Premenstrual Syndrome and Premenstrual Dysphoric Disorder: Quality of Life and Burden of Illness

Andrea J. Rapkin; Sharon A. Winer

Disclosures

Expert Rev Pharmacoeconomics Outcomes Res. 2009;9(2):157-170. 

In This Article

Prospective Studies of HRQoL and Burden of Illness

Since 2000, pioneering small studies using prospective diagnostic instruments for PMS and PMDD have attempted to quantify the direct and indirect costs of the disorder. One goal in determining economic impact of premenstrual conditions is to establish whether treatment of PMS/PMDD would decrease healthcare utilization and improve worker performance, thus decreasing the burden of illness.[2] A more detailed analysis of the health and economic impact of PMS was evaluated by a series of publications by Bornstein et al. A large cross-sectional prospective cohort of 436 women aged 18-45 years, who were members of a large southern California-based medical group was studied via telephone screening interviews, the SF-36, the 10-item Center for Epidemiological Studies-Depression Scale and prospective rating for diagnosis. After screening survey completion, a prospective diary that included the DRSP was completed yielding 125 women (28%) newly diagnosed with PMS and the 311 asymptomatic women who served as controls. Women with PMS in one cycle had significantly lower scores on the Mental Component Summary (49 vs 42%; p < 0.001) and Physical Component Summary (51 vs 53%; p = 0.04) of the Medical Outcomes Study SF36 as compared with controls. Women with PMS in two cycles yielded even lower scores. Premenstrual symptoms significantly affect HRQoL and resulted in increased healthcare utilization and decreased occupational productivity. Women with PMS were nine times more likely to report 1 full week of impairment per month resulting in decreased productivity and interference with hobbies and relationships (OR: 8.8; 95% CI: 4.4-18.1). More women with PMS reported 2 or more workdays missed for health reasons (OR: 2.4; 95% CI: 1.4-4.0; p < 0.001) compared with controls. Women with PMS also experienced a significantly increased frequency of ambulatory healthcare provider visits, and were more likely to accrue more than US$500 in visit costs over two years (p = 0.006). PMS diagnosis was associated with significantly decreased productivity, increased healthcare costs and significant impact on HRQoL.[2]

The economic impact of PMS was further studied by evaluating the relationship between work productivity and impairment. This was an extension of the same large data set described above of women with capitated insurance coverage from a large southern California medical group. The 18-45-year-old women completed the DRSP prospectively for two consecutive menstrual cycles. Of the 125 women diagnosed with PMS, 78 women experienced symptoms for one cycle and 47 women for two cycles. There were 311 controls. The women with one cycle of PMS had significantly higher health-related work absenteeism with 2.5 versus 1.3 workdays per month missed compared with women without PMS. They had higher productivity loss for 7.2 versus 4.2 days, with 50% decrease in work productivity (p < 0.0001) during at least one cycle. Compared to women without PMS, the odds of having high productivity loss (>5 days) was 4.3-times greater in women with one cycle of PMS and six times greater in women with PMS in both cycles. Women with PMS had a high degree of self-reported general impairment (>14 days/month) in occupational and social activities compared with women without PMS (7.2 vs 7.0, respectively; p < 0.0001). Women who met PMS criteria during one cycle were 3.4-times more likely to be impaired (OR: 3.3; 95% CI: 1.9-6.1) while women who met criteria during two cycles were 12-times more likely to have high impairment (OR: 12.2; 95% CI: 5.8-28.8) compared with women without PMS. Another category of social activities, hobbies and interpersonal relationships had similar findings. For example, women who experienced PMS for two consecutive cycles were more that 13-times more likely to have experienced impairment in their interpersonal relationships (OR: 13.5; 95% CI: 6.4-28.6). This group experienced significant general impairment (including work, school and household activities) more days a month than women without PMS (22 ± 6.5 days/month versus 9.6 ± 7.9 days per month; p < 0.0001).[68] This study further confirms Hylan's retrospective study showing 55% of women with self-identified premenstrual symptoms had occupational impairment, and was more reliable, as it was a prospective evaluation using the validated DRSP instrument to compare women with PMS to women without PMS.[64] This study confirmed previous data on work absenteeism and impairment in normal daily activities and expanded the understanding about the economic impact of PMS by confirming the reduced work productivity. The authors also commented that this degree of absenteeism exceeds that of patients with irritable bowel syndrome, who report 1-2 days of missed work per month. The authors assert that PMS may have a more profound effect than irritable bowel syndrome because a larger population of women is affected, including those with moderate symptoms.[68]

