
	A 34-year-old G3P2 is referred to your clinic for evaluation due to chronic vulvar lesions that intermittently become painful with purulent discharge despite antibiotics.

The most likely diagnosis in this patient is hidradenitis suppurativa (HS) (Hurley stage 2) and you could use all of the listed treatments to address this condition. HS is a chronic inflammatory skin condition that involves skin in areas where apocrine glands are found.

 The lesions of HS can mimic other conditions such as acne, carbuncles or Crohn’s disease but they are distinct in their pattern of distribution. 

You should suspect HS if the following three criteria are met:

Lesions are nodules, abscesses, tunnels or scars; 

Location is axillae, inframammary folds, groin, perigenital, or perineal area; and 

Lesions progress (two recurrences within 6 months or chronic or persistent lesions for ≥ 3 months).

It has been suggested that HS develops due to a defect in the folliculopilosebaceous unit.

 This results in weak-walled follicles that when occluded ultimately rupture, resulting in release of multiple inflammatory factors.

 In turn, an acute inflammatory response develops in the surrounding tissue. As the body attempts to heal, chronic inflammation occurs, creating chronic tissue damage and resultant scarring.

 HS also is thought to have a genetic component, with multiple genes likely to be involved.

 Infection appears to be a secondary reaction.

 Androgens also play a role likely secondary to an increased end-organ sensitivity of androgen receptors mediated by insulin and insulin-like growth factor.

HS is seen primarily after puberty and before menopause, with women affected more commonly than men.

 Mean time to diagnosis is 7.2 years, which is unfortunate as the disease can be progressive and debilitating.

Stage 1 is characterized by transient abscess formation without scarring and sinus tracts.

 Stage 2 is characterized by recurrent abscesses (single or multiple) with sinus tracts or scarring.

 If multiple lesions are present, they are separated by normal skin.

 Finally the most severe stage is stage 3, consisting of diffuse disease with multiple connected tracts, tunnels, and significant scarring.

The therapeutic goals of treatment are to treat active disease and prevent disease progression. Most therapies target suspected underlying mechanisms. For stage 1 disease, patients are treated with general care measures, including avoiding vulvar irritants and tight clothing.

 Behavioral and dietary changes such as weight loss, smoking cessation, and elimination of dairy products are encouraged as well.

For the initial flare, amoxicillin/clavulanic acid (875 mg po every 12 hours for 7 to 10 days) helps to treat the inflammation and secondary infection. Other antibiotics that can be considered include doxycycline (100 mg po twice daily) or clindamycin (300 mg po twice daily) for 7 to 10 days. Patients are also advised to take zinc picolinate (30 mg) with copper gluconate (2 mg).

 This is available in a single pill to be taken twice a day. Other therapies offered include topical clindamycin lotion 1% twice daily. Intralesional triamcinolone injections are used at times. Anti-androgens such as drospirenone-containing oral contraceptives, spironolactone (50-100 mg po daily), or finasteride (5 mg po daily) may be helpful to control disease.

 For stage 2 disease, other oral agents can be considered (sulfamethoxazole-trimethoprim, dapsone, or a combination of rifampin, moxifloxacin, and metronidazole), with maintenance on doxycycline or minocycline for approximately 3 months. Local surgical treatments such as unroofing tracts, wide local excision of lesions, skin tissue–sparing excision with electrosurgical peeling (STEEP) surgery and carbon dioxide laser evaporation of diseased tissue may be used forstage 2 HS.

For stage 3 or severe HS, radical wide excision with skin grafting is recommended for definitive treatment (Figure 3). This is an extensive process requiring resection of HS and wound vac placement, wound vac changes, and skin grafting 1 week later, if the tissue is granulating well. A wound vac is applied over the skin graft for 5 days. 

For stage 3 HS, you can also consider medical therapy with clindamycin 300 mg BID with rifampin 300 mg BID and a TNF Î± inhibitor such as adalimumab or infliximab

. This is typically done in consultation with a dermatologist. Unfortunately, medical management is generally not a cure for patients with stage 3 HS. Surgical management of stage 3 HS has been found to have good results.

 Finally, psychosocial support is critical for patients with HS as the condition can be isolating due to its nature.


	Acne vulgaris is a chronic inflammatory skin disease that affects the pilosebaceous unit and is typically seen in adolescents and young adults.

