Introducing a standardized assessment of patients' interest in and usage of CAM in routine cancer care: chances and risks from patients' and physicians' point of view.

BACKGROUND: Cancer patients often use complementary and alternative medicine (CAM), however, standardized assessment in clinical routine is missing. The aim of this study was to evaluate a screening questionnaire on CAM usage that was published in the S3 Guideline Complementary Medicine in the Treatment of Oncological Patients. METHODS: We developed a survey questionnaire to assess the practicability of the guideline questionnaire and communication on CAM between health care providers (HCPs) and patients. We collected 258 guideline questionnaires and 116 survey questionnaires from ten clinics and held twelve semi-structured interviews with HCPs. RESULTS: 85% used at least one of the listed CAM methods, 54 participants (N = 77) never disclosed usage to a physician. The most frequently used CAM methods were physical activity (76.4%) and vitamin D (46.4%). 25.2% used at least one method, that was labeled risky by the guideline. 53.4% did not know of CAM's risk of interactions and side effects. Introducing the guideline questionnaire in routine cancer care increased the rate of patients talking to an HCP regarding CAM significantly from 35.5 to 87.3%. The HCPs stated positive effects as an initiation of conversation, increased safety within CAM usage and patients feeling thankful and taken seriously. However, due to the limited amount of time available for discussions on CAM, generalized distribution to all patients was not feasible. CONCLUSION: Institutions should focus on implementing standard procedures and resources that help HCPs discuss CAM on a regular basis. HCPs should meet the patient's demands for CAM counseling and make sure they are equipped professionally.

The impact of opportunistic salpingectomy on ovarian cancer mortality and healthcare costs: a call for universal insurance coverage.

BACKGROUND: Opportunistic salpingectomy at the time of hysterectomy or as an alternative to bilateral tubal ligation may reduce the incidence of ovarian cancer, because it has been demonstrated that most serous ovarian cancers begin in the fallopian tubes. However, salpingectomy at the time of sterilization is not always financially covered by third-party payers, and this represents a barrier to adoption. Routine salpingectomy has become more common but is not always practiced at the time of hysterectomy. OBJECTIVE: This study aimed to determine the impact of opportunistic salpingectomy as an alternative tubal ligation and routine salpingectomy at the time of hysterectomy on ovarian cancer mortality and overall cost. STUDY DESIGN: An 8-state Markov state transition model was constructed, including hysterectomy, tubal ligation, and ovarian cancer. Transition probabilities were informed by previously reported population data and include age-adjusted rates of elective sterilization and hysterectomy. This model was used to predict ovarian cancer incidence and the cost effectiveness of opportunistic salpingectomy. Testing of this model suggested that it accurately predicted overall life expectancy and closely predicted the rate of hysterectomy in the population. The model may underestimate the rate of tubal sterilization, making it conservative with respect to the benefits of salpingectomy. RESULTS: The recursive Markov model was run from ages 20 to 85 years in 1-year intervals with a half step correction and included age-adjusted rates of tubal ligation, hysterectomy (with and without oophorectomy), and ovarian cancer. The model predicts that opportunistic salpingectomy at the time of tubal ligation will reduce ovarian cancer mortality by 8.13%. Opportunistic salpingectomy at the time of hysterectomy will reduce ovarian cancer mortality by 6.34% for a combined decrease of 14.5%. Both strategies are cost effective when considering only the cost of the opportunistic salpingectomy. The excess cost of opportunistic salpingectomy at the time of tubal ligation was $433.91 with an incremental cost-effective ratio of $6401 per life-year and $5469 per quality-adjusted life year gained when adjusting for ovarian cancer with a utility of 0.64. The incremental cost-effective ratio for opportunistic salpingectomy during hysterectomy at a cost of $124.70 was $2006 per life-year and $1667 per quality-adjusted life year. When considering the impact of ovarian cancer prevention with respect to the cost of ovarian cancer treatment, opportunistic salpingectomy may produce a substantial healthcare savings. Utilizing a 3% discount rate, it is estimated that the total savings for universal salpingectomy could be as high as $445 million annually in the United States. A sensitivity analysis around the benefit of opportunistic salpingectomy suggests that this procedure will be cost effective even if salpingectomy provides only a modest reduction in the risk of ovarian cancer. CONCLUSION: It is estimated that universal opportunistic salpingectomy may prevent 1854 deaths per year from ovarian cancer and may reduce healthcare costs. Given these data, universal opportunistic salpingectomy should be considered at the time of tubal ligation and hysterectomy and covered by third-party payers.

Ovarian cancer screening with the Risk of Ovarian Cancer Algorithm (ROCA): Good, bad, or just expensive?

