European Society of Gynaecological Oncology Guidelines for the Management of Patients with Vulvar Cancer - Update 2023.

BACKGROUND: As part of its mission to improve the quality of care for women with gynecological cancers across Europe, the European Society of Gynaecological Oncology (ESGO) first published in 2017 evidence-based guidelines for the management of patients with vulvar cancer. OBJECTIVE: To update the ESGO guidelines based on the new evidence addressing the management of vulvar cancer and to cover new topics in order to provide comprehensive guidelines on all relevant issues of diagnosis and treatment of vulvar cancer. METHODS: The ESGO Council nominated an international development group comprised of practicing clinicians who provide care to vulvar cancer patients and have demonstrated leadership through their expertize in clinical care and research, national and international engagement and profile as well as dedication to the topics addressed to serve on the expert panel (18 experts across Europe). To ensure that the statements were evidence-based, new data identified from a systematic search were reviewed and critically appraised. In the absence of any clear scientific evidence, judgment was based on the professional experience and consensus of the international development group. Prior to publication, the guidelines were reviewed by 206 international practitioners in cancer care delivery and patient representatives. RESULTS: The updated guidelines cover comprehensively diagnosis and referral, staging, pathology, pre-operative investigations, surgical management (local treatment, groin treatment, sentinel lymph node procedure, reconstructive surgery), (chemo)radiotherapy, systemic treatment, treatment of recurrent disease (vulvar, inguinal, pelvic, and distant recurrences), and follow-up. Management algorithms are also defined.

An experimental comparison of multiple-choice and short-answer questions on a high-stakes test for medical students.

Recent advances in automated scoring technology have made it practical to replace multiple-choice questions (MCQs) with short-answer questions (SAQs) in large-scale, high-stakes assessments. However, most previous research comparing these formats has used small examinee samples testing under low-stakes conditions. Additionally, previous studies have not reported on the time required to respond to the two item types. This study compares the difficulty, discrimination, and time requirements for the two formats when examinees responded as part of a large-scale, high-stakes assessment. Seventy-one MCQs were converted to SAQs. These matched items were randomly assigned to examinees completing a high-stakes assessment of internal medicine. No examinee saw the same item in both formats. Items administered in the SAQ format were generally more difficult than items in the MCQ format. The discrimination index for SAQs was modestly higher than that for MCQs and response times were substantially higher for SAQs. These results support the interchangeability of MCQs and SAQs. When it is important that the examinee generate the response rather than selecting it, SAQs may be preferred. The results relating to difficulty and discrimination reported in this paper are consistent with those of previous studies. The results on the relative time requirements for the two formats suggest that with a fixed testing time fewer SAQs can be administered, this limitation more than makes up for the higher discrimination that has been reported for SAQs. We additionally examine the extent to which increased difficulty may directly impact the discrimination of SAQs.

Help-seeking preferences in Australian mental health website visitors: A latent profile analysis.

OBJECTIVE: Psychological distress and suicide rates are climbing in Australia despite substantial mental health programme investment in recent decades. Understanding where individuals prefer to seek support in the event of a personal or emotional crisis may help target mental health resources to where they are most needed. This study aimed to explore individual differences in help-seeking preferences that may be leveraged for early intervention and mental health service design. METHOD: Latent profile analysis was used to explore the help-seeking preferences of 1561 Australian online help-seekers who elected to complete a psychological distress screening on a popular mental health website, Beyond Blue. RESULTS: Four latent profiles of help-seeker emerged that illustrate distinct preference channels for support: help-negaters, professional help-seekers, family help-seekers and help-affirmatives. Help-negaters were the least likely to consider seeking help from any source, recorded the highest levels of psychological distress and suicidal ideation, and were more likely to be younger. Help-affirmatives were the most likely to seek help from any source, particularly from religious leaders, and were more likely to speak a language other than English at home. CONCLUSION: Many individuals experiencing mental health concerns will prefer to seek support from family or community contacts rather than professionals, and some will not seek help at all. Diversity in help-seeking preferences should be considered when designing mental health services, outreach and psychoeducation materials.

A Self-Guided Online Cognitive Behavioural Therapy to Reduce Fear of Falling in Older People: a Randomised Controlled Trial.

