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.

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.

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.

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.

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.

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 latent factor approach to the Saving Inventory - Revised: Congeneric evaluation of construct and content validity.

BACKGROUND: Inconsistencies have been identified in the three-factor structure and item loadings of the most commonly used self-report hoarding screening tool, the Saving Inventory - Revised (SI-R), which assesses difficulty discarding, clutter and acquisition. The current study aimed to confirm the factor structure of the SI-R using congeneric modelling, and evaluate the construct and content validity of this measure. METHODS: 139 participants with self-identified hoarding completed the SI-R. Congeneric structural equation modelling was then performed to validate the SI-R factor structure. RESULTS: The three-factor structure of the SI-R was confirmed as a valid, reliable and good fitting model. However, the difficulty discarding and clutter subscales were required to covary. CONCLUSIONS: The SI-R was confirmed as an appropriate screening tool for hoarding severity; however, revision of item wording may improve content validity. Future research could consider exploring the relationships between a range of hoarding-related constructs and the differential endorsement of SI-R subscales. LIMITATIONS: As data were collected during the 2020 COVID-19 pandemic, panic buying and hoarding-related acquiring behaviours may have been exacerbated. In addition, the diagnostic status of participants was not verified, despite the inclusion of individuals endorsing clinically significant hoarding symptoms.

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.

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.

Clonal somatic copy number altered driver events inform drug sensitivity in high-grade serous ovarian cancer.

Chromosomal instability is a major challenge to patient stratification and targeted drug development for high-grade serous ovarian carcinoma (HGSOC). Here we show that somatic copy number alterations (SCNAs) in frequently amplified HGSOC cancer genes significantly correlate with gene expression and methylation status. We identify five prevalent clonal driver SCNAs (chromosomal amplifications encompassing MYC, PIK3CA, CCNE1, KRAS and TERT) from multi-regional HGSOC data and reason that their strong selection should prioritise them as key biomarkers for targeted therapies. We use primary HGSOC spheroid models to test interactions between in vitro targeted therapy and SCNAs. MYC chromosomal copy number is associated with in-vitro and clinical response to paclitaxel and in-vitro response to mTORC1/2 inhibition. Activation of the mTOR survival pathway in the context of MYC-amplified HGSOC is statistically associated with increased prevalence of SCNAs in genes from the PI3K pathway. Co-occurrence of amplifications in MYC and genes from the PI3K pathway is independently observed in squamous lung cancer and triple negative breast cancer. In this work, we show that identifying co-occurrence of clonal driver SCNA genes could be used to tailor therapeutics for precision medicine.

Magnetization transfer imaging of ovarian cancer: initial experiences of correlation with tissue cellularity and changes following neoadjuvant chemotherapy.

Objectives: To investigate the relationship between magnetization transfer (MT) imaging and tissue macromolecules in high-grade serous ovarian cancer (HGSOC) and whether MT ratio (MTR) changes following neoadjuvant chemotherapy (NACT). Methods: This was a prospective observational study. 12 HGSOC patients were imaged before treatment. MTR was compared to quantified tissue histology and immunohistochemistry. For a subset of patients (n = 5), MT imaging was repeated after NACT. The Shapiro-Wilk test was used to assess for normality of data and Spearman's rank-order or Pearson's correlation tests were then used to compare MTR with tissue quantifications. The Wilcoxon signed-rank test was used to assess for changes in MTR after treatment. Results: Treatment-naïve tumour MTR was 21.9 ± 3.1% (mean ± S.D.). MTR had a positive correlation with cellularity, rho = 0.56 (p < 0.05) and a negative correlation with tumour volume, ρ = -0.72 (p = 0.01). MTR did not correlate with the extracellular proteins, collagen IV or laminin (p = 0.40 and p = 0.90). For those patients imaged before and after NACT, an increase in MTR was observed in each case with mean MTR 20.6 ± 3.1% (median 21.1) pre-treatment and 25.6 ± 3.4% (median 26.5) post-treatment (p = 0.06). Conclusion: In treatment-naïve HGSOC, MTR is associated with cellularity, possibly reflecting intracellular macromolecular concentration. MT may also detect the HGSOC response to NACT, however larger studies are required to validate this finding. Advances in knowledge: MTR in HGSOC is influenced by cellularity. This may be applied to assess for cell changes following treatment.

