Feasibility Study Research Articles

“It’s just part of who I am…” Living with chronic headache: voices from the CHESS trial, a qualitative study

BackgroundBetween 2015 and 2019 the Chronic Headache Education and Self-management Study (CHESS) developed and tested a supportive self-management approach that aimed to improve outcomes for people with chronic migraine or chronic tension type headache with/without episodic migraine. However, a paucity of qualitative research which explored the lived experiences of people with chronic headache was evidenced. In response, we undertook to explore the experiences of living with chronic headaches of people who participated in the CHESS study.MethodsWe adopted qualitative methodologies, inviting participants in the CHESS study to participate in semi-structured interviews. In phase 1 (feasibility study), a thematic analysis was conducted. In phase 2 (main CHESS trial), interviews were informed by topic guides developed from our learning from the phase 1 interviews. Pen portrait methodology and thematic analysis was employed allowing us to explore the data longitudinally.ResultsPhase 1, 15 interviews (10 female) age range 29 to 69 years (median 47 years) revealed the complexities of living with chronic headache. Six overarching themes were identified including the emotional impact and the nature of their headaches. Phase 2, included 66 interviews (26 participants; median age group 50s (range 20s-60s); 20 females. 14 were interviewed at three points in time (baseline, 4 and 12 months) Through an iterative process four overlapping categories of headache impact emerged from the data and were agreed: i) ‘I will not let headaches rule my life’; ii) ‘Headaches rule my life’; iii) ‘Headaches out of control—something needs to change’; and iv) ‘Headaches controlled—not ruling my life’. One of these categories was assigned to each pen portrait at each timepoint.The remaining 12 participants were interviewed at two time points during a year; pen portraits were again produced. Analysis revealed that the headache impact categories developed above held true in this sample also providing some validation of the categories.ConclusionsThese data give an insight into the complexities of living with chronic headache. Chronic headache is unpredictable, permeating all aspects of an individual’s life; even when an individual feels that their headache is controlled and not interfering, this situation can rapidly change. It shows us that more work needs to be done both medically and societally to help people living with this often-hidden condition.Trial registrationISRCTN79708100

Feasibility Study of Legen Drinks in Gresik Regency

Feasibility Study of Legen Drinks in Gresik Regency

A prospective non-randomized feasibility study of an online membership-based fitness program for promoting physical activity in people with mobility impairments

BackgroundPeople with mobility limitations have a disproportionately higher rate of acquiring secondary conditions such as obesity, cardiovascular comorbidity, pain, fatigue, depression, deconditioning, and type 2 diabetes. These conditions often result from poor access to home and community-based health promotion/wellness programs. The aim of this project was to determine the feasibility of delivering an online community membership-based fitness program for individuals with mobility impairments.MethodsFor this prospective single-arm study, participants were recruited from members of a community fitness facility that serves people with physical disabilities and chronic health conditions. While all members had access to the online platform, individuals had to opt-in to participate in the research component. Activity options included 16 pre-recorded videos and 9 live exercise classes. During the 8-week program, participants had an opportunity to earn three exercise incentives for reaching certain activity milestones. Enrollment percentage, attendance, and attrition were tracked to assess program feasibility and acceptability. Changes in participant-reported outcomes including self-reported physical activity, psychosocial outcomes, and health-related quality of life (HRQOL) were examined using non-parametric analyses.ResultsA total of 146 eligible individuals were screened of which 33 enrolled (22.6%). Two participants withdrew from the study, so a total of 31 were used for analyses. Participants included 29 women and 12 Black people with an average age of 60 (± 15.9) years. Health conditions included stroke, post-polio, arthritis, neuropathy, cerebral palsy, and obesity. Ten participants used an assistive device to get around inside the home. Twenty-six participants (78.8%) completed the online program, and 5 participants earned all 3 participation incentives. The mean number of live Zoom exercise classes attended by the participants was 12.8 (range = 0–43) over 8 weeks; 3 of 31 participants did not attend any classes. On average, participants watched 128 min (range = 0–704 min) of pre-recorded videos; 6 of 31 participants did not view any pre-recorded videos. Self-reported physical activity showed the largest improvement (11.15 units; 95% CI, 3.08, 19.56) with an effect size of 0.51 (Cohen’s d).ConclusionsThis pilot study of an online membership-based fitness program for people with mobility impairments demonstrated preliminary effectiveness in increasing physical activity and was found to be feasible and acceptable. Feasibility endpoints do indicate potential to improve retention. These results suggest that online delivery of exercise programs can broaden the reach of specialized community fitness programs and is a promising direction for future work and fully powered trials are warranted to assess intervention efficacy.Trial registrationClinicalTrials.gov, NCT05138809. Registered September 2, 2021, ClinicalTrials.gov PRS: Record Summary NCT05138809.

