Clinical and surgical factors associated with opioid refill rates following septorhinoplasty.

BACKGROUND: Septorhinoplasty is one the most common class of procedures performed worldwide, and opioids are frequently prescribed for post-operative pain [1]. OBJECTIVE: The objective of this study was to examine the rate of post-operative opioid prescription refills following septorhinoplasty. METHODS: This study was a case-control study of patients who underwent septoplasty and other secondary concomitant procedures. RESULTS: Of the 249 patients included in this study, the majority of patients (94.8%) were prescribed 12 tablets of hydrocodone-acetaminophen 5 mg - 325 mg and only 31 patients (13.3%) received refills. The presence of osteotomies and history of prior opioid use were associated with refills. Nasal valve repair type, open versus closed approach, and presence of autologous auricular cartilage graft harvest were not. DISCUSSION: Our study highlights factors that surgeons should consider when prescribing opioids after septorhinoplasty. Twelve tablets of an opioid are likely sufficient for the majority of patients, but if osteotomies are performed or the patient has a history of prior opioid use, more may be indicated to avoid the need for refills. Additional narcotics are not necessary for an open approach or for patients in which auricular cartilage is needed.

Impact of COVID-19 Pandemic on Patients with Serious Mental Illness (SMI) and Nonpsychiatric Control Subjects in Clinical Trials.

Objective: This study aimed to examine the impact of the COVID-19 pandemic on patients with serious mental illness (SMI), specifically relating to psychiatric morbidity, pandemic-induced stress, and ability to cope with pandemic-related precautionary measures, restrictions, and disruptions to daily life. Design: A cross-sectional survey study of 277 clinical trial patients was conducted. This sample included nonpsychiatric controls (n=139) and patients with a diagnosis of bipolar disorder, major depressive disorder (MDD), or schizophrenia (n=138) located at five clinical trial sites across the United States. A univariate analysis was performed to obtain general frequencies of the sample. Unpaired t-tests were used in comparing the groups on numerical variables, and analysis of variance (ANOVA) was performed to identify differences when comparing three or more categories. Results: Patients with SMI were more likely to report wearing face masks, avoiding large gatherings, and endorsing the use of precautionary measures, despite receiving a COVID-19 vaccine (p<0.001). A total of 70.3 percent (n=97) of all patients with SMI reported experiencing at least one episode of symptom worsening, 48 percent reported experiencing suicidal ideation, and 66 percent reported a need for increased mental healthcare due to COVID-19-related distress. Patients with SMI reported higher levels of stress, compared to controls, with patients with MDD having the highest levels of stress (p<0.001). Conclusion: These findings demonstrate an increased vulnerability to symptom worsening in patients with SMI during a pandemic and suggest the need to account for pandemic-induced psychological stress in clinical trial design, subject selection, and symptoms ratings.

Endometriosis Reccurence ­ is Ultrasound the Solution?

BACKGROUND: Transvaginal and transabdominal ultrasonography has become a widely used investigative method in the diagnostic workup of endometriosis, as well as for the postoperative follow-up. The variety of lesions, the distorted anatomy caused by adhesions and the fibrosis process represent the main challenges of the ultrasound evaluation. Regarding the recurrence of endometriosis, the diagnostic criteria are being imprecise, being adjusted according to the development of ultrasound techniques. OBJECTIVE AND METHODS: To this study, extensive research has been performed interrogating PubMed, Embase and Web of Science databases to identify published research including patients with endometriosis who underwent surgery. Included patients had postoperative ultrasound investigations to detect evidence of endometriosis recurrence. The selected timeframe was 5 years. We conducted a literature review on ultrasound markers of endometriosis recurrence. RESULTS: In this analysis, 2023 patients from 9 studies were included. The recurrence rate detected was 17.26%. The postoperative treatment was different in the selected studies and they include the administration of progesterone, oral combined contraceptives, GnRh antagonists, aromatase inhibitors and intrauterine devices with prolonged release of progesterone. DISCUSSION: The recurrence rate is different in the selected studies as a result of the recurrence definition used by each author and the minimum dimension of the lesions, in case of the cystic pattern. Innovative techniques of differential diagnosis by ultrasound are proposed, one of them being the textural analysis performed by computer-aided diagnosis ­ CAD. In order to standardize the recommendations regarding imaging techniques, we propose an algorithm for following up with patients in the postoperative period. CONCLUSION: The transabdominal or endovaginal ultrasound performed regularly represents a key factor to determine the recurrence of endometriosis in the postoperative period and the imaging reassessment is recommended to be performed at a 6-month interval.

