MRI versus laparoscopy to diagnose the main causes of chronic pelvic pain in women: a test-accuracy study and economic evaluation.

BACKGROUND: Chronic pelvic pain (CPP) symptoms in women are variable and non-specific; establishing a differential diagnosis can be hard. A diagnostic laparoscopy is often performed, although a prior magnetic resonance imaging (MRI) scan may beneficial. OBJECTIVES: To estimate the accuracy and added value of MRI in making diagnoses of (1) idiopathic CPP and (2) the main gynaecological causes of CPP. To quantify the impact MRI can have on decision-making with respect to triaging for therapeutic laparoscopy and to conduct an economic evaluation. DESIGN: Comparative test-accuracy study with cost-effectiveness modelling. SETTING: Twenty-six UK-based hospitals. PARTICIPANTS: A total of 291 women with CPP. METHODS: Pre-index information concerning the patient's medical history, previous pelvic examinations and ultrasound scans was collected. Women reported symptoms and quality of life at baseline and 6 months. MRI scans and diagnostic laparoscopy (undertaken and interpreted blind to each other) were the index tests. For each potential cause of CPP, gynaecologists indicated their level of certainty that the condition was causing the pelvic pain. The analysis considered both diagnostic laparoscopy as a reference standard for observing structural gynaecological causes and consensus from a two-stage expert independent panel for ascertaining the cause of CPP. The stage 1 consensus was based on pre-index, laparoscopy and follow-up data; for stage 2, the MRI scan report was also provided. The primary analysis involved calculations of sensitivity and specificity for the presence or absence of each structural gynaecological cause of pain. A decision-analytic model was developed, with a 6-month time horizon. Two strategies, laparoscopy or MRI, were considered and populated with study data. RESULTS: Using reference standards of laparoscopic and expert panel diagnoses, MRI scans had high specificity but poor sensitivity for observing deep-infiltrating endometriosis, endometrioma, adhesions and ovarian cysts. MRI scans correctly identified 56% [95% confidence interval (CI) 48% to 64%] of women judged to have idiopathic CPP, but missed 46% (95% CI 37% to 55%) of those considered to have a gynaecological structural cause of CPP. MRI added significant value, over and above the pre-index information, in identifying deep-infiltrating endometriosis (p = 0.006) and endometrioma (p = 0.02) as the cause of pain, but not for other gynaecological structural causes or for identifying idiopathic CPP (p = 0.08). Laparoscopy was significantly more accurate than MRI in diagnosing idiopathic CPP (p < 0.0001), superficial peritoneal endometriosis (p < 0.0001), deep-infiltrating endometriosis (p < 0.0001) and endometrioma of the ovary (p = 0.02) as the cause of pelvic pain. The accuracy of laparoscopy appeared to be able to rule in these diagnoses. Using MRI to identify women who require therapeutic laparoscopy would lead to 369 women in a cohort of 1000 receiving laparoscopy unnecessarily, and 136 women who required laparoscopy not receiving it. The economic analysis highlighted the importance of the time horizon, the prevalence of CPP and the cut-off values to inform the sensitivity and specificity of MRI and laparoscopy on the model results. MRI was not found to be a cost-effective diagnostic approach in any scenario. CONCLUSIONS: MRI was dominated by laparoscopy in differential diagnosis of women presenting to gynaecology clinics with CPP. It did not add value to information already gained from history, examination and ultrasound about idiopathic CPP and various gynaecological conditions. TRIAL REGISTRATION: Current Controlled Trials ISRCTN13028601. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 40. See the NIHR Journals Library website for further project information.

MRI reporting standard for chronic pelvic pain: consensus development.

AIM: To identify radiological parameters that should be reported on gynaecological MRI in order to create a standardized assessment pro forma for reporting CPP, which may be used in clinical practice. METHODS: Chronic pelvic pain (CPP) in females is a common problem presenting a major challenge to healthcare providers. The complex multifactorial aetiology requires a multidisciplinary approach and often necessitates diagnostic laparoscopy for assessment. MRI is emerging as a potential non-invasive alternative for evaluation of CPP; however, standardization of reporting is required for it to be used in routine clinical practice. A two-generational Delphi survey with an expert panel of 28 radiologists specializing in gynaecological MRI from across the UK was used to refine a proposed reporting template for CPP. RESULTS: 75% response rate for the first round and 79% for the second. Following the second round, agreement was reached on the structure of the pro forma and the way in which information was sought, with overall consistency of agreement between experts deemed as fair (intraclass correlation coefficient = 0.394). This was accepted as the final version by consensus. CONCLUSION: The standardized pro forma developed in this study will form the basis for future prospective evaluation of MRI in CPP. This template could be modified for the assessment of other benign gynaecological conditions. ADVANCES IN KNOWLEDGE: Female CPP is a significant problem presenting challenges for clinicians. MRI is often used for evaluation and standardization of techniques, and reporting is required. The pro forma developed in this study will form the basis for future prospective MRI evaluation.

