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Ferriman Gallwey Self-Scoring I: Performance Assessment in Women with Polycystic Ovary Syndrome

Departments of Obstetrics and Gynecology (R.A.W.), Biostatistics and Epidemiology (R.A.W., S.V., L.B., W.O.), and Medicine (T.W.), Cardiovascular Section, Oklahoma University Health Sciences Center, Oklahoma City, Oklahoma 73104

Address all correspondence and requests for reprints to: Dr. Robert A. Wild, Oklahoma University Health Sciences Center, 2410 WP, 920 S. L. Young Boulevard, Oklahoma City, Oklahoma 73104. E-mail: robert-wild{at}ouhsc.edu.

	Abstract

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Objective: The objective of this study was to determine performance characteristics of Ferriman Gallwey self-scoring in women with the polycystic ovary syndrome.

Design: A simultaneous Ferriman Gallwey map scoring design was used.

Setting: The study was performed at the General Clinical Research Center in a university medical center.

Patients: Twenty-one hirsute patients with the polycystic ovary syndrome were studied.

Interventions: Interventions included masked patient, physician, and research nurse simultaneous and independent Ferriman Gallwey map scoring.

Main Outcome Measures: The main outcome measures were modified Ferriman Gallwey map scores.

Results: Agreement analysis demonstrated that patient self scores, physician scores, and research nurse scores were quite discrepant.

Conclusion: The modified Ferriman Gallwey Map scoring system has too much variation to be clinically useful.

	Introduction

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BY 1996, THERE had been 41 papers in three major clinical endocrine journals within the prior decade that were concerned with the treatment of hirsutism (1). In 75% of the studies, the Ferriman Gallwey scoring system was used to score excess male pattern body hair. Since then, virtually all studies evaluating medical treatments for hirsutism use this instrument (2, 3, 4, 5, 6, 7). Although more objective tools are available (including photographic evaluation, microscopic measurement of hair diameter with extensive counting of shafts, computerized assessment of photographic measures, and others), these are complex, expensive, or difficult to use. The ease of use and low cost of the Ferriman Gallwey system make it a potentially attractive instrument.

The Ferriman Gallwey Index was originally designed for anthropological research (8). In patients with polycystic ovary syndrome (PCOS), it has been shown to validly reflect androgen excess compared with expensive and elaborate objective methods, including microscopic measurement of hair diameter with extensive counting of individual shafts (9). Although intraobserver agreement is reported to be less than 3 points (10), surprisingly, interobserver reproducibility has not been reported.

The objects of this investigation were 1) to assess performance characteristics and interobserver agreement using self scoring by the Ferriman Gallwey scoring map, and 2) to assess patient self scoring for research and clinical care. If in this context patient self scoring agrees favorably with that by the physician/research nurse team, then this would free up resources and facilitate group comparisons related to the treatment of hirsutism and the identification of PCOS. In contrast, if the level of agreement is found to be unacceptable, then the validity of studies that use only this instrument to grade hirsutism is questioned. Assessment of interobserver variation in a research setting, such as that reported in this study, in a fashion designed to minimize ascertainment bias is very important in determining accurate interobserver agreement. Bias can potentially be introduced by patients themselves, the individuals conducting the assessment, or both. For example, knowledge of laboratory results can be associated with ascertainment bias. To avoid this, this investigation was conducted with proper masking to avoid ascertainment bias.