The Essential Network (TEN): Protocol for an Implementation Study of a Digital-First Mental Health Solution for Australian Health Care Workers During COVID-19.

BACKGROUND: The COVID-19 pandemic has placed health care workers (HCWs) under severe stress, compounded by barriers to seeking mental health support among HCWs. The Essential Network (TEN) is a blend of digital and person-to-person (blended care) mental health support services for HCWs, funded by the Australian Federal Department of Health as part of their national COVID-19 response strategy. TEN is designed as both a preventative measure and treatment for common mental health problems faced by HCWs. New blended services need to demonstrate improvements in mental health symptoms and test acceptability in their target audience, as well as review implementation strategies to improve engagement. OBJECTIVE: The primary objective of this implementation study is to design and test an implementation strategy to improve uptake of TEN. The secondary objectives are examining the acceptability of TEN among HCWs, changes in mental health outcomes associated with the use of TEN, and reductions in mental health stigma among HCWs following the use of TEN. METHODS: The implementation study contains 3 components: (1) a consultation study with up to 39 stakeholders or researchers with implementation experience to design an implementation strategy, (1) a longitudinal observational study of at least 105 HCWs to examine the acceptability of TEN and the effectiveness of TEN at 1 and 6 months in improving mental health (as assessed by the Distress Questionnaire [DQ-5], Patient Health Questionnaire [PHQ-9], Generalized Anxiety Disorder [GAD-7], Oldenburg Burnout Inventory [OBI-16], and Work and Social Adjustment Scale [WSAS]) and reducing mental health stigma (the Endorsed and Anticipated Stigma Inventory [EASI]), and (3) an implementation study where TEN service uptake analytics will be examined for 3 months before and after the introduction of the implementation strategy. RESULTS: The implementation strategy, designed with input from the consultation and observational studies, is expected to lead to an increased number of unique visits to the TEN website in the 3 months following the introduction of the implementation strategy. The observational study is expected to observe high service acceptability. Moderate improvements to general mental health (DQ-5, WSAS) and a reduction in workplace- and treatment-related mental health stigma (EASI) between the baseline and 1-month time points are expected. CONCLUSIONS: TEN is a first-of-a-kind blended mental health service available to Australian HCWs. The results of this project have the potential to inform the implementation and development of blended care mental health services, as well as how such services can be effectively implemented during a crisis. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/34601.

A Brief, Daily, Online Mental Health and Well-being Intervention for University Staff During the COVID-19 Pandemic: Program Description and Outcomes Using a Mixed Methods Design.

BACKGROUND: The unprecedented changes and isolation measures to contain COVID-19 have had multiple psychological and social impacts, with implications for professional and personal functioning. Evidence-informed interventions that can be rapidly implemented under pandemic conditions to support mental health during such times are urgently needed. OBJECTIVE: The aim of this study was to determine the acceptability and preliminary outcomes of a daily online mental health promotion program for tertiary education staff during the COVID-19 pandemic. METHODS: The "Victoria University (VU) Elevenses" program was delivered as an uncontrolled intervention at Victoria University (VU) in the western metropolitan region of Melbourne, Australia. In April 2020, an email invitation was sent to all academic and professional staff inviting them to: (1) participate in the program and (2) opt-in to the research component. The "VU Elevenses" program provided 10-15-minute microinterventions comprising lifestyle and well-being strategies to promote mental health via an online meeting platform at 11 AM each weekday. A mixed methods approach was used to evaluate the program, combining structured questionnaires with semistructured interviews to investigate the experiences of staff who participated in the program. RESULTS: Between 16 and 90 participants provided weekly program feedback. A total of 106 university staff opted into the longitudinal research component and 10 staff participated in the interviews. Participants reported high levels of satisfaction with sessions and perceived benefits for mental health. Approximately one quarter of participants reported moderate to severe symptoms of depression, anxiety, and stress at baseline, with significant reductions in these symptoms in the first 7 weeks of the program, corresponding with easing in mandatory isolation ("lockdown") restrictions. Symptoms of depression, anxiety, and stress all increased when lockdown measures were reintroduced, but not to the same levels as found during the initial lockdown period. Overall changes in depression and anxiety from baseline to the end of the program were explained by changes in COVID-19-related distress, whereas changes in self-compassion explained changes in stress. CONCLUSIONS: We show that it is feasible and acceptable to develop and deliver a program of brief interventions in a timely manner, using a simple and accessible online platform. Although participation in the program was initially associated with reduced symptoms of depression, anxiety, and stress, participants' mental health worsened with the reintroduction of a "lockdown" period. However, as symptoms of depression, anxiety, and stress did not return to levels observed at the start of the VU Elevenses program, participation in the uncontrolled intervention may have offered a protective benefit against the impact of the second significant lockdown period.

