0202609100452
The guideline question development step was conducted as a pragmatic parallel group study. Two guideline development groups were convened, one including patient representatives and one involving physicians alone, with participating physicians randomised to group assignment after joint training. Randomisation was stratified by role. Group assignments were typed on identical cards by an AAN staff member and double-enveloped in opaque envelopes labelled with the respective roles, with a second staff member confirming that assignment could not be determined from the envelopes. Each group was tasked with developing the guideline questions using the Population, Intervention, Comparator, Outcome, Time (PICOT) format, identifying relevant benefits and harms, and crafting patient-language versions of the proposed questions. Data were collected at a day-long in-person guideline question retreat at AAN headquarters in Minneapolis, Minnesota, on 15 July 2016. All participants received identical three-page pre-reading and joint in-person training, both of which had been pilot-tested with participants of the University of Florida Citizen Scientist program. Sessions were audio-recorded and professionally transcribed. Patient and public involvement in this initiative used three strategies. Participation: four patient representatives were members of one guideline development group alongside clinicians, comprising one person with mild cognitive impairment, the spouse of that person, the spouse of a person with dementia, and an advocate from the Alzheimer's Association. Consultation by public comment: the guideline protocol was posted for public consultation for 30 days. Consultation by survey: clinicians, patients, caregivers and dementia advocates were surveyed on topics relating to the draft guideline questions, rating topic importance on a nine-point scale. The AAN takes a patient and stakeholder approach to involvement rather than seeking public or consumer representatives. Reported effects of the involvement include the following. The group including patient representatives met for four hours and eleven minutes, compared with two hours and fifty-five minutes for the group of physicians alone, and drafted eight over-arching PICOT questions compared with four. The group of physicians alone omitted to draft plain-language versions of the questions. Both groups identified the same three populations and largely overlapping benefits and harms, but only the group including patient representatives proposed outcomes relating to the development of cognitive impairment at specific time points after the scan and the rate of progression. Patient representatives shaped how discussions were conducted, set a patient-centred scope, described the personal impact of disease, influenced how professional participants viewed involvement, raised issues not raised by participating physicians, helped craft the plain-language question versions, and argued for dissemination of the guideline to primary care physicians rather than to general neurologists alone. The patient, caregivers and advocate accounted for fourteen per cent of the transcript word count, the same proportion as the non-expert guideline committee members in the comparison group. Of the four patient representatives, only the advocate provided email feedback on the guideline protocol before it was posted for public comment.
The peer-reviewed sources located for this report describe the guideline as still in development. The 2018 paper states that feedback to participants had not occurred at that point because guideline development was ongoing, and the 2020 paper describes the guideline as in development by the AAN. No peer-reviewed source located for this report states whether the guideline was subsequently published.STARDIT ID:
0202609100452State ongoing
Start 2016-07-15
Form updated 2026-09-10
Inputs
American Academy of Neurology (AAN) (link)
Task: Guideline developer. Selected the guideline topic from its guideline subcommittee's waiting list of nominated projects, hosted the guideline question development retreat at its headquarters in Minneapolis, provided staff support to each guideline development group, administered the randomisation of physician participants, and posted the guideline protocol for public consultation
Method: Guideline developer applying its own Clinical Practice Guideline Process Manual, using the PICOT format for all guideline questions
Communication: In-person day-long guideline question retreat, guideline subcommittee meetings, email, public comment posting
The AAN takes a patient and stakeholder approach to patient and public involvement rather than seeking public or consumer representatives. The research was conducted in partnership with a guideline developer described by the study authors as already largely compliant with the standards of the United States Institute of Medicine.
Alzheimer's Association, Minnesota-North Dakota chapter (link)
Task: Recruited the patient, caregiver and advocacy participants for the guideline development group
Method: Patient organisation acting as the recruitment route for patient representatives
The study authors record the hope that recruiting patient representatives through the local Alzheimer's Association chapter would promote additional collaborations.
