Reliability and validity of a daily diary for premenstrual syndrome

PSYCHIATRY RESEARCH ELSEVIER

Psychiatry Research 65 (1996) 97-106

Reliability and validity of a daily diary for premenstrual syndrome Ellen W. Freeman*a7b, Robert J. DeRubeis”“, Karl Rickelsa>b ‘Department of Psychiatv, University of Pennsylvania Medical Center, 3400 Spruce Street, Philadelphia, PA 19104-4283, USA bDepatiment of Obstetrics/Gynecology,

Uniuersity of Pennsylt.unia Medical Center, 3400 Spruce Street, Philadelphia, PA 19104-4283, USA

‘Department of Psychology, University of Pennsylvania Medical Center, 3400 Spruce Street, Phifndelphia, PA 19104-4283, USA

Received 24 October 1995; revised 14 August 1996; accepted 16 August 1996

Abstract Daily ratings of symptoms are essential to confirm a diagnosis of premenstrual syndrome (PMS). The 17-item Daily Symptom Report (DSR) is relatively brief and appropriate for clinical and primary care settings. We report the reliability, factor structure and relationships with other standard mood measures of the DSR as a measure of PMS. The sample includes 170 women who sought medical treatment for severe PMS and a non-clinical comparison group of 54 healthy women in the same age range. Cronbach’s coefficient (Y was 0.92 for the premenstrual DSR scores, indicating very high internal consistency for the 17 symptoms. Factor analysis yielded four factors describing mood, behavioral items, pain, and physical symptoms. In the PMS sample, there were moderate correlations between the DSR and the Hamilton Rating Scale for Depression, the Profile of Mood States, and the Premenstrual Assessment Form. The moderate correlations of the DSR with other standard symptom measures add to the evidence that PMS overlaps with other mood disorders at the premenstrual time but is not simply a brief depression or a truncated anxiety disorder. Copyright 0 1996 Elsevier Science Ireland Ltd. Keywords:

Premenstrual

dysphoric disorder;

Psychometric;

Daily symptom rating; Menstrual

Anxiety

*Corresponding

author. Tel.: + 1 215 6623329; fax: + 1 215 3495521; e-mail: [email protected]

0165-1781/96/$15.W Copyright 0 1996 Elsevier Science Ireland Ltd. All rights reserved. PII SO165-1781(96)02929-O

cycle; Depression;

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E. W. Frretnan et al. /Psychiatry

1. Introduction Severe premenstrual syndrome (PMS) is characterized by chronic symptoms that occur in the luteal phase of the menstrual cycle and disrupt normal functioning. As yet, there are no laboratory or other tests to diagnose PMS, and clinical evaluation requires the daily reporting of symptoms for at least two menstrual cycles. However, there is no standard methodology for this daily symptom assessment, and instruments range from rating several core symptoms (Rubinow et al., 1984) to the extensive symptom evaluation provided by the 95item Premenstrual Assessment Form (Halbreich et al., 1982). Diagnostic criteria for PMS are evolving, as exemplified by the provisional criteria for late luteal phase dysphoric disorder (LLPDD) in DSM-III-R (American Psychiatric Association, 19871, followed by suggested research criteria for premenstrual dysphoric disorder (PMDD) in DSM-N in the category of depressive disorders not otherwise specified (American Psychiatric Association, 1994). The PMDD criteria are important for guiding a more uniform assessment of severe dysphoric premenstrual symptoms in investigations of the treatment and psychobiology of the syndrome. The overlap between PMDD and severe PMS is frequently very high. Seventy-nine percent of the women who met rigorous PMS criteria also met the criteria for PMDD in a recent treatment study (Freeman et al., 1995). Severe PMS, like PMDD, requires a severe level of premenstrual symptoms that disrupt usual functioning, clear decrease or absence of symptoms following menses, absence of other current physical and mental diagnoses, and confirmation of symptoms by prospective daily reports. Women may meet these criteria for severe PMS but not PMDD if they do not have 5 of the 11 required PMDD symptoms which emphasize dysphoric mood. It is noteworthy that the International Classification of Diseases (ICD-10) categorizes premenstrual tension syndrome rather than dysphoria and locates the diagnosis in the annex under the category of pain rather than depression (World Health Organization, 1992).