Since the research showed that PMS was associated with greater absenteeism and decreased occupational performance and productivity, the actual cost to the individual woman and society was important to determine. Borenstein et al. quantified the burden of illness by calculating the direct and indirect costs of PMS to the employer. The goal was to evaluate HRQoL, healthcare utilization, and work-related functioning comparing women with PMS and controls. This study was part of a large epidemiological study of PMS, evaluating data gathered from women, members of a capitated medical group. Subjects were aged 18-45 years with regular menses who prospectively completed the SF-36, the CES-D, and an open-ended questionnaire. The DRSP was completed by 374 PMS patients and compared with 320 patients lacking PMS. The direct costs were calculated based on administrative claims and Medicare schedule for workdays missed and decreased productivity. Based on DRSP reporting for two consecutive cycles, 111 (29%) were diagnosed with PMS. They had increased direct costs of US$59 per year (p < 0.003) and increased indirect costs of US$4333 per year (p < 0.0001) compared with women without PMS. Although over half of the participants met diagnostic criteria for depression based on their CES-D 10 score, the annual average number of counseling sessions was strikingly low at 0.1 per patient. Thus, the indirect costs of PMS from increased absenteeism and decreased work productivity clearly are greater than the direct costs. Indirect costs primarily affect employers suggesting that corporate benefit plans that use clinically effective PMS therapies may be making a cost-effective investment.[69]

The diagnostic criteria for PMS or PMDD and the stringency of the definition used may influence the prevalence and the burden of illness ascribed to it. Dean et al. compared alternative criteria for definition of PMS to a reference definition previously demonstrated to be associated with reduced HRQoL and impaired productivity. The objective was to determine the impact of criteria on the prevalence as well as how HRQoL and impaired productivity correlated with varying diagnostic thresholds.[70] Outcome evaluations compared participants with and without PMS using both sets of criteria. An algorithm was used from the author's previous report for the PMS reference definition.[2] Luteal symptoms were measured over the 5 days prior to the onset of menses. Follicular phase symptoms were measured days 6-10 following the first day of menses and average scores were calculated over the reference time periods for each of the 21 diary items. Symptom scores were calculated from mean item scores within the symptom category, per the DRSP. The reference definition was defined as the occurrence of the following criteria during at least one of two cycles monitored. First, an average luteal score of 30% or more higher than the average follicular phase score on at least three different diary symptoms and, second, an average luteal score of 3 or greater (on a 6-point scale) on at least three diary items. Differences in the alternative definition included:

  • Magnitude of cyclic change: a mean luteal phase score at least 50% higher than the mean follicular phase score on at least three different diary symptoms (vs 30% for reference)

  • Symptom severity: a mean luteal phase score of either 2.5 or 3.5 on at least three different diary items (vs 3.0 for reference)

  • Number of diary symptoms: a mean luteal phase score at least 30% higher than the mean follicular phase score on at least two or four different diary symptoms (vs three symptoms for reference)

  • Number of diary items: a mean luteal phase score of 3.0 on at least four different diary items (vs three items for reference). (Multiple items such as feelings of hopelessness and worthlessness constitute the symptom of depression)<

Combinations and permutations in the occurrence of the four criteria comprised more or less restrictive alternative criteria based on a statistical evaluation.[70]

Women aged 18-45 years who were members of a California capitated medical group filled out the SF-36 and CES-D 10 depression instrument, followed by the DRSP diary prospectively for 1 month, and maintained daily calendars of emotional and physical symptoms and work productivity. Added to the DRSP, were supplemental questions to determine self-reported work absenteeism and occupational productivity impairment. The 436 completers were compared with 261 women who served as controls. The results showed that differences in PMS prevalence were more dependent on symptom severity than on criteria for the magnitude of change between luteal and follicular phases, the number of diary symptoms, or the number of diary items constituting presence of a symptom. Neither increasing the magnitude of change between the follicular and luteal phases from 30 to 50% (increased stringency), nor increasing the number of symptoms resulted in significant change in the number of women with PMS. When the minimum severity score threshold for a candidate symptom was reduced from 3.0 to 2.5, 38% of women met the criteria versus 28% meeting the reference criteria; when the criterion was tightened to 3.5 or greater, the prevalence dropped to 18% of women.[70]

Health-related quality of life based on the SF-36 differed between women defined with PMS by both the reference criteria and the alternative criteria and those without PMS. The SF-36 Mental Components scores were 5-12 points lower for women with PMS compared with those without PMS, and the Physical component summary scores were 1-5 points lower than women without PMS. Decreased mental components subscale among PMS women approached women with clinical depression even when the least restrictive definition was used. The Mental Component scores for the non-PMS cohort paralleled the healthy population. Stricter criteria did not result in a cohort of women with greater reductions in HRQoL. PMS was associated with increased absenteeism regardless of the PMS definition based on symptom severity. Regardless of criteria, work productivity was decreased in women with PMS compared with those without PMS, with four additional days of reduced productivity per month. The authors conclude that even mild PMS impacts HRQoL and minimum symptom severity should be considered when evaluating prevalence and impact on HRQoL, absenteeism and productivity.[70]