 The skin changes can be described as open or closed comedones or as inflammatory nodules, pustules or papules.

 Inflammatory lesions look most similar to HS lesions but the topographical distribution differs. In general, acne tends to be found on the face, neck, and back.

 The two disorders also share some similarities with regards to treatment goals and minimizing comorbid conditions such as depression. 

As with HS, treatment for acne vulgaris is designed based on disease severity. First-line treatment for mild disease is primarily treated with topical medications (e.g. benzoyl peroxide, retinoids or combinations of these with or without antibiotics).

 Moderate disease is treated with topical combination therapy or topical therapy with oral antibiotics.

 Severe disease is treated with an oral antibiotic along with a topical combination regimen or with oral isotretinoin.


	Folliculitis is a bacterial infection of the hair follicles.

 It can occur in any hair-bearing area and is a common skin condition.

 Tissue trauma (e.g. shaving), excess heat (tight clothing) and immunosuppression (chronic steroid use) can predispose to development of these lesions.

 On vulvar examination, one would see papules and pustules. Diagnosis of folliculitis can be confirmed with a culture, in contrast to HS.

 Therapy usually is short-term and can include topical cleansers or medications such as chlorhexidine, benzoyl peroxide, clindamycin, fusidic acid or mupirocin.

 Oral antibiotics such as dicloxacillin, clindamycin or a macrolide can be used for cases that do not respond to topical therapy.

 Good vulvar care hygiene is key to avoid recurrence.

The authors report no potential conflicts of interest with regard to this article.

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Rhode JM, Burke WM, Cederna PS, Haefner HK.  Outcomes of surgical management of stage III vulvar hidradenitis suppurativa. J Reprod Med. 2008;53:420-428..Fox L, Csongradi C, Aucamp M, Plessis J, Gerber M. Treatment modalities for acne. Molecules. 2016;21:1-20.

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Sand FL, Thomsen SF. Skin diseases of the vulvaâ¯: Infectious diseases. J Obstet Gynaecol (Lahore). 2017;37(7):840-848. doi:10.1080/01443615.2017.1306696

Articles

What’s your diagnosis in a patient with lesions that are sometimes painful and do not respond to antibiotics?

Chronic vulvar lesions  in a woman in her 30s

Endometrial polyps are common structural and epithelial abnormalities of the endometrium that are often encountered by gynecologists in office-based practice. These endometrial growths may be found incidentally in as many as 10% to 15% of asymptomatic women, and between 20% to 30% of women with abnormal uterine bleeding (AUB).

 Given their prevalence in patients presenting with AUB, polyps are considered as part of the FIGO classification for causes of abnormal uterine bleeding - PALM-COEIN.

 They may cause a variety of abnormal bleeding patterns, likely due to small muscular arteries found within the growths,

 but they can also be completely asymptomatic. Structural uterine pathologies often cause menstruation that is heavy or prolonged, albeit monthly,

 but polyps can also cause intermenstrual or postmenopausal bleeding.

 Endometrial polyps are usually benign but in 0.5% to 3% of cases, they are malignant.

Endometrial polyps are thought to impact fertility, and removal is recommended prior to initiating treatment, especially before proceeding with in vitro fertilization (IVF). Some proposed mechanisms by which polyps are thought to impact fertility include inhibition of implantation, endometrial inflammation, mechanical blockage of sperm from fertilization, or changes in endometrial receptivity.

 In the infertile population, prevalence of polyps is thought to be between 11% and 45%, which is higher than in the general population.

 Hysteroscopic removal of endometrial polyps found incidentally during fertility evaluation is recommended, with one study showing post-polypectomy implantation rates during IVF to be similar to those in women who do not have endometrial polyps.

True to their name, polyps may grow on a thin stalk from anywhere within the uterine cavity, or they may appear sessile: smooth and flat with a broad base. They typically measure up to about 3 cm.

 Histopathologically, polyps appear as cystic dilation of glands with mononuclear cells, often filled with mucous.

 They may contain vascular pedicles, connective tissue, and even glandular tissue.

 Their prevalence makes them an important pathology to study, so that proper diagnosis and treatment can be undertaken, with the gold standard being hysteroscopy.

Because AUB triggers further evaluation of potential etiologies, endometrial polyps are often diagnosed on ultrasound,

 as seen in Figure 1. The sonographic finding suggestive of an endometrial polyp is a bright, hyperechoic area visualized within the endometrium (Table 1).

