Mixed Methods Feasibility Study Research Articles

Sound healing reduces generalized anxiety during the pandemic: A feasibility study

ObjectivesThis study examined the feasibility and effectiveness of a virtually-delivered, biofield-based sound healing treatment to reduce anxiety for individuals meeting criteria for Generalized Anxiety Disorder. DesignThis one-group, mixed-method feasibility study was conducted virtually via Zoom during the SARS-CoV-2 Pandemic. Fifteen participants with moderate to high levels of anxiety as determined by the Generalized Anxiety Disorder-7 (≥10), were enrolled. InterventionFive certified Biofield Tuning Practitioners performed the interventions. Participants were given three weekly, hour-long sound healing treatments virtually, over a month’s period. Outcome MeasuresAttrition rates and reports on feasibility of intervention delivery and outcomes assessment were obtained by participants. Data on anxiety, positive and negative affect, spiritual experience, perceived stress, and quality of life were obtained via validated surveys and analyzed via repeated-measures analysis of variance with intention-to-treat. Linguistic inquiry and word count was utilized to assess changes in affective processing as reflected in participants’ spoken words over the course of the intervention. Qualitative interviews were conducted to further determine tolerability and experiences with receiving BT that may not have been captured by survey and language data. ResultsAttrition rates were 13.3%, with two participants dropping out of the study after one session. The remaining participants reported acceptability of the data collection process and intervention delivery. Intention to treat analyses revealed statistically significant reductions in anxiety (State-Trait Anxiety Inventory), negative affect (Positive and Negative Affect Scale), and perceived stress (Perceived Stress Scale) (p < .001 in all cases). Linguistic and word count analysis revealed a significant linear decrease (p = .01) of participants’ use of negative affect words over the course of the intervention. Qualitative data results are reported in another paper. ConclusionsResults indicate that BT delivered virtually is feasible and amenable to study, and that the impact of BT may be substantial in reducing anxiety and improving mental health. This is the first study of its kind to report clinically significant reductions in anxiety levels in response to a virtually-delivered, biofield-based sound therapy. Data will be used to power a randomized controlled trial to more deeply examine the effects of BT on whole-person healing for those suffering from anxiety.

Mixed-methods feasibility study to inform a randomised controlled trial of proton pump inhibitors to reduce strictures following neonatal surgery for oesophageal atresia

ObjectivesThis mixed-methods feasibility study aimed to explore parents’ and medical practitioners’ views on the acceptability and design of a clinical trial to determine whether routine prophylactic proton pump inhibitors (PPI)...

Augmented Reality in Medical Education: A Mixed Methods Feasibility Study.

Augmented reality (AR) is a novel technology with many applications in medical education. Perhapsone of the most beneficial potential applications is to enable better clinical access for students; however, there is limited research into this use. The purpose of this mixed-methods feasibility study was to evaluate the applicability and acceptability of AR in undergraduate and early postgraduate medical education. Single-group quasi-experimental study design was developed for critical care-themed simulation teaching delivered using Microsoft HoloLens (Microsoft Corporation, Redmond, Washington, United States). Post-test questionnaires were completed including a validated adapted immersive experience questionnaire (AIEQ) and an abridged intrinsic motivation inventory (AIMI). The AIMI focused on the domains of 'interest and enjoyment', and 'value and usefulness'. Following the teaching, focus group interviews with thematic analysis were conducted to evaluate participants' experiences with AR. All 15 participants (100%) completed the AIEQ and AIMI. Co-located airway teaching (i.e., the demonstrator and participants were placed in the same AR environment) was reported as having a moderate level of user immersion (median 72) and a high level of user enjoyment and value (median 52). Thematic analysis revealed four key themes: visual conceptualization for learning, accessibility, varied immersion, and future application. Conclusions: Remote simulation for the management of airways in critical care was found to be acceptable and afforded a high level of enjoyment and value. Similarly, this was reflected in the thematic analysis. However, immersion was rated variably in both AIEQ and thematic analysis. The challenges identified with the application of AR included technical infrastructure and patient consent. AR-enabled education benefits are relevant to a number of clinical teaching areas.

