Patient and public involvement (PPI) is recognized as a key component of clinical practice guideline development with important implications for guideline implementability. The impact of PPI on guidelines, however, has not been rigorously assessed. Better understanding of the impact of PPI must start with guideline question formation, which drives all subsequent development steps. The aim of this study was to investigate the effect of PPI on guideline question formation and validate a conceptual model of patient and public contributions to guidelines. For development of a clinical practice guideline on the topic of using amyloid positron emission tomography in the diagnosis of dementia, we convened two parallel guideline development groups, one with and one without patient representatives. Participating physicians were randomized to group assignment. Each group developed Population, Intervention, Comparator, Outcome, Time (PICOT) questions and identified key benefits and harms to incorporate in guideline development. Analysis included a descriptive comparison of proposed PICOT questions, benefits, and harms between groups and a qualitative analysis of discussion themes from audio recordings of the question development retreats. Proposed guideline questions, benefits, and harms were largely similar between groups, but only the experimental group proposed outcomes relating to development of cognitive impairment at specific time points and rate of progression. The qualitative analysis of the discussions occurring during guideline question development demonstrated key differences in group conduct and validated the proposed conceptual model of patient and public contributions to guidelines. PPI influenced the conduct of guideline development, scope, inclusion of patient-relevant topics, outcome selection, and planned approaches to recommendation development, implementation, and dissemination with implications for both guideline developers and the guideline development process. Evidence of how PPI impacts guideline development underscores the importance of engaging patient stakeholders in guideline development and highlights developer- and guideline-specific outcomes of PPI, both of which have implications for guideline implementation. It also raises the question of whether guidelines developed without such input are acceptable for use. PPI should be considered an essential element of trustworthy guideline development for purposes of development and funding.

Background: Patient engagement in clinical practice guideline (CPG) development is recommended by multiple institutions and instruments measuring guideline quality. Approaches to engaging patients, however, vary between oversight organizations, quality tools and guideline developers.Objective: We propose a ten‐step framework outlining steps and options for patient engagement in guideline development with the goal of highlighting steps for patient engagement and methods by which this can be achieved.Discussion: This framework provides a model for continuous patient engagement in CPGs by outlining ten steps of guideline development occurring at the levels of the developer/committee and the individual guideline project. At the developer level, patients can assist in topic nomination (step 1), topic prioritization (step 2) and guideline development group selection (step 3). Within specific guideline projects, patients’ opinions may be incorporated when framing the question (step 4), creating an analytic framework and research plan (step 5), conducting the systematic review and conclusion formation (step 6), development of recommendations (step 7) and dissemination and implementation (step 8). At the end of process, patients can again be engaged at the developer level by helping determine when guidelines need updating (step 9) and evaluating the developer's approach to patient engagement (step 10).Conclusions: Patient engagement at each CPG development step has different purposes, mechanisms, advantages and disadvantages, and implications for resource utilization. This framework can serve as a resource for guideline developers desiring to increase patient engagement and reference for researchers investigating engagement methodology at different steps of the CPG lifecycle.

Guidelines support health care decision-making and high quality care and outcomes. However, their implementation is sub-optimal. Theory-informed, tailored implementation is associated with guideline use. Few guideline implementation studies published up to 1998 employed theory. This study aimed to describe if and how theory is now used to plan or evaluate guideline implementation among physicians. A scoping review was conducted. MEDLINE, EMBASE, and The Cochrane Library were searched from 2006 to April 2016. English language studies that planned or evaluated guideline implementation targeted to physicians based on explicitly named theory were eligible. Screening and data extraction were done in duplicate. Study characteristics and details about theory use were analyzed. A total of 1244 published reports were identified, 891 were unique, and 716 were excluded based on title and Among 175 full-text articles, 89 planned or evaluated guideline implementation targeted to physicians; 42 (47.2%) were based on theory and included. The number of studies using theory increased yearly and represented a wide array of countries, guideline topics and types of physicians. The Theory of Planned Behavior (38.1%) and the Theoretical Domains Framework (23.8%) were used most frequently. Many studies rationalized choice of theory (83.3%), most often by stating that the theory described implementation or its determinants, but most failed to explicitly link barriers with theoretical constructs. The majority of studies used theory to inform surveys or interviews that identified barriers of guideline use as a preliminary step in implementation planning (76.2%). All studies that evaluated interventions reported positive impact on reported physician or patient outcomes. While the use of theory to design or evaluate interventions appears to be increasing over time, this review found that one half of guideline implementation studies were based on theory and many of those provided scant details about how theory was used. This limits interpretation and replication of those interventions, and seems to result in multifaceted interventions, which may not be feasible outside of scientific investigation. Further research is needed to better understand how to employ theory in guideline implementation planning or evaluation.

