Osteoarthritis, KneeNCT03822533
A Cost-efficiency Analysis of Primary Assessors for Patients With Knee Pain in Primary Care
A study testing Physiotherapist as primary assessor and Physician as primary assessor in people with Osteoarthritis, Knee, run by Vastra Gotaland Region at 9 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 38 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Physiotherapist as primary assessor and Physician as primary assessor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 363 participants
- Where
- 9 sitesSweden
- Study dates
- 7 Feb 2019to 17 Mar 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 38 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Knee pain most of the days the last month
- Over 38 years old
- Crepitus on active motion
- Morning stiffness less than 30 minutes
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Sweden9 sites
Medpro Clinic Brålanda-Torpa Vårdcentral
Brålanda, Västra Götaland County
Medpro Clinic Lilla Edet Vårdcentral
Lilla Edet, Västra Götaland County
Närhälsan Lilla Edets Rehabmottagning
Lilla Edet, Västra Götaland County
Capio Läkarhus Hjortmossen
Trollhättan, Västra Götaland County
Närhälsan Trollhättan Rehabmottagning
Trollhättan, Västra Götaland County
Primapraktiken
Trollhättan, Västra Götaland County
Närhälsan Vänersborg Rehabmottagning
Vänersborg, VastraGotaland
Medpro Clinic Torpa Vårdcentral
Vänersborg, Västra Götaland County
Vårdcentralen Nordstan
Vänersborg, Västra Götaland County
About this study
Official title: A Cost-efficiency Analysis of Physiotherapist or Physicians as Primary Assessors for Patients With Knee Pain in Primary Care
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.
Read more
Methods: 100 patients will be randomized either to a physiotherapists or to a physician for first assessment, diagnosis and treatment. Measurements of health-related quality of life and costs for visits to physiotherapists, 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.
Read the detailed description
Problem statements:
What is the difference in cost efficiency between a healthcare process with a physiotherapists as primary assessor and a physician as primary assessor for patients with suspected knee osteoarthritis?
Which effect does a clinical pathway with a physiotherapists 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 analysing data for the other clinical trial (ID: NCT03715764).
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 physiotherapists, 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 physiotherapists, physician or other healthcare providers 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.
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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Physiotherapist as primary assessor, Physician as primary assessor
- Keywords
- Primary assessor, cost efficiency, physiotherapist, quality of life
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapist as primary assessorOther
Physiotherapist diagnose and treat the patient.
Physician as primary assessorOther
Physician diagnose and treat the patient.
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapist as primary assessor | Other | 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. Receives: Other: Physiotherapist as primary assessor |
| Physician as primary assessor | Other | 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. Receives: Other: Physician as primary assessor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Difference in Quality Adjusted Life Years (QALY)
Health-related quality of life was used as the generic measure for health improvement and was measured at baseline, 3-, 6- and 12-month follow-up. The Swedish version of Euroqol-5 dimensions-3 levels (EQ5D-3L) was used to assess perceived self-rated health-related quality of life. The questionnaire contained five dimensions and resulted in an index ranging from -0,549 to 1 using the United Kingdom tariffs. An index of 1 indicate full health. For each participant, EQ-5D-3L index was used when calculating quality adjusted life years (QALY) using linear interpolation between each measurement point and the trapezoidal rule to calculate the "area under the curve". QALY range from 0 to 1, where 0 means death and 1 equals full health.
Measured: 12 months
Mean Difference in Total Costs (Societal Perspective)
Total costs with the societal perspective includes health care visits, prescribed drugs, productivity loss and unpaid work compensation. Data were retrieved from medical records.
Measured: 12 months
Mean Difference in Total Costs (Health Care Perspective)
Health care perspective includes health care visits and prescribed drugs. Data were collected through medical records.
Measured: 12 months
Incremental Cost-effectiveness Ratio (ICER) - Societal Perspective
Mean difference in costs divided by mean difference in quality adjusted life years (QALYs). Presenting the results of the cost-effectiveness analysis (ICER). Societal perspective includes health care visits, prescribed drugs, productivity loss and unpaid work compensation
Incremental Cost-effectiveness Ratio was derived from the model where a measure of dispersion was not an output of the model
Measured: 12 months
Incremental Cost-effectiveness Ratio (ICER) - Health Care Perspective
Mean difference in costs divided by mean difference in quality adjusted life years (QALYs). Presenting the results of the cost-effectiveness analysis (ICER). Health care perspective includes health care visits and prescribed drugs.
Incremental Cost-effectiveness Ratio was derived from the model where a measure of dispersion was not an output of the model
Measured: 12 months
Secondary outcomes (7)
Costs for Physiotherapy Visits
Number of visits registered in patients journal multiplied with the cost.