Chronic pelvic pain: how does noninvasive imaging compare with diagnostic laparoscopy?

PURPOSE OF REVIEW: Chronic pelvic pain (CPP) has an annual prevalence of 38/1000 in the UK, with coexisting pathologies often present. Diagnostic laparoscopy has long been the gold standard diagnostic test, but with up to 40% showing no abnormality, we explore the value of noninvasive imaging, such as pelvic ultrasound and MRI. RECENT FINDINGS: A literature review from inception until January 2015 of the following databases: PubMed, MEDLINE, Cumulative Index to Nursing and Allied Health Literature, Excerpta Medica database, and System for Information on Grey Literature in Europe were performed to identify published studies assessing the usefulness of ultrasound, MRI, and laparoscopy in the diagnosis of CPP. Three studies (194 women) addressed their comparative performance in patients with endometriosis, showing the sensitivity of ultrasound ranged between 58 and 88.5%; MRI was 56-91.5% and in the one study using histology as its reference standard, the sensitivity of laparoscopy was 85.7%. Noninvasive imaging has the additional benefit of being well tolerated, safer, and cheaper than surgery. SUMMARY: CPP, by nature of its multifactorial causation, can be difficult to manage and often requires a multidisciplinary team. Ultrasound and MRI may provide information about the presence or lack of abnormality, which would allow general practitioners or office gynaecologists to initiate treatment and think about surgery as a second-line investigative tool.

The management of secondary lower limb lymphoedema in cancer patients: a systematic review.

BACKGROUND: Lower limb lymphoedema is a recognised complication of cancer commonly encountered in palliative care, associated with reduced mobility and poor quality of life. AIM: To evaluate the available evidence for the treatment of secondary lower limb lymphoedema in patients with malignancies. DESIGN: A systematic review of the literature. DATA SOURCES: The MEDLINE, Embase, LILACS, Science Citation Index, Cochrane Databases and conference proceedings for published data from date of inception to July 2014 were searched. Relevant unpublished studies via relevant databases, Internet searches and hand-searches of the bibliographies of relevant papers were performed. RESULTS: From 1617 citations, 32 papers were selected for full-text assessment. Two randomised trials and five observational studies were identified. The two randomised controlled trials evaluated graded compression stockings and Coumarin capsules, respectively. The five observational studies evaluated lymphovenous microsurgical shunts, pneumatic compression devices, compression bandages alone, manual lymphatic drainage with compression and a herbal remedy combining Coumarin, Ginkgo and Melitoto (with or without manual lymphatic drainage), respectively. The extracted studies showed substantial heterogeneity. Hence, a meta-analysis was inappropriate and not performed. CONCLUSION: Few studies have evaluated the clinical effectiveness and potential side effects of treatments for lower limb lymphoedema. Moreover, symptoms and quality-of-life assessments were inconsistently reported. All included studies report lower limb volume reduction after treatment, which includes complex decongestion therapy, graded compression stockings and lymphovenous microsurgical shunts. Adequately powered randomised controlled trials of these interventions are recommended. Effort should be made to establish standardised outcomes, to minimise bias and to improve reporting quality in future trials of treatment for lower limb lymphoedema.

Variations in the reporting of outcomes used in systematic reviews of treatment effectiveness research in bladder pain syndrome.

This paper investigates the quality of outcomes reported in systematic reviews and randomised controlled trials (RCTs) of bladder pain syndrome and its relationship with study quality and journal impact factor. We searched until August 2013 the Cochrane Library, EMBASE, Medline, CINAHL, LILACS and SIGLE, without language restrictions. Quality of outcome reporting in systematic reviews and constituent RCTs was assessed using a 6-point scale. Overall study quality was assessed using the AMSTAR and Jadad scoring systems, and impact factor in the year of publication was noted. Spearman's rank correlation was calculated. There were 8 systematic reviews, with a total of 28 RCTs (1732 patients), reporting 5 outcomes using 19 different measurement scales. The outcomes reported in individual RCTs were urinary symptoms (100%), pain (64%), quality of life (39%), general wellbeing (36%) and bladder capacity (36%). The mean quality of outcomes reported was 1.63 (95% CI 0.29-2.96) for systematic reviews and 3.25 (95% CI 2.80-3.70) for RCTs. The quality of outcomes reported showed correlation with overall study quality (0.90, 95% CI 0.79-0.95, p<0.0001) but not with journal impact factor (0.07, 95% CI -0.31-0.43, p=0.35). Multivariable linear regression showed a relationship between quality of outcome reporting and study quality (ß=0.05, p<0.0001), adjusting for effects of study type, impact factor and journal type. There is a need to generate consensus over a set of core outcomes in bladder pain syndrome using standardised reporting tools and to disseminate these through good publication practice.