OBJECTIVES: To measure the effectiveness of ovarian cancer screening using the Risk of Ovarian Cancer Algorithm (ROCA). METHODS: A Markov model was constructed based on the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS). This model was used to predict the outcome of ovarian cancer screening with ROCA. RESULTS: The model predicted the ovarian cancer mortality from age 50 to age 85 to be 0.954% with a decrease in life expectancy of 0.178years (yrs) per person. Using data from the UKCTOCS the model predicted a similar reduction in mortality (11% vs. 10%), and similar curves for ovarian cancer mortality. Screening at age 50 for 20yrs reduced ovarian cancer mortality from 0.953% to 0.898%, an absolute decrease of 6%, yielding an increase in life expectancy of 0.0101yrs, preventing 55 deaths per 100,000 screened at a cost of $585,946 per life-yr. Screening for 30yrs reduced mortality from 0.954% to 0.872%, an absolute decrease of 9%, preventing 82 deaths at a cost of $763,970 per life-yr. CONCLUSION: The ROCA test can improve the detection of early ovarian cancer but is not practical for screening in an average-risk population. We predict the ROCA test will reduce overall ovarian cancer mortality by 6% to 9% but at a substantial cost. For ROCA to be practical, the cost would need to be reduced ten-fold and would have only a marginal impact on mortality from ovarian cancer. This model supports the FDA's criticism of the ROCA test. Ovarian cancer screening may reduce mortality from ovarian cancer but is not cost effective.

Physician Education on Controllable Costs Significantly Reduces Cost of Laparoscopic Hysterectomy.

STUDY OBJECTIVE: To determine whether educating surgeons about their controllable instrumentation costs by providing cost data on total laparoscopic hysterectomy (LH) would reduce the cost of this procedure. DESIGN: Prospective cohort study (Canadian Task Force classification III). SETTING: Academic-affiliated community hospital. PATIENTS: Patients who underwent LH between April 2014 and March 2015 with surgeons who performed at least 10 LHs during that time period, along with a second group who underwent LH with the same cohort of surgeons between July 2015 and September 2015. INTERVENTION: The cost of LH was calculated for all surgeons who performed more than 10 LHs between April 2014 and March 2015. Itemized cost data were collected. The individual costs, as well as a summary of the data, were shared with all of the physicians to highlight areas of potential cost savings. The costs were then measured for 3 months after the educational intervention (July-September 2015) to gauge the impact of physician cost education. MEASUREMENTS AND MAIN RESULTS: Thirteen surgeons met the criteria for inclusion in this analysis. Together, they performed 271 hysterectomies, with an average instrumentation cost of $1539.47 ± $294.16 and an average operating room time of 178 ± 26 minutes. Bipolar instrument choice represented 37% of the baseline costs, followed by 10% for trocar, 9% for cuff closure, and 8% for uterine manipulator. This same group of surgeons performed a total of 69 hysterectomies in the 3-month follow-up period of July-September 2015, with an average instrumentation cost of $1282.62 ± $235.03 and an average operating room time of 163 ± 50 minutes. There was statistically significant cost reduction of $256.85 ± $190.69 (p = .022), with no significant change in operating room time. Bipolar instrument cost decreased significantly, by $130.02 ± $125.02 (p = .021), representing 51% of the total cost savings. Trocar, cuff closure, and uterine manipulator costs were not significant sources of cost savings on average, but did represent sources of cost savings for some surgeons individually. CONCLUSION: Given adequate education about the products available for use in their institution, surgeons make informed decisions regarding the choice of instrumentation, allowing them to directly impact the cost of total LH, resulting in cost savings.

Make New Friends But Keep the Old: Minimally Invasive Surgery Training in Gynecologic Oncology Fellowship Programs.

OBJECTIVES: To evaluate the role of minimally invasive surgery (MIS) in gynecologic oncology fellowship training and fellows' predictions of their use of MIS in their future practice. METHODS: All fellows-in-training in American Board of Obstetrics and Gynecology-approved training programs were surveyed in 2012 through an online or mailed-paper survey. Data were analyzed and compared to results of a similar 2007 survey. RESULTS: Of 172 fellows, 69 (40%) responded. Ninety-nine percent of respondents (n = 68) indicated that MIS was either very important or important in gynecologic oncology, a proportion essentially unchanged from 2007 (100%). Compared to 2007, greater proportions of fellows considered laparoscopic radical hysterectomy and node dissection for cervical cancer (87% vs 54%; P < 0.0001) and trachelectomy and staging for cervical cancer (83% vs 32%; P < 0.0001) appropriate for MIS. Of the respondents, 92% believed that maximum or some emphasis should be placed on robotic-assisted surgery and 89% on traditional laparoscopy during fellowship training. Ten percent rated their fellowship training in laparoendoscopic single-site surgery as very poor; 44% said that the question was not applicable. Most respondents (60%) in 2012 performed at least 11 procedures per month, whereas most respondents (45%) in 2007 performed 6 to 10 procedures per month (P = 0.005). All respondents at institutions where robotic surgery was used were allowed to operate at the robotic console, and 63% of respondents reported that in robotic-assisted surgery cases when a fellow sat at the robot, the fellow performed more than 50% of the case at the console. CONCLUSIONS: These findings indicate that MIS in gynecologic oncology is here to stay. Fellowship programs should develop a systematic approach to training in MIS and in individual MIS platforms as they become more prevalent. Fellowship programs should also develop and apply an objective assessment of minimum proficiency in MIS to ensure that programs are adequately preparing trainees.

