Peggy M.A.J. Geomini

The Accuracy of Risk Scores in Predicting Ovarian Malignancy: A Systematic Review

OBJECTIVE: To perform a systematic review of the literature on the accuracy of prediction models in the preoperative assessment of adnexal masses. DATA SOURCES: Studies were identified through the MEDLINE and EMBASE databases from inception to March 2008. The MEDLINE search was performed using the keywords [“ovarian neoplasms”[MeSH] NOT “therapeutics”[MeSH] AND “model”] and [“ovarian neoplasms”[MeSH] NOT “therapeutics”[MeSH] AND “prediction”]. The Embase search was performed using the keywords [ovary tumor AND prediction], [ovary tumor AND Mathematical model], and [ovary tumor AND statistical model]. METHODS OF STUDY SELECTION: The search detected 1,161 publications; from the cross-references, another 116 studies were identified. Language restrictions were not applied. Eligible studies contained data on the accuracy of models predicting the risk of malignancy in ovarian masses. Models were required to combine at least two parameters. TABULATION, INTEGRATION, AND RESULTS: Two independent reviewers selected studies and extracted study characteristics, study quality, and test accuracy. There were 109 accuracy studies that met the selection criteria. Accuracy data were used to form two-by-two contingency tables of the results of the risk score compared with definitive histology. We used bivariate meta-analysis to estimate pooled sensitivities and specificities and to fit summary receiver operating characteristic curves. Studies included in our analysis reported on 83 different prediction models. The model developed by Sassone was the most evaluated prediction model. All models has acceptable sensitivity and specificity. However, the Risk of Malignancy Index I and the Risk of Malignancy Index II, which use the product of the serum CA 125 level, an ultrasound scan result, and the menopausal state, were the best predictors. When 200 was used as the cutoff level, the pooled estimate for sensitivity was 78% for a specificity of 87%. CONCLUSION: Based on our review, the Risk of Malignancy Index should be the prediction model of choice in the preoperative assessment of the adnexal mass.

Evaluation of adnexal masses with three-dimensional ultrasonography.

OBJECTIVE: To estimate whether three-dimensional ultrasonography and three-dimensional power Doppler investigation can contribute to the differentiation between benign and malignant ovarian masses. METHODS: Women scheduled for surgical treatment of an adnexal mass were included in a multicenter prospective study. All women underwent two-dimensional and three-dimensional ultrasonographic examination in the week before surgery. All parameters were compared in women with benign tumors, borderline tumors, and malignant tumors using receiver operating characteristic analysis and likelihood ratios. RESULTS: We included 181 women; 144 had a benign mass, 26 had a malignancy, and 11 had a borderline tumor. At three-dimensional ultrasonography, the most striking difference was found in the presence of central vessels in an adnexal mass. Central vessels assessed by three-dimensional ultrasonography were present in 15% (21 of 144) of the benign masses, 69% (18 of 26) of the malignant masses, and 27% (3 of 11) of the masses of borderline malignancy. The likelihood ratios for presence of central vessels for a mass being malignant and/or borderline was 4.9 (95% confidence interval 2.1–12). Mean gray index and flow index were also significantly different between the groups, but other features were not. CONCLUSION: The central localization of vessels in an adnexal mass, as observed by three-dimensional ultrasonography, the mean gray index, and the flow index are potentially important parameters for distinguishing benign from malignant adnexal masses. LEVEL OF EVIDENCE: II-2

Parasitic myoma after laparoscopic morcellation: a systematic review of the literature

Laparoscopic morcellation is frequently used for tissue removal after laparoscopic hysterectomy or myomectomy and may result in parasitic myomas, due to seeding of remained tissue fragments in the abdominal cavity. However, little is known about the incidence and risk factors of this phenomenon.

The pre-operative assessment of the adnexal mass: the accuracy of clinical estimates versus clinical prediction rules

Objective To evaluate the reproducibility of the clinical judgement of gynaecologists, gynaecologists in training and gynaecologic oncologists and to compare the predictive performance of the offhand assessment with the predictive performance of existing mathematical models for the pre‐operative assessment of the adnexal mass.

