Patient and public involvement
The importance of the involvement of patients or people with lived experience (within the problem area domain) is increasingly regarded as important in healthcare,30 mental health31 and emergency care32 research. Therefore, three persons with lived experience (PWLE)10 were involved in the development of this study protocol. Full details of PWLE involvement in this protocol are reported in table 1 in accordance with the Guidance for Reporting Involvement of Patients and the Public (2nd version) – Short Form (GRIPP2-SF) checklist.33 For the Delphi study, the consensus procedure will not start until at least four PWLEs (preferably coming from more than one country) are part of the expert group, and have commented on the literature review results and proposed set of statements for Delphi round 1.
Patient and public involvement (PPI) in this Delphi study protocol, informed by GRIPP2-SF reporting guidelines33
Design
The Delphi method will be used to guide this study. The Delphi method uses the collective opinion of heterogeneous ‘experts’ to seek consensus on a certain subject.34 A steering group (comprised ambulance/ED nurses, physicians, PWLE, academics) will guide the undertaking of the Delphi study. The steering group (chaired by WHWH) will meet regularly (every 2 months) via MS TEAMS, to provide input and feedback on the process, including participation in the rapid literature review, pilot testing the Delphi survey (for face and content validity), support advertisement for panel recruitment, advise of question refinement and participate in dissemination of study findings.
While several guidelines and reviews exist to inform the undertaking and/or reporting of Delphi studies,34–36 we will use the approach from Nasa et al34 which comprises nine points embedded within four steps: (1) problem area, (2) panel members, (3) Delphi rounds and (4) closing criteria (see table 2).
Steps and points for Delphi studies34 how applied to our study, with anticipated time frames
Step 1: problem area
A rapid literature review will be undertaken to identify and summarise the available literature regarding definitions, causes, behaviours of ambulance/ED presentation for people presenting with mental/emotional/somatic complaints. The review will be used to provide a working definition of the concept ‘mental dysregulation’, and inform initial statements used for the Delphi. Rapid literature reviews still comprise a clear research question, search protocol, process of study selection and data extraction, however, the simplified procedures can enable the review to be completed in a shorter timeframe than a systematic literature review.37 The questions informing the rapid review are: (1) what are the concepts used in scientific peer reviewed literature for people presenting to ambulance/ED with mental/emotional/behavioural problems?; (2) what are the causes of these problems?; (3) how are these concepts and causes defined? and (4) what instruments are used to screen/diagnose problems and causes?
In our rapid review, an iterative approach will be applied where the databases of Medline, CINAHL and PsycINFO will be searched using keywords and their combination relating to the population (eg, people presenting to the ED with: mental health problems; mental illness; mental health disorder; psychiatric disorder; substance use disorder; borderline personality disorder; suicide attempt; self-injury); context (eg, ED, emergency room, A&E, accident and emergency, ambulance) and concept (eg, psychological distress; mental distress; anxiety; pain; delirium; disruptive behaviour; problematic behaviour; aggression; violence; emotional dysregulation). A librarian will be involved to assist in creating the search strategy and performing the search. Articles published in English between January 2013 and September 2023 will be included. Titles and abstracts of retrieved articles will be screened for eligibility by one reviewer, while two reviewers will screen potentially relevant full-text articles. Disagreements will be resolved by a third reviewer. Prior to screening, a pilot of 30–50 abstracts and 5–10 full texts will be undertaken by the reviewers to test the review form and calibrate.38 Articles will be excluded if they are abstract, theses, not focused on ambulance or ED, or not focused on the review question. A Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) diagram39 will be used to display the results of the search. Data will be extracted from included articles by one reviewer, checked by another and will include: country, setting, concepts used for mental/emotional/behavioural problems in patients presenting to ambulance/ED, causes of these problems, definitions used to describe these concepts, instruments used to screen/diagnose problems and causes. No quality assessment of included articles will be undertaken because the purpose of the review is the scope of the available evidence, rather than evaluate specific effects of an intervention.40 Moreover, it is not anticipated to include every concept, every definition, every used instrument that is mentioned in the search results. A narrative knowledge synthesis will be used to report the results of included studies and discuss reasons for differences among studies.40 Results from the review will be communicated among participating panel members, submitted to be published in a journal and presented at various forums.
The review will be used to generate statements for round 1 of the Delphi questionnaire regarding: (1) the definition of the concept, (2) possible causes of mental dysregulation and (3) observable behaviours associated with mental dysregulation. Members of the steering group will be invited to pilot test the Delphi questionnaire. Specifically, from the statements generated, they will be asked to comment on face and content validity and score each item on a 7-point scale the relevance of each item with items scoring at the mean or higher included, an approach used elsewhere.41
Step 2: panel members
Our Delphi panel members will comprise a heterogeneous group of ‘experts’ to garner a broad perspective and generalisation of consensus.34 While ‘experts’ can be variably defined in Delphi studies,35 our experts will comprise: (1) PWLEs, (2) ambulance and ED healthcare professionals (HCPs) and (3) emergency care academics; from varying international acute healthcare contexts (ambulance/ED). Criteria for PWLE include: aged ≥18 years, be able to provide informed consent to participate and have received care from ambulance and or ED HCP for a within the past 5 years for a mental/emotional/somatic complaint. Criteria for ambulance and ED HCPs include: aged ≥18 years, hold a professional registration and provide direct patient care or are a manager within ambulance or ED service and have at least 2 years of experience within ambulance/ED care area. Criteria for emergency care academics include: aged ≥18 years, hold at least a master’s degree and have led/been an investigator on a study undertaken within the past 2 years in the field of mental dysregulation in the ambulance or ED setting. Panel members who are both HCP and academic will be asked to participate as an academic. All panel members must be fluent in reading, understanding and writing in English.
