Knowledge translation and exercise for degenerative meniscal pathology and early osteoarthritis  (KNEE-DEeP): Protocol for a single arm feasibility study

Aims

The aim of this study is to test the feasibility of the KNEE-DEeP intervention, a complex health intervention targeted at both HCPs and patients, and designed to promote greater uptake of evidence based care for DMT and early OA.

Specifically, the objectives are to:

Study design

The KNEE-DEeP study is a non-randomised feasibility study that includes an embedded mixed methods process evaluation. The KNEE-DEeP knowledge translation intervention will be targeted at recruited GPs ad physiotherapists, who in turn will deliver the patient intervention to people recruited with knee pain. Quantitative and qualitative data will be collected from GPs, physiotherapists and patients as part of the process evaluation. Assessments will be performed at baseline, 12 weeks (primary endpoint) and 6 months. Recruitment is anticipated to last 6 months, with each patient participant taking part in the study for 6 months and the last follow-up due 12 months after the start of recruitment.

This study will be conducted and reported in line with the Standard Protocol Items for Intervention Trials (SPIRIT) guidelines and the Consolidated Standards of Reporting Trials^53,54. Completed checklists are included in the extended data (File A and B, https://osf.io/fwy36/). The study is registered with ClinicalTrials.gov (Identifier: NCT06576557). Further evaluation work may be necessary to test the feasibility of key study design and processes for a future full-scale effectiveness trial. Figure 1 illustrates the flow of participants through the study and Table 1 outlines the schedule of enrolment, intervention and assessments.

Figure 1. Study Flow Diagram.

This study is located within the feasibility and piloting stage of the MRC’s framework that provides guidance on the design and development of complex interventions³⁵. A single arm feasibility study was chosen rather than a comparative design because the main focus was to resolve uncertainties about the acceptability and feasibility of the intervention itself, and its mode of delivery. A non-randomised design provided an opportunity to test the intervention with a greater number of HCP and patient participants. According to the MRC’s guidance on the development and evaluation of complex healthcare interventions, a feasibility study need not be a scale model of a future planned evaluation but instead is an opportunity to examine the key uncertainties that have been identified during development^35,55.

Setting

This multi-site study is set in general practices in Kerry and North Cork and in the Physiotherapy Department of University Hospital Kerry (UHK), a publicly funded hospital also in the South-West of Ireland.

Public and Patient Involvement

A patient and public involvement (PPI) group was established and have been involved in all aspects of the intervention design phase and planning for this feasibility study. This group comprises of six people who had previously engaged with both primary and secondary care health services for treatment of knee pain attributed to early degenerative changes or knee OA. Two members have previously undergone arthroscopic knee surgery for DMT. This PPI group have met four times and their perspective was integrated into the intervention and study design process. They will continue to be consulted over the course of the feasibility study.

Ethics and informed consent

Ethical approval for this study was granted by Clinical Research Ethics Committee of the Cork Teaching Hospitals on the 5^th December 2023 (Reference Number: ECM 4 (h) 24/10/2023 & ECM 3 (d) 05/12/2023). This committee has remit to provide approval for studies conducted within the HSE Community Health Organisation for Cork/Kerry. This study involves human participants and will adhere to the Declaration of Helsinki⁵⁶. Prior to study recruitment all participants will provide written informed consent, in line with the Data Protection Act 2018⁵⁷. Eligible participants will be invited to ask questions about the study and a time period of several days will elapse between receiving information about the study and making their final decision about whether to participate.

Recruitment and participants

General practitioners. Fifteen GPs will be recruited by contacting local general medical practices known to the research team with study information. Networks such as the Health Research Board (HRB) Primary Care Clinical Trials Network Ireland will also be used to circulate information about the study to practices. Eligible GPs will be practicing in Kerry or North Cork and within traveling distance (< 50 km) of the hospital providing the physiotherapy intervention. It is estimated there are approximately 30 eligible practices. Practices where two or more GPs are willing to participate will be preferentially recruited and recruitment will aim for a geographical spread. At least 15 interested GPs will be recruited. The principal investigator (PI) (HOL) will answer any questions by telephone or on a subsequent practice visit, prior to obtaining consent from each GP (Extended data, File C, https://osf.io/fwy36/)⁵⁸ individually and enrolling them in the study.

