The development of the PAOLI (People with Aphasia and Other Layperson Involvement) guideline for reporting Patient and Public Involvement (PPI) in aphasia research

doi:10.21203/rs.3.rs-2858136/v1

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Research Article

The development of the PAOLI (People with Aphasia and Other Layperson Involvement) guideline for reporting Patient and Public Involvement (PPI) in aphasia research

https://doi.org/10.21203/rs.3.rs-2858136/v1

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published 01 Sep, 2023

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Background: Patient and Public Involvement (PPI) in aphasia research obliges researchers to include people with aphasia (PWA) as research partners from the beginning of the study. Yet the quality of reporting on the level and type of involvement is poorly documented in the absence of a guideline to document contribution. This study aimed to extract the items and statements relevant for the development of the People with Aphasia and Other Layperson Involvement (PAOLI) reporting guideline, in collaboration with people with aphasia.

Method: The EQUATOR method for developing a reporting guideline was followed. This involved: (1) evidence from a scoping review, (2) a thematic analysis of the in-depth interviews, of people with stroke and aphasia, on the topics to be included in the pilot draft, (3) a two round Delphi survey for item/statement selection and (4) an experts’ consensus meeting. The research team involved two PPI partners with chronic stroke-induced aphasia. The research process involved co-design and was informed by the Dialogue model.

Results: Twenty-three participants, from 13 countries, voted in round one with 87% (20/23) responding in round two. The PAOLI guideline includes 17 items (with 66 descriptive statements) on how to: establish collaborations, recruit patients, gain informed consent, organize induction meetings, train patient partners, create communication links, engage communication partners, conceptualize topics, establish research priorities, reach consensus, work with co-design methods, develop proposals, assist with dissemination of results, promote implementation of the outcomes, support patient partners and promote self-evaluation, monitor progress and assess impact of the patient involvement. These items were considered by the participants as the most important for the involvement of people with aphasia as research partners.

Conclusion: The PAOLI is the first international consensus guideline for reporting patient involvement in aphasia research. Researchers are encouraged to adopt the reporting guideline to improve the quality of their research by documenting the meaningful involvement of people with aphasia within the research team from the start.

people with aphasia

patient and public involvement

reporting guideline

co-design

stroke

Until very recently people with aphasia (PWA) were excluded as research partners from qualitative studies [1]. Consequently, the relevance and the impact of the research was compromised [2]. Over time aphasiologists have suggested various strategies to promote the inclusion of PWA as research partners [3, 2]. Patient and Public Involvement (PPI) is the direct and active involvement of PWA (and the public) within the research team, from the start of the research process, to ensure ethically responsible studies and avoid wasting resources [4]. Funding agencies and ethical review boards also endorse the inclusion of national stroke and aphasia associations, stroke support organizations, advocates, and policymakers in the research process to ensure the sustainability and broad dissemination of the research results [5].

The absence of a standardized approach for conducting and reporting PPI in aphasia research prompted the authors in 2020 to develop a guideline specific to involving people with aphasia in research, that is, “the People with Aphasia and Other Layperson Involvement” (PAOLI) guideline. While Staniszewska and colleagues had developed the Guidance for Reporting Involvement of Patients and Public (GRIPP2) checklist [6], the results of a recent review [7] suggested that generic PPI frameworks may not be “accessible” or applicable to all patient populations [8] and especially, in this case, to people with chronic communication impairments. As a result, aphasia researchers may not engage, monitor, or document patient involvement, that is, the contribution of PWA in the research process [7].

The development of the PAOLI guideline was initially informed by the findings of a thematic analysis investigating the facilitators and the barriers that promote or inhibit the active involvement of patient partners with chronic stroke and aphasia [9] in the research process. The results revealed important topics including the types of restrictions that make involvement for PWA in research difficult, and the support PWA require to be active and collaborate effectively with the research process [9]. The findings also highlighted the importance of creating a robust support system, to be put into place, before involving PWA as research partners [9].

The development of the PAOLI guideline aims to encourage the advancement of inclusive research teams for engaging PWA in the research process. This will enable PWA to have ‘a research voice’, to express their views, participate actively in decision-making, and be represented from early on, ultimately improving the impact of the research given that PWA are most often the end-users of the research outcomes/product [2]. PAOLI aims to empower both researchers and PWA and stroke to engage with mutual respect, and experience positive research relationships [4]. The PAOLI mission statement is characterized by six key E-verbs reported in Fig. 1, and described further in the following sections.

For the development of the PAOLI, the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) toolkit for developing a reporting guideline (Moher et al., 2010) was followed. This involved the following stages: (1) gathering evidence from a scoping review [7], (2) conducting interviews with PWA and stroke on the topics to be included in the guideline, (3) undertaking a thematic analysis of the in-depth interviews [9], (4) a two-round Delphi survey for item/statement selection and (5) an experts’ consensus meeting to finalize the guideline. PAOLI was registered as a ‘reporting guideline under development’ on the EQUATOR Network website in June 2022 (https://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines-under-development-for-other-study-designs/ [accessed 10 December 2022]).

The current work builds on the scoping review evidence which previously identified the need for the creation of a functional methodological framework to facilitate patient-centred research design for PWA [7]. Specifically, twenty published studies, from the review, on the involvement of PWA in the creation of quality-of-life assessment tools, revealed significant limitations around the reporting of the context, and the process of PPI, deterring the interpretation of PPI impact [7]. The absence of a standardized approach for conducting and reporting PPI in aphasia qualitative research prompted the creation of the PAOLI reporting guideline, in close collaboration with PWA.