Digital tools to improve parenting behaviour in low-income settings: a mixed-methods feasibility study

IntroductionDigital parenting interventions could be potentially cost-effective means for providing early child development services in low-income settings. This 5-month mixed-methods pilot study evaluated the feasibility of using Afinidata, a comprehensive...

Getting Recovery Right After Neck Dissection (GRRAND-F): Mixed-methods feasibility study to design a pragmatic randomised controlled trial.

To determine the feasibility of a randomised controlled trial to estimate the effectiveness and cost-effectiveness of a rehabilitation intervention following neck dissection (ND) after head and neck cancer (HNC). Two-arm, open, pragmatic, parallel, multicentre, randomised controlled feasibility trial. Two UK NHS hospitals. People who had HNC in whom a ND was part of their care. We excluded those with a life expectancy of six months or less, pre-existing, long-term neurological disease affecting the shoulder and cognitive impairment. Usual care (standard care supplemented with a booklet on postoperative self-management) was received by all participants. The GRRAND intervention programme consisted of usual care plus up to six individual physiotherapy sessions including neck and shoulder range of motion and progressive resistance exercises, advice and education. Between sessions, participants were advised to complete a home exercise programme. 1:1 randomisation. Allocation was based on minimisation, stratified by hospital site and spinal accessory nerve sacrifice. It was not possible to mask treatment received. Primary: Participant recruitment, retention and fidelity to the study protocol and interventions from study participants and staff at six months post-randomisation (and 12 months for those reaching that time-point). Secondary: clinical measures of pain, function, physical performance, health-related quality of life, health utilisation and adverse events. 36 participants were recruited and enrolled. The study achieved five of its six feasibility targets. These included consent - 70% of eligible participants were consented; intervention fidelity - 78% participants discharged completed the intervention sessions; contamination - none - no participants in the control arm received the GRRAND-F intervention and retention - 8% of participants were lost to follow-up. The only feasibility target that was not achieved was the recruitment target where only 36 of the planned 60 participants were recruited over 18 months. This was principally due to the COVID-19 pandemic which caused all research activity to be paused or reduced, with a subsequent reduction in. Based on the findings a full-trial can now be designed to better understand whether this proposed intervention is effective. https://www.isrctn.com/ISRCTN1197999, identifier ISRCTN11979997.

One-minute sit-to-stand test as a quick functional test for people with COPD in general practice

Assessing changes in functional exercise capacity is highly relevant in the treatment of people with Chronic Obstructive Pulmonary Disease (COPD), as lung function is often static. In Denmark, most people with COPD are followed in general practice where traditional functional tests, like six-minute walk test, require too much time and space. Therefore, there is an urgent need for a quick functional exercise capacity test that can be performed in a limited setting, such as general practice. This study aimed to identify a quick test to measure functional exercise capacity in people with COPD and identify which factors could affect the implementation of such a test in general practice. A mixed method feasibility study composed of a literature review and qualitative interviews was used. Quick functional tests for people with COPD were identified and evaluated through the COSMIN methodology. For the interviews, 64 general practices were included, and 50 staff members and 14 general practitioners (GPs) participated in the interviews. Responses were categorized and thematically analyzed. The 1 min sit-to-stand-test (1 M STST) was found suitable for a general practice setting. The COSMIN methodology rated it “sufficient” in reliability (ICC 0.90–0.99), measurement error (MID 2.5–3), construct validity and responsiveness (AUC 0.72), and found a moderate to strong correlation in criterion validity (r = 0.4–0.75). Several GPs wished for a quick functional test and emphasized evidence, information, and limitations as essential when deciding on implementation. Other factors identified included time, other tests, and economy. 1 M STST is a valid test to assess functional exercise capacity in people with COPD. The test is quick and can easily be performed in a standard consultation, and several GPs wished for such a test.

Integrating HPV Vaccination Within PrEP care Delivery for Underserved Populations: A Mixed Methods Feasibility Study.

