Sexual Health and Quality of Life in Patients With Low-Risk Early-Stage Cervical Cancer: Results From GCIG/CCTG CX.5/SHAPE Trial Comparing Simple Versus Radical Hysterectomy.

PURPOSE: Simple hysterectomy and pelvic node assessment (SHAPE) is a phase III randomized trial (ClinicalTrials.gov identifier: NCT01658930) reporting noninferiority of simple compared with radical hysterectomy for oncologic outcomes in low-risk cervical cancer. This study presents secondary outcomes of sexual health and quality of life (QOL) of the SHAPE trial. METHODS: Participants were randomly assigned to receive either radical or simple hysterectomy. Sexual health was assessed up to 36 months postoperatively using the Female Sexual Function Index (FSFI) and Female Sexual Distress Scale-Revised and QOL using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and Cervical Cancer-Specific Module (QLQ-CX24) questionnaires. RESULTS: Among participants with at least one QOL measure, clinical and pathologic characteristics were balanced and with no differences in preoperative baseline scores for sexual health or QOL between groups. FSFI total score met the cutoff for dysfunction up to 6 months (P = .02) in the radical hysterectomy group. Group differences favored simple hysterectomy for FSFI subscales: desire and arousal at 3 months (P ≤ .001) and pain and lubrication up to 12 months (P ≤ .018). Both groups met the cutoff for sexual distress but was higher in radical hysterectomy at 3 months (P = .018). For QLQ-CX24, symptom experience was significantly better up to 24 months (P = .031) and body image better at 3, 24, and 36 months (P ≤ .01) for simple hysterectomy. Sexual-vaginal functioning was significantly better up to 24 months (P ≤ .022) and more sexual activity up to 36 months (P = .024) in the simple hysterectomy arm. Global health status was significantly higher at 36 months for simple hysterectomy (P = .025). CONCLUSION: Simple hysterectomy was associated with lower rates of sexual dysfunction than radical hysterectomy, with a lower proportion of women having sustained sexual-vaginal dysfunction. These results further support the benefit of surgical de-escalation for low-risk cervical cancer.

Stress-induced eating in rural adolescents: Unique variability among boys and adolescents with obesity.

Stress may contribute to the development of obesity through its effects on dysregulated eating, although this has not yet been examined among low-income, rural adolescents. We examined adolescents' stress-induced changes in eating an ad libitum meal, and after, in the absence of hunger (EAH), and the extent to which these varied by sex, race, and weight status. Participants included 260 adolescents, drawn from a sample of rural households experiencing poverty. Adolescents completed two home visits while salivary cortisol was measured; during the control (low stress) visit, they completed questionnaires and procedures thought to elicit low levels of stress and had BMI assessed. During the stress visit, adolescents completed a 20-minute set of psychosocial stress challenges before eating. At each visit, adolescents consumed an ad-libitum meal after which they were additionally given large portions of snacks (EAH task). Results revealed that indeed cortisol was higher during the stress visit, across the sample. Boys showed stress-induced increases during ad-libitum meal intake (for calories, fat, and carbohydrates) whereas girls exhibited decreased intake. Further, adolescents with obesity showed stress-induced increases in fat intake, but only when hunger was satiated (EAH). There were no differences by race. These findings provide the first evidence of stress-induced alterations in food intake in a rural, low-income sample of adolescents and point to a strong vulnerability for stress-induced increases in eating in rural boys as well as stress-induced increases in fat intake when satiated as a possible contributor to obesity in youth.

Validating the Fluctuating Mental Status Evaluation in Neurocritically Ill Patients With Acute Stroke.