To begin the PAOLI development process, the Dialogue Model [10], a multi-phased PPI scheme, based on the methodology of the Responsive Evaluation [11, 12] and the Interactive Learning and Action approach [13], was selected. The rationale for selecting the Dialogue Model for research agenda-setting, was that it enables an equal partnership to be created between all stakeholders (including patients) during the research process. The first author (MC), the lead investigator, served as the facilitator. The Dialogue Model has six phases: Exploration, Consultation, Prioritization, Integration, Programming, and Implementation. These phases are presented in Table 1 with a description of the actions related to the development of the PAOLI guideline.

Table 1

Overview of the six phases of the Dialogue Model as implemented during the PAOLI development.
Phase	1. Exploration	2. Consultation	3. Prioritization	4. Integration	5. Programming	6. Implementation TBA
Aim	To create good communication conditions and to gain the first understanding of the participants’ issues.	To identify topics from patient participants	To prioritize topics for the pilot draft of the PAOLI	To discuss results with stakeholders	To keep stakeholders engaged	To implement the PAOLI guidance on a research project
Research agenda actions	1.Made contacts with patients’ organizations: • Association Internationale Aphasie • Stroke Alliance for Europe • World Stroke Organization • Aphasie Suisse • Cyprus Stroke Association • AVC Portugal	1.Semi-structured Interviews: 8 people with stroke • 4 with aphasia • 4 without from 6 European Countries: Cyprus, Denmark, Greece, Switzerland, France, and Portugal The research team involved a PPI partner (AK)	Creation of the pilot draft of the PAOLI: • Phases of the Patient and service user engagement (PSUE) framework. • Key topics from the thematic analysis • Recommendations from European Alliance of Associations for Rheumatology (EULAR) guidance • Stages of the research cycle from the Enhancing the Quality of User Involvement in care Planning (EQUIP) study • Items from the Guidance for Reporting Involvement of Patients and the Public (GRIPP2) checklist	1.Experts’ consensus meeting (n = 12 participants) • PPI Partners (AK & JRS) • stroke survivor without aphasia • PPI Aphasia Academic Experts • Academic Aphasia Researcher • Aphasia Rehabilitation Clinician • Stroke Advocate from WSO • Policy Maker SAFE • Author of EULAR PPI guideline • MC	1.The programming phase has already been started in previous phases (1–4)	1. It is recommended that PAOLI is tested in a future PPI stroke and aphasia qualitative study
	2. Research team established: Involved leading investigator (author MC), PPI partners (AK & JRS) and communication partners (family members & speech and language therapy students)	2. Thematic Analysis resulted in four themes: • Restrictions: the kinds of restrictions that make involvement in research difficult • Involvement: the preferred levels and ways of involvement during the research process • Support: the support required for active and collaborative involvement • Impact: Impact of their involvement and how it benefits the study’s outcomes.	2. Cognitive Interviews: followed Consensus-based Standards for the selection of health status Measurement Instruments (COSMIN) guidelines to test the content validity on: • Comprehensibility • Comprehensiveness • Relevance and importance of the items n = 2 people with chronic aphasia Made suggestions on: • Vocabulary simplification • Reducing the complexity of the statements • Selection of pictograms • Addition of a statement	2. Consensus • n = 66 statements were confirmed • n = 4 statements were discarded • AK & JRS expressed their views and gave feedback on their involvement	2. MC was updating stakeholders with controlled feedback reports and email	2. Create a shorter version of the PAOLI to be used when patient involvement is secondary to the scope of the study
	3. Informal conversations and preliminary discussions with patient partners and the representatives of the stakeholders: • Informed and motivated potential participants of the PAOLI project • Creation of commitment to be involved right from the start and signed informed consent	3. Published open-access peer-reviewed article on thematic analysis with AK as co-author	3. Pilot tested the Delphi questionnaire online format with a person with chronic aphasia. Made suggestions to: • Provide more simplified instructions on how to access, complete and submit the questionnaire • Indicate a clearer deadline for submission	3. Validation of the PAOLI The final form of the guideline was examined in collaboration with the AK & JRS n = 3 statements were re-worded	3. MC drafted the article with AK & JRS as co-authors	3. Patients Organizations (Cyprus Stroke Association, SAFE, Aphasie Suisse) to disseminate the PAOLI guidance in meetings and informal networks
	4. The PAOLI Consortium was established: • People with aphasia after a stroke • Stroke survivors without aphasia • PPI Aphasia Academic Experts • Academic Aphasia Researchers • Aphasia Rehabilitation Clinician • Clinical Psychologist with PPI experience • Stroke Policy Maker • Aphasia Advocate • Stroke Advocate • PPI Guidelines Author/ Policy Maker • Research Funding Agent	4. MC, AK and her communication partner (SLT student) searched the literature on published PPI frameworks, the internet fora and environmental scan.	4. Delphi survey participants: PAOLI Consortium (n = 23 panellists) 2-round Delphi survey Result: n = 66 statements + n = 17 topics voted at an agreement level of > 80% Consensus levels were the highest to the need of involving people with aphasia in the research team from early on and identifying topics using co-design methods	4. It is recommended that PAOLI is also reviewed and approved by an external board	4. MC and AK presented preliminary data at the European Life After Stroke Forum of the Stroke Alliance for Europe	4. The research team to co-present the PAOLI guidance in scientific conferences (World Stroke Conference, International Aphasia Rehabilitation Conference, World Congress of Neurorehabilitation)

Phase 1. Exploration

The Exploration phase involved contacting patient organizations, such as the Association Internationale Aphasie, the Stroke Alliance for Europe, the World Stroke Organization, to inform potential stakeholders about the PAOLI project, recruit participants, build the PAOLI consortium (see Τable 1) and establish the research team.