Cognitive impairment risk in Parkinson’s disease increases with disease progression and poses a significant burden to the patients, their families and society. There are no disease-modifying therapies or preventative measures for Parkinson’s disease mild cognitive impairment (PD-MCI), or Parkinson’s disease dementia (PDD). This article reviews current and previously investigated treatments and those under investigation, including pharmacologic, non-pharmacologic and surgical procedures. There are currently no effective pharmacologic or non-pharmacologic treatments for PD-MCI. The only recommended treatment for PDD currently is rivastigmine, a cholinesterase inhibitor. Donepezil and galantamine—other cholinesterase inhibitors—are possibly useful. Memantine, a N-methyl-D-aspartate (NMDA) receptor antagonist, is considered investigational in PDD. Drug repurposing (atomoxetine, levodopa, insulin, atomoxetine for PD-MCI; ambroxol and ceftriaxone for PDD) and novel medications (SYN120, GRF6021, NYX-458 for PD-MCI; ANAVEX2-73, LY3154207, ENT-01, DAAOI-P for PDD) currently have insufficient evidence. There is growing research supporting exercise in the treatment of PD-MCI, but most non-pharmacological approaches have insufficient evidence for use in PD-MCI (cognitive rehabilitation, deep brain stimulation, transcranial direct current stimulation, transcranial ultrasound, vestibular nerve stimulation) and PDD (cognitive intervention, deep brain stimulation, transcranial alternating current stimulation, transcranial ultrasound, temporal blood brain barrier disruption). Research is needed for both disease-modifying and symptomatic treatments in PD cognitive impairment.

The 2011 standards for trustworthy development of healthcare guidelines published by the United States-based Institute of Medicine recommend that guideline developers involve patients and public representatives in the development process. The standards recommend that (1) patients and the public be actively involved as members on guideline development panels and (2) guideline developers seek patient and public input during review of the draft guideline. In this study, researchers reviewed the patient and public involvement strategies of guideline developers in the United States by looking at websites and guideline development practices. Of 101 organizations reviewed, only 8% require patient and public involvement on guideline development groups; 15% sometimes require it or describe it as optional. Only 24% of guideline developers always post draft guidelines for public comment. Thirteen percent of guideline developers ask patients or patient organizations to review draft guidelines at least some of the time. Only 20% of guideline developers create patient-targeted guideline products (e.g. patient summaries of guidelines). These low numbers show that there is a substantial gap between standards for patient and public involvement in guideline development and what is actually happening. This is a missed opportunity, as patient and public contributions to guideline development include assessing guideline priorities, introducing new topics, identifying important populations and outcomes, suggesting whether findings are meaningful, prompting holistic approaches to care, assessing how recommendations interact with patient values, and writing plain-language guideline versions. Guideline developers must commit to prioritizing patient and public involvement as one part of trustworthy guideline development. The United States-based Institute of Medicine 2011 standards for trustworthy clinical practice guideline development recommended patient and public involvement in guideline development via participation by patients and public representatives on guideline development groups and via external review and public comment strategies. Guideline developer compliance with these standards has not been assessed. This study aimed to identify the frequency with which United States guideline developers are employing participation, consultation, and communication patient and public involvement strategies. Two reviewers independently extracted current patient and public involvement strategies of independent guideline developers, either (1) an organizational member of the Guidelines-International-Network North America and/or (2) having ≥2 guidelines in the National Guideline Clearinghouse between March 2011 and November 2015. Publicly available information was extracted from guideline developers’ websites, methodology manuals, and guidelines between November 2015 and December 2016. Disagreements were resolved by discussion. Of 101 organizations meeting inclusion criteria, only 8% require patient/public involvement on guideline development groups; 15% sometimes require it or describe it as optional. Only 24% always utilize public comment on draft guidelines; 13% engage patients/public in external review at least some of the time. Twenty percent of developers create patient-targeted guideline products. There remains a substantial gap between patient/public involvement standards for guideline development and practice in the United States, even 5 years after publication of Institute of Medicine standards. This is a missed opportunity, as patient and public contributions to guideline development include assessing guideline priorities, introducing new topics, identifying key populations and outcomes, informing whether findings are meaningful, prompting holistic approaches to care, assessing how recommendations interact with patient values, and writing plain-language guideline versions. Guideline developers must commit to prioritizing patient and public involvement as one element of trustworthy guideline development.