Unleashing patient voices: empowering adverse event assessment with complete patient-reported outcomes.

The 124-item patient reported-outcome common terminology criteria for adverse events (PRO-CTCAE) questionnaire, assessing 78 symptoms, is widely used in cancer clinical trials to identify side effects. However, its regular use in routine cancer care is rarely reported. We aimed to investigate the feasibility of weekly PRO-CTCAE completion over 9 weeks in a prospective study with 30 patients with cancer undergoing chemotherapy. Participants were asked to complete electronic surveys with reminders, but no feedback or incentives. Only 136 (50%) of the planned 270 time points at which a PRO-CTCAE self-report was expected were completed, with an additional 21 (8%) partially completed, and represents a failure to achieve the expected level of completion. Patients reported experiencing up to 51 and a median of 30 symptoms across all time points, highlighting the complexity of symptom assessment in acute cancer care. While weekly implementation of the PRO-CTCAE may not be feasible outside of clinical trial settings, this study highlights the breadth of symptoms experienced.

Constructing a clinical radiographic knee osteoarthritis database using artificial intelligence tools with limited human labor: A proof of principle.

OBJECTIVE: To create a scalable and feasible retrospective consecutive knee osteoarthritis (OA) radiographic database with limited human labor using commercial and custom-built artificial intelligence (AI) tools. METHODS: We applied four AI tools, two commercially available and two custom-built tools, to analyze 6 years of clinical consecutive knee radiographs from patients aged 35-79 at the University of Copenhagen Hospital, Bispebjerg-Frederiksberg Hospital, Denmark. The tools provided Kellgren-Lawrence (KL) grades, joint space widths, patella osteophyte detection, radiographic view detection, knee joint implant detection, and radiographic marker detection. RESULTS: In total, 25,778 knee radiographs from 8575 patients were included in the database after excluding inapplicable radiographs, and 92.5% of the knees had a complete OA dataset. Using the four AI tools, we saved about 800 hours of radiologist reading time and only manually reviewed 16.0% of the images in the database. CONCLUSIONS: This study shows that clinical knee OA databases can be built using AI with limited human reading time for uniform grading and measurements. The concept is scalable temporally and across geographic regions and could help diversify further OA research by efficiently including radiographic knee OA data from different populations globally. We can prevent data dredging and overfitting OA theories on existing trite cohorts by including various gene pools and continuous expansion of new clinical cohorts. Furthermore, the suggested tools and applied approaches provide an ability to retest previous hypotheses and test new hypotheses on real-life clinical data with current disease prevalence and trends.

PET-CT-guided, symptom-based, patient-initiated surveillance versus clinical follow-up in head neck cancer patients (PETNECK2): study protocol for a multicentre feasibility study and non-inferiority, randomised, phase III trial.

BACKGROUND: Approximately 40% of treated head and neck cancer (HNC) patients develop recurrence. The risk of recurrence declines with time from treatment. Current guidelines recommend clinical follow-up every two months for the first two years after treatment, with reducing intensity over the next three years. However, evidence for the effectiveness of these regimes in detecting recurrence is lacking, with calls for more flexible, patient-centred follow-up strategies. METHODS: PETNECK2 is a UK-based multi-centre programme examining a new paradigm of follow-up, using positron emission tomography-computed tomography (PET-CT)-guided, symptom-based, patient-initiated surveillance. This paradigm is being tested in a unblinded, non-inferiority, phase III, randomised controlled trial (RCT). Patients with HNC, one year after completing curative intent treatment, with no clinical symptoms or signs of loco-regional or distant metastasis will be randomised using a 1:1 allocation ratio to either regular scheduled follow-up, or to PET-CT guided, patient-initiated follow-up. Patients at a low risk of recurrence (negative PET-CT) will receive a face-to-face education session along with an Information and Support (I&S) resource package to monitor symptoms and be in control of initiating an urgent appointment when required. The primary outcome of the RCT is overall survival. The RCT also has an in-built pilot, a nested QuinteT Recruitment Intervention (QRI), and a nested mixed-methods study on patient experience and fear of cancer recurrence (FCR). An initial, single-arm feasibility study has been completed which determined the acceptability of the patient-initiated surveillance intervention, the completion rates of baseline questionnaires, and optimised the I&S resource prior to implementation in the RCT. DISCUSSION: We hypothesise that combining an additional 12-month post-treatment PET-CT scan and I&S resource will both identify patients with asymptomatic recurrence and identify those at low risk of future recurrence who will be empowered to monitor their symptoms and seek early clinical follow-up when recurrence is suspected. This change to a patient-centred model of care may have effects on both quality of life and fear of cancer recurrence. TRIAL REGISTRATION: ISRCTN: 13,709,798; 15-Oct-2021.