The research team

The research team consisted of 7 individuals: a leading investigator, 2 PPI partners and 4 communication partners. The first author (MC), a senior speech and language therapist practising in aphasia rehabilitation, with previous PPI experience in aphasia research1 served as the lead investigator [7, 9, 14]. The two PPI partners are co-authors AK and JRS. The term ‘PPI partner’ will be used to reflect the constant commitment and active involvement of the two people with chronic stoke-induced aphasia throughout the research process. The aim for collaborating with AK and JRS was to enhance the quality and transparency of the PPI evidence in this study, by involving them from the beginning and in all stages of developing PAOLI. AK is a 36-year-old female with mild-moderate aphasia and a right hemiparesis, both resulted after a hemorrhagic stroke 8 years ago. AK holds a Master of Science (MSc) in Social Research Methods from the University of Sussex and was enrolled in doctoral studies in Social Care but dropped out after her stroke event. She has previous experience as a PPI partner on research projects, and has co-authored publications from the research [9, 14]. JRS was Professor of English Linguistics at the University of Lausanne and is now retired. He suffered a stroke in 2009 and presents with mild-moderate aphasia and a right hemiplegia. JRS holds a PhD in Linguistics from the University of Cambridge, has a vast background in research as primary investigator, on several projects, and has authored aphasia-related research publications [15–17]. Both AK and JRS were actively involved in all stages of this study, from the conceptualization of the study to patient recruitment and to the final validation of PAOLI. Finally, the research team included four laypeople the so-called communication partners (family members, speech-language therapy (SLT) students) who supported PWA from the onset during the informed consent procedures, the completion of the cognitive interviews, the Delphi survey, and the validation phase.

Phase 2. Consultation

The Consultation phase involved three steps: (1) conducting 8 semi-structured interviews with people with chronic stroke, four with aphasia and four without, (2) a thematic analysis of the in-depth interviews obtained for the identification of key topics to be included in the pilot draft [9] and (3) a literature search on published PPI frameworks [8].

Phase 3. Prioritization

The research team (RT) consulted several published guidelines [8, 18] to become familiar with recommendations from previous research on the conceptual elements required to build a new guideline. Specifically, the RT accessed the following:

the patient and service user engagement (PSUE) framework [19] on how to develop the research phases.
the European Alliance of Associations for Rheumatology (EULAR) guidance [20] to determine topics on conceptualization, researching consensus and co-design methodology.
the research processes from the Enhancing the Quality of User Involvement in care Planning (EQUIP) study [21, 22] to gather information on patient recruitment and induction procedures.
the Guidance for Reporting Involvement of Patients and the Public (GRIPP2) checklist [6] on selected material for the proposal development and impact.

All this information combined, resulted in the concept development of the PAOLI leading to the adoption of 99 statements and the creation of the first pilot draft.

Pilot Draft

The pilot draft of the PAOLI encompassed the following components:

Four phases: Foundation, Development, Translational and Ongoing Processes.
18 items [9].
33 statements in Phase I: Foundation, on establishing collaborations, recruiting patients, gaining informed consent, organizing induction meetings, training patient partners, creating communication links and engaging communication partners.
34 statements in Phase II: Development, on conceptualizing topics, establishing research priorities, reaching consensus, working with co-design methods, and developing research proposals.
18 statements in Phase III: Translational, on data analysis, assisting with the dissemination of the results and promoting the implementation of the outcomes.
14 statements in Phase IV: Ongoing Processes, on supporting patient partners and promoting self-evaluation, monitoring progress, and assessing the impact of the patient involvement.

After organizing the conceptual constructs, the research team formulated questions using a 5-point Likert Scale by asking, “How important is it to…” (1 = not important to 4 = very important 5 = extremely important) using an aphasia-friendly format [23, 24] selected by AK as appropriate for PWA.

Cognitive Interviews and Pilot Test

After the first draft was created, two rounds of cognitive interviewing and a pilot test to explore how patient partners with aphasia understood the statements were completed. The cognitive interview study aimed to improve the validity and acceptability of the questionnaire and followed the Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) guidelines [25]. Participants for this part of the study were stroke survivors with aphasia outside of the research team who were involved only in the piloting stage of the guideline. The first cognitive interview was performed with a male stroke survivor (SO), a retired engineer. SO had suffered a left hemispheric stroke three years prior to the study and presented with a moderate anomic aphasia and right hemiplegia. During the first cognitive interview he completed the questionnaire under the guidance of MC, and with occasional assistance from his communication partner, an SLT student. On completion, SO proposed modifications to 11 statements in terms of simplifying the vocabulary (e.g., replace ‘tailor made’ with ‘personalized’) and the complexity of the statements (e.g., replace ‘PWA to form a steering committee to check, and feedback, on the progress of the research’ with ‘PWA to form a committee to check the progress of the research’). Once modifications were made to the first draft of the questionnaire, the second cognitive interview was undertaken with an unemployed female (MG) who had suffered a left hemispheric stroke five years prior to the study and presented with mild-moderate anomic aphasia. She reviewed the revised questionnaire, approved the content, and proposed an additional statement as follows: ‘PWA to designate as a communication partner another person with aphasia’ as she felt that PWA can support each other very effectively during group discussions. The pilot questionnaire with the 18 items and the 100 statements is reported in Appendix 1.