Human Papillomavirus (HPV) vaccination is effective at preventing anal cancer, which disproportionally impacts gay/bisexual men (GBM) and transgender women (TGW). Vaccine coverage among GBM/TGW is insufficient to reduce anal cancer disparities. Federally qualified health centers (FQHCs) can increase reach and uptake of HPV vaccination by integrating and promoting HPV vaccination in ongoing HIV preventive care (e.g., Pre-exposure Prophylaxis [PrEP]). The purpose of the current study was to assess the feasibility and potential impact of integrating HPV vaccination with PrEP care. We conducted a mixed methods study of PrEP providers and staff (qualitative interviews, N = 9) and PrEP patients (quantitative survey, N = 88) at an FQHC in Philadelphia, Pennsylvania. Qualitative thematic analysis of PrEP provider/staff interviews was informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework to identify and describe barriers and facilitators to HPV vaccination implementation. Quantitative analysis of PrEP patient survey was informed by the Information-Motivation-Behavioral Skills Model. Quantitative interviews resulted in 16 themes related to characteristics of the inner and outer clinic context. Barriers among providers included lack of focus on HPV in PrEP management guidelines, in metrics mandated by funding agencies, and in electronic medical record templates. Lack of anal cancer specific knowledge and motivation was identified in both PrEP patients and providers/staff. Providing HPV vaccination during routine PrEP visits was highly acceptable to both patients and providers. Based on these findings, we recommend several multi-level strategies to increase HPV vaccine uptake among PrEP patients.

Improving balance in community-dwelling elders using trained volunteers within faith-based institutions: a mixed methods feasibility study

Purpose To investigate the feasibility and acceptability of a volunteer-led balance programme for older adults. Methods A feasibility cluster RCT with focus groups were conducted in faith-based institutions. Eligibility criteria were: participants were ≥65 years, able to do five times sit -to-stand, had no falls in the previous six months and had good mental capacity. The intervention included supervised group exercises and exercise booklets for six months, education and a fall poster. Assessments included, TUG, MCTSiB, FTST, FES, mABC, OPQoL and DGLS at baseline, 6 weeks, and 6 months. Feasibility measures included numbers of volunteers, sessions, and volunteers” time commitment, views of participants about sustainability of program using qualitative focus groups and volunteers' ability to deliver programme. Results Three churches participated with 31 participants in each group. Participants had a mean age of 77.3 years, were 100% British, and 79% female. The sample size estimate for a future trial using TUG, was 79 per group. Focus groups showed perceived social and physical improvements in participants, need to extend the programme to the wider community, and increased confidence, participation and socialisation. Conclusion The community-based balance training in faith-based institutions, was feasible and acceptable in one geographical area and requires evaluation in cohesive diverse communities. Implications for Rehabilitation If an institution or a community is united through faith, culture, national roots, or tradition, then these groups are ideal for such balance rehabilitation programmes, because of the familiarity of the location and people, cohesive culture or their ideology to help their communities. Participants and volunteers perceived improved participation, confidence and socialisation and were keen to continue programme. It is important to develop community-based falls prevention programmes that the National Health Service (NHS) can partially support using volunteers to reduce the burden of falls in the community and for the NHS.

Lifestyle integrated functional exercise for people with interstitial lung disease (iLiFE): A mixed-methods feasibility study

BackgroundPeople with interstitial lung disease (ILD) present low levels of physical activity (PA) and spend most of their time at home, especially in advanced stages of the disease. The Lifestyle Integrated Functional Exercise for people with ILD (iLiFE) embedding PA in patients’ daily routines was developed and implemented. ObjectivesThis study aimed to explore the feasibility of iLiFE. MethodsA pre/post mixed-methods feasibility study was conducted. Feasibility of iLiFE was determined by participant recruitment/retention, adherence, feasibility of outcome measures and adverse events. Measures of PA, sedentary behaviour, balance, muscle strength, functional performance/capacity, exercise capacity, impact of the disease, symptoms (i.e., dyspnoea, anxiety, depression, fatigue and cough) and health-related quality of life were collected at baseline and post-intervention (12-weeks). Semi-structured interviews with participants were conducted in-person immediately after iLiFE. Interviews were audio-recorded, transcribed and analysed by deductive thematic analysis. ResultsTen participants (5♀, 77±3y; FVCpp 77.1 ± 4.4, DLCOpp 42.4 ± 6.6) were included, but only nine completed the study. Recruitment was challenging (30%) and retention high (90%). iLiFE was feasible, with excellent adherence (84.4%) and no adverse events. Missing data were associated with one dropout and non-compliance with the accelerometer (n = 1). Participants reported that iLiFE contributed to (re)gain control in their daily life, namely through improving their well-being, functional status and motivation. Weather, symptoms, physical impairments and lack of motivation were identified as threats to keep an active lifestyle. ConclusionsiLiFE seems to be feasible, safe and meaningful for people with ILD. A randomised controlled trial is needed to strengthen these promising findings.

