Eduardo Hariton

Therapeutic Intervention for Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS): A Systematic Review and Meta-Analysis

Background Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) has been treated with several different interventions with limited success. This meta-analysis aims to review all trials reporting on therapeutic intervention for CP/CPPS using the National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI). Methods We searched Medline, PubMed, the Cochrane Pain, Palliative & Supportive Care Trials, the Cochrane Register of Controlled Trials, CINAHL, ClinicalTrials.gov, and the NIDDK website between 1947 and December 31, 2011 without language or study type restrictions. All RCTs for CP/CPPS lasting at least 6 weeks, with a minimum of 10 participants per arm, and using the NIH-CPSI score, the criterion standard for CP/CPPS, as an outcome measure were included. Data was extracted from each study by two independent reviewers. Gillbraith and I-squared plots were used for heterogeneity testing and Eggers and Peters methods for publication bias. Quality was assessed using a component approach and meta-regression was used to analyze sources of heterogeneity. Results Mepartricin, percutaneous tibial nerve stimulation (PTNS), and triple therapy comprised of doxazosin + ibuprofen + thiocolchicoside (DIT) resulted in clinically and statistically significant reduction in NIH-CPSI total score. The same agents and aerobic exercise resulted in clinically and statistically significant NIH-CPSI pain domain score reduction. Acupuncture, DIT, and PTNS were found to produce statistically and clinically significant reductions in the NIH-CPSI voiding domain. A statistically significant placebo effect was found for all outcomes and time analysis showed that efficacy of all treatments increased over time. Alpha-blockers, antibiotics, and combinations of the two failed to show statistically or clinically significant NIH-CPSI reductions. Conclusion Results from this meta-analysis reflect our current inability to effectively manage CP/CPPS. Clinicians and researchers must consider placebo effect and treatment efficacy over time and design studies creatively so we can more fully elucidate the etiology and role of therapeutic intervention in CP/CPPS.

The Effects of a Culturally Sensitive, Empowerment-Focused, Community-Based Health Promotion Program on Health Outcomes of Adults with Type 2 Diabetes

The purpose of the present study was to test the effects of a culturally sensitive, health empowerment-focused, community-based health promotion program tailored to adult patients with type 2 diabetes on these patients’ body mass index (BMI), blood pressure, and self-reported blood glucose levels, treatment adherence, and stress levels. Study participants (N = 130) consisted mostly of African Americans (70%) and Hispanic/Latinos (22.3%) who were divided almost evenly between an intervention group and wait-list control group. The tested health promotion program is informed by Health Self-Empowerment Theory. At post-test, program participants in the intervention group as compared to those in the control group demonstrated significantly lower levels of BMI, diastolic blood pressure, and physical stress. Implications of these study findings for future similar programs and research are discussed.

Incidence and effects on mortality of venous thromboembolism in elderly women with endometrial cancer.

OBJECTIVE: To describe the incidence of thromboembolic events (venous thromboembolism) before and after the diagnosis of epithelial endometrial cancer and to evaluate the effects of these events on survival. METHODS: We used the National Cancer Institutes Surveillance, Epidemiology, and End Results cancer registries linked to Medicare claim files to identify patients with epithelial endometrial cancer diagnosed between 1992 and 2009. To identify venous thromboembolism events 3 months before diagnosis and up to 24 months after diagnosis, we used International Classification of Diseases, 9th Revision, and Healthcare Common Procedure Coding System codes. RESULTS: A total of 23,122 patients were included; of them 1,873 (8.1%) developed a venous thromboembolism. Patients with low-grade (grades 1 and 2) endometrioid adenocarcinoma had a significantly lower rate of venous thromboembolism 3 months before and 6 months after the diagnosis of cancer (3.6%; 95% confidence interval [CI] 3.3–3.9%) compared with carcinosarcoma (9.2%; 95% CI 7.8–10.8%), clear cell (6.9%; 95% CI 4.8–9.7%), uterine serous cancer (8.1%; 95% CI 7.01–9.3%), and grade 3 endometrioid adenocarcinoma (6.1%; 95% CI 5.4–6.9%) (P<.001). On multivariate analysis during the same time period, most recent time periods of diagnosis, carcinosarcoma histology compared with lower grade endometrial cancer, higher stage, African American race, marital status, chemotherapy delivery, and lymph node dissection were associated with increased risk of venous thromboembolism. The median overall survival for women who experienced a venous thromboembolism 3 months before the diagnosis of endometrial cancer was 31 months (95% CI 20–48 months); in women diagnosed with venous thromboembolism 6 months after the cancer diagnosis was 37 months (95% CI 31–44), and in women who did not experienced a venous thromboembolism was 111 months (95% CI 109–114). After adjusting for prognostic factors, there was an association between venous thromboembolism diagnosed 3 months before endometrial cancer (hazard ratio 1.69, 95% CI 1.34–2.13) or 6 months after the diagnosis (hazard ratio 1.57, 95% CI 1.44–1.71) and lower survival. CONCLUSION: Patients with uterine serous cancer, carcinosarcoma, clear cell carcinoma, and grade 3 endometrioid adenocarcinoma had a higher rate of venous thromboembolism than patients with low-grade endometrioid adenocarcinoma. A diagnosis of venous thromboembolism was associated with decreased survival in elderly patients with endometrial cancer. LEVEL OF EVIDENCE: II