Physiotherapists. Five physiotherapists will be recruited from the Physiotherapy Outpatient Department of a local publicly funded hospital (UHK) where participating patients will receive their physiotherapy intervention. Given the small size of the study, for pragmatic reasons in order to train sufficient physiotherapy staff, we opted to have all patients receive their intervention in one central and accessible location. The physiotherapy manager will facilitate recruitment of physiotherapists (n=5) by providing study information to all eligible physiotherapists in UHK (n=8). Eligible physiotherapists will be involved in the delivery of outpatient musculoskeletal physiotherapy services and available to participate in training to deliver the ‘best practice’ physiotherapy intervention. Having considered the study information, interested physiotherapists will make contact with the PI, who will answer any questions pertaining to the study, prior to them signing a consent form (Extended Data, File D, https://osf.io/fwy36/)⁵⁸ and enrolling in the study.

Patients with knee pain. Study information will be displayed in the patient waiting areas of the participating general practices. During their consultation, participating GPs will inform eligible patients about the study and provide them with written study information (Extended Data, File E, https://osf.io/fwy36/)⁵⁸. Patients will also receive verbal and written educational information on their knee pain prior to enrolling in the study, representing an enhanced version of usual care. As part of usual care for people attending their GP with knee pain, patients are routinely assessed and educated about their condition³⁰, therefore this intervention does not represent any risk or burden to patients who ultimately do not enrol in the study and decline to participate in data collection. GPs will also explain that study participation involves attending a ‘best practice’ session of physiotherapy in UHK and this not affect the patient’s access to a routine physiotherapy appointment (typically 6 to 12 months wait for a public appointment), should patients also wish to avail of this. Having discussed the study, GPs will seek written consent from interested patients to forward their contact details to the research team. The PI will contact prospective participants by telephone to answer any questions, confirm their eligibility and that they have read the written study information. Consenting patients will be enrolled in the study, following receipt of a signed consent form either written or electronically. An emailed link to the baseline questionnaires will follow. Participants will also indicate if they are amenable to being contacted for a post-intervention qualitative interview. They will sign a subsequent consent form before this interview is conducted.

If a potential participant ultimately declines to participate, having discussed the study with the researcher, they will still have the opportunity to avail of the ‘best practice’ physiotherapy intervention, but no study data will be collected.

Patients will be eligible for this study if they are:

Criteria for exclusion are: (i) fulfilling the European League Against Rheumatism (EULAR) clinical classification criteria (Proposition No. 5) for knee OA, which reflect more established OA disease⁴⁹, (ii) moderate or advanced knee OA on x-ray (or Kellgren-Lawrence x-ray score ≥ Grade 3), (iii) recent trauma likely to be associated with considerable tissue damage, (iv) having an acutely swollen or locked knee, or suspicion of ligament injury on physical exam, (v) inflammatory arthritis, (vi) surgery or significant trauma of the index knee within the previous 2 years, (vii) pregnancy, (viii) unable to communicate in English (ix) preference for accessing physiotherapy treatment privately prior to the ‘best practice’ session or do not want to avail of the ‘best practice’ physiotherapy session.

There is a clear association between knee OA and DMTs, and meniscal pathology usually exists in the context of other OA changes^5,59,62. The EULAR clinical classification criteria will be used by GPs to rule out later stage or more advanced OA during their clinical assessment⁴⁹. These criteria state that patients aged 40 years or older with movement-related joint pain, knee morning stiffness < 30 minutes, and functional limitations have knee OA, if they also have, on examination, one or more of the following: crepitus, restricted range of motion, and bony enlargement. Should there be uncertainty on clinical exam, a GP-ordered knee x-ray will be necessary for inclusion, to exclude those with moderate or severe osteoarthritis (Kellgren-Lawrence score ≥ Grade 3). Assessment procedures will be a specific component of the training workshop for participating GPs. Patients will have their diagnosis of a DMT or early OA confirmed by the participating physiotherapists, who have expertise in musculoskeletal assessment. They will use a checklist to check and rule out any features of moderate or advanced OA. This research will promote appropriate use of advanced imaging; therefore an MRI will not be required to confirm the diagnosis of a DMT or early OA²⁷.