Study protocol for a single-site feasibility study evaluating the adoption and fidelity of Prep-4-RT: prehabilitation for head and neck cancer patients undergoing radiotherapy

IntroductionPrep-4-RT is a co-designed stepped-care multimodal prehabilitation program for people scheduled to receive radiotherapy for head and neck cancer (HNC). Prehabilitation, which occurs between diagnosis and treatment commencement, aims to improve a patient’s health to reduce the incidence and severity of current and future impairments. HNC treatment can be distressing and has detrimental impacts on function and quality of life. HNC patients have increased social vulnerabilities including higher rates of socio-economic disadvantage and engagement in lifestyle habits which increase cancer risk. High levels of physical and psychological impacts of HNC treatment and increased social vulnerabilities of this population warrant investigation of optimal pathways of care, such as prehabilitation. This paper describes a research protocol to evaluate the feasibility of Prep-4-RT, which was designed to prepare HNC patients for the physical and psychological impacts of radiotherapy.Methods and analysisAt least sixty adult HNC patients, scheduled to receive radiotherapy (with or without chemotherapy), will be recruited over a five-month period. All participants will receive access to Prep-4-RT self-management resources. Participants identified through screening as high-risk will also be offered individualised interventions with relevant allied health professionals prior to the commencement of radiotherapy (psychologists, dietitians, speech pathologists and physiotherapists). Participants will complete evaluation surveys assessing their experiences with Prep-4-RT resources and interventions. Clinicians will also complete program evaluation surveys. Primary feasibility outcomes include adoption (uptake and intention to try) and fidelity (adherence to the specialist prehabilitation pathway). Secondary feasibility outcomes include acceptability (patient and clinician) of and satisfaction (patient) with Prep-4-RT as well as operational costs. Feasibility outcome data will be analysed using exact binomial and one-sample t tests, as appropriate.Ethics and disseminationEthics approval has been obtained at the Peter MacCallum Cancer Centre in Melbourne, Australia. Results will be presented at national conferences and published in peer-reviewed journal(s) so that it can be accessed by clinicians involved in the care of HNC patients receiving radiotherapy. If the model of care is found to be feasible and acceptable, the transferability and scalability to other cancer centres, or for other cancer types, may be investigated.Registration detailsANZCTA (Australian New Zealand Clinical Trials Registry) ACTRN12623000770662.

Methodological Components for Evaluating Treatment Effectiveness of the SOS Approach to Feeding: A Feasibility Study

Abstract Date Presented 03/23/24 This feasibility study offers tools and procedures for researchers and clinicians for implementation of an effectiveness study of the Sequential-Oral-Sensory (SOS) Approach to feeding. A fidelity measure was created and sensitive outcomes identified for future studies. Primary Author and Speaker: Sarah A. Schoen Contributing Authors: Rachel Balderrama

Can we improve the management of inoperable malignant bowel obstruction? Results of a feasibility study of elemental diet as an alternative to parenteral nutrition in patients with advanced gynaecological cancer