The Benefits of a Comprehensive Cardiac Rehabilitation Program for Patients with Acute Coronary Syndrome: A Follow-Up Study.

BACKGROUND AND OBJECTIVES: Secondary prevention after acute coronary syndrome (ACS) is essential to reduce cardiovascular mortality and hospital readmission, ensuring patients return to normal with an improved quality of life. Thus, we investigate the benefits of a comprehensive cardiac rehabilitation (CR) program on lifestyle, risk factors and adherence to guideline-directed medical therapy (GDMT) in patients after ACS and myocardial revascularization through coronary artery by-pass grafting (CABG) or percutaneous coronary intervention (PCI). METHODS: This is a prospective, longitudinal study in consecutive post-CABG or PCI patients after ACS that participated or not in a comprehensive CR. Cardiovascular risk factors, quality of life and adherence to GDMT were analyzed in terms of assessing the benefit of 12 months of comprehensive CR on reaching guidelines secondary prevention targets. RESULTS: At the inclusion in comprehensive CR of all patients (n = 480), 85% had hypertension; 86% had elevated total cholesterol values; 69% were characterized by metabolic syndrome; 43% were obese; 31% were active smokers and 29% had type 2 diabetes mellitus. Only 26.66% (n = 128) followed the entire program for 12 months. No statistically significant differences in the prescription of GDMT at hospital discharge after myocardial revascularization between the CR (+) group (n = 128) versus CR (-) group (n = 352) (p > 0.05) were observed. After 12 moths, a significant adherence to GDMT in the CR (+) group vs. CR (-) group was recorded, as follows: antiplatelet agents (100% versus 96%, p = 0.001), beta-blockers (99% versus 92%, p = 0.02), ACE inhibitors/ARAB (89% versus 79%, p = 0.04), lipid-lowering drugs (100% versus 89%, p = 0.001). In total, 82% of the CR (+) patients had a significantly higher adherence at GDMT (82% versus 64%, p = 0.001). At 12 moths, the CR (+) group was characterized by significantly lower values than at the inclusion but some values still increased: systolic blood pressure (139.25 + 19.20 mmHg (p < 0.03)), total cholesterol (171.07 + 48.59 mg/dL (p = 0.0001)) and LDL-cholesterol (102.83 + 41.30 mg/dL (p = 0.009)). At the same time, the analysis of psychosocial factors using the HAD questionnaire revealed a statistically significant improvement in anxiety and depression scores: HAD-A score (9.1 ± 3.7 at T0 vs. 7.1 ± 4.2 at T1, p = 0.001) and HAD-D score (7.7 ± 3.19 at T0 vs. 6.4 ± 4.3 at T1, p = 0.003). A multivariable analysis, following GDMT, showed the actual value or information and training of patients regarding optimal cardiovascular risk factor control was independently associated with lower values of systolic blood pressure (R2 = 0.48), diastolic (R2 = 0.38), serum glucose (R2 = 0.48), glycated hemoglobin (R2 = 0.50), total cholesterol (R2 = 0.31), LDL-cholesterol (R2 = 0.30), HDL-cholesterol (R2 = 0.19) and serum triglycerides (R2 = 0.20). CONCLUSION: The twelve-month participation of post-ACS patients in comprehensive CR resulted in excellent post-revascularization management, as well as good adherence to guideline-directed medical therapy, provided further confirmation of the benefit of secondary prevention. Despite high adherence to drug treatments, targets for blood pressure, total cholesterol and LDL-cholesterol are inadequately achieved. Therefore, in the era of personalized medicine, patients with ACS should benefit from specific, comprehensive cardiovascular recovery programs that contain physiotherapists, psychologists, nutritionists and an experienced cardiologist in cardiovascular rehabilitation.