Updates in uterine fibroid tissue extraction

Purpose of review Safety concerns regarding morcellation of presumed benign fibroid disease have led to an increase in recent research activity on this topic, as well as advances in surgical technique. Recent findings The prevalence of occult leiomyosarcoma is debated; however, estimates from a robust meta-analysis suggest it may be in the range of 1 case per 1960–8300 fibroid surgeries. Advancing age is an important clinical risk factor for occult malignancy. The impact of tumor morcellation may vary by mode of tissue removal, though tissue fragmentation is consistently associated with poorer outcomes. Decision and cost analyses continue to support laparoscopic hysterectomy as a low-morbidity and cost-effective approach. The increased scrutiny on fibroid procedures in the past few years may lead to changes in surgical approach; however, alternative tissue extraction options are evolving, including incorporation of contained morcellation. Summary Although the incidence of occult leiomyosarcoma is low, outcomes are poor and may be worsened by morcellation. By addressing risk factors for malignancy and incorporating evolving surgical techniques into practice, gynecologists can continue to offer patients a minimally invasive approach for fibroid management.

Hepatosplenic alpha/beta T-cell lymphoma masquerading as cirrhosis.

A 59-year-old man with diabetes mellitus, prior hepatitis B infection and recently diagnosed cirrhosis with prior Babesiosis presented to our institution from an outside hospital with six months of worsening abdominal pain, myalgias and fevers. On admission, physical examination revealed jaundice, hepatosplenomegaly and diffuse lymphadenopathy. Laboratory investigations demonstrated mild anemia, thrombocytopenia, hyperbilirubinemia and elevated lactate dehydrogenase. Tests for human immunodeficiency virus, and active Babesia microti infection were negative, however Epstein-Barr virus DNA by quantitative PCR was markedly elevated. CT scan revealed features suggestive of a cirrhotic liver without focal mass lesions as well as massive splenomegaly with axillary, retroperitoneal and inguinal lymphadenopathy. Bone marrow and lymph node biopsies were obtained which ultimately revealed hepatosplenic T-cell lymphoma. The patients initial liver biopsy from five months prior to presentation was re-evaluated by our institutions pathologists. Histologic analysis showed hepatic sinusoidal and portal infiltration of atypical lymphocytes morphologically identical to those present on the more recently excised lymph node tissue. The hepatic sinusoidal lymphoid cells were strongly positive for CD2, CD3 and CD5 whereas CD4, CD8 stained only minor subsets of the T cells. Subsequent flow cytometric immunophenotypying of peripheral blood identified T-cell receptor alpha/beta positive cells that lacked CD4 and CD8 (double negative alpha/beta T cells). Given the established bone marrow involvement, he was diagnosed with stage IV disease and treated with chemotherapy. His clinical course involved multiple hospitalizations complicated by hyponatremia, neutropenic fevers and pulmonary emboli. Following his fourth cycle of chemotherapy, he developed worsening liver failure and expired approximately three months after initial diagnosis of lymphoma. Hepatosplenic lymphoma of alpha/beta T cells is a rare malignancy with largely unclear risk factors and varied clinical presentations. Notably, diffuse infiltration of liver parenchyma is a prominent feature and the disease can mimic cirrhosis clinically as well as radiographically. Early recognition of this aggressive lymphoma is important and should be considered in the evaluation of patients in whom the etiology of cirrhosis remains in question.

Uterine Transplantation: A Survey of Perceptions and Attitudes of American Reproductive Endocrinologists and Gynecologic Surgeons

OBJECTIVE To determine whether reproductive endocrinologists and minimally invasive surgeons support uterine transplantation as a treatment option for absolute uterine factor infertility (AUFI). DESIGN A cross-sectional study (Canadian Task Force classification II-2). SETTING A Web-based survey. PATIENTS Physician members of the American Society of Reproductive Medicine (ASRM) and the American Association of Gynecologic Laparoscopists (AAGL). INTERVENTIONS A Web-based questionnaire administered between January and February 2017. MEASUREMENTS AND MAIN RESULTS Support for (strongly agree or agree) or opposition to (strongly disagree or disagree) various aspects of uterine transplantation were described using descriptive statistics and analyzed using chi-square tests. A total of 414 physicians (ASRM: 49.5%, AAGL: 50.5%) responded to the Web-based survey; 43.7% were female, 52.4% were between the ages of 45 and 65 years, and 73.4% were white. Nearly fifty-six percent supported women being allowed to donate or receive a transplanted uterus. Fifty-four percent strongly agreed or agreed that uterine transplantation carried an acceptable risk for donors, 28.0% for the recipient and 21.0% for the infant. Forty-two percent agreed that uterine transplantation should be considered a therapeutic option for women with AUFI, whereas 19.6% felt it should be covered by insurance. Nearly 45% of respondents felt uterine transplantation to be ethical. The most common ethical concerns regarding uterine transplantation were related to medical or surgical complications to the recipient (48.8%). CONCLUSION Just under half of the reproductive endocrinologists and minimally invasive surgeons surveyed find uterine transplantation to be an ethical option for patients with AUFI. Important concerns remain regarding the risk to donors, recipients, and resulting infants, all contributing to only a minority currently recommending it as a therapeutic option.

