Systematic review highlights difficulty interpreting diverse clinical outcomes in abnormal uterine bleeding trials.
ABSTRACT: (1) To systematically collect and organize into clinical categories all outcomes reported in trials for abnormal uterine bleeding (AUB); (2) to rank the importance of outcomes for patient decision making; and (3) to improve future comparisons of effects in trials of AUB interventions.Systematic review of English-language randomized controlled trials of AUB treatments in MEDLINE from 1950 to June 2008. All outcomes and definitions were extracted and organized into major outcome categories by an expert group. Each outcome was ranked "critically important," "important," or "not important" for informing patients' choices.One hundred thirteen articles from 79 trials met the criteria. One hundred fourteen different outcomes were identified, only 15 (13%) of which were ranked as critically important and 29 (25%) as important. Outcomes were grouped into eight categories: (1) bleeding; (2) quality of life; (3) pain; (4) sexual health; (5) patient satisfaction; (6) bulk-related complaints; (7) need for subsequent surgical treatment; and (8) adverse events.To improve the quality, consistency, and utility of future AUB trials, we recommend assessing a limited number of clinical outcomes for bleeding, disease-specific quality of life, pain, sexual health, and bulk-related symptoms both before and after treatment and reporting satisfaction and adverse events. Further development of validated patient-based outcome measures and the standardization of outcome reporting are needed.
Project description:A number of randomized controlled trials (RCTs) have investigated the role of perioperative corticosteroids in rhinoplasty. Each of these trials however has an insufficient sample sizes to reach definitive conclusions and detect harms. Three recent reviews have analyzed edema and ecchymosis outcomes following rhinoplasty; each arrived at a different conclusion and recommendation.To estimate the effectiveness of systemic perioperative corticosteroid treatment compared to placebo for clinical outcomes in rhinoplasty using a methodologically rigorous meta-analysis.Electronic databases were searched without language restriction. Included trials were randomized controlled trials of systemic perioperative corticosteroid treatment vs placebo in rhinoplasty evaluating at least one of: edema, ecchymosis, bleeding, cosmetic outcome, and patient satisfaction. The Cochrane risk of bias tool was applied to included trials, and the quality of evidence for each outcome was assessed using the GRADE approach.Analyses included 336 patients from eight trials. Perioperative corticosteroids reduced the worst edema (SMD: -1.03, 95%CI -1.30 to -0.76, P < .001) and ecchymosis (SMD: -0.78, 95%CI -1.09 to 0.47, P < .001) after rhinoplasty. At one day postoperative, a single dose of perioperative corticosteroid reduced edema (SMD -1.15, 95%CI -1.42 to -0.87, P < .001) and ecchymosis (SMD -0.79, 95%CI -1.05 to -0.52, P < .001). No clinical benefit in edema or ecchymosis was found seven days postoperatively, nor did intraoperative bleeding increase.There is high quality evidence to support perioperative systemic corticosteroid treatment in rhinoplasty to reduce short-term edema and ecchymosis without increased intraoperative bleeding. These findings are not present at seven days. For future trials, we suggest evaluation of patient satisfaction, and correlation with long-term cosmetic outcome. LEVEL OF EVIDENCE 2: Therapeutic.
Project description:OBJECTIVE: To compare the clinical outcomes, including efficacy and complications, of Merocel versus Nasopore as a nasal packing material after nasal surgery. METHODS: Relevant randomized controlled trials were identified from electronic databases (The Cochrane Library, PubMed, EMBASE, China National Knowledge Infrastructure and Chinese Biomedical Database). Conference proceedings and references from identified trials and review articles were also searched. Outcome measures were pain during nasal packing, pain and bleeding upon packing removal, pressure sensation, nasal blockage, formation of synechiae, mucosal healing, and patients' general satisfaction. RESULTS: Seven randomized controlled trials met criteria for analysis. Compared with Merocel, Nasopore significantly reduced patients' subjective symptoms including in situ pain (pain experienced while packing is in place), nasal pressure, pain and bleeding during packing removal, and increased patients' general satisfaction with nasal packing. There were no significant differences in nasal obstruction, adhesion and mucosal healing between the Merocel and Nasopore groups. CONCLUSIONS: Preliminary evidence suggests that Nasopore may be superior to Merocel as a nasal packing material with regard to in situ pain, pain and bleeding upon removal, pressure, and general satisfaction and does not differ from Merocel in terms of nasal obstruction, tissue adhesion, and long-term mucosal healing.
