Trial Outcomes & Findings for A Cost-efficiency Analysis of Primary Assessors for Patients With Knee Pain in Primary Care (NCT NCT03822533)

NCT ID: NCT03822533

Last Updated: 2024-05-06

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 363 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2024-05-06

Participant Flow

Excluded (n=294) * Not meeting inclusion criteria (n=185) * Declined to participate (n=15) * Excluded due to exclusion criteria (n=94)

Participant milestones

Measure	Physiotherapist as Primary Assessor The healthcare process started with a physiotherapist assessment and treatment. Treatments could involve individual or group treatment including patient education and physical exercise. Patients could seek a physician anytime after the first assessment with the physiotherapist. Physiotherapist as primary assessor: Physiotherapist diagnosed and treated the patient.	Physician as Primary Assessor The healthcare process started with a physician assessment and treatment. Treatments could involve drug prescription, referral to x-ray, referrals to other healthcare providers and sick-leave. Patients could seek a physiotherapist anytime after the first assessment with the physician. Physician as primary assessor: Physician diagnosed and treated the patient.
Baseline STARTED	35	34
Baseline COMPLETED	35	34
Baseline NOT COMPLETED	0	0
3 Month Follow-up STARTED	35	34
3 Month Follow-up COMPLETED	30	28
3 Month Follow-up NOT COMPLETED	5	6
6 Month Follow-up STARTED	30	28
6 Month Follow-up COMPLETED	27	28
6 Month Follow-up NOT COMPLETED	3	0
12 Month Follow-up STARTED	27	28
12 Month Follow-up COMPLETED	21	23
12 Month Follow-up NOT COMPLETED	6	5

Reasons for withdrawal

Measure	Physiotherapist as Primary Assessor The healthcare process started with a physiotherapist assessment and treatment. Treatments could involve individual or group treatment including patient education and physical exercise. Patients could seek a physician anytime after the first assessment with the physiotherapist. Physiotherapist as primary assessor: Physiotherapist diagnosed and treated the patient.	Physician as Primary Assessor The healthcare process started with a physician assessment and treatment. Treatments could involve drug prescription, referral to x-ray, referrals to other healthcare providers and sick-leave. Patients could seek a physiotherapist anytime after the first assessment with the physician. Physician as primary assessor: Physician diagnosed and treated the patient.
3 Month Follow-up Withdrawal by Subject	3	4
3 Month Follow-up Lost to Follow-up	2	2
6 Month Follow-up Lost to Follow-up	3	0
12 Month Follow-up Lost to Follow-up	2	3
12 Month Follow-up Pregnancy	0	1
12 Month Follow-up Surgery	2	0
12 Month Follow-up Wrong address	1	0
12 Month Follow-up No symptoms	1	0
12 Month Follow-up Changed primary care center	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Physiotherapist as Primary Assessor n=35 Participants The healthcare process started with a physiotherapist assessment and treatment. Treatments could involve individual or group treatment including patient education and physical exercise. Patients could seek a physician anytime after the first assessment with the physiotherapist. Physiotherapist as primary assessor: Physiotherapist diagnosed and treated the patient.	Physician as Primary Assessor n=34 Participants The healthcare process started with a physician assessment and treatment. Treatments could involve drug prescriptions, referral to x-ray, referrals to other healthcare providers and sick-leave. Patients could seek a physiotherapist anytime after the first assessment with the physician. Physician as primary assessor: Physician diagnosed and treated the patient.	Total n=69 Participants Total of all reporting groups
Age, Continuous	62 years STANDARD_DEVIATION 12 • n=35 Participants	59 years STANDARD_DEVIATION 12 • n=34 Participants	60 years STANDARD_DEVIATION 11.6 • n=69 Participants
Sex: Female, Male Female	21 Participants n=35 Participants	23 Participants n=34 Participants	44 Participants n=69 Participants
Sex: Female, Male Male	14 Participants n=35 Participants	11 Participants n=34 Participants	25 Participants n=69 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Level of education Primary school	8 Participants n=35 Participants	4 Participants n=34 Participants	12 Participants n=69 Participants
Level of education Secondary school	15 Participants n=35 Participants	20 Participants n=34 Participants	35 Participants n=69 Participants
Level of education Tertiary school	12 Participants n=35 Participants	10 Participants n=34 Participants	22 Participants n=69 Participants
Current Employment Employed/working	19 Participants n=35 Participants	18 Participants n=34 Participants	37 Participants n=69 Participants
Current Employment Unemployed	0 Participants n=35 Participants	1 Participants n=34 Participants	1 Participants n=69 Participants
Current Employment Retired/early retirement	15 Participants n=35 Participants	13 Participants n=34 Participants	28 Participants n=69 Participants
Current Employment Sick leave	1 Participants n=35 Participants	2 Participants n=34 Participants	3 Participants n=69 Participants
Pain duration (months)	14 months STANDARD_DEVIATION 22 • n=35 Participants	10 months STANDARD_DEVIATION 16 • n=34 Participants	12 months STANDARD_DEVIATION 19 • n=69 Participants
BMI	30 kg/m^2 STANDARD_DEVIATION 4.4 • n=35 Participants	29 kg/m^2 STANDARD_DEVIATION 6.7 • n=34 Participants	29 kg/m^2 STANDARD_DEVIATION 5.6 • n=69 Participants
Health-related quality of life	0.73 score on a scale STANDARD_DEVIATION 0.121 • n=35 Participants	0.62 score on a scale STANDARD_DEVIATION 0.222 • n=34 Participants	0.67 score on a scale STANDARD_DEVIATION 0.185 • n=69 Participants
Pain intensity (visual analogue scale 0-100)	45 units on a scale STANDARD_DEVIATION 15.9 • n=35 Participants	52 units on a scale STANDARD_DEVIATION 16.4 • n=34 Participants	49 units on a scale STANDARD_DEVIATION 16.5 • n=69 Participants
Physical function in lower extremities	12 number of stands from sitting on a chair STANDARD_DEVIATION 4.6 • n=35 Participants	11 number of stands from sitting on a chair STANDARD_DEVIATION 3.3 • n=34 Participants	12 number of stands from sitting on a chair STANDARD_DEVIATION 4.1 • n=69 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Total 21 patients participated in the 12 month follow up in the physiotherapy group and 23 in the physician group. Imputation using multiple imputation and the analysis included all enrolled patients in each group (35 in the physiotherapy group, and 34 in the physician group).