Since the first two pilot tests were face-to-face, a third pilot was completed to test the method online. During the final pilot, a female presenting with stroke-induced expressive aphasia (DT), was emailed the instructions and completed the questionnaire online. DT recommended that instructions in the email be simplified regarding accessing, completing, and submitting the questionnaire. These issues were addressed before the initiation of the Delphi study.

Delphi study

The Delphi technique is widely used to achieve reliable consensus from a group of subject experts on a particular issue [26]. For this study, the Delphi technique

supported the anonymity of the participants and the confidentiality of their responses;
brought together a geographically dispersed international panel of experts;
encouraged honest opinion;
allowed a structured/organized group communication process;
facilitated endorsement of the computer-based survey by the PPI partners (AK and JRS) as simple to use;
was a method free from group pressure, especially for patient participants [27].

The “Recommendations for the Conducting and Reporting of Delphi Studies” (CREDES) [24] was followed (see Appendix 2 for the CREDES checklist). To ensure a wide scope of opinion the expert panel was categorized as follows:

PPI and aphasia experts in academia, scientific publications, and training;
“Experts by experience” who were PWA and stroke survivors without aphasia (SswoA: we aimed for the opinion of people with stroke and unaffected language skills but were experiencing other symptoms of stroke i.e., fatigue, hemiplegia etc);
aphasia rehabilitation clinicians;
stroke and aphasia advocates;
stroke policy makers;
the author of previous PPI guidelines; and a
research funding agent.

The authors (MC, JMA and MK) identified experts in the field of PPI, stroke and aphasia research and rehabilitation through a nomination process. People with stroke and aphasia were also nominated and recruited by MC and JRS in Europe through a snowball effect. Individuals were considered eligible to be invited to participate in the expert panel if they had relevant clinical and or/academic backgrounds and experiences concerning PPI in stroke and aphasia research and/or rehabilitation and could contribute to the topic of the study. The criteria for the patient partners were as follows: (1) to be a stroke survivor, (2) to be in the chronic stage of stroke (> 6 months post-stroke), (3) to be able to speak, understand, read, and write in English post-stroke, (4) to be socially active as confirmed from case history, (5) to have at least one academic qualification (Bachelor), and (6) to have had previous research experience, either as a student or as a researcher. Furthermore, for PWA evidence from case history interview of mild-moderate chronic aphasia was a criterion. The Aphasia Severity Rating Scale (ASRS), of the Boston Diagnostic Aphasia Examination [28] was used to rate the severity of the observed language difficulties. Spontaneous speech samples were elicited during a 15-minute semi-structured interview that comprised of four topics: the illness, previous/current occupation, family and housing, hobbies [29]. Aphasia severity was assessed by MC using the ASRS to allow a classification based on fluency and intelligibility.

Participants

The panel consisted of 23 participants deemed sufficient for the survey [30]. Geographical diversity was achieved by recruiting panellists from various organizations around the world. Demographic characteristics of the panellists are reported in Table 2.

Table 2

The demographic characteristics of panellists in the Delphi study
	Number of Panelists
Characteristics of the Panelists	Round One N = 23 (%)	Round Two N = 20 (%)
Gender
Female	16 (70)	13 (65)
Male	7 (30)	7 (25)
Country
Argentina	1 (5)	-
Australia	2 (8)	2 (10)
Cyprus	5 (20)	5 (25)
Denmark	1 (5)	1 (5)
Estonia	1 (5)	1 (5)
France	1 (5)	1 (5)
Germany	1 (5)	1 (5)
Greece	1 (5)	-
Ireland	1 (5)	1 (5)
Norway	1 (5)	1 (5)
Portugal	2 (8)	2 (10)
Switzerland	2 (8)	1 (5)
United Kingdom	4 (16)	4 (20)
Roles and self-reported job titles*
People with aphasia after stroke	5 (24)	4 (20)
Stroke survivors no aphasia	4 (18)	3 (15)
PPI Aphasia Experts	3 (12)	3 (15)
Academic Aphasia Researchers	4 (18)	3 (15)
Aphasia Rehabilitation Clinician	1 (4)	1 (5)
Clinical Psychologist on PPI	1 (4)	1 (5)
Stroke Policy Maker	1 (4)	1 (5)
Aphasia Advocate	1 (4)	1 (5)
Stroke Advocate	1 (4)	1 (5)
PPI Guidelines Author/ Policy Maker	1 (4)	1 (5)
Research Funder	1 (4)	1 (5)
Years of experience in research
Less than 10	6 (25)	5 (25)
10 to 25 years	8 (35)	7 (35)
More than 25 years	9 (40)	8 (40)
Years of experience in PPI research methods
None	12 (50)	9 (45)
Less than 10	2 (10)	2 (10)
10 to 25 years	9 (40)	9 (45)
*Note that some panellists held multiple roles in addition to their principal job title

Patient partners were recruited from the Cyprus Stroke Association, the French Association S’ Adapter- AVC et Aphasie, the Portugal AVC Stroke Association, the Norwegian Stroke Association, Aphasie Suisse, the British Stroke Association and Say Aphasia UK. Nine people with chronic stroke, five with chronic aphasia and four without, met the inclusion criteria. Patient partners were aged between 27 and 70 years old, with a range of education of 15–22 years. All patient partners had completed a research project during their studies or work commitments prior to the stroke. Specifically, PWA 3 was the primary investigator in several projects throughout his academic career and two SSwoA (1 and 4) are now the primary investigators in studies in their perspective fields. The remaining patient partners were familiar with the research process because of prior experience from the completion of thesis work while studying. The demographic characteristics of the PWA and the SSwoA are reported in Table 3.

