Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000469718
Ethics application status
Approved
Date submitted
28/02/2022
Date registered
25/03/2022
Date last updated
28/10/2024
Date data sharing statement initially provided
25/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Te Tauwhiro Turi ma te Rongoa: Knee Care for Arthritis through Pharmacy Study
Scientific title
A randomised controlled trial of the Knee Care for Arthritis through Pharmacy Service (KneeCAPS) and the effect on pain and disability for people with knee osteoarthritis.
Secondary ID [1] 306316 0
Nil known
Universal Trial Number (UTN)
U1111-1273-7923
Trial acronym
KneeCAPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee Osteoarthritis 325083 0
Condition category
Condition code
Musculoskeletal 322506 322506 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
NAME:

KneeCAPS (Knee Care for Arthritis Through Pharmacy Service)

MATERIALS:

Information booklet and supporting website (designed for this trial, described in Darlow et al. 2020 and 2022, published in Osteoarthritis and Cartilage Open).

PROCEDURES:

Information - Provision of information booklet and accompanying explanation from community pharmacist
Motivation: face to face discussion with pharmacist to address questions, reinforce key messages, exploring priorities, identify goals (and barriers to achieving these), and discuss health care opportunities and referral options that may assist with goal achievement. Ongoing support from pharmacist (2 to 3 interactions over 6 weeks).

Behavioural skills -
1) Core-guideline recommended care (Bannuru et al. OARSI guidelines for the non-surgical management of knee, hip, and polyarticular osteoarthritis): physiotherapist supervised exercise programme delivered one-on-one (exercises to strengthen the buttock, thigh, and calf muscles, as well as functional mobility exercises, that utilise the full available range of joint movement individualised to the capacity and impairments of each participant and progressed over six, 30 minute sessions delivered over 12 weeks with gradually increasing duration between each session to promote self-management) or by group classes (based on the NEuroMuscular Exercise (NEMEX) programme with participants able to attend able to attend two exercise classes per week for 12 weeks); dietitian supervised individualised dietary change programme that aims to improve eating and drinking behaviours (up to 6 sessions over 12 weeks); pharmacist supervised medication review that aims to optimise the use of pain medications (single 30 minute session).

2) No cost or low cost (participant funded) guideline concordant care. Participants will be provided with a list of the resources available and these will be included in the pharmacist discussion of care options available. Participants will be able to access these at their discretion:
a. Online exercise programme : https://mykneeexercise.org.au/
b. Online pain coping skills training: www.paintrainer.org and https://painhealth.csse.uwa.edu.au/pain-management/
c. Community exercise and activity groups
d. Water-based exercise groups

WHO:

There are three categories of intervention provider:
1) Pharmacists: NZ Registered Pharmacists working in community practice.
2) Physiotherapists: NZ Registered Physiotherapists working in community practice.
3) Dietitians: NZ Registered Dietitians working in community practice.

Training for all clinicians:
All clinicians complete online eLearning modules about: 1) cultural safety (whakawahaungatanga, implicit bias, Maori models of health and working with Maori patients/whanau, health literacy, interprofessional practice); 2) empowering people with knee OA (information, explanatory models, and supporting health behaviour change); physical activity, exercise and knee OA; 4) nutrition, body size and knee OA.
Following self-guided eLearning, clinicians will join a 90 minute Zoom training session. The session will have three sections:
1) Practising the process of whakawahaungatanga as means of learning about interprofessional peers.
2) Discussing key messages from eLearning modules.
3) Learning about how each discipline supports and engages with people who have knee osteoarthritis and developing methods of communication.

Discipline specific training:

Pharmacists: online training module related to performing pain medication reviews

Physiotherapists: exercise prescription based on the PEAK program (developed by the Centre for Health, Exercise & Sports Medicine (CHESM) at the University of Melbourne) to enable the delivery of evidence-based structured land-based therapeutic exercise care face to face or via video-conferencing.

Physiotherapists providing group exercise classes will be required to have completed the GLA:D training programme to deliver the NEMEX intervention.

