ADvAnced PhysioTherapy in MuSculosKeletal Triage: Investigating prognostic factors, healthcare utilisation and clinical outcomes (ADAPT MSK) - a cohort study protocol.

Fiona Callan; Louise Keating; Sarah Casserley-Feeney; Helen P. French

doi:10.12688/hrbopenres.13769.2

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Study Protocol

Revised

ADvAnced PhysioTherapy in MuSculosKeletal Triage: Investigating prognostic factors, healthcare utilisation and clinical outcomes (ADAPT MSK) - a cohort study protocol.

[version 2; peer review: 1 approved, 3 approved with reservations]

Fiona Callan ¹, Louise Keating¹, Sarah Casserley-Feeney², Helen P. French¹

PUBLISHED 23 Jan 2025

Author details Author details

¹ School of Physiotherapy, Royal College of Surgeons in Ireland, Dublin, Ireland
² National Musculoskeletal Triage Initiative, National Clinical Programme for Trauma & Orthopaedic Surgery (NCPTOS), Royal College of Surgeons in Ireland, Dublin, Ireland

Fiona Callan
Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing

Louise Keating
Roles: Conceptualization, Formal Analysis, Funding Acquisition, Methodology, Project Administration, Supervision, Writing – Review & Editing

Sarah Casserley-Feeney
Roles: Conceptualization, Methodology, Writing – Review & Editing

Helen P. French
Roles: Conceptualization, Formal Analysis, Funding Acquisition, Methodology, Project Administration, Supervision, Writing – Review & Editing

OPEN PEER REVIEW

REVIEWER STATUS

Abstract

Background

Clinical specialist physiotherapist-led musculoskeletal triage clinics were introduced nationally in Ireland in 2011 to improve patient care and reduce waiting times for secondary care orthopaedics and rheumatology. Evidence has shown them to be effective in reducing waiting lists, however there are currently no data on longitudinal patient outcomes following attendance at these clinics. The primary aim of this prospective, cohort study is to identify predictors of clinical outcome (pain and function) at 12-months post MSK-triage appointment. Secondary aims are to describe the clinical course of patients attending MSK triage clinics and measure self-reported use of healthcare resources up to 12 months post-MSK-triage appointment. This is a prospective cohort study.

Methods

ADvAnced PhysioTherapy in MuSculosKeletal Triage (ADAPT MSK) will recruit a cohort of 252 adults through musculoskeletal triage clinics across five secondary care sites in Ireland. The STrengthening the Reporting of Observational studies in Epidemiology (STROBE) guidelines will be adhered to for future reporting. Adults (≥ 18 years old) attending physiotherapist-led musculoskeletal triage clinics with musculoskeletal pain, who do not require surgical or consultant-led medical care will be considered for participation in this study. Participant demographics, health literacy, healthcare utilisation, and self-report questionnaires on pain, function, musculoskeletal health status, musculoskeletal risk stratification, fear of movement, and psychological distress will be obtained at baseline, with follow-ups at three, six, and 12 months. The primary outcomes are pain intensity and function. Secondary outcomes include musculoskeletal risk stratification status, musculoskeletal health status, healthcare utilisation, and work status. Descriptive statistics will be used to profile the cohort of participants and predictors of outcome will be assessed using multivariable linear regression.

Results

Results will be disseminated via peer-reviewed journal publication and presentation at national and international conferences. Engagement with a public patient involvement (PPI) panel will explore dissemination strategies for public and service user engagement.

Keywords

Musculoskeletal triage; physiotherapy; orthopaedic triage, rheumatology triage; predictors of outcome; musculoskeletal pain, healthcare utilisation, cohort study

Corresponding author: Fiona Callan

Competing interests: No competing interests were disclosed.

Grant information: This work was supported by the Irish Research Council Government of Ireland Postgraduate Scholarship (GOIPG/2021/160).
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Copyright: © 2025 Callan F et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

How to cite: Callan F, Keating L, Casserley-Feeney S and French HP. ADvAnced PhysioTherapy in MuSculosKeletal Triage: Investigating prognostic factors, healthcare utilisation and clinical outcomes (ADAPT MSK) - a cohort study protocol. [version 2; peer review: 1 approved, 3 approved with reservations]. HRB Open Res 2025, 6:73 (https://doi.org/10.12688/hrbopenres.13769.2) First published: 06 Dec 2023, 6:73 (https://doi.org/10.12688/hrbopenres.13769.1) Latest published: 23 Jan 2025, 6:73 (https://doi.org/10.12688/hrbopenres.13769.2)

Revised Amendments from Version 1

In response to reviewer feedback a number of changes have been made to the protocol.
We have provided clarity on our sample size calculation.
We have revised our primary and secondary aims.
We have revised and further developed our statistical analysis plan in line with revised aims.
We have further developed the introduction and discussion section.
Health literacy has been included in the relevant sections and Table 1.
We have addressed grammatical and terminology concerns throughout the manuscript.

See the authors' detailed response to the review by helen o'leary
See the authors' detailed response to the review by Karin Samsson

Introduction

Musculoskeletal (MSK) pain, which includes conditions such as low back pain, neck pain or osteoarthritis is recognised as one of the leading causes of disability worldwide¹, resulting in increased healthcare expenditure and longer waiting times for orthopaedic and rheumatology outpatient services^2,3. Adult orthopaedic services represent the largest waiting list in Ireland (June 2023) with a total of 64,867. Up to 25% of patients are waiting more than 12 months for orthopaedic (22%) and rheumatology (25%) appointments in secondary care⁴.

In 2011, to reduce outpatient Orthopaedic and Rheumatology waiting times in Ireland, the Health Service Executive (HSE) National Clinical Programmes for Trauma and Orthopaedics (NCPTOS), and Rheumatology (NCPR) established the National MSK Triage Initiative, consisting of 24 clinical specialist physiotherapist (CSP) posts in 18 acute Hospital sites nationwide. In these MSK Triage clinics, CSPs triage patients on outpatient orthopaedic and rheumatology waiting lists, who are unlikely to require consultant care, onto appropriate care pathways. In a national audit, over 80% of patients presenting to MSK-triage clinics in Ireland were managed independently by the CSP, with 71% discharged at their initial appointment⁵ and 23% referred to physiotherapy⁶. From 2012 to 2018, 125,852 patients on orthopaedic and rheumatology waiting lists were managed through MSK triage services⁷. Access to primary care physiotherapy also presents a barrier to patients, with 56,200 on primary care waiting lists and 22% (12,502) waiting greater than one year to access primary care physiotherapy services in 2022⁸. Longer waiting times to access physiotherapy can negatively affect patients’ quality of life, psychological wellbeing, healthcare utilisation, health outcomes and economics^3,9,10.

Several predictors of pain and functional outcomes in MSK conditions across primary and community care settings have previously been identified, including baseline function, pain intensity, mental well-being, co-morbidities, age, body mass index (BMI), duration of symptoms, work status, education level¹¹, health literacy¹², and altered pain processing¹³; which can also predict non-response to physiotherapy¹⁴. Recently, MSK core outcome sets, and prognostic stratification tools (such as the Subgroups for Targeted Treatment Back (STarT Back) and Subgroups for Targeted Treatment MSK (STarT MSK)), have been developed, based on established prognostic factors^11,15, and validated to identify earlier, those at risk of developing persistent MSK pain^16,17.

Whilst the National MSK Triage Initiative has been successful in reducing acute hospital outpatient orthopaedic and rheumatology waiting lists, the high discharge rate of 71% at initial appointment⁵ warrants further examination to explore the patient journey and potential reasons why patients are not referred to the right service at the right time, in line with the Irish government health reform plan (Sláintecare)¹⁸. It is possible that suboptimal access to primary care services, may be influencing referrer behaviour and decision making. Research to date has shown that MSK triage is an effective waiting list initiative with good service user and healthcare professional satisfaction^5,7,19–22. However, currently, patient outcomes, prognostic stratification, and predictors of outcome up to 1-year later have not been consistently studied in patients attending MSK triage clinics, who do not require consultant-led orthopaedic or rheumatology care, in Ireland or internationally. Therefore, we wanted to explore the cohort of patients attending secondary care MSK triage who do not require surgical or medical input from the orthopaedic surgeon or rheumatologist to better understand their healthcare journey (healthcare utilisation), clinical outcomes (pain and function) and predictors of clinical outcome.

Aims

The primary aim of this prospective, cohort study is to identify predictors of clinical outcome (pain and function) at 12-months post MSK-triage appointment.

Secondary aims are to: 

1. Describe the clinical course of patients attending MSK triage clinics, on the outcomes of pain intensity, function, work status and MSK health status, at 3 months (short-term), 6 months (medium-term) and 12 months (long-term).

2. Measure self-reported use of healthcare resources over the 12-month follow-up period post-MSK-triage appointment.

Methods

Study design

ADAPT MSK is a prospective, observational, cohort study. The STROBE standardised reporting guidelines will be used to guide the reporting of this study²³. Adults with MSK pain attending CSP-led MSK triage clinics will be recruited from five sites across Ireland. Baseline assessment will consist of baseline demographics, work status, healthcare utilisation and self-report questionnaires on pain, function, MSK health status, fear of movement, anxiety and depression and baseline clinical factors (e.g. number of MSK pain sites, co-morbidities and health literacy) (Table 1). Follow-up at 3, 6 and 12 months will involve repeat measurement of work status, healthcare utilisation and self-report questionnaires.

Table 1. Overview of primary and secondary outcomes, predictor variables, and time of assessment.

Variables	Outcome Measure	Method	Baseline	3 month	6 month	12 month
Primary Outcomes
Pain Function	Numerical pain rating scale Patient-specific functional scale (PSFS)	RC RC	✓ ✓	✓ ✓	✓ ✓	✓ ✓
Secondary Outcomes
Work status	Work classification Work absence Work absence duration	MT/T	✓ ✓ ✓	✓ ✓ ✓	✓ ✓ ✓	✓ ✓ ✓
MSK Health Status	Musculoskeletal Health Questionnaire (MSK-HQ) STarT MSK	RC	✓ ✓	✓ ✓	✓ ✓	✓ ✓
Healthcare Utilisation	Modified MOSAICS Questionnaire	MT/T	✓	✓	✓	✓
Predictor Variables
Demographics	Age Sex Education level	MT/T	✓ ✓ ✓
Co-Morbidities	NICE multi-morbidity index	MT/T	✓
Pain Site	Total number of MSK pain sites (number/11 on body chart)	MT/T	✓	✓	✓	✓
Previous Surgery	Self-reported previous surgery	MT/T	✓
Previous Physiotherapy	Self-reported previous physiotherapy	MT/T	✓
Symptom Duration	Self-reported duration of symptoms	MT/T	✓
Health Literacy	Single item health literacy screener (SILS)		✓
Employment	Work classification	MT/T	✓	✓	✓	✓
Fear of Movement	Tampa Scale for Kinesiophobia (TSK-11)	RC	✓
Anxiety and Depression	Hospital anxiety and depression scale (HADS)	RC	✓
Optional Physical Examination (Two Recruitment Sites)
Pain Phenotype	Quantitative Sensory Testing • Pressure pain threshold • Dynamic mechanical allodynia • Heat pain threshold • Temporal summation Clinical Neurological Exam	Physical	✔ ✔
Grip Strength	Hand-held dynamometer	Physical	✔

MSK, Musculoskeletal; MT/T, Microsoft Teams/Telephone; RC, RedCap

Ethics

Ethical approval for this study was granted by the Research Ethics Committees in Beaumont Hospital (Ref: 22/34), Tallaght University Hospital (Ref: 2418), Merlin Park Hospital (Ref: C.A. 2870), Midlands Regional Hospital Tullamore (Ref: RRECB1022FC) and St Vincent’s University Hospital (Ref: RS23-010). Written informed consent will be obtained from eligible participants prior to study recruitment, in line with the Data Protection Act 2018 (Section 36(2))²⁴.