Bladder pain syndrome: validation of simple tests for diagnosis in women with chronic pelvic pain: BRaVADO study protocol.

BACKGROUND: Bladder pain syndrome (BPS), a condition with no gold standard diagnosis, comprises of a cluster of signs and symptoms. Bladder filling pain and bladder wall tenderness are two basic clinical features, present in a high number of sufferers. This study will validate the performance of these simple tests for BPS in women with chronic pelvic pain (CPP). METHODS/DESIGN: We will conduct a prospective test validation study amongst women with unexplained CPP presenting to gynaecology outpatient clinics. Two index tests will be performed: patient reported bladder filling pain and bladder wall tenderness on internal pelvic bimanual examination. A final diagnosis of BPS will be made by expert consensus panel. We will assess the rates of index tests in women with CPP; evaluate the correlation between index tests and Pelvic Pain Urgency/ Frequency (PUF) questionnaire results; and determine index test sensitivity and specificity using a range of analytical methods. Assuming a 50% prevalence of BPS and an 80% power approximately 152 subjects will be required exclude sensitivity of < 55% at 70% sensitivity. DISCUSSION: The results of this test validation study will be used to identify whether a certain combination of signs and symptoms can accurately diagnose BPS.

How do we define the term idiopathic?

PURPOSE OF REVIEW: The term idiopathic is often used to describe a disease with no identifiable cause. It may be a diagnosis of exclusion; however, what specific minimum investigations need to be performed to define idiopathic is not always clear. This commentary describes the problems inherent in reaching a definition for the term idiopathic. RECENT FINDINGS: There is limited literature describing methodology to define a condition with no clear diagnostic criteria. This article offers chronic pelvic pain (CPP) syndrome as an example, in which structured qualitative interviews, literature searches and group consensus discussions were undertaken to produce a working definition for idiopathic CPP. SUMMARY: It is important to correctly develop these standardized definitions for use as outcome measures in research and as clinical indicators in healthcare.

Nerve stimulation for chronic pelvic pain and bladder pain syndrome: a systematic review.

Chronic pelvic pain (CPP) and bladder pain syndrome (BPS) can have a negative impact on quality of life. Neuromodulation has been suggested as a possible treatment for refractory pain. To assess the effectiveness of tibial and sacral nerve stimulation in the treatment of BPS and CPP. We searched until July 2012: the Cochrane Library, EMBASE (1980-2012), Medline (1950-2012), Web of knowledge (1900-2012), LILACS (1982-2012) and SIGLE (1990-2012) with no language restrictions. We manually searched through bibliographies and conference proceedings of the International Continence Society. Randomized and prospective quasi-randomized controlled studies vs. sham nerve stimulation treatment or usual care of patients with CPP and BPS who underwent sacral or tibial nerve stimulation were included. Any studies involving transcutaneous stimulation were excluded. The outcome was a cure or improvement in symptoms. Three studies with 169 patients treated with tibial nerve stimulation were included; two for CPP and one for BPS. There were improvements in pain, urinary and quality of life scores. There were no reported data for sacral nerve stimulation. There is scanty literature reporting variable success of posterior tibial nerve stimulation in improving pain, urinary symptoms and quality of life in CPP and BPS. In view of the dearth of quality literature, a large multi-centered clinical trial investigating the effectiveness of electrical nerve stimulation to treat BPS and CPP along with the cost-analysis of this treatment is recommended.

Future research in gynaecological surgery.

Gynaecological surgery is constantly evolving. To inform practice with high-impact research, clinicians need to focus on areas of importance. Surveys of specialist members of the British Society of Gynaecological Endoscopy have revealed a range of areas for research: diagnostic performance of laparoscopies; therapeutic laparoscopies in endometriosis; laparoscopic versus hysteroscopic sterilisation; and laparoscopic surgical techniques, among others. Clinical and economic outcomes are important in evaluating effectiveness and use of surgical health technology. For studies to be valid, reliable and generalisable, they would have to be free of bias, large and multi-centred. In a time of financial constraints, it is important to encourage clinicians and trainees to participate in important research studies to improve outcomes for patients.

Assimilating evidence quality at a glance using graphic display: research synthesis on labor induction.

Evidence profiled in the World Health Organization induction of labor guideline extended to 84 tables and 116 pages, which is hard to assimilate. Summarizing this evidence graphically can present information on key outcomes succinctly, illustrating where the gaps, strengths and weaknesses lie. For induction of labor, graphic representation clearly showed that evidence was lacking on maternal complications when comparing oxytocin with other agents, evidence was strong on birth within 24 h when comparing vaginal prostaglandins with placebo or no treatment, but again it was weak on uterine hyperstimulation when comparing oxytocin with vaginal prostaglandins. These graphs/plots allow readers to capture the essence of the information gathered at a glance. The use of graphical displays when interpreting and publishing data on several comparisons and outcomes is encouraged.