Patient and public involvement in numerical aspects of trials: a mixed methods theory-informed survey of trialists’ current practices, barriers and facilitators

ObjectiveWe aimed to find out if trialists involve patients and the public in numerical aspects of trials, how and what are the barriers and facilitators to doing it.DesignWe developed a survey based on the Theoretical Domains Framework. We used a mixed methods approach to analyse the data and to identify important domains.SettingOnline survey targeting UK-based trial units.ParticipantsStakeholders working in UK-based clinical trials, 18 years old or over, understand English and agree to take part in the study.Outcome measuresTrialists’ behaviour of involving patients and the public in numerical aspects of trials and its determinants.ResultsWe included 187 respondents. Majority were female (70%), trial managers (67%) and involved public and patient partners in numerical aspects of trials (60%). We found lack of knowledge, trialists’ perception of public and patient partners’ skills, capabilities and motivations, scarce resources, lack of reinforcement, and lack of guidance were barriers to involving public and patient partners in numerical aspects of trials. Positive beliefs about consequences were an incentive to doing it.ConclusionsMore training, guidance and funding can help trialists involve patient and public partners in numerical aspects, although they were uncertain about public and patient partners’ motivation to be involved. Future research should focus on identifying public and patient partners’ motivations and develop strategies to improve the communication of numerical aspects.

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How to improve diversity in patient and public involvement

British Journal of Hospital Medicine ◽

10.12968/hmed.2021.0176 ◽

2021 ◽

pp. 1-8

Author(s):

Rebecca Golenya ◽

George D Chloros ◽

Michalis Panteli ◽

Peter V Giannoudis ◽

Anthony Howard

Keyword(s):

Lived Experiences ◽

Public Involvement ◽

Healthcare Professionals ◽

Patient And Public Involvement ◽

Future Research ◽

Barriers To Participation ◽

The Public ◽

Common Barriers ◽

Quality Of Research

Patient and public involvement involves ascertaining the opinions of and collaborating with patients and members of the public to holistically improve the quality of research. Patient and public involvement provides patients with a platform to use and share their lived experiences. This allows healthcare professionals to gain a deeper appreciation of the patient's perspective, which enables future research to be more patient centred and tailored to patients' requirements. Patient and public involvement aims to broadly encapsulate the opinions of the public, so ensuring diversity is recommended. This article provides a practical framework to increase diversity and engage hard-to-reach demographics in patient and public involvement. It highlights some common barriers to participation and methods for overcoming this, describes sampling frameworks and provides examples of how these have been adopted in practice.

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Evaluating the national multisite implementation of dialectical behaviour therapy in a community setting: A mixed methods approach

10.21203/rs.2.14353/v2 ◽

2019 ◽

Author(s):

Daniel Flynn ◽

Mary Joyce ◽

Conall Gillespie ◽

Mary Kells ◽

Michaela Swales ◽

...

Keyword(s):

Mixed Methods ◽

National Level ◽

Team Leader ◽

Barriers And Facilitators ◽

Future Research ◽

Evidence Based ◽

Community Settings ◽

Team Leaders ◽

Implementation Framework ◽

Mixed Methods Approach

Abstract Background The implementation of evidence-based interventions for borderline personality disorder in community settings is important given that individuals with this diagnosis are often extensive users of both inpatient and outpatient mental health services. Although work in this area is limited, previous studies have identified facilitators and barriers to successful DBT implementation. This study seeks to expand on previous work by evaluating a coordinated implementation of DBT in community settings at a national level. The Consolidated Framework for Implementation Research (CFIR) [1] provided structural guidance for this national level coordinated implementation.Methods A mixed methods approach was utilised to explore the national multi-site implementation of DBT from the perspective of team leaders and therapists who participated in the coordinated training and subsequent implementation of DBT. Qualitative interviews with DBT team leaders ( n = 8) explored their experiences of implementing DBT in their local service and was analysed using content analysis. Quantitative surveys from DBT therapists ( n = 74) examined their experience of multiple aspects of the implementation process including orienting the system, and preparations and support for implementation. Frequencies of responses were calculated. Written qualitative feedback was analysed using content analysis.Results Five themes were identified from the interview data: team formation, implementation preparation, client selection, service level challenges and team leader role. Participants identified team size and support for the team leader as key points for consideration in DBT implementation. Key challenges encountered were the lack of system support to facilitate phone coaching and a lack of allocated time to focus on DBT. Implementation facilitators included having dedicated team members and support from management.Conclusions The barriers and facilitators identified in this study are broadly similar to those reported in previous research. Barriers and facilitators were identified across several domains of the CFIR and are consistent with a recently published DBT implementation Framework [2]. Future research should pay particular attention to the domain of characteristics of individuals involved in DBT implementation. The results highlight the importance of a mandated service plan for the coordinated implementation of an evidence-based treatment in a public health service.

