Differences in symptom scores and health outcomes in premenstrual syndrome.

BACKGROUND: In studies of premenstrual syndrome (PMS), a significant response to treatment is commonly defined as a 50% reduction in symptom scores, but empirical support for this definition is lacking. We compared healthcare utilization in women with and without PMS according to the Daily Record of Severity of Problems (DRSP) scores in order to determine the degree of symptomatic variation in premenstrual symptoms associated with differences in the burden of illness. METHODS: Participants were women aged 18-45 years enrolled in a medical group in southern California. Respondents completed the Medical Outcomes Study Short Form-36 (SF-36) at baseline and the DRSP symptom and occupational productivity items daily. Luteal phase DRSP scores were averaged over two consecutive cycles. Respondents were categorized as having mild/no and moderate/severe PMS or premenstrual dysphoric disorder (PMDD) using a previously published, validated algorithm. Medical costs were estimated from medical claims data over the 2 years prior to study entry. RESULTS: Compared with women with moderate/severe PMS/PMDD (n = 117), those with mild/no PMS/PMDD (n = 271) had 43% lower DRSP scores (29.7 and 52.4, p < 0.05), higher SF-36 mental component summary (49.9 and 40.5, p < 0.0001) and physical component summary (52.6 and 50.8, p = 0.04) scores, and fewer workdays per month with reduced productivity (13.3 and 22.0, p < 0.0001) and workdays missed due to health reasons (1.2 and 2.7, p = 0.001). Women with moderate/severe PMS/PMDD had greater odds of having >10 office visits (OR = 1.80, 95% CI 1.01, 3.22) and of accumulating >$500 in medical charges (OR = 1.9, 95% CI 1.2, 3.0). CONCLUSIONS: A 43% difference in premenstrual vs. postmenstrual symptom scores is associated with a significant difference in healthcare burden. These data support the use of a 50% reduction in symptom ratings as a clinically relevant improvement in PMS/PMDD treatment trials, although smaller differences may also be meaningful.

Using the daily record of severity of problems as a screening instrument for premenstrual syndrome.

OBJECTIVE: To assess symptom ratings on the first day of menses to identify women at high risk of clinically significant premenstrual syndrome (PMS) who should undergo further evaluation. METHODS: A cohort of 697 women kept daily symptom ratings using the Daily Record of Severity of Problems (DRSP). The DRSP includes 21 symptom items grouped within 11 domains. DRSP scores on the first day of menses were calculated using the sum of all 21 items (standard method), the sum of the highest rated items within each domain (alternative method), and the sum of seven items derived from modeling. Seventy percent of the study sample was randomly assigned into a model-building set to identify optimal cutoff scores for PMS screening. The remaining 30% comprised a testing set used to compare PMS screening results to a PMS diagnosis based on two cycles of daily DRSP ratings. RESULTS: Of the initial study sample, 388 participants (55.7%) completed two cycles of daily ratings. The prevalence of PMS was 30.4%. In the model-building set, the positive and negative predictive values of the 21-item DRSP scores were 53.8% and 83.4% using the standard method and 52.7% and 84.0% using the alternative method. Corresponding values were 55.0% and 84.9% for an abbreviated seven-item DRSP version. These results were confirmed in the testing set. CONCLUSION: The DRSP administered on the first day of menses is an acceptable screening instrument to identify women who may have PMS.

Evaluating the criteria used for identification of PMS.

OBJECTIVE: Criteria for defining premenstrual syndrome (PMS) were assessed by comparing a reference definition previously demonstrated to be associated with reduced health-related quality of life and impaired productivity with alternative definitions based on criteria stringency variations. METHODS: Health-related quality of life data were collected from the Medical Outcomes Study Short Form-36 (SF-36) for women aged 18-64 years. Women maintained daily calendars of emotional and physical symptoms and work productivity. PMS prevalence and differences in health-related quality of life and work productivity between women with and without PMS were compared using alternative definitions. RESULTS: Across criteria, PMS prevalence ranged from 19% to 30%. Regardless of the criteria used, PMS was associated with reductions in health-related quality of life, with Mental Components Subscale scores 5-12 points lower for women with PMS compared to those without PMS. Likewise, across definitions, women with PMS had greater work productivity impairment than women without PMS, netting 4 additional days with reduced productivity per month. CONCLUSIONS: PMS prevalence varies based on criteria used to define illness. However, PMS is associated with reductions in health-related quality of life and work productivity impairment regardless of the criteria used.

A prospective assessment investigating the relationship between work productivity and impairment with premenstrual syndrome.

Our objective was to assess life domain and work-related impairment in patients experiencing premenstrual syndrome (PMS). A sample of women, 18 to 45 years of age, completed the Daily Rating of Severity of Problems Form to record daily symptoms for two consecutive menstrual cycles. In the workplace, women with PMS reported higher absenteeism rates (2.5 days vs. 1.3 days; P = 0.006) and more workdays with 50% or less of typical productivity per month (7.2 days vs. 4.2 days; P < 0.0001). Women with PMS in one of two menstrual cycles reported a greater number of days with impairment in routine work, school, and household activities in comparison with women without PMS. Results indicate that PMS leads to substantial im in normal daily activities and occupational productivity and significantly increased work absenteeism.