Measured: 12 months
Costs for Physician Visits
Number of visits registered in patients journal multiplied with cost
Measured: 12 months
Costs for Referrals to Radiography
Number of referrals to radiography registered in patients journal multiplied with its costs
Measured: 12 months
Costs for Referrals to Orthopedic Surgeon
Number of referrals to orthopedic surgeon registered in patients journal multiplied with the costs
Measured: 12 months
Costs for Collected Prescribed Drugs
Data extraction from a drug database for prescribed drugs belonging to the Anatomical Therapeutic Chemical Classification groups M01 anti-inflammatory and anti-rheumatic products, M02 topical products for joint and muscular pain, M03 muscle relaxants, M09 other drugs for disorders of the musculoskeletal system, N02A opioids, N02B other analgesics and antipyretics.
Measured: 12 months
Costs for Productivity Loss
Productivity loss included the time for visiting health care, telephone calls, traveling, waiting time and costs for sick leave days. The costs was calculated with gross salary including social fees.
Measured: 12 months
Costs for Unpaid Work Compensation
The costs for the time the patients were visiting health care or consulting via telephone, including traveling and waiting time. Production loss was calculated with net mean salary. Included participants that reported they were retired or unemployed.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start7 Feb 2019
- Primary completion17 Mar 2021
- Study completion17 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants with suspected knee osteoarthritis are either randomised to a physiotherapist or a physician as primary assessor for assessment and treatment. After the first assessment that the patients are assigned to, the patients can choose to seek the other health care provider if they want to. This study focuses on analysing cost efficiency of the health care processes for patients with suspected knee osteoarthritis in primary care.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 363 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Lena Nordeman, PhD, Principal investigator, Närhälsan Research and development center Södra Älvsborg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03822533
- Sponsor's protocol ID
- 115841healthecon
- Status last verified
- Apr 2022
- First submitted
- 28 Jan 2019
- Last updated
- 6 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Turkiewicz A, Petersson IF, Bjork J, Hawker G, Dahlberg LE, Lohmander LS, Englund M. Current and future impact of osteoarthritis on health care: a population-based study with projections to year 2032. Osteoarthritis Cartilage. 2014 Nov;22(11):1826-32. doi: 10.1016/j.joca.2014.07.015. Epub 2014 Jul 30.
PubMed 25084132Walters SJ, Brazier JE. Comparison of the minimally important difference for two health state utility measures: EQ-5D and SF-6D. Qual Life Res. 2005 Aug;14(6):1523-32. doi: 10.1007/s11136-004-7713-0.
PubMed 16110932Brazier JE, Harper R, Munro J, Walters SJ, Snaith ML. Generic and condition-specific outcome measures for people with osteoarthritis of the knee. Rheumatology (Oxford). 1999 Sep;38(9):870-7. doi: 10.1093/rheumatology/38.9.870.
PubMed 10515649Ho-Henriksson CM, Svensson M, Thorstensson CA, Nordeman L. Physiotherapist or physician as primary assessor for patients with suspected knee osteoarthritis in primary care - a cost-effectiveness analysis of a pragmatic trial. BMC Musculoskelet Disord. 2022 Mar 17;23(1):260. doi: 10.1186/s12891-022-05201-3.
PubMed 35300671
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cost-efficiency Analysis of Physiotherapist or Physicians as Primary Assessors for Patients With Knee Pain in Primary Care
- ClinicalTrials.gov ID
- NCT03822533
- Acronym / sponsor ID
- 115841healthecon
- Conditions
- Osteoarthritis, Knee
- Keywords
- Primary assessor, cost efficiency, physiotherapist, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 363 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 7 Feb 2019 (actual)
- Primary completion
- 17 Mar 2021 (actual)
- Study completion
- 17 Mar 2022 (actual)
- First posted
- 30 Jan 2019 (actual)
- Results
- Posted 6 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 physiotherapists or to a physician for first assessment, diagnosis and treatment. Measurements of health-related quality of life and costs for visits to physiotherapists, 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 physiotherapists as primary assessor and a physician as primary assessor for patients with suspected knee osteoarthritis?
Which effect does a clinical pathway with a physiotherapists 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 analysing data for the other clinical trial (ID: NCT03715764).