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Patient and public involvement in a study of multimedia clinical trial information for children, young people and families

Research for All ◽

10.18546/rfa.04.1.05 ◽

2020 ◽

Vol 4 (1) ◽

pp. 47-65

Author(s):

Rebecca Sheridan ◽

Jennifer Preston ◽

Simon R Stones ◽

Sammy Ainsworth ◽

Danielle Horton Taylor ◽

...

Keyword(s):

Young People ◽

Public Involvement ◽

Patient And Public Involvement ◽

Future Research ◽

Research Practice ◽

The Public ◽

Specific Input ◽

The People ◽

Clinical Trial Information

There is increasing recognition of the need to involve the public in health research, but accounts of how best to achieve this are scarce. This article describes public involvement in the TRials Engagement in Children and Adolescents (TRECA) study, which is developing and evaluating multimedia information resources to inform children, young people and their familes about clinical trials. A dedicated group of young people with long-term health conditions and their parents met regularly throughout the study; further involvement was sought when specific input was required. Review of formal impact records and informal discussions highlighted how public involvement can positively influence research practice and the people involved. By detailing the methods of involvement used, this work also provides guidance for successfully implementing public involvement in research, and highlights challenges that should be considered in future research projects.

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Patient and public involvement in numerical aspects of trials (PoINT): exploring patient and public partners experiences and identifying stakeholder priorities

Trials ◽

10.1186/s13063-021-05451-x ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Beatriz Goulao ◽

Hanne Bruhn ◽

Marion Campbell ◽

Craig Ramsay ◽

Katie Gillies

Keyword(s):

Focus Groups ◽

Priority Setting ◽

Quantitative Research ◽

Public Involvement ◽

Patient And Public Involvement ◽

Future Research ◽

The Public ◽

James Lind Alliance ◽

Communication Needs ◽

Level Of Understanding

Abstract Background and aims Patient and public involvement is increasingly common in trials, but its quality remains variable in a lot of settings. Many key decisions in trials involve numbers, but patients are rarely involved in those discussions. We aimed to understand patient and public partners’ experiences and opinions regarding their involvement in numerical aspects of research and discuss and identify priorities, according to multiple stakeholders, around the most important numerical aspects in trials to involve patients and the public in. Methods The study had two stages: (1) online focus groups with patient and public partners recruited via online platforms and analysed using inductive thematic analysis and (2) online priority setting meeting with UK- and Ireland-based stakeholders and following James Lind Alliance methodology. Pre-selected numerical aspects were introduced prior to the meeting and discussed and prioritised based on a voting system. Results In stage 1, we held two focus groups with patient and public partners (n = 9). We identified four themes in the analysis: “Determinants of PPI in numerical aspects”, “Identity and roles”, “Impact of involving patients and the public in numerical aspects”. Patient and public partners believed being involved in numerical aspects of research is important and should be facilitated, but communication about these aspects needs to be clearer. An environment and relationship with researchers that facilitates that will include time for discussion, support to improve knowledge and confidence, clear language and definitions and trust. Patient and public partners perceive their role as bringing an outsider perspective and were mainly interested in involvement in assumptions and dissemination of quantitative research. They believed this can lead to more transparency and improve their experience by making involvement more meaningful. In stage 2, we identified twelve numerical aspects of trials to be prioritised. We held a priority setting meeting with 14 stakeholders, which led to the selection of three priority numerical aspects in patient and public involvement: target differences, interpretation of results and cost-effectiveness. Participants felt all aspects should be considered for involvement and their communication needs to ensure a shared level of understanding to avoid power imbalances. Conclusions Our work shows the importance of involving patient and public partners in numerical aspects of trials by assessing their experiences and motivations for the first time and discussing and prioritising which numerical aspects of trials are the most important for patients and the public to contribute to. Our research provides a platform for future efforts to improve patient and public involvement in trials and a prioritised set of future research foci.

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Evaluating the national multisite implementation of dialectical behaviour therapy in a community setting: A mixed methods approach

10.21203/rs.2.14353/v1 ◽

2019 ◽

Author(s):

Daniel Flynn ◽

Mary Joyce ◽

Conall Gillespie ◽

Mary Kells ◽

Michaela Swales ◽

...

