Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2026-02-27 @ 11:18 PM
Study NCT ID:
NCT03822533
Status:
COMPLETED
Last Update Posted:
2024-05-06
First Post:
2019-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Cost-efficiency Analysis of Primary Assessors for Patients With Knee Pain in Primary Care
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059825', 'term': 'Physical Therapists'}, {'id': 'D010820', 'term': 'Physicians'}], 'ancestors': [{'id': 'D006282', 'term': 'Health Personnel'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'chan-mei.ho@vgregion.se', 'phone': '+46709892821', 'title': 'Chan-Mei Ho-Henriksson, PhD-student, RPT', 'organization': 'Region Västra Götaland, Närhälsan'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Major organizational changes in Vastra Gotaland Region, where the study was conducted, affected the recruiting process. The research project was probably de-prioritized since the patient flow declined drastically. Hence the target number of participants needed to achieve target power was not reached due to early termination of the recruiting process.'}}, 'adverseEventsModule': {'timeFrame': '1 year from baseline', 'eventGroups': [{'id': 'EG000', 'title': 'Physiotherapist as Primary Assessor', 'description': 'The healthcare process started with a physiotherapist assessment and treatment. Treatments could involve individual or group treatment including patient education and physical exercise.\n\nPatients could seek a physician anytime after the first assessment with the physiotherapist.\n\nPhysiotherapist as primary assessor: Physiotherapist diagnosed and treated the patient.', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Physician as Primary Assessor', 'description': '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.\n\nPatients could seek a physiotherapist anytime after the first assessment with the physician.\n\nPhysician as primary assessor: Physician diagnosed and treated the patient.', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Difference in Quality Adjusted Life Years (QALY)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Physiotherapist as Primary Assessor', 'description': 'The healthcare process started with a physiotherapist assessment and treatment. Treatments could involve individual or group treatment including patient education and physical exercise.\n\nPatients could seek a physician anytime after the first assessment with the physiotherapist.\n\nPhysiotherapist as primary assessor: Physiotherapist diagnosed and treated the patient.'}, {'id': 'OG001', 'title': 'Physician as Primary Assessor', 'description': '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.\n\nPatients could seek a physiotherapist anytime after the first assessment with the physician.\n\nPhysician as primary assessor: Physician diagnosed and treated the patient.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.74', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '0.73', 'spread': '0.18', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.69', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.015', 'ciLowerLimit': '-0.059', 'ciUpperLimit': '0.089', 'groupDescription': 'Mean difference using independent samples t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.015', 'ciLowerLimit': '-0.093', 'ciUpperLimit': '0.063', 'pValueComment': 'The linear regression analysis was needed to calculate the incremental cost efficiency ratio (ICER). The p-value from this test was not relevant for the ICER calculation.', 'groupDescription': 'Presenting β-values from linear regression analysis for group variable adjusted for baseline differences in EQ-5D-3L-index. The results from this analysis were used to calculate incremental cost-effectiveness ratio (mean difference in costs divided by mean difference in QALYs).', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'First step in a cost-efficiency analysis'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'PRIMARY', 'title': 'Mean Difference in Total Costs (Societal Perspective)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Physiotherapist as Primary Assessor', 'description': 'The healthcare process started with a physiotherapist assessment and treatment. Treatments could involve individual or group treatment including patient education and physical exercise.\n\nPatients could seek a physician anytime after the first assessment with the physiotherapist.\n\nPhysiotherapist as primary assessor: Physiotherapist diagnosed and treated the patient.'}, {'id': 'OG001', 'title': 'Physician as Primary Assessor', 'description': '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.\n\nPatients could seek a physiotherapist anytime after the first assessment with the physician.\n\nPhysician as primary assessor: Physician diagnosed and treated the patient.'}], 'classes': [{'categories': [{'measurements': [{'value': '633', 'spread': '620', 'groupId': 'OG000'}, {'value': '996', 'spread': '1276', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.17', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-364', 'ciLowerLimit': '-891', 'ciUpperLimit': '164', 'groupDescription': 'Independent-samples t-test. Dependent variable cost items, independent variable group (physiotherapist or physician assessment)', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-364', 'ciLowerLimit': '-870', 'ciUpperLimit': '143', 'pValueComment': 'The linear regression analysis was needed to calculate the incremental cost efficiency ratio (ICER). The p-value from this test was not relevant for the ICER calculation.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'First step in a cost-efficiency analysis'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Total costs with the societal perspective includes health care visits, prescribed drugs, productivity loss and unpaid work compensation. Data were retrieved from medical records.', 'unitOfMeasure': 'Euro (currency)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Mean Difference in Total Costs (Health Care Perspective)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Physiotherapist as Primary Assessor', 'description': 'The healthcare process started with a physiotherapist assessment and treatment. Treatments could involve individual or group treatment including patient education and physical exercise.