Kristen A. Matteson

Objective: To develop a core outcome set for heavy menstrual bleeding (HMB).Design: Core outcome set (COS) development methodology described by the COMET initiative.Setting: University hospital gynaecology department, online international survey and web‐based international consensus meetings.Population or sample: An international collaboration of stakeholders (clinicians, patients, academics, guideline developers) from 20 countries and 6 continents.Methods: Phase 1: Systematic review of previously reported outcomes to identify potential core outcomes. Phase 2: Qualitative studies with patients to identify outcomes most important to them. Phase 3: Online two‐round Delphi survey to achieve consensus about which outcomes are most important. Phase 4: A consensus meeting to finalise the COS.Main outcome measures: Outcome importance was assessed in the Delphi survey on a 9‐point scale.Results: From the ‘long list’ of 114, 10 outcomes were included in the final COS: subjective blood loss; flooding; menstrual cycle metrics; severity of dysmenorrhoea; number of days with dysmenorrhoea; quality of life; adverse events; patient satisfaction; number of patients going on to have further treatment for HMB and haemoglobin level.Conclusions: The final COS includes variables that are feasible for use in clinical trials in all resource settings and apply to all known underlying causes of the symptom of HMB. These outcomes should be reported in all future trials of interventions, their systematic reviews, and clinical guidelines to underpin policy.

OBJECTIVE: To assess the amount of opioid medication used by patients and the prevalence of persistent opioid use after discharge for gynecologic surgery for benign indications. DATA SOURCES: We systematically searched MEDLINE, EMBASE, and ClinicalTrials.gov from inception to October 2020. METHODS OF STUDY SELECTION: Studies with data on gynecologic surgical procedures for benign indications and the amount of outpatient opioids consumed, or the incidence of either persistent opioid use or opioid-use disorder postsurgery were included. Two reviewers independently screened citations and extracted data from eligible studies. TABULATION, INTEGRATION, AND RESULTS: Thirty-six studies (37 articles) met inclusion criteria. Data were extracted from 35 studies; 23 studies included data on opioids consumed after hospital discharge, and 12 studies included data on persistent opioid use after gynecologic surgery. Average morphine milligram equivalents (MME) used in the 14 days after discharge were 54.0 (95% CI 39.9–68.0, seven tablets of 5-mg oxycodone) across all gynecologic surgery types, 35.0 (95% CI 0–75.12, 4.5 tablets of 5-mg oxycodone) after a vaginal hysterectomy, 59.5 (95% CI 44.4–74.6, eight tablets of 5-mg oxycodone) after laparoscopic hysterectomy, and 108.1 (95% CI 80.5–135.8, 14.5 tablets of 5-mg oxycodone) after abdominal hysterectomy. Patients used 22.4 MME (95% CI 12.4–32.3, three tablets of 5-mg oxycodone) within 24 hours of discharge after laparoscopic procedures without hysterectomy and 79.8 MME (95% CI 37.1–122.6, 10.5 tablets of 5-mg oxycodone) from discharge to 7 or 14 days postdischarge after surgery for prolapse. Persistent opioid use occurred in about 4.4% of patients after gynecologic surgery, but this outcome had high heterogeneity due to variation in populations and definitions of the outcome. CONCLUSION: On average, patients use the equivalent of 15 or fewer 5-mg oxycodone tablets (or equivalent) in the 2 weeks after discharge after major gynecologic surgery for benign indications. Persistent opioid use occurred in 4.4% of patients who underwent gynecologic surgery for benign indications. Our findings could help surgeons minimize overprescribing and reduce medication diversion or misuse. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42020146120.

Objective Waterpipe tobacco (WPT; hookah) use is common in pregnant and reproductive-age women. Sweet flavours contribute to the appeal of WPT and are a potential regulatory target. This study investigated use, preferences and perceptions of WPT flavours in pregnant WPT users, and the impact of flavour preferences on preconception/prenatal WPT use and exposure biomarkers. Methods 58 pregnant WPT users (mean age=27 years) completed a detailed interview regarding their WPT flavours use, preferences and perceptions. Biomarkers of nicotine and carcinogen exposure (eg, cotinine, benzene, butadiene) were also collected. Results 55% of participants were dual/poly WPT users (ie, reported use of one or more other tobacco products in addition to WPT). Pregnant WPT users reported nearly exclusive use of flavoured WPT, with greater use of menthol/mint (68%) followed by fruit flavours (48%) (pConclusions This is the first study of WPT flavour use, preferences and perceptions in pregnant women. Use of and preference for menthol/mint and fruit WPT flavours in this vulnerable population could be considered in regulating WPT flavours to protect the health of women and children.

(ed from Obstet Gynecol 2017;129:877–886) Barriers to performing a vaginal hysterectomy (VH) include potential complications, technical difficulties, lack of experience, and low-volume caseload. Increased knowledge is needed about factors associated with success and failure of a vaginal approach.

Surgical sterilization is a common method of contraception. There have been few studies evaluating the effect of obesity on procedural complications with either laparoscopic or hysteroscopic methods of sterilization. The purpose of this study was to compare the incidence of intraoperative complications of hysteroscopic tubal occlusion with laparoscopic tubal ligation among obese and nonobese women. This retrospective cohort study compared women undergoing interval laparoscopic or hysteroscopic sterilization in the operating room between September 2009 and December 2011 at a single hospital. Serious complications included: unintended surgery, uterine perforation, anaphylaxis, blood transfusion, infection requiring antibiotics, hospital admission, fluid overload, myocardial infarction, and venous thromboembolism. Post-operative events included: nausea/vomiting, doctor evaluation or additional pain medication required in the recovery room, and emergency department visit within 2 weeks of surgery. The association between sterilization type and incidence of complications was examined overall, separately by BMI group, and also among patients who received general anesthesia. A total of 433 laparoscopic and 277 hysteroscopic procedures were reviewed. The BMI distribution of the sample was 35 % normal weight, 31 % overweight, and 34 % obese which is comparable to the general US female population. No life-threatening events were identified. Serious complications were similar with 20 (4.6 %) in the laparoscopic group and 11 (4.0 %) in the hysteroscopic group (p = 0.9). The most common serious complications were bleeding from the tube, cervical laceration, and uterine perforation. Although not statistically significant, women with a BMI of 30 or greater had only 1 (1 %) serious complication in the hysteroscopic group compared to 7 (5.2 %) in the laparoscopic group. Postoperative events were increased in the laparoscopic group (16.2 %) compared to the hysteroscopic group (6.9 %), especially among overweight and obese women (p <0.01). Failure to complete the intended bilateral occlusion occurred for 14 women in the hysteroscopic group compared to just one woman in the laparoscopic group (p <0.001). Both laparoscopic and hysteroscopic tubal sterilization are safe with few serious complications based on these data. No cases of laparotomy, blood transfusion, or life-threatening events were identified. There was no difference in serious complication rate by sterilization method. Overweight and obese women were no more likely to experience a serious complication with either method than women with a BMI <25. There were fewer postoperative events (p <0.01) with hysteroscopic sterilization, but far fewer failed laparoscopic procedures (p <0.001). These study findings can be used to enhance sterilization counseling.