Table 3

Patient partner demographics
	Gender	Stroke Type (Hemiplegia)	ASRS* (0–5)	Completed Education	Research Experience	Premorbid Empl/ment (RtW*)
People with aphasia (PWA)
1	Female	Haemorrhagic LH* (Yes)	4	Doctoral	Thesis Completion	Teacher (No)
2	Male	Ischemic LH* (Yes)	4	Masters	Thesis Completion	Lawyer (No)
3	Male	Ischemic LH* (Yes)	5	Doctoral	Primary Investigator	Academic (No)
4	Female	Ischemic LH* (No)	5	Masters	Thesis Completion	Admin (No)
5	Male	Ischemic LH* (Yes)	4	Bachelor	Thesis Completion	Businessman (Retired)
Stroke Survivors without Aphasia (SSwoA)
1	Male	Ischemic LH* (Yes)	N/A	Doctoral	Primary Investigator	Academic (Yes)
2	Female	Ischemic LH* (No)	N/A	Masters	Thesis Completion	Nurse (Yes)
3	Female	Ischemic LH* (No)	N/A	Bachelor	Thesis Completion	Unemployed (No)
4	Female	Ischemic LH* (No)	N/A	Doctoral	Primary Investigator	Academic (Yes)
*LH: Left Hemisphere; ASRS: Aphasia Severity Rating Scale: 0 = limited verbal output and comprehension, 5 = mild word finding difficulties; RTW: Return to Work

Prior to obtaining informed consent from the participants MC had individual meetings with all patient partners, aphasia and stroke advocates, the policy maker, the PPI guidelines author, and the research funder to explain the scope of the study. Informed consent to participate was obtained by all panellists prior to their involvement in the study [29]. Furthermore, AK and MC co-designed the aphasia-friendly consent form (see Appendix 3).

Delphi survey

A consensus level of 80% was selected as this percentage marks a clear majority opinion [26] and was used in previous PPI framework development research using the Delphi method [6]. Therefore, a statement was deemed to be ‘very important’ or ‘extremely important’ (it was considered as the most useful for the involvement of PWA as research partners for the PAOLI guideline) if it had been rated as either 4 or 5 on the Likert scale by at least 80% of respondents. In recognition that the 80% cut-off criteria selected is a strict and somewhat arbitrary definition of consensus, the statements that at least 70% of the panellists scored 4 or 5 on the Likert scale were highlighted in the findings as statements that were ‘nearing’ the pre-set cut off point and were voted on again in round two. Statements ‘nearing’ consensus from round one, that did not receive at or more than 80% consensus in round two, were eventually discarded.

In round one participants received an electronic invitation, with an attached link and simplified instructions. While rating all statements in each section, panellists were also asked to comment on each statement, if they wished, in the space provided. Each participant was allowed 4 weeks to respond to the survey questionnaire [30]. After receiving panellists’ responses, the new information collected was used to modify the second version of the questionnaire. The panellists received a personalised report showing quantitative responses to the round one statements. MC examined the anonymised quantitative scores and qualitative comments for each statement and generated round two.

In round two each panellist was asked to review the statements summarized based on the information provided in round one and to rate them again using the Likert scale. As a result of round two, there was a high level of agreement for most statements and consensus was achieved. Again, after round two MC send out a summary report with the revised set of statements to the panel.

Phase 4. Integration

During the Integration phase the aim was to discuss the results of the survey with the stakeholders in an expert’s consensus meeting [10]. Before the experts meeting, each panellist received a report that included all statements and ratings from the two rounds. The meeting was held online, and participants were given the opportunity to discuss both the information generated and the structure of the questionnaire. The meeting provided a final opportunity for experts, patients, and PPI partners to express their viewpoints on the items and the statements. For this Delphi study two iterations and one experts’ meeting (March 2020- Dec 2020) were sufficient to collect the information needed to reach consensus [29]. See the flowchart for the Delphi procedure in Appendix 4. This was then followed by the validation phase of the guideline initiated by PPI partners AK and JRS.

Phase 5. Programming

During Programming, the ongoing phase that was instigated from phase 1, MC was updating continuously all stakeholders with controlled feedback reports and email to sustain engagement [10]. Also, during Programming, MC drafted the manuscript with AK and JRS as co-authors and presented the preliminary data of the study at the European Life After Stroke Forum of the Stroke Alliance for Europe (March 2023).

Data analysis

The statistical measures used for analysis were measures of central tendency (medians and mode) concerning the collective judgments of the respondents [30]. Measures of central tendency were used as they are widely applied in Delphi studies [24, 27]. All statistical analyses were undertaken with the jamovi (version 1.6) statistics computer software [31, 32]. To prevent bias, an independent researcher was employed to statistically analyse the results of the Delphi survey.

During round one, 23/23 (100%) of the panellists responded to the initial questionnaire with items (n = 17) and statements (n = 56) reaching consensus > 80%, 40 statements ‘nearing’ consensus > 70% and 4 statements discarded < 69%. During round two, 20/23 (85%) of the panellists re-voted on the 40 statements that neared consensus from round one with 10 statements meeting the consensus criterion (> 80%). See Appendix 5 for the voting results of each round.