\n\nPatients could seek a physician anytime after the first assessment with the physiotherapist.\n\nPhysiotherapist as primary assessor: Physiotherapist diagnosed and treated the patient.'}, {'id': 'OG001', 'title': 'Physician as Primary Assessor', 'description': '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.\n\nPatients could seek a physiotherapist anytime after the first assessment with the physician.\n\nPhysician as primary assessor: Physician diagnosed and treated the patient.'}], 'classes': [{'categories': [{'measurements': [{'value': '515', 'spread': '541', 'groupId': 'OG000'}, {'value': '748', 'spread': '885', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.23', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-233', 'ciLowerLimit': '-616', 'ciUpperLimit': '150', 'groupDescription': 'Independent-samples t-test. Dependent variable cost items, independent variable group (physiotherapist or physician assessment)', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-233', 'ciLowerLimit': '-605', 'ciUpperLimit': '139', 'pValueComment': 'The linear regression analysis was needed to calculate the incremental cost efficiency ratio (ICER). The p-value from this test was not relevant for the ICER calculation.', 'groupDescription': 'Linear regression analysis. The results from this analysis were used to calculate incremental cost-effectiveness ratio (mean difference in costs divided by mean difference in QALYs).', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'First step in a cost-efficiency analysis.'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Health care perspective includes health care visits and prescribed drugs. Data were collected through medical records.', 'unitOfMeasure': 'Euro (currency)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Incremental Cost-effectiveness Ratio (ICER) - Societal Perspective', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Physiotherapy Assessment vs Physician Assessment', 'description': 'Physiotherapy assessments costs and effects on quality adjusted life years were compared to the costs and effects of physician assessment.'}], 'classes': [{'categories': [{'measurements': [{'value': '24266', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': '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\n\nIncremental Cost-effectiveness Ratio was derived from the model where a measure of dispersion was not an output of the model', 'unitOfMeasure': 'Ratio (Euro/QALY)', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled patients were included in this analysis which included imputed data.'}, {'type': 'PRIMARY', 'title': 'Incremental Cost-effectiveness Ratio (ICER) - Health Care Perspective', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Physiotherapy vs Physician as Primary Assessors', 'description': 'Physiotherapy assessments costs and effects on quality adjusted life years were compared to the costs and effects of physician assessment.'}], 'classes': [{'categories': [{'measurements': [{'value': '15533', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': '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.\n\nIncremental Cost-effectiveness Ratio was derived from the model where a measure of dispersion was not an output of the model', 'unitOfMeasure': 'Ratio (Euro/QALY)', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled patients were included in this analysis which included imputed data.'}, {'type': 'SECONDARY', 'title': 'Costs for Physiotherapy Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Physiotherapist as Primary Assessor', 'description': 'The healthcare process started with a physiotherapist assessment and treatment. Treatments could involve individual or group treatment including patient education and physical exercise.\n\nPatients could seek a physician anytime after the first assessment with the physiotherapist.\n\nPhysiotherapist as primary assessor: Physiotherapist diagnosed and treated the patient.'}, {'id': 'OG001', 'title': 'Physician as Primary Assessor', 'description': '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.\n\nPatients could seek a physiotherapist anytime after the first assessment with the physician.\n\nPhysician as primary assessor: Physician diagnosed and treated the patient.'}], 'classes': [{'categories': [{'measurements': [{'value': '380', 'spread': '377', 'groupId': 'OG000'}, {'value': '332', 'spread': '641', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.72', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '48', 'ciLowerLimit': '-219', 'ciUpperLimit': '314', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Number of visits registered in patients journal multiplied with the cost.', 'unitOfMeasure': 'Euro (currency)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Costs for Physician Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Physiotherapist as Primary Assessor', 'description': 'The healthcare process started with a physiotherapist assessment and treatment. Treatments could involve individual or group treatment including patient education and physical exercise.\n\nPatients could seek a physician anytime after the first assessment with the physiotherapist.\n\nPhysiotherapist as primary assessor: Physiotherapist diagnosed and treated the patient.'}, {'id': 'OG001', 'title': 'Physician as Primary Assessor', 'description': '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.\n\nPatients could seek a physiotherapist anytime after the first assessment with the physician.\n\nPhysician as primary assessor: Physician diagnosed and treated the patient.'