Sample size and recruitment targets. As this is a feasibility study and the primary aim is not to evaluate clinical effectiveness, a formal sample size calculation has not been carried out^54,63. The purpose of the study is to investigate the feasibility and acceptability of the intervention and examine study procedures around recruitment and retention with a view to refining these, if necessary, for a future definitive trial. The feasibility of the intervention will be explored by recruiting 36 eligible patients, 15 GPs and five physiotherapists.

Based on consultations with local GPs, on average, two new patients present per month with a DMT or early OA, permitting a target of one patient recruited per GP per month. Twelve GPs should recruit 36 patients over 4 months. Allowing for some GPs who will not recruit any patients we set a recruitment target of 15 GPs. General practices are likely to be enrolled on a staggered basis; therefore the patient recruitment phase will be of approximately six months duration.

Intervention for health care professional and patient participants

The KNEE-DEeP intervention (Figure 2) is a complex intervention designed to improve the uptake of evidence-based care for early OA and DMTs, by targeting the behaviours of both HCPs and their patients⁴⁸. Evidence based care is informed by clinical practice guidelines and focuses on patient education, exercise and promoting self-management^11,15,26. The KNEE-DEeP intervention will aim to ensure patients receive evidence based management and consistent information at an early point in their care from both the GP and physiotherapist, thereby reducing unnecessary referral to secondary care and inappropriate imaging. GPs and physiotherapists will receive specific training to deliver the patient intervention and enhance their skills and confidence in managing patients with this type of knee pain. Content and design of the HCPs training session will draw on evidence from a range of chronic musculoskeletal conditions^64–69. The content of the intervention aligning to the Template for Intervention Description and Replication (TIDieR) guidelines is summarised in Table 2⁷⁰.

Figure 2. KNEE-DEeP Intervention.

* degenerative meniscal pathology or early osteoarthritis

GP intervention. The main components of the GP intervention are a training workshop to support the delivery of an ‘enhanced consultation’ for this type of knee pain, a Patient Advice Leaflet to support their consultation, and the facility to refer eligible patients to a ‘best practice’ physiotherapy session.

Physiotherapy intervention. This intervention for participating physiotherapists consists of training and provision of educational resources to support the delivery of the ‘best practice’ physiotherapy session.

Patient intervention. The patient intervention consists of an ‘enhanced consultation’ with their GP and a ‘best practice’ physiotherapy session delivered within two weeks of their GP visit. The patient intervention will be guided by clinical guidelines and include education, exercise and where appropriate, weight management advice²⁶. A core focus will be boosting self-management skills and empowering patients with information and resources to manage their symptoms, without the need for inappropriate imaging or surgical consultations. These intervention components will be delivered briefly during the GP consultation through verbal and written information, and addressed more comprehensively during the physiotherapy ‘best practice’ session and using printed and video resources.

Relevant concomitant care permitted or prohibited during the study

During the follow-up period patient participants are not precluded from receiving other non-surgical treatments for their knee pain (e.g pain medication, additional physiotherapy). Utilisation of these co-interventions will be captured by the health utilisation questionnaire at 12 weeks and 6 months. Accessing knee surgery (i.e. arthroscopy) during the follow-up period would result in the patient being excluded from the study.

Outcomes

Feasibility and implementation outcomes

Data will be collect on implementation and feasibility outcomes to inform decisions about the need for further evaluation of the KNEE-DEeP intervention and a fully-powered trial. Proctor and colleagues framework on outcomes for implementation research was used to select a series of appropriate feasibility and implementation outcomes⁷¹. Data will be collected on intervention feasibility, intervention acceptability, the feasibility and acceptability of study procedures, intervention fidelity, and preliminary efficacy. Quantitative data using self-report questionnaires and qualitative interview data from both HCPs and patients will be integrated to gain a comprehensive understanding of intervention delivery and implementation processes. Incorporating qualitative data collection is recommended given the capacity to this type of data to add depth to the interpretation of such feasibility study evaluations⁷². Table 1 illustrates the timing of quantitative and qualitative data collection. Table 3 summarises all data collection from patient participants.