 Using power doppler sonography may reveal a single-vessel pattern of blood flow to the polyp (sensitivity 81.2%, positive predictive value [PPV] 92.9%) compared to fibroids, which more often show an enhancing rim of vessels.

In case you missed it - Patient handout: Endometrial polyps

If further characterization is needed, office hysteroscopy is considered the gold standard for further evaluation,

 however, saline infusion sonography (SIS) is another excellent diagnostic study

 with a sensitivity of 93% and specificity of 81% in diagnosing endometrial polyps.

 Hysteroscopy and SIS are best performed during the proliferative phase of the menstrual cycle shortly after cessation of menses. Hysteroscopy allows for direct visualization of the polyps while SIS with a skillful operator can also provide specific details, such as where the polyp is attached and its size.

 If there is uncertainty about presence of a polyp on transvaginal ultrasound, SIS can be used as the next step for better visualization, with a PPV of 88.5%, compared to only 65.2% with ultrasound alone.

Because endometrial polyps are often the culprit in AUB, treatment is warranted to decrease a patient’s symptoms and confirm the diagnosis, especially because benign and malignant polyps cannot be reliably distinguished with imaging alone.

 Hysteroscopy with polypectomy is the treatment of choice, serving both as a diagnostic and therapeutic procedure.

 With office hysteroscopy now widely available, it is much easier to address polyps than in the past.

Narrow-caliber hysteroscopes with diameters ranging from 2 to 3 mm and flexible hysteroscopes allow for these office procedures to be performed with minimal pain for patients.

 Office hysteroscopy can be used for both diagnosis and treatment and it has the ability to immediately confirm successful polyp removal; therefore, it serves as the gold standard for management of endometrial polyps (Figures 2a and 2b).

 When a polyp is visualized during office hysteroscopy, directed removal or biopsy should be performed, even if it is suspected to be benign.

Office hysteroscopy as opposed to hysteroscopy performed in the operating room is the preferred method for management of endometrial polyps for a variety of reasons.

 Benefits for patients include reduced cost of medical services and time off from work, greater convenience, and more flexibility in scheduling the surgery.

A recent study evaluating the effectiveness of office hysteroscopic removal of endometrial polyps showed that office hysteroscopy was successful in removing endometrial polyps 95.7% of the time, and while hysteroscopy in the operating room resulted in fewer residual polyps (98.1% successful), office hysteroscopy is still preferred due to the aforementioned benefits.

 Because of the convenience and cost savings associated with office hysteroscopy, many women are amenable to it, but special consideration has to be paid to patients’ pain and comfort during the procedure. Patients’ reported pain has been shown to be reasonable and tolerable, with an average reported pain score of 5 on the visual analogue scale, the classic pain scale ranging from 0 to 10.

 When selecting candidates for office hysteroscopy, individual patient self-assessment of pain tolerance and anxiety can help determine who would benefit most from an office-based procedure as opposed to an operating room procedure (Table 2).

 Determinants of successful office-based hysteroscopy for polyp removal are polyp number, size, and location; patient characteristics such as body mass index (BMI) and other comorbidities; availability of an appropriate hysteroscopic system; and physician experience and comfort level with the procedure. 

Traditional mechanical instruments such as polyp scissors or grasping forceps introduced down the operative channel of a hysteroscopy as well as more modern tissue-extracting devices are both excellent ways of resecting polyps under direct visualization.

 The appeal of modern tissue removal systems such as TRUCLEAR, MyoSure, and the Integrated Bigatti Shaver is that they allow for mechanical cutting of tissue and suction extraction, ensuring full removal of the polyp and easy collection of tissue for further histopathologic evaluation and diagnosis.

 Blind, sharp dilation and curettage previously may have been performed for polypectomy, but it is no longer recommended because of its lack of targeted effect.

Treatment of all visible endometrial polyps is recommended, but some patients decline removal, perhaps because they are asymptomatic. In those cases, data on the natural history of polyps may help guide clinical management. One retrospective study estimated that 6.3% of polyps may spontaneously resolve after 6 months in premenopausal women, however, 15% of these patients may develop AUB in that same time period.

 Hysteroscopic polypectomy should be recommended and advocated, especially in patients with higher risk factors for malignant transformation. 

Although in polyps, risk of underlying malignancy is not very high, careful clinical evaluation to rule it out is critical.