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.

Outcome measures

Measure	Physiotherapist as Primary Assessor n=35 Participants The healthcare process started with a physiotherapist assessment and treatment. Treatments could involve individual or group treatment including patient education and physical exercise. Patients could seek a physician anytime after the first assessment with the physiotherapist. Physiotherapist as primary assessor: Physiotherapist diagnosed and treated the patient.	Physician as Primary Assessor n=34 Participants The healthcare process started with a physician assessment and treatment. Treatments could involve drug prescriptions, referral to x-ray, referrals to other healthcare providers and sick-leave. Patients could seek a physiotherapist anytime after the first assessment with the physician. Physician as primary assessor: Physician diagnosed and treated the patient.
Mean Difference in Quality Adjusted Life Years (QALY)	0.74 score on a scale Standard Deviation 0.17	0.73 score on a scale Standard Deviation 0.18

PRIMARY outcome

Timeframe: 12 months

Population: Based on retrieved medical records where 32 patients could be analysed in the physiotherapy group and 29 patients in the physician group regardless if they attended to the planned follow ups in the study.

Total costs with the societal perspective includes health care visits, prescribed drugs, productivity loss and unpaid work compensation. Data were retrieved from medical records.

Outcome measures

Measure	Physiotherapist as Primary Assessor n=32 Participants The healthcare process started with a physiotherapist assessment and treatment. Treatments could involve individual or group treatment including patient education and physical exercise. Patients could seek a physician anytime after the first assessment with the physiotherapist. Physiotherapist as primary assessor: Physiotherapist diagnosed and treated the patient.	Physician as Primary Assessor n=29 Participants The healthcare process started with a physician assessment and treatment. Treatments could involve drug prescriptions, referral to x-ray, referrals to other healthcare providers and sick-leave. Patients could seek a physiotherapist anytime after the first assessment with the physician. Physician as primary assessor: Physician diagnosed and treated the patient.
Mean Difference in Total Costs (Societal Perspective)	633 Euro (currency) Standard Deviation 620	996 Euro (currency) Standard Deviation 1276

PRIMARY outcome

Timeframe: 12 months

Population: Based on retrieved medical records where 32 patients could be analysed in the physiotherapy group and 29 patients in the physician group regardless if they attended to the planned follow ups in the study.

Health care perspective includes health care visits and prescribed drugs. Data were collected through medical records.

Outcome measures

Measure	Physiotherapist as Primary Assessor n=32 Participants The healthcare process started with a physiotherapist assessment and treatment. Treatments could involve individual or group treatment including patient education and physical exercise. Patients could seek a physician anytime after the first assessment with the physiotherapist. Physiotherapist as primary assessor: Physiotherapist diagnosed and treated the patient.	Physician as Primary Assessor n=29 Participants The healthcare process started with a physician assessment and treatment. Treatments could involve drug prescriptions, referral to x-ray, referrals to other healthcare providers and sick-leave. Patients could seek a physiotherapist anytime after the first assessment with the physician. Physician as primary assessor: Physician diagnosed and treated the patient.
Mean Difference in Total Costs (Health Care Perspective)	515 Euro (currency) Standard Deviation 541	748 Euro (currency) Standard Deviation 885

PRIMARY outcome

Timeframe: 12 months

Population: All enrolled patients were included in this analysis which included imputed data.