There is no set size for Delphi expert panels, however, 39 is average in emergency nursing Delphi studies35 and 10–100 is typical in healthcare research.34 Given the diverse groups of experts in our Delphi study, as suggested elsewhere,41 42 we aim to have 10–18 panel members from each of the three subgroups identified (PWLEs/HCPs/academics) and thus a minimum of 30 participants overall. It has been reported that the more participants, the higher reliability of the consensus.41 43 We will strive for equal representation across the groups of panel members, which consequently guides the number of panel members. Therefore, we aim to include 3–5 panel members per group, per country.
Potential panel members will be recruited via the following routes: personal networks of the steering group; purposive personalised approach using publicly available email address of academics who have published at least one paper in the area of interest; via steering group members LinkedIn/X (formerly known as Twitter) profile; steering group member affiliate newsletter(s); national colleges or international associations of relevant HCPs (ie, ambulance/paramedics/ED physicians/ED nurses) and consumer organisations. (Inter)National organisations and associations will be asked to recruit a heterogeneous representation of their membership. A study advertisement poster or email will provide a brief description of the Delphi study and if interested the potential participant can connect to a link to read the study information sheet and then, if agreeing, progress to complete the questionnaire. Completing the questionnaire will indicate implied consent (as will be advised in the study information sheet). Other detail in the study information sheet will include the aim and scope of the study, the methods used for this study, data storage and security, and participants rights. Participation is voluntary and participants can withdraw from the study at any time. The questionnaire will be distributed and stored using Crowdtech,44 a secure platform for managing online surveys for which the University of Applied Sciences, Utrecht, the Netherlands has a formal agreement. An individual participant number will be generated for each panel member to enable individual results to be provided in subsequent rounds.
Step 3: Delphi rounds
Participation in the three Delphi rounds will be anonymous, to minimise dominance and group conformity.34 Three Delphi rounds are typical in emergency nursing studies.35 Expert panel members will be asked to score their agreement of each statement using a 7-point Likert scale, where 1=strongly disagree and 7=strongly agree. Participants will also be asked if they agree with the wording of the items (yes/no/do not know); and to add suggestions for improving the wording of each statement, if required. For each round, participants will be asked to respond within 2 weeks. A reminder will be sent to non-responders after 1 week.
At the end of each round, data will be analysed using descriptive statistics (frequency, percentages, median/mean, SD/IQR) and improvements/wording changes summarised. These results will be discussed among the steering group, the Delphi questionnaire revised accordingly, and then the results (along with the revised Delphi questionnaire) will be presented in aggregate form back to expert panel members in an easy-to-understand format.34 The purpose of this controlled feedback is to give insight to the individual member about their response, the trend overall and for their subgroup (PWLE/HCP/academic). If applicable, a summary of comments and suggestions may be provided.
Step 4: closing criteria
While various meanings of consensus exist,34 and agreement level between 70% and 80% is widely embraced and acknowledged as thorough45 in our study, consensus on the term, definition, description, causes and observable behaviours of ‘mental dysregulation’ will be considered to have been reached after three rounds (or before) when >75% agreement (ie, rating statements as either ‘fully agree’ or ‘agree’) is reached. The higher the score, the better the consensus among the group for the item. If consensus is reached on items they will not be dropped for the subsequent round. If >50% of panel members rate a statement with 1 (strongly disagree) or 2 (disagree), without providing sufficient suggestions for adjustment of the statement, the statement will be dropped.
We will make an effort to assess the stability/consistency of responses between successive rounds (if more than two rounds occur), as recommended by Nasa et al.34 SPSS V. 29.0 will be used to assess stability using SD test. As guided by a previous Delphi study,46 if SD≤1 for an item, this will indicate consensus.
Data storage and security
Our data management plan considers three types of data: informed consent data, personal data and research data. These data will be collected and stored within the Crowdtech server as part of the Delphi process. The informed consent data (ie, approval on participation/being informed on the results of the study; willing to participate in additional research related to the topic of interest; approval on use of the email address), and a key document which lists and links the participants email address and study number, will be extracted from Crowdtech, and stored in a separate secure digital data safe. The personal data (ie, panel members answers to characteristics questions, country, PWLE status/function, years of expertise) and research data (ie, responses to the statements and, if applicable, suggestions for improvement/adjustment of the statements) will be extracted from Crowdtech and stored in Research Drive. Both the digital data safe and the Research Drive are provided via the University of Applied Sciences, Utrecht, the Netherlands. The provision of the study information letter, informed consent procedure and data storage complies with European Privacy and Good Clinical Practice in research guidelines.47 Data will be retained for 10 years from study completion and then destroyed.
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