A mixed-method feasibility study of a novel transitional regime of incremental haemodialysis: study design and protocol

Abstract Background Incremental haemodialysis/haemodiafiltration (HD) may help reduce early mortality rates in patients starting HD. This mixed-method feasibility study aims to test the acceptability, tolerance and safety of a novel incremental HD regime, and to study its impact on parameters of patient wellbeing. Method We aim to enrol 20 patients who will commence HD twice-weekly with progressive increases in duration and frequency, achieving conventional treatment times over 15 weeks (incremental group). Participants will be followed-up for 6 months and will undergo regular tests including urine collections, bio-impedance analyses and quality-of-life questionnaires. Semi-structured interviews will be conducted to explore patients’ prior expectations from HD, their motivations for participation and experiences of receiving incremental HD. For comparison of safety and indicators of dialysis adequacy, a cohort of 40 matched patients who previously received conventional HD will be constructed from local dialysis records (historical controls). Results Data will be recorded on the numbers screened and proportions consented and completing the study (primary outcome). Incremental and conventional groups will be compared in terms of differences in blood pressure control, interdialytic weight changes, indicators of dialysis adequacy and differences in adverse and serious adverse events. In analyses restricted to incremental group, measurements of RRF, fluid load and quality-of-life during follow-up will be compared with baseline values. From patient interviews, a narrative description of key themes along with anonymised quotes will be presented. Conclusion Results from this study will address a significant knowledge gap in the prescription HD therapy and inform the development novel future therapy regimens.

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1031 A Mixed Methods Feasibility Study of Extracorporeal Shockwave Therapy for Diabetic Foot Ulcers

British Journal of Surgery ◽

10.1093/bjs/znab259.1127 ◽

2021 ◽

Vol 108 (Supplement_6) ◽

Author(s):

L Hitchman ◽

J Totty ◽

R Lathan ◽

M Sidapra ◽

G Smith ◽

...

Keyword(s):

Quality Of Life ◽

Mixed Methods ◽

Feasibility Study ◽

Randomised Control Trial ◽

Eligibility Criteria ◽

Serious Adverse Events ◽

Patient Reported ◽

The Mean

Abstract Aim The purpose of this mixed methods feasibility study was to assess the feasibility of delivering ESWT to patients with DFUs. It also aimed to explore any potential clinical effect of ESWT on wound healing and investigate whether ESWT may offer any patient reported benefits. Method A single centre mixed methods feasibility study. Patients with a DFU who met the eligibility criteria underwent ESWT 3 times in over 7 days. Primary outcome was feasibility of delivering the intervention. Secondary outcomes included wound size, number of DFU healed at 12 weeks and quality of life. Semi-structured interviews explored participants experience of undergoing ESWT. Results 22.6% (24/106) of patients screened were recruited. The mean attendance to clinic was 90.9% and 65.1% to follow up. The mean score for acceptability and tolerability was 9.86 (SD 0.48, 95% CI 9.62-10.01) and 9.15 (SD 2.57, 95% CI 7.87-10.42) respectively. There were no serious adverse events or side effects. 45.5% of DFU healed during follow up and quality of life scores improved until 8 weeks. Key themes identified from the qualitative interviews were desire for the fast healing, improved quality of life, new treatments must be flexible and accessible on transport. Conclusions This study has shown it is possible to recruit and retain patents into this research. This study supports development of a large randomised control trial to determine the clinical and cost effectiveness of ESWT for DFU healing.

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Collaborative Model of Care between Orthopaedics and Allied Healthcare Professionals Trial (CONNACT) – A Feasibility Study in patients with knee osteoarthritis using a mixed method approach

10.21203/rs.2.22349/v1 ◽

2020 ◽

Author(s):

Bryan Tan ◽

Benjamin Tze Keong DING ◽

Michelle Jessica PEREIRA ◽

Soren Thorgaard SKOU ◽

Julian THUMBOO ◽

...