HOW:

All care (except initial pharmacist discussion) can be provided face to face or via telehealth (depending on patient preference and clinician availability).

All interventions delivered individually except for when participants choose group rather than one-on one exercise classes.

WHERE:

Community pharmacy, physiotherapy, and dietetic practices.

WHEN AND HOW MUCH:

Initial pharmacist explanation: One explanation of up to ten minutes
Extended discussion: one discussion of up to 25 minutes duration.
Medication review: up to 30 minutes.
Follow-up support: two to three contacts of up to 5 minutes each.
One-on-one physiotherapy: up to six, 30 minute sessions over 12 weeks.
Group supervised exercise: up to two exercise classes per week for 12 weeks.
Dietitian: one 60 minute consultation and up to five 30 minute consultations over 12 weeks.

TAILORING:

Extended discussions with the pharmacist will be personalised based on the questions, goals and priorities of the participant.

Participants will choose which care options they will access during their extended discussion with the pharmacist. They can choose to access all or none of the options but must choose between one-on-one and group exercise classes.

Participants may receive fewer than 6 physiotherapy or dietetic sessions at their own or the clinician’s discretion.

ADHERENCE:

Delivery of care: For each participant, we will explore:
1) Whether they had an extended pharmacist consultation
2) What care they were referred for
3) Whether they attended referred care
4) How many sessions they attended for each referred care option
5) Whether they accessed any of the online resources
Intervention code [1] 322742 0
Treatment: Other
Intervention code [2] 322743 0
Lifestyle
Intervention code [3] 322744 0
Behaviour
Comparator / control treatment
NAME:

Current usual care (active comparator)

MATERIALS:

Pharmaceutical Society of New Zealand Arthritis Fact Sheet

PROCEDURES:

Information - Provision of Pharmaceutical Society of New Zealand Arthritis Fact Sheet (with no active explanation). Participants will read this after they have left the pharmacy and their reading of this information will not be supervised or assessed.

WHO:

Pharmacist (without explanation)

HOW:

Provided in closed envelope

WHERE:

Community pharmacy (envelope opened after participant has left the premise)

WHEN and HOW MUCH

One off interaction for provision of fact sheet.

Control group participants will not be restricted in their access to any other care for their osteoarthritis during the study but they will not be directed to, or supported to access, the core-guideline recommended care nor directed to the online resources.

ADHERENCE:

Health care received outside of the study will be monitored for inclusion in the economic analysis.
Control group
Active

