Effects of SARS-COVID-19 lockdown on menstrual patterns: A transversal large sample survey.

OBJECTIVE: To elucidate the presence, importance, and characteristics of menstrual changes related to stressful circumstances during the COVID-19 lockdown in Spain. STUDY DESIGN: An online survey was administered in Spain to menstruating women aged 15-55 who had not contracted COVID-19. It collected information on activities during the lockdown, sexual activity, perceptions of emotional status, any changes in menstrual characteristics, and impact on quality of life. The analysis of menstrual changes was limited to responders who did not use hormonal contraception. RESULTS: A total of 6449 women answered the survey, and 4989 surveys were valid for the final analysis. 92.3% of women had at least one menstruation period during the lockdown, while 7.7% had amenorrhea. Quality of life (QoL) associated with menstruation worsened in 19% of women, did not change in 71.7%, and improved in 1.6%. For 50.1% of the women, global QoL worsened during the lockdown; 41.3% remained about the same and 8.7% reported improvement. Sexual activity during the lockdown decreased in 49.8% of the respondents, remained unchanged in 40.7%, and increased in 9.5%. As far the menstrual changes are concerned, there were no statistically significant differences in amenorrhea incidence, regularity of the menstrual cycle, or the amount or duration of menstrual bleeding in non-hormonal contraceptive users when evaluated by the length and characteristics of isolation, the perception of exposure to COVID-19 and the economic or employment situation. Conversely, we found statistically significant differences according to the intensity of changes in emotional status due to lockdown stressors and changes in regularity, duration, and heaviness of menstruation. CONCLUSION: Changes in emotional status, but not the length and intensity of the isolation or exposure to the disease, significantly influenced menstrual disturbances during the COVID-19 lockdown.

A review of the pharmacology, clinical outcomes, and real-world effectiveness, safety, and non-contraceptive effects of NOMAC/E2.

Selecting an appropriate oral contraceptive can be challenging for healthcare professionals due to the abundance of marketed contraceptive options with different clinical and real-world effectiveness and safety profiles. Nomegestrol acetate + 17ß-estradiol (NOMAC/E2) is a combined oral contraceptive (COC) that inhibits ovulation by suppressing ovarian function by a 17-hydroxy-progesterone derivative and an estrogen identical to that endogenously produced by the ovaries. This narrative review examines clinical and real-world studies of NOMAC/E2 based on a background literature search using PubMed and Google Scholar. The review outlines the pharmacology of NOMAC/E2, including its progestational activity, pharmacokinetics, and effects on carbohydrate metabolism, lipid metabolism, and coagulation parameters, and summarizes key clinical efficacy and safety data that led to the approval of NOMAC/E2 in Europe, Brazil, and Australia. To help elucidate how NOMAC/E2 clinical trial data translate into a real-world setting, this review describes the effectiveness and safety of NOMAC/E2 in prospective studies that include over 90,000 users (half of whom received NOMAC/E2), outlining its effects on risk of thrombosis, menstrual bleeding patterns, weight, mood, acne, bone health, and patient quality of life. Non-contraceptive benefits of NOMAC/E2 for women with endometriosis, dysmenorrhea, or pre-menstrual dysphoric disorder are also discussed. These data demonstrate that NOMAC/E2 has a long half-life and rapid absorption, is effective at preventing unwanted pregnancies, and exhibits a favorable safety profile in both clinical trials and real-world settings. Importantly, NOMAC/E2 is not associated with increased risk of venous thromboembolism, a major safety concern of healthcare professionals for women receiving hormonal contraceptives. This review highlights NOMAC/E2 as a differentiated option among COCs and could help inform oral contraceptive choice to ultimately improve patient management and outcomes in real-world settings.

Update on the combination of myo-inositol/d-chiro-inositol for the treatment of polycystic ovary syndrome.

In this article, we present a narrative review on the use of inositol in the treatment of polycystic ovary syndrome (PCOS). Of the different inositols that exist, only myo-inositol (MYO) and D-chiro inositol (DCI) have been studied in the treatment of PCOS. The results of the studies show that there is insufficient or controversial evidence to recommend the use of DCI alone, while MYO alone shows positive results and, above all, the MYO/DCI combination is effective when used at a ratio of at least 40:1, but there is enough rationale to further study ratios such as 66:1 to 100:1 as other possible effective combinations.