Research 65 (19966) 97-106

Although PMDD stresses dysphoric symptoms and does not include all women with severe PMS, responses to medications including antidepressants have not differed between the PMS and PMDD groups in comparisons made thus far (Freeman et al., 1990, 1993, 1994, 1995; Rickels et al., 1990). This further suggests the importance of rigorous examination of the broader category of PMS as well as PMDD, particularly in primary care settings where clinicians are called upon to diagnose and treat the condition. A number of instruments have been used for rating PMS symptoms, but there is considerable variability in their scope and utility for clinical settings (Moos, 1968; Abraham, 1980; Steiner et al., 1980; Muse et al., 1984; Endicott et al., 1986; Hammarback et al., 1989; Metcalf et al., 1989; Mortola et al., 1990; Thys-Jacobs et al., 1995). Although fewer than 20 symptoms appear to be the most common in PMS (Gitlin and Pasnau, 1989), most of the symptom rating scales employ not only the possible core PMS symptoms but a range of other symptoms, adding to the complexity of the scales for primary care settings. The measurement scales vary, and differences in scoring methods affect the numbers of women who meet diagnostic criteria, as was shown in an analysis of data for the LLPDD diagnosis (Hurt et al., 1992). Some scales have been formally validated or examined for their factor structures (Halbreich et al., 1982; Endicott et al., 1986; Mortola et al., 1990; Allen et al., 1991; Mira et al., 1995; Thys-Jacobs et al., 19951, but information on relationships among the scales or with other standard mood measures is scant. We previously designed the 17-item Daily Symptom Report (DSR) as a relatively brief measure of common premenstrual symptoms to be used in clinical treatment studies of PMS over extended time periods. Subsequent treatment trials provided evidence that the DSR detected differences in treatment effects (Freeman et al., 1993, 1994, 1995; Rickels et al., 1990). This report compares the DSR ratings of a sample of women who sought medical treatment for PMS with a non-clinical comparison group and examines the reliability of the DSR, its factor

E. W. Freeman et al. /Psychiatry Research 65 (1996) 97-106

structure, and correlations with other standard mood measures in the PMS sample. 2. Methods 2.1. Sample The PMS subjects (n = 170) were self-referred for medical treatment of PMS. A provisional diagnosis of PMS was made at the initial office visit based on clinical interview, which included the Structured Clinical Interview for LXM-III-R WED; Spitzer et al., 19881, administered by a trained clinician. Additional interview items inquired about the specific symptoms that were experienced premenstrually and whether the premenstrual symptoms interfered with work, relationships, or usual social or sexual activity. A provisional diagnosis of PMS was made if: (a) subjects reported four or more symptoms, including at least one mood symptom, that occurred only premenstrually; (b) the symptoms were severe enough to interfere with usual functioning; and (c) there was no other major mood disorder based on the SCID. After the provisional diagnosis of PMS, the subjects completed two additional cycles of daily symptom ratings to confirm the PMS diagnosis. Two hundred eighty-four subjects who continued to meet PMS criteria were given a single-blind placebo in the third screening cycle. Fifty-eight women dropped out for various reasons and 56 women no longer met the symptom criteria, leaving 170 women in the PMS sample. The PMS subjects were between the ages of 18 and 45, and had regular menstrual cycles of 22-35 days. All were in general good health, were free of concurrent gynecological problems, and had no current major psychiatric illness as determined by the SCID. All participants signed informed consent approved by the Institutional Review Board of the University of Pennsylvania. The non-clinical comparison group (n = 54) comprised volunteers from the community who were contacted through fliers at health fairs and work sites. The comparison subjects reported that they did not have PMS and that they were in general good health. They completed the daily