Outcomes
Primary outcome [1] 330308 0
Change in knee-related physical function as measured with the function subscale of the Short Form of the Western Ontario and McMaster Universities Osteoarthritis Index
Timepoint [1] 330308 0
3 months, 6 months, 9 months, 12 months (primary timepoint) post-randomisation
Primary outcome [2] 330309 0
Change in knee-related pain as measured with a 11-point numeric rating scale (How bad has your knee pain been over the last 7 days? 0 = no pain; 10 = worst possible pain)
Timepoint [2] 330309 0
3 months, 6 months, 9 months, 12 months (primary timepoint) post-randomisation
Secondary outcome [1] 405721 0
Change in osteoarthritis knowledge as measured by the 11-item Knee Osteoarthritis Knowledge Scale (KOAKS)
Timepoint [1] 405721 0
3 months, 6 months, 9 months and 12 months post-randomisation
Secondary outcome [2] 405722 0
Change in fear of movement as measured by the 6-item Brief Fear of Movement Scale for Osteoarthritis
Timepoint [2] 405722 0
3 months, 6 months, 9 months and 12 months post-randomisation
Secondary outcome [3] 405723 0
Change in health-related quality of life as measured by the EuroQol EQ-5D-5L
Timepoint [3] 405723 0
3 months, 6 months, 9 months and 12 months post-randomisation
Secondary outcome [4] 405730 0
Change in productivity as measured by the Work Productivity and Activity Impairment (WPAI) questionnaire
Timepoint [4] 405730 0
3 months, 6 months, 9 months and 12 months post-randomisation
Secondary outcome [5] 405732 0
Change in health care use (GP consultation, allied health care, non-sugical medical specialist (rheumatologist, sports physician, musculoskeletal medicine physician), orhtopaedic surgeon, X-ray, MRI) as measured by self-report using the Short Otago Costs and Consequences Questionnaire (SOCCQ)
Timepoint [5] 405732 0
3 months, 6 months, 9 months and 12 months post-randomisation
Secondary outcome [6] 405735 0
Change in medication use (strong opioid, weak opioid, anti-inflammatory (oral and topical), analgesic, capsaicin) as measured by self-report of use in the past 7 days recorded using the Short Otago Costs and Consequences Questionnaire (SOCCQ)
Timepoint [6] 405735 0
3 months, 6 months, 9 months and 12 months post-randomisation
Secondary outcome [7] 405737 0
Change in anti-inflammatory and pain medication use as measured by Ministry of Health dispensing data
Timepoint [7] 405737 0
2 years, 5 years, 10 years post-randomisation
Secondary outcome [8] 405741 0
Change in receipt of knee joint arthroplasty as measured with New Zealand Orthopaedic Association Joint Registry data
Timepoint [8] 405741 0
2 years, 5 years, 10 years post-randomisation
Secondary outcome [9] 405742 0
Changes in costs associated with osteoarthritis care as measured by the Short Otago Costs and Consequences Questionnaire (SOCCQ).
Timepoint [9] 405742 0
3 months, 6 months, 9 months and 12 months post-randomisation
Secondary outcome [10] 405743 0
Changes in quality-adjusted life years as measured by the EuroQol EQ-5D-5L
Timepoint [10] 405743 0
3 months, 6 months, 9 months and 12 months post-randomisation
Secondary outcome [11] 407124 0
Adverse events will be monitored actively and passively and assessed using a standardised Adverse Event Reporting Form, adapted from the World Health Organization template, by a member of the research team who is a rheumatologist. The researcher will judge whether the event is: 1) expected or unexpected; 2) potentially related or unrelated to the intervention; 3) serious or not serious. These reports will be reviewed by an independent academic GP and an independent data monitoring committee.
Timepoint [11] 407124 0
12 months post-randomisation
Secondary outcome [12] 407179 0
Delivery of care - for each intervention participant, we will explore:
• Whether they had an extended pharmacist consultation (from pharmacist invoicing)
• What care they were referred for (from that recorded by the pharmacist in the participant log book)
• Whether they attended referred care (from clinician invoicing)
• How many sessions they attended for each referred care option (from clinician invoicing)
• Whether they accessed any of the online resources (from participant self-report)
Timepoint [12] 407179 0
12 months post-randomisation
Secondary outcome [13] 407180 0
Planned care received - We will identify two subgroups of intervention arm participants to enable exploratory per protocol analyses:
1. Those who receive care an extended pharmacist consultation (the minimal definition of the intervention).
2. Those who completed any referrals made by the pharmacist (to physiotherapy and/or dietetics and/or for medication review).
Timepoint [13] 407180 0
12 months post-randomisation
Secondary outcome [14] 407181 0
Process evaluation - longitudinal qualitative case studies (qualitative interviews with 12 intervention and 12 control group participants). Interviews will be one-on-one and semi-structured. The initial interview will be conducted face-to-face (up to 60 minutes) . Subsequent interviews will by telephone, Zoom or face-to-face (up to 30 minutes).
Timepoint [14] 407181 0
4 weeks, 4 months, 12 months (following final data collection) post-randomisation .
Secondary outcome [15] 407182 0
Process evaluation - 4 free text items specifically designed for this study exploring: 1) views about the information and support received; 2) changes in in how they manage their knee pain; 3) changes in how they manage their health; and 4) changes in their knee problem.
Timepoint [15] 407182 0
3 months 6 months, 9 months, 12 months post-randomisation
Secondary outcome [16] 407183 0
Process evaluation - qualitative interviews with 12 responders and 12 non-responders. Participants will be identified from analysis of free text data provided over course of study but the outcome will be assessed from interview responses.. Interviews will be one-on-one and semi-structured. Interviews will conducted by telephone, Zoom or face-to-face (up to 30 minutes).
Timepoint [16] 407183 0
More than 12 months post-randomisation (after completion of 12 month survey) up to 14 months post-randomisation.
Secondary outcome [17] 407184 0
Exposure to study information measured by self-report of having accessed the range of information resources available to intervention participants.
Timepoint [17] 407184 0
12 months post-randomisation.