University of Florida College of Medicine (link)
Task: Host institution of the principal investigator | its Institutional Review Board provided ethical approval for the study of the guideline question development process
Method: Academic host institution
Patient representatives on the guideline development group (4) (link)
Task: Members of one of the two guideline development groups. Took part in the day-long guideline question development retreat, contributed to developing PICOT questions and to identifying anticipated benefits and harms of amyloid PET, and helped craft the plain-language versions of the proposed guideline questions
Method: Participation strategy: patient representatives as members of a guideline development group, alongside clinicians, in a parallel group study comparing groups with and without patient representatives
Recruitment: Recruited through the Alzheimer's Association's Minnesota-North Dakota chapter
Communication: Day-long in-person retreat at AAN headquarters, identical three-page pre-reading, joint in-person training, email
Compensation: other(Reimbursed for expenses related to meeting attendance but not otherwise compensated)
Impact: Shaped how discussions were conducted, including introductions that began with personal experiences of cognitive impairment rather than with names and academic affiliations | set a patient-centred scope | described the personal impact of disease | influenced how professional participants viewed patient and public involvement | raised issues not raised by participating physicians, including the importance of receiving a diagnosis, physicians not recognising that something is wrong, poor communication between primary care physicians and neurologists, physician reluctance to give a dementia diagnosis, and the way in which a diagnosis is communicated | contributed to the selection of patient-relevant outcomes, with only this group proposing outcomes on the development of cognitive impairment at one, three, five, ten and fifteen years after the scan and on the rate of progression | helped craft plain-language versions of the guideline questions | and argued that the guideline should be disseminated to primary care physicians and not only to general neurologists
The four patient representatives comprised one person with mild cognitive impairment, the spouse of that person, the spouse of a person with dementia, and an advocate from the Alzheimer's Association. They are not named in the peer-reviewed sources. The patient, caregivers and advocate accounted for fourteen per cent of the transcript word count of their group's discussion, the same proportion as the non-expert guideline committee members in the comparison group. Of the four, only the advocate provided email feedback on the guideline protocol before it was posted for public comment.
Guideline development group participants (19) (link)
Task: Consented to take part in the guideline question development retreat, receive joint training, be randomised to one of two parallel guideline development groups, develop PICOT questions and identify anticipated benefits and harms, and have sessions audio-recorded
Method: Parallel group study with randomised assignment of physician participants, stratified by role, using concealed identical cards in double opaque envelopes
Recruitment: An open invitation was offered at a guideline subcommittee meeting, as per usual AAN practice | facilitators with prior experience of leading guideline development groups were invited to chair the two groups | additional content experts were recruited by their reputation in the field and by recommendations from colleagues or prior AAN interactions
Communication: Day-long in-person retreat at AAN headquarters in Minneapolis, identical three-page pre-reading, joint in-person training
Compensation: other(Reimbursed for expenses related to meeting attendance but not otherwise compensated)
Nineteen individuals consented to participate: two methodologists, two facilitators, two dementia content experts, two dementia imaging content experts, seven members of the guideline subcommittee with and without dementia expertise, and four lay participants. Eight panel members were randomised to each group, each group supported by a methodologist and a staff person, and the published participant table reports nine participants in each group. Two guideline subcommittee members contacted for participation declined, one because they had not volunteered and one because they were too busy, and five content experts declined because of busyness, schedule conflicts or conflicts of interest. No volunteer was turned down for participation. One consenting content expert was unexpectedly unable to travel as planned. All participants reviewed the approved consent document and verbally agreed to participate and to be audio-recorded, under a waiver of documentation of informed consent.
Patient, caregiver and dementia advocate survey respondents (107) (link)
Task: Completed a survey rating the importance of topics relating to the draft amyloid PET guideline questions, on a nine-point scale
Method: Consultation strategy: survey of individuals with cognitive impairment, families of individuals with cognitive impairment and dementia advocates, alongside a parallel survey of clinicians, with the two groups compared using the Mann-Whitney U test
Impact: Rated all survey topics as equal to or more important than clinicians did, with one exception, an item discussing the potential harms of false-positive diagnoses. Differences between patient representatives and clinicians were greatest when comparing the competing values of false-positive and false-negative diagnoses, and the value of testing asymptomatic individuals. The published case study reports that patient survey participants confirmed the priorities voiced by the patient representatives on the guideline development group
Reported in the peer-reviewed source as patient representatives, comprising individuals with cognitive impairment, families of individuals with cognitive impairment, and dementia advocates.