Keyword(s):

Quality Of Life ◽

Knee Osteoarthritis ◽

Mixed Method ◽

Randomized Control Trial ◽

Outcome Measure ◽

Model Of Care ◽

Structured Interviews ◽

Randomized Control ◽

Method Approach

Abstract Background Osteoarthritis is a leading cause of global disability resulting in significant morbidity and cost to the healthcare system. Current guidelines recommend lifestyle changes such exercises and weight loss as first line treatment prior to surgical consideration. Our current model of care is inefficient with suboptimal allied health intervention for effective behaviour changes. A 12-week community based, individualized, multidisciplinary new model of care for knee osteoarthritis was developed in light of current deficiencies. Methods The primary aim of this study was to determine the feasibility of a full randomized controlled trial evaluating this new model of care using pre-defined progression criteria. The secondary aim was to optimize the intervention and study design through a process evaluation. A pilot randomized trial design using a mixed method approach was utilized. Progression criteria for a full trial including key domains of patient recruitment and retention, outcome measure acceptability and improvement, adverse events were developed. The primary outcome measure was the Knee Injury and Osteoarthritis Outcome Score (KOOS) at baseline and 12-weeks. Secondary outcomes included quality of life, functional and psychological assessments. Semi-structured interviews were conducted with the patients at 12-weeks. Results 20 patients (3 males, 17 females) were randomized (10 intervention, 10 control). Intervention arm patients reported better improvements in their knee function, quality of life, psychological outcome, dietary improvement and weight loss compared to the control arm at 12-weeks. Semi-structured interviews revealed several themes pertaining to feasibility and intervention optimization. 5 out of the 6 progression criteria’s domains were met. Conclusion This pilot has demonstrated the feasibility of a full randomized control trial investigating the potential effectiveness of the new proposed model of care for knee osteoarthritis using pre-defined progression criteria and process evaluation. Results from the qualitative study were used to modify and improve the intervention content, delivery model and study design for a large effectiveness-implementation hybrid randomized control trial that is currently underway.

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ACCESSIBLE HOUSING AND HEALTH-RELATED QUALITY OF LIFE: MEASUREMENTS OF WELLBEING OUTCOMES FOLLOWING HOME MODIFICATIONS

International Journal of Architectural Research Archnet-IJAR ◽

10.26687/archnet-ijar.v10i2.977 ◽

2016 ◽

Vol 10 (2) ◽

pp. 38 ◽

Cited By ~ 5

Author(s):

Phillippa Carnemolla ◽

Catherine Bridge

Keyword(s):

Quality Of Life ◽

Mixed Method ◽

Exploratory Research ◽

Health Related Quality ◽

Care Giving ◽

Home Modifications ◽

Related Quality ◽

Health Related ◽

The Impact

The multi-dimensional relationship between housing and population health is now well recognised internationally, across both developing and developed nations. This paper examines a dimension within the housing and health relationship – accessibility – that to date has been considered difficult to measure. This paper reports on the mixed method results of larger mixed-method, exploratory study designed to measure the impact of home modifications on Health-Related Quality of Life, supported by qualitative data of recipients’ experiences of home modifications. Data was gathered from 157 Australian HACC clients, who had received home modifications. Measurements were taken for both before and after home modifications and reveal that home modifications were associated with an average 40% increase in Health-Related Quality of Life levels. The qualitative results revealed that participants positively associated home modifications across six effect themes: increased safety and confidence, improved mobility at home, increased independence, supported care-giving role, increased social participation, and ability to return home from hospital. This exploratory research gives an insight into the potential for accessible architecture to impact improvements in community health and wellbeing.

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Duloxetine versus ‘active’ placebo, placebo or no intervention for major depressive disorder; a protocol for a systematic review of randomised clinical trials with meta-analysis and trial sequential analysis

Systematic Reviews ◽

10.1186/s13643-021-01722-5 ◽

2021 ◽

Vol 10 (1) ◽

Author(s):

Faiza Siddiqui ◽

Marija Barbateskovic ◽

Sophie Juul ◽

Kiran Kumar Katakam ◽

Klaus Munkholm ◽

...