PurposeNutrition support in inoperable bowel obstruction (IBO) remains challenging. Parenteral nutrition (PN) is recommended if the prognosis is > 2 months. An elemental diet (ED) is licensed for strictures in Crohn’s disease but has not been used in malignant bowel obstruction. The aim of this study was to evaluate the use of ED in patients with IBO and provide a proof of concept of ED as an acceptable feeding option.MethodsThis was a mixed-methods single-arm feasibility study. The primary endpoint was to provide a ‘proof of concept’ of ED as an acceptable feeding option for patients with IBO. Secondary endpoints included taste acceptability, incidences of vomiting and pain, the proportion of women who tolerated ED, the number of cartons drunk, quality of life (QOL) and the number of women treated with chemotherapy. Patients (> 18 years) with CT-confirmed IBO who could tolerate 500 ml of liquid in 24 h remained on the trial for 2 weeks.ResultsA total of 29 patients were recruited; of those, 19 contributed to the analysis for the primary endpoint; 13 (68.4%) participants tolerated the ED; 26 patients contributed to MSAS and EORTC QLQ questionnaires at baseline to allow for the assessment of symptoms. At the start of the study, 18 (69%) of patients experienced vomiting, reducing to 4 (25%) by the end of day 15 of the study; 24 (92%) of patients reported pain at consent, reducing to 12 (75%) by the end of day 15. QOL scores improved from 36.2 (95% CI 27.7–44.7) at baseline to 53.1 (95% CI 40.3–66) at the end of day 15; 16 (84%) participants commenced chemotherapy within the first week of starting ED. The number of cartons across all participants showed a median of 1.3 cartons per day (range 0.8 to 2.5).ConclusionED is well tolerated by patients with IBO caused by gynaecological malignancies and may have a positive effect on symptom burden and QOL.

Large Language Models and Regular Expressions in Automated Data Extraction From Free-Text Echocardiogram Reports: A Feasibility Study

Large Language Models and Regular Expressions in Automated Data Extraction From Free-Text Echocardiogram Reports: A Feasibility Study

Improving follow-up care for people after minor stroke using early personalised care: A protocol for a randomised, mixed-methods, feasibility study.

Improving follow-up care for people after minor stroke using early personalised care: A protocol for a randomised, mixed-methods, feasibility study.

Photon-counting detector CT (PCD-CT) generated iodine maps to characterize parenchymal lung disease: A feasibility study

BackgroundWith photon-counting CT, spectral imaging is always available, and iodine maps with high spatial and spectral resolution can be generated. ObjectivesThe aim of this study was to investigate whether iodine uptake in different parenchymal patterns can be used to characterise parenchymal disease with increased lung attenuation. Methods325 patients were scanned with a photon-counting CT using four scan protocols, all with lung parenchymal contrast. Lesions were classified into three basic patterns: consolidation, ground-glass opacities (GGO), and reticular pattern. Lesion classification was performed by 2 of 3 radiologists who were blinded to the diagnosis. Classification was performed twice using a 5-point Likert scale (with and without iodine maps). In case of disagreement, a third reader was consulted, and the decision was made by consensus. Results206 lesions were found with a confirmed diagnosis (83 consolidations, 72 GGO, and 51 reticular). Diagnostic confidence improved when iodine maps were included in the evaluation. The mean Likert score increased significantly for all three basic patterns (consolidations: 3.3 vs. 3.9, GGO: 3.4 vs. 4.1, and reticular: 3.6 vs. 4.4, p < 0.001). However, the score for GGO and reticular pattern was downgraded in three and one cases, respectively. The downgrading occurred for morphologically uncertain GGO findings (3) and atelectasis (1) with inhomogeneous iodine uptake. In 29 lesions, the classification was changed when the iodine maps were included in the evaluation. ConclusionIncluding iodine maps adds contrast uptake information and improves the diagnostic confidence of radiologists in the characterization of parenchymal pathologies. Clinical ImpactIodine maps have the potential to provide complementary information for the interpretation of lung opacities with overlapping morphology.

