A Cost-efficiency Analysis of Physiotherapist or Physicians as Primary Assessors for Patients With Knee Pain in Primary Care
Phase: NA
Conditions: Osteoarthritis, Knee
Sponsor: Vastra Gotaland Region

STUDY PROTOCOL WITH STATISTICAL ANALYSIS PLAN 
 
 
 
Official title:  
A Cost-efficiency Analysis of Primary Assessors for Patients With Knee Pain in Primary Care 
 
NCT number: NCT03822533 
The Regional Ethical Review Board in Gothenburg approved the study 2013-03-15, 
reference numbers: 979–12, T674–13, T497–14, T791–15 and 2020-00432. 
Document date: Protocol published and released on clinicaltrial.gov 2019-01-30. Minor 
spelling and grammar changes made 2022-08-08, which are highlighted in yellow.  
 
Sponsors:   
Region Vastra Gotaland, Närhälsan, Sweden 
Principal Investigator:  
Lena Nordeman, PhD 
Närhälsan Research and development center Södra Älvsborg 
Contact person:  
Chan-Mei Ho, PhD-student 
 
 
Närhälsan Lidköping Rehabilitation center 
 

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Study Description 
Brief Summary 
Background: Almost half of the Swedish population are overweight or obese. This will 
probably affect the incidence of osteoarthritis since overweight is a strong risk factor. 
Osteoarthritis consultations is expected to increase with 30-50% within the next 20 years. 
Today, in Swedish primary care, both physicians and physiotherapists are primary assessors 
for patients with suspected knee osteoarthritis. A task shifting with physiotherapists as the 
only primary assessor could increase the access rate to physicians in primary care for 
patients with more severe disorders. Yet, it is unclear what effects these different healthcare 
processes have and the costs of it. 
Purpose: The overall purpose of this study is to perform an economic evaluation of two 
healthcare processes, where a healthcare process initiated by a physiotherapist is compared 
with when it is initiated with a physician for patients with suspected knee osteoarthritis. 
Methods: 100 patients will be randomized either to a physiotherapist or to a physician for 
first assessment, diagnosis and treatment. Measurements of health-related quality of life and 
costs for visits to physiotherapist, physician or other healthcare provider, drug prescriptions 
and sick-leave will be collected. A cost-effectiveness analysis will be conducted, presenting 
incremental cost-effectiveness ratio (ICER) and a non-parametric bootstrapping will be 
conducted to demonstrate the uncertainties surrounding the ICER. 
Expected results: It is expected that this randomized controlled study will show the effects 
on quality adjusted life years, cost-efficiency, and cost-utility of two different primary 
assessors for patients with suspected knee osteoarthritis consulting primary care. The results 
could clarify which profession that is most appropriate to be the primary assessor for patients 
with suspected knee osteoarthritis in primary care. 
 
 
Detailed Description 
Problem statements 
What is the difference in cost efficiency between a healthcare process with a physiotherapist 
as primary assessor and a physician as primary assessor for patients with suspected KOA? 

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Which effect does a clinical pathway with a physiotherapist as primary assessor for patients 
with suspected knee osteoarthritis have on quality adjusted life years compared with a 
physician as primary assessor? 
What are the differences in costs between the two healthcare processes initiated by either a 
physiotherapist or a physician set against the differences in effects? 
 
Patient recruitment 
Some data has already been collected for another clinical trial (ID: NCT03715764), which will 
be used in this study too. The patient recruitment is finished, while data collection regarding 
cost variables has not started yet. 
Patients were recruited from primary care centers and rehabilitation centers in southwestern 
Sweden. 
Screening procedure 
Nurses and administration personnel at the recruitment units got information about the study 
and the screening protocol from the data collector and project leader. Each recruiting unit 
had a contact person that were responsible for the protocols and to contact the data collector 
when an eligible patient was found. It was regular contact between the project leader and the 
contact persons at the recruiting units. All screening protocols were sent to the data collector. 
All participants got orally and written information about the study from the data collector, and 
patients provided written informed consent. 
 
Randomization 
A computer-generated list of random numbers was used, where participants were randomly 
assigned to being assessed, diagnosed and treated either by a physiotherapist or a 
physician first. The project coordinator managed the sequence generation, allocation 
concealment, enrolment and assignments of participants and kept the concealed 
randomization scheme and sequentially numbered, sealed envelopes in a locked cupboard 
(in the same building where the enrolment was), only available for the project coordinator. 
The project coordinator revealed the allocation to the participant shortly after the baseline 
measurement and to the health care providers. Data collector, data analyst and statistician 
were blinded of allocation until completion of data collection for the primary outcome 
measures at the 12 months follow up for the last recruited patient. Group allocation was 
revealed when analyzing data for the other clinical trial (ID: NCT03715764). 

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The project coordinator was not involved in the screening procedure nor the data collection 
and was not included among the healthcare providers in the study. The blinded data collector 
and analyst, whom is a physiotherapist, were not involved in assessing, diagnosing and 
treating patients with knee osteoarthritis while the first study (ID: NCT03715764) was 
conducted. 
 