OBJECTIVES: Neurocritically ill patients are at high risk for developing delirium, which can worsen the long-term outcomes of this vulnerable population. However, existing delirium assessment tools do not account for neurologic deficits that often interfere with conventional testing and are therefore unreliable in neurocritically ill patients. We aimed to determine the accuracy and predictive validity of the Fluctuating Mental Status Evaluation (FMSE), a novel delirium screening tool developed specifically for neurocritically ill patients. DESIGN: Prospective validation study. SETTING: Neurocritical care unit at an academic medical center. PATIENTS: One hundred thirty-nine neurocritically ill stroke patients (mean age, 63.9 [sd, 15.9], median National Institutes of Health Stroke Scale score 11 [interquartile range, 2-17]). INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Expert raters performed daily Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition-based delirium assessments, while paired FMSE assessments were performed by trained clinicians. We analyzed 717 total noncomatose days of paired assessments, of which 52% (n = 373) were rated by experts as days with delirium; 53% of subjects were delirious during one or more days. Compared with expert ratings, the overall accuracy of the FMSE was high (area under the curve [AUC], 0.85; 95% CI, 0.82-0.87). FMSE scores greater than or equal to 1 had 86% sensitivity and 74% specificity on a per-assessment basis, while scores greater than or equal to 2 had 70% sensitivity and 88% specificity. Accuracy remained high in patients with aphasia (FMSE ≥ 1: 82% sensitivity, 64% specificity; FMSE ≥ 2: 64% sensitivity, 84% specificity) and those with decreased arousal (FMSE ≥ 1: 87% sensitivity, 77% specificity; FMSE ≥ 2: 71% sensitivity, 90% specificity). Positive FMSE assessments also had excellent accuracy when predicting functional outcomes at discharge (AUC, 0.86 [95% CI, 0.79-0.93]) and 3 months (AUC, 0.85 [95% CI, 0.78-0.92]). CONCLUSIONS: In this validation study, we found that the FMSE was an accurate delirium screening tool in neurocritically ill stroke patients. FMSE scores greater than or equal to 1 indicate "possible" delirium and should be used when prioritizing sensitivity, whereas scores greater than or equal to 2 indicate "probable" delirium and should be used when prioritizing specificity.

Family history and cancer risk study (FOREST): A clinical trial assessing electronic patient-directed family history input for identifying patients at risk of hereditary cancer.

BACKGROUND: Hereditary cancer syndromes cause a high lifetime risk of early, aggressive cancers. Early recognition of individuals at risk can allow risk-reducing interventions that improve morbidity and mortality. Family health history applications that gather data directly from patients could alleviate barriers to risk assessment in the clinical appointment, such as lack of provider knowledge of genetics guidelines and limited time in the clinical appointment. New approaches allow linking these applications to patient health portals and their electronic health records (EHRs), offering an end-to-end solution for patient-input family history information and risk result clinical decision support for their provider. METHODS: We describe the design of the first large-scale evaluation of an EHR-integrable, patient-facing family history software platform based on the Substitutable Medical Applications and Reusable Technologies on Fast Healthcare Interoperability Resources (SMART on FHIR) standard. In our study, we leverage an established implementation science framework to evaluate the success of our model to facilitate scalable, systematic risk assessment for hereditary cancers in diverse clinical environments in a large pragmatic study at two sites. We will also evaluate the success of the approach to improve the efficiency of downstream genetic counseling resulting from pre-counseling pedigree generation. CONCLUSIONS: Our research study will provide evidence regarding a new care delivery model that is scalable and sustainable for a variety of medical centers and clinics. TRIAL REGISTRATION: This study was registered on ClinicalTrials.gov under NCT05079334 on 15 October 2021.

Engaging with Social Media: Implications for COVID-19 Research Participation Among Adults Living in the State of Florida.