BACKGROUND: Traditional face-to-face cognitive behavioural therapy (CBT) has been successful at reducing fear of falling (FOF) in older people but can be labour-intensive and costly. Online CBT has been suggested as a cost-effective alternative but has not yet been tested in the context of FOF. This study evaluates the effectiveness of a readily available, self-guided and generalised online CBT program (myCompass) on reducing FOF in older people. METHODS: Fifty community-dwelling older people with FOF received a paper-based health education program, and half were randomly assigned to receive three selected modules from myCompass for 6 weeks. The primary outcome was feared consequences of falling at 6 weeks. Secondary outcomes were concern about falling, balance confidence, activity avoidance, physical activity, exercise self-efficacy, health literacy and mental health at 6/26/52 weeks and falls incidence at 12 months. RESULTS: All intervention participants completed at least 2-out-of-3 myCompass modules. There was a significant main effect of time on feared consequences of falling (Cohen's f = 0.55). The group by time interactions for concern about falling (f = 0.28), stress (f = 0.26) and social support for health (health literacy) (f = 0.26) was also significant, favouring the control group. The overall attrition rate at 12 months was 24% (n = 12). CONCLUSION: The high program compliance and low attrition rate suggest that online CBT is feasible among older people. However, the myCompass program had no effect at reducing FOF in older people. A more targeted CBT program with a well-integrated psychoeducation module on FOF might be the solution to boost the therapeutic effects of a generalised CBT program at reducing FOF for older people.

A comparative study of peri-operative outcomes for 100 consecutive post-chemotherapy and primary robot-assisted and open retroperitoneal lymph node dissections.

PURPOSE: To describe and compare differences in peri-operative outcomes of robot-assisted (RA-RPLND) and open (O-RPLND) retroperitoneal lymph node dissection performed by a single surgeon where chemotherapy is the standard initial treatment for Stage 2 or greater non-seminomatous germ cell tumour. METHODS: Review of a prospective database of all RA-RPLNDs (28 patients) and O-RPLNDs (72 patients) performed by a single surgeon from 2014 to 2020. Peri-operative outcomes were compared for patients having RA-RPLND to all O-RPLNDs and a matched cohort of patients having O-RPLND (20 patients). Further comparison was performed between all patients in the RA-RPLND group (21 patients) and matched O-RPLND group (18 patients) who had previous chemotherapy. RA-RPLND was performed for patients suitable for a unilateral template dissection. O-RPLND was performed prior to the introduction of RA-RPLND and for patients not suitable for RA-RPLND after its introduction. RESULTS: RA-RPLND showed improved peri-operative outcomes compared to the matched cohort of O-RPLND-median blood loss (50 versus 400 ml, p < 0.00001), operative duration (150 versus 195 min, p = 0.023) length-of-stay (1 versus 5 days, p < 0.00001) and anejaculation (0 versus 4, p = 0.0249). There was no statistical difference in complication rates. RA-RPLND had lower median lymph node yields although not significant (9 versus 13, p = 0.070). These improved peri-operative outcomes were also seen in the post-chemotherapy RA-RPLND versus O-RPLND analysis. There were no tumour recurrences seen in either group with median follow-up of 36 months and 60 months, respectively. CONCLUSIONS: Post-chemotherapy RA-RPLND may have decreased blood loss, operative duration, hospital length-of-stay and anejaculation rates in selected cases and should, therefore, be considered in selected patients. Differences in oncological outcomes require longer term follow-up.

e-Mental Health Program Usage Patterns in Randomized Controlled Trials and in the General Public to Inform External Validity Considerations: Sample Groupings Using Cluster Analyses.

