scholarly journals A qualitative investigation of reasoning behind decisions to decline participation in a research intervention: A study-within-a-trial

2021 ◽  
pp. 135910532110377
Author(s):  
Christopher P Dwyer ◽  
Anusha Moses ◽  
Fionnuala M Rogers ◽  
Dympna Casey ◽  
Robert Joyce ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Chronic Illness ◽  
Public Involvement ◽  
Trial Recruitment ◽  
Qualitative Investigation ◽  
Structured Interviews ◽  
Study Within A Trial ◽  
Participation In Research ◽  
Participant Information

The current study-within-a-trial explored individuals’ decisions to decline participation in research trialling a chronic illness-focused therapy (i.e. multiple sclerosis). Four themes were identified from seven semi-structured interviews with participation decliners and were confirmed by the host trial’s Patient & Public Involvement (PPI) panel: acknowledgement of the value of research; ‘fit’ of the study; misinterpretation of participant information; and ‘ignorance is bliss’ – discussed in light of theory and research. This study-within-a-trial extends research on trial recruitment and participation decline; while also suggesting that PPI can be utilised in both a practical and impactful manner.

scholarly journals An examination of the effects of a patient-designed-and-informed participant information sheet in comparison with a standard, researcher-designed information sheet on recruitment, retention and understanding: Protocol for a study-within-a-trial

2020 ◽  
Vol 3 ◽  
pp. 4 ◽  
Author(s):  
Christopher P. Dwyer ◽  
Robert A. Joyce ◽  
Eimear M. Bane ◽  
Anusha Moses ◽  
Alberto Alvarez-Iglesias ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Public Involvement ◽  
Patient And Public Involvement ◽  
Information Sheet ◽  
Double Blind ◽  
Link Type ◽  
Participant Information Sheet ◽  
Study Within A Trial ◽  
Trials Methodology ◽  
Participant Information

Background: This protocol describes a double-blind, randomised non-inferiority study-within-a-trial (SWAT), comparing the effects of a patient-designed-and-informed participant information sheet with a standard, researcher-designed participant information sheet on recruitment, retention, decision certainty, participant information sheet understanding and likeability. The SWAT is part of a larger trial that aims to evaluate the feasibility and preliminary efficacy of a cognitive occupation-based programme for people with MS (COB-MS) on cognitive and daily functioning for people with multiple sclerosis. Methods: During the study, 120 people with multiple sclerosis will be randomly allocated to one of the two groups, where they will either receive a standard participant information sheet or a patient-designed participant information sheet. Recruitment and retention will be analysed, as well as decision certainty, likability and understanding. Discussion: Results will provide recommendations for recruitment, consent and retention for future trials, as well as shed some light on the factors influencing the understanding and likeability of a trial’s participant information sheet. Recommendations will also be made regarding patient and public involvement in developing and/or aiding the development of participant information sheets.  Registration: SWAT: Northern Ireland Hub for Trials Methodology Research SWAT Repository Store (SWAT105). COB-MS trial: ISRCTN11462710.

scholarly journals An examination of the effects of a patient-designed-and-informed participant information sheet in comparison with a standard, researcher-designed information sheet on recruitment, retention and understanding: Protocol for a study-within-a-trial

2020 ◽  
Vol 3 ◽  
pp. 4 ◽  
Author(s):  
Christopher P. Dwyer ◽  
Robert A. Joyce ◽  
Eimear M. Bane ◽  
Anusha Moses ◽  
Alberto Alvarez-Iglesias ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Public Involvement ◽  
Patient And Public Involvement ◽  
Information Sheet ◽  
Double Blind ◽  
Link Type ◽  
Participant Information Sheet ◽  
Study Within A Trial ◽  
Trials Methodology ◽  
Participant Information