Can change in high-density lipoprotein cholesterol levels reduce cardiovascular risk?

BACKGROUND: The cardiovascular risk reduction observed in many trials of lipid-lowering agents is greater than expected on the basis of observed low-density lipoprotein cholesterol (LDL-C) level reductions. Our objective was to explore the degree to which high-density lipoprotein cholesterol (HDL-C) level changes explain cardiovascular risk reduction. METHODS: A systematic review identified trials of lipid-lowering agents reporting changes in HDL-C and LDL-C levels and the incidence of coronary heart disease (CHD). The observed relative risk reduction (RRR) in CHD morbidity and mortality rates was calculated. The expected RRR, given the treatment effect on total cholesterol level, was calculated for each trial with logistic regression coefficients from observational studies. The difference between observed and expected RRR was plotted against the change in HDL-C level, and a least-squares regression line was calculated. RESULTS: Fifty-one trials were identified. Nineteen statin trials addressed the association of HDL-C with CHD. Limited numbers of trials of other therapies precluded additional analyses. Among statin trials, therapy reduced total cholesterol levels as much as 32% and LDL-C levels as much as 45%. HDL-C level increases were <10%. Treatment effect on HDL-C levels was not a significant linear predictor of the difference in observed and expected CHD mortality rates, although we observed a trend in this direction (P =.08). Similarly, HDL-C effect was not a significant linear predictor of the difference between observed and expected RRRs for CHD morbidity (P =.20). CONCLUSIONS: Although a linear trend toward greater risk reduction was observed with greater effects on HDL-C, differences were not statistically significant. The narrow range of HDL-C level increases in the statin trials likely reduced our ability to detect a beneficial HDL-C effect, if present.

Health and economic impact of the premenstrual syndrome.

OBJECTIVE: To explore the effect of the premenstrual syndrome (PMS) on health-related quality of life, health care utilization and occupational functioning. STUDY DESIGN: A cross-sectional cohort study of women prospectively diagnosed with PMS. RESULTS: Among women completing the survey, 28.7% were diagnosed with PMS. Women with PMS had significantly lower scores on the Mental Component Summary (MCS) and Physical Component Summary (PCS) scale scores of the Medical Outcomes Study Short Form-36 as compared to women without PMS (MCS = 42.8 vs. 49.5, P < .001, and PCS = 51.1 vs. 53.0, P = .04). Women with PMS reported reduced work productivity, interference with hobbies and greater number of work days missed for health reasons (P < .001). In addition, women with PMS experienced an increased frequency of ambulatory health care provider visits (P = .04) and were more likely to accrue > $500 in visit costs over 2 years (P < .006). CONCLUSION: Findings from this study suggest that premenstrual symptoms significantly affect health-related quality of life and may result in increased health care utilization and decreased occupational productivity.

Physician-pharmacist comanagement of hypertension: a randomized, comparative trial.

OBJECTIVE: To compare the effectiveness of an evidence-based, systematic approach to hypertension care involving comanagement of patients by primary care physicians and clinical pharmacists versus usual care in reducing blood pressure in patients with uncontrolled hypertension. METHODS: Patients in a staff model medical group with uncontrolled hypertension were randomized to either a usual care (UC) or a physician-pharmacist comanagement (PPCM) group. All physicians in the study received both group and individual education and participated in the development of an evidence-based hypertension treatment algorithm. Physicians were then given the names of their patients whose medical records documented elevated blood pressures (defined as systolic > or = 140 mm Hg and/or diastolic > or = 90 mm Hg for patients aged < 65 yrs, and systolic > or = 160 mm Hg and/or diastolic > or = 90 mm Hg for those aged > or = 65 yrs). Patients randomized to the UC group were managed by primary care physicians alone. Those randomized to the PPCM group were comanaged by their primary care physician and a clinical pharmacist, who provided patient education, made treatment recommendations, and provided follow-up. Blood pressure measurements, antihypertensive drugs, and visit costs/patient were obtained from medical records. RESULTS: One hundred ninety-seven patients with uncontrolled hypertension participated in the study. Both PPCM and UC groups experienced significant reductions in blood pressure (systolic -22 and -11 mm Hg, respectively, p < 0.01; diastolic -7 and -8 mm Hg, respectively, p < 0.01). The reduction in systolic blood pressure was greater in the PPCM group after adjusting for differences in baseline blood pressure between the groups (p < 0.01). More patients achieved blood pressure control in the PPCM than in the UC group (60% vs 43%, p = 0.02). Average provider visit costs/patient were higher in the UC than the PPCM group ($195 vs $160, p = 0.02). CONCLUSIONS: An evidence-based, systematic approach using physician-pharmacist comanagement for patients with uncontrolled hypertension resulted in improved blood pressure control and reduced average visit costs/patient.