Vincristine exposure in Kenyan children with cancer: CHAPATI feasibility study.

The low incidence of vincristine-induced peripheral neuropathy (VIPN) in Kenyan children may result from low vincristine exposure. We studied vincristine exposure in Kenyan children and dose-escalated in case of low vincristine exposure (NCT05844670). Average vincristine exposure was high. Individual vincristine exposure was assessed with a previously developed nomogram. A 20% dose increase was recommended for participants with low exposure and no VIPN, hyperbilirubinemia, or malnutrition. None of the 15 participants developed VIPN. Low vincristine exposure was seen in one participant: a dose increase was implemented without side effects. In conclusion, the participants did not develop VIPN despite having high vincristine exposure.

Feasibility randomised controlled trial of face-to-face counselling and mobile phone messages compared to usual care for smokeless tobacco cessation in Indian primary care: Project CERTAIN.

INTRODUCTION: Smokeless tobacco (SLT) use in low- and middle-income countries (LMICs) has adverse health consequences. We hypothesize that it is feasible to test an intervention of mobile phone messages and face-to-face counselling session for SLT cessation in India. METHODS: We conducted an exploratory, individual parallel two group, randomised controlled trial (RCT), with baseline -and end-point (three months from randomisation) assessments in urban primary health centres in Odisha, India. A total of 250 current (i.e., users in the last three months) SLT users or dual users (i.e., smokers and SLT users) were recruited to the trial (125 in each group). Participants were randomised to either routine care, face-to-face counselling, and reminder mobile messages or routine care only. The primary outcomes were to assess the feasibility of running a full RCT including recruitment, compliance, and retention. RESULTS: A total seven (77.8%) out of nine primary care centres took part in the trial. Out of the 315 SLT users invited to participate, 250 provided consent and were randomised [79.4% (95% CI: 74.5, 83.7)]. Out of the 250 randomised SLT users, 238 [95% (95% CI: 91.8, 97.5)] were followed up at three months (117 in the intervention group and 121 in the control group). Of the participants in the intervention group, 74 (63.8%) reported that they received the mobile messages. CONCLUSIONS: This exploratory trial demonstrated the feasibility of delivering and evaluating an intervention of mobile phone messages and face-to-face counselling for SLT users in Indian primary care in a full randomised trial. IMPLICATIONS: This study found that combining mobile messages with face-to-face counselling for smokeless tobacco users visiting primary health care settings in India is feasible in terms of recruitment of users, compliance with the intervention, and retention of study participants within the trial.The biochemically verified smokeless tobacco abstinence rate was higher in the intervention group compared with the control groupThere was poor agreement between self-reported tobacco cessation and the measured salivary cotinine in smokeless tobacco users.The findings support the feasibility and acceptability of the intervention signalling the need for a larger clinical trial to test effectiveness of the intervention.

Acceptability and experience of a smartphone symptom monitoring app for people with psychosis in China (YouXin): a qualitative study.

BACKGROUND: Access to high-quality mental healthcare remains challenging for people with psychosis globally, including China. Smartphone-based symptom monitoring has the potential to support scalable mental healthcare. However, no such tool, until now, has been developed and evaluated for people with psychosis in China. This study investigated the acceptability and the experience of using a symptom self-monitoring smartphone app (YouXin) specifically developed for people with psychosis in China. METHODS: Semi-structured interviews were conducted with 10 participants with psychosis to explore the acceptability of YouXin. Participants were recruited from the non-randomised feasibility study that tested the validity, feasibility, acceptability and safety of the YouXin app. Data analysis was guided by the theoretical framework of acceptability. RESULTS: Most participants felt the app was acceptable and easy to use, and no unbearable burdens or opportunity costs were reported. Participants found completing the self-monitoring app rewarding and experienced a sense of achievement. Privacy and data security were not major concerns for participants, largely due to trust in their treating hospital around data protection. Participants found the app easy to use and attributed this to the training provided at the beginning of the study. A few participants said they had built some form of relationship with the app and would miss the app when the study finished. CONCLUSIONS: The YouXin app is acceptable for symptom self-monitoring in people with experience of psychosis in China. Participants gained greater insights about their symptoms by using the YouXin app. As we only collected retrospective acceptability in this study, future studies are warranted to assess hypothetical acceptability before the commencement of study to provide a more comprehensive understanding of implementation.

