Letters

Healthcare Safety and Quality, Boston, Massachusetts (Biondolillo); Massachusetts Department of Public Health, Boston (Biondolillo). Corresponding Author: Gordon D. Schiff, MD, Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, 1620 Tremont St, Third Floor, Boston, MA 02120 ([email protected]). Conflict of Interest Disclosures: None reported. Funding/Support: This project was supported by grant number R18HS019508 from the Agency for Healthcare Research and Quality (AHRQ). Role of the Sponsor: The AHRQ had no role in the preparation, review, or approval of the manuscript or the decision to submit the manuscript for publication. Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the Agency for Healthcare Research and Quality. 1. Schiff GD, Puopolo AL, Huben-Kearney A, et al. Primary care closed claims experience of Massachusetts malpractice insurers. JAMA Intern Med. 2013;173 (22):2063-2068. 2. Jena AB, Seabury S, Lakdawalla D, Chandra A. Malpractice risk according to physician specialty. N Engl J Med. 2011;365(7):629-636. 3. The PROMISES Project. Brigham and Women’s Hospital website. http://www.brighamandwomens.org/PBRN/PROMISES. Accessed March 5, 2014. 4. Schiff G, Griswold P, Ellis BR, et al. Doing right by our patients when things go wrong in the ambulatory setting. Jt Comm J Qual Patient Saf. 2014;40(2):91-96. 5. The PROMISES Project. When things go wrong in the ambulatory setting. http://www.brighamandwomens.org/Research/depts/Medicine/General _Medicine/PBRN/docs/WhenThingsGoWrongInTheAmbulatorySetting.pdf. Published October 9, 2013. Accessed March 5, 2014.

In Reply Dr Harris’ calculated lifetime risk is similar to the results of a study done by Jena et al.1 Using data from a single large malpractice insurer, Jena et al1 calculated a 76.7% lifetime risk of a medical malpractice claim for physicians practicing family medicine and a 88.5% lifetime risk for physicians practicing internal medicine and subspecialties. The lifetime risk of a medical malpractice claim for physicians practicing obstetrics and gynecology (97.2%) and general surgery and surgical subspecialties (98.4%) approached certainty. We are currently conducting a study of this issue using closed claims data from Illinois. For a physician, being accused of malpractice is deeply traumatic. We do not mean to discount the emotional stakes. However, most claims do not result in payment, and malpractice insurers almost always cover the entire cost if a payment is made. Defensive medicine, in addition to being wasteful, can cause injury and economic harm to patients. So the question for Dr Harris and others is straightforward: if 1 malpractice claim over a 40-year career is sufficient to justify defensive medicine, what level of claiming will not justify defensive medicine? David A. Hyman, MD, JD William M. Sage, MD, JD Author Affiliations: College of Law and College of Medicine, University of Illinois, Champaign (Hyman); School of Law, University of Texas, Austin (Sage). Corresponding Author: David A. Hyman, MD, JD, College of Law, University of Illinois, 504 E Pennsylvania Ave, Champaign, IL 61820 ([email protected]). Conflict of Interest Disclosures: None reported. 1. Jena AB, Seabury S, Lakdawalla D, Chandra A. Malpractice risk according to physician specialty. N Engl J Med. 2011;365(7):629-636.