Clinician survey respondents (114) (link)
Task: Completed a survey rating the importance of topics relating to the draft amyloid PET guideline questions, on a nine-point scale
Method: Consultation strategy: survey of clinicians, compared with the parallel survey of patients, caregivers and dementia advocates using the Mann-Whitney U test
Respondents to the public comment on the guideline protocol (link)
Task: Submitted comments on the guideline protocol during the public consultation period
Method: Consultation strategy: the guideline protocol was posted for public consultation for 30 days
Impact: The published case study reports that professionals responded to the public comment more than patient representatives did, and that the final guideline questions included populations and outcomes promoted by the patient representatives despite negative feedback from professional public commenters
The number of public comment responses could not be extracted for this report, because the full text of the source article was not retrievable.
University of Florida Citizen Scientist program participants (link)
Task: Pilot-tested the three-page pre-reading and the in-person training materials used at the guideline question development retreat
Method: Public involvement in pilot-testing of participant materials
Formally acknowledged in the peer-reviewed publication.
Melissa J Armstrong (link)
Task: Principal investigator. Contributed to the study concept and design, acquisition of the data, analysis and interpretation of the data, drafting of the manuscript and critical revision of the manuscript | added blinded speaker codes to the transcripts and confirmed removal of identifying information | independently analysed the retreat discussions using an inductive open coding approach | reviewed existing studies of involvement in guidelines and drafted the conceptual model | and is first author of all three peer-reviewed publications used as sources for this report
Method: Principal investigator, Department of Neurology, University of Florida College of Medicine
Communication: In-person retreat, email
Compensation: paid
Declared interests: In the 2018 publication the authors declare that they have no competing interests. In the 2020 publication it is recorded that Melissa J Armstrong is supported by an Agency for Healthcare Research and Quality K08 career development award (K08HS24159) through which the work was performed, receives research support from a 1Florida Alzheimer's Disease Research Center pilot grant (AG047266), as local principal investigator of a Lewy Body Dementia Association Research Center of Excellence, and from the Michael J Fox Foundation, and receives compensation from the American Academy of Neurology for work as an evidence-based medicine methodology consultant
Listed with the affiliation Department of Neurology, University of Florida College of Medicine, Gainesville, Florida, and in the 2020 publication as an Associate Professor. Published as the correspondence author, at melissa.armstrong@neurology.ufl.edu.
C Daniel Mullins (link)
Task: Contributed to the study concept and design, analysis and interpretation of the data, and critical revision of the manuscript | co-author of all three peer-reviewed publications used as sources for this report
Method: Co-investigator, Pharmaceutical Health Services Research Department, University of Maryland School of Pharmacy
Compensation: paid
Declared interests: In the 2018 publication the authors declare that they have no competing interests. The same publication records that C Daniel Mullins is supported by Agency for Healthcare Research and Quality grant R24HS022135
Gary S Gronseth (link)
Task: Contributed to the study concept and design, acquisition of the data, analysis and interpretation of the data, and critical revision of the manuscript | co-author of all three peer-reviewed publications used as sources for this report, and a co-author of the American Academy of Neurology Clinical Practice Guideline Process Manual
Method: Co-investigator, Department of Neurology, University of Kansas Medical Center
Compensation: paid
Declared interests: In the 2018 publication the authors declare that they have no competing interests
Listed in the 2020 publication as Professor and Chair.
Anna R Gagliardi (link)
Task: Contributed to the analysis and interpretation of the data and critical revision of the manuscript | reviewed and discussed the emerging themes with the principal investigator to achieve consensus and to expand or merge thematic codes
Method: Co-investigator, Toronto General Research Institute, University Health Network, Toronto, Canada
Compensation: paid
Declared interests: In the 2018 publication the authors declare that they have no competing interests
Listed in the 2020 publication as a Senior Scientist.