BACKGROUND: Randomized controlled trials (RCTs) with vigorous study designs are vital for determining the efficacy of treatments. Despite the high internal validity attributed to RCTs, external validity concerns limit the generalizability of results to the general population. Bias can be introduced, for example, when study participants who self-select into a trial are more motivated to comply with study conditions than are other individuals. These external validity considerations extend to e-mental health (eMH) research, especially when eMH tools are designed for public access and provide minimal or no supervision. OBJECTIVE: Clustering techniques were employed to identify engagement profiles of RCT participants and community users of a self-guided eMH program. This exploratory approach inspected actual, not theorized, RCT participant and community user engagement patterns. Both samples had access to the eMH program over the same time period and received identical usage recommendations on the eMH program website. The aim of this study is to help gauge expectations of similarities and differences in usage behaviors of an eMH tool across evaluation and naturalistic contexts. METHODS: Australian adults signed up to myCompass, a self-guided online treatment program created to reduce mild to moderate symptoms of negative emotions. They did so either by being part of an RCT onboarding (160/231, 69.6% female) or by accessing the program freely on the internet (5563/8391, 66.30% female) between October 2011 and October 2012. During registration, RCT participants and community users provided basic demographic information. Usage metrics (number of logins, trackings, and learning activities) were recorded by the system. RESULTS: Samples at sign-up differed significantly in age (P=.003), with community users being on average 3 years older (mean 41.78, SD 13.64) than RCT participants (mean 38.79, SD 10.73). Furthermore, frequency of program use was higher for RCT participants on all usage metrics compared to community users through the first 49 days after registration (all P values <.001). Two-step cluster analyses revealed 3 user groups in the RCT sample (Nonstarters, 10-Timers, and 30+-Timers) and 2 user groups in the community samples (2-Timers and 20-Timers). Groups seemed comparable in patterns of use but differed in magnitude, with RCT participant usage groups showing more frequent engagement than community usage groups. Only the high-usage group among RCT participants approached myCompass usage recommendations. CONCLUSIONS: Findings suggested that external validity concerns of RCT designs may arise with regards to the predicted magnitude of eMH program use rather than overall usage styles. Following up RCT nonstarters may help provide unique insights into why individuals choose not to engage with an eMH program despite generally being willing to participate in an eMH evaluation study. Overestimating frequency of engagement with eMH tools may have theoretical implications and potentially impact economic considerations for plans to disseminate these tools to the general public.

A Web-Based Mental Health Intervention to Improve Social and Occupational Functioning in Adults With Type 2 Diabetes (The Springboard Trial): 12-Month Outcomes of a Randomized Controlled Trial.

BACKGROUND: People with type 2 diabetes mellitus (T2DM) often experience mental health symptoms that exacerbate illness and increase mortality risk. Access to psychological support is low in people with T2DM. Detection of depression is variable in primary care and can be further hampered by mental health stigma. Electronic mental health (eMH) programs may provide an accessible, private, nonstigmatizing mental health solution for this group. OBJECTIVE: This study aims to evaluate the efficacy over 12 months of follow-up of an eMH program (myCompass) for improving social and occupational functioning in a community sample of people with T2DM and self-reported mild-to-moderate depressive symptoms. myCompass is a fully automated and self-guided web-based public health program for people with depression or anxiety. The effects of myCompass on depressive symptoms, diabetes-related distress, anxiety symptoms, and self-care behavior were also examined. METHODS: Adults with T2DM and mild-to-moderate depressive symptoms (N=780) were recruited via online advertisements, community organizations, and general practices. Screening, consent, and self-report questionnaires were administered online. Eligible participants were randomized to receive either myCompass (n=391) or an attention control generic health literacy program (Healthy Lifestyles; n=379) for 8 weeks. At baseline and at 3, 6, and 12 months postintervention, participants completed the Work and Social Adjustment Scale, the Patient Health Questionnaire-9 item, the Diabetes Distress Scale, the Generalized Anxiety Disorder Questionnaire-7 item, and items from the Self-Management Profile for Type 2 Diabetes. Glycosylated hemoglobin measurements were obtained at baseline and 6 and 12 months postintervention. RESULTS: A total of 38.9% (304/780) of the trial participants completed all postintervention assessments. myCompass users logged in on an average of 6 times and completed an average of 0.29 modules. Healthy Lifestyles users logged in on an average of 4 times and completed an average of 1.37 modules. At baseline, the mean scores on several outcome measures, including the primary outcome of work and social functioning, were close to the normal range, despite a varied and extensive recruitment process. Intention-to-treat analyses revealed slightly greater improvement at 12 months in work and social functioning for the Healthy Lifestyles group relative to the myCompass group. All participants reported equivalent improvements in depression anxiety, diabetes distress, diabetes self-management, and glycemic control across the trial. CONCLUSIONS: The Healthy Lifestyles group reported higher ratings of social and occupational functioning than the myCompass group, but no differences were observed for any secondary outcome. Although these findings should be interpreted in light of the near-floor symptom scores at baseline, the trial yields important insights into how people with T2DM might be engaged in eMH programs and the challenges of focusing specifically on mental health. Several avenues emerge for continued investigation into how best to deal with the growing mental health burden in adults with T2DM. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry Number (ACTRN) 12615000931572; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368109&isReview=true.