99

ratings on the DSR for one menstrual cycle, mailed the completed forms to the research offices, and were reimbursed $10 for their time. The comparison subjects ranged in age from 18 to 45 and had regular menstrual cycles (22-35 days). Cycle length in the rated cycle was confirmed on the DSR. All DSRs completed by the non-clinical comparison group were included in this report regardless of the severity or pattern of the symptom ratings. 2.2. DSR The DSR listed 17 common symptoms of premenstrual distress: irritability, mood swing, nervous tension, anxiety, depression, feeling out of control, poor coordination, confusion, insomnia, crying, fatigue, food cravings, breast tenderness, swelling, cramps, aches, and headache. Subjects were instructed to rate the symptoms at the end of each day using a 5-point scale with the following descriptors: 0 = not present at all; 1 = minimal, only slightly apparent to you; 2 = moderate, aware of symptom but does not affect daily routine; 3 = a lot, continuously bothered by symptom and/or symptom interferes with daily activity; 4 = severe, symptom is overwhelming and/or unable to carry out daily activity. The subjects started the daily ratings whenever they received the DSR, with a cycle consisting of a complete menstrual cycle (from day 1 of menses to the next day 1 of menses). The DSR scores were calculated in each cycle by summing the ratings of cycle days 5-10 for the postmenstrual score (day 1 was the first day of menses) and the ratings of the 6 days before the next menses for the premenstrual score. 2.3. Other symptom measures Additional symptom measures were obtained at the office visits. The symptom measures and the DSR ratings reported here were obtained in the same cycle. The office visits were scheduled according to the menstrual cycle, with the premenstrual visits occurring on cycle days 1 k 3. At these visits, all subjects were instructed to report

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their symptomatic status for the premenstrual week. The Hamilton Rating Scale for Depression (HRSD) is a widely used clinician-rated scale that measures the severity of depression (Hamilton, 1960). The 25item scale included the original 17 items plus items for hypersomnia, increased appetite and weight gain, and psychic and motoric retardation. The item ratings were summed for a total score. The HRSD has demonstrated reliability between samples, discriminates well between depressed and normal subjects (Rehm and O’Hara, 1985), and is more sensitive than patient-rated depression scales in assessing short-term treatment for depression (Beth, 1995). The State-Trait Anxiety Inventory (STAI; Spielberger et al., 1970) is a widely used measure in medical and psychological research to assess feelings of present anxiety (state) and general feelings of anxiety (trait). Subjects rated 4-point scales, with higher scores indicating greater anxiety. Cronbach’s coefficient (Y was 0.93 for the state anxiety scale and 0.91 for the trait anxiety scale in a sample of employed adults (Spielberger et al., 1970). The Profile of Mood States (POMS) is a selfreport questionnaire that assesses transient mood states and has been shown to be a sensitive measure for both normal and clinical subjects (McNair et al., 1981). Items are rated from 0 (not present) to 4 (extremely) and scored in six factoranalytically derived mood dimensions: tensionanxiety, depression, anger-hostility, vigor, fatigue, and confusion. The scores are the sums of item ratings for each dimension. Reliability coefficients for internal consistency are 2 0.90, with numerous validity studies and normative sample data provided in the manual (McNair et al., 1981). The Premenstrual Assessment Form (PAF) is a self-report questionnaire designed to measure changes in mood, behavior, and physical condition during the premenstrual period (Halbreich et al., 1982). The PAF has 95 items grouped into 18 scales which provide a broader spectrum and more specific descriptions of positive and negative premenstrual changes. The (Ycoefficients of internal consistency of the scales are high overall, with a range of 0.61-0.91 (Halbreich et al., 1982).

Research 65 (1996) 97-106

2.4. Statistical analysis The reliabilities of the DSR and its factors were estimated with Cronbach’s (Y coefficient. The factor structure of the DSR was examined in a principal components factor analysis with varimax rotation. The DSR scores were compared between the PMS group and the non-clinical comparison group by t tests, with effect sizes calculated by dividing the mean difference in DSR scores by the S.D. of the comparison group (or by the postmenstrual S.D. in same-group comparisons) (Cohen’s d; Cohen, 1988). Correlations between the DSR scores and the other standard symptom measures (HRSD, POMS, STAI and PAF) were examined using Pearson correlation coefficients. Two-tailed tests were used with P values 5 0.05 considered significant, The SAS statistical package was used for the computer analyses (SAS/STAT Guide, 1989). 3. Results Table 1 shows background characteristics of the sample. The differences in mean age (PMS 33.3 years vs. control 29.8 years) and cycle length (PMS 28.2 days vs. control 29.6 days) did not appear to be clinically meaningful. When age and

Table 1 Background

characteristics

of the sample

No. of subjects Mean agea (SD) Mean cycle lengthb (SD) Ethnicity (%) White Black Other Duration of premenstrual syndrome (years) aP < 0.003 (t test). bP < 0.002. NA, not applicable.