In the Women's Daily Activity Study of Health (W-DASH), Chawla studied the economic burden associated with PMDD by assessing healthcare utilization and related expenditures including work loss, role limitation and productivity. Women aged 21-45 years, randomly selected from a northern California HMO (n = 1194) prospectively rated their symptoms with DRSP and provided data on healthcare use and work productivity for two menstrual cycles. The SF-10 and the Endicott Work Productivity Scale (EWPS) were also administered and questions were asked about time missed from work and decreased effectiveness in the workplace. Women taking medications for PMDD were excluded. These women were not seeking treatment for premenstrual symptoms. Based on daily symptom ratings, the DRSP, the authors classified the women as having minimal (n = 186), moderate (n = 801), and severe (n = 151) premenstrual symptoms, or PMDD (n = 56). There was no control group. A summary of 12-month utilization and expenditures based on HMO encounter data was also used. Women with PMDD had more decreased productivity than those with minimal PMS symptoms (p < 0.01). As symptom severity increased, the likelihood of healthcare service utilization increased for the emergency department, obstetrician/gynecologist and alternative medicine providers. The impact of premenstrual symptoms on the burden of illness was not the direct cost but rather an indirect cost based on self-reported decreased productivity. Women took little time off from work but rather worked less than a full day. Women with PMDD and severe PMS reported significantly more hours missed from work than women with minimal PMS. There were trends suggesting opportunity cost, the direct loss of income from time away from work, has some impact on the degree that premenstrual symptoms affect luteal phase productivity. Women with more intense demands in the home (such as a child under 5 years of age) and outside the home (part-time or full-time employment) were more likely to have scores reflecting impairment during the luteal phase. The authors noted absenteeism and healthcare utilization were less common than reported in the Bornstein studies.[71]

Successful treatment of PMS can impact the burden of illness. Successful PMS/PMDD treatment trials have generally led to at least a 50% reduction in symptoms. Bornstein studied members of a southern California medical group who completed the Medical Outcomes Study SF-36 at baseline and the DRSP symptom and occupational productivity scales daily. Luteal phase DRSP scores were averaged over two consecutive cycles. Two respondent categories were determined according to the authors previously published algorithm: mild/no PMS (n = 271) and the moderate/severe PMS/PMDD (n = 117). Medical utilization and cost data was estimated from claims for the 2 years prior to the study. The moderate/severe PMDD group had greater odds of having more than ten office visits (OR: 1.80; 95% CI: 1.01-3.22) and of accumulating more than US$500 in medical bills (OR: 1.90; 95% CI: 1.2-3.0). Compared with women with moderate/severe PMS/PMDD, those with mild/no PMS had 43% lower (better) DRSP scores (29.7 and 52.4; p < 0.05). Compared to the moderate/severe group, the mild/no PMS group had significantly higher (better) SF-36 mental component summary (49.9 and 40.5; p < 0.0001), physical component summary scores (52.6 and 50.8; p = 0.04), fewer workdays per month with reduced productivity (13.3 and 22.0; p < 0.0001), and fewer workdays missed due to health reasons (1.2 and 2.7; p = 0.001). Thus, 43% differences in symptom scores were associated with a significant difference in healthcare burden between the two groups. The authors believe that this data supports the use of a 50% symptom reduction in PMS/PMDD treatment trials as a clinically relevant parameter consistent with improvement, since it correlates with burden of illness outcome parameters. Chawla et al. may have obtained different results regarding work absenteeism because their population excluded women taking psychotropic medications, implying that they selected for a milder symptom group.[72]

Premenstrual syndrome has also been found to impacted health status in female veterans.[73] The premenstrual symptom data was part of an analysis of menstrual symptoms in the Veteran's Administration Women's Health Project, a national cross-sectional study of women veterans receiving ambulatory care through the Veteran's Administration. The category 'Menstrual Symptoms' was evaluated as well as each of four components, which were PMS, menorrhagia, irregular menstruation and painful menses. Of 1744 self-reporting participants, 67% reported one or more menstrual symptoms and 55% reported premenstrual symptoms specifically interfered with their usual activities or lifestyle. All eight of the SF-36 domains (physical and mental), were significantly lower in women with menstrual symptoms, and women with PMS scored significantly lower than those without PMS in all domains except energy/vitality. The authors conclude that premenstrual symptoms explain a large proportion of the health status differences between women with and without menstrual symptoms. Furthermore these differences were comparable to those seen in major chronic illnesses.[74]

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