Dataset Information

Quality of ultrasonography reporting and factors associated with selection of imaging modality for uterine fibroids in Canada: results from a prospective cohort registry.

ABSTRACT:

Background

Uterine fibroids are common in women and their management is heavily influenced by information gathered through imaging. We aimed to evaluate the type and quality of imaging performed for assessment of uterine fibroids in Canada.

Methods

Starting in July 2015, premenopausal women with symptomatic fibroids were enrolled in a prospective, noninterventional, observational registry (Canadian Women With Uterine Fibroids Registry [CAPTURE]) that included 19 Canadian sites. Clinical characteristics were extracted from the baseline visit. We evaluated the association between demographic and clinical variables of interest with regard to imaging type using unadjusted and adjusted logistic regression models.

Results

Of 1493 women, 1148 had ultrasonography, 135 had magnetic resonance imaging (MRI), 80 had other types of imaging and 130 did not have imaging reported within 12 months of the baseline visit. After adjusting for demographic and clinical characteristics, patients who underwent MRI had larger fibroids (odds ratio [OR] per 1-cm increase 1.11, 95% confidence interval [CI] 1.05-1.17) and more numerous fibroids (1 v. > 1; OR 1.74, 95% CI 1.14-2.64) compared with those who underwent ultrasonography only. For ultrasonography reporting, quality criteria were met for 268 of 1148 patients (23.3%). There was a difference in the quality of reporting among the 19 sites (p < 0.001). Logistic regression model accounting for within-site variability showed that reporting results from ultrasonography in the province of Quebec were less likely to meet all quality criteria (OR 0.20, 95% CI 0.06-0.66) and those from sites in more populated cities (? 400 000 inhabitants) were more likely to do so (OR 6.15, 95% CI 2.20-17.18).

Interpretation

We determined that imaging modality for fibroids is associated with patient characteristics. The quality of reporting results for ultrasonography of fibroids in Canada falls short of internationally endorsed guidelines and needs improvement.

Study registration

ClinicalTrials.gov, no. NCT02580578.

SUBMITTER: Bougie O

PROVIDER: S-EPMC7850143 | biostudies-literature | 2020 Jul-Sep

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Quality of ultrasonography reporting and factors associated with selection of imaging modality for uterine fibroids in Canada: results from a prospective cohort registry.

Bougie Olga O Bedaiwy Mohamed A MA Laberge Philippe P Lebovic Gerald G Leyland Nicholas N Atri Mostafa M Murji Ally A

CMAJ open 20200701 3

<h4>Background</h4>Uterine fibroids are common in women and their management is heavily influenced by information gathered through imaging. We aimed to evaluate the type and quality of imaging performed for assessment of uterine fibroids in Canada.<h4>Methods</h4>Starting in July 2015, premenopausal women with symptomatic fibroids were enrolled in a prospective, noninterventional, observational registry (Canadian Women With Uterine Fibroids Registry [CAPTURE]) that included 19 Canadian sites. Cl ...[more]

PMID: 32792350

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Project description:BackgroundUterine fibroids are the most common benign tumor in women. Among those with fibroids, approximately 30% become symptomatic, with abnormal uterine bleeding, pelvic pain, and bulk symptoms. Despite the high prevalence of fibroids, little information is available regarding symptoms, treatment choices, and outcomes for patients.ObjectiveA Canada-wide patient registry was established to understand the real-world practice. This registry included patient presentation and treatment preferences, health care provider attitudes, and clinical outcomes in the management of symptomatic uterine fibroids.MethodsThis study is a prospective, noninterventional, observational patient registry. It will include women diagnosed with uterine fibroids and being managed for symptoms. Participant inclusion criteria were (1) at least 18 years of age, (2) premenopausal with a confirmed diagnosis of uterine fibroids, and associated symptoms, and (3) initiating treatment (drug intervention, procedure intervention, or a combination of both) or watchful waiting. Patients (or legal representative) must understand the nature of the project and provide written informed consent before enrollment. Participant exclusion criteria were (1) they have known or suspected clinically significant pelvic pathology not associated with uterine fibroids, and (2) they are undergoing an emergency hysterectomy at the initial visit. Outcomes will be evaluated in the context of routine clinical practice.ResultsParticipant recruitment of this registry began in July 2015. This study currently has a total sample of 1500 patients.ConclusionsThis registry, a first in Canada, will accumulate evidence on the risks and benefits of watchful waiting, and medical and procedural interventions. It will contribute to enhancing access to treatment options for patients.Trial registrationClinicalTrials.gov NCT02580578; https://clinicaltrials.gov/ct2/show/NCT02580578 (Archived by WebCite at http://www.webcitation.org/6yax4Hpvr).International registered report identifier (irrid)RR1-10.2196/10926.