Premenstrual syndrome (n = 170)

Control subjects (n = 54)

179 33.3 (5.9) 28.2 (2.9)

:;.s (7.8) 29.6 (2.3)

88 9 3

81 11 8

10.0 (7.4)

NA

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E. W. Freeman et al. /Psychiatry Research 65 (1996) 97-106

cycle length were added as covariates in a model of group and DSR scores, differences between the PMS and comparison groups remained strong and significant. Cronbach’s coefficient (Y for the premenstrual DSR scores was 0.92, indicating high internal consistency for the 17 symptoms (Table 2). The (Y coefficient remained very high at 0.91 in the postmenstrual phase. The item-total correlations (shown in Table 2) were generally highest for the psychological symptoms both premenstrually and postmenstrually. The factor structure of the DSR was examined using the premenstrual scores (i.e., the sums of ratings for each symptom on cycle days 23-28) of the PMS subjects (n = 170). A principal components analysis produced five factors with eigenvalues > 1, and five factors were retained after varimax rotation. Because factor 5 had only one item (food cravings), a forced four-factor solution was also examined. Table 3 shows the four-factor solution, which generally retained the same factor

structure with only slight shifts in the items. As shown in Table 3, headache had the highest loading on the behavioral factor, but for clinical use it could be included in factor 3, pain, as indicated by its eigenvalue, which exceeded 0.40 for the pain factor as well. The scales constructed from the DSR factors showed acceptable to high internal consistency, with (Y coefficients ranging from 0.93 for factor 1 (mood) to 0.63 for factor 3 (pain> (Table 4). To illustrate the degree of separation between the PMS and comparison groups and between the premenstrual and postmenstrual phases of the cycle, effect sizes were calculated (Fig. 1). The effect size is the difference between two means divided by the S.D. of the reference group. An effect size > 1.0 is considered large and clinically meaningful. The effect size considerably exceeded 1.0 throughout the premenstrual period and into menses (from day 17 through day 2 of the cycle). Even after adjustment for the postmenstrual scores, the effect size of the premenstrual DSR

Table 2 Daily Symptom Report symptoms in the total sample (n = 224) of patients means, standard deviations, and correlations with total score Symptoma

Irritability Fatigue Mood swing Swelling Nervous tension Anxiety Food cravings Depression Breast tenderness Aches Feeling out of control Headache Confusion Insomnia Poor coordination Crying Cramps

Postmenstrual

with premenstrual

syndrome

(PMS) and control

subjects:

Premenstrualb

Mean

SD.

r

2.5 4.5 2.1 1.3 2.9 2.8 1.6 2.5 0.4 2.2 1.3 2.5 1.1 1.5 1.0 1.2 0.5

3.8 4.9 3.6 3.0 4.4 4.5 3.0 4.1 1.2 4.1 3.0 3.7 2.7 3.6 2.5 2.7 1.3

0.78 0.67 0.75 0.47 0.79 0.79 0.57 0.72 0.14 0.54 0.77 0.55 0.65 0.49 0.64 0.59 0.27

Mean

SD.

r

11.6 11.0 9.9 9.9 9.8 9.6 8.5 8.2 8.1 7.2 6.1 5.8 4.9 4.7 4.6 4.6 3.7

7.0 6.9 7.5 7.3 7.2 7.4 7.2 6.8 7.1 6.9 7.0 6.0 5.9 5.8 5.8 5.7 5.0

0.80 0.71 0.77 0.61 0.78 0.82 0.60 0.72 0.51 0.54 0.73 0.55 0.57 0.48 0.60 0.61 0.36

“Cronbach’s (Y coefficient is 0.92 for premenstrual scores and 0.91 for postmenstrual scores. All data are raw scores. listed in order of premenstrual severity. bDifference between postmenstrual and premenstrual mean scores significant for all symptoms (P < 0.0001, paired

Symptoms

t test).

are

E. W. Freeman et al. /Psychiatry Research 65 (1996) 97-106

102

Table 3 Factor coefficients of Daily Symptom Report items in rotated factor solutiona Factor 1 Mood

Factor 2 Behavior

Anxiety Irritability Depression Nervous tension Mood swing Feeling out of control