The COVID-19 pandemic led to an increased use of social media, with many people turning to it for social support. Given the varying effects of social media, this study examines how social media use influences the willingness of adults in the State of Florida to participate in COVID-19-related research. The study used data collected through the Florida Statewide Registry for Aging Studies (FSRAS), which included 587 participants who were 25 years and older. The primary outcome variables were COVID-19 treatment and COVID-19 vaccine research. Ordinal logistic regression was used to evaluate the association between social media use and willingness to participate in COVID-19 treatment and vaccination research, adjusting for sociodemographic variables. The analysis did not find a statistically significant relationship between social media use and the likelihood of participating in COVID-19 research. However, significant differences were observed across racial/ethnic groups. Participants who identified as "Hispanic/Latino" (OR-2.44, 95% CI-1.11-5.35, p = 0.03) and "Other" (OR-12.51, 95% CI-1.98-79.22, p = 0.01) were significantly associated with willingness to participate in a COVID-19 treatment research. Similarly, participants of all other races/ethnicities were significantly more willing to participate in research testing COVID-19 vaccines. Additionally, females were more likely to express willingness to participate in COVID-19 vaccine research. Social media use did not significantly affect willingness to participate in COVID-19 treatment and vaccine research; however, racial and ethnic differences significantly influenced willingness to participate. These findings suggest that implementing targeted culturally sensitive recruitment strategies and community engagement efforts can improve participation in COVID-19 research.

QCManyBody: A flexible implementation of the many-body expansion.

While the many-body expansion (MBE) and counterpoise treatments are commonly used to mitigate the high scaling of accurate ab initio methods, researchers may need to piece together tools and scripts if their primary chosen software does not support targeted features. To further modular software in quantum chemistry, the arbitrary-order, multiple-model-chemistry, counterpoise-enabled MBE implementation from Psi4 has been extracted into an independent, lightweight, and open-source Python module, QCManyBody, with new schema underpinning, application programming interface, and software integrations. The package caters to direct users by facilitating single-point and geometry optimization MBE calculations backed by popular quantum chemistry codes through the QCEngine runner and by defining a schema for requesting and reporting many-body computations. It also serves developers and integrators by providing minimal, composable, and extensible interfaces. The design and flexibility of QCManyBody are demonstrated via integrations with geomeTRIC, OptKing, Psi4, QCEngine, and the QCArchive project.

Music alters heart rate and psychological responses but not muscle activation during light-intensity isometric exercise.

Listening to music manipulates attention to be more externally focused, which has the potential to improve muscular efficiency. This study aimed to determine the effect of listening to music on muscle activation during an isometric exercise task, and compare this effect to those of other attentional focus conditions. Apparently healthy subjects (n = â€‹35; 16 men/19 women) completed an isometric elbow flexion task for 1 â€‹min in three randomized and counterbalanced conditions: internal focus (INT), external focus with a simple distraction task (EXT), or listening to music (MUS). Muscle activation of the biceps and triceps brachii and heart rate (HR) were recorded throughout the exercise tasks. Ratings of perceived exertion (RPE), affective valence, and motivation were measured at the end of each trial. There was no difference in muscle activation measures among the three conditions. HR during MUS was lower than EXT at 15 â€‹s ([89.4 â€‹± â€‹11.8] beats/min vs. [93.1 â€‹± â€‹12.9] beats/min; p â€‹= â€‹0.018) and 30 â€‹s ([90.6 â€‹± â€‹12.4] beats/min vs. [94.2 â€‹± â€‹12.5] beats/min; p â€‹= â€‹0.026), and lower than INT at 60 â€‹s ([93.3 â€‹± â€‹13.3] beats/min vs. [96.7 â€‹± â€‹12.0] beats/min; p â€‹= â€‹0.016). Overall RPE was higher for INT (13.4 â€‹± â€‹2.2) than for MUS ([12.6 â€‹± â€‹2.0]; p â€‹= â€‹0.020) and EXT ([11.94 â€‹± â€‹2.22]; p â€‹< â€‹0.001). Affective valence was higher for MUS than for INT ([2.7 â€‹± â€‹1.4] vs. [2.1 â€‹± â€‹1.5]; p â€‹= â€‹0.011). Manipulating attentional focus did not alter muscle activation for a light-intensity isometric muscular endurance task, though MUS was reported as more positive and requiring less exertion to complete than INT. Using music can therefore be recommended during light-intensity isometric exercise based on the psychological benefits observed.