KNEE-DEeP intervention feasibility. Feasibility is the extent to which a new treatment or an innovation can be successfully used or carried out in a given setting⁷¹. A feasibility questionnaire containing a previously validated measure to assess intervention feasibility will be completed by participating physiotherapists and GPs⁷³. The Feasibility of Intervention Measure (FIM) is a 4-item scale that measures the extent to which a new intervention can be successfully delivered within a given setting. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree) and a mean score is calculated.

Qualitative one-to one interviews with HCPs will explore aspects of feasibility, including if the GP ‘enhanced consultation’ and ‘best practice’ physiotherapy session were practical and feasible for the respective HCPs to deliver. HCPs perspectives on how, why and for whom the interventions did or did not work, and possible barriers to future delivery of the intervention within the broader health care system will also be explored through these interviews. Patients will be interviewed to understand their perceptions of the relevance, usefulness and feasibility of the intervention. Whether participants felt their confidence and ability to manage their knee pain had changed in response to the intervention will also be explored.

Feasibility and acceptability of KNEE-DEeP study procedures. Data collected on feasibility of recruitment will include the number of eligible GP practices and GPs approached, the number of GPs attending the educational workshop who consented to participate, the number of patients screened by the GP who consented to be contacted by the researcher, the number of patients contacted by the researcher who consented to participating, reasons for declining to participate or ineligibility (logged by either participating GP or researcher responsible for enrolling patients) and the number of recruited participants who attended the ‘best practice’ physiotherapy intervention. The retention rate is the proportion (%) of enrolled patients who complete the 12-week (primary endpoint) and 6-month follow-up. Retention rate for GPs will be the proportion who engaged with the study by referring at least one patient to the ‘best practice’ physiotherapy session by the end of the recruitment period. The follow-up response rate is the proportion (%) of returned outcome forms at 12-weeks and 6-month follow-up and the proportion (%) of missing data. Data will be collected on adherence to study procedures around the referral to physiotherapy and completeness of referral forms and other study documentation by GPs and physiotherapists adherence to protocols around these.

Qualitative data from individual GP interviews will enhance quantitative data collection, and explore barriers and facilitators to recruitment. It will also explore the ease of procedures like explaining the study to patients and referring to the physiotherapy session. Patients will be asked about what motivated them to take-part in the study. Interviews with both HCPs and patients will seek to understand the burden associated with any outcomes measures.

Intervention acceptability. Acceptability is the perception among stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory⁷¹. Acceptability should be assessed based on the participants’ direct experience or knowledge of various dimensions of the intervention delivered.

Intervention acceptability will be measured quantitively with HCPs and patients using the Theoretical Framework of Acceptability-Based Questionnaire (TFA-BQ). The validated generic TFA-BQ was developed as an adaptable tool to measure acceptability across various healthcare interventions⁷⁴. Questions on the seven component constructs (affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness and self-efficacy) are adapted for the KNEE-DEeP study and each rated using a five-point Likert scale ranging from ‘Strongly disagree’ to ‘Strongly agree’.

Qualitative data collection with HCPs will explore the acceptability of the HCP intervention and their experience of the training workshops. How acceptable the HCPs perceived the patient intervention to be will also be discussed during these interviews. Patient interviews to explore acceptability will focus on understanding if patients liked and valued the various components of the KNEE-DEeP intervention as it was delivered.

KNEE-DEeP fidelity. Fidelity is the degree to which an intervention was implemented as the developers of the intervention intended^71,75. Fidelity of delivery and receipt of the KNEE-DEeP intervention will be assessed using quantitative and qualitative data collection. While it is not practical to measure directly GPs delivery of the components of the ‘enhanced consultation’, an indirect or proxy measure will be used in the form of two checklists. GPs will indicate their delivery of the four components of the ‘enhanced consultation’ on a checklist as part of completing the ‘best practice’ physiotherapy referral form. Patient participants will complete a checklist as part of their baseline questionnaire, indicating receipt of these intervention components during the GP consultation. At the end of each session, physiotherapists delivering the KNEE-DEeP ‘best practice’ session will complete treatment logs. This consists of a checklist documenting the key session components (e.g., clinical assessment, exploring beliefs, aspects of patient education, self-management skills, goal setting etc).