Fetal Ovarian Cyst-A Scoping Review of the Data from the Last 10 Years.

Abdominal cystic masses are diagnosed during the intrauterine period and have a relatively low incidence. Fetal ovarian cysts are the most common form diagnosed prenatally or immediately after birth. The pathophysiology of the development of these types of tumors is not fully elucidated, with ovarian hyperstimulation caused by maternal and placental hormones being the most accepted hypothesis. During intrauterine development, the diagnosis of fetal ovarian cysts is most often made accidentally during usual check-up ultrasounds corresponding to the first, second, and third trimesters of pregnancy. We conducted a scoping review with the aim to map the current knowledge regarding the treatment of fetal ovarian cysts diagnosed in the intrauterine period. Focusing on the articles published in the last 10 years in the specialized literature, we tried to identify a conceptualization regarding the surveillance and treatment of these anomalies.

Amniocentesis-When It Is Clear That It Is Not Clear.

A fetus identified to be at risk for chromosomal abnormalities may benefit from identification of genetic defects through amniocentesis. Although the risks associated with amniocentesis are considered to be minimal, being an invasive procedure it is not completely without complications. BACKGROUND AND OBJECTIVES: The current study aims to identify correlations between blood contamination of samples collected during amniocentesis and certain factors dependent on the instruments used (thickness of the needle used to aspirate the fluid), the location of the placenta, and uterine vascularity (more pronounced in multiparous patients). MATERIALS AND METHODS: The study included 190 patients in the second trimester of pregnancy who met one of the criteria for invasive prenatal diagnosis (age over 35 years, high risk in first trimester screening, history of pregnancies with genetic abnormalities, etc.). The amniotic fluid samples collected from these patients were analyzed in terms of blood contamination of the amniotic fluid aspirated with maternal cells Results: Of the patients in whom the procedure was performed using 21 G size needles, 16 samples (13.33% of the total) were contaminated. None of the samples collected from patients where a 20 G needle was used were contaminated. There was a statistically significant association between the lack of contamination and the use of Doppler ultrasound in multiparous patients with anterior placenta in whom a 21-gauge needle was used for amniocentesis. CONCLUSIONS: There is an increased rate of sample contamination (statistically significant) when using 21 G needle sizes and a significant difference in contamination between primiparous and multiparous patients, with contamination being more frequent in multiparous patients. The use of Doppler ultrasonography may benefit the procedure, as the contamination rate was significantly reduced when used during amniocentesis.

Increased Susceptibility for Thromboembolic Events versus High Bleeding Risk Associated with COVID-19.

The infection with the SARS-CoV-2 virus is associated with numerous systemic involvements. Besides the severe respiratory injuries and cardiovascular complications, it became obvious early on that this disease carries an increased risk of thromboembolic events, but a higher propensity for bleedings as well. We researched the medical literature over significant PubMed published articles debating on the prevalence, category of patients, the moment of occurrence, and evolution of venous thromboembolism (VTE), but also of venous and arterial "in situ" thrombosis (AT), and hemorrhagic events as well. Most researchers agree on an increased prevalence of thromboembolic events, ranging between 25 and 31% for VTE, depending on the analyzed population. For AT and hemorrhagic complications lower rates were reported, namely, about 2-3%, respectively, between 4.8 and 8%, occurring mostly in older patients, suffering from moderate/severe forms of COVID-19, with associated comorbidities. It is important to mention that patients suffering from hemorrhages frequently received thromboprophylaxis with anticoagulant drugs. As a consequence of thromboembolic and hemorrhagic complications which are both important negative prognostic factors, the evolution of patients infected with the SARS-CoV-2 virus is aggravated, determining an augmented morbidity and mortality of this population.