 In postmenopausal women who have AUB, risk of finding precancerous pathology in polyps may be as high as 6%.

 Risk factors that increase concerns about cancer include: postmenopausal status (OR 8.274)

, obesity, AUB, polyp size, and even diabetes and hypertension.

One study suggests that BMI > 32 or endometrial thickness > 10 mm increases risk of hyperplasia or malignancy.

 Use of tamoxifen, a common maintenance medication taken by women with a history of estrogen receptor-positive breast cancer or who are at risk of breast cancer, has been shown to increase risk not only of endometrial polyps, but of endometrial hyperplasia and cancer. It is thought that while tamoxifen has an anti-estrogenic effect on breast tissue, it may selectively promote proliferation in the endometrium (Table 3).

Endometrial polyps, whether found on ultrasound during a workup for AUB or suspected to be the etiology of a patient’s infertility, are commonly encountered and easily managed with office-based hysteroscopic procedures. Given the underlying risk of malignancy in endometrial polyps, which may be as low as 0.5% to 3% in all women diagnosed with polyps

 or up to 6% in postmenopausal women presenting with bleeding,

 removal is strongly recommended with hysteroscopic polypectomy for eventual histopathologic diagnosis.

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Yang JH, Yang PK, Chen, MJ, et al. Management of endometrial polyps incidentally diagnosed during IVF: a case-control study. Reprod Biomed Online. 2017 Mar;34(3):285-290.

Luerti M, VitaglianoA, Di Spiezio Sardo A, et al. Effectiveness of hysteroscopic techniques for endometrial polyp removal: the Italian Multicenter Trial. J Minim Invasive Gynecol. 2018 Dec 7. pii: S1553-4650(18)31402-X. [Epub ahead of print]

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Bittencourt CA, Dos Santos SimÃµes R, Bernardo WM, et al. Accuracy of saline contrast sonohysterography in detection of endometrial polyps and submucosal leiomyomas in women of reproductive age with abnormal uterine bleeding: systematic review and meta-analysis. Ultrasound Obstet Gynecol. 2017 Jul;50(1):32-39.

Ghoubara A, Sundar S, Ewies AAA. Predictors of malignancy in endometrial polyps: study of 421 women with postmenopausal bleeding. Climacteric. 2018 Feb;21(1):82-87.

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New EP, Sarkar P, Sappenfield E, et al. Comparison of patients reported pain following office hysteroscopy with and without endometrial biopsy: a prospective study. Minerva Ginecol. 2018 Dec;70(6):710-715.

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Practical tips on how to spot these common growths on ultrasound and how to remove them.

Endometrial polyps: In-office management

Management of an adnexal mass is a common clinical scenario for obstetricians, gynecologists, and other providers in women’s health. Masses may be identified upon routine annual examinations, incidentally during imaging for other conditions, or when women present with pelvic and/or abdominal symptomatology. Many masses are ultimately found to be benign at time of surgery. Others, however, are malignant, and appropriate preoperative referral to a gynecologic oncologist for surgical management, staging, and determination of potential adjuvant therapy is critical to the outcome in these patients. 

Epithelial ovarian cancer remains an aggressive disease. The American Cancer Society estimates that in 2019, 22,530 women will be diagnosed with ovarian cancer and 13,980 of them will die, ranking this malignancy the fifth most lethal behind lung, breast, colon and pancreas.

 Unfortunately, fewer than half of all women with ovarian cancer are cared for by a gynecologic oncologist, despite data supporting improved outcomes when a specialist is managing their care.

 These findings underscore the importance of appropriate and early referral.

Determining which women with adnexal masses will ultimately have cancer at time of surgery remains a clinical challenge. To assist in this risk stratification, initial evaluation of women with a pelvic mass has typically included ultrasound imaging and serum biomarker testing. To best care for patients most at risk, the American College of Obstetricians and Gynecologists (ACOG) recommends referral to a gynecologic oncologist for women who have a pelvic mass combined with elevated serum CA125, ascites, and/or evidence of metastatic disease.

 For women who have a mass but no ascites or imaging suggestive of metastatic disease, the accuracy of biomarkers for identification of those at highest risk of cancer is crucial to determine whether they would benefit from specialty referral. This review updates our current knowledge of preoperative biomarker utilization to optimize outcomes for women with a pelvic mass.