Project description:BackgroundTranscervical fibroid ablation (TFA) is a minimally invasive, effective treatment of symptomatic uterine fibroids that utilizes intrauterine ultrasound for imaging and radiofrequency energy for ablation. Outcomes reported with TFA have been positive, with significant reductions in fibroid volume, improvements in symptom severity and health-related quality of life, and low complication and surgical reintervention rates. The SAGE registry characterizes the long-term (5-year) outcomes of TFA when used to treat symptomatic uterine fibroids in real-world usage.Methods/designSAGE is an ongoing postmarket global registry involving up to 50 sites and up to 500 women who select TFA with the Sonata system for treatment of symptomatic uterine fibroids. Patients are followed for 5 years. Main outcomes include symptom severity score and health-related quality of life subscales of the UFS-QoL, general health status on the EQ-5D, perceived treatment benefit, treatment satisfaction, work and activity patterns, overall patient treatment outcome, adverse events, pregnancy incidence and outcomes, and surgical reinterventions for heavy menstrual bleeding.DiscussionThe SAGE registry represents the largest known study of TFA for uterine fibroids and will generate up to 2500 patient-years of outcome data. Preliminary results from the first 160 treated women suggest broad applicability of TFA to a wide range of fibroid types and sizes and an excellent safety profile, with a device-related adverse event rate of 0.6% and a serious procedure-related adverse event rate of 0.6%. Of the 241 fibroids treated, 10% were submucous, 52% transmural, 28% intramural, and 10% subserous. Ablated fibroid diameters ranged from <1 cm to >10 cm, with 27% of fibroids having maximum diameters >5 cm. The real-world experience from SAGE will strengthen the existing evidence on the durability of TFA in providing meaningful relief from uterine fibroid symptoms and will have important clinical and economic implications for patients, physicians, and healthcare payers.Trial registrationhttps://clinicaltrials.gov, NCT03118037. Registered on 18 April 2017.

Project description:BackgroundUterine fibroids are the most common benign uterine tumours present in women of reproductive age. Mifepristone (RU-486) competitively binds and inhibits progesterone receptors. Studies have suggested that fibroid growth depends on the sexual steroids. Mifepristone has been shown to decrease fibroid size. This review summarises the effects of mifepristone treatment on fibroids and the associated adverse effects as described in randomised controlled trials.ObjectivesTo determine the efficacy and safety of mifepristone for the management of uterine fibroids in pre-menopausal women.Search methodsWe searched the specialised register of the Cochrane Menstrual Disorders and Subfertility (Cochrane Menstrual Disorders and subfertility Review Group), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 4), MEDLINE, EMBASE, PsycINFO, and CINAHL (to November 2011). We handsearched a number of journals, and searched reference lists, databases of ongoing trials and the Internet. There were no language restrictions.Selection criteriaOnly truly randomised controlled trials of mifepristone versus other forms of medical therapy or placebo in pre-menopausal women with confirmed uterine fibroids were included.Data collection and analysisFour authors independently extracted data and assessed trial quality. Data were analysed using the Peto odds ratios (OR) for dichotomous data and the weighted mean differences for continuous data, with 95% confidence intervals (CI). Meta-analyses were performed using the fixed-effect model.Main resultsThree studies involving 112 participants were included. Comparison interventions included different dosages of mifepristone, placebo and vitamin B tablets. There is evidence that treatment with mifepristone relieves heavy menstrual bleeding compared with placebo (Peto OR 17.84; 95% CI 6.72 to 47.38; 2 RCTs, 77 women, I(2) = 0%). Three studies (Bagaria 2009; Engman 2009; Fiscella 2006) were included in the meta-analysis of this comparison. There was no evidence of an effect of mifepristone on the fibroid volume (standardised mean difference (SMD) -0.02; 95% CI -0.38 to 0.41; 99 women). Two studies (Bagaria 2009; Fiscella 2006) were included in the meta-analysis of this comparison. There was no evidence of an effect of mifepristone on uterine volume (mean difference (MD) -77.24; 95% CI -240.62 to 86.14; 72 women). The pooled data suggest an increased adverse event (abnormal endometrial histology) in the mifepristone group compared to placebo (OR 31.65; 95% CI 4.83 to 207.35; 2 RCTs; 54 women; I(2) = 0%). Only one study (Bagaria 2009) reported endometrial hyperplasia at the end of the therapy (12/19 women in the mifepristone group versus 0/16 in the placebo group; OR 55.0; 95% CI 2.86 to 105.67). Engman 2009 found a significantly higher rate of cystic glandular dilatation in women in the mifepristone group (5/8 women biopsied) compared with the placebo group (1/11 women biopsied) (OR 16.67; 95% CI 1.36 to 204.03). One study (Fiscella 2006) suggested significant improvements (P < 0.001) for specific quality of life outcomes.Authors' conclusionsMifepristone reduced heavy menstrual bleeding and improved fibroid-specific quality of life. However, it was not found to reduce fibroid volume. Further well-designed, adequately powered RCTs are needed before a recommendation can be made on the use of mifepristone for the treatment of uterine fibroids.