Purine nucleoside phosphorylase as a target for the treatment of interstitial cystitis/bladder pain syndrome with and without Hunner lesions.

Chronic visceral pain disorders, such as interstitial cystitis/bladder pain syndrome (IC/BPS), are difficult to treat, and therapies are limited in number and efficacy. Emerging evidence suggests that alterations in the enzyme purine nucleoside phosphorylase (PNPase) may participate in oxidative injury and cellular damage. PNPase is important for the metabolism of 'tissue-protective' purine metabolites to 'tissue-damaging' purines that generate free radicals. The aim of this study is to test whether patients living with IC/BPS without or with Hunner lesions and irrespective of any therapies exhibit purine dysregulation with higher levels of tissue-damaging purine metabolites as measured by liquid chromatography-tandem mass spectrometry. Our results demonstrate that levels of urotoxic purine metabolites (hypoxanthine and xanthine) in IC/BPS patients with and without Hunner lesions are elevated compared to healthy controls. These findings suggest there may be pathophysiologic commonalities between patient subtypes. Furthermore, the accumulation of uroprotective purines and depletion of urodamaging purines by PNPase inhibition may be therapeutically effective in both groups of patients.

Active Vibrational Achilles Tendon Sensing for Identifying and Characterizing Inflammatory Symptomatology in Enthesitis Related Arthritis.

OBJECTIVE: This study explores the potential of active vibrational sensing as a digital biomarker to identify and characterize inflammatory symptomatology in the Achilles tendon and its entheses in juvenile idiopathic arthritis (JIA), particularly enthesitis related arthritis (ERA), a subcategory of JIA. METHODS: Active vibrational data were non-invasively recorded using a miniature coin vibration motor and accelerometer. Twenty active vibration recordings from children diagnosed with JIA were used in the analysis. Machine learning algorithms were leveraged to classify the vibrational signatures according to the corresponding subject groups. Subjects were classified into symptomatic ERA (sxERA), asymptomatic ERA (asxERA), and asymptomatic JIA (non-ERA) (asxNERA) groups based on clinical evaluations and ILAR criteria. RESULTS: Distinct vibrational signatures were observed during tiptoe standing, providing differentiation between subject groups. Feature-based and waveform-based approaches effectively classified the sxERA group against asxNERA and asxERA groups using leave-one-subject-out (LOSO-CV) and 3-fold cross-validation. For the 3-fold crossvalidation, the mean accuracies for distinguishing sxERA from asxNERA were 81% (feature-based) and 81% (waveform-based), while the accuracies for discriminating sxERA against asxERA were 73% (feature-based) and 74% (waveform-based). CONCLUSION: Active vibrational sensing demonstrates promise as a tool for identifying Achilles tendon inflammation in JIA, potentially aiding in early diagnosis and disease monitoring. SIGNIFICANCE: Developing active vibrational sensing as a diagnostic modality could address challenges in diagnosing ERA and facilitate timely intervention and personalized care for JIA, potentially enhancing long-term patient outcomes.

8-Aminoguanine and its actions in the metabolic syndrome.