0.77 0.75 0.75 0.75 0.72 0.70

Poor coordination Insomnia Confusion Headache Crying Fatigue Aches Cramps Breast tenderness Food cravings Swelling Variance explained

Factor 3 Pain

Factor 4 Physical

0.12 0.13 0.10 0.10 0.31 0.36

0.15 0.00 0.12 0.08 0.01 - 0.07

0.14 0.01 - 0.07 0.39 0.05 0.02

0.25 0.05 0.44 0.16 0.46 0.17

0.76 0.70 0.60 0.55 0.48 0.47

0.12 0.03 0.03 0.42 - 0.05 0.23

0.01 0.20 0.09 -0.14 - 0.19 0.11

0.08 0.16 0.17

0.33 0.08 - 0.03

0.76 0.70 0.62

-0.04 - 0.08 0.30

0.14 - 0.03

0.15 0.04

- 0.07 0.56

0.83 0.63

3.86

2.62

2.08

1.49

aN = 170 (premenstrual syndrome group)

scores exceeded 1.0 for the total DSR and all factors (Table 5). Comparisons of each of the DSR symptoms showed that all 17 premenstrual symptom scores were higher in the PMS group than in the comparison group (all P values < 0.0001, data not shown). Postmenstrually, all symptom scores declined in the PMS group (all P values < O.OOOl>, and all but four symptoms, which the comparison group scored very low premenstrually (poor coordination, feeling out of control, headache, and Table 4 Daily Symptom Report (DSR) factors: Means, standard deviations for the total samplea and Cronbach’s a coefficients Factorb

Mean

S.D.

lY

Fl: F2: F3: F4:

55.3 35.7 19.0

36.8 25.5 14.6

0.93 0.80 0.63

18.4

12.8

0.72

Mood (6 items) Behavioral (6 items) Pain (3 items) Physical symptoms (2 items)

aN = 224. Data are DSR symptom ratings summed on cycle days 23-28 for each subject. bTable 3 shows the items in each factor.

confusion), declined significantly (P < 0.05) in the comparison group. The postmenstrual scores remained at a higher level in the PMS group, accounted for by the mood and behavioral symptoms, which, although significantly diminished, were not completely absent in many subjects. Further inspection of the comparison group DSRs showed that 15% (8/54) had high premenstrual scores (> 90>, which were within 1 S.D. of the scores of the PMS sample. Four of these subjects had high postmenstrual scores as well, indicating ongoing symptoms rather than a premenstrual increase. However, all these non-clinical subjects stated that they did not have PMS and were in general good health. The premenstrual DSR scores of the PMS subjects were examined in relation to other standard symptom measures, which were obtained premenstrually in the same cycle as the DSR scores. Since the DSR assesses a symptom spectrum rather than a single mood dimension, only modest correlations were expected. As predicted, there were moderate correlations of the total DSR with the premenstrual HRSD scores, the STAI state

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E. W. Freeman et al. / Psychialy Research 65 (1996) 97-106

Table 5 Daily Symptom

Report

(DSR) factor

scores

for patients

with premenstrual

35.4 15.7 13.5 3.4 3.1

Total DSR Factor 1: MoodC Factor 2: Behavioral Factor 3: Pain Factor 4: Physical

(40.5) (21.1) (15.3) (5.3) (5.4)

(PMS) and control

subjects,

and effect size

Premenstrualh

Postmenstruala PMS (n = 170)

syndrome

Control 21.1 9.9 1.2 2.1 2.0

(n = 54)

(29.7) (6.2) (9.2) (4.0) (3.8)

Effect size

PMS

0.5 0.4 0.7 0.3 0.3

154.8 68.1 43.1 22.2 22.1

(65.2) (31.5) (23.3) (14.6) (11.9)

Control

Effect size

Adjusted

45.7 (49.2) 16.5 (21.0) 12.7 (16.7) 9.4 (9.7) 7.OC7.9)

2.2 2.5 1.8 1.3 1.9

1.7 2.1 1.1 1.0 1.6

effect sized

aP values for postmenstrual PMS vs. control (t tests) are 0.01 for total DSR; 0.07 for Factor 1; 0.003 for Factor 2; 0.11 for Factor 0.13 for Factor 4. bP < 0.0001 for all premenstrual scores: PMS vs. control (I tests). ‘Table 3 shows the symptoms in each factor. dPostmenstrual effect size was subtracted from premenstrual effect size to adjust for the postmenstrual baseline.