Extracorporeal shockwave therapy for diabetic foot ulcers: a feasibility study

The purpose of this study was to assess the feasibility of delivering extracorporeal shockwave therapy (ESWT) to patients with diabetic foot ulcers (DFUs). It also aimed to explore any potential clinical effect of ESWT on wound healing and investigate whether ESWT offers any patient-reported benefits. In this single-centre, mixed methods feasibility study, patients with a DFU who met the eligibility criteria underwent ESWT three times over a seven-day period. Primary outcome was feasibility of delivering the intervention. Secondary outcomes included wound size, number of DFUs healed at 12 weeks and quality of life (QoL). Semi-structured interviews explored participants' experience of undergoing ESWT. Of 106 patients screened, 24 (22.6%) were recruited. Following recruitment, two patients were withdrawn from the study with 22 patients included in the final analysis. The mean attendance at clinic was 90.9% and 65.1% for follow-up. The mean score for acceptability and tolerability was 9.86±0.48 (95% confidence interval (CI): 9.62-10.01) and 9.15±2.57 (95% CI: 7.87-10.42), respectively. There were no serious adverse events or side-effects. Of the DFUs, 45.5% healed during follow-up and QoL scores improved until eight weeks. Key themes identified from the qualitative interviews were: desire for fast healing; improved QoL; flexibility of new treatments; and accessibility of transport. This study has shown that it is possible to recruit and retain patents into a single-arm study of ESWT for DFUs. This study supports development of a large randomised control trial to determine the clinical and cost-effectiveness of ESWT for DFU healing.

Mid-career switch nursing students' perceptions and experiences of using immersive virtual reality for clinical skills learning: A mixed methods study

BackgroundThere has been an increase of mid-career professionals joining nursing. These adult students possess significant expertise in other areas and may benefit substantially in deliberate practice to acquire skills competency using immersive virtual reality (IVR) for clinical procedures before they practise in actual clinical settings. ObjectivesThis study aims to (1) examine the impact of IVR clinical procedures on mid-career switch students in knowledge, game perception and user reaction; (2) to explore the mid-career switch students' perceptions and experiences in using the IVR clinical procedures. DesignA mixed methods feasibility study was used. Setting and participantsThis study was conducted at a university in Singapore with 34 first-year mid-career switch students. MethodsThis study is a single-group pre-test and post-test experimental study on learning clinical procedures using IVR in the home setting. The study took place from September to November 2021. Focus group discussions were conducted and analysed verbatim using thematic analysis. ResultsThe students demonstrated significant improvement of knowledge for subcutaneous insulin, but overall, the increase in combined scores for both intravenous therapy and subcutaneous insulin were not statistically significant. Three overarching themes included: 1) Learning and practice, 2) Challenges and barriers, and 3) Personal attributes. Most of the participants found the experiences to be engaging, relevant, and satisfying. Some reported experiencing giddiness, headache, and lack of familiarity with technologies. ConclusionsIVR simulation can potentially be used as a supplementary learning tool to improve knowledge of clinical procedures in mid-career switch students.