Associations between Menopausal Hormone Therapy and Colorectal, Lung, or Melanoma Cancer Recurrence and Mortality: A Narrative Review.

Objective: to develop eligibility criteria for use in non-gynecological cancer patients. Methods: We searched all the articles published in peer-reviewed journals up to March 2021. We utilized the PICOS standards and the following selection criteria: menopausal women with a history of non-gynecological and non-breast cancer who underwent hormone replacement therapy (HRT) using various preparations (oestrogens alone or in combination with a progestogen, tibolone, or tissue selective oestrogen complex) and different routes of administration (including oral, transdermal, vaginal, or intra-nasal). We focused on randomized controlled trials as well as relevant extension studies or follow-up reports, specifically examining recurrence and mortality outcomes. Results: Women colorectal cancer survivors who use MHT have a lower risk of death from any cause than those survivors who do not use MHT. Women who are skin melanoma survivors using MHT have a longer survival rate than non-MHT survivors. There is no evidence that women lung cancer survivors who use MHT have a different survival rate than those who do not use MHT. Conclusions: MHT is safe for women who have a history of colorectal, lung, or skin melanoma cancers.

The views of women and pharmacists on the desirability of a progestogen-only pill over the counter. Results of a survey in Germany, Italy and Spain.

PURPOSE: To explore the perceived need and enthusiasm for over the counter (OTC) progestogen-only pills (POP). MATERIALS AND METHODS: A web-based survey of 1000 sexually active women (16-45) and 100 pharmacists in Germany, Italy and Spain. RESULTS: Despite not wanting to conceive, 5-6% of women in each country were not using contraception and 8-20% were using methods less effective than condoms. At least 74% of respondents felt knowledgeable about the different contraceptives available but at least 1/3 had experienced difficulty accessing oral contraceptive (OCs) in the past two years. The cost of contraceptives, the need to see a doctor and long waits for appointments were cited as barriers for not using OCs. The majority agreed they would discuss with their doctor the decision to buy the POP, consult about side effects and other reproductive health issues. Over 2/3 of pharmacists in each country would be very, or fairly, likely to recommend the POP, agreeing that the benefits included improved access for women, and offered them more independence. CONCLUSIONS: Asked directly, women in Germany, Spain and Italy currently using contraception are positive about a POP OTC. Pharmacists are also positive, with the overwhelming majority in favour of providing POPs.

Eligibility criteria for Menopausal Hormone Therapy (MHT): a position statement from a consortium of scientific societies for the use of MHT in women with medical conditions. MHT Eligibility Criteria Group.

This project aims to develop eligibility criteria for menopausal hormone therapy (MHT). The tool should be similar to those already established for contraception A consortium of scientific societies coordinated by the Spanish Menopause Society met to formulate recommendations for the use of MHT by women with medical conditions based on the best available evidence. The project was developed in two phases. As a first step, we conducted 14 systematic reviews and 32 metanalyses on the safety of MHT (in nine areas: age, time of menopause onset, treatment duration, women with thrombotic risk, women with a personal history of cardiovascular disease, women with metabolic syndrome, women with gastrointestinal diseases, survivors of breast cancer or of other cancers, and women who smoke) and on the most relevant pharmacological interactions with MHT. These systematic reviews and metanalyses helped inform a structured process in which a panel of experts defined the eligibility criteria according to a specific framework, which facilitated the discussion and development process. To unify the proposal, the following eligibility criteria have been defined in accordance with the WHO international nomenclature for the different alternatives for MHT (category 1, no restriction on the use of MHT; category 2, the benefits outweigh the risks; category 3, the risks generally outweigh the benefits; category 4, MHT should not be used). Quality was classified as high, moderate, low or very low, based on several factors (including risk of bias, inaccuracy, inconsistency, lack of directionality and publication bias). When no direct evidence was identified, but plausibility, clinical experience or indirect evidence were available, "Expert opinion" was categorized. For the first time, a set of eligibility criteria, based on clinical evidence and developed according to the most rigorous methodological tools, has been defined. This will provide health professionals with a powerful decision-making tool that can be used to manage menopausal symptoms.

Impact of the Lockdown Due to COVID-19 Pandemic in the Use of Combined Hormonal Oral Contraception in Spain - Results of a National Survey: Encovid.