	The serum biomarker CA125 has long been considered one of the primary evaluation tools in preoperative assessment of women with pelvic or adnexal masses. CA125 is a protein expressed in epithelial tissues, including the mesothelial lining of the pleura and peritoneum, and the MÃ¼llerian cells of the fallopian tube, endometrium, and endocervix.

Surprisingly, CA125 is not typically expressed by the surface epithelium of benign ovaries. However, 90% of women with metastatic epithelial ovarian cancer have elevated serum levels, which has led to widespread adoption of this test in evaluation of potential malignancy. Unfortunately, the sensitivity and specificity of CA125 in predicting ovarian cancer remains low. Fifty percent of women with stage I ovarian cancers, where disease is confined to the ovaries, will have a normal preoperative CA125 level. In addition, several conditions will lead to serum elevations in CA125. These include both benign gynecologic processes, such as uterine fibroids, ovulation, menstruation, and endometriosis, and malignancies of other abdominal organs, such as gastric, colon, and pancreatic cancers.

 For these reasons, the US Food and Drug Administration (FDA) has not approved CA125 for preoperative use, but only for cancer surveillance after a diagnosis of ovarian cancer. 


	Over recent decades, limitations in the ability of CA125 to detect ovarian cancer have led investigators to evaluate additional serum proteins as potential candidates for biomarker utility, given the relative ease and reliable reproducibility of serum testing. Several initial studies in the early 2000s suggested combinations of serum markers, in contrast to CA125 alone, as a diagnostic tool in women with adnexal masses. These include the OvaSure serum test, which incorporated serum levels of leptin, prolactin, osteopontin, insulin-like growth factor II, macrophage inhibitory factor, and CA125 into a diagnostic algorithm. The OvaCheck test similarly expanded this scale into proteomic profile analyses of thousands of serum proteins.

 Unfortunately, the lack of validation studies undermined the effectiveness of these modalities in clinical care. 


	New data identified additional markers, which have led to development and validation of diagnostic tests in clinical care of women with a pelvic mass. Human epididymis protein 4, or HE4, is a protease inhibitor expressed by malignant epithelial ovarian cells that can be identified in the sera of women with ovarian cancer.

 In 2008, data on HE4 led to FDA approval of it as a monitoring tool for women who have a history of ovarian cancer. 

Subsequent research examining HE4 in combination with CA125, in the context of menopausal status, led to development of a logistic regression model as a diagnostic tool in women with a pelvic mass. This Risk of Malignancy Algorithm (ROMA) classifies patients into high risk or low risk for ovarian cancer based upon a score, which is a predictive index calculated with equations that differ based on the patient’s menopausal status (Table 1). 

 are available online that can generate the risk assessment based upon CA125 and HE4 assay results, along with menopausal status. 

Validation studies that led to FDA approval of ROMA were detailed in a prior review in this journal.

 In brief, the initial prospective study in a high-risk population (women recruited after seeing a gynecologic oncologist) identified sensitivities of 92% and 76% (for postmenopausal and premenopausal women, respectively), with a specificity of 75%.

 A subsequent study in a low-risk population (women with an adnexal mass recruited into the study after seeing a gynecologist, family practitioner, internist, or general surgeon) reported sensitivities of 100% and 92% and specificities of 76% and 74% (in postmenopausal and premenopausal women, respectively).

 These data led to the 2011 FDA approval of ROMA to determine risk of ovarian cancer in women with a pelvic mass.


	In parallel studies, other investigators examined additional biomarkers in a multivariate index assay as a diagnostic tool in women with suspected ovarian malignancies. This assay, now known as OVA1, incorporates serum levels of five serum proteins (transthyretin, apolipoprotein A-1, b2-microglobulin, transferrin, and CA125) in a proprietary software calculation to generate a high or low probability for malignancy score (Table 2). As with ROMA, menopausal status affects interpretation of the score; 5.0 or higher is considered high probability of ovarian cancer in premenopausal women, whereas a score of 4.4 or higher is high probability in postmenopausal women.

Validation studies that led to FDA approval of OVA1 were detailed in a prior review in this journal.

 In brief, the sensitivity of OVA1 was found to be 100% for stages II, III, and IV ovarian cancer, and 90% for stage I ovarian cancer. The specificity in this cohort, however, was 43% for OVA1 alone, and 35% for OVA1 combined with physician assessment.