Role of Minimally Invasive Surgery in Gynecologic Oncology: An Updated Survey of Members of the Society of Gynecologic Oncology.

OBJECTIVES: To evaluate the current patterns of use of minimally invasive surgical procedures, including traditional, robotic-assisted, and single-port laparoscopy, by Society of Gynecologic Oncology (SGO) members and to compare the results to those of our 2004 and 2007 surveys. METHODS: The Society of Gynecologic Oncology members were surveyed through an online or mailed-paper survey. Data were analyzed and compared with results of our prior surveys. RESULTS: Four hundred six (32%) of 1279 SGO members responded. Eighty-three percent of respondents (n = 337) performed traditional laparoscopic surgery (compared with 84% in 2004 and 91% in 2007). Ninety-seven percent of respondents performed robotic surgery (compared with 27% in 2007). When respondents were asked to indicate procedures that they performed with the robot but not with traditional laparoscopy, 75% indicated radical hysterectomy and pelvic lymphadenectomy for cervical cancer. Overall, 70% of respondents indicated that hysterectomy and staging for uterine cancer was the procedure they most commonly performed with a minimally invasive approach. Only 17% of respondents who performed minimally invasive surgery performed single-port laparoscopy, and only 5% of respondents indicated that single-port laparoscopy has an important or very important role in the field. CONCLUSIONS: Since our prior surveys, we found a significant increase in the overall use and indications for robotic surgery. Radical hysterectomy or trachelectomy and pelvic lymphadenectomy for cervical cancer and total hysterectomy and staging for endometrial cancer were procedures found to be significantly more appropriate for the robotic platform in comparison to traditional laparoscopy. The indications for laparoscopy have expanded beyond endometrial cancer staging to include surgical management of early-stage cervical and ovarian cancers, but the use of single-port laparoscopy remains limited.

The role of radiation therapy in early endometrial cancer.

Few randomized studies have addressed the best choice of adjuvant radiation therapy after surgery for stage I endometrial cancer. Although whole pelvic radiation decreases the incidence of pelvic and vaginal cancer recurrence, there is no convincing evidence that it improves survival in women who have been completely staged. Several studies have indicated that women with high-risk stage I endometrial adenocarcinoma are treated adequately with extended surgical staging and vaginal cuff radiation. In the absence of randomized trials suggesting that whole pelvic radiation improves survival, it should be limited only to the highest risk stage I subgroups. Vaginal cuff brachytherapy appears to provide excellent local control of disease with minimal morbidity.

Dose-reduced conditioning for allogeneic blood stem cell transplantation: durable engraftment without antithymocyte globulin.

Between February 1998 and October 1999, 24 patients with advanced leukemia, lymphoma or solid tumors received G-CSF mobilized peripheral blood stem cells (PBSC) from HLA-matched sibling donors after dose-reduced conditioning therapy. Only patients with reduced performance status or major infectious complications, not eligible for standard transplant procedures, were included. The 5-day conditioning therapy consisted of 3.3 mg/kg intravenous busulphan x 2 days and 30 mg/m2 fludarabine x 5 days. GVHD prophylaxis was performed with either CsA alone (n = 5), CsA combined with short course methotrexate (n = 5) or mycophenolate mofetil (n = 14). The day 100 survival was 95.2% for the whole group. All patients engrafted after a median of 15 days (range, 11-19) and 12.5 days (range, 10-19) for neutrophils and platelets, respectively. The median time to a neutrophil count of <0.5 x 109/l was 7 days (range, 2 to 12). Acute GVHD >I was observed in six patients, whereas eight patients have signs of chronic GVHD. The prospective 12 month overall survival with a median follow-up of 7 months is 63%. Relapse of disease and toxicity associated with chronic GVHD were the main causes of death. The treatment-related mortality was 12.5%. Dose-reduced conditioning using intravenous busulphan and fludarabine allows stable engraftment without ATG in related transplants and leads to a reduction of transplant-related mortality.