Keyword(s):

Quality Of Life ◽

Systematic Review ◽

Sequential Analysis ◽

Citation Index ◽

Trial Sequential Analysis ◽

Random Errors ◽

Major Depressive ◽

Serious Adverse Events ◽

Meta Analyses

Abstract Background Major depression significantly impairs quality of life, increases the risk of suicide, and poses tremendous economic burden on individuals and societies. Duloxetine, a serotonin norepinephrine reuptake inhibitor, is a widely prescribed antidepressant. The effects of duloxetine have, however, not been sufficiently assessed in earlier systematic reviews and meta-analyses. Methods/design A systematic review will be performed including randomised clinical trials comparing duloxetine with ‘active’ placebo, placebo or no intervention for adults with major depressive disorder. Bias domains will be assessed, an eight-step procedure will be used to assess if the thresholds for clinical significance are crossed. We will conduct meta-analyses. Trial sequential analysis will be conducted to control random errors, and the certainty of the evidence will be assessed using GRADE. To identify relevant trials, we will search Cochrane Central Register of Controlled Trials, Medical Literature Analysis and Retrieval System Online, Excerpta Medica database, PsycINFO, Science Citation Index Expanded, Social Sciences Citation Index, Conference Proceedings Citation Index—Science and Conference Proceedings Citation Index—Social Science & Humanities. We will also search Chinese databases and Google Scholar. We will search all databases from their inception to the present. Two review authors will independently extract data and perform risk of bias assessment. Primary outcomes will be the difference in mean depression scores on Hamilton Depression Rating Scale between the intervention and control groups and serious adverse events. Secondary outcomes will be suicide, suicide-attempts, suicidal ideation, quality of life and non-serious adverse events. Discussion No former systematic review has systematically assessed the beneficial and harmful effects of duloxetine taking into account both the risks of random errors and the risks of systematic errors. Our review will help clinicians weigh the benefits of prescribing duloxetine against its adverse effects and make informed decisions. Systematic review registration PROSPERO 2016 CRD42016053931

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Implementation of Person-Centered Care: A Feasibility Study Using the WE-CARE Roadmap

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18052205 ◽

2021 ◽

Vol 18 (5) ◽

pp. 2205

Author(s):

Roman A. Lewandowski ◽

Jędrzej B. Lewandowski ◽

Inger Ekman ◽

Karl Swedberg ◽

Jan Törnell ◽

...

Keyword(s):

Pilot Study ◽

Feasibility Study ◽

Health Care Professionals ◽

Quality Care ◽

Structured Interviews ◽

Rehabilitation Hospital ◽

Person Centered Care ◽

Centered Care ◽

Multi Disciplinary Team

Background: Person-Centered Care (PCC) is a promising approach towards improved quality of care and cost containment within health systems. It has been evaluated in Sweden and England. This feasibility study examines initial PCC implementation in a rehabilitation hospital for children in Poland. Methods: The WE-CARE Roadmap of enablers was used to guide implementation of PCC for patients with moderate scoliosis. A multi-disciplinary team of professionals were trained in the PCC approach and the hospital Information Technology (IT) system was modified to enhance PCC data capture. Semi-structured interviews were conducted with the nine health care professionals involved in the pilot study and three patients/parents receiving care. Transcribed data were analyzed via content analysis. Results: 51 patients and their families were treated via a PCC approach. High proportions of new PCC data fields were completed by the professionals. The professionals were able to implement the three core PCC routines and perceived benefits using the PCC approach. Patients and their families also perceived improved quality care. The WE-CARE framework enablers facilitated PCC implementation in this setting. Conclusions: This feasibility pilot study indicates that the Gothenburg PCC approach can be successfully transferred to a rehabilitation hospital in Poland with favorable perceptions of implementation by both professionals and patients/their families.