Statements with the highest consensus level

Consensus levels were the highest in relation to the need to document several aspects regarding involving PWA in the research process from the preparation phase to the conceptualization of the topic, and the dissemination of the outcomes. These included establishing collaborations with aphasia organizations and practice-based research networks, preparing research materials and resources using aphasia-friendly formats, and providing training sessions to patient partners on PPI design and processes. Also, co-design methodologies and deciding on a specific topic that is mutually important and interesting to explore, both for researchers and patient partners, were also voted with very high consensus. Panelists further considered as extremely important the creation of ethical and responsible research and the clear acknowledgment of the work delivered by/from patients by referring to them as patient partners when writing the research proposals (avoiding tokenism). See Table 4 for the statements with the highest consensus level.

Table 4

Statements with the highest consensus level from both rounds
		Round one scores		Round two scores
Items	Statement Description How important is it to:	Median	% of total	Median	% of total
Establishing Collaborations	Make contact with local and national aphasia organisations	5.00	95%	5.00	95%
Establishing Collaborations	Establish collaborations with practice-based research networks and community clinicians	5.00	90%	5.00	90%
Recruitment	Develop an aphasia friendly information leaflet in collaboration with PWA	5.00	95%	5.00	95%
Recruitment	Create aphasia friendly invitation letters in collaboration with PWA	5.00	90%	5.00	90%
Gaining Informed Consent	Prepare aphasia friendly consent forms in collaboration with PWA	5.00	90%	5.00	80%
Patient Partner Training	Prepare and present aphasia friendly training sessions about the research design and process	5.00	90%	5.00	95%
Patient Partner Training	Confirm that the training is accessible to the communication needs of PWA	4.00	90%	4.00	95%
Conceptualisation	Generate ideas from conversations and in- depth interviews	5.00	90%	5.00	90%
Conceptualisation	Run focus groups with PWA as facilitators to identify topics	4.00	80%	4.00	90%
Research priorities	Promote patient centeredness and a focus on specific concerns	5.00	90%	5.00	95%
Research priorities	Examine the areas of concern as revealed by PWA	5.00	90%	5.00	85%
Reach Consensus	Identify the topics most important to PWA	5.00	100%	5.00	100%
	Set the research question(s) with PWA in a manner comprehensible to all partners	4.00	95%	4.00	95%
	Ensure that the purpose of the study is understood by all partners	5.00	100%	5.00	100%
Proposal Development	Ensure ethically responsible research	5.00	90%	5.00	90%
Proposal Development	Ensure that PWA are named research partners	5.00	90%	5.00	90%
Outcomes and Implementation	Present case studies of PWA experiences to suggest potential areas of improvements in research methodology	4.00	90%	4.00	90%
Dissemination and Sustainability	Involve national aphasia associations and stroke support groups in the dissemination of the results	5.00	90%	5.00	95%

Experts’ meeting

The experts meeting (n = 12 participants) involved AK and JRS, a patient partner with stroke and no aphasia, three aphasia academic experts, an aphasia researcher, an aphasia rehabilitation clinician, a stroke advocate from the World Stroke Organization, a policy maker from Stroke Alliance for Europe, the author of the EULAR PPI guidelines and MC serving as the facilitator of the meeting (see Table 1). The meeting was held via the Zoom-online conferencing platform, for 90 minutes and gave the participants the opportunity to further discuss the importance of the statements and the structure of the guideline. MC presented the trajectory of the development of the PAOLI guideline with the results from each round. The experts discussed the topics and statements that did not reach consensus, e.g., the fact that no statement from the section ‘Data analysis and Interpretation’ was voted on in any of the two rounds. The group discussed this issue at length and agreed that data analysis should not be included in the PAOLI guideline as it was considered a complex task for PWA. Also, AK and JRS and the patient partner with stroke, expressed their views on PPI and gave feedback on their experience of this procedure. The PPI academic experts and patient advocates shared their views on the challenges of PPI in aphasia and stroke research. The n = 66 statements were confirmed within the experts’ consensus meeting. See the experts’ meeting outcomes in Appendix 6.

Validation of the PAOLI reporting guideline

The final draft of the guideline was examined in collaboration with AK and JRS. Specifically, JRS made edits to some of the statements for clarity with PWA. The draft guideline was then sent to AK who reviewed it, and agreed on the final version. AK proposed the substitution of the word ‘layperson’ with ‘non-professional persons’ in the statements’ description. See Appendix 7 for examples of the edited statements. Table 5 describes the final PAOLI reporting guideline with phases, items, statements, and pictograms. AK and JRS selected the pictograms from the Mulberry symbols (https://mulberrysymbols.org/).

Validity and reliability of the Delphi study

The quality of this Delphi survey was increased by the quick turnaround (4 weeks) between the two rounds [24]. This enabled swift agreement from a diverse group of stakeholders with commitment to the project and excellent response rates (100% for round one and 85% for round two). To avoid directly or indirectly influencing the experts’ judgements, MC maintained the anonymity and confidentiality of the participants by communicating solely with individuals via email. Further, PWA were involved in the cognitive interviews for content validity using the COSMIN guidelines [25], pilot tested the survey and assisted in the design of the aphasia-friendly format of the questionnaire. After completing the Delphi survey, AK and JRS reviewed and validated the final questionnaire.

In this study the authors developed, with international consensus, the PAOLI reporting guideline, with the active involvement of PWA as PPI partners at all stages of the research. The PAOLI reporting guideline aims to encourage and support researchers to include PWA within their research teams from the start of the research process.

Phase 1: Foundation

The Foundation involves items related to the creation of a profound support system, for people with stroke and aphasia, to sustain meaningful involvement within the research team. These items include the onset of collaborations for patient-partner recruitment, the groundwork for the induction of PWA to the project, and the delivery of adapted PPI research training sessions accustomed to the specific communication needs of PWA. The Foundation phase illustrates the importance of establishing functional communication by proposing the use of various communication means and the liaison with communication partners to prompt positive encounters and collaborations with the other members of the research team and to function autonomously and equally.