Setting

This study will be based in MSK Triage clinics across five urban and regional secondary care sites in Ireland. These clinics are run by CSPs with more than five years clinical experience and the majority achieving a postgraduate MSc or PhD degree, in the field of MSK physiotherapy⁵. They provide expert assessment, diagnosis and education to patients and identify the most appropriate management pathway for patients with MSK disorders. The typical journey for patients attending these clinics (Figure 1) involves an initial referral from the patient’s GP to secondary care orthopaedics or rheumatology. The consultant in secondary care then triages this referral to the MSK triage clinic or the consultant-led clinic. Patients deemed unlikely to require orthopaedic surgeon or rheumatology consultant care are triaged to these MSK triage clinics, which aims to improve service efficiency by reducing secondary care waiting lists and directing patients towards the appropriate service for their needs⁷.

Figure 1. Screening process for pain classification based on IASP criteria for nociplastic pain²⁵ and NeuPSIG grading system for Neuropathic pain²⁶.

Participants

A consecutive sample of patients presenting to orthopaedic and rheumatology MSK-triage clinics with MSK pain will be recruited. Participants will be eligible if they are aged 18 years or over, are triaged for non-consultant care at one of the five participating MSK triage services across Ireland and have sufficient English language proficiency for the completion of self-reported questionnaires.

Patients will be ineligible to participate if they’ve been triaged by the CSP for orthopaedic surgical or rheumatologist assessment, are unable to communicate in English (written and spoken word), along with those who present with clinical indicators of suspected ‘red flag’ pathology (e.g. recent trauma with significant injury; acute, red, hot, or swollen joints; suspected fracture; joint infection; cancer)²⁷; or a diagnosed systemic inflammatory MSK condition (such as rheumatoid arthritis) or a diagnosis of dementia or terminal illness.

Sample size

The estimated sample size is based on the primary study aim ‘to identify predictors of clinical outcome (pain and function) at 12-months post MSK-triage appointment’. Sample size is determined based on including 18 predictor variables in univariate analysis and with 10 events required per predictor variable²⁸, a sample of 180 participants is required. To allow for a 40% drop-out at the 12-month follow-up, an additional 72 participants were added, resulting in a final sample size estimate of 252 participants.

Recruitment and data collection

The MSK triage physiotherapist will identify and screen prospective participants for eligibility following their MSK triage appointment. If eligible, they will provide a participant information leaflet, briefly explain the aims of the study, and obtain written consent to be contacted by the primary investigator (FC). This allows the primary investigator to contact prospective participants to answer any questions about the study and if interested in participating, obtain informed written or electronic consent.

Once recruited, each participant will undergo a baseline assessment with the primary investigator, capturing participant demographics and healthcare utilisation, via Microsoft Teams or telephone, depending on participant preference. Thereafter, participants will complete a number of self-report questionnaires based on established prognostic factors i.e., baseline function, pain intensity, mental wellbeing, symptom duration, fear avoidance/catastrophising, quality of life/self-efficacy, widespread pain, age, co-morbidities, work absence duration, and education level^15,29,30. This data will be collected through Research Electronic Data capture (REDCap) software^31,32, hosted at RCSI, on their personal device, or via posted paper questionnaires, to facilitate participants with limited information technology skills.

Demographic information will include participant gender, age, level of education, presenting MSK complaint, duration of symptoms, number of MSK pain sites, previous physiotherapy/surgery for presenting complaint, and work status (work absence, work classification and work absence duration). Co-morbidities will be identified from a list of 12 comorbid conditions, informed by the National Institute of Clinical Excellence (NICE) indicator for multi-morbidity in primary care³³. Health literacy will be explored using the single-item literacy screener³⁴. Healthcare utilisation will be recorded using a modified version of the Managing of OSteoArthritis In ConsultationS (MOSAICS) trial questionnaire³⁵, which captures advice and information received about their condition, self-management, prescribed medications, aids and appliances, private/public health services (e.g., physiotherapy, GP, nursing, occupational therapy, podiatry), treatments, and investigations.

Self-report questionnaires will include the Musculoskeletal Health Questionnaire (MSK-HQ)³⁶, STarT MSK tool¹⁷, and Patient Specific Functional Scale (PSFS)³⁷ to assess functional and MSK health status; pain intensity through the Numerical Pain Rating Scale (NPRS)^38,39; fear of movement through the 11-item Tampa Scale for Kinesiophobia⁴⁰ and psychological distress via the Hospital Anxiety and Depression scale (HADS)⁴¹.

All participants recruited in two sites (Beaumont Hospital and Tallaght University Hospital) will be invited to participate in a once-off baseline physical examination, consisting of grip strength examination, neurological exam, and quantitative sensory testing (Table 1).

Pain hypersensitivity, measured by quantitative sensory testing, has been shown to be a predictor of worse outcome (pain and disability) at follow-up across multiple MSK conditions (e.g., osteoarthritis, low back pain, whiplash, post-operative pain) and different body sites (e.g., hip, knee, low back, shoulder and neck)¹³. Quantitative sensory testing uses standardised testing protocols of somatosensory nerve function, to investigate potential underlying pain mechanisms^42,43. The International Association for the Study of Pain (IASP) task force clinical criteria and grading system for nociplastic pain involves a stepwise approach to differentiate between predominant nociceptive, neuropathic or nociplastic pain²⁵, which, in conjunction with the NeuPSIG guidelines on neuropathic assessment²⁶ will be used to categorise participants’ dominant pain phenotype (Figure 1). A quantitative sensory testing protocol including pressure pain thresholds (PPT), dynamic mechanical allodynia, pinprick, temporal summation and cold pain thresholds will be used to assess pain sensitivity in accordance with IASP and NeuPSIG grading systems^25,26.

Grip strength is regarded as a biomarker of current health status and has been adopted as a singular indicator of overall body strength^44–46. Grip strength will be assessed isometrically using a calibrated Jamar Plus Digital dynamometer following a standard protocol⁴⁷.

Follow-up assessment

The primary investigator will contact participants at three, six, and 12 months via Microsoft Teams or telephone to collect healthcare utilisation data and work status (work absence, work classification and work absence duration). Self-report questionnaires (MSK-HQ, STarT MSK, Patient Specific Functional scale, and NPRS) will be sent electronically via REDCap software or via post. Any participant withdrawals or loss to follow-up will be recorded.

Outcomes

The primary outcomes of interest are pain intensity (NPRS) and function (PSFS). Secondary outcomes are musculoskeletal risk stratification status (STarT MSK), musculoskeletal health (MSK-HQ), healthcare utilisation and work status (work classification, work absence and work absence duration).

Statistical analysis

Statistical methods will follow the STROBE guidelines²³ and the TRIPOD consensus statement for transparent reporting of a multivariable prediction model for individual prognosis and/or diagnosis for transparent reporting of a multivariable prediction model for individual prognosis and/or diagnosis⁴⁸. Descriptive statistics will be used to profile the characteristics of the cohort at baseline, three, six, and 12 months. Multivariable linear regression will be used to identify baseline predictors of pain and function outcomes at the primary timepoint of 12 months following MSK triage appointment. Models will be adjusted for potential confounding factors, checking for interactions and collinearity. The extent of missing data will be assessed and reported, and the mechanism causing the missing data explored. Multiple imputation will be used if the conditions support its use and a sensitivity analysis conducted with complete case data. Variables included in the multivariable regression model will be selected if deemed clinically significant, or if they have a univariable p-value of <0.2. Statistical significance will be inferred when the pvalue is <0.05. Stata 18 statistical software (StataCorp, College Station, Tx, USA) will be used for statistical analyses.

Dissemination

Findings from this study will be disseminated via peer-reviewed journal publication and presentation at national and international conferences. Engagement with a public patient involvement (PPI) panel will explore dissemination strategies for public and service user engagement.

Study status

Data collection commenced in December 2022, with study completion anticipated in January 2025.

Discussion

The burden of MSK disorders is increasing exponentially worldwide, resulting in significant pressure on healthcare systems. People with MSK pain who present to their GP in Ireland are faced with difficulties accessing first-line public services, such as primary care physiotherapy and subsequently specialised orthopaedic and rheumatology services. To address secondary care waiting lists and improve service efficiency, the National MSK Triage Initiative, MSK triage clinics, run by CSPs under the clinical governance of Orthopaedic and Rheumatology Consultants commenced in Ireland in 2011, and has demonstrated success as a waiting list initiative. However, high discharge rates and onward referral to primary care physiotherapy following MSK triage suggest that these patients may have been managed more appropriately in primary care if sufficiently resourced. Currently, the patient journey and long-term outcomes following their MSK triage attendance are unknown. This longitudinal cohort study aims to identify predictors of pain and function outcomes up to 1 year following MSK triage attendance; measure individuals’ self-reported use of healthcare resources and explore MSK phenotypes based on identified prognostic factors. Identifying predictors of outcome (pain and function) at 12 months has the potential to inform decision making on the optimal patient pathway and trajectory of care by enabling the identification of those at risk of a poor outcome at 1 year, earlier in their journey. This research has the potential to inform future needs within primary care for those with MSK conditions, as well as the implementation of pathways from primary to secondary care orthopaedics and rheumatology, ensuring that patients receive the ‘right care, at the right place, at the right time’ in line with SláinteCare principles¹⁸.

Data availability

No data are associated with this article.

Faculty Opinions recommended

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VERSION 2 PUBLISHED 06 Dec 2023

Author details Author details

Louise Keating
Roles: Conceptualization, Formal Analysis, Funding Acquisition, Methodology, Project Administration, Supervision, Writing – Review & Editing

Sarah Casserley-Feeney
Roles: Conceptualization, Methodology, Writing – Review & Editing

Helen P. French
Roles: Conceptualization, Formal Analysis, Funding Acquisition, Methodology, Project Administration, Supervision, Writing – Review & Editing

Competing interests

No competing interests were disclosed.

Grant information

This work was supported by the Irish Research Council Government of Ireland Postgraduate Scholarship (GOIPG/2021/160).
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

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https://doi.org/10.12688/hrbopenres.13769.2

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https://doi.org/10.12688/hrbopenres.13769.1

© 2025 Callan F et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Callan F, Keating L, Casserley-Feeney S and French HP. ADvAnced PhysioTherapy in MuSculosKeletal Triage: Investigating prognostic factors, healthcare utilisation and clinical outcomes (ADAPT MSK) - a cohort study protocol. [version 2; peer review: 1 approved, 3 approved with reservations]. HRB Open Res 2025, 6:73 (https://doi.org/10.12688/hrbopenres.13769.2)

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Key to Reviewer Statuses VIEW HIDE

ApprovedThe paper is scientifically sound in its current form and only minor, if any, improvements are suggested

Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.

Not approvedFundamental flaws in the paper seriously undermine the findings and conclusions

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Reviewer Report 25 Feb 2025

Shahnawaz Anwer, The Hong Kong Polytechnic University, Hong Kong, Hong Kong

Approved with Reservations

https://doi.org/10.21956/hrbopenres.15444.r45241

The protocol of this cohort study primarily aimed to identify predictors of clinical outcome (pain and function) at 12-months post MSK-triage appointment. Secondarily, this study aimed to describe the clinical course of patients attending MSK triage clinics and measure self-reported use of healthcare resources up to 12 months post-MSK-triage appointment. The topic is interesting and useful. The study design is well planned and feasible. However, there are some inconsistencies in reporting primary and secondary outcomes.