A feasibility Randomised Controlled Trial as a first step towards evaluating the effectiveness of a digital health dashboard in preventive child health care: a mixed methods approach

BackgroundWithin preventive Child Health Care (CHC), the 360°CHILD-profile has been developed. This digital tool visualises and theoretically orders holistic health data in line with the International Classification of Functioning, Disability and Health. It is anticipated that evaluating the effectiveness of the multifunctional 360°CHILD-profile within the preventive CHC-context is complex. Therefore, this study aimed at investigating the feasibility of RCT procedures and the applicability of potential outcome measures for assessing the accessibility and transfer of health information.MethodsDuring the first introduction of the 360°CHILD-profile in CHC practice, a feasibility RCT with an explanatory-sequential mixed methods design was executed. CHC professionals (n=38) recruited parents (n=30) who visited the CHC for their child (age 0–16). Parents were randomised to “care as usual” (n=15) or “care as usual with, in addition, the availability of a personalised 360°CHILD-profile during 6 months” (n=15). Quantitative data on RCT feasibility were collected on recruitment, retention, response, compliance rates and outcome data on accessibility and transfer of health information (n=26).Subsequently, thirteen semi-structured interviews (5 parents, 8 CHC professionals) and a member check focus group (6 CHC professionals) were performed to further explore and gain a deeper understanding of quantitative findings.ResultsIntegration of qualitative and quantitative data revealed that the recruitment of parents by CHC professionals was problematic and influenced by organisational factors. The used randomisation strategy, interventions and measurements were executable within the setting of this specific study. The outcome measures showed skewed outcome data in both groups and a low applicability to measure accessibility and transfer of health information. The study revealed points to reconsider regarding the randomisation and recruitment strategy and measures in the next steps.ConclusionsThis mixed methods feasibility study enabled us to gain a broad insight into the feasibility of executing an RCT within the CHC context. Trained research staff should recruit parents instead of CHC professionals. Measures, potentially for evaluating 360°CHILD-profile’s effectiveness, need further exploration and thorough piloting before proceeding with the evaluation process. Overall findings revealed that executing an RCT within the context of evaluating 360°CHILD-profile’s effectiveness in the CHC setting will be much more complex, time-consuming and costly than expected. Thereby, the CHC context requires a more complex randomisation strategy than executed during this feasibility study. Alternative designs including mixed methods research must be considered for the next phases of the downstream validation process.Trial registrationNTR6909; https://trialsearch.who.int/.

“Before I was like a Tarzan. But now, I take a pause”: mixed methods feasibility study of the Naungan Kasih parenting program to prevent violence against children in Malaysia

BackgroundDespite impressive strides in health, social protection, and education, children continue to experience high rates of child maltreatment in Malaysia. This mixed-methods study assessed the feasibility of a five-session, social learning-based parenting program delivered by government staff in a community setting to reduce violence against children.MethodsParents of children from birth to 17 years were recruited from two communities near Kuala Lumpur to participate in the government-run program called the Naungan Kasih Positive Parenting Program (“Protecting through Love” in Bahasa Melayu). Quantitative data from female caregivers (N = 74) and children ages 10–17 (N = 26) were collected along with qualitative interviews and focus groups with parents, children, and facilitators. The primary outcome was child maltreatment with secondary outcomes including neglect, positive parenting, acceptability of corporal punishment, harsh parenting, positive discipline, and child behavior problems. Multilevel Poisson regression and multilevel linear regression were conducted to compare baseline and post-test outcomes. Qualitative interviews and focus groups examined how participants experienced the program utilizing a thematic analysis approach.ResultsQuantitative analyses found pre-post reductions in overall child maltreatment, physical abuse, emotional abuse, attitudes supporting corporal punishment, parent sense of inefficacy, and child behavior problems. There were no reported changes on positive and harsh parenting, parental mental health, and marital satisfaction, nor were there any other significant changes reported by children. Qualitative findings suggested that the program had tangible benefits for female caregivers involved in the program, with the benefits extending to their family members.ConclusionsThis feasibility study is one of the few studies in Southeast Asia that examined the feasibility and initial program impact of a parenting program delivered by government staff to families with children across the developmental spectrum from birth to 17 years. Promising results suggest that the program may reduce child maltreatment across a range of child ages. Findings also indicate areas for program improvement prior to further delivery and testing, including additional training and content on sexual and reproductive health, parenting children with disabilities, and online child protection.

Perinatal support for breastfeeding using mHealth: A mixed methods feasibility study of the My Baby Now app.