OBJECTIVE: To know the contraceptive behaviour of Spanish women who use combined oral contraception (COC) during the period of lockdown due to COVID-19. METHODS: Cross-sectional, descriptive study of a sample of Spanish women who use COC based on a survey conducted through social networks using the online platform Survey Monkey. The survey was conducted during the period of home confinement. RESULTS: A total of 1407 women answered the survey and 937 were valid for the analysis. A total of 675 women (71.8%) were confined all day at home. During confinement 96,6% of women continued to use the COC, 53.5% responded that their sexual activity decreased during this time and 54% that their physical activity had decreased. A significant percentage of women (10.3%) recognized a worsening of premenstrual symptoms. CONCLUSION: Despite the lockdown and the decrease in the frequency of sexual intercourse, the Spanish women who use COC did not abandon its use during the period of time analysed.

Combined hormonal contraception and COVID-19.

Aim: This article reviews the possibility of using combined hormonal contraception during the COVID-19 pandemic. Methods: narrative reviewResults: The factors that protect women from the severity of the disease are analysed, as well as the risk factors for the use of this type of contraception, especially related to the increased risk of a thrombotic event in patients affected by the disease. Finally, the information available on the guidelines for action in patients with COVID-19 using combined hormonal contraception is collected.Conclusions: We can continue to prescribe and use hormonal methods with EE.

Prevention of unintended pregnancies by using emergency contraception: the differences between levonorgestrel and ulipristal acetate. A theoretical model using data from a survey on the use of emergency contraception in Spain, 2017.

Objective: To estimate the differences in unintended pregnancies avoided using either levonorgestrel (LNG) or ulipristal acetate (UPA) emergency contraception (EC). Design: Cross-sectional study. Setting: Survey carried out in Spain. Participants: 1000 Spanish women reporting unprotected sex in 2017. Main measurements: EC use, reasons for not using EC, calculation of the number of unintended pregnancies avoided. Results: 39% of Spanish women having had unprotected sex used EC. 61% of those women did not use EC and 11% did not know the existence of this resource. In 2017 the use of EC prevented 101,271 unintended pregnancies. If instead of using LNG every woman had used UPA another 15,979 additional pregnancies could have been prevented. Conclusions: If all Spanish women having unprotected sex used EC we could expect a significant decrease in the number of unintended pregnancies and abortions. Using UPA instead of LNG would have a greater impact on that reduction with the corresponding benefit for women and society as a whole.

Cross-sectional evaluation of the impact of information on flexible extended regimens of oral contraceptives in the choices made by women seeking contraceptive counselling: the FLEXO study.

OBJECTIVE: Oral combined hormonal contraceptives (CHCs) are available that limit the number of menses when used in a flexible extended regimen. Our aim was to investigate the decision-making processes of women presented with a flexible extended CHC option. METHODS: The FLEXO study is an epidemiological, cross-sectional, multicentre study conducted under typical clinical practice conditions to determine women's acceptance of a flexible continuous CHC regimen versus a cyclical 21/7 day regimen, after receiving standardised information during contraceptive counselling. RESULTS: A total of 1350 women were invited to participate, of whom 1156 were enrolled. Of these, 47.2% chose the flexible extended CHC regimen. Their main reason for choosing this regimen was to reduce the number of menses (25.7%), followed by the desire to avoid symptoms related to menstruation (21.6%). The reasons given for rejecting this regimen were the desire to have monthly menstrual cycles (24.9%) and the fear of becoming pregnant and not being aware of it due to the absence of menstruation (18.1%). CONCLUSION: Many women chose the extended flexible regimen when they received information about this option. Women primarily chose this pattern to relieve or eliminate discomfort related to menstruation.

Effectiveness of an antioxidant preparation with N-acetyl cysteine, alpha lipoic acid and bromelain in the treatment of endometriosis-associated pelvic pain: LEAP study.

OBJECTIVE: To assess the impact of an antioxidant preparation with N-acetyl cysteine, alpha lipoic acid and bromelain on endometriosis-associated pelvic pain. STUDY DESIGN: Multicenter, open-label, non-comparative clinical trial in a representative sample of women with endometriosis-associated pelvic pain. RESULTS: In total, 398 patients with a mean age of 34.6 ±â€¯7.2 years were treated with a combination of N-acetyl cysteine, alpha lipoic acid and bromelain for 6 months. At baseline, 92.7% of the patients had pain intensity > 4 on the visual analogue scale (VAS); at 3 months of treatment, this percentage decreased to 87.2% (p = 0.074) and at 6 months the percentage was 82.7% (p < 0.05). CONCLUSIONS: Women with endometriosis who wish to become pregnant and are treated with a preparation containing N-acetyl cysteine, alpha lipoic acid and bromelain experienced a significant improvement in endometriosis-associated pelvic pain and required lower intake of rescue analgesics.