Keyword(s):

Mixed Methods ◽

National Level ◽

Team Leader ◽

Barriers And Facilitators ◽

Future Research ◽

Evidence Based ◽

Community Settings ◽

Team Leaders ◽

Implementation Framework ◽

Mixed Methods Approach

Abstract Background The implementation of evidence-based interventions for borderline personality disorder in community settings is important given that individuals with this diagnosis are often extensive users of both inpatient and outpatient mental health services. Although work in this area is limited, previous studies have identified facilitators and barriers to successful DBT implementation. This study seeks to expand on previous work by evaluating a coordinated implementation of DBT in community settings at a national level. The Consolidated Framework for Implementation Research (CFIR) [1] provided structural guidance for this national level coordinated implementation.Methods A mixed methods approach was utilised to explore the national multi-site implementation of DBT from the perspective of team leaders and therapists who participated in the coordinated training and subsequent implementation of DBT. Qualitative interviews with DBT team leaders (n = 8) explored their experiences of implementing DBT in their local service and was analysed using content analysis. Quantitative surveys from DBT therapists (n = 74) examined their experience of multiple aspects of the implementation process including orienting the system, and preparations and support for implementation. Frequencies of responses were calculated. Written qualitative feedback was analysed using content analysis.Results Five themes were identified from the interview data: team formation, implementation preparation, client selection, service level challenges and team leader role. Participants identified team size and support for the team leader as key points for consideration in DBT implementation. Key challenges encountered were the lack of system support to facilitate phone coaching and a lack of allocated time to focus on DBT. Implementation facilitators included having dedicated team members and support from management.Conclusions The barriers and facilitators identified in this study are broadly similar to those reported in previous research. Barriers and facilitators were identified across several domains of the CFIR and are consistent with a recently published DBT implementation Framework [2]. Future research should pay particular attention to the domain of characteristics of individuals involved in DBT implementation. The results highlight the importance of a mandated service plan for the coordinated implementation of an evidence-based treatment in a public health service.Trial Registration: ClinicalTrials.gov ID: NCT03180541; Registered June 7th 2017 ‘retrospectively registered’

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‘Give Us The Tools!’: development of knowledge transfer tools to support the involvement of patient partners in the development of clinical trial protocols with patient-reported outcomes (PROs), in accordance with SPIRIT-PRO Extension

BMJ Open ◽

10.1136/bmjopen-2020-046450 ◽

2021 ◽

Vol 11 (6) ◽

pp. e046450

Author(s):

Samantha Cruz Rivera ◽

Richard Stephens ◽

Rebecca Mercieca-Bebber ◽

Ameeta Retzer ◽

Claudia Rutherford ◽

...

Keyword(s):

Clinical Trial ◽

Public Involvement ◽

Patient And Public Involvement ◽

Patient Reported Outcome ◽

Flow Diagram ◽

Additional Patient ◽

The Public ◽

Patient Reported ◽

Trial Protocols ◽

User Friendly

Objectives(a) To adapt the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)-patient-reported outcome (PRO) Extension guidance to a user-friendly format for patient partners and (b) to codesign a web-based tool to support the dissemination and uptake of the SPIRIT-PRO Extension by patient partners.DesignA 1-day patient and public involvement session.ParticipantsSeven patient partners.MethodsA patient partner produced an initial lay summary of the SPIRIT-PRO guideline and a glossary. We held a 1-day PPI session in November 2019 at the University of Birmingham. Five patient partners discussed the draft lay summary, agreed on the final wording, codesigned and agreed the final content for both tools. Two additional patient partners were involved in writing the manuscript. The study compiled with INVOLVE guidelines and was reported according to the Guidance for Reporting Involvement of Patients and the Public 2 checklist.ResultsTwo user-friendly tools were developed to help patients and members of the public be involved in the codesign of clinical trials collecting PROs. The first tool presents a lay version of the SPIRIT-PRO Extension guidance. The second depicts the most relevant points, identified by the patient partners, of the guidance through an interactive flow diagram.ConclusionsThese tools have the potential to support the involvement of patient partners in making informed contributions to the development of PRO aspects of clinical trial protocols, in accordance with the SPIRIT-PRO Extension guidelines. The involvement of patient partners ensured the tools focused on issues most relevant to them.

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Barriers and facilitators to implementing clinical imaging guidelines by healthcare professionals using theoretical domains framework: a mixed-methods systematic review protocol

BJR|Open ◽

10.1259/bjro.20210004 ◽

2021 ◽

Vol 3 (1) ◽

pp. 20210004

Author(s):

Harriet Nalubega Kisembo ◽

Ritah Nassanga ◽

Faith Ameda Ameda ◽

Moses Ocan ◽

Alison A Kinengyere ◽

...