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.

A Natural-Language-Processing-Based Procedure for Generating Distractors for Multiple-Choice Questions.

One of the most challenging aspects of writing multiple-choice test questions is identifying plausible incorrect response options-i.e., distractors. To help with this task, a procedure is introduced that can mine existing item banks for potential distractors by considering the similarities between a new item's stem and answer and the stems and response options for items in the bank. This approach uses natural language processing to measure similarity and requires a substantial pool of items for constructing the generating model. The procedure is demonstrated with data from the United States Medical Licensing Examination (USMLE®). For about half the items in the study, at least one of the top three system-produced candidates matched a human-produced distractor exactly; and for about one quarter of the items, two of the top three candidates matched human-produced distractors. A study was conducted in which a sample of system-produced candidates were shown to 10 experienced item writers. Overall, participants thought about 81% of the candidates were on topic and 56% would help human item writers with the task of writing distractors.

Radiotherapy Versus Inguinofemoral Lymphadenectomy as Treatment for Vulvar Cancer Patients With Micrometastases in the Sentinel Node: Results of GROINSS-V II.

PURPOSE: The Groningen International Study on Sentinel nodes in Vulvar cancer (GROINSS-V)-II investigated whether inguinofemoral radiotherapy is a safe alternative to inguinofemoral lymphadenectomy (IFL) in vulvar cancer patients with a metastatic sentinel node (SN). METHODS: GROINSS-V-II was a prospective multicenter phase-II single-arm treatment trial, including patients with early-stage vulvar cancer (diameter < 4 cm) without signs of lymph node involvement at imaging, who had primary surgical treatment (local excision with SN biopsy). Where the SN was involved (metastasis of any size), inguinofemoral radiotherapy was given (50 Gy). The primary end point was isolated groin recurrence rate at 24 months. Stopping rules were defined for the occurrence of groin recurrences. RESULTS: From December 2005 until October 2016, 1,535 eligible patients were registered. The SN showed metastasis in 322 (21.0%) patients. In June 2010, with 91 SN-positive patients included, the stopping rule was activated because the isolated groin recurrence rate in this group went above our predefined threshold. Among 10 patients with an isolated groin recurrence, nine had SN metastases > 2 mm and/or extracapsular spread. The protocol was amended so that those with SN macrometastases (> 2 mm) underwent standard of care (IFL), whereas patients with SN micrometastases (≤ 2 mm) continued to receive inguinofemoral radiotherapy. Among 160 patients with SN micrometastases, 126 received inguinofemoral radiotherapy, with an ipsilateral isolated groin recurrence rate at 2 years of 1.6%. Among 162 patients with SN macrometastases, the isolated groin recurrence rate at 2 years was 22% in those who underwent radiotherapy, and 6.9% in those who underwent IFL (P = .011). Treatment-related morbidity after radiotherapy was less frequent compared with IFL. CONCLUSION: Inguinofemoral radiotherapy is a safe alternative for IFL in patients with SN micrometastases, with minimal morbidity. For patients with SN macrometastasis, radiotherapy with a total dose of 50 Gy resulted in more isolated groin recurrences compared with IFL.

Factors Predicting Trial Engagement, Treatment Satisfaction, and Health-Related Quality of Life During a Web-Based Treatment and Social Networking Trial for Binge Drinking and Depression in Young Adults: Secondary Analysis of a Randomized Controlled Trial.