Magnetic Resonance Imaging Screening after Silicone Implant Breast Surgery: Patient Survey of Adherence to U.S. Food and Drug Administration Recommendations.

BACKGROUND: The U.S. Food and Drug Administration recommends women with silicone breast implants undergo magnetic resonance imaging surveillance to detect asymptomatic rupture. Screening is costly and often not covered by insurance. The authors assessed awareness of and adherence to these recommendations among patients with silicone breast implants. METHODS: The authors searched electronic medical records for patients aged 18 years or older with silicone breast implants placed between 2011 and 2016. Consenting patients were surveyed by telephone using a standardized script to assess awareness of U.S. Food and Drug Administration recommendations, whether they had undergone magnetic resonance imaging screening, and barriers to testing. Patients who declined to participate or could not be contacted were excluded. Demographics and operative data were collected. Odds ratios were calculated with one-sample 95 percent confidence intervals, and Fisher exact tests of independence were conducted under assumptions of normality. Multivariable logistic regression analysis was performed to test for confounding. RESULTS: Of 370 patients meeting inclusion criteria, 109 consented to participate. Adherence to U.S. Food and Drug Administration recommendations was 5.9 percent (95 percent CI, 0.15 to 28.7 percent). There was no difference in adherence between patients undergoing cosmetic versus reconstructive surgery ( p = 1.00; OR, 0.80; 95 percent CI, 1.17 to 2.93), having health insurance ( p = 0.58), or residing in a county with median annual household income greater than that of the state of residence ( p = 0.33). CONCLUSIONS: A small proportion of respondents had undergone magnetic resonance imaging in accordance with U.S. Food and Drug Administration recommendations. Low adherence highlights a potential limitation of current federal surveillance recommendations. Additional research is needed to better characterize adherence to magnetic resonance imaging surveillance recommendations, identify barriers to implementation, and determine whether this recommendation remains valid.

Maternal and neonatal outcomes associated with delivery techniques for impacted fetal head at cesarean section: a systematic review and meta-analysis.

OBJECTIVES: Late first-stage or second-stage cesarean section is commonly associated with fetal head impaction, leading to maternal and neonatal complications. This situation requires safe delivery techniques, but the optimal management remains controversial. The aim of this meta-analysis was to compare maternal and neonatal outcomes associated with delivery techniques via cesarean section. METHODS: An electronic search of three databases, from inception to June 2021, was conducted. Cohort and randomised comparative studies on maternal and neonatal outcomes associated with techniques to deliver an impacted fetal head during cesarean section were included. The methodological quality of the primary studies was assessed. Review Manager 5.4 was used for statistical analyses. RESULTS: Nineteen articles, including 2,345 women were analyzed. Three fetal extraction techniques were identified. Meta-analyses showed that the "pull" technique carries lower risks as compared to the "push" technique and the "Patwardhan" technique is safer compared to the "push" or the "push and pull" technique. CONCLUSIONS: In the absence of robust evidence to support the use of a specific technique, the choice of the obstetrician should be based on best available evidence. Our study suggests that the "pull", as well as the "Patwardhan" technique represent safe options to deliver an impacted fetal head.

Outcome reporting in randomized controlled trials (RCTs) on the pharmacological management of idiopathic overactive bladder (OAB) in women; a systematic review for the development of core outcome sets (COS).