Qualitative data on aspects of fidelity, including delivery and receipt of HCP training, delivery of the patient intervention by HCPs and enactment of the clinical intervention by patients, will be gathered during interviews with a subset of patients and HCPs.

Preliminary efficacy. Preliminary efficacy will be assessed by the change in the primary clinical outcome measure of self-reported knee-function. All primary and secondary clinical outcome measures are described below.

Baseline descriptive data

Demographic and descriptive data is collected using a baseline questionnaire. Table 3 includes a summary of descriptive data from patient participants. Descriptive data from GP participants will include: i) age; ii) gender; iii) years qualified as a GP; iv) practice size and location; v) special clinical interests, and; vi) any additional musculoskeletal training. Descriptive data from physiotherapist participants will include: i) age; ii) gender; iii) years qualified as a physiotherapist; iv) grade and v) special clinical interests.

Patient clinical outcomes

Selected clinical outcome measures are recommended by Outcome Measures in Rheumatology (OMERACT), Osteoarthritis Research Society International (OARSI). These include pain, physical function, quality of life, global assessment of the target joint, and adverse events⁷⁶. Table 3 provides the full list of clinical outcome measures and time points of assessment.

Knee function. Self-reported knee function will be assessed using the Knee Injury and Osteoarthritis Outcome Score Physical Function Short Form (KOOS-PS)⁷⁷. This 7-item measure of physical function is derived from the activities of daily living and sport/recreation subscales of the Knee Injury and Osteoarthritis Outcome Score (KOOS). The KOOS-PS has been shown to be valid and reliable for use in people with knee OA. Scores range from 0 to 100 (extreme problems to no problems)⁷⁷.

Knee pain. Knee pain will be measured by the nine item pain subscale of the KOOS. Questions on this subscale pertain to the previous 7 days. It is scored (0 to 100) and reported individually⁷⁸. This KOOS subscale is a valid, responsive and reliable measure that have been used extensively in knee OA and knee arthroscopy trials⁷⁹.

Pain self-efficacy. The 2-items on the shortened form of the Pain Self-Efficacy Scale Questionnaire (PSEQ-2) reflect confidence in one's ability to work and lead a normal life despite pain⁸⁰. Items are scored on a 7-point Likert scale from "Not at all confident" to "Completely confident", with scores ranging from 0 (no confidence) to 12 (maximal confidence to perform activity despite pain). PSEQ-2 is valid and reliable and considered responsive enough to be used in a research context to evaluate changes after an intervention for chronic musculoskeletal disorders⁸¹.

Fear-avoidance beliefs. A modified version of the four-item fear avoidance beliefs about physical activity subscale (FABQ-PA) will be used⁸². Participants will rate their beliefs about the activity from 0 (completely disagree) to 6 (completely agree) and scores range from 0 to 24. While not formally validated in the knee, other studies have used this modified version in people with knee pain^83,84. The word “back” has been substituted with the word “knee,” and the physical activities examples have been substituted with “running, walking, kneeling, and driving.”

Health related quality of life. The EuroQol Five-Dimensional Questionnaire (EQ-5D-5L) measures across five dimensions (mobility, self-care, usual activities, pain/ discomfort and anxiety/depression). The response options range from no problems (1) to unable or extreme problems (5). Overall health status is rated on a visual analogue scale from 0 (worst imaginable health) to 100 (best imaginable health)⁸⁵. Validity and reliability has been demonstrated in people with knee osteoarthritis populations⁸⁶.

Global rating of change. Self-rated overall level of improvement in knee symptoms (pain and physical function) will be assessed. Participants will be asked to respond to the questions: ‘Overall, how has your knee pain changed since the start of the study?’ and ‘Overall, how has your knee function changed since the start of the study?’ using Likert scale (7-point) ranging from ‘much worse’ to ‘much better’.