 The investigators of this study further evaluated their cohort in the context of the ACOG referral guidelines; when substituting OVA1 for CA125, they found improved sensitivity (94% with OVA1 versus 77% with CA125) but decreased specificity (35% versus 68%).

 These studies led to FDA approval of this assay in 2009 as a tool for use by a patient’s primary physician to decide whether a patient with an ovarian mass should be referred to a gynecologist or a gynecologic oncologist. It is not approved for use to screen or to determine whether a patient should proceed to surgery.


	The relatively low specificity of OVA1 led to valid concerns by many obstetricians and gynecologists about a larger proportion of patients with benign disease being referred to specialists outside their practices. As such, additional biomarker breakthroughs have led to a second-generation OVA1 test. Initially known as OVA2, this novel assay is now trademarked as Overa. Overa replaces transthyretin and beta-2-microglobulin from OVA1 with HE4 and follicle-stimulating hormone (FSH) (Table 2). The goals of this new assay are to improve the specificity and positive predictive value (PPV) of OVA1 while maintaining high sensitivity and negative predictive value; in addition, inclusion of FSH abrogated the need for clinicians to determine menopausal status when interpreting the results. Overa stratifies patients with an adnexal mass into high- or low-risk categories based upon a scale of 0 to 10, and uses a single cutoff of 5. Clinical validity was determined using banked serum samples from a prospective cohort of 493 women undergoing surgery for an adnexal mass, with an observed cancer prevalence of 18.7%. The sensitivity of Overa remained high at 91%; combining Overa score with physician assessment demonstrated a sensitivity of 94%.

 Specificity of Overa was significantly higher at 69%, compared to 54% seen in the same cohort with OVA1. The PPV of Overa was also superior (40% versus 31%). Inclusion of Overa with physician assessment identified 75% of the malignancies missed by physician assessment alone. These data led to FDA approval in 2016 to market this second-generation assay in conjunction with independent clinical and imaging assessment prior to planned surgery for women with a pelvic mass.

Overa has been further examined in an independent cohort to assess the combination of a symptom index with this assay to predict risk of malignancy in a prospective cohort of 216 women with a documented adnexal mass planned for surgery. In this cohort where 64 patients (21%) were found to have epithelial ovarian or fallopian tube cancers, self-reported symptoms (pelvic and/or abdominal pain, increased abdominal size and/or bloating, and difficulty eating and/or feeling full) and Overa independently demonstrated high sensitivities (87% and 92%, respectively). However, the combination of both a positive symptom index and a positive Overa test led to a significant improvement in sensitivity (96%).

 Taken together, these data suggest that physician assessment, including evaluation of patient self-reported symptoms, combined with Overa are powerful and accurate tools to determine which patients are at highest risk of malignancy. 


	Advances in biomarker discovery have led to several FDA-approved tests superior to CA125 in preoperative evaluation of women with a pelvic mass. While OVA1 has higher sensitivity for determining malignancy than CA125, its decreased specificity may generate referrals of benign disease to gynecologic oncologists. Both Overa and ROMA have comparable higher sensitivities, and their improved specificities can more accurately determine which subgroups of patients would most benefit from consultation with a gynecologic oncologist. While none of these three tests can be or should be used for screening asymptomatic women with unremarkable imaging, Overa and ROMA represent the culmination of significant efforts that can improve risk stratification in women with a pelvic mass to triage their care to the appropriate provider. 

The author reports no potential conflicts of interest with regard to this article.

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Coleman RL, Herzog TJ, Chan DW, et al. Validation of a second-generation multivariate index assay for malignancy risk of adnexal masses. Am J Obstet Gynecol. 2016;82:e1-e11.

Urban RR, Pappas TC, Bullock RG, et al. Combined symptom index and second-generation multivariate biomarker test for prediction of ovarian cancer in patients with an adnexal mass. Gynecol Oncol. 2018;150:318-323.

Three tests are now FDA-approved for triaging pelvic masses in asymptomatic women. 

What’s new in biomarker testing for ovarian cancer

 shows that patients fail to disclose pertinent information to their physicians, which can undermine patient care or even cause unexpected harm.

Scientists at University of Utah Health and Middlesex Community College led the study in collaboration with colleagues at University of Michigan and University of Iowa. The research was conducted to determine if a conventional belief that patients lie to physicians has merit. Previous studies that attempted to examine this hypothesis were limited in scope, usually examining a single issue. This study attempted to focus on the types of behavior deemed basic and essential to health care and the characteristics of the nondisclosure.