Project description:Abnormal uterine bleeding (AUB) affects 30% of reproductive age women globally. However, there are limited local studies evaluating the management of these women. The diagnostic guideline using structural and functional causes of AUB adopts the PALM-COEIN criteria, namely: Polyp; Adenomyosis; Leiomyoma; Malignancy and Hyperplasia; Coagulopathy; Ovulatory dysfunction; Endometrial; Iatrogenic; and Not yet classified. This study aimed to determine the clinical bleeding patterns, adherence to PALM-COEIN diagnosis guidelines and management of AUB among women in their reproductive age. This was a cross-sectional study among 108 women with AUB aged 18-45 years was conducted at the gynaecology department of Moi Teaching and Referral Hospital in Western Kenya between April 2018 and April 2019. Their sociodemographic and clinical characteristics were collected using interviewer administered structured questionnaire and chart reviews. Adherence to diagnosis recommendations was assessed using PALM COEIN classification. Descriptive and inferential data analysis was conducted at 95% confidence interval. The median age was 30 (IQR: 22, 41) years with prolonged bleeding as the most predominant pattern at 41.7%. Bleeding patterns were significantly associated with age (p = 0.04). Only 16.7% were diagnosed as per the PALM-COEIN criteria with PALM and COEIN accounting for 60% and 40% respectively. Leiomyoma (44.5%) was the common cause of AUB. Laboratory evaluation included: pregnancy tests, full haemogram, hormonal profile and biopsy. Most (79.6%) of the women had abdominopelvic ultrasound done. Medical management was provided for 78.7% of women. Prolonged bleeding was the most common pattern with medical management preferred. There is need for in-hospital algorithms to ensure adherence to PALM-COEIN guidelines.
Project description:BACKGROUND:Dydrogesterone has shown significant efficacy in treatment of irregular menstrual cycle due to abnormal uterine bleeding - ovulation dysfunction (AUB-O), but there were few relevant studies. This observational study was designed to evaluate the effectiveness of dydrogesterone for the treatment of Chinese patients with AUB-O. AIM:To evaluate the effects of dydrogesterone on menstrual-cycle (MC) regularization and metabolism in the patients with AUB-O. METHODS:A prospective, non-interventional, single-arm, post-marketing observational study was conducted. Chinese women aged 16 years or above with AUB-O who had been prescribed dydrogesterone were enrolled. The patients were treated with dydrogesterone 10 mg from day 16 to day 25 of each cycle, consecutively for at least 3 cycles. The main outcome was defined as the percentage of patients whose MCs returned to normal (defined as 21 d < menstrual cycle ? 35 d) after three cycles of dydrogesterone treatment. RESULTS:One hundred and fourteen women with AUB-O were enrolled in the present study. Of 89 patients who completed treatment, 72 (80.9%) achieved a regular MC at the end of the 3rd circle. The level of androgen, including testosterone and dehydroepiandrosterone sulfate, declined significantly (P = 0.01 and 0.031, respectively), whereas other hormone levels remained steady. During the treatment, 44/80 (55.0%) subjects in the per-protocol set had reported biphasic basal body temperature. CONCLUSION:Dydrogesterone therapy was effective in achieving MC regularization for Chinese patients with AUB-O.