The influence of personality on trajectories of distress, health and functioning in mild-to-moderately depressed adults with type 2 diabetes.

Identification of mental health risk is important for optimising diabetes care in type 2 diabetes mellitus (T2DM). Personality is linked to diabetes health and may assist detection of individuals with T2DM most at risk of chronic mental health difficulties. This study examined the moderator effect of personality factors on changes in psychological distress and functioning in adults with T2DM and mild-to-moderate depressive symptoms across a 12-month period. Data were obtained from participants in a randomised controlled trial of adults with T2DM.  Participants completed measures of depression (Patient Health Questionnaire-9), anxiety (General Anxiety Disorder-7), general functioning (Work and Social Adjustment Scale), diabetes distress (Diabetes Distress Scale), and diabetes self-management (Self-Management Profile for Type 2 Diabetes) at baseline, 3-, 6- and 12-months. Glycaemic control (HbA1c) was measured at baseline, 6- and 12-months. Two hundred trial completers agreed to complete a personality inventory (Big Five Inventory). Low neuroticism was linked with reduced depression, anxiety, functional impairment and diabetes distress over the year. High extraversion was associated with decreased anxiety and functional impairment. High conscientiousness was linked to increased healthy eating. No personality trait moderated HbA1c levels. Personality screening may help identify mental health risk and guide medical carer approach in T2DM patients.

Using Cluster Analysis to Explore Engagement and e-Attainment as Emergent Behavior in Electronic Mental Health.

BACKGROUND: In most e-mental health (eMH) research to date, adherence is defined according to a trial protocol. However, adherence to a study protocol may not completely capture a key aspect of why participants engage with eMH tools, namely, to achieve personal mental health goals. As a consequence, trial attrition reported as non-adherence or dropout may reflect e-attainment, the discontinuation of eMH engagement after personal goals have been met. Clarifying engagement patterns, such as e-attainment, and how these align with mental health trajectories, may help optimize eMH design and implementation science. OBJECTIVE: This study aimed to use clustering techniques to identify real-world engagement profiles in a community of eMH users and examine if such engagement profiles are associated with different mental health outcomes. The novelty of this approach was our attempt to identify actual user engagement behaviors, as opposed to employing engagement benchmarks derived from a trial protocol. The potential of this approach is to link naturalistic behaviors to beneficial mental health outcomes, which would be especially informative when designing eMH programs for the general public. METHODS: Between May 2013 and June 2018, Australian adults (N=43,631) signed up to myCompass, a self-guided eMH program designed to help alleviate mild to moderate symptoms of depression, anxiety, and stress. Recorded usage data included number of logins, frequency of mood tracking, number of started and completed learning activities, and number of tracking reminders set. A subset of users (n=168) completed optional self-assessment mental health questionnaires (Patient Health Questionnaire-9 item, PHQ-9; Generalized Anxiety Disorder Questionnaire-7 item, GAD-7) at registration and at 28 and 56 days after sign-up. Another subset of users (n=861) completed the PHQ-9 and GAD-7 at registration and at 28 days. RESULTS: Two-step cluster analyses revealed 3 distinct usage patterns across both subsamples: moderates, trackers, and super users, signifying differences both in the frequency of use as well as differences in preferences for program functionalities. For both subsamples, repeated measures analysis of variances showed significant decreases over time in PHQ-9 and GAD-7 scores. Time-by-cluster interactions, however, did not yield statistical significance in both subsamples, indicating that clusters did not predict symptom reduction over time. Interestingly, users who completed the self-assessment questionnaires twice had slightly but significantly lower depression and anxiety levels at sign-up compared with users who completed the questionnaires a third time at 56 days. CONCLUSIONS: Findings suggested that although users engaged with myCompass in different but measurable ways, those different usage patterns evoked equivalent mental health benefits. Furthermore, the randomized controlled trial paradigm may unintentionally limit the scope of eMH engagement research by mislabeling early mental health goal achievers as dropouts. More detailed and naturalistic approaches to study engagement with eMH technologies may improve program design and, ultimately, program effectiveness.