The metabolic syndrome is characterized by obesity, insulin resistance, dyslipidemia and hypertension and predisposes to cardiorenal injury. Here, we tested our hypothesis that 8-aminoguanine, an endogenous purine, exerts beneficial effects in Zucker Diabetic-Sprague Dawley (ZDSD) rats, a preclinical model of the metabolic syndrome. ZDSD rats were instrumented for blood pressure radiotelemetry and randomized to vehicle or 8-aminoguanine (10 mg/kg/day, po). The protocol was divided into four phases: Phase 1: 17 days of tap water/normal diet; Phase 2: 30 days of 1% saline/normal diet; Phase 3: 28 days of 1% saline/diabetogenic diet; Phase 4: acute/terminal measurements. 8-Aminoguanine: (1) decreased mean arterial blood pressure (P = 0.0004; 119.5 ± 1.0 (vehicle) versus 116.3 ± 1.0 (treated) mmHg) throughout all three phases of the radiotelemetry study; (2) rebalanced the purine metabolome away from hypoxanthine (pro-inflammatory) and towards inosine (anti-inflammatory); (3) reduced by 71% circulating IL-1ß, a cytokine that contributes to hypertension-induced adverse cardiovascular events and type 2 diabetes; (4) attenuated renovascular responses to angiotensin II; (5) improved cardiac and renal histopathology; (6) attenuated diet-induced polydipsia/polyuria; and (7) reduced HbA1c. In the metabolic syndrome, 8-aminoguanine lowers blood pressure, improves diabetes and reduces organ damage, likely by rebalancing the purine metabolome leading to reductions in injurious cytokines such as IL-1ß.

High-Throughput Image-Based Assay for Identifying In Vitro Hepatocyte Microtubule Disruption.

Disruption of microtubule stability in mammalian cells may lead to genotoxicity and carcinogenesis. The ability to screen for microtubule destabilization or stabilization is therefore a useful and efficient approach to aid in the design of molecules that are safe for human health. In this study, we developed a high-throughput 384-well assay combining immunocytochemistry with high-content imaging to assess microtubule disruption in the metabolically competent human liver cell line: HepaRG. To enhance analysis throughput, we implemented a supervised machine learning approach using a curated training library of 180 compounds. A majority voting ensemble of eight machine learning classifiers was employed for predicting microtubule disruptions. Our prediction model achieved over 99.0% accuracy and a 98.4% F1 score, which reflects the balance between precision and recall for in-sample validation and 93.5% accuracy and a 94.3% F1 score for out-of-sample validation. This automated image-based testing can provide a simple, high-throughput screening method for early stage discovery compounds to reduce the potential risk of genotoxicity for crop protection product development.

Cell Spatial Analysis in Crohn's Disease: Unveiling Local Cell Arrangement Pattern with Graph-based Signatures.

Crohn's disease (CD) is a chronic and relapsing inflammatory condition that affects segments of the gastrointestinal tract. CD activity is determined by histological findings, particularly the density of neutrophils observed on Hematoxylin and Eosin stains (H&E) imaging. However, understanding the broader morphometry and local cell arrangement beyond cell counting and tissue morphology remains challenging. To address this, we characterize six distinct cell types from H&E images and develop a novel approach for the local spatial signature of each cell. Specifically, we create a 10-cell neighborhood matrix, representing neighboring cell arrangements for each individual cell. Utilizing t-SNE for non-linear spatial projection in scatter-plot and Kernel Density Estimation contour-plot formats, our study examines patterns of differences in the cellular environment associated with the odds ratio of spatial patterns between active CD and control groups. This analysis is based on data collected at the two research institutes. The findings reveal heterogeneous nearest-neighbor patterns, signifying distinct tendencies of cell clustering, with a particular focus on the rectum region. These variations underscore the impact of data heterogeneity on cell spatial arrangements in CD patients. Moreover, the spatial distribution disparities between the two research sites highlight the significance of collaborative efforts among healthcare organizations. All research analysis pipeline tools are available at https://github.com/MASILab/cellNN.

Atrial Fibrillation Burden on a 14-Day ECG Monitor: Findings From the GUARD-AF Trial Screening Arm.