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

Outcome measures

Measure	Physiotherapist as Primary Assessor n=69 Participants The healthcare process started with a physiotherapist assessment and treatment. Treatments could involve individual or group treatment including patient education and physical exercise. Patients could seek a physician anytime after the first assessment with the physiotherapist. Physiotherapist as primary assessor: Physiotherapist diagnosed and treated the patient.	Physician as Primary Assessor The healthcare process started with a physician assessment and treatment. Treatments could involve drug prescriptions, referral to x-ray, referrals to other healthcare providers and sick-leave. Patients could seek a physiotherapist anytime after the first assessment with the physician. Physician as primary assessor: Physician diagnosed and treated the patient.
Incremental Cost-effectiveness Ratio (ICER) - Societal Perspective	24266 Ratio (Euro/QALY)	—

PRIMARY outcome

Timeframe: 12 months

Population: All enrolled patients were included in this analysis which included imputed data.

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

Outcome measures

Measure	Physiotherapist as Primary Assessor n=69 Participants The healthcare process started with a physiotherapist assessment and treatment. Treatments could involve individual or group treatment including patient education and physical exercise. Patients could seek a physician anytime after the first assessment with the physiotherapist. Physiotherapist as primary assessor: Physiotherapist diagnosed and treated the patient.	Physician as Primary Assessor The healthcare process started with a physician assessment and treatment. Treatments could involve drug prescriptions, referral to x-ray, referrals to other healthcare providers and sick-leave. Patients could seek a physiotherapist anytime after the first assessment with the physician. Physician as primary assessor: Physician diagnosed and treated the patient.
Incremental Cost-effectiveness Ratio (ICER) - Health Care Perspective	15533 Ratio (Euro/QALY)	—

SECONDARY outcome

Timeframe: 12 months

Population: Based on retrieved medical records where 32 patients could be analysed in the physiotherapy group and 29 patients in the physician group regardless if they attended to the planned follow ups in the study.

Number of visits registered in patients journal multiplied with the cost.

Outcome measures

Measure	Physiotherapist as Primary Assessor n=32 Participants The healthcare process started with a physiotherapist assessment and treatment. Treatments could involve individual or group treatment including patient education and physical exercise. Patients could seek a physician anytime after the first assessment with the physiotherapist. Physiotherapist as primary assessor: Physiotherapist diagnosed and treated the patient.	Physician as Primary Assessor n=29 Participants The healthcare process started with a physician assessment and treatment. Treatments could involve drug prescriptions, referral to x-ray, referrals to other healthcare providers and sick-leave. Patients could seek a physiotherapist anytime after the first assessment with the physician. Physician as primary assessor: Physician diagnosed and treated the patient.
Costs for Physiotherapy Visits	380 Euro (currency) Standard Deviation 377	332 Euro (currency) Standard Deviation 641

SECONDARY outcome

Timeframe: 12 months

Population: Based on retrieved medical records where 32 patients could be analysed in the physiotherapy group and 29 patients in the physician group regardless if they attended to the planned follow ups in the study.

Number of visits registered in patients journal multiplied with cost

Outcome measures

Measure	Physiotherapist as Primary Assessor n=32 Participants The healthcare process started with a physiotherapist assessment and treatment. Treatments could involve individual or group treatment including patient education and physical exercise. Patients could seek a physician anytime after the first assessment with the physiotherapist. Physiotherapist as primary assessor: Physiotherapist diagnosed and treated the patient.	Physician as Primary Assessor n=29 Participants The healthcare process started with a physician assessment and treatment. Treatments could involve drug prescriptions, referral to x-ray, referrals to other healthcare providers and sick-leave. Patients could seek a physiotherapist anytime after the first assessment with the physician. Physician as primary assessor: Physician diagnosed and treated the patient.
Costs for Physician Visits	39 Euro (currency) Standard Deviation 95	217 Euro (currency) Standard Deviation 140

SECONDARY outcome

Timeframe: 12 months

Population: Based on retrieved medical records where 32 patients could be analysed in the physiotherapy group and 29 patients in the physician group regardless if they attended to the planned follow ups in the study.

Number of referrals to radiography registered in patients journal multiplied with its costs

Outcome measures

Measure	Physiotherapist as Primary Assessor n=32 Participants The healthcare process started with a physiotherapist assessment and treatment. Treatments could involve individual or group treatment including patient education and physical exercise. Patients could seek a physician anytime after the first assessment with the physiotherapist. Physiotherapist as primary assessor: Physiotherapist diagnosed and treated the patient.	Physician as Primary Assessor n=29 Participants The healthcare process started with a physician assessment and treatment. Treatments could involve drug prescriptions, referral to x-ray, referrals to other healthcare providers and sick-leave. Patients could seek a physiotherapist anytime after the first assessment with the physician. Physician as primary assessor: Physician diagnosed and treated the patient.
Costs for Referrals to Radiography	7.9 Euro (currency) Standard Deviation 25	32 Euro (currency) Standard Deviation 42

SECONDARY outcome

Timeframe: 12 months

Population: Based on retrieved medical records where 32 patients could be analysed in the physiotherapy group and 29 patients in the physician group regardless if they attended to the planned follow ups in the study.