3.0

32 28 Mean DSR Scorsr

3;

PM9

-

2.5 Zffeot are

Control - 24

2.0 20 1.5

16 12

1.0

6 0.5 4 0.0

0 0

7

14 CYCLE DAY

21

28

Fig. 1. Daily Symptom Report (DSR) scores and effect size for each cycle day: premenstrual syndrome (PMS) and control. Data are means with standard errors. Results of I tests were significant (P < 0.0001) for days l-3 and 16-28. Only days 9-11 and day 13 did not reach a significant level of P < 0.05; the remaining days were P < 0.05 > 0.001.

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E. W. Freeman et al. /Psychiatry Research 65 (1996) 97-106

measure, and the POMS and PAF scales (see Table 6). 4. Discussion The present report shows high internal consistency of the 17-item DSR, an indication that this

measure can be relied upon as an overall index of the severity of PMS. The DSR also yields four clinically relevant factors, which facilitate the examination of more specific symptom clusters. The DSR previously demonstrated its ability to detect differences in medication effects, both in the total symptom score and in the factor scores (Rickels et al., 1990; Freeman et al., 1993, 1994, 1995).

Table 6 Pearson correlations of the Daily Symptom Report (DSR) with other symptom measures assessed premenstrually Premenstrual DSRasb Total DSR Factor 1: Mood HRSD (25-item)

0.39

0.30

0.48 0.33 0.40 0.35 0.37 0.45 - 0.22

0.47 0.40 0.34 0.36 0.26 0.46 - 0.23

STAI State Trait

0.30 0.09

PAF (total) Sl S2 S3 S4 S5 S6 S7 S8 S9 SIO Sll S12 S13 S14 S15 S16 S17 Sl8

POMS (total) Anger-hostility Confusion Depression Fatigue Tension-anxiety Vigor

Low mood Endogenous depression Lability Atypical depression Hysteroid Hostility/anger Social withdrawal Anxiety Increased well-being lmpulsivity Organic Water retention Physical Autonomic Fatigue Impaired social function Miscellaneous mood Miscellaneous physical changes

Note. Premenstrual

Factor 2: Behavior 0.40

Factor 3: Pain

Factor 4: Physical

0.22

0.29

0.49 0.29 0.49 0.34 0.46 0.38 -0.19

0.16 0.02 0.12 0.09 0.23 0.16 - 0.07

0.25 0.14 0.16 0.18 0.18 0.23 -0.17

0.29 0.08

0.29 0.05

0.09 0.05

0.18 0.12

0.40

0.33

0.34

0.25

0.34

0.30 0.37 0.25 0.30 0.35 0.23 0.27 0.28 0.20 0.28 0.37 0.28 0.35 033 033 035 031

0.29 0.25 0.30 0.25 0.34 0.30 0.22 0.24 0.13 0.34 0.30 0.17 0.17 0.18 0.23 0.35 0.29

0.30 0.37 0.15 0.21 0.31 0.18 0.27 0.23 0.13 0.22 0.43 0.11 0.27 0.33 0.35 0.35 0.28

0.10 0.26 0.08 0.13 0.11 - 0.00 0.11 0.19 0.21 - 0.03 0.13 0.36 0.53 0.32 0.21 0.09 0.13

0.17 0.27 0.14 0.36 0.26 0.11 0.20 0.15 0.18 0.21 0.21 0.46 030 0.34 0.22 0.21 0.21

0.23

0.12

0.21

0.26

0.26

syndrome group (n = 170) only; numbers vary slightly with missing data. HRSD, Hamilton Rating Scale for Depression. POMS, Profile of Mood States. STAI, State-Trait Anxiety Inventory. PAF, Premenstrual Assessment Form. aAll correlations 2 0.30 (significant at PI; 0.0001 in this sample size) are shown in bold; r 2 0.25 significant at PI 0.001; r 2 0.19 significant at PI 0.01. ‘Table 3 shows the DSR factor items.