Phase 2: Development

Under the Development phase, items and statements highlight the importance of the meaningful involvement of PWA and stroke in the conceptualization and the identification of the topics most important and relevant to them, and the mutual recognition of their importance by both patient partners and researchers. The Development phase stresses that the topics that are mutually decided by PWA and the researchers, should be important and relevant to their needs as this will constantly boost their personal motivation and scope to participate and deliver in the project. Also, this phase emphasizes the importance of following co-design and co-production methodologies [33], how PWA (and the public) can be actively involved in the development of the research proposal and that patients are acknowledged as partners in the research team.

Phase 3: Translational

The content of this phase is classified based on the implementation and dissemination of the findings. This includes the creation of case studies for PWA to express their experiences during their involvement in the study and to suggest potential improvements in the participatory project [6]. During the Translational phase the dissemination of the research findings is a key topic by adding the importance of the contribution of national stroke and aphasia associations and support groups [34]. It is recommended that patient partners and researchers inform both scientific and informal networks on how the research findings can be implemented in new services related to stroke and aphasia rehabilitation.

Phase 4: Ongoing Processes

This ongoing phase includes items and statements on the provision of constant support of PWA to self-evaluate their involvement in each stage of the study [35]. This involves providing feedback on their personal experiences within the team [36] along with the monitoring of the co-design procedures. By using the PAOLI reporting guideline researchers will ensure equal opportunities for informed decision-making and guarantee the autonomous commitment of PWA within the research team [4]. The implementation of the Dialogue Model [10] throughout this study promoted this equal partnership between stakeholders and enabled patient partners to have an independent role in decision-making for the development process of the PAOLI guideline.

Specificities of the PAOLI in comparison to the GRIPP2

The PAOLI and the GRIPP2 aim to promote and advance the quality, transparency, and consistency of the international PPI evidence base, and to ensure best PPI practice. Both guidelines followed the EQUATOR method for their development which included evidence from already published reviews that underpinned the need for the development of the two guidelines, for GRIPP2 [37] and the PAOLI [7]; a Delphi survey and an expert consensus meeting to finalize the checklists. Jointly, GRIPP2 and the PAOLI involved PPI partners from the beginning during the conceptualization, recruitment, content selection, consensus meeting participation, validation, and finalization of the guideline.

Nevertheless, the GRIPP2 is structured differently as it aims for researchers to design all-purpose PPI, and retrospectively be used as a quality assurance measure in the documentation of PPI in the research publication. In contrast, the PAOLI, serves as an end-user targeted guideline, aiming to help researchers support the active involvement of patients with communication challenges and acquired language and motor deficits in the research team.

PAOLI endorses the constant support of PWA for self-evaluation. The consortium deems necessary that researchers receive constant feedback from the patient partners to avoid dropouts, inactivity, and tokenism. Additionally, although the GRIPP2 provides key items on PPI data analysis and the economic assessment of PPI; the PAOLI does not include any of these items, as they were considered by the consortium as irrelevant to the aim of this guideline and the needs of the targeted population. Finally, PAOLI directs the guidance of end-users on how to generate research topics that are mutually inclusive of PWA; an area which was previously acknowledged as vague in aphasia qualitative participatory studies [7].

Scope and Illustration of the PAOLI

The PAOLI reporting guideline aims to advance the quality in reporting the level and type of involvement, the impact and comparative effectiveness of patient involvement in qualitative studies on chronic stroke and aphasia. PAOLI encourages patient-centered priorities, aims the equal balance of power within the research team and fosters the creation of ethically responsible research. PAOLI represents the first international evidence-based, consensus informed guidance for reporting PPI in aphasia qualitative research. It encompasses the issues and complexities of involving patients with persistent communication challenges and/or other disabilities within research teams. The PAOLI reporting guideline provides key PPI concepts for stroke and aphasia qualitative research that authors of future papers should report in their manuscripts, to enhance the transparency of the evidence of patient involvement. Stroke and aphasia researchers can use the PAOLI guideline in advance to plan and support patient and other layperson involvement in qualitative studies. The authors propose that researchers use the PAOLI reporting guideline to measure the impact of PPI at different stages in the research process. Also, researchers can use PAOLI to present the PPI aspects included in their study by reporting on the relevant titles of the items at the end of their paper in a table in close collaboration with PWA. Table 5 in the Results section provides an illustration of how the PAOLI could be completed. PAOLI provides practical guidance and actions how to transition from intention to operationalizing meaningful involvement and aims to promote stroke and aphasia advocacy and dissemination via stroke/aphasia networks. It is recommended that qualitative research studies are carried out with or by PWA through their involvement from the beginning and in as many stages as possible.

PPI Evidence during PAOLI development

This Delphi survey for the development of the PAOLI reporting guideline included the consistent and active involvement of two partners with chronic aphasia (AK and JRS) throughout the project timeline. JRS was involved with the recruitment of additional people with aphasia and stroke whereas AK was involved in the preparation of aphasia-friendly invitation letters, the consent forms, and the design of the aphasia friendly format of the questionnaire. Also, AK was involved in collating the evidence and identifying topics and statements for the PAOLI guideline. People with aphasia advised on the comprehensiveness, comprehensibility, and relevance of the included statements during the cognitive interviews. The communication partners (SLT students and family members) assisted PWA with the procedure for informed consent, the technical aspects of completing the cognitive interviews, and with the online Delphi questionnaires for improving the response rate in each Delphi round. AK and JR and a patient partner with stroke, took part in the experts meeting. Also, JRS and AK completed the validation stage of the PAOLI guideline and contributed to the lay section of this paper, during the write-up phase. For this study, the GRIPP2 checklist [6] was followed to report on patient and public involvement (see GRIPP2 checklist in Appendix 8).