Comments:
1. There are inconsistencies in pain measurements. For example, if pain intensity is assessed through multiple methods, it should be consistently defined and reported to avoid ambiguity.
2. Some outcomes are not included in all follow-up assessments. For example, if certain outcomes such as health literacy, Fear of Movement, Anxiety and Depression, and grip strength are recorded at baseline but not during follow-ups, it may leave gaps in the understanding of how these factors evolve over time.
3. Protocol should identify and report any potential limitations and how to address those limitations.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Rehabilitation, Osteoarthritis, Musculoskeletal Research, Ergonomics, Physical Fatigue

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

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Reviewer Report 20 Feb 2024

helen o'leary, University of Limerick, Limerick, County Limerick, Ireland

Approved

https://doi.org/10.21956/hrbopenres.15061.r37418

Introduction

Overall could include more information to expand on the gap this research is addressing/what is known already and why this research is important

While the background contains interesting info on the MSK triage initiative it’s not clear from the Introduction why this is an important question? Why is knowing predictors of outcome for this particular patient cohort at 1 year is important? What are the implications of better predicting outcomes? Could it be used for early identification of those at risk of persistent pain and subsequent prioritisation by physiotherapy services? How will this information be used to improve or better current MSK services in Ireland? (some mention of this in Discussion)

Also, while the authors refer to previous SRs of predictors of pain and function in MSK conditions, it would be useful to know what type of patient population these relate to (primary care or secondary care). It is stated that MSK triage clinics have not been studied, which is true, however this cohort are essentially very similar to cohort attending secondary care elective othopaedic clinics, what are the main findings from these studies?

Methods
Study Design- Follow-up at 3, 6 and 12 months- is there a pre-specified primary end-point?

How many are estimated to undergo a baseline physical exam? Will there be sufficient data from these two sites to carry out the anticipated data analysis e.g. latent class analysis or multi-variable analysis? Or is this info solely to categorise the pain phenotype? Should make reference to this sub-group in the data analysis section.

Pain phenotyping- using IASP criteria and NeuPSIG based on baseline physical exam. Is this different to the Latent Class Analysis to explore underlying pain phenotypes “based on a range of categorical variables”? Clarify this.

How soon will the physical exam be after the patient is recruited? What is the anticipated duration of this examination eg. 1 hour?

QST- Would have expected in a protocol to see more detail here in order that your testing procedures are reproducible. For example how do you intend to choose anatomical testing sites (related to the primary pain complaint?) What is the order of testing? Instruments- Device you are using for pressure pain algometry, what thermal testing devices?. What is pinprick testing? References (41, 42) provided are for grading systems and not for a QST protocol. Did the authors mean to reference the Rolke et al, 2006 (40)DFNS protocol here?

If DFNS Rolke 2006 protocol is what the researchers are using, are the researchers following a modified version of DFNS Rolke 2006 protocol or reproducing exactly. For example, this protocol uses testing of 1 pinprick versus 10 repeated pinpricks and repeats this procedure 5 times, this (55 pinpricks !) may be poorly tolerated by patients, esp hyperalgesic. Have the researcher’s modified this? How?

Perhaps Table 1 could include more detail on protocol or how differs to referenced protocol or include as supplementary info

Table 1- different QST info compared to text- pinprick omitted, heat pain threshold here instead of cold pain thresholds

Clinical Neurological Exam- indicate in Table 1 what will this entail? Is the main purpose to help with pain classification?

Patients attending Rheumatology MSK triage clinics are typically multi-site MSK pain, eg. Small joints of the hands plus other several painful area. It is not clear how it's decided which is the index site for the primary outcome pain NRS. Similarly for QST indicate how will select test site?

Is the rationale for, and objectives of, the study clearly described?

Partly
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: musculoskeletal pain, knee pain

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

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Author Response 23 Jan 2025

Fiona Callan, School of Physiotherapy, Royal College of Surgeons in Ireland, Dublin, Ireland

23 Jan 2025

Author Response
Thank you, Dr O’Leary, for your time and expertise in reviewing our protocol. We greatly appreciate all your comments and suggested amendments. We have reviewed and addressed each point you ... Continue reading
Thank you, Dr O’Leary, for your time and expertise in reviewing our protocol. We greatly appreciate all your comments and suggested amendments. We have reviewed and addressed each point you have raised below, and amended the paper accordingly.

Reviewer comment 1:
While the background contains interesting info on the MSK triage initiative it’s not clear from the Introduction why this is an important question?

Why is knowing predictors of outcome for this particular patient cohort at 1 year is important?

What are the implications of better predicting outcomes? Could it be used for early identification of those at risk of persistent pain and subsequent prioritisation by physiotherapy services?

How will this information be used to improve or better current MSK services in Ireland? (some mention of this in Discussion)

Whilst we know from the pre-existing literature that MSK triage is effective at decreasing waiting times for secondary care orthopaedics and rheumatology (Fennelly et al., 2018), we do not know what happens to these patients following MSK triage attendance. There is no national research on patient outcomes or what factors may predict patient outcomes in this cohort. The high discharge rate from MSK triage warrants further exploration. It is potentially a consequence of insufficient resources in primary care services resulting in referring practitioners generating referrals to multiple services in primary and secondary care to access the quickest care, and not necessarily the right care at the right time, in line with the Irish government health reform plan (Burke et al., 2018). Identifying predictors of outcome (pain and function) at 12 months has the potential to inform decision making on the optimal patient pathway and trajectory of care by enabling the identification of those at risk of a poor outcome at 1 year, earlier in their journey.

Burke S, Barry S, Siersbaek R, Johnston B, Ní Fhallúin M, Thomas S. Sláintecare - A ten-year plan to achieve universal healthcare in Ireland. Health Policy. 2018 Dec;122(12):1278-1282. doi: 10.1016/j.healthpol.2018.05.006. Epub 2018 May 22. PMID: 29843901.

Fennelly O, Blake C, FitzGerald O, Breen R, Ashton J, Brennan A, Caffrey A, Desmeules F, Cunningham C. Advanced practice physiotherapy-led triage in Irish orthopaedic and rheumatology services: national data audit. BMC Musculoskelet Disord. 2018 Jun 1;19(1):181. doi: 10.1186/s12891-018-2106-7. PMID: 29859072; PMCID: PMC5984783.

Reviewer comment 2:
Also, while the authors refer to previous SRs of predictors of pain and function in MSK conditions. It would be useful to know what type of patient population these relate to (primary care or secondary care).

The manuscript has been updated to reflect this in the introduction section.

Reviewer comment 3:
It is stated that MSK triage clinics have not been studied, which is true, however this cohort are essentially very similar to cohort attending secondary care elective orthopaedic clinics, what are the main findings from these studies?

As the focus of this study is on patients who do not receive specialist orthopaedic or rheumatology care, rather than all patients who attend elective orthopaedic clinics, the below sentence in the introduction has been reworded as follows for clarification. Additionally, we’re primarily interested in participants clinical course (i.e. healthcare utilisation) and outcomes over 1 year following their MSK triage appointment. The findings from our study will be discussed in comparison with pre-existing literature in the published paper.

‘However, currently, patient outcomes, prognostic stratification, and predictors of outcome up to 1-year later have not been consistently studied in patients attending MSK triage clinics, who do not require referral to specialist orthopaedic or rheumatology care, in Ireland or internationally’.
Thank you, Dr O’Leary, for your time and expertise in reviewing our protocol. We greatly appreciate all your comments and suggested amendments. We have reviewed and addressed each point you have raised below, and amended the paper accordingly.

Reviewer comment 1:
While the background contains interesting info on the MSK triage initiative it’s not clear from the Introduction why this is an important question?

Why is knowing predictors of outcome for this particular patient cohort at 1 year is important?

What are the implications of better predicting outcomes? Could it be used for early identification of those at risk of persistent pain and subsequent prioritisation by physiotherapy services?

How will this information be used to improve or better current MSK services in Ireland? (some mention of this in Discussion)

Whilst we know from the pre-existing literature that MSK triage is effective at decreasing waiting times for secondary care orthopaedics and rheumatology (Fennelly et al., 2018), we do not know what happens to these patients following MSK triage attendance. There is no national research on patient outcomes or what factors may predict patient outcomes in this cohort. The high discharge rate from MSK triage warrants further exploration. It is potentially a consequence of insufficient resources in primary care services resulting in referring practitioners generating referrals to multiple services in primary and secondary care to access the quickest care, and not necessarily the right care at the right time, in line with the Irish government health reform plan (Burke et al., 2018). Identifying predictors of outcome (pain and function) at 12 months has the potential to inform decision making on the optimal patient pathway and trajectory of care by enabling the identification of those at risk of a poor outcome at 1 year, earlier in their journey.

Burke S, Barry S, Siersbaek R, Johnston B, Ní Fhallúin M, Thomas S. Sláintecare - A ten-year plan to achieve universal healthcare in Ireland. Health Policy. 2018 Dec;122(12):1278-1282. doi: 10.1016/j.healthpol.2018.05.006. Epub 2018 May 22. PMID: 29843901.

Fennelly O, Blake C, FitzGerald O, Breen R, Ashton J, Brennan A, Caffrey A, Desmeules F, Cunningham C. Advanced practice physiotherapy-led triage in Irish orthopaedic and rheumatology services: national data audit. BMC Musculoskelet Disord. 2018 Jun 1;19(1):181. doi: 10.1186/s12891-018-2106-7. PMID: 29859072; PMCID: PMC5984783.

Reviewer comment 2:
Also, while the authors refer to previous SRs of predictors of pain and function in MSK conditions. It would be useful to know what type of patient population these relate to (primary care or secondary care).

The manuscript has been updated to reflect this in the introduction section.

Reviewer comment 3:
It is stated that MSK triage clinics have not been studied, which is true, however this cohort are essentially very similar to cohort attending secondary care elective orthopaedic clinics, what are the main findings from these studies?

As the focus of this study is on patients who do not receive specialist orthopaedic or rheumatology care, rather than all patients who attend elective orthopaedic clinics, the below sentence in the introduction has been reworded as follows for clarification. Additionally, we’re primarily interested in participants clinical course (i.e. healthcare utilisation) and outcomes over 1 year following their MSK triage appointment. The findings from our study will be discussed in comparison with pre-existing literature in the published paper.

‘However, currently, patient outcomes, prognostic stratification, and predictors of outcome up to 1-year later have not been consistently studied in patients attending MSK triage clinics, who do not require referral to specialist orthopaedic or rheumatology care, in Ireland or internationally’.
Competing Interests: No competing interests were disclosed. Close
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COMMENTS ON THIS REPORT

Author Response 23 Jan 2025

Fiona Callan, School of Physiotherapy, Royal College of Surgeons in Ireland, Dublin, Ireland

23 Jan 2025

Author Response
Thank you, Dr O’Leary, for your time and expertise in reviewing our protocol. We greatly appreciate all your comments and suggested amendments. We have reviewed and addressed each point you ... Continue reading
Thank you, Dr O’Leary, for your time and expertise in reviewing our protocol. We greatly appreciate all your comments and suggested amendments. We have reviewed and addressed each point you have raised below, and amended the paper accordingly.

Reviewer comment 1:
While the background contains interesting info on the MSK triage initiative it’s not clear from the Introduction why this is an important question?

Why is knowing predictors of outcome for this particular patient cohort at 1 year is important?