A Web-Based Cognitive Behavior Therapy Intervention to Improve Social and Occupational Functioning in Adults With Type 2 Diabetes (The SpringboarD Trial): Randomized Controlled Trial.

BACKGROUND: Depressive symptoms are common in people with type 2 diabetes mellitus (T2DM). Effective depression treatments exist; however, access to psychological support is characteristically low. Web-based cognitive behavioral therapy (CBT) is accessible, nonstigmatizing, and may help address substantial personal and public health impact of comorbid T2DM and depression. OBJECTIVE: The aim of this study was to evaluate the Web-based CBT program, myCompass, for improving social and occupational functioning in adults with T2DM and mild-to-moderate depressive symptoms. myCompass is a fully automated, self-guided public health treatment program for common mental health problems. The impact of treatment on depressive symptoms, diabetes-related distress, anxiety symptoms, and self-care behavior was also examined. METHODS: Participants with T2DM and mild-to-moderate depressive symptoms (N=780) were recruited online via Google and Facebook advertisements targeting adults with T2DM and via community and general practice settings. Screening, consent, and self-report scales were all self-administered online. Participants were randomized using double-blind computerized block randomization to either myCompass (n=391) for 8 weeks plus a 4-week tailing-off period or an active placebo intervention (n=379). At baseline and postintervention (3 months), participants completed the Work and Social Adjustment Scale, the primary outcome measure. Secondary outcome measures included the Patient Health Questionnaire-9 item, Diabetes Distress Scale, Generalized Anxiety Disorder Questionnaire-7 item, and items from the Self-Management Profile for Type 2 Diabetes. RESULTS: myCompass users logged in an average of 6 times and completed an average of .29 modules. Healthy Lifestyles users logged in an average of 4 times and completed an average of 1.37 modules. At baseline, mean scores on several outcome measures, including the primary outcome of work and social functioning, were near to the normal range, despite an extensive recruitment process. Approximately 61.6% (473/780) of participants completed the postintervention assessment. Intention-to-treat analyses revealed improvement in functioning, depression, anxiety, diabetes distress, and healthy eating over time in both groups. Except for blood glucose monitoring and medication adherence, there were no specific between-group effects. Follow-up analyses suggested the outcomes did not depend on age, morbidity, or treatment engagement. CONCLUSIONS: Improvement in social and occupational functioning and the secondary outcomes was generally no greater for myCompass users than for users of the control program at 3 months postintervention. These findings should be interpreted in light of near-normal mean baseline scores on several variables, the self-selected study sample, and sample attrition. Further attention to factors influencing uptake and engagement with mental health treatments by people with T2DM, and the impact of illness comorbidity on patient conceptualization and experience of mental health symptoms, is essential to reduce the burden of T2DM. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12615000931572; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368109&isReview=true (Archived by WebCite at http://www.webcitation.org/7850eg8pi).

Recruiting to a Randomized Controlled Trial of a Web-Based Program for People With Type 2 Diabetes and Depression: Lessons Learned at the Intersection of e-Mental Health and Primary Care.

BACKGROUND: E-mental health (eMH) interventions are now widely available and they have the potential to revolutionize the way that health care is delivered. As most health care is currently delivered by primary care, there is enormous potential for eMH interventions to support, or in some cases substitute, services currently delivered face to face in the community setting. However, randomized trials of eMH interventions have tended to recruit participants using online recruitment methods. Consequently, it is difficult to know whether participants who are recruited online differ from those who attend primary care. OBJECTIVE: This paper aimed to document the experience of recruiting to an eMH trial through primary care and compare the characteristics of participants recruited through this and other recruitment methods. METHODS: Recruitment to the SpringboarD randomized controlled trial was initially focused on general practices in 2 states of Australia. Over 15 months, we employed a comprehensive approach to engaging practice staff and supporting them to recruit patients, including face-to-face site visits, regular contact via telephone and trial newsletters, and development of a Web-based patient registration portal. Nevertheless, it became apparent that these efforts would not yield the required sample size, and we therefore supplemented recruitment through national online advertising and promoted the study through existing networks. Baseline characteristics of participants recruited to the trial through general practice, online, or other sources were compared using the analysis of variance and chi square tests. RESULTS: Between November 2015 and October 2017, 780 people enrolled in SpringboarD, of whom 740 provided information on the recruitment source. Of these, only 24 were recruited through general practice, whereas 520 were recruited online and 196 through existing networks. Key barriers to general practice recruitment included perceived mismatch between trial design and diabetes population, prioritization of acute health issues, and disruptions posed by events at the practice and community level. Participants recruited through the 3 different approaches differed in age, gender, employment status, depressive symptoms, and diabetes distress, with online participants being distinguished from those recruited through general practice or other sources. However, most differences reached only a small effect size and are unlikely to be of clinical importance. CONCLUSIONS: Time, labor, and cost-intensive efforts did not translate into successful recruitment through general practice in this instance, with barriers identified at several different levels. Online recruitment yielded more participants, who were broadly similar to those recruited via general practice.