Evaluation of a knowledge-attitude-practice model based narrative life education program for community-dwelling older adults: a mixed-methods feasibility study.

BACKGROUND: The global aging population presents challenges that are particularly acute in China. Older Chinese adults' attitudes towards death significantly impact their quality of life. Death education is crucial for promoting positive perspectives on life and death. Narrative education offers a promising approach to facilitating death education. Integrating the Knowledge-Attitude-Practice (KAP) model into death education will enhance the feasibility and acceptability of death education programs. METHODS: This mixed-methods feasibility study included a quasi-experimental trial and semi-structured interviews. Older adults in the intervention group (N = 27) received a 6-week KAP-based narrative life education program in addition to standard community health education; participants in the control group (N = 20) received only the normal community health education. In both groups, attitudes toward death and the meaning of life were assessed at baseline and immediately after the intervention. A post-intervention semi-structured interview and satisfaction survey were also conducted for the intervention group. RESULTS: Forty out of 47 older adults completed the program for an 85.1% retention rate. All of the older adults in the experiment were very satisfied and satisfied with the life education program, and no adverse events were reported. Compared to the control group, participants in the intervention group had a significant decrease in the fear of death (P = 0.028), and substantial improvement in their value of life (P = 0.031), goal of life (P = 0.035), freedom of life (P = 0.003), and the total score for purpose in life (P = 0.017). The qualitative results yielded four themes: profound recognition of life and death, contradiction between thoughts and action, conflict between one's acceptance and others' avoidance, and evaluation of the life education program. CONCLUSIONS: The KAP-based narrative life education program is feasible and acceptable for older Chinese community-dwelling adults. It is also potentially effective in improving attitudes toward death attitudes and the meaning of life in this cohort. TRIAL REGISTRATION: This study was retrospectively registered at China Clinical Trial Registry as ChiCTR2300069551 on 2023-03-20. URL of registration: https://www.chictr.org.cn/showproj.html?proj=183176 .

Pharmacist-led intervention for older people with atrial fibrillation in long-term care (PIVOTALL study): a randomised pilot and feasibility study.

BACKGROUND: Older care home residents are a vulnerable group of people with atrial fibrillation (AF) at high risk of adverse health events. The Atrial Fibrillation Better Care (ABC: Avoid stroke; Better symptom management; Cardiovascular and other comorbidity management) pathway is the gold-standard approach toward integrated AF care, and pharmacists are a potential resource with regards to its' implementation. The aim of this study was to determine the feasibility of pharmacist-led medicines optimisation in care home residents, based on the ABC pathway compared to usual care. METHODS: Individually randomised, prospective pilot and feasibility study of older (aged ≥ 65 years) care home residents with AF (ISRCTN14747952); residents randomised to ABC pathway optimised care versus usual care. The primary outcome was a description of study feasibility (resident and care home recruitment and retention). Secondary outcomes included the number and type of pharmacist medication recommendations and general practitioner (GP) implementation. RESULTS: Twenty-one residents were recruited and 11 (mean age [standard deviation] 85.0 [6.5] years, 63.6% female) were randomised to receive pharmacist-led medicines optimisation. Only 3/11 residents were adherent to all three components of the ABC pathway. Adherence was higher to 'A' (9/11 residents) and 'B' (9/11 residents) components compared to 'C' (3/11 residents). Four ABC-specific medicines recommendations were made for three residents, and two were implemented by residents' GPs. Overall ABC adherence rates did not change after pharmacist medication review, but adherence to 'A' increased (from 9/11 to 10/11 residents). Other ABC recommendations were inappropriate given residents' co-morbidities and risk of medication-related adverse effects. CONCLUSIONS: The ABC pathway as a framework was feasible to implement for pharmacist medication review, but most residents' medications were already optimised. Low rates of adherence to guideline-recommended therapy were a result of active decisions not to treat after assessment of the net risk-benefit.

The frail-LESS (LEss sitting and sarcopenia in frail older adults) remote intervention to improve sarcopenia and maintain independent living via reductions in sedentary behaviour: findings from a randomised controlled feasibility trial.