INTRODUCTION AND HYPOTHESIS: Evidence on OAB management remains suboptimal and methodological limitations in randomized control trials (RCTs) affect their comparability. High quality meta-analyses are lacking. This study aimed to compare selection and reporting of outcomes and outcome measures across RCTs as well as evaluate methodological quality and outcome reporting quality as a first stage in the process of developing core outcome sets (COS). METHODS: RCTs were searched using Pubmed, EMBASE, Medline, Cochrane, ICTRP and Clinicaltrials.gov from inception to January 2020, in English language, on adult women. Pharmacological management, interventions, sample size, journal type and commercial funding were documented. Methodological and outcome reporting quality were evaluated using JADAD and MOMENT scores. RESULTS: Thirty-eight trials (18,316 women) were included. Sixty-nine outcomes were reported, using 62 outcome measures. The most commonly reported outcome domains were efficacy (86.8%), safety (73.7%) and QoL (60.5%). The most commonly reported outcomes in each domain were urgency urinary incontinence episodes (UUI) (52.6%), antimuscarinic side effects (76.3%) and change in validated questionnaire scores (36.8%). A statistically significant correlation was found between JADAD and MOMENT (Spearman's rho = 0.548, p < 0.05) scores. This indicates that higher methodological quality is associated with higher outcome reporting quality. CONCLUSIONS: Development of COS and core outcome measure sets will address variations and lead to higher quality evidence. We recommend the most commonly reported outcomes in each domain, as interim COS. For efficacy we recommend: UUI episodes, urgency and nocturia episodes; for safety: antimuscarinic adverse events, other adverse events and discontinuation rates; for QoL: OAB-q, PPBC and IIQ scores.

A meta-synthesis of qualitative studies on stress urinary incontinence in women for the development of a Core Outcome Set: A systematic review.

OBJECTIVE: Given the high variation of perceptions of women with stress urinary incontinence (SUI), qualitative meta-synthesis in this field appears warranted. We aimed to synthesize evidence on women's experiences of SUI by analyzing qualitative data. METHODS: A literature search of Medline, Embase, Scopus, PsycInfo, and CINAHL databases was performed by a CHORUS Working Group, from inception to August 2020. Qualitative studies on women's perspectives on SUI were included. Thematic analysis was used as a conceptual approach to analyze the data and develop a set of overarching themes. The quality of studies was assessed based on the Critical Appraisal Skills Program tool. RESULTS: Seven studies were included. Six themes encompassing women's perspectives on SUI emerged: experiencing SUI, awareness of SUI, treatments for SUI, sexuality, communication, and psychosocial effects. The quality appraisal of the studies showed good coherence. CONCLUSION: This study revealed six overarching themes, of which treatment had the highest prevalence. Assessment of women's perceptions of SUI in the context of a qualitative meta-synthesis may inform policy and practice around this condition, may guide and help set research priorities, and will ideally contribute to the development of a Core Outcome Set for SUI.

Reversal of colpocleisis-A surgical technique for recurrent pelvic organ prolapse.

Given the rarity of recurrent pelvic organ prolapse after obliterative procedures and the paucity of data in the literature on this topic, optimal management is challenging. We describe a technique of reversal of colpocleisis in an 81-year-old woman with recurrent prolapse as the first step in a staged, reconstructive procedure. Basic principles underlying our approach include multidisciplinary team involvement, detailed preoperative planning, and a series of investigations including different imaging modalities and a meticulous stepwise surgical technique. The distortion of anatomical planes, anticipated scarring, and close proximity of pelvic organs specifically bladder and rectum are important considerations. In our case, the multidisciplinary surgical team included urogynecologists, a urologist, and a colorectal surgeon. Detailed preoperative planning was agreed following multiple patient and team consultations. Preoperative investigations included ultrasound and videourodynamics. Intraoperatively, cystoscopy and sigmoidoscopy were performed to identify anatomical landmarks and planes, rule out fistulae, and evaluate for anatomical distortions involving pelvic organs. Subsequently, reversal of the colpocleisis was undertaken and uneventful. Postoperative recovery was uncomplicated and a sacrospinous fixation, anterior vaginal repair, and perineorrhaphy were performed as a secondary restorative procedure for the correction of recurrent prolapse.

Outcome reporting in trials on conservative interventions for pelvic organ prolapse: A systematic review for the development of a core outcome set.

