Study design
A mixed-methods study will be undertaken, with three distinct phases to collate both qualitative and quantitative data. These will include an integrative narrative review, focus groups with therapists, patients and key stakeholders (completed between November 2024 and January 2025) and a multicentre (at five health boards in Wales between October 2025 and March 2026) pilot study of the CAT (including questionnaires and elicitation interviews) in which acceptability to therapists will be tested. The six-step model guidance for developing CATs has been used to develop this protocol.6
Participants
Adults with lived experience of being patients with blunt chest trauma, and all allied health professional therapists and clinical stakeholders who are involved in the direct care of these patients from prehospital care to long-term follow-up (defined as care received before arriving at hospital, during any hospital attendance and following hospital discharge). This will include therapists working in various care provision teams in the community or hospital setting and from different geographical locations within Wales, reflecting the diversity and underserved groups in society. Using the INCLUDE Framework as a guide,10 representation and inclusivity will be ensured, in terms of gender, disability, race, religion, social status, neurodiversity and sexuality.
Inclusion criteria
-
Currently employed as a therapist (allied health professional) working with patients with blunt chest trauma, working in either primary, secondary or tertiary care setting.
-
Stakeholders: clinical professionals who are responsible for the care of patients after chest wall injuries; these may include (but not limited to) trauma surgeons, trauma/emergency care/critical care physicians, geriatricians, advanced clinical practitioners, pharmacists, registered nurses, paramedics and general practitioners.
-
A member of the public who has been a patient with blunt chest trauma requiring hospital care in the last 3 years (regardless of whether admission to hospital was required or not).
Exclusion criteria
-
Healthcare professionals not involved with the care of patients with blunt chest trauma.
-
Therapy students (not yet qualified).
-
Patients lacking sufficient capacity to participate in the focus group (without support of a family member/carer).
Setting and recruitment
Phase I
Not applicable as this phase will involve completing an integrative review.
Phase II
Participants (therapists, public research partners and key stakeholders).
CB is currently completing a coproduction project, in which a large and diverse group of public research partners (adults with lived experience of being patients with blunt chest trauma) are engaged. This group will be approached to consider participating in the phase II focus groups. Additional patients will be approached and asked to consider participating in the focus groups while under the care of the physiotherapy chest trauma team conducting this study. They will be provided with a Participant Information Sheet at the point of recruitment, with consent to participate in the focus group taken at the focus group meeting, either verbally if online (and signed by the researcher facilitating the meeting) or in writing if the meeting is face to face. Phase II also involves recruiting therapists and key stakeholders. Adverts and clinician participant information sheets will be sent to the therapy teams managing the patients with blunt chest trauma in five Welsh participating health boards. Consent will be sought and obtained verbally and recorded at the start of each focus group meeting.
Phase III
Participants (therapists piloting the CAT).
Participants will be recruited by local principal investigators (PIs) at each of the five participating health boards. A Clinician Participant Information Sheet will be provided and the study discussed with the site’s PI. Written consent to complete the CAT and feedback survey will be obtained by the PI from the therapist participants. At the point of completion of the tool and feedback survey, a small sample of therapists from each hospital will be invited by the PI to participate in an online elicitation interview (approximately 1 hour) and provided with a clinician information sheet outlining study processes for the interview. Consent will be sought and obtained verbally and recorded at the start of each interview.
Sample size
Phase I
Not applicable as this phase will involve completing an integrative review.
Phase II
Based on methodological guidance, it is proposed that the total sample size will be between 40 and 50 participants for the focus groups. In relation to competency development, there is no defined ‘gold standard’ for sample size; therefore, the proposed sample was based on previous competency development studies.5 7 For the final tool development work, a panel of 10 international experts will be identified, with a subgroup of 3–5 experts who will be recruited to confirm content validity.11
Phase III
We will pilot the tool at five health boards in Wales, aiming for 10 therapists from each. This will give an overall sample size of 50 therapists. Methodological guidance recommends that as the pilot study is not conducted for the purpose of inference, a power calculation is not needed.12 13 The sample size does, however, need to be justified on the basis of the goal of the pilot study which, in this instance, is to test that the competencies included in the tool are expressed in a manner that is easily understood, recognisable and demonstrable in professional practice.14 The survey responses completed by the sample will allow us to evaluate clinician perceptions of the tool itself, while taking into account our predetermined sampling framework, aiming for a diverse sample from across Wales. Elicitation interviews will be undertaken with a smaller sample size of between 15 and 20 therapists.