Attenuation Tomography Using Low-Frequency Ultrasound for Thorax Imaging: Feasibility Study.

Low-frequency ultrasound can permeate human thorax and can be applied in functional imaging of the respiratory system. In this study, we investigate the transmission of low-frequency ultrasound through the human thorax and propose a waveform matching method to track the changes in the transmission signal during subject's respiration. The method's effectiveness is validated through experiments involving ten human subjects. Furthermore, the experimental findings indicate that the traveltime of the first-arrival signal remains consistent throughout the respiratory cycle. Leveraging this observation, we introduce an algorithm for ultrasound thorax attenuation factor differential imaging. By computing the paths and energy variation of the first-arrival signal from the received waveform, the algorithm reconstructs the distribution of attenuation factor differences between two different thorax states, providing insights into the functional status of the respiratory system. Numerical experiments, using both normal thorax and defective thorax models, confirm the algorithm's feasibility and its robustness against noise, variations in transducer position and orientation. These results highlight the potential of low-frequency ultrasound for bedside, continuous monitoring of human respiratory system through functional imaging.

Time-lapse full-waveform permeability inversion: A feasibility study

Time-lapse seismic monitoring necessitates integrated workflows that combine seismic and reservoir modeling to enhance reservoir property estimation. We present a feasibility study of an end-to-end inversion framework that directly inverts for permeability from multiple prestack time-lapse seismic data sets. To assess the method's robustness, we design experiments focusing on its sensitivity to initial models, potential errors in modeling, and crosstalk during multiparameter inversion. Our study leverages the publicly available Compass model to simulate CO2 storage in saline aquifers. This model is derived from well and seismic data from the North Sea in an area that is currently considered for geologic carbon storage.

Single-arm, first-in-human feasibility study results for an ultra-low-cost insulin pump

BackgroundUse of Continuous Subcutaneous Insulin Infusion (CSII) has been shown to improve glycemic outcomes in Type 1 Diabetes (T1D), but high costs limit accessibility. To address this issue, an inter-operable, open-source Ultra-Low-Cost Insulin Pump (ULCIP) was developed and previously shown to demonstrate comparable delivery accuracy to commercial models in standardised laboratory tests. This study aims to evaluate the updated ULCIP in-vivo, assessing its viability as an affordable alternative for those who cannot afford commercially available devices.MethodsThis first-in-human feasibility study recruited six participants with T1D. During a nine-hour inpatient stay, participants used the ULCIP under clinical supervision. Venous glucose, insulin, and β-Hydroxybutyrate were monitored to assess device performance.ResultsParticipants displayed expected blood glucose and blood insulin levels in response to programmed basal and bolus insulin dosing. One participant developed mild ketosis, which was treated and did not recur when a new pump reservoir was placed. All other participants maintained β-Hydroxybutyrate < 0.6 mmol/L throughout.ConclusionThe ULCIP safely delivered insulin therapy to users in a supervised inpatient environment. Future work should focus on correcting a pump hardware issue identified in this trial and extending device capabilities for use in closed loop control. Longer-term outpatient studies are warranted.Trial RegistrationThe trial was prospectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN12623001288617) on the 11 December 2023.

Combining robotics and functional electrical stimulation for assist-as-needed support of leg movements in stroke patients: A feasibility study

PurposeRehabilitation technology can be used to provide intensive training in the early phases after stroke. The current study aims to assess the feasibility of combining robotics and functional electrical stimulation (FES), with an assist-as-needed approach to support actively-initiated leg movements in (sub-)acute stroke patients. MethodNine subacute stroke patients performed repetitions of ankle dorsiflexion and/or knee extension movements, with and without assistance. The assist-as-needed algorithm determined the amount and type of support needed per repetition. The number of repetitions and range of motion with and without assistance were compared with descriptive statistics. Fatigue scores were obtained using the visual analogue scale (score 0–10). ResultsSupport was required in 44 % of the repetitions for ankle dorsiflexion and in 5 % of the repetitions of knee extension, The median fatigue score was 2.0 (IQR: 0.2) and 4.0 (IQR: 1.5) for knee and ankle, respectively, indicating mild to moderate perceived fatigue. ConclusionThis study demonstrated the feasibility of assist-as-needed assistance through combined robotic and FES support of leg movements in stroke patients. It proved particularly useful for ankle dorsiflexion. Future research should focus on implementing this approach in a clinical setting, to assess clinical applicability and potential effects on leg function.