BACKGROUND: Sarcopenia leads to functional disability, dependence in activities of daily living (ADL), and is a key contributor to frailty. Reducing and breaking up sedentary time is associated with improved sarcopenia and frailty-related outcomes. The aim of this study was to determine the feasibility of delivering and evaluating a remote sedentary behaviour intervention to improve sarcopenia and independent living in older adults with frailty. METHODS: A two-arm randomised controlled feasibility trial was conducted with a target of 60 older adults (mean age 74 ± 6 years) with very mild or mild frailty. Participants were randomised to the Frail-LESS (LEss Sitting and Sarcopenia in Frail older adults) intervention or usual care control group for six months. The intervention included tailored feedback on sitting, standing and stepping; an education workbook that included goal setting and action planning; one-to-one health coaching; peer support; and a wearable device to self-monitor sedentary behaviour. Participant recruitment (percentage of eligible individuals recruited), retention and data completion rates were used to assess trial feasibility. Acceptability of the trial was explored through interviews and safety was evaluated via unplanned healthcare utilisation and number of falls. Sitting, standing, stepping and sarcopenia were measured to evaluate potential intervention effects. RESULTS: Sixty participants were recruited. Recruitment and retention rates were 72% and 83%, respectively. Completion rates for outcome measures ranged from 70 to 100%. The trial was safe (< 1 fall per participant on average at each timepoint) and trial procedures were acceptable. Descriptive analysis (mean ± SD) showed that daily sitting was 25.1 ± 82.1 min/day lower in the intervention group, and 6.4 ± 60.5 min/day higher in the control group, at 6 months compared with baseline. Hand grip strength and sit-to-stand score were improved by 1.3 ± 2.4 kg and 0.7 ± 1.0, respectively, in the intervention group. CONCLUSIONS: This study demonstrates the feasibility and safety of delivering and evaluating a remote intervention to reduce and break up sitting in older adults with frailty. The intervention showed evidence towards reducing daily sitting and improving sarcopenia, supporting its evaluation in a definitive randomised controlled trial. TRIAL REGISTRATION: ISRCTN registry (registration number: ISRCTN17158017). Registered 6th August 2021.

Promoting physical activity in rheumatoid arthritis through a physiotherapist led behaviour change-based intervention (PIPPRA): a feasibility randomised trial.

Physical activity (PA) is recommended as a key component in the management of people with rheumatoid arthritis (RA). The objective of this study was to examine the feasibility of a physiotherapist led, behaviour change (BC) theory-informed, intervention to promote PA in people with RA who have low levels of current PA. A feasibility randomised trial (ClinicalTrials.gov NCT03644160) of people with RA over 18 years recruited from outpatient rheumatology clinics and classified as insufficiently physically active using the Godin-Shephard Leisure Time Physical Activity Questionnaire. Participants were randomised to intervention group (4 BC physiotherapy sessions in 8 weeks) delivered in person/virtually or control group (PA information leaflet only). Feasibility targets (eligibility, recruitment, and refusal), protocol adherence and acceptability were measured. Health care professionals (HCPs) involved in the study and patients in the intervention and control arms were interviewed to determine acceptability. Descriptive statistics were used to analyse the data with SPSS (v27) with interviews analysed using content analysis using NVivo (v14). Three hundred and twenty participants were identified as potentially eligible, with n = 183 (57%) eligible to participate, of which n = 58 (32%) consented to participate. The recruitment rate was 6.4 per month. Due to the impact of COVID-19 on the study, recruitment took place over two separate phases in 2020 and 2021. Of the 25 participants completing the full study, 23 were female (mean age 60 years (SD 11.5)), with n = 11 allocated to intervention group and n = 14 to control. Intervention group participants completed 100% of sessions 1 & 2, 88% of session 3 and 81% of session 4. The study design and intervention were acceptable overall to participants, with enhancements suggested. The PIPPRA study to improve promote physical activity in people with RA who have low PA levels was feasible, acceptable and safe. Despite the impact of COVID-19 on the recruitment and retention of patients, the study provides preliminary evidence that this physiotherapist led BC intervention is feasible and a full definitive intervention should be undertaken. Health care professionals involved in the study delivery and the patient participants described a number of positive aspects to the study with some suggestions to enhance the design. These findings hence inform the design of a future efficacy-focused clinical trial.

Development of a supportive care needs eHealth application for patients with cervical cancer undergoing surgery: a feasibility study.