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Sexual Activity in Midlife Women and Beyond To the Editor We read with interest the article by Thomas et al1 on sexual activity in midlife women. The World Health Organization has been working in the area of sexual health since at least 1974 (http://www.who.int/topics/sexual_health/en/). There are, however, some aspects of the study that need clarification to make the results straightforward. An important aspect relates to the separation of women into the 2 categories of sexually activity at baseline (Table 1 in the article by Thomas et al1): any flaw in this starting point would undermine the validity of prospective results. The prevalence of known and unknown diabetes in US women (age range, 45-64 years) is 13.7% (http://www.cdc.gov /diabetes/pubs/factsheet11.htm), which translates in nearly 82 diabetic women of the 602 who completed study year 4. However, diabetes was not mentioned in Table 1 of their article, which leads to the suspicion that it was not considered as an important factor in sexual function. Alternatively, diabetic women were excluded, but this was not stated. The same reasoning applies to hypertension, dyslipidemia, and metabolic syndrome; needless to say, all these conditions are associated with sexual dysfunction in women.2 Another aspect of the study that leaves us puzzled is the method used to separate women into sexually active vs sexually inactive groups. It is stated that the primary outcome was sexual activity at year 8, as assessed by the question: “During the past 6 months, have you engaged in any sexual activities with a partner?”1(p631) However, the reader is left confused about the construction of baseline data. If we assume that the same question was used at baseline to differentiate sexually active vs inactive women, it may be hard to accept that a single question can be used as a cutoff point, also considering that this question does not measure the “quality” of sex. This may explain, in part, the data in Table 1 indicating that sexually active women are more likely to take an antidepressant, to have vaginal dryness, and to be married, which is the opposite of what the literature says for diabetic women.3,4 Female Sexual Function Index (FSFI) is a validated instrument based on 6 domains and 19 questions: a 0.5 difference between scores of 2 groups of women is neither statistically nor biologically significant. The absence of any dispersion data (standard deviation) of FSFI score does not help, and the percentage of women falling below the cutoff of 26 was not given. The whole story can hardly help in defining the natural history of sexual activity in midlife women. Maria Ida Maiorino, MD Giuseppe Bellastella, MD, PhD Katherine Esposito, MD, PhD Author Affiliations: Department of Medical, Surgical, Neurological, Metabolic, and Geriatric Sciences, Second University of Naples, Naples, Italy (Maiorino, Bellastella); Department of Clinical and Experimental Medicine, Second University of Naples, Naples, Italy (Esposito). Corresponding Author: Katherine Esposito, MD, PhD, Unit of Endocrinology and Metabolic Diseases, Department of Internal and Clinical Medicine, Second University of Naples, Piazza L. Miraglia n° 2, 80138 Naples, Italy (katherine [email protected]). Conflict of Interest Disclosures: None reported. JAMA Internal Medicine July 2014 Volume 174, Number 7

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1. Thomas HN, Chang CC, Dillon S, Hess R. Sexual activity in midlife women: importance of sex matters. JAMA Intern Med. 2014;174(4):631-633. 2. Miner M, Esposito K, Guay A, Montorsi P, Goldstein I. Cardiometabolic risk and female sexual health: the Princeton III summary. J Sex Med. 2012;9(3):641651. 3. Enzlin P, Rosen R, Wiegel M, et al; DCCT/EDIC Research Group. Sexual dysfunction in women with type 1 diabetes: long-term findings from the DCCT/EDIC study cohort. Diabetes Care. 2009;32(5):780-785. 4. Esposito K, Maiorino MI, Bellastella G, Giugliano F, Romano M, Giugliano D. Determinants of female sexual dysfunction in type 2 diabetes. Int J Impot Res. 2010;22(3):179-184.

thors’ conclusion that the results should be attributed to inaccuracy of the measure. Raymond C. Rosen, PhD James A. Simon, MD Author Affiliations: New England Research Institutes Inc, Watertown, Massachusetts (Rosen); George Washington University, Women's Health & Research Consultants, Washington, DC (Simon). Corresponding Author: Raymond C. Rosen, PhD, New England Research Institutes Inc, 9 Galen St, Watertown, MA 02472 ([email protected]). Conflict of Interest Disclosures: None reported.

To the Editor What determines whether a woman maintains sexual activity during the midlife transition and beyond? Thomas and colleagues1 report findings from a recent longitudinal cohort study of 600 midlife women enrolled in an academic general medicine practice. Contrary to expectations, the authors found that a single measure of the importance of sex was more predictive of long-term maintenance of sexual activity than a sexual function score obtained from the Female Sexual Function Index (FSFI), a brief, validated scale of sexual function in women. 2,3 The authors report low overall FSFI scores at year 4 in both sexually active and inactive women, which did not predict continuation of sexual activity at year 8. This unexpected finding is explained as likely due to inaccuracy or insensitivity of the measure: “The FSFI’s focus on intercourse may not accurately reflect what constitutes satisfying sex in this population, yielding falsely low scores.”1(p632-633) However, a simpler explanation of their finding can be offered. Specifically, we propose that low sexual function scores in their sample are likely a reflection of comorbid illnesses, medication effects, or lifestyle factors. In support of this explanation, nearly half of the sexually active women in their sample reported symptoms of vaginal dryness, a common symptom of vulvovaginal atrophy, and almost onethird were taking serotonin norepinephrine reuptake inhibitors.1 The prevalence of vaginal dryness complaints is indicative of hormonal or other medical comorbidities in their sample, whereas the high rate of serotonin norepinephrine reuptake inhibitor use is associated with the presence of mood disorders and potential pharmacologic interference with normal sexual function. Unfortunately, the authors failed to report component scores or domains of sexual function affected, which FSFI scoring instructions strongly recommend. 2,3 Domain scoring is important to determine which components of sexual function (eg, lubrication difficulties, absence of sexual desire) were affected, thus elucidating reasons for diminished sexual function scores in their sample. Also worth noting is that the FSFI was developed originally for use as an outcome measure in clinical trials of female sexual dysfunction,2,4,5 and repeated administration of the scale across study visits is recommended to assess changes over time.2,4,5 This was lacking in the current study. In conclusion, given the atypical conditions of test administration in the study, inadequate scoring and faulty interpretation of the FSFI findings, we disagree strongly with the au1204