BACKGROUND: Significant risk of bias and limitations in outcome selections in trials evaluating conservative treatments for the management of Pelvic Organ Prolapse (POP) have been highlighted and preclude comparability of outcomes, synthesis of primary studies and high quality evidence. OBJECTIVES: As systematic review of the reported outcomes is the first step in the process of development of a Core Outcome Set (COS), we aimed to systematically review reporting of outcomes and outcome measures in Randomised Control Trials (RCTs) on conservative treatments for POP and develop an inventory of them for consideration as core outcome and outcome measures sets. We evaluated methodological quality, outcome reporting quality and publication characteristics and their associations among published RCTs. STUDY DESIGN: Systematic review of RCTs identified from the following databases: Cochrane Central Register of Controlled Trials (CENTRAL), EMBASE and MEDLINE (Pubmed). RCTs evaluating the effectiveness of conservative interventions for the management of POP were considered for inclusion. Outcomes and outcome measures were obtained from the RCTs and an inventory was created. Outcomes were grouped in domains and themes. Methodological quality, outcome reporting quality and publication characteristics were evaluated and statistically analysed. RESULTS: Twenty-five trials (3179 women) were included and reported 31 outcomes and 50 outcome measures. Reporting rates of the outcomes investigated ranged between 4% and 56%. The most commonly reported outcome domains were patient reported symptoms, stage of POP expressed as POP-Q stage, and quality of life. Univariate analysis demonstrated no significant correlations of methodological and outcome reporting parameters. CONCLUSIONS: There is a need to increase comparability of RCTs. Reporting standardized outcomes included in a COS for conservative interventions for POP will facilitate the comparability across RCTs. While the process of developing COS is in progress, we propose the interim use of the three most commonly reported outcomes in each domain: patient-reported outcomes (symptom distress including bowel and urinary symptoms, sexual function), stage of prolapse and quality of life parameters using validated questionnaires (Pelvic Floor Distress Inventory 20 (PFDI-20), Pelvic Floor Impact Questionnaire/Health related quality of life (PFIQ-7/HRQOL) and Pelvic Organ Prolapse Impact Questionnaire (POPIQ-7).

Impact of COVID-19 Pandemic on Psychiatric Patients at Clinical Trial Sites.

Introduction: Recent research on the COVID-19 pandemic suggests that individuals who suffer from serious mental illness (SMI) are at heightened risk of infection and have increased mortality due to their illness and/or lack of access to healthcare. Consequently, progress in developing new treatments for SMIs has been disrupted, with many interruptions to clinical trials in psychiatry due to concerns regarding the pandemic and its risks to patients with SMI. Objective: This study aimed to examine the impact of the COVID-19 pandemic on patients with SMI, specifically relating to psychiatric morbidity, pandemic-induced stress, and ability to cope with pandemic-related precautionary measures, restrictions, and disruptions to daily life. Design: A cross-sectional survey study of 94 clinical trial patients diagnosed with bipolar disorder, major depressive disorder (MDD), or schizophrenia was conducted in three geographically distinct clinical trial sites between June and September 2020. Prevalence rates were calculated for sample characteristics and demographics, and low versus high stress groups were compared on survey variables using Pearson's Chi-squared test of independence. Results: The results from the surveys indicated that COVID-19 knowledge, awareness, and the use of precautionary safety measures (e.g., handwashing, personal protective equipment [PPE], and social distancing) were robust and mirrored the general population. While the majority of patients reported experiencing moderate or extreme levels of distress (61.5%, n=56), high levels of stress were correlated with positive coping skills. Conclusion: These findings suggest that clinical trial patients with SMI can safely participate in clinical trials despite the increase safety risks posed by the COVID-19 pandemic.

Developing Core Outcome Sets (COS) and Core Outcome Measures Sets (COMS) in Cosmetic Gynecological Interventions: Protocol for a Development and Usability Study.