Male perception about the inconveniences associated with monthly bleeding for their partner - an international survey.

OBJECTIVE: To assess men's perceptions about monthly bleeding and associated inconveniences for their partner, as well as men's attitudes regarding the desired menstruation frequency for their partner and knowledge about hormonal contraceptives. METHODS: A 15 min quantitative online survey was conducted among 5044 men aged 18-45 years, who had been in a relationship for more than 6 months, across 13 European countries (Austria, Belgium, Czech Republic, France, Germany, Hungary, Italy, Latvia, The Netherlands, Poland, Portugal, Spain and Switzerland). Responses were compared to those obtained in a similar study among European women. RESULTS: Most men perceived that their partner considered her menstrual flow as moderate, lasting an average of 5.2 d, slightly longer than previously reported by women. Almost all men reported that their partners experience menstruation-related symptoms. However, prevalence of mood-related symptoms was perceived to be more frequent and physical symptoms less frequent, relative to women's self-reported symptoms. Given the option, 71% of men would choose longer intervals between their partner's periods. Maintaining the couple's sex life, social life and relationship quality were key factors cited in their preference. Overall, 42% of respondents stated that women taking hormonal contraceptives needed to have monthly periods. CONCLUSIONS: Men's perception regarding their partner's periods was generally consistent with that previously reported by women. Most men would prefer less frequent bleeding episodes for their partners. Although, the present data suggest that couples are discussing periods, knowledge about contraception could be improved. Health care professionals should intensify counselling to better inform both partners about their contraceptive options.

Real-world experience of women using extended-cycle vs monthly-cycle combined oral contraception in the United States: the National Health and Wellness Survey.

BACKGROUND: The real-world experience of women receiving extended-cycle combined oral contraception (COC) versus monthly-cycle COC has not been reported. METHODS: Data were from the United States 2013 National Health and Wellness Survey. Eligible women (18-50 years old, premenopausal, without hysterectomy) currently using extended-cycle COC (3 months between periods) were compared with women using monthly-cycle COC. Treatment satisfaction (1 "extremely dissatisfied" to 7 "extremely satisfied"), adherence (8-item Morisky Medication Adherence Scale©), menstrual cycle-related symptoms, health-related quality of life (HRQOL) and health state utilities (Medical Outcomes Short Form Survey-36v2®), depression (9-item Patient Health Questionnaire), sleep difficulties, Work Productivity and Activity Impairment-General Health, and healthcare resource use were assessed using one-way analyses of variance, chi-square tests, and generalized linear models (adjusted for covariates). RESULTS: Participants included 260 (6.7%) women using extended-cycle and 3616 (93.3%) using monthly-cycle COC. Women using extended-cycle COC reported significantly higher treatment satisfaction (P = 0.001) and adherence (P = 0.04) and reduced heavy menstrual bleeding (P = 0.029). A non-significant tendency toward reduced menstrual pain (39.5% versus 47.3%) and menstrual cycle-related symptoms (40.0% versus 48.7%) was found in women using extended-cycle versus monthly-cycle COC. Significantly more women using extended-cycle COC reported health-related diagnoses, indicating preferential prescription for extended-cycle COC among women reporting more health problems. Consistent with this poorer health, more women using extended-cycle COC reported fatigue, headache, and activity impairment (P values < 0.05). There were no other significant differences between groups. CONCLUSIONS: This real-world observational study supports extended-cycle COC as a valuable treatment option with high satisfaction, high adherence, and reduced heavy menstrual bleeding.

The inconvenience due to women's monthly bleeding (ISY) survey: a study of premenstrual symptoms among 5728 women in Europe.