1. Thomas HN, Chang CC, Dillon S, Hess R. Sexual activity in midlife women: importance of sex matters. JAMA Intern Med. 2014;174(4):631-633. 2. Rosen R, Brown C, Heiman J, et al. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000;26(2):191-208. 3. Wiegel M, Meston C, Rosen R. The female sexual function index (FSFI): cross-validation and development of clinical cutoff scores. J Sex Marital Ther. 2005;31(1):1-20. 4. Meston CM. Validation of the Female Sexual Function Index (FSFI) in women with female orgasmic disorder and in women with hypoactive sexual desire disorder. J Sex Marital Ther. 2003;29(1):39-46. 5. Gerstenberger EP, Rosen RC, Brewer JV, et al. Sexual desire and the female sexual function index (FSFI): a sexual desire cutpoint for clinical interpretation of the FSFI in women with and without hypoactive sexual desire disorder. J Sex Med. 2010;7(9):3096-3103.

To the Editor We read with interest the findings from the longitudinal cohort study by Thomas and colleagues,1 dissociating midlife sexual activity from the classic norms of the Female Sexual Function Index. Rather than focusing on the events in a sexual response cycle, more accurate estimates of sexual function for women aged 40 to 65 years will require a number of measurement tools that take into consideration events such as relationship issues, sexual interest, desire, satisfaction, and/or personal distress from any cause. A woman’s participation in sexual activity often stems from reasons beyond her own interest, and therefore coital frequency would be an inadequate determinant of her sexual health.2 Physical, emotional and socioenvironmental factors are major determinants on women’s sexual function; subjectively, mood or sleep disturbances, fatigue, medical, psychological issues, and partner’s health-related outcomes may be important confounders.3 Some contextual factors not duly credited would include the physical and/or emotional drain of caring for an elderly parent or children in the same household and the lack of privacy therein. Aside from menopausal hormonal and vaginal changes, emotional, social, and cultural taboos or boundaries often exert a significant impact on how women react to sexuality as they age. It is therefore not surprising to find a third of postmenopausal Asian women in our clinical cohort completely asexual for considerable lengths of time, yet were not distressed to seek medical advice.4 In a conservative society, hugging, kissing, or any other form of physical intimacy is construed as a prelude to sexual intercourse and thereby avoided. It was in the initial years of sexual health assessment that frequency-based measures were used as primary end points for women’s sexual functioning.5 This emphasis underwent a paradigm shift, together with inclusion of

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Letters

personal distress and quality of life as additional pertinent outcomes, and the reporting of functional changes presently dates back to 6 months, giving a wider window. With the understanding that a woman’s sexual response waxes and wanes in the context of widespread influences in the familial and sociocultural setting in addition to health- or couple-related factors, it appears that more than a single tool would be required for a holistic sexual assessment. Adding a simple, structured questionnaire to standard validated instrument(s) in a faceto-face interview may be a proactive approach, to be adopted by the physicians caring for these women with extended lifespan requirements. The chosen items may also be useful in delineating the etiology and customizing intervention. Balasubramanian Srilatha, MD, PhD Zhongwei Huang, MBBS, PhD, AHEA(UK) Ganesan P. Adaikan, PhD, DSc Author Affiliations: Department of Obstetrics & Gynecology, Yong Loo Lin School of Medicine, National University Hospital, National University of Singapore, Singapore. Corresponding Author: Balasubramanian Srilatha, MD, PhD, Department of Obstetrics & Gynecology, Yong Loo Lin School of Medicine, National University Hospital, National University of Singapore, NUHS Tower Block Level 12, 1E Kent Ridge Rd, Singapore 119228 ([email protected]). Conflict of Interest Disclosures: None reported. 1. Thomas HN, Chang CC, Dillon S, Hess R. Sexual activity in midlife women: importance of sex matters. JAMA Intern Med. 2014;174(4):631-633. 2. Davis SR, Jane F. Sex and perimenopause. Aust Fam Physician. 2011;40(5):274278. 3. Ringa V, Diter K, Laborde C, Bajos N. Women’s sexuality: from aging to social representations. J Sex Med. 2013;10(10):2399-2408. 4. Srilatha B. Addressing sexual concerns in menopause. Fifth Scientific Meeting of the Asia Pacific Menopause Federation; October 18-20, 2013; Tokyo, Japan. 5. Rosen RC. Assessment of female sexual dysfunction: review of validated methods. Fertil Steril. 2002;77(4)(suppl 4):S89-S93.