What are the implications of better predicting outcomes? Could it be used for early identification of those at risk of persistent pain and subsequent prioritisation by physiotherapy services?

How will this information be used to improve or better current MSK services in Ireland? (some mention of this in Discussion)

Whilst we know from the pre-existing literature that MSK triage is effective at decreasing waiting times for secondary care orthopaedics and rheumatology (Fennelly et al., 2018), we do not know what happens to these patients following MSK triage attendance. There is no national research on patient outcomes or what factors may predict patient outcomes in this cohort. The high discharge rate from MSK triage warrants further exploration. It is potentially a consequence of insufficient resources in primary care services resulting in referring practitioners generating referrals to multiple services in primary and secondary care to access the quickest care, and not necessarily the right care at the right time, in line with the Irish government health reform plan (Burke et al., 2018). Identifying predictors of outcome (pain and function) at 12 months has the potential to inform decision making on the optimal patient pathway and trajectory of care by enabling the identification of those at risk of a poor outcome at 1 year, earlier in their journey.

Burke S, Barry S, Siersbaek R, Johnston B, Ní Fhallúin M, Thomas S. Sláintecare - A ten-year plan to achieve universal healthcare in Ireland. Health Policy. 2018 Dec;122(12):1278-1282. doi: 10.1016/j.healthpol.2018.05.006. Epub 2018 May 22. PMID: 29843901.

Fennelly O, Blake C, FitzGerald O, Breen R, Ashton J, Brennan A, Caffrey A, Desmeules F, Cunningham C. Advanced practice physiotherapy-led triage in Irish orthopaedic and rheumatology services: national data audit. BMC Musculoskelet Disord. 2018 Jun 1;19(1):181. doi: 10.1186/s12891-018-2106-7. PMID: 29859072; PMCID: PMC5984783.

Reviewer comment 2:
Also, while the authors refer to previous SRs of predictors of pain and function in MSK conditions. It would be useful to know what type of patient population these relate to (primary care or secondary care).

The manuscript has been updated to reflect this in the introduction section.

Reviewer comment 3:
It is stated that MSK triage clinics have not been studied, which is true, however this cohort are essentially very similar to cohort attending secondary care elective orthopaedic clinics, what are the main findings from these studies?

As the focus of this study is on patients who do not receive specialist orthopaedic or rheumatology care, rather than all patients who attend elective orthopaedic clinics, the below sentence in the introduction has been reworded as follows for clarification. Additionally, we’re primarily interested in participants clinical course (i.e. healthcare utilisation) and outcomes over 1 year following their MSK triage appointment. The findings from our study will be discussed in comparison with pre-existing literature in the published paper.

‘However, currently, patient outcomes, prognostic stratification, and predictors of outcome up to 1-year later have not been consistently studied in patients attending MSK triage clinics, who do not require referral to specialist orthopaedic or rheumatology care, in Ireland or internationally’.
Thank you, Dr O’Leary, for your time and expertise in reviewing our protocol. We greatly appreciate all your comments and suggested amendments. We have reviewed and addressed each point you have raised below, and amended the paper accordingly.

Reviewer comment 1:
While the background contains interesting info on the MSK triage initiative it’s not clear from the Introduction why this is an important question?

Why is knowing predictors of outcome for this particular patient cohort at 1 year is important?

What are the implications of better predicting outcomes? Could it be used for early identification of those at risk of persistent pain and subsequent prioritisation by physiotherapy services?

How will this information be used to improve or better current MSK services in Ireland? (some mention of this in Discussion)

Whilst we know from the pre-existing literature that MSK triage is effective at decreasing waiting times for secondary care orthopaedics and rheumatology (Fennelly et al., 2018), we do not know what happens to these patients following MSK triage attendance. There is no national research on patient outcomes or what factors may predict patient outcomes in this cohort. The high discharge rate from MSK triage warrants further exploration. It is potentially a consequence of insufficient resources in primary care services resulting in referring practitioners generating referrals to multiple services in primary and secondary care to access the quickest care, and not necessarily the right care at the right time, in line with the Irish government health reform plan (Burke et al., 2018). Identifying predictors of outcome (pain and function) at 12 months has the potential to inform decision making on the optimal patient pathway and trajectory of care by enabling the identification of those at risk of a poor outcome at 1 year, earlier in their journey.

Burke S, Barry S, Siersbaek R, Johnston B, Ní Fhallúin M, Thomas S. Sláintecare - A ten-year plan to achieve universal healthcare in Ireland. Health Policy. 2018 Dec;122(12):1278-1282. doi: 10.1016/j.healthpol.2018.05.006. Epub 2018 May 22. PMID: 29843901.

Fennelly O, Blake C, FitzGerald O, Breen R, Ashton J, Brennan A, Caffrey A, Desmeules F, Cunningham C. Advanced practice physiotherapy-led triage in Irish orthopaedic and rheumatology services: national data audit. BMC Musculoskelet Disord. 2018 Jun 1;19(1):181. doi: 10.1186/s12891-018-2106-7. PMID: 29859072; PMCID: PMC5984783.

Reviewer comment 2:
Also, while the authors refer to previous SRs of predictors of pain and function in MSK conditions. It would be useful to know what type of patient population these relate to (primary care or secondary care).

The manuscript has been updated to reflect this in the introduction section.

Reviewer comment 3:
It is stated that MSK triage clinics have not been studied, which is true, however this cohort are essentially very similar to cohort attending secondary care elective orthopaedic clinics, what are the main findings from these studies?

As the focus of this study is on patients who do not receive specialist orthopaedic or rheumatology care, rather than all patients who attend elective orthopaedic clinics, the below sentence in the introduction has been reworded as follows for clarification. Additionally, we’re primarily interested in participants clinical course (i.e. healthcare utilisation) and outcomes over 1 year following their MSK triage appointment. The findings from our study will be discussed in comparison with pre-existing literature in the published paper.

‘However, currently, patient outcomes, prognostic stratification, and predictors of outcome up to 1-year later have not been consistently studied in patients attending MSK triage clinics, who do not require referral to specialist orthopaedic or rheumatology care, in Ireland or internationally’.
Competing Interests: No competing interests were disclosed. Close
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Reviewer Report 01 Feb 2024

Karin Samsson, University of Gothenburg, Gothenburg, Sweden

Approved with Reservations

https://doi.org/10.21956/hrbopenres.15061.r37424

This is an important aspect to address in research, to improve on the knowledge regarding the patients that are referred for MSK triage. Furthermore, to be able to screen patients prior to referral could reduce waiting times as well as ... Continue reading

You state in the introduction that 71% of patients were discharged at their initial appointment and 23% referred to physiotherapy, which makes me wonder. The 71% who were discharged, do you think that they would have needed different care than what they received? And since this large number of patients were discharged, and not referred to physiotherapy, why do you think predictors of clinical outcome and prognostic factors for MSK pain. is important to investigate for this patients group?
The aims are not consistently reported throughout the paper.
You have a great number of predictors and outcomes, but I struggle to make them out clearly since they are inconsistently reported in introduction and various sections in the methods. It would be highly beneficial for the reader to have these clearly and consistently presented regarding what outcome you want to measure and what outcome measure you use. Furthermore, to use the same terms i.e. in some sections you use workers' sick leave, sick leave or work-related factors.

Participants
Regarding patients included in the study - who is responsible for deciding which patients are "unlikely to require consultant care" and based on what?
Are the patients to be included in the study after the triage? When is the patient asked to participate? And why don’t you include the patients in need of orthopaedic surgeon to be able to investigate predictors of clinical outcome and prognostic factors for MSK pain for them as well? Considering that 71% are discharged, it would probably be quite beneficial to know if there is a difference between these two groups.

Sample size
There is no formal sample size calculation.

Recruitment and data collection
You state that the MSK triage physiotherapist will identify and screen prospective participants for eligibility – is this before the actual triage? I think this process needs to be clearly described (as also addressed in previous question).
If I understand correctly you are collecting two written consents? What is the purpose of that?
Why did you chose to have a teams or telephone data collection as well as questionnaires?
Inconsistent reporting of outcomes collected and through what outcome measures, order and the use of abbreviations or not. Furthermore not clear which ones are collected via self-reported questionnaires vs telephone/teams. Furthermore, not all outcomes are included in the primary or secondary outcomes.
The outcome health literacy is not mentioned or described prior to data collection.
The whole section starting with “Pain hypersensitivity, measured by… / (Figure 1) seems more to belong in the introduction section.
Outcomes
Outcomes are not consistent with aims.

Is the rationale for, and objectives of, the study clearly described?

Partly
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Physiotherapist led orthopaedic triage. Have not focused on the statistics part as that is not my area of expertise.

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Author Response 23 Jan 2025

Fiona Callan, School of Physiotherapy, Royal College of Surgeons in Ireland, Dublin, Ireland

23 Jan 2025

Author Response
Thank you, Dr Samsson, for your time and expertise in reviewing our protocol. We greatly appreciate all your comments and suggested amendments. We have reviewed and addressed each point you ... Continue reading
Thank you, Dr Samsson, for your time and expertise in reviewing our protocol. We greatly appreciate all your comments and suggested amendments. We have reviewed and addressed each point you have raised below, and amended the paper accordingly.

Reviewer Comment 1:
You state in the introduction that 71% of patients were discharged at their initial appointment and 23% referred to physiotherapy, which makes me wonder. The 71% who were discharged, do you think that they would have needed different care than what they received? And since this large number of patients were discharged, and not referred to physiotherapy, why do you think predictors of clinical outcome and prognostic factors for MSK pain is important to investigate for this patients group?

Currently, we do not know from the literature why there is a high discharge rate, nor why a lower percentage are referred to physiotherapy. Historically waiting times to access primary care physiotherapy and secondary care services in Ireland (e.g. pain management, orthopaedics, rheumatology) are long, resulting in delays to patients accessing MSK care. It is hypothesised that many patients are referred for imaging, primary care physiotherapy and secondary care orthopaedics or rheumatology simultaneously in order to receive the quickest care in the absence of a resourced stepwise integrated care pathway. Therefore, we wanted to study the cohort of patients who attended secondary care MSK triage services and did not require surgical or medical input from the orthopaedic surgeon or rheumatologist to better understand their healthcare journey (healthcare utilisation), clinical outcomes (pain and function) and predictors of outcome. We have reflected the importance of this research study in the introduction section.

Reviewer Comment 2:
The aims are not consistently reported throughout the paper.

We have updated and addressed the aims of our study in the introduction, methods and discussion sections.

Reviewer comment 3:
You have a great number of predictors and outcomes, but I struggle to make them out clearly since they are inconsistently reported in introduction and various sections in the methods. It would be highly beneficial for the reader to have these clearly and consistently presented regarding what outcome you want to measure and what outcome measure you use. Furthermore, to use the same terms i.e. in some sections you use workers' sick leave, sick leave or work-related factors.

Primary outcomes, secondary outcomes and predictor variables are outlined in Table 1, along with their method of collection (e.g. Microsoft teams/telephone or REDCap/postal questionnaire).

Reviewer comment 4:
Regarding patients included in the study - who is responsible for deciding which patients are "unlikely to require consultant care" and based on what?

Participants in this study will be recruited after attending a MSK triage clinic in a participating site. There, a MSK triage physiotherapist will triage the patient and decide if the patient requires consultant review for surgical or medical management, or alternative management options (e.g. discharge to GP, physiotherapy referral, referral for imaging, pain medicine referral etc.) as is their normal clinical practice. Only those patients who do not require consultant referral following MSK triage review are eligible for inclusion in this study. It’s at this point, once the decision for non-consultant care is decided and eligibility is determined, that participants are invited to participate in the study by the MSK triage physiotherapist.