OBJECTIVES: The aim of the ISY study was to investigate the prevalence of menstrual-related symptoms prior to and/or during menstrual or withdrawal bleeding among women from 12 European countries. METHODS: A 15-min quantitative online survey was conducted in two waves from February to September 2015 among 5728 women aged between 18 and 45 years, with an equal distribution of women using a combined hormonal contraceptive, including regular combined oral contraceptives (COCs) (CHC group, n = 2739) and women using a non-hormonal contraceptive or no contraceptive (non-HC group, n = 2989). RESULTS: The prevalence of at least one menstrual-related symptom was high in CHC users (93%) and in non-HC users (95%) (p < .0001) and the average number of symptoms reported was 5.3 vs. 5.9, respectively, (p < .0001). Pelvic pain, bloating/swelling, irritability and mood swing were reported in more than half of the women in both groups. Although generally modest, symptom severity was higher in non-HC users, except for headache. Overall, during the last four cycles, 60-75% of women did not require a treatment for most symptoms but headaches and pelvic pain. Mood swings/irritability, water retention/weight gain, lack of energy/mood swings and lack of energy/irritability were common symptoms that frequently co-occurred. No associations were reported between symptoms and age, educational qualifications or women's desire to reduce the frequency of menstruation. CONCLUSIONS: Premenstrual and menstrual symptomatology was less frequent, less numerous and less severe (except for headache) in women using CHCs; however, it remains a common concern. Reducing the frequency of menstrual periods could reduce withdrawal-related symptoms.

Women's preferences for menstrual bleeding frequency in 12 European countries: the Inconvenience Due to Women's Monthly Bleeding (ISY) survey.

OBJECTIVES: Our aim was to assess the level of inconvenience associated with menstrual bleeding and determine how many women across 12 European countries would prefer a bleeding frequency of less than once a month and what would motivate their choice. METHODS: A 15-min quantitative online survey was conducted in two waves among 5728 women aged between 18 and 45 years, with an equal distribution of women using a combined hormonal contraceptive (CHC group, n = 2739) and women using a non-hormonal contraceptive or no contraceptive (non-HC group, n = 2989). The first wave was carried out in Austria, Belgium, France, Italy, Poland and Spain, in February 2015, and the results have been published. The second wave was conducted in the Czech Republic, Germany, Hungary, Portugal, Latvia and the Netherlands, between August and September 2015. RESULTS: The menstrual period was significantly longer (5.0 versus 4.6 days) and heavier (15 versus 7%) in non-HC users than in CHC users (p < .0001). Given the choice, ∼60% of women would like less frequent menstrual bleeding. There was heterogeneity in the preference across countries. Sexuality, social life, work and sporting activities were key factors affecting women's preference. CONCLUSION: The majority of women in the 12 European countries would prefer to reduce the frequency of menstrual periods. Quality of life was the main factor affecting their preference.

Efficacy and side-effects profile of the ethinylestradiol and etonogestrel contraceptive vaginal ring: a systematic review and meta-analysis.

OBJECTIVE: To assess the efficacy and tolerability (side-effects profile), and compliance of the combined contraceptive vaginal ring (CCVR) compared with combined oral hormonal contraceptives (COC). DATA SOURCES: The PubMed, Embase, POPLINE, Cochrane Central Register of Controlled Trials (CENTRAL), LILACS, ClinicalTrials.gov, Clinical Trials Registry Platform (ICTRP) and CINAHL databases were searched. METHODS OF STUDY SELECTION: Electronic databases were searched for randomised clinical trials comparing the CCVR with COC with a duration of at least 3 months between 01 December and 15 December 2015. The primary outcome was efficacy. The secondary outcomes were compliance, absence of withdrawal bleeding, breakthrough bleeding, nausea and headache. Heterogeneity was assessed using I2 statistic and Cochran's Q statistic. Results were expressed as odds ratios (OR) with 95% confidence intervals (CIs) using random-effects models or fixed-effects models depending on the heterogeneity. RESULTS: 4368 records were identified, 2844 of which were removed after duplicates and 1524 records were screened. Of these, 1503 were excluded and 21 full text articles were assessed for eligibility. After removing another 7 articles, 14 records were finally included in the qualitative and quantitative analysis. The results show a trend to higher efficacy for the CCVR in preventing pregnancy (Peto OR: 0.52 [95% CI: 0.26-1.04]) and a significantly lower presence of nausea (Peto OR: 0.66 [95% CI: 0.46-0.93]). More cycles were compliant in the CCVR group (Peto OR: 1.22 [95% CI: 1.12-1.32]) and fewer women reported breakthrough bleeding (Peto OR: 0.68 [95% CI: 0.51-0.91]). CONCLUSIONS: Our findings demonstrate that the CCVR is as effective and tolerable as the COC but with a better bleeding profile.