In Reply We appreciate and read with interest the thoughtprovoking letters submitted to the editor in regard to our Research Letter.1 Maiorino et al expressed concern about excluding sexually inactive women at baseline. For this analysis, we were interested in the factors associated with continuation of sexual activity at midlife, so we necessarily only included women who were sexually active at baseline. They also noted that the 0.5 difference in Female Sexual Function Index (FSFI) scores between women who became sexually inactive and women who remained sexually active was not significant. We agree, and that is why we concluded that FSFI scores did not differ significantly between these 2 groups. The mean (SD) FSFI scores among women who became sexually inactive vs women who remained sexually active were 21.8 (3.8) and 22.3 (3.8), respectively (P = .67). In this cohort, 92.3% of the women had an FSFI score below 27, consistent with a designation of sexual dysfunction.2 Maiorino et al as well as Rosen and Simon expressed concern that we did not control for key comorbidities that may affect sexual function, including diabetes and hypertension. Re-examining the multivariable model originally reported in

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Table. Mean Scores on Each Domain of FSFI Among Sexually Active Women in STRIDE1 Domain

FSFI Score, Mean (SD) [Range]

Desire

3.7 (1.3) [1.2-6]

Arousal

4.5 (1.4) [0-6]

Lubrication

3.4 (4.0) [0.-6]

Orgasm

3.8 (0.7) [0-6]

Satisfaction

4.7 (1.3) [0.8-6]

Pain

2.0 (1.4) [0-6]

Abbreviations: FSFI, Female Sexual Function Index; STRIDE, Do Stage Transitions Result in Detectable Effects.

Table 2 of our article,1 while controlling for presence or absence of diabetes, hypertension, and heart failure, yields similar results: FSFI score is not related to continuation of sexual activity (P = .94), but importance of sex is related (P = .03). Rosen and Simon noted that scores for individual domains of the FSFI were not reported. We summarize these in the accompanying Table. Not surprisingly, scores are lowest for the pain and lubrication domains. No domain score was significantly related to maintenance of sexual activity in univariable analysis. We agree with Rosen and Simon that examining changes in sexual function scores over time is more informative than a single assessment. We are planning such a study. Srilantha et al highlight that, in their research, many sexually inactive women are not bothered by lack of sex. This dovetails with our finding that importance of sex is highly related to sexual activity; women who do not feel sex is important may not make efforts to maintain sexuality with aging. This emphasizes the need to assess both the importance of a sexual relationship to women, as well as the level of distress associated with the lack of a sexual relationship. We also agree with Srilanta et al that the study of sexuality in women of all ages benefits from a broader view of sexual function that goes beyond just the physical aspects to include psychosocial, interpersonal, and sociocultural factors. We believe that the FSFI remains an important tool for the study of female sexual function but that studies should supplement this with measures that focus on other aspects of female sexuality. Holly N. Thomas, MD Rachel Hess, MD, MS Author Affiliations: Center for Research on Healthcare, Division of General Internal Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania (Thomas, Hess); Department of Veterans Affairs Pittsburgh Healthcare System (Thomas). Corresponding Author: Holly N. Thomas, MD, University of Pittsburgh, 230 McKee Pl, Ste 600, Pittsburgh, PA 15213 ([email protected]). Conflict of Interest Disclosures: None reported. 1. Thomas HN, Chang CC, Dillon S, Hess R. Sexual activity in midlife women: importance of sex matters. JAMA Intern Med. 2014;174(4):631-633. 2. Wiegel M, Meston C, Rosen R. The Female Sexual Function Index (FSFI): cross-validation and development of clinical cutoff scores. J Sex Marital Ther. 2005;31(1):1-20.

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Sexual activity in midlife women and beyond.

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