Satisfaction with care. Participants will be asked to rate the “overall satisfaction with the care you received in this study” using a 7-point scale ranging from “extremely unsatisfied” to “extremely satisfied”

Adherence to the exercise and physical activity plan. Adherence to the exercise and physical activity plan agreed with the physiotherapists will be rated by the patient participant on an 11-point Numerical Rating Scale (0 = not at all and 10 = completely as instructed).

Recovery expectations. Expectation of recovery are assessed using a 7-point ordinal scale in response to the question “How much do you expect your knee problem to change in the next 6 months?” ranging from ‘completely recovered’ to ‘worse than ever’.

Use of health care and co-interventions for knee pain. A self-report checklist will record visits to health care providers (additional physiotherapy and GP consultations, other health professional or secondary care consultations), injection use, complementary therapies and imaging between baseline to 12 weeks and at 6-month follow-up using a customised questionnaire.

Change in pain medication usage. Self-report change in pain medication use from baseline to 12-week and 24 follow-up will be assessed with a 7-point Likert scale (much less to much more).

Number of working days missed. The number of work days (paid employment or unpaid work) missed due to the knee problem since baseline will be recorded.

Adverse events. Defined as any problem that participants believe was caused by the intervention (exercise or advice) and requiring them to seek treatment and/or lasted for two or more days. Adverse events reported to the research team by participating patients, GPs or physiotherapists will be recorded in an adverse events log. Follow-up questionnaire at 12 weeks and 6 months will specifically ask patients about adverse events by including an open probing question. All qualitative interviews conducted with participants will ask about adverse events.

Data collection and analysis plan

Data analysis plan

As this is a feasibility study, the main focus will be on feasibility and implementation outcomes to inform decisions about further evaluation and a fully-powered trial. For the process evaluation, insights into intervention feasibility, acceptability and the feasibility of study procedures will be identified from coded interview transcripts and survey results will be analysed using descriptive statistics. These findings will be integrated by accompanying quantitative data with qualitative findings in a joint display⁸⁷. A more detailed description of quantitative and qualitative analysis is included below.

Quantitative data collection and analysis

Data relating to study procedures (recruitment, retention etc) will be collected throughout. Participants will be invited to complete the baseline and follow-up questionnaires via an online link to Microsoft (MS) Forms. Data from MS Forms will be stored electronically on UL’s secure OneDrive cloud storage, exported to Microsoft Excel. Participants will also have the option of completing paper questionnaires, if this is their preference. Data from paper based questionnaires will be transferred by a researcher to Microsoft Excel. Demographic data from GPs and physiotherapists will be collected following study enrolment at the training workshops by paper questionnaire.

Follow-up questionnaires will be sent to patient participant at 12 weeks and 6 months. For those who do not respond, at least one reminder will be sent, via email or by post. For those who do not respond to the reminder, a telephone follow-up will be used to contact participants. Participating GPs and physiotherapists will complete a follow-up questionnaire at the conclusion of recruitment and intervention delivery.

Participants’ characteristics and implementation outcomes will be described using descriptive statistics such as means, standard deviations and ranges for quantitative variables, and counts and proportions for categorical variables. Descriptive statistics will also be used to measure change in outcome measures from baseline to 12 weeks and 6-month time-points and results will be treated as exploratory. Means and confidence intervals of the KOOS-PS will be calculated in order to inform the sample size calculation for a future definitive RCT.

Qualitative data collection and data analysis

Patient interviews. Semi-structured interviews will be conducted by a female researcher with a background in qualitative methods, and who is not directly involved in the study. Interviews will be by telephone or online, depending on participant preference. Ten to 12 of the patient participants will be purposively recruited with the aim of interviewing a diverse sample, based on clinical characteristics, and participants from a range of participating GP practices. Interviews will be conducted within a month of receipt of the ‘best practice’ physiotherapy intervention, where possible, and last for approximately thirty minutes. The interview topic guide will focus on acceptability and feasibility of the study intervention and procedures, as outlined above, and also include : 1) patients’ experience of receiving the intervention from the GP and the physiotherapist; 2) perception of its benefits, 3) barriers to engagement with aspects of the intervention; 4) suggested improvements on aspects of the intervention or study design.