Reviewer comment 5:
Are the patients to be included in the study after the triage? When is the patient asked to participate? And why don’t you include the patients in need of orthopaedic surgeon to be able to investigate predictors of clinical outcome and prognostic factors for MSK pain for them as well? Considering that 71% are discharged, it would probably be quite beneficial to know if there is a difference between these two groups.

The purpose of this research was to evaluate the patient journey through MSK triage services in Ireland of those who, in reality may never have needed to attend secondary care. Whilst lots of research has reported the percentage of patients who are discharged from MSK triage, without needing specialist referral, there is limited research on their outcomes up to one–year. Therefore, we excluded those patients who required onward referral to consultant orthopaedic surgeons or rheumatologists, as they may often require surgical management (e.g. joint replacement surgery) or medical management of a systemic condition (e.g. inflammatory arthritis). There is also a cohort of patients, whom following GP referral, are seen directly by the consultant, following triaging of referrals. This cohort of patients do not attend MSK triage and are instead managed directly by the consultant. Therefore, we wanted to focus on the cohort of patients who did not require consultant led surgical or medical management to evaluate their outcomes (pain and function) and healthcare utilisation following MSK triage and identify predictors of outcome, which may help inform the development of modernised care pathways for the management of musculoskeletal pain.

Reviewer comment 6:
You state that the MSK triage physiotherapist will identify and screen prospective participants for eligibility – is this before the actual triage? I think this process needs to be clearly described (as also addressed in previous question).

This has been updated in the ‘Recruitment and Data Collection’ section to say “The MSK triage physiotherapist will identify and screen prospective participants for eligibility following their MSK triage appointment”. Therefore, eligibility can only be determined once the triage appointment is complete.

Reviewer comment 7:
There is no formal sample size calculation.

Patient outcomes and potential explanatory variables associated with outcomes up to 1-year after musculoskeletal triage review have not been consistently studied in patients attending MSK triage clinics in Ireland or internationally, and thus there is limited information on potential explanatory variables associated with pain. We agree the number "10" is somewhat arbitrary, and its applicability can vary depending on the context and characteristics of the data (Vittinghoff and Mcculloch, 2007, Peduzzi et al., 1996). We used this as a guideline to the minimum sample size required, acknowledging practical constraints, and carefully considering explanatory variables to explore in this study based on theory and previous research.

Please also refer to our response to Reviewer 1 regarding the sample size query

Vittinghoff E, McCulloch CE. Relaxing the rule of ten events per variable in logistic and Cox regression. Am J Epidemiol. 2007;165(6):710-8.

Peduzzi P, Concato J, Kemper E, Holford TR, Feinstein AR. A simulation study of the number of events per variable in logistic regression analysis. J Clin Epidemiol. 1996;49(12):1373-9.

Reviewer comment 8:
If I understand correctly you are collecting two written consents? What is the purpose of that?

A cooling off period is required between the time of introduction to the study and the obtaining of informed consent. The researcher (FC) is not present at the MSK triage clinics and due to the busy nature of these clinics, it would not be feasible to allow for a cooling off period on the day. Therefore, MSK triage physios, upon introducing the study to the patient obtain consent to contact(i.e. be contacted by the research team) from interested patients. This allows the researcher (FC) to contact the participant the following day (12-24 hours later) to obtain informed consent and recruit participants to the study. This is in line with our research ethics requirements.

Reviewer comment 9:
Why did you chose to have a teams or telephone data collection as well as questionnaires?

The patient demographic attending MSK triage clinics have varied information technology (IT) skills, therefore we decided it would be best to offer those with limited IT skills the ability to still participate by allowing for telephone call assessments and paper questionnaires.

This sentence in the recruitment and data collection section has been updated as follows:
‘This data will be collected through Research Electronic Data capture (REDCap) software (28, 29), hosted at RCSI, on their personal device, or via posted paper questionnaires to facilitate participants with limited information technology skills.’

Reviewer comment 10:
Inconsistent reporting of outcomes collected and through what outcome measures, order and the use of abbreviations or not. Furthermore not clear which ones are collected via self-reported questionnaires vs telephone/teams. Furthermore, not all outcomes are included in the primary or secondary outcomes.

All predictor variables and outcomes are outlined in table 1, along with their method of collection (e.g. Microsoft teams/telephone or REDCap/postal questionnaire). Consistency in reporting of outcomes/variables and the measures used has been revised in the new manuscript.

Reviewer comment 11:
The outcome health literacy is not mentioned or described prior to data collection.

Health literacy is now included in the introduction and data collection sections along with table 1.

Reviewer comment 12:
The whole section starting with “Pain hypersensitivity, measured by… / (Figure 1) seems more to belong in the introduction section.

This was included to further describe the quantitative sensory testing component of this project. Reference to altered pain processing is also included in the introduction section.

Reviewer comment 13:

Outcomes are not consistent with aims.

We have revised our aims to align with our outcomes in the revised manuscript.
Thank you, Dr Samsson, for your time and expertise in reviewing our protocol. We greatly appreciate all your comments and suggested amendments. We have reviewed and addressed each point you have raised below, and amended the paper accordingly.

Reviewer Comment 1:
You state in the introduction that 71% of patients were discharged at their initial appointment and 23% referred to physiotherapy, which makes me wonder. The 71% who were discharged, do you think that they would have needed different care than what they received? And since this large number of patients were discharged, and not referred to physiotherapy, why do you think predictors of clinical outcome and prognostic factors for MSK pain is important to investigate for this patients group?

Currently, we do not know from the literature why there is a high discharge rate, nor why a lower percentage are referred to physiotherapy. Historically waiting times to access primary care physiotherapy and secondary care services in Ireland (e.g. pain management, orthopaedics, rheumatology) are long, resulting in delays to patients accessing MSK care. It is hypothesised that many patients are referred for imaging, primary care physiotherapy and secondary care orthopaedics or rheumatology simultaneously in order to receive the quickest care in the absence of a resourced stepwise integrated care pathway. Therefore, we wanted to study the cohort of patients who attended secondary care MSK triage services and did not require surgical or medical input from the orthopaedic surgeon or rheumatologist to better understand their healthcare journey (healthcare utilisation), clinical outcomes (pain and function) and predictors of outcome. We have reflected the importance of this research study in the introduction section.

Reviewer Comment 2:
The aims are not consistently reported throughout the paper.

We have updated and addressed the aims of our study in the introduction, methods and discussion sections.

Reviewer comment 3:
You have a great number of predictors and outcomes, but I struggle to make them out clearly since they are inconsistently reported in introduction and various sections in the methods. It would be highly beneficial for the reader to have these clearly and consistently presented regarding what outcome you want to measure and what outcome measure you use. Furthermore, to use the same terms i.e. in some sections you use workers' sick leave, sick leave or work-related factors.

Primary outcomes, secondary outcomes and predictor variables are outlined in Table 1, along with their method of collection (e.g. Microsoft teams/telephone or REDCap/postal questionnaire).

Reviewer comment 4:
Regarding patients included in the study - who is responsible for deciding which patients are "unlikely to require consultant care" and based on what?

Participants in this study will be recruited after attending a MSK triage clinic in a participating site. There, a MSK triage physiotherapist will triage the patient and decide if the patient requires consultant review for surgical or medical management, or alternative management options (e.g. discharge to GP, physiotherapy referral, referral for imaging, pain medicine referral etc.) as is their normal clinical practice. Only those patients who do not require consultant referral following MSK triage review are eligible for inclusion in this study. It’s at this point, once the decision for non-consultant care is decided and eligibility is determined, that participants are invited to participate in the study by the MSK triage physiotherapist.

Reviewer comment 5:
Are the patients to be included in the study after the triage? When is the patient asked to participate? And why don’t you include the patients in need of orthopaedic surgeon to be able to investigate predictors of clinical outcome and prognostic factors for MSK pain for them as well? Considering that 71% are discharged, it would probably be quite beneficial to know if there is a difference between these two groups.

The purpose of this research was to evaluate the patient journey through MSK triage services in Ireland of those who, in reality may never have needed to attend secondary care. Whilst lots of research has reported the percentage of patients who are discharged from MSK triage, without needing specialist referral, there is limited research on their outcomes up to one–year. Therefore, we excluded those patients who required onward referral to consultant orthopaedic surgeons or rheumatologists, as they may often require surgical management (e.g. joint replacement surgery) or medical management of a systemic condition (e.g. inflammatory arthritis). There is also a cohort of patients, whom following GP referral, are seen directly by the consultant, following triaging of referrals. This cohort of patients do not attend MSK triage and are instead managed directly by the consultant. Therefore, we wanted to focus on the cohort of patients who did not require consultant led surgical or medical management to evaluate their outcomes (pain and function) and healthcare utilisation following MSK triage and identify predictors of outcome, which may help inform the development of modernised care pathways for the management of musculoskeletal pain.

Reviewer comment 6:
You state that the MSK triage physiotherapist will identify and screen prospective participants for eligibility – is this before the actual triage? I think this process needs to be clearly described (as also addressed in previous question).

This has been updated in the ‘Recruitment and Data Collection’ section to say “The MSK triage physiotherapist will identify and screen prospective participants for eligibility following their MSK triage appointment”. Therefore, eligibility can only be determined once the triage appointment is complete.

Reviewer comment 7:
There is no formal sample size calculation.

Patient outcomes and potential explanatory variables associated with outcomes up to 1-year after musculoskeletal triage review have not been consistently studied in patients attending MSK triage clinics in Ireland or internationally, and thus there is limited information on potential explanatory variables associated with pain. We agree the number "10" is somewhat arbitrary, and its applicability can vary depending on the context and characteristics of the data (Vittinghoff and Mcculloch, 2007, Peduzzi et al., 1996). We used this as a guideline to the minimum sample size required, acknowledging practical constraints, and carefully considering explanatory variables to explore in this study based on theory and previous research.

Please also refer to our response to Reviewer 1 regarding the sample size query

Vittinghoff E, McCulloch CE. Relaxing the rule of ten events per variable in logistic and Cox regression. Am J Epidemiol. 2007;165(6):710-8.

Peduzzi P, Concato J, Kemper E, Holford TR, Feinstein AR. A simulation study of the number of events per variable in logistic regression analysis. J Clin Epidemiol. 1996;49(12):1373-9.

Reviewer comment 8:
If I understand correctly you are collecting two written consents? What is the purpose of that?

A cooling off period is required between the time of introduction to the study and the obtaining of informed consent. The researcher (FC) is not present at the MSK triage clinics and due to the busy nature of these clinics, it would not be feasible to allow for a cooling off period on the day. Therefore, MSK triage physios, upon introducing the study to the patient obtain consent to contact(i.e. be contacted by the research team) from interested patients. This allows the researcher (FC) to contact the participant the following day (12-24 hours later) to obtain informed consent and recruit participants to the study. This is in line with our research ethics requirements.

Reviewer comment 9:
Why did you chose to have a teams or telephone data collection as well as questionnaires?

The patient demographic attending MSK triage clinics have varied information technology (IT) skills, therefore we decided it would be best to offer those with limited IT skills the ability to still participate by allowing for telephone call assessments and paper questionnaires.

This sentence in the recruitment and data collection section has been updated as follows:
‘This data will be collected through Research Electronic Data capture (REDCap) software (28, 29), hosted at RCSI, on their personal device, or via posted paper questionnaires to facilitate participants with limited information technology skills.’