Paraneoplastic Cerebellar Degeneration: Neurological Symptoms Pointing to Occult Ovarian Cancer

Paraneoplastic cerebellar degeneration with anti-Yo antibodies is a rare but disabling neurodegenerative disease that may point to an occult ovarian cancer. Symptoms usually accompanying paraneoplastic cerebellar degeneration include truncal and limb ataxia, dysarthria, dysphagia, nystagmus, vertigo, and diplopia. The pathogenesis of paraneoplastic neurological syndromes is unknown. Treatment results of the neurological symptoms are disappointing. The present case illustrates how neurological symptoms pointed to an occult ovarian cancer.

Women’s preference for laparoscopic or abdominal hysterectomy

In the present study, women’s preferences on advantages and disadvantages of laparoscopic hysterectomy (LH) and abdominal hysterectomy (AH) have been studied. Patients’ preferences were evaluated in individual, structured interviews in women scheduled for hysterectomy and questionnaires in nurses. Forty-three patients and 39 nurses were included. After general information, 84% of patients and 74% of nurses preferred LH over AH. This preference did not change after supplying more detailed information or after hysterectomy. The avoidance of complications was indicated as the most important factor in the decision. More than half of the women evaluated a difference of 1% as the maximum acceptable risk of major complications. When confronted with scenarios based on current evidence, both patients and nurses prefer LH over AH. This study supports further implementation of LH in clinical practice. The actual major complication rate in hysterectomy, however, is perceived as high.

Should we centralise care for the patient suspected of having ovarian malignancy

OBJECTIVES Outcome of ovarian cancer is better when surgery is provided by a gynaecological oncologist than by a general gynaecologist. However, when all patients with an adnexal mass have to be operated by gynaecological oncologists, this requires a change in the organisation of care, which generates additional costs. In this study, we assess the costs and effects of centralised and regular care for women with an ovarian malignancy in the Netherlands. METHODS We performed a cost-effectiveness analysis. We considered three strategies. In the first strategy, patients were operated by a general gynaecologist (general care strategy). In the second strategy, patients were operated by a gynaecological oncologist (specialised care strategy). In the third strategy, evaluation of the adnexal mass took place prior to surgery by means of the Risk of Malignancy Index (diagnostic strategy). Patients at high risk for malignancy were supposed to be operated in a specialised care setting, whereas low risk patients were supposed to be operated in a general care setting. For each strategy we calculated life expectancy and incremental costs per life year gained (LYG). RESULTS Mean life expectancy of a patient with an ovarian malignancy in the general strategy was 2.7 years, in the diagnostic strategy 3.0 years and in the specialised strategy 3.1 years. The incremental costs to gain one additional life year with specialised surgery as compared to the diagnostic strategy were € 61,871 per LYG. CONCLUSION In women with an adnexal mass, a diagnostic strategy prior to the decision for surgery by a general gynaecologist or a gynaecological oncologist provides the best balance between costs and effects.

Surgical versus expectant management in women with an incomplete evacuation of the uterus after treatment with misoprostol for miscarriage: the MisoREST trial

BackgroundMedical treatment with misoprostol is a non-invasive and inexpensive treatment option in first trimester miscarriage. However, about 30% of women treated with misoprostol have incomplete evacuation of the uterus. Despite being relatively asymptomatic in most cases, this finding often leads to additional surgical treatment (curettage). A comparison of effectiveness and cost-effectiveness of surgical management versus expectant management is lacking in women with incomplete miscarriage after misoprostol.Methods/DesignThe proposed study is a multicentre randomized controlled trial that assesses the costs and effects of curettage versus expectant management in women with incomplete evacuation of the uterus after misoprostol treatment for first trimester miscarriage.Eligible women will be randomized, after informed consent, within 24 hours after identification of incomplete evacuation of the uterus by ultrasound scanning. Women are randomly allocated to surgical or expectant management. Curettage is performed within three days after randomization.Primary outcome is the sonographic finding of an empty uterus (maximal diameter of any contents of the uterine cavity < 10 millimeters) six weeks after study entry. Secondary outcomes are patients’ quality of life, surgical outcome parameters, the type and number of re-interventions during the first three months and pregnancy rates and outcome 12 months after study entry.DiscussionThis trial will provide evidence for the (cost) effectiveness of surgical versus expectant management in women with incomplete evacuation of the uterus after misoprostol treatment for first trimester miscarriage.Trial registrationDutch Trial Register: NTR3110

Vaginal and Laparoscopic hysterectomy as an outpatient procedure: A systematic review.