Despite the well-known benefits of breastfeeding, breastfeeding rates remain suboptimal, particularly for women with lower socioeconomic position. Although popular, breastfeeding apps are often poor quality; their impact on breastfeeding knowledge, attitudes, confidence and intentions is unknown. A mixed method pre-post feasibility study was conducted to: 1) explore the feasibility of the My Baby Now app in providing perinatal breastfeeding support; 2) examine the impact on breastfeeding knowledge, attitudes, confidence and intentions; 3) to examine any differences in acceptability and impact of the app according to maternal education. The My Baby Now app was offered to pregnant women 20-30 weeks gestation. Breastfeeding knowledge and intentions were collected at baseline (T1) and 36-38 weeks gestation (T2); attitudes and confidence were collected at baseline, T2 and T3 (8-12 weeks post-partum). App engagement was measured via app analytics. Qualitative interviews were conducted with a purposeful sample following T3. Of 266 participants recruited, 169 (64%) completed T2 and 157 (59%) completed T3. Mothers without university education rated the app to be higher quality, more useful and impactful than mothers with university education. From T1-T2, breastfeeding knowledge (59.6% vs. 66.5%, p < 0.001) and exclusive breastfeeding intentions (76.6% vs. 80.9%, p < 0.001) increased. Breastfeeding attitudes and confidence scores also increased significantly across T1-T2 and T1-T3. App engagement during pregnancy predicted changes in breastfeeding attitudes from T1-T2 among participants without university education. App engagement did not predict changes in breastfeeding knowledge, confidence or intentions. Future randomised controlled studies should examine the effectiveness of mHealth interventions on breastfeeding outcomes.

Personalised exercise therapy and self-management support for people with multimorbidity: feasibility of the MOBILIZE intervention

BackgroundExercise therapy is safe and effective in people with single conditions, but the feasibility in people with two or more conditions is unclear. Therefore, the aim was to evaluate the feasibility of exercise therapy and self-management in people with multimorbidity prior to a randomised, controlled trial (RCT).MethodsThis was a mixed-methods feasibility study performed in two general hospitals and one psychiatric hospital. 20 adult patients (8 females; mean age (SD) 67 (6.9)) with at least two long-term conditions and a score of ≥ 3 on Disease Burden Impact Scale for at least one condition (at least moderate limitations of daily activities) and of ≥ 2 for at least one other condition. Patients with unstable health conditions, at risk of serious adverse events (SAE) or with terminal conditions were excluded. Participants received 12 weeks of exercise (18 60-min group-based and 6 home-based sessions) and self-management support (6 90-min group-based sessions) supervised by physiotherapists. Pre-defined progression to RCT criteria were the primary outcomes and included recruitment rate (acceptable 20 participants in 3 months), retention through follow-up (75% retention), compliance (75% complete > 9 of exercise and > 3 self-management sessions), outcome burden (80% do not find outcomes too burdensome), improvement in quality of life (EQ-5D-5L) and function (6-min walk test; ≥ 50% experience clinically relevant improvements) and intervention-related SAEs (No SAEs). Furthermore, a purposeful sample including eleven participants and two facilitators were interviewed about their experiences of participating/facilitating. Qualitative data was analysed using thematic analysis.ResultsRecruitment rate (20 in 49 days), retention (85%), outcome burden (95%), and SAEs (0 related to intervention) were acceptable, while compliance (70%) and improvements (35% in quality of life, 46% in function) were not (amendment needed before proceeding to RCT). The intervention was found acceptable by both participants and physiotherapists with some barriers among participants relating to managing multiple chronic conditions while caring for others or maintaining a job. Physiotherapists expressed a need for additional training.ConclusionsExercise therapy and self-management are feasible in people with multimorbidity. The subsequent RCT, amending the intervention according to progression criteria and feedback, will determine whether the intervention is superior to usual care alone.Trial registrationClinicalTrials.gov registration: NCT04645732Open Science Framework https://osf.io/qk6yg/

Technology-Enabled Collaborative Care for Concurrent Diabetes and Distress Management During the COVID-19 Pandemic: Protocol for a Mixed Methods Feasibility Study.