E. W. Freeman et al. /Psychiatry Research 65 (1996) 97-106

The internal consistency of the DSR items, which include six physical symptoms as well as the well-recognized mood and behavioral symptoms of PMS, suggests a close relationship between the physical, mood, and behavioral symptoms in PMS that is not well understood. Although physical symptoms alone are insufficient for a diagnosis of severe PMS, they are usually present in the constellation of symptoms, as illustrated in these results. However, the physical symptoms differed the least in comparisons between the PMS sample and the non-clinical subjects, which also suggests that the physical symptoms reported in the PMS sample may be relatively normal changes associated with the menstrual cycle. It is also noteworthy that the physical symptoms comprised two discrete factors rather than a single dimension. Possibly these two clusters of physical symptoms signify different underlying biological factors that may trigger or interact with the predominant mood symptoms of PMS. In the comparison group, which comprised non-clinical women who denied having PMS or any health problems, 15% were high-symptom scorers, a well-identified issue in other PMS studies (Mortola et al., 1990; Gallant et al., 1991). Discrimination between self-reported clinical and non-clinical conditions will necessarily have this confound until objective tests for the disorder are identified. As expected, there were low to moderate correlations between the DSR scores and other standard mood measures in the PMS sample. Methodological procedures could affect the modest correlations (e.g., the restricted score range of a clinical sample and the retrospective assessments at the clinical visits compared with the prospective ratings of the DSR), but it nonetheless appears that the DSR assessment of a broad symptom spectrum relates to but does not duplicate other mood scales that assess specific mood dimensions. The present results add to the evidence that severe premenstrual distress has a moderate overlap with a number of symptom profiles in the premenstrual phase, but it is not merely a depression or anxiety disorder in women whose PMS symptoms abate following menses.

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The DSR is not identical to a daily symptom measure for the specific PMDD diagnosis, which has recently been developed for rating the symptoms of PMDD (Endicott and Harrison, 1996). Nonetheless, we conclude that the DSR is a reliable measure of the broader condition of PMS, and has clinical and research utility to identify and investigate the common mood, behavioral, and physical symptoms of this disorder. References Abraham, G. (1980) Premenstrual tension. Crxr Prob Obstet Gynecot 3, 1-39. Allen, S.S., McBride, C.M. and Pirie, P.L. (1991) The shortened Premenstrual Assessment Form. J Reprod Med 36 (111, 769-772. American Psychiatric Association. (1987) DSM-III-R: Diagnostic and Statistical Manual of Mental Disorders. 3rd rev. edn. American Psychiatric Press, Washington, DC. American Psychiatric Association. (1994) DSM-N: Diagnostic and Statistical Manual of Mental Disorders. 4th edn. American Psychiatric Press, Washington, DC. Beth, P. (1995) Quality-of-life measurements for patients taking which drugs? The clinical PCASEE perspective. PharmacoEconomics 7(2), 141-151. Cohen, J. (1988) Statisticat Power Analysis for the Behauioraf Sciences. 2nd edn. Lawrence Erlbaum Associates, Hillsdale, NJ. Endicott, J. and Harrison, W. (1996) Daily record of severity of problems. Unpublished manuscript, New York State Psychiatric Institute, 722 W. 168th St., New York, NY 10032. Endicott, J., Nee, J., Cohen, J. and Halbreich, U. (1986) Premenstrual changes: Patterns and correlates of daily ratings. J Affect Disord 19, 127-135. Freeman, E.W., Rickels, K., Sondheimer, S.J., Denis, A., Pfeifer, S. and Weil, S. (1994) Nefazodone in the treatment of premenstrual syndrome: A preliminary study. J Clin Psychophatmacol 14, 180-186. Freeman, E.W., Rickels, K., Sondheimer, S.J. and Polansky, M. (1990) Ineffectiveness of progesterone suppository treatment for premenstrual syndrome. JAMA 264,349-353. Freeman, E.W., Rickels, K., Sondheimer, S.J. and Polansky M. (1995) A double-blind trial of oral progesterone, alprazolam, and placebo in treatment of severe premenstrual syndrome. JAMA 274, 51-57. Freeman, E.W., Sondheimer, S.J., Rickels, K. and Albert, J. (1993) Gonadotropin-releasing hormone agonist in treatment of premenstrual symptoms with and without comorbidity of depression: A pilot study. J Clin Psychiatry 54, 192-195. Gallant, S.J., Hamilton, J.A., Popiel, D.A., Morokoff, P.J. and Chakraborty, P.K. (1991) Daily moods and symptoms: Ef-

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