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4580 Development of a play-based coaching intervention to improve quality of life and wellbeing for mothers with cancer and their young children

Journal of Clinical and Translational Science ◽

10.1017/cts.2020.121 ◽

2020 ◽

Vol 4 (s1) ◽

pp. 27-27

Author(s):

Rosa Roman-Oyola ◽

Anita Bundy ◽

Eida Castro ◽

Osiris Castrillo

Keyword(s):

Quality Of Life ◽

Young Children ◽

Depression Symptoms ◽

Improve Quality ◽

Structured Interviews ◽

Yield Data ◽

Implementation Phase ◽

Coaching Intervention ◽

Phase 1B

OBJECTIVES/GOALS: Mothers with cancer who have young children experience life disruptions when treatment procedures limit mother-child interactions. This study proposes the development of an intervention combining the Coaching approach with the Model of Playfulness to improve Quality of Life (QoL) and wellbeing of these patients and their young children. METHODS/STUDY POPULATION: This embedded mixed method study will be guided by the two initial phases of the ORBIT Model for the development of behavioral interventions for patients with chronic diseases. Participants will be mothers in the post-acute treatment stage of cancer (n = 6) and their children who are between 2 years and a half and 6 years, 11 months. Phase 1A, Definition, builds on qualitative data from a concurrent study exploring the experiences of mothers with cancer playing with their young children. As part of this phase, we will develop a play-based coaching intervention. In Phase 1B, Refinement, we will employ in-depth semi-structured interviews and standardized tools to evaluate acceptability of the intervention and preliminary outcomes. This will serve to further refine the intervention. RESULTS/ANTICIPATED RESULTS: Phase 1A will yield a plan for the intervention and data to enhance its initial implementation. Phase 1B will yield data, from the perspective of the mothers, about acceptability of the intervention procedures (e.g., delivery strategy, place for the intervention, time devoted, and outcome measures). This will enable modifications to the intervention. Additionally, Phase IB will yield preliminary data from specific QoL and wellbeing measures. For the mother, data about anxiety and depression symptoms, stress levels, and parental self-efficacy; for the child, emotional and behavioral indicators; for both: playfulness. DISCUSSION/SIGNIFICANCE OF IMPACT: This study entails the development of an intervention to enhance QoL and wellbeing of mothers with cancer and their children. Play moments as the centerpiece of the intervention, represent an innovative approach. Findings will guide the design of future feasibility studies to advance the development of this outcome driven intervention.

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Long-Term Effectiveness of Fingolimod for Multiple Sclerosis in a Real-World Clinical Setting

European Neurology ◽

10.1159/000514828 ◽

2021 ◽

pp. 1-6

Author(s):

Cihat Uzunköprü ◽

Yesim Beckmann ◽

Sabiha Türe

Keyword(s):

Quality Of Life ◽

Multiple Sclerosis ◽

Real Life ◽

Life Assessment ◽

Health Related Quality ◽

Serious Adverse Events ◽

Related Quality ◽

Health Related

Introduction: The primary aim of the present study was to evaluate the long-term efficacy of fingolimod in patients with multiple sclerosis (MS); secondary aims were to describe the safety of fingolimod with the evaluation of treatment satisfaction and impact on the quality of life in real life. Methods: We collected clinical, demographical, neuroradiological, and treatment data, including pre- and posttreatment status health-related quality of life from 286 MS patients consecutively treated with fingolimod. Clinical assessment was based on the Expanded Disability Status Scale (EDSS), and quality of life assessment was performed with MS-related quality of life inventory (MSQOLI). The data were recorded at baseline and every 6 months for 2 years. Results: One hundred and fourteen males and 172 females were enrolled. The annualized relapse rate and EDSS showed a statistically significant reduction during the observation period (p < 0.001). The patients also demonstrated substantial improvements in magnetic resonance imaging (MRI) outcomes (p < 0.001). Health-related quality of life scores improved significantly between baseline and 24-month visit (p < 0.001). No serious adverse events occurred. Conclusion: In our cohort, fingolimod treatment was associated with reduced relapse, MRI activity, and improved EDSS and MSQOLI scores. Additionally, fingolimod has been able to maintain its effectiveness over a considerable long period of treatment.