Background: This protocol describes a double-blind, randomised non-inferiority study-within-a-trial (SWAT), comparing the effects of a patient-designed-and-informed participant information sheet with a standard, researcher-designed participant information sheet on recruitment, retention, decision certainty, participant information sheet understanding and likeability. The SWAT is part of a larger trial that aims to evaluate the feasibility and preliminary efficacy of a cognitive occupation-based programme for people with MS (COB-MS) on cognitive and daily functioning for people with multiple sclerosis. Methods: During the study, 120 people with multiple sclerosis will be randomly allocated to one of the two groups, where they will either receive a standard participant information sheet or a patient-designed participant information sheet. Recruitment and retention will be analysed, as well as decision certainty, likability and understanding. Discussion: Results will provide recommendations for recruitment, consent and retention for future trials, as well as shed some light on the factors influencing the understanding and likeability of a trial’s participant information sheet. Recommendations will also be made regarding patient and public involvement in developing and/or aiding the development of participant information sheets.  Registration: SWAT: Northern Ireland Hub for Trials Methodology Research SWAT Repository Store (SWAT105). COB-MS trial: ISRCTN11462710.

Patients’ Perspective on the Psychological Impact of Multiple Sclerosis on Their Life

2021 ◽  
pp. 105413732110068
Author(s):  
Chrysoula Baka ◽  
Kalliopi Chatira ◽  
Evangelos C. Karademas ◽  
Konstantinos G. Kafetsios
Keyword(s):  
Multiple Sclerosis ◽  
Grounded Theory ◽  
Psychological Impact ◽  
Autoimmune Disorder ◽  
Positive Outcomes ◽  
Structured Interviews ◽  
Psychosocial Wellbeing ◽  
Positive Meaning ◽  
Patients Perspective ◽  
The Way

Multiple sclerosis is a chronic autoimmune disorder that greatly impacts on patients’ physical and psychosocial wellbeing. The purpose of this study is to investigate the experiences of people diagnosed with multiple sclerosis in Greece (N = 30), with regard to the way they coped with the diagnosis and the symptoms, the psychological implications of the disorder and the meaning they attributed to it. Data were collected through semi-structured interviews and they were analyzed using grounded theory. The findings showed that despite the negative implications of the disorder and the difficulty in managing the diagnosis and the symptoms, half of the patients attributed positive meaning to the disorder. Taking care of oneself, re-evaluation of life and a sense of liberation were described as the positive outcomes of experiencing multiple sclerosis.

scholarly journals Views of the Future of Partners of People with Multiple Sclerosis Who Attended a Lifestyle Modification Workshop: A Qualitative Analysis of Perspectives and Experiences

2020 ◽  
Vol 18 (1) ◽  
pp. 85
Author(s):  
Sandra L. Neate ◽  
Keryn L. Taylor ◽  
Nupur Nag ◽  
George A. Jelinek ◽  
Steve Simpson-Yap ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Health Outcomes ◽  
Lifestyle Modification ◽  
Structured Interviews ◽  
Interpretive Phenomenology ◽  
Related Risk ◽  
The Future ◽  
Partner Perceptions ◽  
And Control ◽  
The Impact

People with multiple sclerosis (PwMS) often experience uncertainty and fear about their futures. Partners of PwMS may share their concerns and experience fears about their own futures, limitations on their lives, ability to work, and becoming a carer. For PwMS, modification of lifestyle-related risk factors has been associated with improved health outcomes. For PwMS who attended residential lifestyle modification workshops (RLMW), sustained improved health outcomes have been demonstrated. Whether improved outcomes for PwMS who engage with lifestyle modification translate to improved partner perceptions of the future, is yet to be explored. We explored the perspectives of partners of PwMS who had attended a RLMW and the impact that the person with MS’s illness and their engagement with lifestyle modification had on their partners’ views of the future. Analysis of 21 semi-structured interviews used a methodology informed by Heidegger’s Interpretive Phenomenology. Three themes emerged: ‘uncertainty’, ‘planning for the future’ and ‘control, empowerment and confidence’. Subthemes included MS and lifestyle modification being a catalyst for positive change; developing a sense of control and empowerment; and hope, optimism and positivity. Lifestyle modification may provide benefits, not only to PwMS, but also to their partners, and should be considered part of mainstream management of MS.

scholarly journals “Kicking and Screaming” or “Gracefully Conceding”: Creative Nonfiction Stories of Aging With Multiple Sclerosis