BACKGROUND: The "burden" of atrial fibrillation (AF) detected by screening likely influences stroke risk, but the distribution of burden is not well described. OBJECTIVES: This study aims to determine the frequency of AF and the distribution of AF burden found when screening individuals ≥70 years of age with a 14-day electrocardiograph monitor. METHODS: This is a cohort study of the screening arm of a randomized AF screening trial among those ≥70 years of age without a prior AF diagnosis (between 2019 and 2021). Screening was performed with a 14-day continuous electrocardiogram patch monitor. RESULTS: Analyzable patches were returned by 5,684 (95%) of screening arm participants; the median age was 75 years (Q1-Q3: 72-78 years), 57% were female, and the median CHA2DS2-VASc score was 3 (Q1-Q3: 2-4). AF was detected in 252 participants (4.4%); 29 (0.5%) patients had continuous AF and 223 (3.9%) had paroxysmal AF. Among those with paroxysmal AF, the average indices of AF burden were of low magnitude with right-skewed distributions. The median percent time in AF was 0.46% (Q1-Q3: 0.02%-2.48%), or 75 (Q1-Q3: 3-454) minutes, and the median longest episode was 38 (Q1-Q3: 2-245) minutes. The upper quartile threshold of 2.48% time in AF corresponded to 7.6 hours. Age greater than 80 years was associated with screen-detected AF in our multivariable model (OR: 1.46; 95% CI: 1.06-2.02). CONCLUSIONS: Most AF detected in these older patients was very low burden. However, one-quarter of those with AF had multiple hours of AF, raising concern about stroke risk. These findings have implications for targeting populations for AF screening trials and for responding to heart rhythm alerts from mobile devices (GUARD-AF [A Study to Determine if Identification of Undiagnosed Atrial Fibrillation in People at least 70 Years of Age Reduces the Risk of Stroke]; NCT04126486).

Association of nursing home antipsychotic reduction policies with antipsychotic use in community dwellers with dementia.

BACKGROUND: Antipsychotic and other psychotropic medication use is prevalent among community-dwelling older adults with dementia despite the potential for adverse effects. Two Centers for Medicare & Medicaid Services (CMS) initiatives, the National Partnership to Improve Dementia Care ("the Partnership") and the Five Star Quality Rating System for antipsychotic use reporting, have been successful in reducing antipsychotic use in nursing home residents. We assessed if these initiatives had a spillover effect in antipsychotic and other psychotropic medication use among community dwellers with dementia due to potential overlap in prescribers across settings. METHODS: Among community-dwelling older adults with dementia, we examined psychotropic medication class use (i.e., antipsychotics, antidepressants, anxiolytics, anticonvulsants/mood stabilizers, antidementia) in 2010-2017 Medicare fee-for-service claims using interrupted time series analyses across three periods ("Pre-Partnership": July 1, 2010 to March 31, 2012; "Post-Partnership": April 1, 2012 to January 31, 2015; "Five Star Quality Rating": February 1, 2015 to December 31, 2017). RESULTS: We included 1,289,401 community dwellers with dementia contributing 26,609,697 person-months. The mean age was 80 years, most were female (70%), approximately 80% were non-Hispanic Whites, 10% were non-Hispanic Blacks, and 5% were Hispanic ethnicity. Antipsychotic use was declining pre-Partnership (ß = -0.06, 95% CI: -0.08, -0.05) and post-Partnership (ß = -0.02, 95% CI: -0.02, -0.01). Post-Five Star Quality Rating, antipsychotic use remained stable with a nearly flat slope (ß = -0.01, 95% CI: -0.01, 0.00). Anticonvulsant and antidepressant use increased and anxiolytic and antidementia medication use decreased among community-dwelling older adults with dementia. CONCLUSIONS: These two CMS policies on antipsychotic use for nursing home residents were not associated with a spillover effect to community-dwelling older adults with dementia. Strategies to monitor the appropriateness of psychotropic medication use may be warranted for community-dwellers with dementia.

Vascular Ultrasound.