	Patients and Methods

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General

Each patient participating in this investigation signed an informed consent in accordance with Oklahoma University Health Sciences Center institutional review board approval of the protocol. All patients evaluated in this report met the National Institutes of Health criteria of PCOS: they had signs/symptoms of androgen excess (Ferriman Gallwey score, >6), and irregular menses (10 menses/yr). Other endocrinopathies were excluded. The modified Ferriman Gallwey map scoring system used has 12 domains depicting portions of the body. There are five categories graded from 0–4 using an ordinal scale within each body surface domain. Total scores are obtained by adding scores from all domains. The maximum score is 60 (8). Our experience revealed that intraobserver agreement was consistent with previous reports. Once the principal investigator (PI) demonstrated that his intraobserver agreement was within 3 points (10%), three research nurses were trained by the PI and were shown to agree with the physician within 10% before the study began. Research nurse 1 and the physician were present for every scoring. To accommodate scheduling, scores for research nurse 2 could have come from one of the two other trained nurses. Four persons independently and blindly graded each patient’s hirsutism. Three observers were from the research team; the fourth observer was the patient herself using the modified Ferriman Gallwey map. After physician instruction in using the map, 21 PCOS patients graded their own hirsutism independently and blindly. Simultaneously, the PI and two research nurses scored the patient’s hirsutism using the Ferriman Gallwey map. Each observer scored independently without knowledge of the other observers’ scores.

Statistical analysis

Power analysis assumed a 3-point difference, which is 15% of the average Ferriman Gallwey scores reported in the literature. This is also the reported intraobserver agreement. Using an of 0.05 and a ß of 0.20, the calculated sample size was 20 patients. Twenty-one consecutive PCOS patients were evaluated in a similar fashion to test interobserver agreement. Data were entered into Microsoft Excel (Microsoft Corp., Redmond, WA). Descriptive statistics were performed for each variable. Correlation, regression, and agreement analysis were performed using Excel Analyze It (London, UK) and SAS version 9.0 (SAS Institute, Cary, NC). We tested for normality of distribution by graphic methods and Shapiro-Wilke test of all variables. Ferriman Gallwey scores ranged between 11 and 34 for both the patient and the physician. The scores were normally distributed and were well represented across the range. Parametric analysis was used to compare normally distributed variables, and nonparametric analysis was used when significant departure from normality was detected.

	Results

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The ages of the patients ranged from 18–36 yr. There were 10 Caucasians, seven African-Americans, two Hispanics, one Asian, and one Native American. Thirteen patients had more than a high school education, and the rest were high school graduates. Their median income was $30,000, ranging from less than $10,000 to $100,000. Their body mass indexes (kilograms per square meter) ranged from 18–50 and averaged 32.2, thus meeting the National Institutes of Health criteria of obesity. Nine patients were married, and 12 were not married. The average number of menses per year was six, ranging from zero to 10. Approximately half of the patients had never been pregnant; however, seven had more than two children.

A plot of the raw scores for each patient comparing the patient-reported scores to those reported by the physician and the two research nurses is shown in Fig. 1. An informative analysis for clinical purposes is agreement analysis. This plots the differences in the scores against the average of the scores. An example is shown in Fig. 2. This plots the difference in the patient scores and the physician scores on the y-axis labeled difference in the methods vs. the average of each score on the x-axis labeled as the mean of the methods. We found that individual scores could differ by 12 points, and that the range of differences was 21 points (from –9 to +12)! Agreement analysis also showed that patient and research nurse 1 could differ individually by as much as 11 points, with a range of 21 points. The difference between the patient’s self score and the score of research nurse 2 was as much as 14 points. The range was 27 points. This even wider difference between the score of research nurse 2 and the patient’s self score was not unexpected, because of the need to use more than one trained second nurse to evaluate blindly.

View larger version (45K): [in this window] [in a new window]   FIG. 1. Comparison of blinded simultaneous Ferriman Gallwey scores comparing patient (FGPt), physician (FGDr), and research nurses (FGN1 and FGN2). The blinded simultaneously obtained Ferriman Gallwey scores contrast patient’s, physician’s, and the two research nurses’ scores.

View larger version (14K): [in this window] [in a new window]   FIG. 2. The difference in patient’s self-scores vs. physician’s scores is shown on the vertical axis (labeled as difference between methods) vs. the average of both scores (patient and physician) on the horizontal axis (labeled as the mean of all methods). Zero on the vertical axis indicates perfect agreement.