Eligibility
Key inclusion criteria
Participants will be eligible for the study if they meet the following criteria:
1) They are over 18 years of age; and
2) They have knee pain that is due to OA.

Diagnosis of knee OA will occur in one of two ways:
a) Self-reported (by participant) as diagnosed by a specified health professional (e.g. general practitioner ; or
b) Fulfilled National Institute for Health and Care Excellence (NICE) knee OA diagnostic criteria assessed by questionnaire (as part of the recruitment visit).

The NICE diagnostic criteria are:
i. Are you 45 years of age or older? (required response: Yes)
ii. Do you have knee pain when you use your knee? (such as with or after walking, stairs, squatting, running etc.) (required response: Yes)
iii. Have you had an acute (sudden) knee injury in the last 6 months? (required response: No)
iv. Do you have knee stiffness in the morning that takes longer than 30 minutes to ease? (required response: No)
v. Is your knee hot and swollen or getting worse quickly? (required response: No)

These criteria mean that:
- if someone has been diagnosed with knee OA by a health professional, they do not need to meet the NICE requirement of being 45 years of age or older (i.e. a 25 year old who had been diagnosed with knee OA by a health professional is eligible).
- If someone has not previously had their knee pain diagnosed as being due to OA by a health professional, they must meet NICE diagnostic criteria including that they are 45 years of age or older (i.e. a 35 year old with knee pain that has not been diagnosed as being due to OA by a health professional, will not be eligible).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Consumer participants will not be eligible for the study if they:
1) have had a total or partial knee joint replacement or have an existing booking for knee joint replacement surgery in the next 12 months.
2) have had knee surgery (e.g. arthroscopy) or other knee procedures (e.g. joint injection) in the last 12 months or have an existing booking for knee surgery or other procedure in the next 12 months.
3) are unable to read and write in English.
4) live in the same household as someone who has already been recruited into the study (to prevent group contamination).
5) have taken part in the feasibility study.
6) have participated in a DHB funded Mobility Action Programme or ACC funded Escalated Care Programme for knee OA
7) have a psychotic disorder.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Consumer information (intervention booklets or Pharmaceutical Society of New Zealand Arthritis Fact Sheets) will be contained within identical appearing opaque, sealed (tamper-proof), coded, plastic courier envelopes. These envelopes will be padded and similar quantities of material will be included in both intervention and control envelopes to ensure group allocation cannot be identified without opening the envelope. The envelopes will be sealed so that these cannot be opened without disrupting the seal or tearing the envelope. Feasibility testing demonstrated the success of this concealment process.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation schedule stratified by pharmacy and ethnicity (Maori or non-Maori).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
SAMPLE SIZE

Sample size was calculated to provide 80% power and two-sided significance of 0.05 (assuming a correlation between baseline and follow-up measures of 0.4) to detect an MCID of 9.3 points (on an adjusted 100 point scale with a rescaled SD of 24.5) on the Short-MAC function subscale. The calculation allows for multilevel models with random effects for pharmacists in the intervention arm (~36 pharmacists, rho=0.01; n=110 per group). Based on these calculations, we have a target of 110 participants from each group to enter analyses (n=220 total, with baseline values and at least one follow-up measurement required to enter analysis).

Sample size for the NPRS outcome fits well within these bounds: to detect an MCID effect size of 1 point when SD = 2.2 requires a sample size of 76 per arm (80% power, two-sided significance of 0.05, allowing for worst-case pre-post correlation of zero).

