The specific aims are to:. Evaluate shoulder pain, shoulder-related function, psychological distress, shoulder-related parenting disability, paid and unpaid work participation and work productivity in this patient group. Explore health service utilisation and medication use for shoulder pain and associated out-of-pocket healthcare expenditure.
A multicentre cohort study will be undertaken. Participant recruitment commenced in May , and it is anticipated that data collection will be completed by May Eligibility criteria for the study are summarised in table 1. This broad range of diagnoses will enable us to capture a spectrum of relevant shoulder conditions that are associated with persistent shoulder pain.
Figure 1 presents an overview of the study procedures, including approaches for participant identification and recruitment. Participants will be recruited from the orthopaedic outpatient clinics including specific shoulder clinics at three major metropolitan and regional public hospitals in the state of Victoria, Australia. Clinic referrals and clinic list records at each site will be screened regularly by a senior physiotherapist to identify potentially eligible individuals, based on their age and diagnosis.
Completed screening forms will then be forwarded to the research team, and potentially eligible individuals will be sent an introductory letter signed by the head of orthopaedic surgery or a senior orthopaedic surgeon at that hospital site. The introductory letter will provide preliminary information about the study and invite participation in the research.
After mailing of the introductory letter, the study research assistant will contact potentially eligible individuals by telephone to provide more detailed information about the study. At this time, a short screening survey to confirm eligibility will also be conducted. Eligible individuals who provide verbal consent will receive either an emailed participant information and consent form and individual electronic link to the electronic baseline study questionnaire or be mailed a hard copy of these documents.
The electronic version of the questionnaire will contain exactly the same items as the paper-based questionnaire. For the electronic option, participants will be asked to electronically provide their consent to participate and then complete the baseline questionnaire via a secure Qualtrics online platform. For the mailed option, a reply-paid envelope will be provided to maximise response rates.
The mailed option will be offered where the participant does not have an email address or is unable or unwilling to provide consent and complete the questionnaire online. All participants will be mailed a baseline costs diary for completion over a 2-week period, together with a reply-paid envelope. Self-reported sociodemographic data marital status, highest level of education completed, height and weight, dominant hand and duration of shoulder pain and information on doctor-diagnosed comorbidities including asthma, diabetes, hypertension, increased cholesterol, coronary artery disease, anxiety or depression will be collected as part of the study questionnaire.
Participants will also be asked to specify what sources they have used to obtain information about their shoulder pain including printed information materials, online information from websites, online pain management or education programmes, telephone helplines and social media. A range of validated plus purpose-designed patient-reported outcome measures will be administered for this study, as shown in table 2.
These instruments are widely used in shoulder dysfunction research, and their validity and reliability have been extensively demonstrated. For female and male participants who have children, shoulder-related parenting disability will be evaluated using a modified version of the Parenting Disability Index. In particular, it covers a broad range of pertinent parenting tasks that require adequate upper limb functioning, such as getting a child in and out of a car seat, using a stroller, administering medications and playing with a child.
The Parenting Disability Index has a section for parents of younger children aged 0—5 years and a section for parents of older children aged 6—18 years. Participants will also be asked whether they have had shoulder surgery or joint injections and about their use of prescribed and non-prescribed medications or supplements for shoulder pain. Out-of-pocket healthcare and medication expenditure expenditure that is not reimbursed by government, private health insurance or other sources will be collected for a 2-week period using a purpose-designed costs diary.
This timeframe was chosen to minimise participant burden and maximise cost diary return rates. To address aim 4, participants will be sent a follow-up questionnaire at 12 months from the date of completing the baseline questionnaire. A follow-up costs diary will also be mailed to all participants at 12 months for collecting out-of-pocket healthcare and medication expenditure over a 2-week period.
As the primary aim is to compare HRQoL for the study sample with population norms, sample size calculations were based on normative AQoL data from the Australian population aged 20—59 years. This is considered to be a conservative estimate of difference, based on the published minimal important difference for the AQoL instrument. Our discussions with senior orthopaedic surgeons at each hospital site indicate that recruiting this sample size is feasible within the proposed timeline eg, a review of outpatient clinic visits showed that 40 potentially eligible patients were seen in a week period at one site alone.
It is proposed that approximately 50 participants will be recruited from each of the three hospital sites; however, the study will not compare participants across the hospital sites, and the actual number recruited from each site may vary depending on clinical caseload, volume of outpatient clinic bookings and referrals, and eligibility factors. Baseline HRQoL data will be compared with Australian population norms 17 overall and stratified by age group and sex using independent t-tests.
Associations between sociodemographic factors, shoulder pain, shoulder function, HRQoL, psychological distress and work productivity will be evaluated using univariate and multivariate analyses. Data on paid and unpaid work participation, health service utilisation, medication use and out-of-pocket healthcare expenditure will be analysed descriptively.