Missed pills: frequency, reasons, consequences and solutions.

OBJECTIVES: Oral hormonal contraception is an effective contraceptive method as long as regular daily intake is maintained. However, a daily routine is a constraint for many women and can lead to missed pills, pill discontinuation and/or unintended pregnancy. This article describes the frequency of inconsistent use, the consequences, the risk factors and the possible solutions. METHODS: The article comprises a narrative review of the literature. RESULTS: Forgetting one to three pills per cycle is a frequent problem among 15-51% of users, generally adolescents. The reasons for this are age, inability to establish a routine, pill unavailability, side effects, loss of motivation and lack of involvement in the initial decision to use oral contraceptives. The consequences are 'escape ovulations' and, possibly, unintended pregnancy. Solutions are either to use a long-acting method or, for women who prefer to take oral contraceptives, use a continuous or long-cycle regimen to reduce the risks of follicular development and thus the likelihood of ovulation and unintended pregnancy. A progestogen with a long half-life can increase ovarian suppression. CONCLUSIONS: For women deciding to use oral contraceptives, a shortened or eliminated hormone-free interval and a progestogen with a long half-life may be an option to reduce the negative consequences of missed oral contraceptive pills.

Parasitic leiomyomas: a systematic review.

BACKGROUND: Parasitic leiomyomas were first described as early as 1909 but are a rare condition. In recent years, due to the rise of laparoscopic surgery and power morcellation, several cases of parasitic leiomyomas associated with this surgical procedure have been reported. METHODS: A literature search was performed using PubMed, Embase and Google Scholar with the following combination of keywords: leiomyoma OR uterine neoplasms OR uterine myomectomy OR laparoscopy OR hysterectomy OR peritoneal neoplasms AND parasitic. Papers describing parasitic leiomyomas were included. The results of these studies are summarized herein. RESULTS: We retrieved abstracts of 756 papers. Of these, 591 were excluded for not fulfilling the inclusion criteria and 54 were removed as duplicates; after full-text assessment, 8 were rejected for presenting cases of malignancy and finally 103 were included in our systematic review. From these, we present information about 274 patients with parasitic leiomyomas. The mean age of women was 40 years (range 18-79 years); and 154 (56%) had no history of uterine surgery, the others (120, 44%) having had a previous myomectomy or hysterectomy. Of the total, 106 (39%) women had a history of power morcellation. The most frequent clinical symptom was abdominal pain (49%) and the most frequent presentation was disseminated peritoneal leiomyomatosis. CONCLUSIONS: While parasitic leiomyoma was first described a century ago, the recent introduction of laparoscopic power morcellation has increased the number of reported cases.

Should We Perform the Intraoperative Sentinel Lymph Node Biopsy in Breast Cancer?

INTRODUCTION: The purpose of this study was to evaluate the utility of performing a selective intraoperative sentinel lymph node biopsy (SLNB) in breast cancer patients. PATIENTS AND METHODS: Patients in this prospective study were women with breast cancer seen at our hospital in 2014. These patients were divided into 2 groups on the basis of the clinical criteria age, tumor size, and molecular subtype: (1) Group A: women with clinical criteria indicative of the need to perform an intraoperative analysis of the sentinel lymph node (SLN); and (2) Group B: women in whom postoperative analysis of the SLN was performed. The final anatomopathologic findings obtained for the SLNs were analyzed and the sensitivity, specificity, positive predictive value, and negative predictive value of the clinical criteria used to decide between intraoperative or postoperative analysis of the SLN were estimated. RESULTS: A total of 170 patients were included: 106 in group A and 64 in group B. The number of positive SLNs was 29 (22 in group A and 7 in group B; P = .09). The sensitivity of our clinical criteria for establishing the indication to perform an axillary SLNB was 75.86% (95% confidence interval [CI], 56.05%-88.98%), the specificity was 40.43% (95% CI, 32.35%-49.03%), the positive predictive value was 20.75% (95% CI, 13.73%-29.95%), and the negative predictive value was 89.06% (95% CI, 78.16%-95.12%). CONCLUSIONS: The clinical findings used to decide whether or not to perform an SLNB exhibit low sensitivity and specificity and must therefore not be used to decide the need for an intraoperative SLNB.