“If patients are withholding information about what they’re eating, or whether they are taking their medication, it can have significant implications for their health. Especially if they have a chronic illness,” said the study’s first author, Andrea Gurmankin Levy, PhD, MBe, an associate professor in social sciences at Middlesex Community College in Middletown, Connecticut.

The study used two separate surveys. The first sample was recruited from users from Amazon’s Mechanical Turk (MTurk) marketplace, a population of internet users who participate in surveys and other tasks in exchange for financial compensation. These participants were age 18 and older. The second sample group, aged 50 and older, was obtained from Survey Sampling International (SSI) and received reward points for their participation. Both online surveys were self-administered.

Of 4510 total respondents, 2011 (mean age of 36 years, range 18-79) completed a MTurk survey, and 2685 participants (mean age 61 years, range 50-91), completed an SSI survey. In both groups, approximately 80% of participants were white. Of the MTurk and SSI participants, 60.7% and 51.5%, respectively, were female. Nearly 80% of the respondents reported their health as good, very good, or excellent. Chronic illness was reported by 22.5% of those in the MTurk group and 39.2% in the SSI group.

Medically relevant information was divided into types with reasons for avoiding the truth regarding that information. The information included disagreeing with the clinician’s recommendation, not understanding instructions, an unhealthy diet, not taking prescription medication as instructed, not exercising, taking a certain medication/not mentioning taking the medication, and taking someone else’s medication. 

Of the MTurk participants, 81.1% reported being untruthful with their physicians about any of seven types of relevant information. The same was true of 61.4% of those in the SSI group. 

The most common reasons for avoiding the truth included not wanting to be judged or lectured on behaviors, not wanting to hear something is bad, being embarrassed, not wanting to be seen as difficult or stupid, not wanting to take up the provider’s time, and not wanting information recorded in the medical record.

“I’m surprised that such a substantial number of people chose to withhold relatively benign information, and that they would admit to it,” said Levy. “We also have to consider the interesting limitation that survey participants might have withheld information about what they withheld, which would mean that our study has underestimated how prevalent this phenomenon is.” 

Dishonesty from patients can not only undermine care, it can cause unexpected harm.

Patients not always truthful when dealing with clinicians

Maternal sepsis is a significant cause of maternal morbidity and mortality. Recent US data report that maternal sepsis complicates 4 to 10 per 10,000 live births. Incidence of maternal sepsis appears to be increasing; in the United States between 1998 and 2008, rates of severe maternal sepsis and sepsis-related deaths increased 10% per year. Nulliparity, black race, and public or no insurance have been identified as risk factors for pregnancy-associated sepsis. Obstetric risk factors include cesarean delivery, use of assisted reproductive technologies, and multiple gestation. More than 50% of the women who die from sepsis have one or more chronic comorbid conditions, including chronic renal disease, chronic liver disease, and congestive heart failure. 

How is sepsis defined and what are the clinical features? 

In 2016, The Third Internal Consensus Definitions for Sepsis and Septic Shock task force defined sepsis as “life-threatening organ dysfunction caused by a dysregulated host response to infection.” Organ dysfunction may be objectively defined as an acute increase of two or more points in the Sequential Organ Failure Assessment (SOFA) score. Septic shock can be identified within a clinical construct of sepsis with persistent hypotension requiring vasopressors to maintain mean arterial pressure (MAP) ≥ 65 mm Hg and a serum lactate level > 2 mmol/L despite adequate volume resuscitation.

A brief bedside assessment tool known as the quick SOFA score (qSOFA) can be used to assist in evaluation of suspected sepsis. The qSOFA score evaluates presence of three clinical criteria: systolic blood pressure ≤ 100 mm Hg, respiratory rate ≥ 22/min, and altered mental status. If two or more of these criteria are present, the patient is at increased risk for poor-sepsis related outcomes. These signs should prompt the physician to look carefully for organ dysfunction, start or escalate therapy, increase the acuity of monitoring, and consider transfer to an intensive care unit. Importantly, fever is neither necessary nor sufficient to determine whether sepsis is present. 