Reviewer comment 10:
Inconsistent reporting of outcomes collected and through what outcome measures, order and the use of abbreviations or not. Furthermore not clear which ones are collected via self-reported questionnaires vs telephone/teams. Furthermore, not all outcomes are included in the primary or secondary outcomes.

All predictor variables and outcomes are outlined in table 1, along with their method of collection (e.g. Microsoft teams/telephone or REDCap/postal questionnaire). Consistency in reporting of outcomes/variables and the measures used has been revised in the new manuscript.

Reviewer comment 11:
The outcome health literacy is not mentioned or described prior to data collection.

Health literacy is now included in the introduction and data collection sections along with table 1.

Reviewer comment 12:
The whole section starting with “Pain hypersensitivity, measured by… / (Figure 1) seems more to belong in the introduction section.

This was included to further describe the quantitative sensory testing component of this project. Reference to altered pain processing is also included in the introduction section.

Reviewer comment 13:

Outcomes are not consistent with aims.

We have revised our aims to align with our outcomes in the revised manuscript.
Competing Interests: No competing interests were disclosed. Close
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COMMENTS ON THIS REPORT

Author Response 23 Jan 2025

Fiona Callan, School of Physiotherapy, Royal College of Surgeons in Ireland, Dublin, Ireland

23 Jan 2025

Author Response
Thank you, Dr Samsson, for your time and expertise in reviewing our protocol. We greatly appreciate all your comments and suggested amendments. We have reviewed and addressed each point you ... Continue reading
Thank you, Dr Samsson, for your time and expertise in reviewing our protocol. We greatly appreciate all your comments and suggested amendments. We have reviewed and addressed each point you have raised below, and amended the paper accordingly.

Reviewer Comment 1:
You state in the introduction that 71% of patients were discharged at their initial appointment and 23% referred to physiotherapy, which makes me wonder. The 71% who were discharged, do you think that they would have needed different care than what they received? And since this large number of patients were discharged, and not referred to physiotherapy, why do you think predictors of clinical outcome and prognostic factors for MSK pain is important to investigate for this patients group?

Currently, we do not know from the literature why there is a high discharge rate, nor why a lower percentage are referred to physiotherapy. Historically waiting times to access primary care physiotherapy and secondary care services in Ireland (e.g. pain management, orthopaedics, rheumatology) are long, resulting in delays to patients accessing MSK care. It is hypothesised that many patients are referred for imaging, primary care physiotherapy and secondary care orthopaedics or rheumatology simultaneously in order to receive the quickest care in the absence of a resourced stepwise integrated care pathway. Therefore, we wanted to study the cohort of patients who attended secondary care MSK triage services and did not require surgical or medical input from the orthopaedic surgeon or rheumatologist to better understand their healthcare journey (healthcare utilisation), clinical outcomes (pain and function) and predictors of outcome. We have reflected the importance of this research study in the introduction section.

Reviewer Comment 2:
The aims are not consistently reported throughout the paper.

We have updated and addressed the aims of our study in the introduction, methods and discussion sections.

Reviewer comment 3:
You have a great number of predictors and outcomes, but I struggle to make them out clearly since they are inconsistently reported in introduction and various sections in the methods. It would be highly beneficial for the reader to have these clearly and consistently presented regarding what outcome you want to measure and what outcome measure you use. Furthermore, to use the same terms i.e. in some sections you use workers' sick leave, sick leave or work-related factors.

Primary outcomes, secondary outcomes and predictor variables are outlined in Table 1, along with their method of collection (e.g. Microsoft teams/telephone or REDCap/postal questionnaire).

Reviewer comment 4:
Regarding patients included in the study - who is responsible for deciding which patients are "unlikely to require consultant care" and based on what?

Participants in this study will be recruited after attending a MSK triage clinic in a participating site. There, a MSK triage physiotherapist will triage the patient and decide if the patient requires consultant review for surgical or medical management, or alternative management options (e.g. discharge to GP, physiotherapy referral, referral for imaging, pain medicine referral etc.) as is their normal clinical practice. Only those patients who do not require consultant referral following MSK triage review are eligible for inclusion in this study. It’s at this point, once the decision for non-consultant care is decided and eligibility is determined, that participants are invited to participate in the study by the MSK triage physiotherapist.

Reviewer comment 5:
Are the patients to be included in the study after the triage? When is the patient asked to participate? And why don’t you include the patients in need of orthopaedic surgeon to be able to investigate predictors of clinical outcome and prognostic factors for MSK pain for them as well? Considering that 71% are discharged, it would probably be quite beneficial to know if there is a difference between these two groups.

The purpose of this research was to evaluate the patient journey through MSK triage services in Ireland of those who, in reality may never have needed to attend secondary care. Whilst lots of research has reported the percentage of patients who are discharged from MSK triage, without needing specialist referral, there is limited research on their outcomes up to one–year. Therefore, we excluded those patients who required onward referral to consultant orthopaedic surgeons or rheumatologists, as they may often require surgical management (e.g. joint replacement surgery) or medical management of a systemic condition (e.g. inflammatory arthritis). There is also a cohort of patients, whom following GP referral, are seen directly by the consultant, following triaging of referrals. This cohort of patients do not attend MSK triage and are instead managed directly by the consultant. Therefore, we wanted to focus on the cohort of patients who did not require consultant led surgical or medical management to evaluate their outcomes (pain and function) and healthcare utilisation following MSK triage and identify predictors of outcome, which may help inform the development of modernised care pathways for the management of musculoskeletal pain.

Reviewer comment 6:
You state that the MSK triage physiotherapist will identify and screen prospective participants for eligibility – is this before the actual triage? I think this process needs to be clearly described (as also addressed in previous question).

This has been updated in the ‘Recruitment and Data Collection’ section to say “The MSK triage physiotherapist will identify and screen prospective participants for eligibility following their MSK triage appointment”. Therefore, eligibility can only be determined once the triage appointment is complete.

Reviewer comment 7:
There is no formal sample size calculation.

Patient outcomes and potential explanatory variables associated with outcomes up to 1-year after musculoskeletal triage review have not been consistently studied in patients attending MSK triage clinics in Ireland or internationally, and thus there is limited information on potential explanatory variables associated with pain. We agree the number "10" is somewhat arbitrary, and its applicability can vary depending on the context and characteristics of the data (Vittinghoff and Mcculloch, 2007, Peduzzi et al., 1996). We used this as a guideline to the minimum sample size required, acknowledging practical constraints, and carefully considering explanatory variables to explore in this study based on theory and previous research.

Please also refer to our response to Reviewer 1 regarding the sample size query

Vittinghoff E, McCulloch CE. Relaxing the rule of ten events per variable in logistic and Cox regression. Am J Epidemiol. 2007;165(6):710-8.

Peduzzi P, Concato J, Kemper E, Holford TR, Feinstein AR. A simulation study of the number of events per variable in logistic regression analysis. J Clin Epidemiol. 1996;49(12):1373-9.

Reviewer comment 8:
If I understand correctly you are collecting two written consents? What is the purpose of that?

A cooling off period is required between the time of introduction to the study and the obtaining of informed consent. The researcher (FC) is not present at the MSK triage clinics and due to the busy nature of these clinics, it would not be feasible to allow for a cooling off period on the day. Therefore, MSK triage physios, upon introducing the study to the patient obtain consent to contact(i.e. be contacted by the research team) from interested patients. This allows the researcher (FC) to contact the participant the following day (12-24 hours later) to obtain informed consent and recruit participants to the study. This is in line with our research ethics requirements.

Reviewer comment 9:
Why did you chose to have a teams or telephone data collection as well as questionnaires?

The patient demographic attending MSK triage clinics have varied information technology (IT) skills, therefore we decided it would be best to offer those with limited IT skills the ability to still participate by allowing for telephone call assessments and paper questionnaires.

This sentence in the recruitment and data collection section has been updated as follows:
‘This data will be collected through Research Electronic Data capture (REDCap) software (28, 29), hosted at RCSI, on their personal device, or via posted paper questionnaires to facilitate participants with limited information technology skills.’

Reviewer comment 10:
Inconsistent reporting of outcomes collected and through what outcome measures, order and the use of abbreviations or not. Furthermore not clear which ones are collected via self-reported questionnaires vs telephone/teams. Furthermore, not all outcomes are included in the primary or secondary outcomes.

All predictor variables and outcomes are outlined in table 1, along with their method of collection (e.g. Microsoft teams/telephone or REDCap/postal questionnaire). Consistency in reporting of outcomes/variables and the measures used has been revised in the new manuscript.

Reviewer comment 11:
The outcome health literacy is not mentioned or described prior to data collection.

Health literacy is now included in the introduction and data collection sections along with table 1.

Reviewer comment 12:
The whole section starting with “Pain hypersensitivity, measured by… / (Figure 1) seems more to belong in the introduction section.

This was included to further describe the quantitative sensory testing component of this project. Reference to altered pain processing is also included in the introduction section.

Reviewer comment 13:

Outcomes are not consistent with aims.

We have revised our aims to align with our outcomes in the revised manuscript.
Thank you, Dr Samsson, for your time and expertise in reviewing our protocol. We greatly appreciate all your comments and suggested amendments. We have reviewed and addressed each point you have raised below, and amended the paper accordingly.

Reviewer Comment 1:
You state in the introduction that 71% of patients were discharged at their initial appointment and 23% referred to physiotherapy, which makes me wonder. The 71% who were discharged, do you think that they would have needed different care than what they received? And since this large number of patients were discharged, and not referred to physiotherapy, why do you think predictors of clinical outcome and prognostic factors for MSK pain is important to investigate for this patients group?

Currently, we do not know from the literature why there is a high discharge rate, nor why a lower percentage are referred to physiotherapy. Historically waiting times to access primary care physiotherapy and secondary care services in Ireland (e.g. pain management, orthopaedics, rheumatology) are long, resulting in delays to patients accessing MSK care. It is hypothesised that many patients are referred for imaging, primary care physiotherapy and secondary care orthopaedics or rheumatology simultaneously in order to receive the quickest care in the absence of a resourced stepwise integrated care pathway. Therefore, we wanted to study the cohort of patients who attended secondary care MSK triage services and did not require surgical or medical input from the orthopaedic surgeon or rheumatologist to better understand their healthcare journey (healthcare utilisation), clinical outcomes (pain and function) and predictors of outcome. We have reflected the importance of this research study in the introduction section.

Reviewer Comment 2:
The aims are not consistently reported throughout the paper.

We have updated and addressed the aims of our study in the introduction, methods and discussion sections.

Reviewer comment 3:
You have a great number of predictors and outcomes, but I struggle to make them out clearly since they are inconsistently reported in introduction and various sections in the methods. It would be highly beneficial for the reader to have these clearly and consistently presented regarding what outcome you want to measure and what outcome measure you use. Furthermore, to use the same terms i.e. in some sections you use workers' sick leave, sick leave or work-related factors.

Primary outcomes, secondary outcomes and predictor variables are outlined in Table 1, along with their method of collection (e.g. Microsoft teams/telephone or REDCap/postal questionnaire).

Reviewer comment 4:
Regarding patients included in the study - who is responsible for deciding which patients are "unlikely to require consultant care" and based on what?

Participants in this study will be recruited after attending a MSK triage clinic in a participating site. There, a MSK triage physiotherapist will triage the patient and decide if the patient requires consultant review for surgical or medical management, or alternative management options (e.g. discharge to GP, physiotherapy referral, referral for imaging, pain medicine referral etc.) as is their normal clinical practice. Only those patients who do not require consultant referral following MSK triage review are eligible for inclusion in this study. It’s at this point, once the decision for non-consultant care is decided and eligibility is determined, that participants are invited to participate in the study by the MSK triage physiotherapist.