Vascular point-of-care ultrasound is a useful tool for emergency department (ED) clinicians to evaluate lower extremity pain and swelling. It can quickly and safely detect deep vein thrombosis, a serious condition that can lead to pulmonary embolism and post-thrombotic syndrome as well as diagnose pseudoaneurysm, hematoma, and acute arterial occlusion, a vascular emergency that requires urgent surgical intervention. Point-of-Care Ultrasound can be a useful tool for the evaluation of ED patients with vascular emergencies.

Climate change's implications for practice: Pharmacologic considerations of heat-related illness.

ABSTRACT: Climate change is the greatest threat to global health. As climate change worsens, heat waves will be longer, more intense, and more frequent. Increased health risks from climate change and heat waves include heat-related illness (HRI). HRI increases ED visits, hospitalizations, and mortality. Healthcare providers should be aware of the impact of medications on risk for HRI. This article elucidates signs and symptoms, populations at risk, drugs and mechanisms that increase risk, and patient education to reduce risk.

A parallel-group, randomized trial examining impact of colposcopy results delivery by a Nurse Liaison on patient-reported outcomes and adherence.

OBJECTIVE: Cervical cancer is on the rise in Canada. Addressing patient anxiety and improving patient understanding of colposcopy and results may improve adherence. This randomized controlled trial examined the impact of colposcopy results delivery by a nurse liaison versus the referring primary care provider (PCP) on patient anxiety, and secondary outcomes including patient satisfaction, knowledge of diagnosis, and 9-month adherence to follow-up. METHODS: Patients ≥ 18 years old presenting for initial appointment at the study colposcopy clinic were randomized 1:1 to intervention group (nurse liaison) versus control group (PCP). After receiving colposcopy results, participants completed online measures of anxiety (STAI), health care satisfaction scales (PSQ-18, HAI, VSQ-9), self-reported colposcopy diagnosis, and demographics. Chart review at 9 months assessed adherence to recommended colposcopy follow-up. Groups were compared on continuous and categorical variables, controlling for diagnosis severity and trait anxiety. RESULTS: The intervention group had significantly lower state anxiety with STAI-state mean scores 37.3 versus 40.7 in controls (P = 0.03). Intervention group participants were more likely to correctly report their diagnosis (84% vs. 66.3%, P = 0.003). Questionnaire responders were more likely to be in the intervention group and had a higher proportion of CIN2+ pathology. There were no differences in demographics, patient satisfaction, or adherence to follow-up between groups. CONCLUSION: Direct delivery of colposcopy results by a trained nurse liaison was associated with decreased patient anxiety around colposcopy results, and increased patient knowledge regarding diagnosis. This model may be considered to improve patient-centered care. OBJECTIF: Le cancer du col de l'utérus est en augmentation au Canada. Il est possible d'améliorer l'observance des patientes en se préoccupant de leur anxiété et en leur expliquant bien la colposcopie et les résultats. Cet essai clinique randomisé a examiné l'impact de la transmission des résultats de colposcopie par une infirmière de liaison ou par le médecin de première ligne (MPL) demandeur sur l'anxiété des patientes. Les critères de jugement secondaires étaient la satisfaction des patientes, la connaissance du diagnostic et l'observance du suivi à 9 mois. MéTHODES: Les patientes de 18 ans ou plus se présentant pour un premier rendez-vous à la clinique de colposcopie de l'étude ont été assignées aléatoirement, dans un ratio de 1:1, dans le groupe intervention (infirmière de liaison) ou le groupe témoin (MPL). Après avoir reçu les résultats de la colposcopie, les participantes ont rempli en ligne l'échelle d'anxiété (STAI) et les échelles de satisfaction des soins de santé (PSQ-18, HAI, VSQ-9) et donné leur diagnostic autodéclaré de la colposcopie et leurs caractéristiques démographiques. L'examen des dossiers à 9 mois a permis d'évaluer l'observance du suivi post-colposcopie recommandé. Les groupes ont été comparés en fonction de variables continues et nominales en prenant en compte la gravité du diagnostic et le trait d'anxiété. RéSULTATS: Le groupe intervention présentait un état anxiété significativement plus faible, le score moyen de l'échelle STAI étant de 37,3 comparativement à 40,7 dans le groupe témoin (P = 0,03). Les participantes du groupe intervention étaient plus susceptibles de correctement déclarer leur diagnostic (84 % p/r à 66,3 %; P = 0,003). Les personnes ayant répondu au questionnaire étaient plus susceptibles d'appartenir au groupe intervention et avaient une plus forte proportion de pathologies CIN2+. Il n'y a pas eu de différences entre les groupes en ce qui concerne les caractéristiques démographiques, la satisfaction des patientes et l'observance du suivi. CONCLUSION: La communication directe des résultats de la colposcopie par une infirmière de liaison qualifiée a été associée à une diminution de l'anxiété des patientes face aux résultats de l'examen et à une augmentation des connaissances des patientes concernant le diagnostic. Ce modèle peut être envisagé pour améliorer les soins centrés sur la patiente.