Feasibility Study on the Heat Transfer Enhancement of Gap Flow Induced by Wasted Vibration of Linear Compressor Body

Feasibility Study on the Heat Transfer Enhancement of Gap Flow Induced by Wasted Vibration of Linear Compressor Body

A Cognitive Strategy Approach to EMDR for Trauma Post Severe Traumatic Brain Injury: A Single-Case Feasibility and Acceptability Study

A Cognitive Strategy Approach to EMDR for Trauma Post Severe Traumatic Brain Injury: A Single-Case Feasibility and Acceptability Study

Feasibility and Safety Study of the Use of a New Robot (Maestro™) for Laparoscopic Surgery.

In laparoscopic surgery, telerobotic systems such as Da Vinci™ were developed, among other things, to give back exposure and vision control to the operating surgeon. However, new limitations such as the separation of the operating surgeon from the operating table, cost, and size were unveiled. A new device, Maestro™, appears promising in addressing these limitations. The current work evaluates the feasibility, safety, and surgeon satisfaction with the assistance provided by the Maestro System. Non-consecutive patients who were candidates for laparoscopic digestive surgery were enrolled in a descriptive prospective, monocentric study. Case selection was solely based on the availability of the device, but not on the patient's characteristics. Surgery was performed by a leading surgeon with the help of one less experienced surgeon. Feasibility was defined by the maintenance of the initial surgical plan. Safety was assessed by the absence of serious adverse events related to the device and surgeon satisfaction was evaluated by a questionnaire following the intervention. All 50 procedures were completed without conversion in laparotomy and without adjustment of the surgical team. Four complications were recorded during the study; however, none related to the use of the Maestro System. In 92% of the cases, the surgeon was satisfied with the assistance provided by the Maestro System. In standard elective digestive procedures by laparoscopy, the use of the Maestro System is feasible and safe. It is beneficial to the surgeon and operative room organization by limiting the size of the surgical team.

Enhanced methylene blue dye sequestration by carbon-embedded mesoporous zinc oxide nanoparticles fabricated utilizing Aloe barbadensis miller biowaste: Batch optimization, simulation modeling, and textile effluent feasibility

The present study reports novel carbon-embedded mesoporous zinc oxide nanoparticles (ZnO/C NPs) utilizing Aloe barbadensis miller (Aloe vera) biowaste extract as size-reducing agent and bio-stabilizer via a one-pot green fabrication approach. The fabricated nanoparticles were carbonized at 250 °C and characterized using FTIR, UV-Vis, ZPA, TEM, SEM/EDX, XRD, BET, and TGA techniques. Using Brunauer, Emmett, and Teller's theory, the ZnO/C NPs specific surface area was determined to be 63.25 m2/g, and the average pore diameter (3.46 nm) was in the mesoporous range. Fabricated ZnO/C NPs have an un-uniform size distribution, with an average crystallite size of 17.37 nm. The methylene blue (MB) dye adsorption of mesoporous ZnO/C NPs was studied in batch mode experiments at 37 °C using an aqueous solution. Detailed isotherms and kinetics modeling were performed, and it established that the Langmuir isotherm and Pseudo second order kinetic correctly fit the optimized MB dye adsorption data due to their higher correlation coefficients than other analyzed models. The Langmuir isotherm-based monolayer adsorption was found to be 105.26 mg/g. The pseudo second order kinetic best explains the adsorption reaction, indicating that the chemisorption mechanism is more likely to regulate the MB dye adsorption. Further, thermodynamics parameters showed that the MB dye adsorption onto ZnO/C NPs was spontaneous, endothermic, and accompanied by increased entropy. The ZnO/C NPs demonstrated remarkable MB dye sequestration from aqueous solution upto four reusability cycles, with regenerability of ≥84.52 %. Furthermore, feasibility study revealed an outstanding decolorization efficacy of MB dye upto 58.18 % from textile effluent, establishing mesoporous ZnO/C NPs as viable, environment-friendly, and cost-effective remedies for textile wastewater treatment.