HCP interviews. Qualitative data will be collected from six to eight GPs on conclusion of the patient recruitment phase. Data collection will be via a combination of one to one interviews and a small focus group moderated by clinician researcher not directly involved with the study. The dynamics of the focus group discussion should help promote debate and a range of views about the KNEE-DEeP study intervention⁸⁸, yielding rich data on acceptability and feasibility. Interviews will take place either in-person or online, depending on participant preference. Five physiotherapists who delivered the physiotherapy intervention will also be interviewed. The topic guides will explore the experiences of those HCPs participating in the study and issues of implementation relating to acceptability, feasibility, fidelity, as outlined in the outcome section above.

Transcription will be undertaken in parallel to data collection. Transcripts will be de-identified and offered to participants for approval or amendment. The NVivo qualitative analysis software programme⁸⁹ will be used to support data analysis and enable an audit trail of analysis decisions. Open coding of the data set will be undertaken before using thematic analysis⁹⁰. The research team will code the data, with peer coding of select transcripts, to enable cross-coding comparisons, before identifying themes and sub-themes. The wider research team including the PPI group, will contribute to interpretation the findings.

Data management plan and study oversight

Each participant will be assigned a unique study identifier. All electronic data collected via online questionnaires or manually entered into Microsoft Excel will be transferred automatically and securely stored on University of Limerick’s cloud storage (which is GDPR compliant and uses a two-step sign-in procedure to ensure security) in pseudo-anonymised format. A quality check of 20% of the data will be completed by an independent researcher. The PI will maintain the key to this pseudo-anonymisation and this will be stored securely in UHK. Only the study team will have access to pseudo-anonymised data. Written data containing participant information will be kept to a minimum and any information will be scanned and transferred to electronic format and stored securely with other study information. Written data pertaining to the physiotherapists ‘best practice’ session will be retained in UHK and filed with the patient’s clinical notes. Information from checklist documenting the key elements of the session will be pseudo-anonymised and transferred to electronic format. Consent forms will be stored separately to other data for six months after study completion. Data will then be anonymised and retained for another 7 years. Deidentified data will be made available on reasonable request to the PI after publication according to the University of Limerick Research Data Management Policy.

The Trial Management Committee (TMC) will oversee the day to day running of the trial and have responsibility for data monitoring. This committee will comprise of the PI and five grant collaborators. An independent Trial Steering Committee (TSC) will oversee the study. This includes an independent chairperson, two other independent members and a lay representative. The PI (HOL), and another member (KMC) of the TMC will attend the TSC meetings and report progress. The TSC meetings will be scheduled approximately every three months, and it is anticipated the committee will meet five times over the course of the study. Safety considerations associated with this trial are minimal because education and exercise for knee pain are associated with minimal adverse events. Any serious adverse events will be recorded and reported to both the ethics committee and the TSC. The committee will have responsibility for making decisions about modifying or discontinuing the intervention in response to any reported or potential harms. As this is a low risk trial, the Steering Committee will also act as the Independent Data Monitoring Committee (IDMC).

Progression criteria

Progression criteria were developed for this study to aid subsequent decisions around the need for further developmental work or proceeding to a full RCT. The criteria which focus on key feasibility and acceptability variables and are presented in the extended data (File J, https://osf.io/fwy36/). Development of these benchmarks were guided by existing literature⁹¹, and the research team’s experience and knowledge of the local context.

Dissemination plan

Study outcomes will be widely disseminated through a variety of sources. Feasibility study results will be presented at relevant conferences and published in a relevant peer-reviewed open-access journal. Patient participants will be provided with a lay summary of findings. Other wider dissemination strategies will be explored with the PPI group. Findings will also be disseminated through GP and physiotherapy professional networks in Ireland.

Trial status

This is version 1 of the protocol (December 2024). Recruitment of patient participants commenced in June 1^st 2024 and is ongoing. The study is due for completion in June 2025. Deviations from this protocol will be submitted to the ethics board, updated on the trial registry (clinicaltrials.gov), and described in the final manuscript of the results.

Name and contact of the trial sponsor

University of Limerick, Castletroy Co. Limerick, Ireland.