Ohnut vs waitlist control for the self-management of endometriosis-associated deep dyspareunia: a pilot randomized controlled trial.

Background: Deep dyspareunia affects 50% of people with endometriosis. The Ohnut is a set of interlocking rings that fit over the penis/insertive object. One or more rings can be used to limit insertion depth and reduce deep dyspareunia. Aim: We conducted a pilot, parallel, open-label randomized controlled trial (RCT) to investigate the feasibility of the study design and the acceptability and preliminary efficacy of the Ohnut. Method: Participants were recruited from a tertiary center for endometriosis. Eligibility criteria were surgically confirmed endometriosis, age 19-49 years, monogamous sexual relationship with a partner willing to participate in the study, and no comorbid superficial dyspareunia, anxiety, or depression. Couples were randomized into an intervention group or a waitlist control group using a 1:1 allocation ratio. All couples had sex as normal during weeks 1 to 4 (baseline period), and couples in the intervention group used the Ohnut with sex during weeks 5 to 10 (intervention period) while controls had sex as normal. Patient participants used daily diaries to record sexual activity and deep dyspareunia score (0-10) for the 10-week study. Intervention group participants completed an acceptability questionnaire at the end of the study. Outcomes: The primary outcomes were feasibility of the study and acceptability of the Ohnut. We also assessed differences in deep dyspareunia scores in the participants who used the Ohnut compared to the control participants who did not. Results: We recruited approximately 5 couples per month of active recruitment. Of 864 potentially eligible participants, we successfully contacted 44.7% (n = 386), of whom 8.0% (n = 31) consented, 64.8% (n = 250) were ineligible, and 27.2% (n = 105) declined. Thirty-one couples were randomly assigned to the intervention or control group, and 17 couples completed the study. Intervention group couples used the Ohnut for an average of 72.4% (32.7%) of sexual encounters during the intervention period. The mean acceptability index score for the Ohnut was 0.83 (0.078) among patients and 0.83 (0.049) among partners (index between 0 and 1). After controlling for baseline deep dyspareunia, there was a significant difference in the intervention period mean deep dyspareunia scores between the control and intervention group (4.69 (2.44) vs 2.46 (1.82), P = .012). Clinical Implications: We identified preliminary evidence for the acceptability and efficacy of the Ohnut among both patients and partners, suggesting that the Ohnut may be a useful stand-alone or adjuvant management tool for endometriosis-associated deep dyspareunia. Strengths and Limitations: Strengths of this study were the "real-world" use of the Ohnut and data collection from both patients and partners. Limitations of the study design included the strict eligibility criteria that affected feasibility and generalizability. Conclusion: This pilot RCT indicated that the Ohnut may be an acceptable and effective intervention to reduce endometriosis-associated deep dyspareunia. We identified opportunities to improve design for a larger RCT. Clinical Trial Registration: This clinical trial was registered with clinicaltrials.gov (#NCT04370444).