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QOLP-04. PILOT STUDY OF A VIDEOCONFERENCE-BASED PSYCHOLOGICAL INTERVENTION FOR FAMILY CAREGIVERS OF PATIENTS WITH MALIGNANT GLIOMAS

Neuro-Oncology ◽

10.1093/neuonc/noaa215.729 ◽

2020 ◽

Vol 22 (Supplement_2) ◽

pp. ii175-ii175

Author(s):

Deborah Forst ◽

Michelle Mesa ◽

Emilia Kaslow-Zieve ◽

Areej El-Jawahri ◽

Joseph Greer ◽

...

Keyword(s):

Quality Of Life ◽

Self Efficacy ◽

Coping Skills ◽

Malignant Gliomas ◽

Anxiety Symptoms ◽

Structured Interviews ◽

Post Intervention ◽

Clinically Significant ◽

And Coping

Abstract BACKGROUND Caregivers of patients with malignant gliomas experience substantial anxiety symptoms while caring for someone with progressive neurological decline. Yet, interventions to reduce psychological distress and improve quality of life (QoL) in this caregiver population are lacking. METHODS We conducted an open pilot study evaluating feasibility and acceptability of a cognitive behavioral therapy-based intervention for caregivers of patients with malignant gliomas with clinically significant anxiety (Generalized Anxiety Disorder [GAD-7] score ≥ 5). Caregivers participated in six videoconference sessions with a mental health provider. We defined the intervention as feasible if ≥ 70% of eligible caregivers enrolled and ≥ 70% of those enrolled completed ≥ 50% of sessions. We evaluated intervention acceptability in semi-structured interviews. Caregivers completed baseline and post-intervention surveys assessing anxiety and depression symptoms (Hospital Anxiety and Depression Scale), QoL (Caregiver Oncology Quality of Life Questionnaire), caregiving burden (Caregiver Reaction Assessment), self-efficacy (Lewis Cancer Self-Efficacy Scale), and perceived coping skills (Measure of Current Status-Part A). We explored post-intervention changes using paired t-tests. RESULTS We obtained consent from 70.0% (21/30) of caregivers approached, of which 66.7% (14/21) had clinically significant anxiety and thus were eligible to participate (mean age=55.7 years, 64.3% female). Among enrolled caregivers, 71.4% (10/14) completed ≥ 50% of sessions. In semi-structured interviews, all participants found the intervention helpful and valued the ability to participate remotely via videoconference. Among caregivers who completed at least one session, 80.0% (8/10) completed all assessments and were included in analyses. Post-intervention, caregivers reported reduced anxiety symptoms (P=.02) and improved QoL (P=.03) and coping skills (P=.001). We found no significant change in depression, caregiving burden, or self-efficacy. CONCLUSION Our videoconference-based intervention is feasible and acceptable to caregivers. Participants reported significant improvements in anxiety symptoms, quality of life, and coping skills post-intervention, supporting further investigation of the intervention in a randomized controlled trial.

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A randomised controlled clinical trial comparing the effectiveness of bandaging compared to the JuxtaCures™ device in the management of people with venous ulceration: Feasibility study

Phlebology The Journal of Venous Disease ◽

10.1177/0268355520988226 ◽

2021 ◽

pp. 026835552098822

Author(s):

Philip Stather ◽

Carroll Petty ◽

Helen Langthorne ◽

Emma Rayner ◽

Jufen Zhang ◽

...