}], 'classes': [{'categories': [{'measurements': [{'value': '39', 'spread': '95', 'groupId': 'OG000'}, {'value': '217', 'spread': '140', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-178', 'ciLowerLimit': '-239', 'ciUpperLimit': '118', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Number of visits registered in patients journal multiplied with cost', 'unitOfMeasure': 'Euro (currency)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Costs for Referrals to Radiography', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Physiotherapist as Primary Assessor', 'description': 'The healthcare process started with a physiotherapist assessment and treatment. Treatments could involve individual or group treatment including patient education and physical exercise.\n\nPatients could seek a physician anytime after the first assessment with the physiotherapist.\n\nPhysiotherapist as primary assessor: Physiotherapist diagnosed and treated the patient.'}, {'id': 'OG001', 'title': 'Physician as Primary Assessor', 'description': '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.\n\nPatients could seek a physiotherapist anytime after the first assessment with the physician.\n\nPhysician as primary assessor: Physician diagnosed and treated the patient.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.9', 'spread': '25', 'groupId': 'OG000'}, {'value': '32', 'spread': '42', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-24', 'ciLowerLimit': '-42', 'ciUpperLimit': '6.2', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Number of referrals to radiography registered in patients journal multiplied with its costs', 'unitOfMeasure': 'Euro (currency)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Costs for Referrals to Orthopedic Surgeon', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Physiotherapist as Primary Assessor', 'description': 'The healthcare process started with a physiotherapist assessment and treatment. Treatments could involve individual or group treatment including patient education and physical exercise.\n\nPatients could seek a physician anytime after the first assessment with the physiotherapist.\n\nPhysiotherapist as primary assessor: Physiotherapist diagnosed and treated the patient.'}, {'id': 'OG001', 'title': 'Physician as Primary Assessor', 'description': '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.\n\nPatients could seek a physiotherapist anytime after the first assessment with the physician.\n\nPhysician as primary assessor: Physician diagnosed and treated the patient.'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'spread': '85', 'groupId': 'OG000'}, {'value': '33', 'spread': '100', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.62', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12', 'ciLowerLimit': '-59', 'ciUpperLimit': '36', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Number of referrals to orthopedic surgeon registered in patients journal multiplied with the costs', 'unitOfMeasure': 'Euro (currency)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Costs for Collected Prescribed Drugs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Physiotherapist as Primary Assessor', 'description': 'The healthcare process started with a physiotherapist assessment and treatment. Treatments could involve individual or group treatment including patient education and physical exercise.\n\nPatients could seek a physician anytime after the first assessment with the physiotherapist.\n\nPhysiotherapist as primary assessor: Physiotherapist diagnosed and treated the patient.'}, {'id': 'OG001', 'title': 'Physician as Primary Assessor', 'description': '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.\n\nPatients could seek a physiotherapist anytime after the first assessment with the physician.\n\nPhysician as primary assessor: Physician diagnosed and treated the patient.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.8', 'spread': '34', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.87', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.2', 'ciLowerLimit': '-13', 'ciUpperLimit': '15', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': '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.', 'unitOfMeasure': 'Euro (currency)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Costs for Productivity Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Physiotherapist as Primary Assessor', 'description': 'The healthcare process started with a physiotherapist assessment and treatment. Treatments could involve individual or group treatment including patient education and physical exercise.\n\nPatients could seek a physician anytime after the first assessment with the physiotherapist.\n\nPhysiotherapist as primary assessor: Physiotherapist diagnosed and treated the patient.'}, {'id': 'OG001', 'title': 'Physician as Primary Assessor', 'description': '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.\n\nPatients could seek a physiotherapist anytime after the first assessment with the physician.\n\nPhysician as primary assessor: Physician diagnosed and treated the patient.'}], 'classes': [{'categories': [{'measurements': [{'value': '111', 'spread': '91', 'groupId': 'OG000'}, {'value': '365', 'spread': '853', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.27', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-254', 'ciLowerLimit': '-728', 'ciUpperLimit': '220', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': '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.', 'unitOfMeasure': 'Euro (currency)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Costs for Unpaid Work Compensation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Physiotherapist as Primary Assessor', 'description': 'The healthcare process started with a physiotherapist assessment and treatment. Treatments could involve individual or group treatment including patient education and physical exercise.\n\nPatients could seek a physician anytime after the first assessment with the physiotherapist.