Gregory S Day (link)
Task: Co-author of the peer-reviewed survey of patient stakeholder and physician preferences regarding amyloid PET testing
Method: Co-investigator on the survey strand of the initiative
Declared interests: Recorded as being involved in research supported by an in-kind gift of radiopharmaceuticals from Avid Radiopharmaceuticals, as participating in clinical trials of antidementia drugs sponsored by Eli Lilly and Biogen, and as holding stocks valued at more than ten thousand US dollars in ANI Pharmaceuticals
Carol Rheaume (link)
Task: Co-author of the peer-reviewed survey of patient stakeholder and physician preferences regarding amyloid PET testing
Method: Co-investigator on the survey strand of the initiative
Slande Alliance (link)
Task: Co-author of the peer-reviewed survey of patient stakeholder and physician preferences regarding amyloid PET testing
Method: Co-investigator on the survey strand of the initiative, University of Florida
(link)
Melissa J Armstrong is supported by an Agency for Healthcare Research and Quality (AHRQ) K08 career development award, grant number K08HS24159, for research on patient engagement in clinical practice guidelines, through which this work was conducted. AHRQ played no role in the study design, the collection, analysis or interpretation of data, or the writing of the manuscript.
(link)
C Daniel Mullins is supported by Agency for Healthcare Research and Quality grant number R24HS022135.
Outputs and impacts
Start: 2016-07-15
Impact: The group including patient representatives drafted eight over-arching PICOT questions and the group of physicians alone drafted four, with multiple populations nested within each. Both groups identified the same three populations and largely overlapping benefits and harms. Only the group including patient representatives proposed outcomes relating to the development of cognitive impairment at one, three, five, ten and fifteen years after the scan, and the rate of progression. The group of physicians alone omitted to draft plain-language versions of the questions.
Published in full as an additional file to the 2018 peer-reviewed article.
The guideline protocol was posted for public consultation for a period of 30 days.
Start: 2018-04-16
Impact: Reports that engaging patient representatives on guideline development groups at the question development step influences the conduct of guideline development, scope, inclusion of patient-relevant topics, outcome selection, and planned approaches to recommendation development, implementation and dissemination, and concludes that patient and public involvement should be considered an essential element of trustworthy guideline development
Published open access under a Creative Commons Attribution 4.0 International License. All data generated or analysed during the study are included in the article and its supplementary files, which comprise the conceptual model, a COREQ checklist, the qualitative coding from the transcripts, and the PICOT questions from both groups.
Impact: Reports that patients and caregivers emphasised the importance of having a dementia diagnosis and placed more value on testing and outcomes for asymptomatic populations than clinicians did, and concludes that this underscores the importance of research investigating the effect of amyloid PET results on asymptomatic individuals and the need for amyloid PET ordering and disclosure standards
Start: 2019-12-29
Impact: Reports that participation strategies shaped discussions, set a patient-centred scope, highlighted personal aspects of disease, affected how professionals viewed involvement, identified issues overlooked by medical professionals, and contributed to selecting patient-relevant guideline populations and outcomes | that professionals responded to the public comment more than patient representatives did | that patient survey participants confirmed the priorities voiced by patient representatives on the guideline development group | and that the final guideline questions included populations and outcomes promoted by patient representatives despite negative feedback from professional public commenters
Published open access under a Creative Commons Attribution License.
Cited in the 2018 article as the pilot study whose results informed the design of the pre-reading and training given to retreat participants.
Impact: Adapts the Patient-Centered Outcomes Research Institute conceptual model of patient-centered outcomes research to guidelines, reframing near-term and intermediate outcomes as organisational and guideline outcomes, and reframing the long-term goal as optimised patient care and health outcomes
Developed from a review of existing studies of patient and public involvement in guidelines and validated against the themes identified in this initiative.
Described as in development in the most recent peer-reviewed source located for this report, published in 2020. No peer-reviewed source located for this report states whether the guideline was subsequently published.
STARDIT report information
0000-0003-0316-3254
Report author. Directed the drafting of this report and used AI to generate it (Claude Opus version 5, September 2026), setting the rule that data be extracted only from peer-reviewed articles. The AI was used to locate the peer-reviewed sources, extract the data from them and draft the wikitext, working under direction and to that rule; every statement in this report is drawn from one of three peer-reviewed articles and no data has been inferred or filled in, so a blank field means the source did not state it. Full text was retrievable for one of the three articles and data from the other two was taken from published abstracts and indexed excerpts only, because the hosting sites block automated retrieval. The author is seeking verification of the report content from the initiative, and the report has not yet been verified.