PURPOSE: To inform the development of an eHealth application for patients with cervical cancer for monitoring supportive care needs, perceived care supply and quality of life. METHODS: A mixed-method design was used. The 19-month process involved five phases: (1) a literature review to screen the components of applications, (2) a cross-sectional needs assessment for patients with cervical cancer to define the needs and application program frame, (3) expert consultation to refine the draft, (4) software development, and (5) pilot testing and user comment collection. Patients in the intervention group received a 7-day application intervention combined with usual care. Supportive care needs, perceived care supply, quality of life and user's additional comments were collected. RESULTS: The literature review results in phase 1 revealed the importance of full preparation, especially a supportive care needs assessment, before application development. Subsequent supportive care needs investigation in phase 2 revealed that the most urgent needs were informational needs and privacy protection. In phase 3, 43 expert recommendations for application improvement were refined. The new application contained the patient and the health care professional portal in phase 4. Then, on Day 7, there existed score changes of the outcome measures in both intervention and control group. Users had a positive experience with the application. CONCLUSIONS: This study demonstrates the feasibility of applications targeting access to supportive care, which may be effective for improving the outcome measures but needed to be evaluated in future studies.

Value-Based Payment to Support Health Care Transition for Young Adults with Intellectual and Developmental Disabilities: A Feasibility Study.

INTRODUCTION: Only 20% of youth with intellectual and developmental disability (ID/DD) receive health care transition (HCT) preparation from their health care providers (HCPs). To address HCT system gaps, the first-of-its-kind HCT value-based payment (VBP) pilot was conducted for young adults (YA) with ID/DD. METHODS: This feasibility study examined the acceptability, implementation, and potential for expansion of the pilot, which was conducted within a specialty Medicaid managed care organization (HSCSN) in Washington, DC. With local pediatric and adult HCPs, the HCT intervention included a final pediatric visit, medical summary, joint HCT visit, and initial adult visit. The VBP was a mix of fee-for-service and pay-for-performance incentives. Feasibility was assessed via YA feedback surveys and interviews with HSCSN, participating HCPs, and selected state Medicaid officials. RESULTS: Regarding acceptability, HSCSN and HCPs found the HCT intervention represented a more organized approach and addressed an unmet need. YA with ID/DD and caregivers reported high satisfaction. Regarding implementation, nine YA with ID/DD participated. Benefits were reported in patient engagement, exchange of health information, and care management and financial support. Challenges included care management support needs, previous patient gaps in care, and scheduling difficulties. Regarding expansion, HSCSN and HCPs agreed that having streamlined care management support, medical summary preparation, and payment for HCT services are critical. DISCUSSION: This study examined the benefits and challenges of a HCT VBP approach and considerations for future expansion, including payer/HCP collaboration, HCT care management support, and updated system technology and interoperability.

Comparison of needle and conventional arthroscopy for visualisation of predefined anatomical structures of the knee joint: a feasibility study in human cadavers and patients.

BACKGROUND: In terms of the optics used for Knee arthroscopy, a large number of different endoscopes are currently available. However, the use of the 30° optics in knee arthroscopy has been established as the standard procedure for many years. As early as the 1990s, needle arthroscopy was occasionally used as a diagnostic tool. In addition to the development of conventional optics technology in terms of camera and resolution, needle arthroscopes are now available with chip-on-tip image sensor technology. To date, no study has compared the performance of this kind of needle arthroscopy versus standard arthroscopy in the clinical setting in terms of the visibility of anatomical landmarks. In this monocentric prospective feasibility study, our aim was to evaluate predefined anatomical landmarks of the knee joint using needle arthroscopy (0° optics) and conventional knee arthroscopy (30° optics) and compare their performance during knee surgery. METHODS: Examinations were performed on eight cadavers and seven patients who required elective knee arthroscopy. Two surgeons independently performed the examinations on these 15 knee joints, so that we were able to compare a total of 30 examinations. The focus was on the anatomical landmarks that could be visualized during a conventional diagnostic knee arthroscopy procedure. The quality of visibility was evaluated using a questionnaire. RESULTS: In summary, the average visibility for all the anatomic landmarks was rated 4.98/ 5 for the arthroscopy using 30° optics. For needle arthroscopy, an average score of 4.89/ 5 was obtained. Comparatively, the needle arthroscope showed slightly limited visibility of the retropatellar gliding surface in eight (4.5/ 5 vs. 5/ 5), medial rim of the patella in four (4.85/ 5 vs. 5/ 5), and suprapatellar recess in four (4.83/ 5 vs. 5/ 5) cases. Needle arthroscopy was slightly better at visualizing the posterior horn of the medial meniscus in four knee joints (4.9/ 5 vs. 4.85/ 5). CONCLUSION: Needle arthroscopy is a promising technology with advantages in terms of minimally invasive access and good visibility of anatomical landmarks. However, it also highlights some limitations, particularly in cases with challenging anatomy or the need for a wide field of view.