Recent Australian Bureau of Statistics labour force data on average weekly and hourly earnings for ANZSCO occupation categories 27 will be used to estimate the financial cost of reduced work participation due to shoulder pain. Changes in HRQoL, shoulder pain, shoulder function, psychological distress, work productivity and parenting scores from baseline to 12 months will be analysed using paired t-tests.
Any changes in out-of-pocket healthcare expenditure will be analysed using paired t-tests or non-parametric Wilcoxon signed-rank tests.
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A subgroup analysis may also be performed for participants who undergo shoulder surgery during the follow-up period. Patients were not directly involved in the development of the research question; however, the study design and selection of outcome measures were informed by our earlier research involving younger people with osteoarthritis.
Little is known about the well-being or work limitations experienced by younger adults with shoulder pain or health service utilisation by this patient group. In particular, comprehensive data on the healthcare costs incurred in relation to general practitioner, medical specialist, surgeon and allied health consultations, as well as diagnostic tests and prescribed and non-prescribed medications including analgesic and anti-inflammatory drugs are not available. Using an efficient methodology, this study will generate comprehensive information about the burden of shoulder pain among younger people presenting to metropolitan and regional public hospital outpatient services.
With broad eligibility criteria, the study has been designed to capture a range of painful shoulder conditions affecting people of working age, although the specific diagnoses may vary by age within the cohort eg, internal derangement may be more common among participants aged 20—30 years and rotator cuff pathology and osteoarthritis may be more common towards the upper age limit of 55 years.
We intend to report the type and frequency of shoulder diagnoses in order to fully characterise the study sample. Improving our understanding of the personal, work-related and financial impacts of painful shoulder conditions is essential for optimising patient care and planning future health service delivery.
The longitudinal study design will also enable us to track the burden of shoulder pain over a month period. Our earlier research involving other patient groups with persistent musculoskeletal pain including patients on waiting lists for joint replacement surgery and younger patients with hip or knee osteoarthritis has revealed marked reductions in quality of life and high levels of distress, compared with population norms.
The research team also has expertise in examining the socioeconomic determinants of musculoskeletal healthcare, 36 37 and this study provides new opportunities for identifying and addressing inequities in health service utilisation among patients accessing the public healthcare system.
Although all recruitment and data collection will be undertaken within one Australian state, we anticipate that our multisite recruitment strategy comprising a large metropolitan tertiary public hospital, a smaller metropolitan tertiary public hospital and a regional tertiary public hospital, each with a sizeable catchment area will enable the findings to be generalised more broadly to younger Australians with persistent shoulder pain. However, we acknowledge that there are likely to be differences in waiting times, healthcare costs and socioeconomic status including employment and capacity to pay for healthcare for patients accessing the public hospital system, compared with those who are privately insured, and that the findings may not be generalisable to patients accessing private orthopaedic services.
This study focuses on orthopaedic outpatient clinic settings, and we recognise that patients seen only in primary care settings will not be captured. However, in Australia, patients who have ongoing shoulder pain would be referred for specialist opinion and management. Finally, this study will collect important information on personal out-of-pocket healthcare costs but will not examine costs from a healthcare system perspective. All data will be stored securely at the coordinating site Department of Epidemiology and Preventive Medicine, Monash University and will only be accessible to authorised study staff.
The data will be reidentifiable, with a unique code assigned to each participant for use on the questionnaires and costs diaries. Name and contact information will be stored separately to any information provided as part of the study questionnaires and costs diaries. The study findings will be reported according to the Strengthening the Reporting of Observational Studies in Epidemiology checklist 39 and submitted to peer-reviewed journals for publication.
They will also be presented at relevant national and international scientific meetings. A detailed summary of the results will also be submitted to the funding body to fulfil grant reporting requirements. The authors wish to thank Mr Mark Tacey Monash University for his assistance with sample size calculations. All authors contributed to the development and refinement of the study protocol. All authors contributed to manuscript preparation. All authors have approved the final version of the manuscript. Funding This study is supported by a research grant from the Victorian Orthopaedic Research Trust and in-kind support from Monash University, with additional support from a targeted donation via the Barwon Centre for Orthopaedic Research and Education.
Dr Brennan-Olsen has received personal fees from Amgen Australia, outside the submitted work. Provenance and peer review Not commissioned; externally peer reviewed. You will be able to get a quick price and instant permission to reuse the content in many different ways.click
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Forgot your user name or password? Search for this keyword. Advanced search. Latest Content Archive Authors About. Log in via Institution. Email alerts. Article Text. Article menu. Exploring the personal burden of shoulder pain among younger people in Australia: protocol for a multicentre cohort study. Statistics from Altmetric. Monitor changes in well-being, work productivity and healthcare expenditure over time. Methods and analysis Study design A multicentre cohort study will be undertaken. Eligibility criteria Eligibility criteria for the study are summarised in table 1. View this table: View inline View popup.