Data collection 
Demographic data and measurements of health-related quality of life (HrQoL) has already 
been collected for another clinical trial (ID: NCT03715764). These data will also be used for 
the cost-efficiency analysis. Demographic data were collected at baseline. Measurements of 
HrQoL were measured with EuroQol 5 dimensions 3 levels (EQ5D-3L) and collected at 
baseline (before randomization), 3- , 6- and 12 months follow ups. 
New data collection will be made for cost variables. Data regarding costs for the healthcare 
processes will be extracted from patient journals. The costs for visits to physiotherapist, 
physician or other healthcare provider will be collected from the healthcare organization. The 
drug prices will be collected from the Swedish Association of Local Authorities and Regions 
for the time period the drugs were prescribed. Production loss due to sick-leave and health 
care visits will be valued according to mean gross salary (including taxes and social fees). 
Calculating total costs (number of contacts per patient * costs ) for: 
• 
Physiotherapy contacts in primary care 
• 
Physician contacts in primary care 
• 
Referrals to x-ray 
• 
Referrals to other healthcare givers 
• 
Drug prescriptions 
• 
Sick-leave days 
 
Data management 
All data will be coded and managed according to the General Data Protection Regulation. All 
data will be confidential and only authorized will have access to the patient registry. No 
individual information can be identified since the results will be presented at group level. Data 
will be saved for at least 10 years to enable audit. 
 

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Sample size 
A sample size of 50 patients per group will be necessary to detect a minimal clinical 
improvement of 0.121(SD 0.2) on the EQ5D-3L-index, given an anticipated dropout rate of 
14%. The sample size calculation was calculated with a two-sided 5% significance level and 
a power of 80%. 
 
Statistical analysis plan 
Data will be analyzed descriptively and presented as numbers and percent, mean and 
standard deviation or median and 25th to 75th percentiles. Statistical analysis will be made in 
SPSS Windows and the analysis will be applied with intention-to-treat (ITT). 
The economic evaluation will be developed together with a health economist. The method 
will be a cost-effectiveness analysis alongside the clinical trial comparing costs and effects 
for the two alternatives based on collected data from the trial. The EQ5D-3L measurements 
will be used for analyzing quality adjusted life years. The result will be presented as an 
incremental cost-effectiveness ratio (ICER) and a non-parametric bootstrapping will be 
conducted to demonstrate the uncertainties surrounding the ICER. 
 
Study Design 
Study Type:  
Interventional  (Clinical Trial) 
Actual Enrollment: 
69 participants 
Allocation: 
 
Randomized 
Intervention Model: 
Parallel Assignment 
Participants with suspected knee osteoarthritis were either 
randomized to a physiotherapist or a physician as primary 
assessor for assessment and treatment. After the first assessment 
that the patients were assigned to, the patients could choose to 
seek the other health care provider if they wanted to. This study 
focuses on analyzing cost efficiency of the health care processes 
for patients with suspected knee osteoarthritis in primary care. 
Masking: 
 
Single (Outcomes Assessor) 
Primary Purpose: 
Treatment 
 

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Arms and Interventions 
Physiotherapist as primary assessor - Intervention 
The healthcare process will be started with a physiotherapist assessment and treatment. 
Treatments could involve individual or group treatment including patient education and 
physical exercise. Patients can seek a physician anytime after the first assessment with the 
physiotherapist. 
Physician as primary assessor – control  
The healthcare process will be started with a physician assessment and treatment. 
Treatments could involve drug prescription, referral to x-ray, referral to other healthcare 
providers and sick-leave. 
Patients can seek a physiotherapist anytime after the first assessment with the physician. 
 
Outcome Measures 
Primary Outcome Measures  
Health related quality of life  
[Time Frame: Baseline to one year after baseline.] 
A Swedish version of Euroqol-5 dimensions-3 levels (EQ5D-3L) was used to assess 
perceived self-rated HrQoL. EQ5D-index respectively EQ5D-VAS will be presented. The 
questionnaire contained five dimensions and resulted in an index ranging from -0,549 to 1 
using the UK tariffs. An index of 1 indicate full health. The EQ5D-VAS is a visual analogue 
scale ranging from 0 to 100, where 0 is worst imaginable health state and 100 is best 
imaginable health state. 
Secondary Outcome Measures 
A) Costs for physiotherapy contacts  
[Time Frame: Baseline to one year after baseline.] 
Number of visits registered in patients journal * cost 
B) Costs for physician contacts  
[Time Frame: Baseline to one year after baseline.] 
Number of visits registered in patients journal * cost 
 
 

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C) Costs for sick-leave  
[Time Frame: Baseline to one year after baseline.] 
Number of sick-leave periods, including number of days with sick leave * costs 
D) Costs for drug prescription  
[Time Frame: Baseline to one year after baseline.] 
Number of drug prescriptions* costs 
E) Costs for referral to x-ray  
[Time Frame: Baseline to one year after baseline.] 
Number of referrals to an x-ray examination of the knee * costs 
F) Costs for referral to other healthcare professionals  
[Time Frame: Baseline to one year after baseline.] 
Number of referrals to other professionals for an examination of the knee * costs 
 
Eligibility Criteria 
Ages Eligible for Study:   38 Years and older   (Adult, Older Adult) 
Sexes Eligible for Study:   All 
Accepts Healthy Volunteers:  No 
Inclusion Criteria 
• 
Knee pain most of the days the last month 
• 
Over 38 years old 
• 
Crepitus on active motion 
• 
Morning stiffness less than 30 minutes 
Exclusion Criteria 
• 
Not been diagnosed for current knee pain 
• 
Non-traumatic cause due to current knee pain 
• 
No other rheumatic, severe somatic or psychological diseases that can affect the 
outcome measures. 
• 
Not pregnant 
• 
Does not know enough Swedish to answer questionnaires.