Project description:BackgroundUterine fibroids are the most common non-malignant growths in women of childbearing age. They are associated with heavy menstrual bleeding and subfertility. Herbal preparations are commonly used as alternatives to surgical procedures.ObjectivesTo assess the benefits and risks of herbal preparations for uterine fibroids.Search strategyAuthors searched following electronic databases: the Trials Registers of the Cochrane Menstrual Disorders and Subfertility Group and the Cochrane Complementary Medicine Field, the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2008, Issue 3), MEDLINE, EMBASE, the Chinese Biomedical Database, the Traditional Chinese Medical Literature Analysis and Retrieval System (TCMLARS), AMED, and LILACS. The searches ended on 31st December 2008.Selection criteriaRandomised controlled trials comparing herbal preparations with no intervention, placebo, medical treatment or surgical procedures in women with uterine fibroids. We also included trials of herbal preparations with or without conventional therapy.Data collection and analysisTwo review authors collected data independently. We assessed trial risk of bias according to our methodological criteria . We presented dichotomous data as risk ratios (RR) and continuous outcomes as mean difference (MD), both with 95% confidence intervals (CI).Main resultsWe included two randomised trials (involved 150 women) with clear description of randomisation methods. The methodological risk of bias of the trials varied. There were variations in the tested herbal preparations, and the treatment duration was six months. The outcomes available were not the primary outcomes selected for this review, such as symptom relief or the need for surgical treatment; trials mainly reported outcomes in terms of shrinkage of the fibroids.Compared with mifepristone, Huoxue Sanjie decoction showed no significant difference in the disappearance of uterine fibroids, number of patients with shrinking of uterine fibroids or average volume of uterine fibroids, but less effective than mifepristone on reducing average size of uterus (mean difference 23.23 cm(3),95% confidence interval 17.85 to 28.61). There was no significant difference between Nona Roguy herbal product and GnRH agonist in average volume of uterine fibroids or size of uterus. No serious adverse effects from herbal preparations was reported.Authors' conclusionsCurrent evidence does not support or refute the use of herbal preparations for treatment of uterine fibroids due to insufficient studies of large sample and high quality. Further high quality trials evaluating clinically relevant outcomes are warranted.

Dataset Information

Quality of ultrasonography reporting and factors associated with selection of imaging modality for uterine fibroids in Canada: results from a prospective cohort registry.

Background

Methods

Results

Interpretation

Study registration

Publications

Quality of ultrasonography reporting and factors associated with selection of imaging modality for uterine fibroids in Canada: results from a prospective cohort registry.

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