\n\nPhysiotherapist as primary assessor: Physiotherapist diagnosed and treated the patient.'}, {'id': 'OG001', 'title': 'Physician as Primary Assessor', 'description': '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.\n\nPatients could seek a physiotherapist anytime after the first assessment with the physician.\n\nPhysician as primary assessor: Physician diagnosed and treated the patient.'}], 'classes': [{'categories': [{'measurements': [{'value': '125', 'spread': '103', 'groupId': 'OG000'}, {'value': '123', 'spread': '191', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.96', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.8', 'ciLowerLimit': '-113', 'ciUpperLimit': '118', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': '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.', 'unitOfMeasure': 'Euro (currency)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Physiotherapist as Primary Assessor', 'description': 'The healthcare process started with a physiotherapist assessment and treatment. Treatments could involve individual or group treatment including patient education and physical exercise.\n\nPatients could seek a physician anytime after the first assessment with the physiotherapist.\n\nPhysiotherapist as primary assessor: Physiotherapist diagnosed and treated the patient.'}, {'id': 'FG001', 'title': 'Physician as Primary Assessor', 'description': '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.\n\nPatients could seek a physiotherapist anytime after the first assessment with the physician.\n\nPhysician as primary assessor: Physician diagnosed and treated the patient.'}], 'periods': [{'title': 'Baseline', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': '3 Month Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': '6 Month Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': '12 Month Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Surgery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Wrong address', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'No symptoms', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Changed primary care center', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Excluded (n=294)\n\n* Not meeting inclusion criteria (n=185)\n* Declined to participate (n=15)\n* Excluded due to exclusion criteria (n=94)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Physiotherapist as Primary Assessor', 'description': 'The healthcare process started with a physiotherapist assessment and treatment. Treatments could involve individual or group treatment including patient education and physical exercise.\n\nPatients could seek a physician anytime after the first assessment with the physiotherapist.\n\nPhysiotherapist as primary assessor: Physiotherapist diagnosed and treated the patient.'}, {'id': 'BG001', 'title': 'Physician as Primary Assessor', 'description': '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.\n\nPatients could seek a physiotherapist anytime after the first assessment with the physician.\n\nPhysician as primary assessor: Physician diagnosed and treated the patient.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '62', 'spread': '12', 'groupId': 'BG000'}, {'value': '59', 'spread': '12', 'groupId': 'BG001'}, {'value': '60', 'spread': '11.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Level of education', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Primary school', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Secondary school', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Tertiary school', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Current Employment', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Employed/working', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'Unemployed', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Retired/early retirement', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Sick leave', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Pain duration (months)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '14', 'spread': '22', 'groupId': 'BG000'}, {'value': '10', 'spread': '16', 'groupId': 'BG001'}, {'value': '12', 'spread': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '30', 'spread': '4.4', 'groupId': 'BG000'}, {'value': '29', 'spread': '6.7', 'groupId': 'BG001'}, {'value': '29', 'spread': '5.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Health-related quality of life', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0.73', 'spread': '0.121', 'groupId': 'BG000'}, {'value': '0.62', 'spread': '0.222', 'groupId': 'BG001'}, {'value': '0.67', 'spread': '0.185', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '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. Only the baseline value is presented. The index was collected to calculate quality adjusted life years (QALY), see Primary outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Pain intensity (visual analogue scale 0-100)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '45', 'spread': '15.9', 'groupId': 'BG000'}, {'value': '52', 'spread': '16.4', 'groupId': 'BG001'}, {'value': '49', 'spread': '16.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Pain intensity were collected using a visual analogue scale (VAS) ranging from 0 to 100, were 0 represents no pain and 100 worst imaginable pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Physical function in lower extremities', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '12', 'spread': '4.6', 'groupId': 'BG000'}, {'value': '11', 'spread': '3.3', 'groupId': 'BG001'}, {'value': '12', 'spread': '4.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Physical function were measured with the performance test, 30 seconds chair stand test, where patients were encouraged to perform as many stands as possible in 30 seconds. The start position was sitting on a chair. The stands were counted if the participant were fully raised to straight hips and knees. The arms were folded across the chest during the test.', 'unitOfMeasure': 'number of stands from sitting on a chair', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-08-08', 'size': 195741, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-08-08T05:07', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.