Reviewer comment 5:
Are the patients to be included in the study after the triage? When is the patient asked to participate? And why don’t you include the patients in need of orthopaedic surgeon to be able to investigate predictors of clinical outcome and prognostic factors for MSK pain for them as well? Considering that 71% are discharged, it would probably be quite beneficial to know if there is a difference between these two groups.

The purpose of this research was to evaluate the patient journey through MSK triage services in Ireland of those who, in reality may never have needed to attend secondary care. Whilst lots of research has reported the percentage of patients who are discharged from MSK triage, without needing specialist referral, there is limited research on their outcomes up to one–year. Therefore, we excluded those patients who required onward referral to consultant orthopaedic surgeons or rheumatologists, as they may often require surgical management (e.g. joint replacement surgery) or medical management of a systemic condition (e.g. inflammatory arthritis). There is also a cohort of patients, whom following GP referral, are seen directly by the consultant, following triaging of referrals. This cohort of patients do not attend MSK triage and are instead managed directly by the consultant. Therefore, we wanted to focus on the cohort of patients who did not require consultant led surgical or medical management to evaluate their outcomes (pain and function) and healthcare utilisation following MSK triage and identify predictors of outcome, which may help inform the development of modernised care pathways for the management of musculoskeletal pain.

Reviewer comment 6:
You state that the MSK triage physiotherapist will identify and screen prospective participants for eligibility – is this before the actual triage? I think this process needs to be clearly described (as also addressed in previous question).

This has been updated in the ‘Recruitment and Data Collection’ section to say “The MSK triage physiotherapist will identify and screen prospective participants for eligibility following their MSK triage appointment”. Therefore, eligibility can only be determined once the triage appointment is complete.

Reviewer comment 7:
There is no formal sample size calculation.

Patient outcomes and potential explanatory variables associated with outcomes up to 1-year after musculoskeletal triage review have not been consistently studied in patients attending MSK triage clinics in Ireland or internationally, and thus there is limited information on potential explanatory variables associated with pain. We agree the number "10" is somewhat arbitrary, and its applicability can vary depending on the context and characteristics of the data (Vittinghoff and Mcculloch, 2007, Peduzzi et al., 1996). We used this as a guideline to the minimum sample size required, acknowledging practical constraints, and carefully considering explanatory variables to explore in this study based on theory and previous research.

Please also refer to our response to Reviewer 1 regarding the sample size query

Vittinghoff E, McCulloch CE. Relaxing the rule of ten events per variable in logistic and Cox regression. Am J Epidemiol. 2007;165(6):710-8.

Peduzzi P, Concato J, Kemper E, Holford TR, Feinstein AR. A simulation study of the number of events per variable in logistic regression analysis. J Clin Epidemiol. 1996;49(12):1373-9.

Reviewer comment 8:
If I understand correctly you are collecting two written consents? What is the purpose of that?

A cooling off period is required between the time of introduction to the study and the obtaining of informed consent. The researcher (FC) is not present at the MSK triage clinics and due to the busy nature of these clinics, it would not be feasible to allow for a cooling off period on the day. Therefore, MSK triage physios, upon introducing the study to the patient obtain consent to contact(i.e. be contacted by the research team) from interested patients. This allows the researcher (FC) to contact the participant the following day (12-24 hours later) to obtain informed consent and recruit participants to the study. This is in line with our research ethics requirements.

Reviewer comment 9:
Why did you chose to have a teams or telephone data collection as well as questionnaires?

The patient demographic attending MSK triage clinics have varied information technology (IT) skills, therefore we decided it would be best to offer those with limited IT skills the ability to still participate by allowing for telephone call assessments and paper questionnaires.

This sentence in the recruitment and data collection section has been updated as follows:
‘This data will be collected through Research Electronic Data capture (REDCap) software (28, 29), hosted at RCSI, on their personal device, or via posted paper questionnaires to facilitate participants with limited information technology skills.’

Reviewer comment 10:
Inconsistent reporting of outcomes collected and through what outcome measures, order and the use of abbreviations or not. Furthermore not clear which ones are collected via self-reported questionnaires vs telephone/teams. Furthermore, not all outcomes are included in the primary or secondary outcomes.

All predictor variables and outcomes are outlined in table 1, along with their method of collection (e.g. Microsoft teams/telephone or REDCap/postal questionnaire). Consistency in reporting of outcomes/variables and the measures used has been revised in the new manuscript.

Reviewer comment 11:
The outcome health literacy is not mentioned or described prior to data collection.

Health literacy is now included in the introduction and data collection sections along with table 1.

Reviewer comment 12:
The whole section starting with “Pain hypersensitivity, measured by… / (Figure 1) seems more to belong in the introduction section.

This was included to further describe the quantitative sensory testing component of this project. Reference to altered pain processing is also included in the introduction section.

Reviewer comment 13:

Outcomes are not consistent with aims.

We have revised our aims to align with our outcomes in the revised manuscript.
Competing Interests: No competing interests were disclosed. Close
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Reviewer Report 16 Jan 2024

Subhash Aryal, University of Pennsylvania, Philadelphia, Pennsylvania, USA

Approved with Reservations

https://doi.org/10.21956/hrbopenres.15061.r37570

I focused on the statistical analysis component of the manuscript. Here are my specific concerns regarding this manuscript.

1) There is no formal sample size calculation. Rule of thumb of 10 events per variable is used. Software including PASS, SAS can actually provide a more formal sample size estimation.

2) The authors propose using repeated measures multivariable regression. I recommend being more specific in terms of whether it is random-effects model, covariance pattern model or marginal GEE model.

3) The authors have adjusted sample size to account for attrition. But missing data is not addressed in the statistical analysis plan.

4) If the authors are going to run separate models for baseline predictors of pain and function outcomes at three, six and the primary timepoint of 12 months, they should adjust the statistical significance level to adjust for inflated type I error rate.

5) There is no detail provided regarding the proposed Latent Class Analysis.

6) On page 4, column 2 the authors state "..... multiple MSK conditions (e.g., osteoarthritis, low back pain, whiplash, post-operative pain). It is quite possible that a large majority with post-operative pain may be lost to follow-up at 12 months. If the participant's pain is not chronic, they may drop-out of the study.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Biostatist

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Version 2

VERSION 2 PUBLISHED 06 Dec 2023

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Subhash Aryal, University of Pennsylvania, Philadelphia, USA
Karin Samsson, University of Gothenburg, Gothenburg, Sweden
helen o'leary, University of Limerick, Limerick, Ireland
Shahnawaz Anwer, The Hong Kong Polytechnic University, Hong Kong, Hong Kong

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25 Feb 2025 | for Version 2

Shahnawaz Anwer, The Hong Kong Polytechnic University, Hong Kong, Hong Kong

2 Views Cite this report Responses(0)

Approved With Reservations

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Rehabilitation, Osteoarthritis, Musculoskeletal Research, Ergonomics, Physical Fatigue

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14 Views

20 Feb 2024 | for Version 1

helen o'leary, University of Limerick, Limerick, County Limerick, Ireland

14 Views Cite this report Responses(1)

Approved

Is the rationale for, and objectives of, the study clearly described?

Partly
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

musculoskeletal pain, knee pain

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

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Author Response

23 Jan 2025

Fiona Callan, School of Physiotherapy, Royal College of Surgeons in Ireland, Dublin, Ireland

Thank you, Dr O’Leary, for your time and expertise in reviewing our protocol. We greatly appreciate all your comments and suggested amendments. We have reviewed and addressed each point you have raised below, and amended the paper accordingly.

Reviewer comment 1:
While the background contains interesting info on the MSK triage initiative it’s not clear from the Introduction why this is an important question?

Why is knowing predictors of outcome for this particular patient cohort at 1 year is important?
What are the implications of better predicting outcomes? Could it be used for early identification of those at risk of persistent pain and subsequent prioritisation by physiotherapy services?
How will this information be used to improve or better current MSK services in Ireland? (some mention of this in Discussion)

Whilst we know from the pre-existing literature that MSK triage is effective at decreasing waiting times for secondary care orthopaedics and rheumatology (Fennelly et al., 2018), we do not know what happens to these patients following MSK triage attendance. There is no national research on patient outcomes or what factors may predict patient outcomes in this cohort. The high discharge rate from MSK triage warrants further exploration. It is potentially a consequence of insufficient resources in primary care services resulting in referring practitioners generating referrals to multiple services in primary and secondary care to access the quickest care, and not necessarily the right care at the right time, in line with the Irish government health reform plan (Burke et al., 2018). Identifying predictors of outcome (pain and function) at 12 months has the potential to inform decision making on the optimal patient pathway and trajectory of care by enabling the identification of those at risk of a poor outcome at 1 year, earlier in their journey.

Burke S, Barry S, Siersbaek R, Johnston B, Ní Fhallúin M, Thomas S. Sláintecare - A ten-year plan to achieve universal healthcare in Ireland. Health Policy. 2018 Dec;122(12):1278-1282. doi: 10.1016/j.healthpol.2018.05.006. Epub 2018 May 22. PMID: 29843901.

Fennelly O, Blake C, FitzGerald O, Breen R, Ashton J, Brennan A, Caffrey A, Desmeules F, Cunningham C. Advanced practice physiotherapy-led triage in Irish orthopaedic and rheumatology services: national data audit. BMC Musculoskelet Disord. 2018 Jun 1;19(1):181. doi: 10.1186/s12891-018-2106-7. PMID: 29859072; PMCID: PMC5984783.

Reviewer comment 2:
Also, while the authors refer to previous SRs of predictors of pain and function in MSK conditions. It would be useful to know what type of patient population these relate to (primary care or secondary care).

The manuscript has been updated to reflect this in the introduction section.

Reviewer comment 3:
It is stated that MSK triage clinics have not been studied, which is true, however this cohort are essentially very similar to cohort attending secondary care elective orthopaedic clinics, what are the main findings from these studies?

As the focus of this study is on patients who do not receive specialist orthopaedic or rheumatology care, rather than all patients who attend elective orthopaedic clinics, the below sentence in the introduction has been reworded as follows for clarification. Additionally, we’re primarily interested in participants clinical course (i.e. healthcare utilisation) and outcomes over 1 year following their MSK triage appointment. The findings from our study will be discussed in comparison with pre-existing literature in the published paper.

‘However, currently, patient outcomes, prognostic stratification, and predictors of outcome up to 1-year later have not been consistently studied in patients attending MSK triage clinics, who do not require referral to specialist orthopaedic or rheumatology care, in Ireland or internationally’.

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Competing Interests

No competing interests were disclosed.

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Reviewer Report

10 Views

01 Feb 2024 | for Version 1

Karin Samsson, University of Gothenburg, Gothenburg, Sweden

10 Views Cite this report Responses(1)

Approved With Reservations

You state in the introduction that 71% of patients were discharged at their initial appointment and 23% referred to physiotherapy, which makes me wonder. The 71% who were discharged, do you think that they would have needed different care than what they received? And since this large number of patients were discharged, and not referred to physiotherapy, why do you think predictors of clinical outcome and prognostic factors for MSK pain. is important to investigate for this patients group?
The aims are not consistently reported throughout the paper.
You have a great number of predictors and outcomes, but I struggle to make them out clearly since they are inconsistently reported in introduction and various sections in the methods. It would be highly beneficial for the reader to have these clearly and consistently presented regarding what outcome you want to measure and what outcome measure you use. Furthermore, to use the same terms i.e. in some sections you use workers' sick leave, sick leave or work-related factors.