European Society of Gynaecological Oncology Guidelines for the Management of Patients With Vulvar Cancer.

OBJECTIVE: The aim of this study was to develop clinically relevant and evidence-based guidelines as part of European Society of Gynaecological Oncology's mission to improve the quality of care for women with gynecologic cancers across Europe. METHODS: The European Society of Gynaecological Oncology Council nominated an international development group made of practicing clinicians who provide care to patients with vulvar cancer and have demonstrated leadership and interest in the management of patients with vulvar cancer (18 experts across Europe). To ensure that the statements are evidence based, the current literature identified from a systematic search has been reviewed and critically appraised. In the absence of any clear scientific evidence, judgment was based on the professional experience and consensus of the development group (expert agreement). The guidelines are thus based on the best available evidence and expert agreement. Prior to publication, the guidelines were reviewed by 181 international reviewers including patient representatives independent from the development group. RESULTS: The guidelines cover diagnosis and referral, preoperative investigations, surgical management (local treatment, groin treatment including sentinel lymph node procedure, reconstructive surgery), radiation therapy, chemoradiation, systemic treatment, treatment of recurrent disease (vulvar recurrence, groin recurrence, distant metastases), and follow-up.

Spatial and temporal heterogeneity in high-grade serous ovarian cancer: a phylogenetic analysis.

BACKGROUND: The major clinical challenge in the treatment of high-grade serous ovarian cancer (HGSOC) is the development of progressive resistance to platinum-based chemotherapy. The objective of this study was to determine whether intra-tumour genetic heterogeneity resulting from clonal evolution and the emergence of subclonal tumour populations in HGSOC was associated with the development of resistant disease. METHODS AND FINDINGS: Evolutionary inference and phylogenetic quantification of heterogeneity was performed using the MEDICC algorithm on high-resolution whole genome copy number profiles and selected genome-wide sequencing of 135 spatially and temporally separated samples from 14 patients with HGSOC who received platinum-based chemotherapy. Samples were obtained from the clinical CTCR-OV03/04 studies, and patients were enrolled between 20 July 2007 and 22 October 2009. Median follow-up of the cohort was 31 mo (interquartile range 22-46 mo), censored after 26 October 2013. Outcome measures were overall survival (OS) and progression-free survival (PFS). There were marked differences in the degree of clonal expansion (CE) between patients (median 0.74, interquartile range 0.66-1.15), and dichotimization by median CE showed worse survival in CE-high cases (PFS 12.7 versus 10.1 mo, p = 0.009; OS 42.6 versus 23.5 mo, p = 0.003). Bootstrap analysis with resampling showed that the 95% confidence intervals for the hazard ratios for PFS and OS in the CE-high group were greater than 1.0. These data support a relationship between heterogeneity and survival but do not precisely determine its effect size. Relapsed tissue was available for two patients in the CE-high group, and phylogenetic analysis showed that the prevalent clonal population at clinical recurrence arose from early divergence events. A subclonal population marked by a NF1 deletion showed a progressive increase in tumour allele fraction during chemotherapy. CONCLUSIONS: This study demonstrates that quantitative measures of intra-tumour heterogeneity may have predictive value for survival after chemotherapy treatment in HGSOC. Subclonal tumour populations are present in pre-treatment biopsies in HGSOC and can undergo expansion during chemotherapy, causing clinical relapse.

Safety and Hemostatic Effectiveness of the Fibrin Pad for Severe Soft-Tissue Bleeding During Abdominal, Retroperitoneal, Pelvic, and Thoracic (Non-cardiac) Surgery: A Randomized, Controlled, Superiority Trial.