The impact of an integrated early palliative care telehealth intervention on the quality of life of heart failure patients: a randomized controlled feasibility study.

BACKGROUND: While palliative care for patients with heart failure has gained global attention, in Iran most palliative care interventions have focused only on cancer patients. The purpose of this study is to determine the feasibility and acceptability of a telehealth palliative care intervention to improve the quality of life in patients with heart failure in Iran. METHODS: This single-site, pilot randomized controlled trial of a telehealth palliative care intervention versus usual care was conducted on patients with New York Heart Association class II/III heart failure recruited from a heart failure clinic in Iran. Under the supervision of a nurse interventionist, intervention participants received 6 weekly educational webinars and concurrent WhatsApp® group activities, with 6 weeks of follow-up. Feasibility was assessed by measuring recruitment, attrition, and questionnaire completion rates; acceptability was assessed via telephone interviews asking about satisfaction and attitudes. Secondary outcomes measured at baseline and 6 weeks included quality of life (PKCCQ and FACIT-Pal-14), anxiety and depression (HADS), and emergency department visits. RESULTS: We recruited and randomized 50 patients (mean age 47.5 years, 60% men). Among those approached for consent, 66% of patients agreed to participate and total study attrition was 10%. Also 68% of patients successfully completed at least 4 out of the 6 webinar sessions. Acceptability: 78% of patient participants expressed willingness to participate in the present study again or recommend other patients to participate. There was a trend towards improvement in anxiety and depression scores in the intervention group though the study was not powered to detect a statistical difference. CONCLUSION: This nurse-led, early telehealth-palliative care intervention demonstrated evidence of feasibility, acceptability, and potential improvement on quality of life in patients with heart failure in Iran. TRIAL REGISTRATION: The study was registered at the Iranian Registry of Clinical Trials (IRCT) at 14 November, 2021, and can be found on the Iranian Registry of Clinical Trials Platform. IRCT registration number: IRCT20100725004443N29.

Managing mental health in chronic care in general practice: a feasibility study of the Healthy Mind intervention.

BACKGROUND AND OBJECTIVE: Mental health issues are common among patients with chronic physical conditions. This study aims to evaluate the feasibility of the Healthy Mind intervention, a general practice-based programme that provides problem-solving therapy (PST) to patients with poor mental well-being and type 2 diabetes (T2D) and/or ischaemic heart disease (IHD). DESIGN AND SETTING: A one-arm feasibility study was conducted in three general practices in the Central Denmark Region. INTERVENTION: Eight healthcare providers from the included general practices underwent a two-day course to acquire PST skills. Screening for poor mental health was carried out at the annual chronic care consultation for T2D or IHD, and PST sessions were offered to patients on indication of poor mental health. Nine patients received PST. METHODS: Semi-structured interviews with eight healthcare providers and six patients were conducted. Data were analysed deductively focusing on appropriateness, acceptability and fidelity of the intervention. RESULTS: The intervention was considered appropriate for the patient group and the general practice setting. The providers acknowledged PST as a valuable tool for managing psychological issues in general practice, and the patients perceived PST as an effective and tangible treatment. Since practice nurses' schedules were generally better suited for longer consultations, they were often the preferred intervention providers. The intervention was largely delivered as intended. However, the GPs generally expected patients to prefer a more directive approach, which sometimes challenged their role as facilitator and guide. CONCLUSION: The Healthy Mind intervention was found to be feasible, and the results support proceeding to a full-scale evaluation trial.

Patients with type 2 diabetes and/or ischaemic heart disease often experience poor mental well-being, revealing a shortage of general practice-based interventions targeting this issue.This study evaluates the feasibility of a problem-solving therapy intervention in general practice for patients with poor mental health and type 2 diabetes and/or chronic ischemic heart disease.Both patients and healthcare providers regarded problem-solving therapy as an acceptable intervention for managing psychological issues in general practice.Healthcare providers preferred practice nurses as the providers of problem-solving therapy since their schedules were often more suitable for longer consultations.In problem-solving therapy, the provider is expected to take a facilitating and guiding role, but GPs sometimes struggled remaining in this role due to a preconceived anticipation that patients expected them to take a more directive approach.