Project description:BACKGROUND:A wide selection of Interdental Oral Hygiene (IOH) aids is available to consumers. Recommendations for selection are, however, limited by the lack of direct comparisons in available studies. We aimed to assess the comparative efficacy of IOH aids using Bayesian Network Meta-Analysis (BNMA). METHODS:Two independent reviewers performed a systematic literature review of randomized clinical trials assessing IOH aids, based on a focused question. Gingival inflammation (Gingival Index (GI), Bleeding-on-probing (BOP)) was the primary outcome and plaque and probing depth were secondary outcomes A random-effects arm-based BNMA model was run for each outcome; posterior medians and 95% credible-intervals (CIs) summarized marginal distributions of parameters. RESULTS:A two-phase selection process identified 22 trials assessing 10 IOH aids as brushing adjuncts. Interdental brushes (IB) yielded the largest reduction in GI (0.23 [95% CI: 0.09, 0.37]) as toothbrushing adjuncts, followed by water-jet (WJ) (0.19 [95% CI: 0.14, 0.24]). Rankings based on posterior probabilities revealed that IB and WJ had the highest probability of being "best" (64.7% and 27.4%, respectively) for GI reduction, whereas the probability for toothpick and floss being the "best" IOH aids was near zero. Notably, except for toothpicks, all IOH aids were better at reducing GI as compared with control. CONCLUSIONS:BNMA enabled us to quantitatively evaluate IOH aids and provide a global ranking of their efficacy. Interdental brushes and water-jets ranked high for reducing gingival bleeding, whereas toothpicks and floss ranked last. The patient-perceived benefit of IOH aids is not clear because gingival inflammation measures are physical indicators of periodontal health.
Project description:BACKGROUND:A niche in the uterus, present in 60% of women after caesarean section (CS), is associated with several gynaecological symptoms and possibly with subfertility. Studies that focus on quality of life (QoL) in relation to a niche are lacking. PURPOSE:To identify niche-related outcomes that influence QoL and to compare patient-reported outcomes with outcomes studied in the literature. METHODS:Two focus group discussions (FGDs, N?=?8 and 5) were conducted in Amsterdam UMC-location VUmc. Participants were Dutch patients with a large niche, with (planned) surgical treatment for their symptoms. Niche-related symptoms and impact on functioning or participation were fixed topics. The transcripts of the FGDs were coded into outcomes, themes and domains of QoL according to the WHOQOL model. Additionally, participants created a top five important outcomes. Next, we performed a systematic review (SR) on niche-related outcomes and compared the FGDs with niche-related outcomes from the SR. RESULTS:In four domains (physical health, psychological domain, social relationships and environment), fifteen themes were reported in the FGDs. Abnormal uterine bleeding (AUB), subfertility, sexual activity, abdominal pain and self-esteem were themes prioritised by participants. In the literature, gynaecological symptoms and reproductive outcomes were predominantly studied. Sexuality and self-esteem were prioritised in the FGDs but hardly or never studied in the literature. CONCLUSION:We found a broad range of niche-related outcomes influencing QoL. Apart from symptoms evaluated in the literature such as AUB, abdominal pain and subfertility, clinicians and researchers should be more aware of sexual activity and self-esteem in this population.
Project description:We conducted a prospective observational study investigating the clinical relevance of endometrial thickness (ET) and abnormal uterine bleeding (AUB) on endometrial cancer (EC) risk in a cohort of postmenopausal patients undergoing diagnostic hysteroscopy and endometrial biopsy. Patients were divided into two groups according to the indication of diagnostic hysteroscopy: ET_Group (asymptomatic patients with endometrial thickness ? 4 mm) and AUB_Group (patients with a history of abnormal uterine bleeding). We further divided the AUB_Group into two subgroups based on endometrial thickness (AUB_Subgroup1: ET < 4 mm; AUB_Subgroup2: ET ? 4 mm). The primary outcome was the risk of endometrial cancer and atypical hyperplasia according to the indications of diagnostic hysteroscopy (AUB, ET ? 4 mm or both). The secondary outcome was to determine the best cut-off value of endometrial thickness to predict endometrial cancer in asymptomatic postmenopausal women. The prevalence of endometrial cancer and atypical hyperplasia in AUB_Group and ET_Group was 21% and 6.7% respectively. As well as for EC alone, higher prevalence of both conditions was observed in AUB_Subgroup2 (29.3%) in comparison to AUB_Subgroup1 (10.6%; p < 0.001). In asymptomatic patients the cut-off of endometrial thickness that showed the best sensitivity and specificity to diagnose endometrial cancer (100% and 80% respectively) was 11 mm (AUC of 91.4%; Exp?: 1067; CI 95%). In conclusion, considering the high risk of neoplasia, diagnostic hysteroscopy with endometrial biopsy should be mandatory in cases of abnormal uterine bleeding in postmenopausal patients. Moreover, we want to emphasize the need for further evidence stating the clinical relevance of endometrial thickness value in asymptomatic patients and the impact of individual risk factors on endometrial cancer development.