Keyword(s):

Systematic Review ◽

Mixed Methods ◽

Systematic Reviews ◽

Financial Incentives ◽

Healthcare Professionals ◽

Information Source ◽

Theoretical Domains Framework ◽

Barriers And Facilitators ◽

Cochrane Library ◽

Clinical Imaging

Objectives: To identify, categorize, and develop an aggregated synthesis of evidence using the theoretical domains framework (TDF) on barriers and facilitators that influence implementation of clinical imaging guidelines (CIGs) by healthcare professionals (HCPs) in diagnostic imaging Methods: The protocol will be guided by the Joanna Briggs Institute Reviewers’ Manual 2014. Methodology for JBI Mixed Methods Systematic Reviews and will adhere to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines (PRISMA-P). Information source will include databases (MEDLINE, EMBASE and The Cochrane Library), internet search (https://www.google.com/scholar), experts’ opinion, professional societies/organizations websites and government bodies strategies/recommendations, and reference lists of included studies. Articles of any study design published in English from 1990 to date, having investigated factors operating as barriers and/or facilitators to the implementation CIGs by HCPs will be eligible. Selecting, appraising, and extracting data from the included studies will be independently performed by at least two reviewers using validated tools and Rayyan – Systematic Review web application. Disagreements will be resolved by consensus and a third reviewer as a tie breaker. The aggregated studies will be synthesized using thematic analysis guided by TDF. Results: Identified barriers will be defined a priori and mapped into 7 TDF domains including knowledge, awareness, effectiveness, time, litigationand financial incentives Conclusion: The results will provide an insight into a theory-based approach to predict behavior-related determinants for implementing CIGs and develop strategies/interventions to target the elicited behaviors. Recommendations will be made if the level of evidence is sufficient Advances in knowledge: Resource-constrained settings that are in the process of adopting CIGs may opt for this strategy to predict in advance likely impediments to achieving the goal of CIG implementation and develop tailored interventions during the planning phase. Systematic review Registration: PROSPERO ID = CRD42020136372 (https://www.crd.york.ac.uk/PROSPERO).

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Patient and public involvement and engagement: Practice case study with reflections and learnings from a small rural district general hospital

Research for All ◽

10.14324/rfa.05.2.16 ◽

2021 ◽

Vol 5 (2) ◽

Author(s):

Zoë A. Sheppard ◽

Sarah Williams ◽

Richard Lawson ◽

Kim Appleby

Keyword(s):

General Hospital ◽

Public Involvement ◽

District General Hospital ◽

Patient And Public Involvement ◽

Rural District ◽

Relevant Research ◽

The Public ◽

Research Volunteers ◽

Large Groups

The notion of patient and public involvement and engagement (PPIE) in research has been around for some time, and it is considered essential to ensure high-quality relevant research that is shared and that will make a difference. This case study of practice aims to share the PPIE practice from Dorset County Hospital NHS Foundation Trust, a small rural district general hospital. It describes the process of recruiting patients and members of the public as research volunteers, as well as the plethora of engagement and involvement activities with which they have been involved to date. This is followed by a reflection on the process and an overview of plans for the future, highlighting key challenges as well as learnings. A dedicated role to support/oversee PPIE activities is recommended to coordinate large groups of research volunteers, as well as to monitor the important impact of their input, which is considerable. Increasing diversity and access to under-served groups, and embedding the research volunteer role within the wider clinical research team, are also highlighted as fundamental challenges, as well as opportunities to make the most from this valuable resource. The case study of practice puts forward a recommendation to all research departments to embed PPIE in all of the work that they do.

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“Like Static Noise in a Beautiful Landscape”: A Mixed-Methods Approach to Rationales and Features of Disliked Voices in Popular Music

10.31234/osf.io/65gnz ◽

2020 ◽

Author(s):

Julia Merrill ◽

Taren-Ida Ackermann

Keyword(s):

Mixed Methods ◽

Popular Music ◽

Online Survey ◽

Group Testing ◽

Human Interaction ◽

Emotional Impact ◽

Voice Perception ◽

Mixed Methods Approach ◽

Vocal Activity ◽

Everyday Communication

The use of the voice in everyday communication is vital for our understanding of human interaction. The singing of popular music often amplifies vocal features from speech, which can provide insights into vocal activity in the context of the intense emotional impact of music. Three studies with a mixed-methods approach aimed at evaluating rationales and features of disliked voices in the context of popular music. In an interview study (N = 20), rationales and features for disliked voices were identified using self-selected voices. In a group testing session (N = 48) and an online survey (N = 216), these disliked voices were presented to new participants, and the vocal features and evoked emotions by the singers were investigated, assuming that the participants did not have strong opinions about the voices. The results showed that participants justified their dislikes based on object-related/sound and emotional reasons, similar to findings from studies on musical taste. Specific features of disliked voices were confirmed in the following studies, including a specific feature of popular singing styles, the twang, perceived as a squeaky and nasal sound. Further disliked features include a pressed sound, imprecise and ordinary articulation and a uniform expression. Notably, a rough voice was no predictor of aesthetic judgments. Evoked feelings relate to vocal features with similar tension levels. The measures created in the current study will also be informative for studying voice perception and evaluation more generally, which is a tool to evaluate vocal expression and items to evaluate reasons for disliked voices.

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