No-implant Interatrial Shunt for Heart Failure With Preserved Ejection Fraction: Six-Month Outcomes from Multi-Centre Pilot Feasibility Studies

No-implant Interatrial Shunt for Heart Failure With Preserved Ejection Fraction: Six-Month Outcomes from Multi-Centre Pilot Feasibility Studies

Climate finance-driven feasibility study of a green ammonia and urea production plant in Italy

Ammonia is an essential feedstock widely used in the chemical sector with interesting new potential uses as fuel and hydrogen vector. Most of the produced ammonia is utilized in the manufacturing of urea. Industrial scale production relies on fossil fuels but, considering the energy transition path, a decarbonization of the sector is required. The proposed study developed a techno-economic assessment with an integrated climate finance analysis of a medium scale green ammonia and urea plant located in the South of Italy. Five different scenarios of production, all based on the electrolysis of desalinated water, were evaluated in terms of levelized cost of product, levelized cost of carbon abatement and emission intensity. Based on the output of the analysis, an enhanced scenario was further proposed to maximize the reuse and the monetization of the by-products: this scenario resulted in a competitive levelized cost of products of 640 EUR/ton of ammonia and 415 EUR/ton of urea respectively. A substantial decarbonization of ammonia and urea, with emission intensities well below the limitations set out by the new European standards, was obtained. The methodological approach developed proved climate finance to be a key economic instrument to enable decarbonization.

Effectiveness of a guided digital self-help intervention to improve sleep and the biological clock in university students – Study protocol for a randomized controlled trial

BackgroundSleep problems occur in many university students which affects their mental health and daily functioning. Cognitive behavioural therapy for insomnia (CBT-I) has been proven effective in adults but research in university students, who struggle to maintain a 24-hour rhythm, is still limited. We hypothesize that a guided digital CBT-I intervention, enriched with components on the biological clock (‘i-Sleep & BioClock’) will be effective in reducing insomnia severity and improving mental health outcomes for students with sleep problems. ObjectivesWe aim to evaluate the effectiveness of a guided online sleep and biological clock self-help intervention in improving sleep, depression symptoms, anxiety symptoms, functioning, academic performance, and quality of life in university students at 6 weeks and 18 weeks. MethodsThis is a two-arm parallel-group superiority randomized controlled trial, comparing a 5-week guided online ‘i-Sleep & BioClock’ intervention to online psychoeducation (PE). We aim to include 192 university students (Bachelor, Master, and PhD) with at least subthreshold insomnia (Insomnia Severity Index ≥10), aged ≥16, who can speak Dutch or English. We are excluding students with current risk for suicide or night shifts. The primary outcome is insomnia severity. Secondary outcomes include sleep estimates (sleep and light exposure diary), depression, anxiety, functioning, quality of life, and academic performance. The effectiveness of the intervention compared to online PE will be evaluated using linear mixed models. DiscussionThe current study tests the effectiveness of an online self-help intervention for university students who suffer from sleep problems. This trial builds upon an open feasibility study and will provide evidence of an online guided self-help program for students. The findings of this study will determine the potential wider dissemination of the intervention to address the high need for available and accessible help for students experiencing insomnia. Trial registrationClinicalTrials.Gov (NCT06023693), registered on August 3rd, 2023.