OBJECTIVES Laparoscopic and vaginal hysterectomies are common gynaecological procedures. Same-day discharge is usual care in various gynaecological procedures like laparoscopic sterilisation and laparoscopic oophorectomies. In major procedures like vaginal or laparoscopic hysterectomy patients are usually admitted overnight. We systematically reviewed the literature to identify complications, risk factors for (re)admittance, financial consequences and patient satisfaction of same-day discharge after a vaginal or laparoscopic hysterectomy. METHODS We systematically searched PubMed, UptoDate, Embase, Cochrane and CINAHL database from inception until July 16th 2016. We selected randomized controlled trials, prospective and retrospective cohort studies assessing the safety and feasibility of same-day discharge after vaginal or laparoscopic hysterectomy. The outcome parameters that were assessed were admission rate, re-admission rate, minor and major complications, patient satisfaction and financial consequences. RESULTS 27 articles were included in the systematic review. All studies provided data about the admission rate and therefore failure of same-day discharge. Eleven prospective studies were included which compromised a total of 2391 hysterectomies. The percentage of overnight admissions was median 9.3% [0-25%]. Eight retrospective studies, which screened their patients before undergoing an outpatient hysterectomy, showed in 1500 subjects a mean admission rate of 10% [4,4-64%]. Four retrospective studies, which considered a large total cohort of 142,799 hysterectomies had a mean admission rate of 59,7% [48-79%]. The overall re-admission rate was low, varying from 0.73-4.0%. Minor complications were reported in respectively 4,3% and 7,3% in prospective respectively retrospective trials. Major complications were described in 0.7%-3.6% of all cases. Generally high satisfaction rates were reported in the observational trials. CONCLUSIONS Same-day discharge after laparoscopic and vaginal hysterectomy seems feasible in a pre-selected, healthy population. It is associated with a low (re)admission rate, low complication rate and a reduction in hospital costs. Patient satisfaction seems generally high.

eHealth program to empower patients in returning to normal activities after general surgical and gynecological procedures: Intervention Mapping as a useful method for further development (Preprint)

Background Support for guiding and monitoring postoperative recovery and resumption of activities is usually not provided to patients after discharge from the hospital. Therefore, a perioperative electronic health (eHealth) intervention (“ikherstel” intervention or “I recover” intervention) was developed to empower gynecological patients during the perioperative period. This eHealth intervention requires a need for further development for patients who will undergo various types of general surgical and gynecological procedures. Objective This study aimed to further develop the “ikherstel” eHealth intervention using Intervention Mapping (IM) to fit a broader patient population. Methods The IM protocol was used to guide further development of the “ikherstel” intervention. First, patients’ needs were identified using (1) the information of a process evaluation of the earlier performed “ikherstel” study, (2) a review of the literature, (3) a survey study, and (4) focus group discussions (FGDs) among stakeholders. Next, program outcomes and change objectives were defined. Third, behavior change theories and practical tools were selected for the intervention program. Finally, an implementation and evaluation plan was developed. Results The outcome for an eHealth intervention tool for patients recovering from abdominal general surgical and gynecological procedures was redefined as “achieving earlier recovery including return to normal activities and work.” The Attitude-Social Influence-Self-Efficacy model was used as a theoretical framework to transform personal and external determinants into change objectives of personal behavior. The knowledge gathered by needs assessment and using the theoretical framework in the preparatory steps of the IM protocol resulted in additional tools. A mobile app, an activity tracker, and an electronic consultation (eConsult) will be incorporated in the further developed eHealth intervention. This intervention will be evaluated in a multicenter, single-blinded randomized controlled trial with 18 departments in 11 participating hospitals in the Netherlands. Conclusions The intervention is extended to patients undergoing general surgical procedures and for malignant indications. New intervention tools such as a mobile app, an activity tracker, and an eConsult were developed. Trial Registration Netherlands Trial Registry NTR5686; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5686