BACKGROUND: Mental health and alcohol use problems are among the most common causes of disease burden in young Australians, frequently co-occur (comorbidity), and lead to significant lifetime burden. However, comorbidities remain significantly underdetected and undertreated in health settings. Digital mental health tools designed to identify at-risk individuals, encourage help-seeking, or deliver treatment for comorbidity have the potential to address this service gap. However, despite a strong body of evidence that digital mental health programs provide an effective treatment option for a range of mental health and alcohol use problems in young adults, research shows that uptake rates can be low. Thus, it is important to understand the factors that influence treatment satisfaction and quality-of-life outcomes for young adults who access e-mental health interventions for comorbidity. OBJECTIVE: In this study, we seek to understand the factors that influence treatment satisfaction and quality-of-life outcomes for young adults who access e-mental health interventions for comorbid alcohol and mood disorders. The aim is to determine the importance of personality (ie, Big Five personality traits and intervention attitudes), affective factors (ie, depression, anxiety, and stress levels), and baseline alcohol consumption in predicting intervention trial engagement at sign-up, satisfaction with the online tool, and quality of life at the end of the iTreAD (Internet Treatment for Alcohol and Depression) trial. METHODS: Australian adults (N=411) aged between 18 and 30 years who screened positive for depression and alcohol use problems signed up for the iTreAD project between August 2014 and October 2015. During registration, participants provided information about their personality, current affective state, alcohol use, treatment expectations, and basic demographic information. Subsequent follow-up surveys were used to gauge the ongoing trial engagement. The last follow-up questionnaire, completed at 64 weeks, assessed participants' satisfaction with web-based treatment and quality-of-life outcomes. RESULTS: Multiple linear regression analyses were used to assess the relative influence of predictor variables on trial engagement, treatment satisfaction, and quality-of-life outcomes. The analyses revealed that the overall predictive effects of personality and affective factors were 20% or lower. Neuroticism constituted a unique predictor of engagement with the iTreAD study in that neuroticism facilitated the return of web-based self-assessments during the study. The return of incentivized follow-up assessments predicted treatment satisfaction, and state-based depression predicted variance in quality-of-life reports at study completion. CONCLUSIONS: Our findings suggest that traditional predictors of engagement observed in face-to-face research may not be easily transferable to digital health interventions, particularly those aimed at comorbid mental health concerns and alcohol misuse among young adults. More research is needed to identify what determines engagement in this population to optimally design and execute digital intervention studies with multiple treatment aims. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ACTRN): 12614000310662; http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=365137&isReview=true. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12889-015-2365-2.

IDTWO: A Protocol for a Randomised Controlled Trial of a Web-Based Mental Health Intervention for Australians with Intellectual Disability.

People with intellectual disability (ID) experience higher rates of mental illness and reduced access to appropriate care and treatment. Tailored electronic mental health (eMH) programs offer opportunities to address these disparities. The aim of this study is to examine whether a fully automated and self-guided eMH program tailored to the needs of people with ID can reduce symptoms of anxiety and depression and improve daily functioning in people with borderline-to-mild ID. Australians with borderline-to-mild ID, aged 16 years and older with mild-to-moderate depression and/or anxiety symptoms will be eligible to participate with the help of a nominated carer, if necessary. A randomised controlled trial with a sample size of 150 participants divided into treatment and waitlist control arms will be conducted. Participants randomised to the intervention group will have full access to the Healthy Mind program for eight weeks. The waitlist control group will gain full access to the program following the eight-week treatment period. Efficacy will be assessed on the Anxiety, Depression, and Mood Scale; Kessler-10; and the World Health Organisation Disability Assessment Schedule 2.0 across three time-points (baseline, eight weeks, and three months). We expect that people who use the intervention will report reduced depression and anxiety, relative to the control group. To our knowledge, this is the first study to examine the effectiveness of a fully automated eMH program for improving mental health in people with ID. We expect our study to render new knowledge on the delivery and effects of internet-based cognitive behaviour therapy (CBT) tools for people with ID.

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.