Project description:OBJECTIVE:The objective of the study was to compare success rates, complications and management costs of different surgical techniques for abnormal uterine bleeding (AUB). METHODS:This was a retrospective analysis of the French national hospital discharge database. All hospital stays with a diagnostic code for AUB and an appropriate surgical procedure code between 2009 and 2015 inclusive were identified, concerning 109,884 women overall. Outcomes were compared between second generation procedures (2G surgery), first-generation procedures (1G surgery), curettage and hysterectomy. Clinical outcomes were treatment failure and complications during the follow-up period. Costs were attributed using standard French hospital tariffs. RESULTS:7,863 women underwent a 2G procedure (7.2%), 39,935 a 1G procedure, (36.3%), 38,923 curettage (35.4%) and 23,163 hysterectomy (21.1%). Failure rates at 18 months were 9.9% for 2G surgery, 12.7% for 1G surgery, 20.6% for curettage and 2.8% for hysterectomy. Complication rates at 18 months were 1.9% for 2G surgery, 1.5% for 1G surgery, 1.4% for curettage and 5.3% for hysterectomy. Median 18-month costs were € 1 173 for 2G surgery, € 1 059 for 1G surgery, € 782 for curettage and € 3 090 for hysterectomy. CONCLUSION:Curettage has the highest failure rate. Hysterectomy has the lowest failure rate but the highest complication rate and is also the most expensive. Despite good clinical outcomes and relatively low cost, 1G and 2G procedures are not widely used. Current guidelines for treatment of AUB are not respected, the recommended 2G procedures being only used in <10% of cases.
Project description:Incomplete abortion, a procedure for terminating pregnancy, will lead to abnormal uterine bleeding (AUB), infections, and even death. Taohong Siwu decoction (TSD) is a traditional Chinese medicine (TCM) formula, which has been developed to treat AUB for hundreds of years. However, the mechanism of the protective effect of TSD against AUB is not clear. We performed mass spectrometry (MS) of uterine samples to observe metabolic profile resulting from the treatment with TSD. An integrated gas chromatography-mass spectrometry and liquid chromatography-mass spectrometry based untargeted metabolomics approach combined with multivariate statistical analyses were used to investigate the metabolic profile of TSD against AUB. There was clear separation between pregnant and incomplete aborting rats as well as incomplete aborting and TSD administered rats. Based on random forest algorithm and receiver operator characteristic analysis, 12 biomarkers were optimized related to TSD administered. The effect of TSD on AUB are related to several pathways, such as AA metabolism, glyoxylate and dicarboxylate metabolism, alanine, aspartate, and glutamate metabolism. To our knowledge, this is the first uterine metabolomics study focusing on TSD on AUB and provide a new perspective for explaining the mechanism of TSD on AUB.
Project description:BACKGROUND:There is limited consensus regarding risk factors for postoperative bleeding. The objective of this work was to investigate the capability of machine learning techniques in combination with practice-based longitudinal electronic medical record data for identifying potential new risk factors for postoperative bleeding and predicting patients at high risk of postoperative bleeding. METHODS:A retrospective study was conducted for patients who underwent colorectal surgery 1998-2015 at a single tertiary referral center. Various predictors were extracted from electronic medical record. The outcome of interest was the occurrence of postoperative bleeding within 7 days of surgery. Logistic regression and gradient boosting machine models were trained. Area under the receiver operating curve and area under the precision recall curve were used to evaluate the performance to different models. RESULTS:Of 13,399 cases undergoing colorectal resection, 1,680 (12.5%) experienced postoperative bleeding. A total of 299 variables were evaluated. Logistic regression and gradient boosting machine models returned an area under the receiver operating curve of 0.735 and 0.822 and area under the precision recall curve of 0.287 and 0.423, respectively. In addition to well-known risk factors for postoperative bleeding, nutrition (ranked third), weakness (ranked fifth), patient mobility (ranked sixth), and activity level (ranked eighth) were found to be novel predictors in the gradient boosting machine model based on permutation importance. CONCLUSION:The study identified measures of functional capacity of patient as novel predictors of postoperative bleeding. The study found that risk of postoperative bleeding can be assessed, allowing for better use of human resources in addressing this important adverse event after surgery.