ANALYSIS

Statistical significance will be judged with an alpha of 0.05. All results will be reported as estimates of effect size (e.g. mean difference, risk ratio) with two-sided 95% confidence intervals (95% CI). Analyses will be conducted on an intention-to-treat basis (that is, analysed according to the random allocation arm irrespective of actual receipt of treatment).

Consumer participant self-reported outcomes:
The ShortMAC function subscale, NPRS, and EuroQol EQ-5D-5L health- analyses will be conducted on an intention-to-treat basis using linear mixed models to consider whether the intervention changes health outcomes. These models include baseline score on the outcome as a covariate (e.g. analysis of ShortMAC function scale score at follow-up will include baseline ShortMAC function score, as per analysis of covariance style approaches) as well being adjusted for important baseline covariates (age and gender; furthermore, analysis of ShortMAC function subscale will adjust for baseline pain score; and analysis of NPRS will adjust for baseline ShortMAC function subscale score). These baseline covariate data will be imputed using mean imputation for any participants missing baseline covariate data in order to allow models to be adjusted for all planned covariates.

A per-protocol subgroup analysis will be conducted for those who received care as described in the protocol. This will be defined for the Intervention group as having completed the discussion session with the pharmacist (as a minimal definition of the intervention), and compared with the Control group (no further restriction). A secondary analysis will further restrict the per-protocol Intervention group as those who completed any referrals made by the pharmacist. This second per-protocol analysis will introduce substantial bias (undoing the study randomisation) and so is considered useful for exploring reasons for outcome heterogeneity rather than as a robust analysis of intervention efficacy.

Pre-specified sensitivity analyses will exclude the following from analysis:
1. Those in the control arm who report accessing the intervention booklet/website.
2. Those in either group who received knee surgery or other procedures during the follow-up period.

Health service utilisation and employment participation measures (such rate of secondary health care utilisation, e.g. consulting a medical specialist in the past three months) will be analysed using generalised linear mixed models suitable for count-type outcome data. Results will be reported as rate or risk ratios as appropriate, with 95% confidence intervals, and re-expressed as risk-differences where appropriate (both risk ratios and risk differences will be back-estimated from the logistic regression model). These models will be adjusted for similar covariates as noted for the patient reported outcome measures (e.g. adjusted for age, gender, and baseline NPRS and ShortMAC function subscale sores).

Descriptive data:
Participant characteristics will be analysed with descriptive statistics.

Economic analysis:
Economic analysis will be conducted as a cost-utility analysis, comparing the incremental costs of the intervention, from both health system and societal perspectives, with the incremental gain in participants’ quality-adjusted life years (QALYs).

Both costs and QALYs will be calculated over 12-month follow-up from the date of randomisation. The SOCCQ and WPAI capture costs and lost productivity over the 3 months prior to the date of data collection; 12-month costs will thus be calculated as the sum of costs captured at the 3-, 6-, 9-, and 12-month follow-up surveys. QALYs accrued will be calculated by assuming a linear trajectory between the health-related quality of life values captured at the baseline and 3-, 6-, 9-, and 12-month surveys. Discounting of future outcomes will not be required as the study has a 1-year time horizon.

The incremental costs and QALYs over 12 months will be jointly estimated using multivariate linear regression, adjusted for baseline covariates (age, gender, knee pain, duration of symptoms, and baseline outcome measures).

The primary economic evaluation outcomes will be incremental cost-effectiveness ratios (ICER; Costs/QALYs) and incremental net monetary benefit (INMB; (QALYs×WTP)-Costs, at willingness-to-pay (WTP) levels of 0.5, 1, 2, and 3 times GDP/capita), calculated using the incremental costs and QALYs estimates from the adjusted regression model. In the event that either the incremental costs or incremental QALYs are negative (the intervention has lower total costs or worse health outcomes than the control), ICERs will not be reported.