BACKGROUND: In surgery, rapid hemostasis can be required in various settings and bleeding intensities to minimize complications related to blood loss. While effective hemostats are available for mild-to-moderate surgical bleeding, few are effective against challenging severe hemorrhage. We report the effectiveness and safety of the fibrin pad (FP), a novel combination hemostat (device/human biologic), in controlling severe soft-tissue bleeding as compared to the standard of care (SoC). METHODS: This randomized, controlled, superiority study enrolled subjects ≥18 years, requiring elective abdominal, retroperitoneal, pelvic, or thoracic (non-cardiac) surgery. A severe target bleeding site (TBS) was identified intra-operatively following which, subjects were randomized to the FP or the SoC group. Hemostatic status was observed at 4 min (primary endpoint) and 10 min post-randomization. Safety variables included TBS-related bleeding and thrombotic events. RESULTS: At 4 min post-randomization, 50/59 (84.7 %) subjects in the FP group and 10/32 (31.3%) [Corrected] subjects in the SoC group achieved hemostasis without needing re-treatment (P < 0.0001). Compared to the SoC group, the FP group showed better hemostasis at 10 min post-randomization [58/59 (98.3 %) vs. 28/32 (87.5 %); P = 0.01], lower mean time to hemostasis (6.1 ± 13.5 vs. 17.8 ± 32.0 min), and a less frequent need for re-treatment (5.1 vs. 53.1 %). The triangular test for binary response demonstrated the FP to be superior to SoC (95 % CI 1.474-3.290; P < 0.0001). Safety profiles in both groups were similar to those typically observed after long-duration surgery. CONCLUSION: The FP is safe and superior to SoC for controlling challenging severe soft-tissue bleeding encountered during intra-abdominal and thoracic surgical procedures.

Examining ChatGPT Performance on USMLE Sample Items and Implications for Assessment.

PURPOSE: In late 2022 and early 2023, reports that ChatGPT could pass the United States Medical Licensing Examination (USMLE) generated considerable excitement, and media response suggested ChatGPT has credible medical knowledge. This report analyzes the extent to which an artificial intelligence (AI) agent's performance on these sample items can generalize to performance on an actual USMLE examination and an illustration is given using ChatGPT. METHOD: As with earlier investigations, analyses were based on publicly available USMLE sample items. Each item was submitted to ChatGPT (version 3.5) 3 times to evaluate stability. Responses were scored following rules that match operational practice, and a preliminary analysis explored the characteristics of items that ChatGPT answered correctly. The study was conducted between February and March 2023. RESULTS: For the full sample of items, ChatGPT scored above 60% correct except for one replication for Step 3. Response success varied across replications for 76 items (20%). There was a modest correspondence with item difficulty wherein ChatGPT was more likely to respond correctly to items found easier by examinees. ChatGPT performed significantly worse ( P < .001) on items relating to practice-based learning. CONCLUSIONS: Achieving 60% accuracy is an approximate indicator of meeting the passing standard, requiring statistical adjustments for comparison. Hence, this assessment can only suggest consistency with the passing standards for Steps 1 and 2 Clinical Knowledge, with further limitations in extrapolating this inference to Step 3. These limitations are due to variances in item difficulty and exclusion of the simulation component of Step 3 from the evaluation-limitations that would apply to any AI system evaluated on the Step 3 sample items. It is crucial to note that responses from large language models exhibit notable variations when faced with repeated inquiries, underscoring the need for expert validation to ensure their utility as a learning tool.

Can natural language processing be effectively applied for audit data analysis in gynaecological oncology at a UK cancer centre?