Treatment of cervical dysplasia with large loop excision of the transformation zone: is endocervical curettage necessary?

Endocervical curettage (ECC) is done during most colposcopic examinations. To evaluate the need for routine ECC, we reviewed the records of all new patients seen in the colposcopy clinic at our institution from July 15, 1992, to April 15, 1993. During the study period, ECC was done in 341 patients with an adequate colposcopy. Only one case of mild dysplasia was discovered after ECC in the 123 patients referred for evaluation of cervical intraepithelial neoplasia (CIN) I or atypia seen on Pap smear. ECC specimens were positive for dysplastic cells in only 3 of 203 patients (1.4%) in whom biopsy revealed CIN I or atypia, and Pap smears for all 3 patients were suggestive of more severe lesions. Routine ECC during the initial colposcopic examination adds expense and may cause significant patient discomfort. ECC can be safely omitted in patients with CIN I on referral Pap smear and before large loop excision of the transformation zone for treatment of more severe lesions.

A decision analysis of practice patterns used in evaluating and treating abnormal Pap smears.

OBJECTIVE: The purpose of this study was to investigate contemporary methods of evaluating and treating abnormal Pap smears, in terms of their potential for excessive treatment and financial impact on health care delivery systems. METHODS: Clinical algorithms for the evaluation and treatment of abnormal Pap smears were constructed, taking into consideration different philosophies on the need for colposcopic biopsy, the role of cryotherapy, and LLETZ. The algorithms employed (1) colposcopy of all patients with cryotherapy of mild dysplasia and LLETZ of moderate to severe dysplasia; (2) colposcopy with observation of mild dysplasia, treatment of moderate dysplasia by cryotherapy, and severe dysplasia by LLETZ; (3) colposcopy of LGSIL Paps before treatment and immediate LLETZ of HGSIL; and (4) immediate LLETZ of LGSIL and HGSIL Paps. Each algorithm was theoretically applied to a cohort of colposcopy clinic patients based upon referral Pap smear, with excessive treatment and costs calculated. The cohort's repeat Pap smear, colposcopic biopsy, and candidacy for cryotherapy were included in the analysis. The decision to use repeat Pap smear in treatment planning, submit only diagnostic LLETZ pathology, and select immediate LLETZ candidates by HGSIL/severe dysplasia Pap smear was considered. Financial impact was calculated using nationwide fiftieth-percentile reimbursement costs for procedures and related pathology. RESULTS: Colposcopy provided little opportunity for excessive treatment. In contrast, 49.3% of cases subjected to immediate LLETZ would theoretically not have required treatment, if initially evaluated by colposcopy. The use of the subset of HGSIL cases encompassing severe dysplasia only identified patients suitable for immediate LLETZ, with an excessive treatment rate of only 2.8%. Traditional colposcopy (algorithm 2) would have been least expensive at $718 per patient. Algorithms 1 and 3 were intermediate at $785 and $754 per patient, respectively. Immediate LLETZ of all abnormal Paps (algorithm 4) would have been most costly at $838 per patient. CONCLUSIONS: The abandonment of colposcopy and reliance on immediate LLETZ for evaluation and treatment of cervical lesions would have been expensive and had significant potential for excessive treatment. Traditional colposcopic evaluation, coupled with observation of mild dysplasia, appeared to be the most cost-effective means of treating cervical dysplasia and had a low potential for excessive treatment.

Prospective randomized trial of LLETZ versus laser ablation in patients with cervical intraepithelial neoplasia.

Three hundred seventy-five patients with CIN on referral Pap and with a distinct cervical lesion on colposcopy were prospectively randomized to treatment with LLETZ or to standard colposcopic evaluation with directed cervical biopsies, endocervical curettage, and laser ablation of the transformation zone for biopsy proven CIN. Of the 195 patients that randomized to treatment with LLETZ, 32.5% had no evidence of dysplasia, 26.5% had CIN 1, 17.3% had CIN 2, 22.7% had CIN 3, and 0.5% had microinvasive carcinoma on final histologic evaluation. Of the 180 patients randomized to laser ablation, initial cervical biopsies demonstrated no evidence of dysplasia in 52.8% of patients, CIN 1 in 22.0%, CIN 2 in 18.3%, and CIN 3 in 5.7%. Only 114 (63.3%) of the women in the laser group required therapy. Complications were comparable for each treatment arm. Only 6.7% of patients randomized to LLETZ and 4.4% with laser ablation had persistent CIN on follow-up Pap. LLETZ appears to be effective, well tolerated, and less expensive, but the cost savings advantage of LLETZ over laser ablation may not apply to patients with CIN 1 on referral Pap smear since many do not require treatment.