Keyword(s):

Quality Of Life ◽

Feasibility Study ◽

Multicentre Trial ◽

Compression Therapy ◽

Controlled Clinical Trial ◽

Venous Ulceration ◽

Significant Difference ◽

Potential Benefits ◽

Randomised Controlled

Introduction The mainstay of treatment for venous ulceration remains compression therapy. Velcro Wrap devices are being increasingly used in these patients despite limited evidence. This feasibility study aimed to compare standard bandaging to the JuxtaCures™ Velcro wrap device. Methods A single centre, unblinded RCT compared participants with venous ulceration randomised to either the JuxtaCures™ device or short stretch bandaging. Participants were followed up for 26 weeks. Results 160 participants were screened with 40 randomised. 3 participants in bandaging and 1 in JuxtaCures™ didn’t complete the study. 60% in JuxtaCures™ healed v 55% in bandaging despite larger ulcers in the JuxtaCures™ arm (9.33 cm2 v 6.97 cm2). There was no significant difference in time to healing (12.17 v 13.64 weeks). JuxtaCures™ showed improved ulcer reduction for those that didn’t heal (14.91–5.00 cm2 v 14.20–8.62 cm2; P = 0.06). JuxtaCures™ had more consistent sub-bandage pressure dropping from 39–36 mmHg versus 41–25 mmHg in bandaging between application and removal (P < 0.001). Quality of life (EQ5D) was improved in JuxtaCures at 3 months (mean difference 0.14, p = 0.04), but not at 1 and 6 months, or in disease specific quality of life. Cost was lower in JuxtaCures™ £842.47 v £1064.68. Duration of appointment was significantly shorter in JuxtaCures™ (41 minutes v 53 minutes; P = 0.003). Conclusion This study has shown the feasibility and necessity of running a multicentre trial to evaluate the use of Velcro wrap devices for venous ulceration. It highlights the potential benefits of more consistent pressure, increased self-care, and potential with regards to ulcer healing, cost, nursing resource and quality of life.

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Acceptability and Feasibility of a Mindfulness Intervention Delivered via Videoconferencing for People With Parkinson’s

Journal of Geriatric Psychiatry and Neurology ◽

10.1177/0891988720988901 ◽

2021 ◽

pp. 089198872098890

Author(s):

Angeliki Bogosian ◽

Catherine S. Hurt ◽

John V. Hindle ◽

Lance M. McCracken ◽

Debora A. Vasconcelos e Sa ◽

...

Keyword(s):

Quality Of Life ◽

Cost Effectiveness ◽

Qualitative Interviews ◽

Quality Adjusted Life Year ◽

Secondary Outcome ◽

Structured Interviews ◽

Potential Cost ◽

Mindfulness Intervention ◽

Related Quality

Mindfulness-based group therapy is a rapidly growing psychological approach that can potentially help people adjust to chronic illness and manage unpleasant symptoms. Emerging evidence suggests that mindfulness-based interventions may benefit people with Parkinson’s. The objective of the paper is to examine the appropriateness, feasibility, and potential cost-effectiveness of an online mindfulness intervention, designed to reduce anxiety and depression for people with Parkinson’s. We conducted a feasibility randomized control trial and qualitative interviews. Anxiety, depression, pain, insomnia, fatigue, impact on daily activities and health-related quality of life were measured at baseline, 4, 8, and 20 weeks. Semi-structured interviews were conducted at the end of the intervention. Participants were randomized to the Skype delivered mindfulness group (n = 30) or wait-list (n = 30). Participants in the mindfulness group were also given a mindfulness manual and a CD with mindfulness meditations. The intervention did not show any significant effects in the primary or secondary outcome measures. However, there was a significant increase in the quality of life measure. The incremental cost-effectiveness ratio was estimated to be £27,107 per Quality-Adjusted Life Year gained. Also, the qualitative study showed that mindfulness is a suitable and acceptable intervention. It appears feasible to run a trial delivering mindfulness through Skype, and people with Parkinson’s found the sessions acceptable and helpful.

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