BACKGROUND: Studies evaluating cosmetic gynecological interventions have followed variable methodology and reported a diversity of outcomes. Such variations limit the comparability of studies and the value of research-based evidence. The development of core outcome sets (COS) and core outcome measures sets (COMS) would help address these issues, ensuring a minimum of outcomes important to all stakeholders, primarily women requesting or having experienced cosmetic gynecological interventions. OBJECTIVE: This protocol describes the methods used in developing a COS and COMS for cosmetic gynecological interventions. METHODS: An international steering group within CHORUS, including health care professionals, researchers, and women with experience in cosmetic gynecological interventions from 4 continents, will guide the development of COS and COMS. Potential outcome measures and outcomes will be identified through comprehensive literature reviews. These potential COS and COMS will be entered into an international, multi-perspective web-based Delphi survey where Delphi participants judge which domains will be core. A priori thresholds for consensus will get established before each Delphi round. The Delphi survey results will be evaluated quantitatively and qualitatively in subsequent stakeholder group consensus meetings in the process of establishing "core" outcomes. RESULTS: Dissemination and implementation of the resulting COS and COMS within an international context will be promoted and reviewed. CONCLUSIONS: This protocol presents the steps in developing a COS and COMS for cosmetic gynecological interventions. Embedding the COS and COMS for cosmetic gynecological interventions within future clinical trials, systematic reviews, and practice guidelines could contribute to enhancing the value of research and improving overall patient care. TRIAL REGISTRATION: Core Outcome Measures in Effectiveness Trials (COMET) 1592; https://tinyurl.com/n8faysuh. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/28032.

Patient-reported outcomes and outcome measures in childbirth perineal trauma research: a systematic review.

INTRODUCTION AND HYPOTHESIS: In evaluating the effectiveness of interventions in perineal trauma research, outcomes reported by patients should have a prominent focus. There is no international consensus regarding the use of either patient-reported outcomes (PROs) or tools used to determine these outcomes (patient-reported outcome measures, PROMs). The objective was to evaluate the selection, reporting and geographical variations of PROs and PROMs in randomised controlled trials (RCTs) on perineal trauma. METHODS: We performed a systematic review of RCTs in perineal trauma research evaluating outcome and outcome measure reporting. We identified PROs and PROMs and grouped PROs into domains and themes, a classification system based on a medical outcome taxonomy. RESULTS: Of 48 included RCTs, 47 reported PROs. In total, we identified 51 PROs. Outcome reporting consistency was low, with 27 PROs reported only once. Nine PROs were reported more than five times, the most frequent being perineal pain, with no geographical variation in reporting. Four themes encompassing 12 domains were identified. The most frequently reported theme was "Clinical", with 25 PROs grouped within four domains. "Resource use" and "Adverse events" themes were rarely reported, with only five PROs. PROMs also exhibited variation. Most common were visual analogue scale (VAS; 100 mm), Cleveland Clinic Continence Score, The Faecal Incontinence Quality of Life scale, VAS (0-10) and the McGill Pain Questionnaire. CONCLUSIONS: Significant heterogeneity in PROs and PROMs was observed among RCTs. Despite inconsistency, PROs are the most prevalent outcome in perineal trauma research. Patient-reported adverse events are underreported. Their use in determining the effectiveness and safety of interventions makes their integration important in perineal trauma core outcome sets. Identification and grouping of outcomes will assist future core outcome consensus studies.

Structure-property relationships on recrystallized ß-cyclodextrin solvates: A focus on X-ray diffractometry, FTIR and thermal analyses.

The goal of the study was to evaluate the influence of the solvent properties on the crystal characteristics of ß-cyclodextrin (ß-CD) recrystallized from alcohol-water solvent mixtures, with possible applications for the preparation, purifying and complexation of ß-CD. For the first time, structure-property relationships (QSPRs) between the hydrophobicity of alcohols or dielectric constant of solvents used for recrystallization of ß-CD and its properties (such as crystallinity index, CI) have been obtained. Recrystallized ß-CD from water and C1-C4 alcohol-water solutions provide ß-CD with higher CI values of 99.4(±5.9)% for ethanol-water (1:4, v/v) as recrystallizing system. This property has a parabolic variation with the logP (octanol/water partition coefficient) of the alcohol (r2 = 0.998). Solvent parameters also influence the ß-CD crystal characteristics, as was demonstrated by X-ray diffractometry refinement, infrared spectroscopy and thermal analyses.

The profile of urinary biomarkers in overactive bladder.