Interventions
Phase I
A search strategy will be developed for the integrative review, to identify all relevant sources, using a narrative synthesis of findings to enable a more comprehensive understanding of what is a complex and unclear phenomenon.15 The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines will be followed.16 A comprehensive search strategy will be employed for Embase (Ovid), MEDLINE (Ovid), AMED (Ovid), CINAHL Plus with Full Text (EBSCO), Cochrane Central Register of Controlled Trials (Wiley) and PEDro (Physiotherapy Evidence Database) from inception to July 2024. The search strategy will include a combination of relevant index terms and keywords, with consideration of lay terms. The concepts for our search will include word variants for blunt chest trauma, combined with relevant terms for therapy using Boolean operators. Forward and backward citation searches will be conducted on relevant references to supplement the electronic search. Relevant Therapy and Trauma Journals will be hand-searched from inception to September 2024 for relevant studies. All available Therapy Trauma Conference abstracts will be searched, in addition to TRIP Pro (Turning Research into Practice) to identify relevant grey literature. No geographical filters, language or date limitations will be used in the search. Authors will be contacted if further information is required.
Phase II
Focus group meetings will be undertaken in which the participants will be asked to consider the key aspects of patient care, including knowledge and skills they feel are relevant to managing the patients with blunt chest trauma. Patients will be asked to consider the important aspects of their own blunt chest trauma experience and therapy received (if any).
The development of the tool will then be undertaken using a nominal group technique, following the guidance outlined in Harb et al.17 In the first instance, the research team will collate a list of domains and items, based on evidence gained in the review and focus groups. A panel of 10 international experts will meet via MS Teams to discuss and vote on the proposed domains and items. The experts will eliminate items that are agreed not to be important, thus generating the shortlist of domains/items for the final tool. Content validity of the final tool will be confirmed using a subgroup of experts who, in a second MS Teams meeting, will review and rate for relevancy, readability and clarity. We will use a method described by Polit et al, in which item-level content validity indexes will be translated into values of a modified kappa statistic.11
Phase III
The tool will then be piloted at five health boards in Wales, where questionnaires will be distributed to a diverse convenience sample of therapists working in (1) prehospital care teams (such as those based in GP (General Practitioners) practices or paramedic teams), (2) hospital settings (such as emergency care, frailty and ortho-geriatric services, respiratory and cardiothoracic specialists) and (3) community setting (such as rehabilitation teams, outreach or follow-up services). Elicitation interviews will also be conducted. Figure 1 illustrates the study phases.
Data management
Quantitative data will be managed using Research Electronic Data Capture (REDCap) electronic data capture tools hosted at Swansea University.18 REDCap is a secure, web-based software platform designed to support data capture for research studies, providing (1) an intuitive interface for validated data capture, (2) audit trails for tracking data manipulation and export procedures, (3) automated export procedures for seamless data downloads to common statistical packages and (4) procedures for data integration and interoperability with external sources. A database specification and data management plan will be agreed before recruitment and data collection commence.
Qualitative data will be managed using NVivo V.12 (computer-assisted qualitative data analysis software).19 Focus groups will be recorded with audio equipment if face to face or through MS Teams and transcribed in real time using the auto-transcribing function. This will be checked for accuracy by two researchers, with the patient focus groups also being checked by a public research partner. Data from these focus groups will be anonymised prior to data analysis. Transcribed focus group data will be uploaded to NVivo V.12 in preparation for analysis. Public research partners will work with the qualitative research experts in the team by assisting with running the focus groups and commenting on code books and summaries as they are produced
Outcome measures
Phases I and II of this study will identify a template of key themes (rather than ‘outcomes’), which will form the basis of the CAT. The intervention development phase will be based on the Medical Research Council framework.20 In phase III, the tool will be piloted on therapists working with patients with blunt chest trauma. Therapists will be asked to complete the CAT according to their current perceived level of competence, then complete a predesigned and piloted questionnaire regarding their perceptions of the usefulness of the CAT. Elicitation interviews will also be conducted which will explore the participants’ attitudes towards the tool, appropriateness, suitability, convenience and perceived effectiveness of the CAT.