Number of referrals to orthopedic surgeon registered in patients journal multiplied with the costs

Outcome measures

Measure	Physiotherapist as Primary Assessor n=32 Participants The healthcare process started with a physiotherapist assessment and treatment. Treatments could involve individual or group treatment including patient education and physical exercise. Patients could seek a physician anytime after the first assessment with the physiotherapist. Physiotherapist as primary assessor: Physiotherapist diagnosed and treated the patient.	Physician as Primary Assessor n=29 Participants The healthcare process started with a physician assessment and treatment. Treatments could involve drug prescriptions, referral to x-ray, referrals to other healthcare providers and sick-leave. Patients could seek a physiotherapist anytime after the first assessment with the physician. Physician as primary assessor: Physician diagnosed and treated the patient.
Costs for Referrals to Orthopedic Surgeon	22 Euro (currency) Standard Deviation 85	33 Euro (currency) Standard Deviation 100

SECONDARY outcome

Timeframe: 12 months

Population: Based on retrieved medical records where 32 patients could be analysed in the physiotherapy group and 29 patients in the physician group regardless if they attended to the planned follow ups in the study.

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.

Outcome measures

Measure	Physiotherapist as Primary Assessor n=32 Participants The healthcare process started with a physiotherapist assessment and treatment. Treatments could involve individual or group treatment including patient education and physical exercise. Patients could seek a physician anytime after the first assessment with the physiotherapist. Physiotherapist as primary assessor: Physiotherapist diagnosed and treated the patient.	Physician as Primary Assessor n=29 Participants The healthcare process started with a physician assessment and treatment. Treatments could involve drug prescriptions, referral to x-ray, referrals to other healthcare providers and sick-leave. Patients could seek a physiotherapist anytime after the first assessment with the physician. Physician as primary assessor: Physician diagnosed and treated the patient.
Costs for Collected Prescribed Drugs	7.8 Euro (currency) Standard Deviation 34	6.6 Euro (currency) Standard Deviation 16

SECONDARY outcome

Timeframe: 12 months

Population: Based on retrieved medical records where 32 patients could be analysed in the physiotherapy group and 29 patients in the physician group regardless if they attended to the planned follow ups in the study.

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.

Outcome measures

Measure	Physiotherapist as Primary Assessor n=32 Participants The healthcare process started with a physiotherapist assessment and treatment. Treatments could involve individual or group treatment including patient education and physical exercise. Patients could seek a physician anytime after the first assessment with the physiotherapist. Physiotherapist as primary assessor: Physiotherapist diagnosed and treated the patient.	Physician as Primary Assessor n=29 Participants The healthcare process started with a physician assessment and treatment. Treatments could involve drug prescriptions, referral to x-ray, referrals to other healthcare providers and sick-leave. Patients could seek a physiotherapist anytime after the first assessment with the physician. Physician as primary assessor: Physician diagnosed and treated the patient.
Costs for Productivity Loss	111 Euro (currency) Standard Deviation 91	365 Euro (currency) Standard Deviation 853

SECONDARY outcome

Timeframe: 12 months

Population: Based on retrieved medical records where 32 patients could be analysed in the physiotherapy group and 29 patients in the physician group regardless if they attended to the planned follow ups in the study.

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.

Outcome measures

Measure	Physiotherapist as Primary Assessor n=32 Participants The healthcare process started with a physiotherapist assessment and treatment. Treatments could involve individual or group treatment including patient education and physical exercise. Patients could seek a physician anytime after the first assessment with the physiotherapist. Physiotherapist as primary assessor: Physiotherapist diagnosed and treated the patient.	Physician as Primary Assessor n=29 Participants The healthcare process started with a physician assessment and treatment. Treatments could involve drug prescriptions, referral to x-ray, referrals to other healthcare providers and sick-leave. Patients could seek a physiotherapist anytime after the first assessment with the physician. Physician as primary assessor: Physician diagnosed and treated the patient.
Costs for Unpaid Work Compensation	125 Euro (currency) Standard Deviation 103	123 Euro (currency) Standard Deviation 191

Adverse Events

Physiotherapist as Primary Assessor

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Physician as Primary Assessor

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Chan-Mei Ho-Henriksson, PhD-student, RPT

Region Västra Götaland, Närhälsan

Phone: +46709892821

Email: chan-mei.ho@vgregion.se

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place