Statistical analyses
Descriptive statistics were obtained for each PCOS risk group (confirmed cases, screen negative and screen positive cases). The chi-square and analysis of variance were used to compare groups at intake on age, education and income. Then, outcomes at intake listed in Table 1 were compared among 3 groups while adjusting for the demographic characteristics to determine the effects of cancer diagnosis. For each questionnaire and neuropsychological performance principal outcome, the Linear Mixed Effects (LME) model was employed to evaluate the predictive significance of demographic characteristics and group membership (confirmed cases, screen negative and screen positive cases) for these outcomes. Unfortunately, our PCOS medically confirmed sample size (N = 11) from our base sample of 120 women is too small for us to compute a sensitivity or specificity analysis for our FPCOS screening measure, assuming a disease prevalence of 10% or less and a power of 0.80 at a 5% significance level [44]. Our statistical analyses could only be correlational in nature, as a preliminary evaluation of the possible utility of this screening tool in a university population of young women.
Table 1 Descriptive statistics for the quality of life and emotional wellbeing questionnaire measures for the PCOS screen negative, PCOS screen positive, and PCOS medically confirmed groups. (group mean compared to reference group: *p < 0.05; **p < 0.02; ***p < 0.001)