Sepsis results from a dysregulated host response to infection resulting in organ damage, and virtually any organ system can be affected. The excessive inflammatory response that occurs with sepsis includes extravasation of albumin and fluid, with resultant intravascular hypovolemia. Cytokine release leads to decreased systemic vascular resistance and increased cardiac output, although up to 60% of patients with sepsis have an ejection fraction below 45% (systolic dysfunction). Septic cardiomyopathy may also manifest with diastolic dysfunction due to cardiac edema and diminished compliance. The noncompliant left ventricle will result in decreased diastolic filling and less stroke volume, increasing risk of pulmonary edema with excessive fluid resuscitation. Tissue ischemia (and dysfunction) results not only from hypotension but also secondary to microvasculature occlusion from microthrombi due to disseminated intravascular coagulation. 

How do clinical features of sepsis differ in pregnancy?  

Normal human pregnancy is a state of expanded plasma volume, increased cardiac output, and peripheral vasodilation. None of the existing definitions of sepsis account for physiologic alterations of normal pregnancy. When nonpregnant norms are used, either overdiagnosis or underdiagnosis of sepsis may occur. Of the SOFA criteria, those most affected by pregnancy are creatinine and MAP. An obstetric-modified qSOFA has been proposed by the Society of Obstetric Medicine Australia and New Zealand (SOMANZ) and includes systolic blood pressure ≤ 90 mm Hg, respiratory rate > 25/min, and altered mental status. The SOMANZ guidelines also include modifications to laboratory components when applying the SOFA score to pregnancy, including a point value above zero for a creatinine > 90 µmol/L (1.02 mg/dL).

Most important in optimizing outcomes is early recognition of organ dysfunction in the septic patient. In addition to the SOMANZ guidelines described above, there have been other attempts to devise a pregnancy-specific scoring system for sepsis. Evaluation of the “Sepsis in Obstetrics Score,” a combination of maternal temperature, blood pressure, heart rate, respiratory rate, peripheral oxygen saturation, white blood cell count, and lactic acid level as predictors of intensive care unit (ICU) admission for sepsis and modified to account for normal physiologic changes of pregnancy reported a positive predictive value (PPV) of only 16.7% for ICU admission. A prospective validation study of the Sepsis in Obstetrics Score found that a score of 6 or greater had a sensitivity of 64%, specificity of 88%, PPV of 15%, and negative predictive value of 98.6%.

What are the most common infectious etiologies of sepsis?

The source of infection in puerperal sepsis can be either pelvic or nonpelvic. Antepartum cases of sepsis are most commonly nonpelvic in origin, while intrapartum and postpartum cases are more likely to have a pelvic source. In 30% of cases, no source is identified. In the UK Obstetric Surveillance System, clinical laboratory testing was only able to identify the causative microorganism in 64% of maternal sepsis cases, and the clinician could identify the source in only 74%. In 16%, neither the inciting organism nor the source of sepsis was identified. 

The most frequently isolated organisms in maternal sepsis are Escherichia coli and group A and group B 

, although staphylococci, gram-negative and anaerobic bacteria, and many other organisms have been reported. Mixed infections are also possible; in 15% of maternal sepsis deaths in which organisms could be identified, the infection was polymicrobial. Empiric antibiotic choices will be driven by the presumed source, likely microorganisms, and local patterns of antibiotic resistance and should include coverage of anaerobic and aerobic gram-positive and gram-negative bacteria. Hospitals may have specific recommendations in place or guidance may be sought from a consultant in infectious disease or from specialty society guidelines. Antibiotic coverage should be narrowed and focused once culture results are available.

Molecular techniques, such as polymerase chain reaction (PCR)-based systems, can identify inciting organisms not detected by culture-based methods and can provide pathogen identification from blood samples before cultures become positive. PCR testing results are positive in approximately 11% of patients with a clinical suspicion of bacteremia but negative blood cultures. 

Incidence of maternal sepsis appears to be increasing. Here's what ob/gyns need to know about identification and treatment.

Vol. 64 No 04

Chronic vulvar lesions in a woman in her 30s

Endometrial polyps: In-office management

What’s new in biomarker testing for ovarian cancer

Patients not always truthful when dealing with clinicians

Sepsis during pregnancy and the puerperium

Mistakes

When a routine prenatal visit is not-so-‘routine’

Contemporary OB/GYN contributors at ACOG

What is pediatric and adolescent gynecology?

Help HIV-positive women reach reproductive goals