	Discussion

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The importance of applying agreement graphic testing when determining acceptable clinical variation is obvious. This is not revealed when a correlation coefficient is used to determine how these scores are correlated. The variability determines the clinical usefulness or lack thereof. In the preceding analysis, the differences did not vary in any systematic way over the range of measurement. In other words, higher scores were not associated with wider differences (the slope of the regression was not significant).

The Ferriman Gallwey score has been described both as the instrument of choice and as subjective and not useful. Although it has been shown to reflect androgen excess, we found in this study that self scoring is not clinically useful. We found poor interobserver agreement. More objective measures to evaluate hirsutism are needed. Research needs to continue toward developing a method to grade hirsutism in women with PCOS that is simple, convenient, inexpensive, valid, and reproducible.

	Acknowledgments

 
We thank Michele Young, administrative secretary at the Department of Biostatistics and Epidemiology, and the General Clinical Research Center nurses, Beverly Bonnewell, R.N.; Jodie Groff, R.N.; and Mai Muse, R.N., for their diligent contributions. We also thank Dr. Gary Raskob, advisor.

	Footnotes

 
This work was supported in part by the National Institutes of Health, National Center for Research Resources, General Clinical Research Center Grant MO1-RR-14467, and the Department of Biostatistics and Epidemiology Oklahoma University Health Science Center.

First Published Online April 12, 2005

Abbreviations: PCOS, Polycystic ovary syndrome; PI, principal investigator.

Received November 16, 2004.

Accepted March 31, 2005.

	References

Top Abstract Introduction Patients and Methods Results Discussion References

 

1. Barth JH 1996 How robust is the methodology for trials of therapy in hirsute women? Clin Endocrinol (Oxf) 45:379–380[CrossRef][Medline]
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3. Sert M, Tetiker T, Kirim S 2003 Comparison of the efficiency of anti-androgenic regimens consisting of spironolactone, Diane 35, and cyproterone acetate in hirsutism. Acta Med Okayama 57:73–76
4. Muderris II, Bayram F, Guven M 2000 A prospective, randomized trial comparing flutamide (250 mg/d) and finasteride (5 mg/d) in the treatment of hirsutism. Fertil Steril 73:984–987[CrossRef][Medline]
5. Harborne L, Fleming R, Lyall H, Sattar N, Norman J 2003 Metformin or antiandrogen in the treatment of hirsutism in polycystic ovary syndrome. J Clin Endocrinol Metab 88:4116–4123[Abstract/Free Full Text]
6. Sahin Y, Dilber S, Kelestimur F 2001 Comparison of Diane 35 and Diane 35 plus finasteride in the treatment of hirsutism. Fertil Steril 75:496–500[CrossRef][Medline]
7. Bayram F, Muderris II, Guven M, Kelestimur F 2002 Comparison of high-dose finasteride (5 mg/day) versus low-dose finasteride (2.5 mg/day) in the treatment of hirsutism. Eur J Endocrinol 147:467–471[Abstract]
8. Ferriman DM, Gallwey JD 1961 Clinical assessment of body hair growth in women. J Clin Endocrinol 21:1440–1447
9. Barth JH 1997 Semi-quantitative measurements of body hair in hirsute women compare well with direct diameter measurements of hair shafts. Acta Dermatol Venereol 77:317–318[Medline]
10. Barth JH 1996 How robust is the methodology for trials of therapy in hirsute women? Clin Endocrinol (Oxf) 45:379–380
11. Bland JM, Altman DG 1986 Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1:307–310[CrossRef][Medline]

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This Article Abstract Full Text (PDF) All Versions of this Article: 90/7/4112    most recent Author Manuscript (PDF) Submit a related Letter to the Editor Purchase Article View Shopping Cart Alert me when this article is cited Alert me when eLetters are posted Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Request Copyright Permission Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Wild, R. A. Articles by Owen, W. Search for Related Content PubMed PubMed Citation Articles by Wild, R. A. Articles by Owen, W. Related Collections Female Endocrinology