A limitation of this study is that PPI partners did not have extensive experience with PPI projects; AK was involved in the thematic analysis [9] and in the Greek adaptation of the Aphasia Impact Questionnaire [38]. Also, the patient partners (panellists) presented with diverse levels of previous exposure to research as they were recruited if they had a university degree and research experience. But this can be reported as advantageous as participants had dissimilar experiences in research engagement before participating in this study. Some had minor experience in research, for example the completion of a bachelor’s thesis, compared to others who had completed doctoral studies, were tenured Academics and had a vast experience in research processes and management. Also, for this study patient partners presented with mild to moderate chronic aphasia and were competent to participate (independently or with minor assistance) using written (Delphi survey) and oral communication (during the semi-structured interviews and the expert’s meeting).

A further limitation was the lack of funding to proceed with a more extensive, and probable face-to-face, international expert’s consensus meeting. Further obstacles throughout the process were initially a difficulty to identify global guidelines for determining consensus, sample size, and sampling techniques for the Delphi survey. In addition, PWA and stroke, found it challenging to keep up with time commitments. MC noted that to send out feedback reports to panelists with communication difficulties required additional skills in written communication for messages to be ‘accessible’ to PWA. Also, the research team experienced some challenges in developing the initial questionnaire to start the process, as there were numerous frameworks, checklists, and published resources to reference.

Phase 6. Implementation

For the completion of the Implementation phase [10] it is recommended that PAOLI is tested in a future PPI stroke and aphasia qualitative study.

Future Recommendations

It is recommended that the PAOLI guideline is also reviewed and approved by an external board or authority [24]. Also, the authors urge stakeholders to disseminate the PAOLI guideline to member meetings, networks, and scientific conferences. The authors aim to create a shorter version of the PAOLI checklist to be used in studies where PPI in aphasia and stroke studies is a secondary focus.

The PAOLI guideline represents the first international evidence-based, consensus informed guidance document for reporting patient and public (meaningful) involvement in stroke and aphasia research. It encompasses the issues and complexities of involving patients with persistent communication impairments, and other difficulties after stroke, within research teams. The PAOLI reporting guideline will improve the quality, transparency, and consistency of the international PPI aphasia evidence base. To facilitate more effective synthesis of PPI teams in qualitative studies, researchers need to set up a robust support system, develop patient-relevant research questions and co-design studies adjusted to the unique needs of people with stroke and aphasia. The PAOLI will contribute to the advancement of understanding, knowledge, and action around meaningful involvement through an evolving evidence base for exploring the impact of PPI on future research involving people with aphasia.

PPI

Patient and Public Involvement

PWA

People with Aphasia

GRIPP

Guidance for Reporting Involvement of Patients and the Public

PAOLI

People with Aphasia and Other Lay People Involvement

Marina Charalambous

Alexia Kountouris

JRS

Jürg Rainer Schwyter

JMA

Jean-Marie Annoni

Maria Kambanaros

EQUATOR

Enhancing the QUAlity and Transparency Of health Research

ASRS

Aphasia Severity Rating Scale

BDAE

Boston Diagnostic Aphasia Examination

SSwoA

Stroke Survivors without aphasia

Acknowledgements

The authors wish to thank all people with chronic stroke and aphasia, their communication partners and all stakeholders who participated in the study for their generosity and patience.

Funding

This work was supported by the A.G. Leventis Foundation Doctorate Full Scholarship Grant, Geneva, Switzerland.

Availability of Data and Material

The data generated during the current study and support the conclusions of this article are publicly available in the Appendix. Any further data queries and requests should be submitted to the corresponding author, Marina Charalambous PhD Researcher, for consideration.

Ethics approval and consent to participate

The PI was supervised by the University of Fribourg in Switzerland, but since the Delphi survey was extended to Cyprus and was completed online, the study received ethics approval for conduct from the Cyprus Bioethics Committee (ΕΕΒΚ/ΕΠ/2017/37).

Competing interests

The authors declare that they have no competing interests.

Consent for Publication

Not applicable.

Authors Contribution

TBA

Authors Details

TBA

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Table 5 is available in the Supplementary Files section.

No competing interests reported.

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The development of the PAOLI (People with Aphasia and Other Layperson Involvement) guideline for reporting Patient and Public Involvement (PPI) in aphasia research

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Journal Publication

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Abstract

Figures

Background

Methods

Phase 1. Exploration

The research team

Phase 2. Consultation

Phase 3. Prioritization

Pilot Draft

Cognitive Interviews and Pilot Test

Delphi study

Participants

Delphi survey

Phase 4. Integration

Phase 5. Programming

Data analysis

Results

Statements with the highest consensus level

Experts’ meeting

Validation of the PAOLI reporting guideline

Validity and reliability of the Delphi study

Discussion

Phase 1: Foundation

Phase 2: Development

Phase 3: Translational

Phase 4: Ongoing Processes

Specificities of the PAOLI in comparison to the GRIPP2

Scope and Illustration of the PAOLI

PPI Evidence during PAOLI development

Limitations

Phase 6. Implementation

Future Recommendations

Conclusion

Abbreviations

Declarations

References

Tables

Additional Declarations

Supplementary Files

Status:

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