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 physiotherapists, 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 physiotherapists, physician or other healthcare providers 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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants with suspected knee osteoarthritis are either randomised to a physiotherapist or a physician as primary assessor for assessment and treatment. After the first assessment that the patients are assigned to, the patients can choose to seek the other health care provider if they want to. This study focuses on analysing cost efficiency of the health care processes for patients with suspected knee osteoarthritis in primary care.
| Arm | Type | Receives |
|---|---|---|
| Physiotherapist as primary assessor | Other | Other: Physiotherapist as primary assessorThe 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 | Other | Other: Physician as primary assessorThe 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. |
Who may qualify
- Ages
- 38 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Knee pain most of the days the last month
- Over 38 years old
- Crepitus on active motion
- Morning stiffness less than 30 minutes
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiotherapist as primary assessorPhysiotherapist diagnose and treat the patient. | Other | Physiotherapist as primary assessor |
| Physician as primary assessorPhysician diagnose and treat the patient. | Other | Physician as primary assessor |
Primary outcome
Mean Difference in Quality Adjusted Life Years (QALY)
Time frame: 12 months
Health-related quality of life was used as the generic measure for health improvement and was measured at baseline, 3-, 6- and 12-month follow-up. The Swedish version of Euroqol-5 dimensions-3 levels (EQ5D-3L) was used to assess perceived self-rated health-related quality of life. The questionnaire contained five dimensions and resulted in an index ranging from -0,549 to 1 using the United Kingdom tariffs. An index of 1 indicate full health. For each participant, EQ-5D-3L index was used when calculating quality adjusted life years (QALY) using linear interpolation between each measurement point and the trapezoidal rule to calculate the "area under the curve". QALY range from 0 to 1, where 0 means death and 1 equals full health.
Mean Difference in Total Costs (Societal Perspective)
Time frame: 12 months
Total costs with the societal perspective includes health care visits, prescribed drugs, productivity loss and unpaid work compensation. Data were retrieved from medical records.
Mean Difference in Total Costs (Health Care Perspective)
Time frame: 12 months
Health care perspective includes health care visits and prescribed drugs. Data were collected through medical records.
Incremental Cost-effectiveness Ratio (ICER) - Societal Perspective
Time frame: 12 months
Mean difference in costs divided by mean difference in quality adjusted life years (QALYs). Presenting the results of the cost-effectiveness analysis (ICER). Societal perspective includes health care visits, prescribed drugs, productivity loss and unpaid work compensation Incremental Cost-effectiveness Ratio was derived from the model where a measure of dispersion was not an output of the model
Incremental Cost-effectiveness Ratio (ICER) - Health Care Perspective
Time frame: 12 months
Mean difference in costs divided by mean difference in quality adjusted life years (QALYs). Presenting the results of the cost-effectiveness analysis (ICER). Health care perspective includes health care visits and prescribed drugs. Incremental Cost-effectiveness Ratio was derived from the model where a measure of dispersion was not an output of the model
7 secondary outcomes
Costs for Physiotherapy Visits
Time frame: 12 months
Costs for Physician Visits
Time frame: 12 months
Costs for Referrals to Radiography
Time frame: 12 months
Costs for Referrals to Orthopedic Surgeon
Time frame: 12 months
Costs for Collected Prescribed Drugs
Time frame: 12 months
Costs for Productivity Loss
Time frame: 12 months
Costs for Unpaid Work Compensation
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25084132Turkiewicz A, Petersson IF, Bjork J, Hawker G, Dahlberg LE, Lohmander LS, Englund M. Current and future impact of osteoarthritis on health care: a population-based study with projections to year 2032. Osteoarthritis Cartilage. 2014 Nov;22(11):1826-32. doi: 10.1016/j.joca.2014.07.015. Epub 2014 Jul 30.
- Background: PubMed 16110932Walters SJ, Brazier JE. Comparison of the minimally important difference for two health state utility measures: EQ-5D and SF-6D. Qual Life Res. 2005 Aug;14(6):1523-32. doi: 10.1007/s11136-004-7713-0.
- Background: PubMed 10515649Brazier JE, Harper R, Munro J, Walters SJ, Snaith ML. Generic and condition-specific outcome measures for people with osteoarthritis of the knee. Rheumatology (Oxford). 1999 Sep;38(9):870-7. doi: 10.1093/rheumatology/38.9.870.
- Derived from this study: PubMed 35300671Ho-Henriksson CM, Svensson M, Thorstensson CA, Nordeman L. Physiotherapist or physician as primary assessor for patients with suspected knee osteoarthritis in primary care - a cost-effectiveness analysis of a pragmatic trial. BMC Musculoskelet Disord. 2022 Mar 17;23(1):260. doi: 10.1186/s12891-022-05201-3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lena Nordeman, PhD principal investigator
Närhälsan Research and development center Södra Älvsborg
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapist as primary assessor and Physician as primary assessor in people with Osteoarthritis, Knee, run by Vastra Gotaland Region at 9 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Difference in Quality Adjusted Life Years (QALY) (time frame: 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03822533, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024.