The COVID-19 pandemic disrupted the delivery of diabetes care and worsened mental health among many patients with type 2 diabetes (T2D). This disruption puts patients with T2D at risk for poor diabetes outcomes, especially those who experience social disadvantage due to socioeconomic class, rurality, or ethnicity. The appropriate use of communication technology could reduce these gaps in diabetes care created by the pandemic and also provide support for psychological distress. The purpose of this study is to test the feasibility of an innovative co-designed Technology-Enabled Collaborative Care (TECC) model for diabetes management and mental health support among adults with T2D. We will recruit 30 adults with T2D residing in Ontario, Canada, to participate in our sequential explanatory mixed methods study. They will participate in 8 weekly web-based health coaching sessions with a registered nurse, who is a certified diabetes educator, who will be supported by a digital care team (ie, a peer mentor, an addictions specialist, a dietitian, a psychiatrist, and a psychotherapist). Assessments will be completed at baseline, 4 weeks, and 8 weeks, with a 12-week follow-up. Our primary outcome is the feasibility and acceptability of the intervention, as evident by the participant recruitment and retention rates. Key secondary outcomes include assessment completion and delivery of the intervention. Exploratory outcomes consist of changes in mental health, substance use, and physical health behaviors. Stakeholder experience and satisfaction will be explored through a qualitative descriptive study using one-on-one interviews. This paper describes the protocol of the study. The recruitment commenced in June 2021. This study was registered on October 29, 2020, on ClinicalTrials.gov (Registry ID: NCT04607915). As of June 2022, all participants have been recruited. It is anticipated that data analysis will be complete by the end of 2022, with study findings available by the end of 2023. The development of an innovative, technology-enabled model will provide necessary support for individuals living with T2D and mental health challenges. This TECC program will determine the feasibility of TECC for patients with T2D and mental health issues. ClinicalTrials.gov NCT04607915; https://clinicaltrials.gov/ct2/show/NCT04607915. DERR1-10.2196/39724.

Barriers and facilitators to bracing in adults with painful degenerative scoliosis: a single-centred mixed-method feasibility study

BackgroundConservative treatments including bracing and exercise therapy are prescribed on the first-line in adults with degenerative scoliosis. However, adherence to conservative treatments is low. We aimed to assess barriers and facilitators to bracing in adults with painful degenerative scoliosis.MethodsWe conducted a single-centred mixed-method pilot and feasibility study. All patients scheduled for a multidisciplinary custom-made bracing consultation, from July 2019 to January 2020, in a French tertiary care centre, were screened. Patients were eligible if they had painful adult degenerative scoliosis and a prescription for a rigid custom-made lumbar-sacral orthosis. The primary outcome was barriers and facilitators to bracing assessed by a qualitative approach using semi-structured interviews. Secondary outcomes were back pain, spine-specific activity limitations, symptoms of depression and satisfaction with bracing post-intervention assessed by a quantitative approach.ResultsOverall, 56 patients were screened and 14 (25%) were included. Mean age was 68.2 (12.3) years. Mean follow-up was 9.8 (2.0) months. Barriers to bracing were increased limitations in some activities, discomfort in hot weather and burden of aesthetic appearance. Facilitators to bracing were reduced pain, improved activities of daily living, suitable weight and improved spinal alignment. Participants self-implemented solutions to enhance adherence. The mean reduction from baseline in pain intensity was 1.7 (2.3) of 10 points, and 6 of 13 patients (46%) had pain intensity < 4 of 10 points.ConclusionBracing is a feasible intervention for people with painful adult degenerative scoliosis. Patients self-implemented their own solutions to enhance adherence.

Towards an integrated blood pressure self-monitoring solution for stroke/TIA in Ireland: a mixed methods feasibility study for the TASMIN5S IRL randomised controlled trial