Treatment fidelity:
The proportion of intervention group participants who received core guideline recommended care as described in the protocol will be analysed. Participants who were referred to one or more of these care options by the pharmacist but who did not receive the physiotherapist, NEMEX programme, dietetic, or pharmacist to whom they were referred (as identified through clinician invoices) will be recorded as not having received per-protocol care.

The proportion of control group participants who report accessing intervention resources will be analysed.

Use of online resources will be analysed descriptively for both groups to assess utilisation of these freely accessible resources.

Process evaluation:
Free text data will be analysed with Template Analysis. Qualitative interview data will be analysed using Interpretive Description.

Adverse events:
The number of minor side effects, cases of serious pathology, and serious adverse events will be compared between groups at the end of the study. Due to the small sample size, no formal statistical analysis will be undertaken.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
26/09/2022
Actual
12/10/2022
Date of last participant enrolment
Anticipated
31/03/2023
Actual
20/10/2023
Date of last data collection
Anticipated
3/05/2033
Actual
Sample size
Target
220
Accrual to date
Final
242
Recruitment outside Australia
Country [1] 24534 0
New Zealand
State/province [1] 24534 0
Canterbury, Waikato

Funding & Sponsors
Funding source category [1] 310661 0
Government body
Name [1] 310661 0
Health Research Council of New Zealand
Country [1] 310661 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Dr Martin Gagnon
Research and Enterprise
University of Otago
Centre for Innovation,, Level 1 (East Wing), 87 St David St,
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 311877 0
None
Name [1] 311877 0
Address [1] 311877 0
Country [1] 311877 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310253 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 310253 0
Ethics committee country [1] 310253 0
New Zealand
Date submitted for ethics approval [1] 310253 0
21/03/2022
Approval date [1] 310253 0
12/04/2022
Ethics approval number [1] 310253 0
2022 EXP 11725

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117018 0
A/Prof Ben Darlow
Address 117018 0
Department of Primary Health Care and General Practice
University of Otago, Wellington
PO Box 7343,
Wellington South 6242
Country 117018 0
New Zealand
Phone 117018 0
+64210794693
Fax 117018 0
Email 117018 0
[email protected]
Contact person for public queries
Name 117019 0
Ben Darlow
Address 117019 0
Department of Primary Health Care and General Practice
University of Otago, Wellington
PO Box 7343,
Wellington South 6242
Country 117019 0
New Zealand
Phone 117019 0
+64210794693
Fax 117019 0
Email 117019 0
[email protected]
Contact person for scientific queries
Name 117020 0
Ben Darlow
Address 117020 0
Department of Primary Health Care and General Practice
University of Otago, Wellington
PO Box 7343,
Wellington South 6242
Country 117020 0
New Zealand
Phone 117020 0
+64210794693
Fax 117020 0
Email 117020 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial (except for qualitative data collected as part of the process evaluation), after de-identification
When will data be available (start and end dates)?
12 months after publication of the primary outcome paper for 24 months
Available to whom?
Anyone who wishes to access it
Available for what types of analyses?
Any purpose
How or where can data be obtained?
University of Otago publicly accessible repository (https://ourdrive.otago.ac.nz/Research)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14897Study protocolDarlow B, Brown M, Stanley J, Abbott JH, Briggs AM, Clark J, Frew G, Grainger R, Hood F, Hudson B, Keenan R, Marra C, McKinlay E, Pask A, Pierobon A, Simmonds S, Vincent L, Wilson R, Dean S. Reducing the burden of knee osteoarthritis through community pharmacy: Protocol for a randomised controlled trial of the Knee Care for Arthritis through Pharmacy Service. Musculoskeletal Care 2023;21(1053-67)https://doi.org/10.1002/msc.1785 
14898Statistical analysis plan    To be published on University of Otago publicly ac... [More Details]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseReducing the burden of knee osteoarthritis through community pharmacy: Protocol for a randomised controlled trial of the Knee Care for Arthritis through Pharmacy Service.2023https://dx.doi.org/10.1002/msc.1785
N.B. These documents automatically identified may not have been verified by the study sponsor.