Identification of health-related problems in youth: a mixed methods feasibility study evaluating the Youth Health Report System.

BACKGROUND: Because poor health in youth risk affecting their entry in adulthood, improved methods for their early identification are needed. Health and welfare technology is widely accepted by youth populations, presenting a potential method for identifying their health problems. However, healthcare technology must be evidence-based. Specifically, feasibility studies contribute valuable information prior to more complex effects-based research. The current study assessed the process, resource, management, and scientific feasibility of the Youth Health Report System prototype, developed within a youth health clinic context in advance of an intervention study. METHODS: This mixed-methods feasibility study was conducted in a clinical setting. The process, resource, management, and scientific feasibility of the Youth Health Report System were investigated, as recommended in the literature. Participants were youth aged 16-23 years old, attending a youth health clinic, and healthcare professionals from three clinics. The youth participants used their smart phones to respond to Youth Health Report System health questions and healthcare professionals used their computer to access the results and for registration system entries. Qualitative data were collected from interviews with healthcare professionals, which were described with thematic analysis. Youth participants' quantitative Youth Health Report System data were analyzed for descriptive statistics. RESULTS: Feasibility analysis of qualitative data from interviews with 11 healthcare professionals resulted in three themes: We expected it could be hard; Information and routines helped but time was an issue; and The electronic case report form was valuable in the health assessment. Qualitative data were collected from the Youth Health Report System. A total of 54 youth participants completed the evaluation questionnaire, and healthcare professionals retrieved information from, and made post-appointment system entries. Quantitative results revealed few missing items and acceptable data variability. An assessment template of merged qualitative and quantitative data guided a consensus discussion among the researchers, resulting in acceptable feasibility. CONCLUSIONS: The process-, resource-, management-, and scientific feasibility aspects were acceptable, with some modifications, strengthening the potential for a successful Youth Health Report System intervention study.

Teaching breaking bad news in a gyneco-oncological setting: a feasibility study implementing the SPIKES framework for undergraduate medical students.

BACKGROUND: It is a crucial task for physicians to deliver life threatening information to patients (breaking bad news; BBN). Many aspects influence these conversations on both sides, patients, and doctors. BBN affects the patient-physician relationship, patients' outcome, and physicians' health. Many physicians are still untrained for this multi-facetted task and feel unprepared and overburdened when facing situations of BBN. Therefore, any faculties should aim to integrate communication skills into their medical curricula as early as possible. The SPIKES protocol is an effective framework to deliver BBN. Aim of this study is to evaluate the feasibility and obstacles of a BBN seminar and its acceptance and learning curve among undergraduate medical students. METHODS: 158 2nd year undergraduate medical students attended a compulsory BBN seminar. The task was to deliver a cancer diagnosis to the patient within a patient - physician role-play in a gyneco-oncological setting before and after a presentation of the SPIKES protocol by the lecturer. The students evaluated important communication skills during these role-plays respectively. Self-assessment questionnaires were obtained at the beginning and end of the seminar. RESULTS: Most students indicated that their confidence in BBN improved after the seminar (p < 0.001). They like the topic BBN to be part of lectures (76%) and electives (90%). Communication skills improved. Lecturer and seminar were positively evaluated (4.57/5). CONCLUSION: The seminar significantly increased confidence and self-awareness in delivering life-threatening news to patients among undergraduate medical students. Important learning aspects of BBN and communication skills could be delivered successfully to the participants within a short time at low costs. The integration of communication skills should be implemented longitudinally into medical curricula starting before clinical education to increase the awareness of the importance of communication skills, to decrease anxiety, stress, and workload for future doctors and- most importantly- to the benefit of our patients.

Physiological Responses to Organizational Stressors Among Police Managers.