BackgroundOptimising blood pressure (BP) control is one of the most important modifiable risk factors in preventing subsequent stroke where the risk increases by one-third for every 10 mmHg rise in systolic BP. This study evaluated the feasibility and potential effectiveness of blood pressure self-monitoring with planned medication titration, to inform a definitive trial of the intervention, in patients with a previous stroke or transient ischaemic attack (TIA).MethodsPatients with a history of stroke/TIA and sub-optimal BP control were invited to take part in a mixed methods feasibility study for a randomised controlled trial. Those meeting the inclusion criteria with systolic BP >130 mmHg were randomised to a self-monitoring intervention group or usual care group. The intervention involved self-monitoring BP twice a day for 3 days within a 7-day period, every month, following text message reminders. Treatment escalation, based on a pre-agreed plan by the general practitioner (GP) and patient, was initiated according to the results of these readings. Semi-structured interviews were carried out with patients and clinicians and analysed thematically.ResultsOf those identified, 47% (32/68) attended for assessment. Of those assessed, 15 were eligible for recruitment and were consented and randomised to the intervention or control group on a 2:1 basis. Of those randomised, 93% (14/15) completed the study and there were no adverse events. Systolic BP was lower in the intervention group at 3 months. Participants found the intervention acceptable and easy to use. GPs found it easy to incorporate into their practice activity without increasing workload.ConclusionsTASMIN5S, an integrated blood pressure self-monitoring intervention in patients with a previous stroke/TIA, is feasible and safe to deliver in primary care. A pre-agreed three-step medication titration plan was easily implemented, increased patient involvement in their care, and had no adverse effects. This feasibility study provides important information to inform a definitive trial to determine the potential effectiveness of the intervention in patients post-stroke or TIA.Trial registrationISRCTN57946500. Registered on 12/08/2019.

Art therapy and eating disorders: A mixed methods feasibility study

The aim of this mixed methods feasibility study was to investigate the feasibility of conducting a large-scale randomised controlled trial. Six feasibility domains proposed by Bowen et al. were investigated: demand, implementation, practicality, limited efficacy, adaptation, and acceptability. Nine adults with anorexia nervosa took part in 1.5-h group art therapy twice a week across an 8-week Day Patient Program at the Royal Melbourne Hospital, Australia. Interviews were conducted at weeks 4 and 8, and data were analysed using thematic analysis. Outcome measures included the World Health Organization Quality of Life Instrument – Short Version and the Experience of Shame Scale (measured at baseline and weeks 2, 4, 6 and 8). The Session Rating Scale was administered after each session. A convergent, parallel mixed analysis design was used to integrate methods. Results showed that conducting a large-scale randomised controlled trial would only be feasible if key issues could be addressed, such as high attrition rates. However, art therapy was shown to be acceptable, practical to run, and adaptable. Qualitative findings revealed that art therapy facilitated self-expression, flexibility, accomplishment and connectedness in participants. No adverse events were recorded.

Implementation of Eye-Tracking Technology to Monitor Clinician Fatigue in Routine Clinical Care: A Feasibility Study

Abstract Background Physician fatigue increases the likelihood of medical errors. Eye-tracking technology offers an unobtrusive and objective way to measure fatigue but has only been implemented in controlled settings. Objective Our objective was to determine the feasibility of capturing physiological indicators of fatigue using eye-tracking technology in a real-world clinical setting. Methods A mixed-methods feasibility study was performed in a convenience sample of clinicians practicing in an urban, academic emergency department from November 11 to December 15, 2021. Outcomes included fatigue assessed at the beginning and end of each shift via eye-tracking (with low scores indicating greater fatigue) and self-report. Results Among 15 participants, self-reported fatigue and task load increased from the beginning to the end of their shift (fatigue visual analog scale [FVAS] 3.7–4.6, p = 0.04; physician task load [PTL] 97.7–154.3, p = 0.01). It was feasible to collect eye-tracking data at a fixed computer workstation with twice daily calibration and 61% capture of reliable data when the clinician was working at the study computer. Eye-tracking metrics did not change significantly from the beginning to the end of the shift. Eye metric fatigue score was associated with the change in PTL score (r 0.59, p = 0.02) but not FVAS. This association persisted after adjusting for age, gender, and role, with every 10-point increase in PTL, there was a 0.02-point increase in fatigue score (p = 0.04). Conclusion It is unclear whether the inability to detect fatigue via eye-tracking in routine clinical care was due to confounding factors, the technology, study design, sample size, or an absence of physiological fatigue. Further research and advances in functionality are needed to determine the eye-tracking technology's role in measuring clinician fatigue in routine care.