AIMS: In overactive bladder (OAB) research, different biomarkers have been proposed as diagnostic tools and may be used to create individual patient profiles. Assessing the diagnostic performance of biomarkers would better outline their utility. Therefore, our aim was to investigate the diagnostic value of four urinary biomarkers: human brain derived neurotrophic factor (hBDNF), malondialdehyde (MDA), h nerve growth factor (hNGF) and h 8-hydroxydeoxyguanosine in women with OAB. These are neurotrophins/oxidative stress markers that have been linked to lower urinary tract symptoms. METHODS: A total of 105 women were included in the study and distributed in two groups: a group with OAB (n = 53) and a control group (n = 50). The levels of the biomarkers were determined using enzyme-linked immunosorbent assay technique and they were compared between the groups. If the Mann-Whitney test demonstrated a statistically significant difference, receiver operating curves (ROC) analysis was undertaken. RESULTS: When normalized to urinary creatinine, hBDNF, MDA, and hNGF showed significantly increased values in women with OAB as compared to controls, whereas 8-OHdG showed no significant difference. The diagnostic performance of these biomarkers was analyzed based on the area under the ROC curve (AUC). MDA had the highest AUC (0.75), followed by hNGF (0.69) and hBDNF (0.67). CONCLUSIONS: Our findings suggest that MDA, a relatively novel biomarker in OAB research, has a fair performance as a diagnostic tool for OAB. Moreover, urinary neurotrophins (NGF and BDNF) as biomarkers may have a role in the diagnostic pathways of women with OAB symptoms.

Uterine Artery Doppler Ultrasonography for First Trimester Prediction of Preeclampsia in Individuals at Risk from Low-Resource Settings.

Background and objectives: The objective of this study was to evaluate the potential of first trimester uterine artery Doppler ultrasonography for the early prediction of preeclampsia (PE), in at-risk pregnant women. Materials and Methods: This was a prospective longitudinal study, including 120 Caucasian pregnant women with risk factors for PE. The potential of pulsatility indexes (PI) and notch was assessed as a tool for preeclampsia screening. Results: Doppler examination of the uterine artery performed early at 11-14 WA allows the detection of pregnancies that will develop PE with a sensitivity of 61.5% and a specificity of 63.8% based on PI analysis. Predictive power increases slightly by adding bilateral notch (sensitivity = 65.4%; specificity = 66%). Conclusions: Uterine artery Doppler examination is an effective non-invasive screening test for the development of PE in pregnancies at risk, particularly appropriate in health systems with limited means of evaluating other biomarkers.

A protocol for developing, disseminating, and implementing a core outcome set (COS) for childbirth pelvic floor trauma research.

BACKGROUND: More than 85% of women sustain different degrees of trauma during vaginal birth. Randomized controlled trials on childbirth pelvic floor trauma have reported a wide range of outcomes and used different outcome measures. This variation restricts effective data synthesis, impairing the ability of research to inform clinical practice. The development and use of a core outcome set (COS) for childbirth pelvic floor trauma aims to ensure consistent use of outcome measures and reporting of outcomes. METHODS: An international steering group, within CHORUS, an International Collaboration for Harmonising Outcomes, Research and Standards in Urogynaecology and Women's Health, including academic community members, researchers, healthcare professionals, policy makers and women with childbirth pelvic floor trauma will lead the development of this COS. Relevant outcome parameters will be identified through comprehensive literature reviews. The selected outcomes will be entered into an international, multi-perspective online Delphi survey. Subsequently and based on the results of the Delphi surveys consensus will be sought on 'core' outcomes. DISCUSSION: Dissemination and implementation of the resulting COS within an international context will be supported and promoted. Embedding the COS for childbirth pelvic floor trauma within future clinical trials, systematic reviews, and clinical practice guidelines is expected to enrich opportunities for comparison of future clinical trials and allow better synthesis of outcomes, and will enhance mother and child care. The infrastructure created by developing a COS for childbirth pelvic floor trauma could be leveraged in other settings, for example, advancing research priorities and clinical practice guideline development.