Police officers demonstrate increased risk of physical and mental health conditions due to repeated and prolonged exposure to stressful occupational conditions. Occupational stress is broken into two types: operational stress, related to the content of field duties (e.g., physical demands); and organizational stress, related to cultural and structural contexts (e.g., interpersonal relationships). Applied police research focuses on physiological activation in operational tasks as a mechanism explaining health risk and non-optimal performance outcomes. However, recent survey-based studies indicate numerous organizational stressors associated with self-reported mental health symptoms. The question of whether organizational stressors elicit significant physiological activity remains unknown. The current proof-of-concept field study tests the hypothesis that police managers will display significant physiological reactivity before, during, and after engaging in reality-based scenarios representative of stressful police management tasks developed from evidence-based pedagogical approaches. A sample of 25 training police managers (7 female, M = 16 +/- 5.3 years of experience) completed 5 reality-based scenarios, including resolving a heated conflict between colleagues, delivering negative feedback to a subordinate, and critical incident command. Significant increases in heart rate relative to rest were observed during all tasks, and in anticipation of several tasks. Greater increases in reactive heart rate were associated with longer recovery times. Sex differences and relationships between objective biological and subjective psychological measures of stress are discussed. The current findings demonstrate significant physiological responses to organizational stressors similar to levels observed during operational tasks, despite the absence of physical or aerobic exertion. Implications for police health and training are discussed.

Take-home naloxone administered in emergency settings: feasibility of intervention implementation in a cluster randomized trial.

BACKGROUND: Opioids kill more people than any other class of drug. Naloxone is an opioid antagonist which can be distributed in kits for peer administration. We assessed the feasibility of implementing a Take-home Naloxone (THN) intervention in emergency settings, as part of designing a definitive randomised controlled trial (RCT). METHODS: We undertook a clustered RCT on sites pairing UK Emergency Departments (ED) and ambulance services. At intervention sites, we recruited emergency healthcare practitioners to supply THN to patients presenting with opioid overdose or related condition, with recruitment across 2019-2021. We assessed feasibility of intervention implementation against four predetermined progression criteria covering site sign up and staff training; identification of eligible patients; issue of THN kits and Serious Adverse Events. RESULTS: At two intervention sites, randomly selected from 4, 299/687 (43.5%) clinical staff were trained (ED1 = 107, AS1 = 121, ED2 = 25, AS2 = 46). Sixty THN kits were supplied to eligible patients (21.7%) (n: ED1 = 36, AS1 = 4, ED2 = 16, AS2 = 4). Across sites, kits were not issued to eligible patients on a further 164 occasions, with reasons reported including: staff forgot (n = 136), staff too busy (n = 15), and suspected intentional overdose (n = 3), no kit available (n = 2), already given by drugs nurse (n = 4), other (n = 4). Staff recorded 626 other patients as ineligible but considered for inclusion, with reasons listed as: patient admitted to hospital (n = 194), patient absconded (n = 161) already recruited (n = 64), uncooperative or abusive (n = 55), staff not trained (n = 43), reduced consciousness level (n = 41), lack of capacity (n = 35), patient in custody (n = 21), other (n = 12). No adverse events were reported. CONCLUSION: Staff and patient recruitment were low and varied widely by site. This feasibility study did not meet progression criteria; a fully powered RCT is not planned. TRIAL REGISTRATION: ISRCTN13232859 (Registered 16/02/2018).

Is a randomised controlled trial of take home naloxone distributed in emergency settings likely to be feasible and acceptable? Findings from a UK qualitative study exploring perspectives of people who use opioids and emergency services staff.

OBJECTIVE: Distribution of take-home naloxone (THN) by emergency services may increase access to THN and reduce deaths and morbidity from opioid overdose. As part of a feasibility study for a randomised controlled trial (RCT) of distribution of THN kits and education within ambulance services and Emergency Departments (EDs), we used qualitative methods to explore key stakeholders' perceptions of feasibility and acceptability of delivering the trial. METHODS: We undertook semi-structured interviews and focus groups with 26 people who use opioids and with 20 paramedics and ED staff from two intervention sites between 2019 and 2021. Interviews and focus groups were recorded, transcribed verbatim and analysed using Framework Analysis. RESULTS: People using opioids reported high awareness of overdose management, including personal experience of THN use. Staff perceived emergency service provision of THN as a low-cost, low-risk intervention with potential to reduce mortality, morbidity and health service use. Staff understood the trial aims and considered it compatible with their work. All participants supported widening access to THN but reported limited trial recruitment opportunities partly due to difficulties in consenting patients during overdose. Procedural problems, restrictive recruitment protocols, limited staff buy-in and patients already owning THN limited trial recruitment. Determining trial effectiveness was challenging due to high levels of alternative community provision of THN. CONCLUSIONS: Distribution of THN in emergency settings was considered feasible and acceptable for stakeholders but an RCT to establish the effectiveness of THN delivery is unlikely to generate further useful evidence due to difficulties in recruiting patients and assessing benefits.