Participants
Regarding patients included in the study - who is responsible for deciding which patients are "unlikely to require consultant care" and based on what?
Are the patients to be included in the study after the triage? When is the patient asked to participate? And why don’t you include the patients in need of orthopaedic surgeon to be able to investigate predictors of clinical outcome and prognostic factors for MSK pain for them as well? Considering that 71% are discharged, it would probably be quite beneficial to know if there is a difference between these two groups.

Sample size
There is no formal sample size calculation.

Recruitment and data collection
You state that the MSK triage physiotherapist will identify and screen prospective participants for eligibility – is this before the actual triage? I think this process needs to be clearly described (as also addressed in previous question).
If I understand correctly you are collecting two written consents? What is the purpose of that?
Why did you chose to have a teams or telephone data collection as well as questionnaires?
Inconsistent reporting of outcomes collected and through what outcome measures, order and the use of abbreviations or not. Furthermore not clear which ones are collected via self-reported questionnaires vs telephone/teams. Furthermore, not all outcomes are included in the primary or secondary outcomes.
The outcome health literacy is not mentioned or described prior to data collection.
The whole section starting with “Pain hypersensitivity, measured by… / (Figure 1) seems more to belong in the introduction section.
Outcomes
Outcomes are not consistent with aims.

Is the rationale for, and objectives of, the study clearly described?

Partly
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Physiotherapist led orthopaedic triage. Have not focused on the statistics part as that is not my area of expertise.

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Responses (1)

Author Response

23 Jan 2025

Fiona Callan, School of Physiotherapy, Royal College of Surgeons in Ireland, Dublin, Ireland

Thank you, Dr Samsson, for your time and expertise in reviewing our protocol. We greatly appreciate all your comments and suggested amendments. We have reviewed and addressed each point you have raised below, and amended the paper accordingly.

Reviewer Comment 1:
You state in the introduction that 71% of patients were discharged at their initial appointment and 23% referred to physiotherapy, which makes me wonder. The 71% who were discharged, do you think that they would have needed different care than what they received? And since this large number of patients were discharged, and not referred to physiotherapy, why do you think predictors of clinical outcome and prognostic factors for MSK pain is important to investigate for this patients group?

Currently, we do not know from the literature why there is a high discharge rate, nor why a lower percentage are referred to physiotherapy. Historically waiting times to access primary care physiotherapy and secondary care services in Ireland (e.g. pain management, orthopaedics, rheumatology) are long, resulting in delays to patients accessing MSK care. It is hypothesised that many patients are referred for imaging, primary care physiotherapy and secondary care orthopaedics or rheumatology simultaneously in order to receive the quickest care in the absence of a resourced stepwise integrated care pathway. Therefore, we wanted to study the cohort of patients who attended secondary care MSK triage services and did not require surgical or medical input from the orthopaedic surgeon or rheumatologist to better understand their healthcare journey (healthcare utilisation), clinical outcomes (pain and function) and predictors of outcome. We have reflected the importance of this research study in the introduction section.

Reviewer Comment 2:
The aims are not consistently reported throughout the paper.

We have updated and addressed the aims of our study in the introduction, methods and discussion sections.

Reviewer comment 3:
You have a great number of predictors and outcomes, but I struggle to make them out clearly since they are inconsistently reported in introduction and various sections in the methods. It would be highly beneficial for the reader to have these clearly and consistently presented regarding what outcome you want to measure and what outcome measure you use. Furthermore, to use the same terms i.e. in some sections you use workers' sick leave, sick leave or work-related factors.

Primary outcomes, secondary outcomes and predictor variables are outlined in Table 1, along with their method of collection (e.g. Microsoft teams/telephone or REDCap/postal questionnaire).

Reviewer comment 4:
Regarding patients included in the study - who is responsible for deciding which patients are "unlikely to require consultant care" and based on what?

Participants in this study will be recruited after attending a MSK triage clinic in a participating site. There, a MSK triage physiotherapist will triage the patient and decide if the patient requires consultant review for surgical or medical management, or alternative management options (e.g. discharge to GP, physiotherapy referral, referral for imaging, pain medicine referral etc.) as is their normal clinical practice. Only those patients who do not require consultant referral following MSK triage review are eligible for inclusion in this study. It’s at this point, once the decision for non-consultant care is decided and eligibility is determined, that participants are invited to participate in the study by the MSK triage physiotherapist.

Reviewer comment 5:
Are the patients to be included in the study after the triage? When is the patient asked to participate? And why don’t you include the patients in need of orthopaedic surgeon to be able to investigate predictors of clinical outcome and prognostic factors for MSK pain for them as well? Considering that 71% are discharged, it would probably be quite beneficial to know if there is a difference between these two groups.

The purpose of this research was to evaluate the patient journey through MSK triage services in Ireland of those who, in reality may never have needed to attend secondary care. Whilst lots of research has reported the percentage of patients who are discharged from MSK triage, without needing specialist referral, there is limited research on their outcomes up to one–year. Therefore, we excluded those patients who required onward referral to consultant orthopaedic surgeons or rheumatologists, as they may often require surgical management (e.g. joint replacement surgery) or medical management of a systemic condition (e.g. inflammatory arthritis). There is also a cohort of patients, whom following GP referral, are seen directly by the consultant, following triaging of referrals. This cohort of patients do not attend MSK triage and are instead managed directly by the consultant. Therefore, we wanted to focus on the cohort of patients who did not require consultant led surgical or medical management to evaluate their outcomes (pain and function) and healthcare utilisation following MSK triage and identify predictors of outcome, which may help inform the development of modernised care pathways for the management of musculoskeletal pain.

Reviewer comment 6:
You state that the MSK triage physiotherapist will identify and screen prospective participants for eligibility – is this before the actual triage? I think this process needs to be clearly described (as also addressed in previous question).

This has been updated in the ‘Recruitment and Data Collection’ section to say “The MSK triage physiotherapist will identify and screen prospective participants for eligibility following their MSK triage appointment”. Therefore, eligibility can only be determined once the triage appointment is complete.

Reviewer comment 7:
There is no formal sample size calculation.

Patient outcomes and potential explanatory variables associated with outcomes up to 1-year after musculoskeletal triage review have not been consistently studied in patients attending MSK triage clinics in Ireland or internationally, and thus there is limited information on potential explanatory variables associated with pain. We agree the number "10" is somewhat arbitrary, and its applicability can vary depending on the context and characteristics of the data (Vittinghoff and Mcculloch, 2007, Peduzzi et al., 1996). We used this as a guideline to the minimum sample size required, acknowledging practical constraints, and carefully considering explanatory variables to explore in this study based on theory and previous research.

Please also refer to our response to Reviewer 1 regarding the sample size query

Vittinghoff E, McCulloch CE. Relaxing the rule of ten events per variable in logistic and Cox regression. Am J Epidemiol. 2007;165(6):710-8.

Peduzzi P, Concato J, Kemper E, Holford TR, Feinstein AR. A simulation study of the number of events per variable in logistic regression analysis. J Clin Epidemiol. 1996;49(12):1373-9.

Reviewer comment 8:
If I understand correctly you are collecting two written consents? What is the purpose of that?

A cooling off period is required between the time of introduction to the study and the obtaining of informed consent. The researcher (FC) is not present at the MSK triage clinics and due to the busy nature of these clinics, it would not be feasible to allow for a cooling off period on the day. Therefore, MSK triage physios, upon introducing the study to the patient obtain consent to contact(i.e. be contacted by the research team) from interested patients. This allows the researcher (FC) to contact the participant the following day (12-24 hours later) to obtain informed consent and recruit participants to the study. This is in line with our research ethics requirements.

Reviewer comment 9:
Why did you chose to have a teams or telephone data collection as well as questionnaires?

The patient demographic attending MSK triage clinics have varied information technology (IT) skills, therefore we decided it would be best to offer those with limited IT skills the ability to still participate by allowing for telephone call assessments and paper questionnaires.

This sentence in the recruitment and data collection section has been updated as follows:
‘This data will be collected through Research Electronic Data capture (REDCap) software (28, 29), hosted at RCSI, on their personal device, or via posted paper questionnaires to facilitate participants with limited information technology skills.’

Reviewer comment 10:
Inconsistent reporting of outcomes collected and through what outcome measures, order and the use of abbreviations or not. Furthermore not clear which ones are collected via self-reported questionnaires vs telephone/teams. Furthermore, not all outcomes are included in the primary or secondary outcomes.

All predictor variables and outcomes are outlined in table 1, along with their method of collection (e.g. Microsoft teams/telephone or REDCap/postal questionnaire). Consistency in reporting of outcomes/variables and the measures used has been revised in the new manuscript.

Reviewer comment 11:
The outcome health literacy is not mentioned or described prior to data collection.

Health literacy is now included in the introduction and data collection sections along with table 1.

Reviewer comment 12:
The whole section starting with “Pain hypersensitivity, measured by… / (Figure 1) seems more to belong in the introduction section.

This was included to further describe the quantitative sensory testing component of this project. Reference to altered pain processing is also included in the introduction section.

Reviewer comment 13:

Outcomes are not consistent with aims.

We have revised our aims to align with our outcomes in the revised manuscript.

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Competing Interests

No competing interests were disclosed.

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Reviewer Report

19 Views

16 Jan 2024 | for Version 1

Subhash Aryal, University of Pennsylvania, Philadelphia, Pennsylvania, USA

19 Views Cite this report Responses(0)

Approved With Reservations

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Biostatist

Respond to this report

Responses (0)

Alongside their report, reviewers assign a status to the article:

Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested

Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.

Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions

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ADvAnced PhysioTherapy in MuSculosKeletal Triage: Investigating prognostic factors, healthcare utilisation and clinical outcomes (ADAPT MSK) - a cohort study protocol.

Abstract

Background

Methods

Results

Keywords

Revised Amendments from Version 1

Introduction

Aims

Methods

Study design

Table 1. Overview of primary and secondary outcomes, predictor variables, and time of assessment.

Ethics

Setting

Figure 1. Screening process for pain classification based on IASP criteria for nociplastic pain²⁵ and NeuPSIG grading system for Neuropathic pain²⁶.

Participants

Sample size

Recruitment and data collection

Follow-up assessment

Outcomes

Statistical analysis

Dissemination

Study status

Discussion

Data availability

References

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Open Peer Review

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Are you a HRB-funded researcher?

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ADvAnced PhysioTherapy in MuSculosKeletal Triage: Investigating prognostic factors, healthcare utilisation and clinical outcomes (ADAPT MSK) - a cohort study protocol.

Abstract

Background

Methods

Results

Keywords

Revised Amendments from Version 1

Introduction

Aims

Methods

Study design

Table 1. Overview of primary and secondary outcomes, predictor variables, and time of assessment.

Ethics

Setting

Figure 1. Screening process for pain classification based on IASP criteria for nociplastic pain25 and NeuPSIG grading system for Neuropathic pain26.

Participants

Sample size

Recruitment and data collection

Follow-up assessment

Outcomes

Statistical analysis

Dissemination

Study status

Discussion

Data availability

References

Comments on this article Comments (0)

Open Peer Review

Comments on this article Comments (0)

Open Peer Review

Reviewer Status

Reviewer Reports

Comments on this article

Competing Interests Policy

Stay Updated

Are you a HRB-funded researcher?

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Figure 1. Screening process for pain classification based on IASP criteria for nociplastic pain²⁵ and NeuPSIG grading system for Neuropathic pain²⁶.