Data analysis
Phase I
As we are proposing an integrative review methodology, a narrative synthesis and presentation of results will be used. We will follow the principles laid out in published guidance. In the first stage of analysis, extracted data from all identified sources are compared item by item, resulting in similar data being categorised and grouped together. Following this stage, these coded categories are further compared as part of the analysis and synthesis process. The overall method consists of data reduction, data display, data comparison, conclusion drawing and verification.11
Phase II
Qualitative data analysis will be undertaken by both the qualitative experts and public research partners in the team using Braun and Clarke’s process of reflexive thematic coding.5 6 This method of analysis primarily identifies, examines and records data patterns from multiple similar data sets. These patterns are key in the description of the participants’ experiences, ideas and opinions. Themes are identified by combining these data from individual interviews to build a comprehensive image of the collective experiences of the participants.21 22 The analysis plan will broadly follow previously completed qualitative work on chest wall injury.23 Transcribed interviews will be uploaded on the data management system NVivo V.12 (QSR International Ltd), and initial data coding will be undertaken by two researchers.
Analysis will follow the following six-step process: (1) familiarisation with the data, (2) generating initial codes, (3) searching for themes, (4) reviewing themes, (5) defining and naming themes and (6) producing the report.21 Consensus on codes and themes will be achieved through an integrated process of discussion between members of the research team. Trustworthiness and rigour are key to effective analysis using these methods. To ensure these values are maintained, a trustworthiness criterion will be applied throughout the research process.24 As the concept of data saturation is not recognised within reflexive thematic analysis, the evaluation of data saturation will not be undertaken, rather data collection and analysis will be pragmatically driven.14 25
Phase III
Quantitative analysis of the questionnaire Likert response data will be completed using McNemar’s test. Qualitative analysis of elicitation interviews will be completed as in phase III above, and again the public research partners will assist the qualitative experts with this process. The elicitation interviews will be used to capture the therapists’ narrative accounts of their engagement with the checklist. The interviews will be structured around the domains/fields of the checklist, and the therapists will be asked to describe their own subjective interactions with the checklist in order to understand the meaning they attach to the process of completing it. The resulting data will then be analysed according to the principles of interpretative phenomenological analysis (IPA), which examines how a given person, in a given context, makes sense of a given situation.
IPA is rooted in phenomenology and is based on a commitment to examining the detailed experience of each case, in turn, before making more general claims. It is particularly useful for looking at complex issues where the researcher and the participant are trying to make sense of their experience. The process involves multiple readings of the transcripts to create a descriptive account of the experience through the eyes of the participant. At each stage, themes are examined to highlight convergences and divergences to illuminate the breadth and depth of each. The next step is interpretation and the use of existing theories such as self-efficacy as determinants of behaviour and social cognitive theory that emphasises the influence of the social environment (including role modelling, re-enforcement and expectation) on behaviour. The researchers maintain a systematic and reflexive approach to the recognition of themes to ensure they can be traced back to the expressions of the research participants. A summary of themes and subthemes will be reviewed by a non-participant therapist to confirm the analysis.26 Quantitative and qualitative data will be integrated following a triangulation design and convergence model.27
Patient and public involvement
Two public research partners have been involved from the outset in this phase of work. They have advised us on aspects of the study design, including the inclusion of patients in phase II of the work, the choice of elicitation interview in phase III and the diverse sampling framework throughout the study. Both representatives will be members of the study management group for the duration of the study. Experienced patient representatives will be involved in the data analysis process through the study and will be co-authoring outcomes to ensure that these remain inclusive and patient centred.