2021 ◽  
pp. 104973232110098
Author(s):  
Emma V. Richardson ◽  
Robert W. Motl
Keyword(s):  
Quality Of Life ◽  
Multiple Sclerosis ◽  
Older Adults ◽  
Knowledge Translation ◽  
Creative Nonfiction ◽  
Complex Phenomenon ◽  
Structured Interviews ◽  
Cognitive Dysfunctions ◽  
Positive Experiences

Aging with multiple sclerosis (MS) is a complex phenomenon. Some individuals report physical and cognitive dysfunctions regarding these combined experiences, whereas others report perceived improvements in quality of life. Beyond this, little is known regarding how people make sense of, and come to embody, negative or positive experiences of MS. Thus, our objectives were to (a) explore how people made sense of aging with MS and (b) present this in an artful, engaging, transformative way. To achieve this, we conducted 40 semi-structured interviews with older adults who had MS, analyzed data using pluralistic narrative analyses, and presented results through two creative nonfictions. We detail our process of creating the nonfictions before presenting the different stories of aging with MS, namely “Kicking and Screaming” and “Gracefully Conceding.” We then offer recommendations and implications for using these stories as knowledge translation devices, and further critique the limitations of these stories in practice.

scholarly journals Parent-child collaboration in health care decision making: perspectives of young people with chronic illness

2021 ◽  
Author(s):  
Elana Jackson
Keyword(s):  
Health Care ◽  
Decision Making ◽  
Chronic Illness ◽  
Young People ◽  
Organ Transplant ◽  
Chronic Illnesses ◽  
Structured Interviews ◽  
Health Care Decision ◽  
Role Of Parents ◽  
Care Decision

This study explores the perspectives of young people with chronic illness on their participation in health care discussions and decision making, with a specific focus on the role of parents in facilitating participation. Semi-structured interviews were conducted with 26 participants between the ages of 5 and 18. Participants were recruited from inpatient units at a pediatric hospital. A range of chronic illnesses were represented among members of the sample, including kidney failure, Crohn’s disease, organ transplant, and sickle cell anemia. Following data collection, a focused analysis was conducted of participants’ statements related to parent involvement in the health care decision making process. Salient themes that emerged from analysis of the data reveal a complex and bidirectional process in which young people and parents negotiate children’s participation in making decisions related to their health care. Based on the findings, a collaborative-contextual model of decision making is proposed.

scholarly journals The Health Inequalities Assessment Toolkit: supporting integration of equity into applied health research

2020 ◽  
Author(s):  
Ana Porroche-Escudero ◽  
Jennie Popay
Keyword(s):  
Health Inequalities ◽  
Health Research ◽  
Public Involvement ◽  
Routine Data ◽  
Positive Contribution ◽  
Political Commitment ◽  
Structured Interviews ◽  
North West ◽  
The North ◽  
Applied Health Research

Abstract Background Despite insistent calls for more and better evidence to inform action to reduce health inequities, applied health research sensitive to these inequalities is rare. Recognising this problem, the Collaboration for Leadership in Applied Research and Care in the North West Coast (England) developed the Health Inequalities Assessment Toolkit (HIAT) to support those involved in health research to integrate equity into their work. Objective This paper reports on an evaluation of the extent to which HIAT enhances the equity focus of the work of users. Methods The evaluation used semi-structured interviews, focus groups and workshops (n = 131 respondents including Public Advisers, university, NHS and local government partners). Routine data included HIAT feedback forms. Findings HIAT can help to strengthen the equity focus of applied health research by: increasing understanding of how socioeconomic inequities impact on health; building capacity for integrating equity into all aspects of research, implementation and capacity building; stimulating thinking on action to address local structural drivers of health inequalities; and increasing understanding of the positive contribution public involvement can make to research. Conclusion If we are to advance health equity goals delivering research and training needs to be combined with political commitment to create more equal societies.

scholarly journals Planning for success: overcoming challenges to recruitment and conduct of an open-label emergency department–led paediatric trial