BACKGROUND: The British Gynaecological Cancer Society (BGCS) has highlighted the disparity of ovarian cancer outcomes in the UK compared to other European countries. Therefore, cancer quality assurance audits and subspecialty training are important in improving the UK standard of care for these patients. The current workforce crisis afflicting the NHS creates difficulty in dedicating teams of clinicians to these audits. We present a single institution study to evaluate if NLP-generated code can improve the efficiency of ovarian cancer and subspeciality reaccreditations audits. We used the chat bot Google Bard to write Visual Basic Applications algorithms that utilise Excel files from electronic health records. METHODS: Primary ovarian cancer data from 2019 to 2022 was retrospectively collected from the Cambridge University Hospital electronic health records. The surgical subspecialty reaccreditation audit analysed the 2022 surgical database. A modular coding approach with Google Bard was applied to generate audit algorithms. The time to complete these current audits was compared against the 2016 ovarian cancer and 2020 subspeciality reaccreditation audits. RESULTS: The previous ovarian cancer audit conducted in 2016 required 3 clinicians for the 135 cases and data collection required 1800 min. Data analysis was completed in 300 min. The current ovarian cancer audit allocated 2 clinicians to the 600 surgical cases. Data collection was completed in 3120 min, 3360 min for code development and 720 min for testing. The 2020 subspecialty reaccreditation audit was completed in 360 min. The 2022 subspecialty reaccreditation audit was completed in 1680 min, with 960 min for code development, 240 for debugging and 480 min for testing. CONCLUSION: We have demonstrated that NLP-generated code can significantly increase the efficiency of surgical quality assurance audits by eliminating the need for manual data analysis. With the current trajectory of NLP development, increasingly complex algorithms can be developed with minimal programming knowledge.

Translational approaches to improving cervical screening.

Screening programmes for cervical cancer using the current test--the Pap smear--have markedly reduced the incidence of the disease. However, an individual Pap test is of limited sensitivity and is difficult and expensive to perform. Increased understanding of the molecular pathogenesis of cervical cancer indicates that new approaches to screening might offer increased accuracy, affordability and the potential for automation. Such approaches exemplify how improved understanding of the biology of neoplasia might be translated into clinical benefit.

Psychological Distress and Suicidal Ideation in Australian Online Help-Seekers: The Mediating Role of Perceived Burdensomeness.

BACKGROUND: Psychological distress, an umbrella term encompassing emotional anguish and cognitive-behavioral symptoms of anxiety and depression, is closely linked to suicidal ideation. However, the mechanism of this relationship is unclear, dampening the utility of distress screening in suicide prevention. PURPOSE: This study aimed to identify potential mediators of this relationship, and whether effects are sex-specific. METHOD AND PARTICIPANTS: A sample of online help-seekers who had just completed the K10 psychological distress checklist on the Beyond Blue website [N = 1,528] consented to complete measures of help-seeking intentions, financial wellbeing, alcohol use, social connection (belongingness), sense of being a burden on others (burdensomeness); and suicidal ideation. Moderated mediation analysis examined the indirect effects of psychological distress on suicidal ideation through these risk factors, and whether effects were moderated by sex. RESULTS: The model accounted for 44% of the variance in suicidal ideation. The majority of participants had experienced very high psychological distress (77.3%) and at least some suicidal ideation (74.7%) in the past four weeks. A significant indirect effect of burdensomeness was found for both men and women. No other risk factors produced significant indirect effects. CONCLUSIONS: Perceived burdensomeness appears to be central in determining how psychological distress might progress to suicidal thinking. The experience of distress may lead a person to believe that loved ones would be better off without them, prompting suicidal thinking.HighlightsPsychological distress screening is an early intervention opportunity for suicide.Intervention plans could be improved by including perceived burdensome measures.Online screening for distress is a potential bridge to offline-help seeking.

Evaluating the effects of a brief motivational interviewing protocol on excessive acquisition.

BACKGROUND AND OBJECTIVES: Individuals with hoarding disorder, especially those with problems around acquiring, typically demonstrate a lack of motivation and awareness of their problematic behaviours. Since acquiring behaviours are important targets in interventions for hoarding, effective strategies for increasing motivation in this population are required to enhance the acceptability and efficacy of these interventions. METHODS: The aim of the current study was to evaluate the ability of a brief online motivational intervention to reduce acquiring in a community sample of high acquirers (N = 159). Participants were randomly assigned to either a motivational interviewing protocol (n = 73) or progressive muscle relaxation control condition (n = 86). Readiness to change and motivation to acquire was measured via self-report, and acquiring behaviour was measured using a modified version of the Preston Acquisition Decision Making Task (to increase ecological validity). RESULTS: In both conditions, participants' readiness and motivation to change increased over time. Contrary to hypotheses, the magnitude of this improvement did not significantly differ between conditions. Furthermore, conditions did not perform differently on the behavioural measure of acquiring. LIMITATIONS: Insufficient dose of the intervention may have precluded any differences being observed between conditions. CONCLUSIONS: Results underscore the need to better address the problem of lowered motivation in this population.