Update on Fibroid Morcellation

Purpose of ReviewThe aim of this paper is to review the risks associated with morcellation of uterine and fibroid tissue during minimally invasive surgery, and provide updated suggestions for practice.Recent FindingsThe prevalence of occult uterine sarcoma has been estimated to be in the range of 1 case per 278–8300, with significant variance reported. Strong predictors of occult malignancy include age, black race, and long-term tamoxifen use. Patient symptoms, lab abnormalities, imaging findings, and preoperative sampling may be useful in preoperative patient selection. Several tissue extraction techniques have been developed and studied in an effort to mitigate risk of morcellating fibroid tissue with potentially occult malignancy.SummaryMinimally invasive surgery at times requires removal of large tissue specimens through small incisions. The risk of encountering an occult uterine sarcoma during tissue extraction is low, but may result in worsened oncologic outcomes if tissue is fragmented at time of removal. Several novel techniques and tools are being studied as risk reducing strategies to allow for safer gynecologic surgery.

The Role of Oncofertility Clinics in Facilitating Access to Reproductive Specialists

Purpose: To determine the impact of the establishment of a dedicated oncofertility clinic on the frequency of patient referrals for fertility preservation (FP) consultation and the time from patient referral to consultation. Methods: A retrospective chart review of all women aged 21 to 44 years with an active cancer diagnosis who were referred for FP consultation from 2011 to 2015. Results: A total of 6895 female patients eligible for FP were seen at the Massachusetts General Hospital (MGH) Cancer Center. Of those eligible, a total of 209 patients were referred for FP consultation with 150 included in the final analysis. Since the establishment of the oncofertility clinic, the mean time to nonemergent consultation with a reproductive endocrinologist decreased by 27%, from 10.4 to 7.6 days (P = .03). Furthermore, the proportion of reproductive-aged females seen at the MGH Cancer Center referred for FP consultation increased from 1.7% to 3.0% (P < .01). Conclusion: A dedicated oncofertility clinic increases physician referrals for FP and decreases the mean time to consultation, improving access to FP consultation for reproductive-aged women with cancer.

Resident and Program Director’s Perceptions of Milestone-Based Feedback in Obstetrics and Gynecology:

Introduction: In July 2014, US residency programs fully implemented the Next Accreditation System including the use of milestone evaluation and reporting. Currently, there has been little investigation into the result of implementation of this new system. Therefore, this study sought to evaluate perceptions of Obstetrics and Gynecology residents and program directors regarding the use of milestone-based feedback and identify areas of deficiency. Methods: A Web-based survey was sent to US-based Obstetrics and Gynecology residents and program directors regarding milestone-based assessment implementation. Results: Out of 245 program directors, 84 responded to our survey (34.3% response rate). Of responding program directors, most reported that milestone-based feedback was useful (74.7%), fair (83.0%), and accurate (76.5%); however, they found it administratively burdensome (78.1%). Residents felt that milestone-based feedback was useful (62.7%) and fair (70.0%). About 64.3% of residents and 74.7% of program directors stated that milestone-based feedback is an effective tool to track resident progression; however, a sizable minority of both groups believe that it does not capture surgical aptitude. Qualitative analysis of free response comments was largely negative and highlighted the administrative burden and lack of accuracy of milestone-based feedback. Conclution: Overall, both Obstetrics and Gynecology program directors and residents report that milestone-based feedback is useful and fair. Issues of administrative burden, timeliness, evaluation of surgical aptitude, and ability to act on assigned milestone levels were identified. Although this study is limited to one specialty, such issues are likely important to all residents, faculty, and program directors who have implemented the Next Accreditation System requirements.

Randomised controlled trials – the gold standard for effectiveness research

Learning points Randomised controlled trials (RCTs) are the reference standard for studying causal relationships between interventions and outcomes as randomisation eliminates much of the bias inherent with other study designs. To provide a true, reliable assessment of effectiveness, RCTs need to be conducted robustly, i.e. with concealment of allocation, blinding, intention-to-treat analysis and sufficiently large sample size.