2020 ◽  
pp. emermed-2020-209487
Author(s):  
Louise Roper ◽  
Mark D Lyttle ◽  
Carrol Gamble ◽  
Amy Humphreys ◽  
Shrouk Messahel ◽  
...  
Keyword(s):  
Focus Groups ◽  
Trial Design ◽  
Research Question ◽  
Pragmatic Trial ◽  
Valuable Insight ◽  
Trial Recruitment ◽  
Open Label ◽  
Prior Consent ◽  
Study Within A Trial ◽  
Conducting Research

BackgroundKey challenges to the successful conduct of The Emergency treatment with Levetiracetam or Phenytoin in Status Epilepticus in children (EcLiPSE) trial were identified at the pre-trial stage. These included practitioner anxieties about conducting research without prior consent (RWPC), inexperience in conducting an ED-led trial and use of a medication that was not usual ED practice. As part of an embedded study, we explored parent and practitioner experiences of recruitment, RWPC and conduct of the trial to inform the design and conduct of future ED-led trials.MethodsA mixed-methods study within a trial involving (1) questionnaires and interviews with parents of randomised children, (2) interviews and focus groups with EcLiPSE practitioners and (3) audio-recorded trial discussions. We analysed data using thematic analysis and descriptive statistics as appropriate.ResultsA total of 143 parents (93 mothers, 39 fathers, 11 missing information) of randomised children completed a questionnaire and 30 (25 mothers, 5 fathers) were interviewed. We analysed 76 recorded trial recruitment discussions. Ten practitioners (4 medical, 6 nursing) were interviewed, 36 (16 medical, 20 nursing) participated in one of six focus groups. Challenges to the success of the trial were addressed by having a clinically relevant research question, pragmatic trial design, parent and practitioner support for EcLiPSE recruitment and research without prior consent processes, and practitioner motivation and strong leadership. Lack of leadership negatively affected practitioner engagement and recruitment. EcLiPSE completed on time, achieving its required sample size target.ConclusionsSuccessful trial recruitment and conduct in a challenging ED-led trial was driven by trial design, recruitment experience, teamwork and leadership. Our study provides valuable insight from parents and practitioners to inform the design and conduct of future trials in this setting.

An electronic, unsupervised patient-reported Expanded Disability Status Scale for multiple sclerosis

2020 ◽  
pp. 135245852096881
Author(s):  
Andrew R Romeo ◽  
William M Rowles ◽  
Erica S Schleimer ◽  
Patrick Barba ◽  
Wan-Yu Hsu ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Care ◽  
Expanded Disability Status Scale ◽  
Clinical Assessments ◽  
Patient Reported ◽  
Disability Status ◽  
Two Measures ◽  
Highly Correlated ◽  
Participation In Research ◽  
Good Agreement

Background: In persons with multiple sclerosis (MS), the Expanded Disability Status Scale (EDSS) is the criterion standard for assessing disability, but its in-person nature constrains patient participation in research and clinical assessments. Objective: The aim of this study was to develop and validate a scalable, electronic, unsupervised patient-reported EDSS (ePR-EDSS) that would capture MS-related disability across the spectrum of severity. Methods: We enrolled 136 adult MS patients, split into a preliminary testing Cohort 1 ( n = 50), and a validation Cohort 2 ( n = 86), which was evenly distributed across EDSS groups. Each patient completed an ePR-EDSS either immediately before or after a MS clinician’s Neurostatus EDSS evaluation. Results: In Cohort 2, mean age was 50.6 years (range = 26–80) and median EDSS was 3.5 (interquartile range (IQR) = [1.5, 5.5]). The ePR-EDSS and EDSS agreed within 1-point for 86% of examinations; kappa for agreement within 1-point was 0.85 ( p < 0.001). The correlation coefficient between the two measures was 0.91 (<0.001). Discussion: The ePR-EDSS was highly correlated with EDSS, with good agreement even at lower EDSS levels. For clinical care, the ePR-EDSS could enable the longitudinal monitoring of a patient’s disability. For research, it provides a valid and rapid measure across the entire spectrum of disability and permits broader participation with fewer in-person assessments.

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