\n\nThis study focuses on analysing cost efficiency of the health care processes for patients with suspected knee osteoarthritis in primary care.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 363}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-03', 'studyFirstSubmitDate': '2019-01-28', 'resultsFirstSubmitDate': '2022-08-08', 'studyFirstSubmitQcDate': '2019-01-29', 'lastUpdatePostDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-03', 'studyFirstPostDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Difference in Quality Adjusted Life Years (QALY)', 'timeFrame': '12 months', 'description': '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.'}, {'measure': 'Mean Difference in Total Costs (Societal Perspective)', 'timeFrame': '12 months', 'description': 'Total costs with the societal perspective includes health care visits, prescribed drugs, productivity loss and unpaid work compensation. Data were retrieved from medical records.'}, {'measure': 'Mean Difference in Total Costs (Health Care Perspective)', 'timeFrame': '12 months', 'description': 'Health care perspective includes health care visits and prescribed drugs. Data were collected through medical records.'}, {'measure': 'Incremental Cost-effectiveness Ratio (ICER) - Societal Perspective', 'timeFrame': '12 months', 'description': '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\n\nIncremental Cost-effectiveness Ratio was derived from the model where a measure of dispersion was not an output of the model'}, {'measure': 'Incremental Cost-effectiveness Ratio (ICER) - Health Care Perspective', 'timeFrame': '12 months', 'description': '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.\n\nIncremental Cost-effectiveness Ratio was derived from the model where a measure of dispersion was not an output of the model'}], 'secondaryOutcomes': [{'measure': 'Costs for Physiotherapy Visits', 'timeFrame': '12 months', 'description': 'Number of visits registered in patients journal multiplied with the cost.'}, {'measure': 'Costs for Physician Visits', 'timeFrame': '12 months', 'description': 'Number of visits registered in patients journal multiplied with cost'}, {'measure': 'Costs for Referrals to Radiography', 'timeFrame': '12 months', 'description': 'Number of referrals to radiography registered in patients journal multiplied with its costs'}, {'measure': 'Costs for Referrals to Orthopedic Surgeon', 'timeFrame': '12 months', 'description': 'Number of referrals to orthopedic surgeon registered in patients journal multiplied with the costs'}, {'measure': 'Costs for Collected Prescribed Drugs', 'timeFrame': '12 months', 'description': '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.'}, {'measure': 'Costs for Productivity Loss', 'timeFrame': '12 months', 'description': '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.'}, {'measure': 'Costs for Unpaid Work Compensation', 'timeFrame': '12 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Primary assessor', 'cost efficiency', 'physiotherapist', 'quality of life'], 'conditions': ['Osteoarthritis, Knee']}, 'referencesModule': {'references': [{'pmid': '25084132', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '16110932', 'type': 'BACKGROUND', 'citation': 'Walters 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.'}, {'pmid': '10515649', 'type': 'BACKGROUND', 'citation': 'Brazier 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.'}, {'pmid': '35300671', 'type': 'DERIVED', 'citation': 'Ho-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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nPurpose: 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.\n\nMethods: 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.\n\nExpected 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.', 'detailedDescription': 'Problem statements:\n\nWhat 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?\n\nWhich 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?\n\nWhat are the differences in costs between the two healthcare processes initiated by either a physiotherapist or a physician set against the differences in effects?\n\nPatient recruitment:\n\nSome 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.\n\nPatients were recruited from primary care centers and rehabilitation centers in southwestern Sweden.\n\nScreening procedure:\n\nNurses 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.\n\nRandomization:\n\nA 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).\n\nThe 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.\n\nData collection:\n\nDemographic 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.\n\nNew 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).\n\nCalculating total costs (number of contacts per patient \\* costs ) for:\n\n* Physiotherapy contacts in primary care\n* Physician contacts in primary care\n* Referrals to x-ray\n* Referrals to other healthcare givers\n* Drug prescriptions\n* Sick-leave days\n\nData management:\n\nAll 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.\n\nSample size:\n\nA 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%.\n\nStatistical analysis plan:\n\nData 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).\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '38 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Knee pain most of the days the last month\n* Over 38 years old\n* Crepitus on active motion\n* Morning stiffness less than 30 minutes\n\nExclusion Criteria:\n\n* Not been diagnosed for current knee pain\n* Non-traumatic cause due to current knee pain\n* No other rheumatic, severe somatic or psychological diseases that can affect the outcome measures.\n* Not pregnant\n* Does not know enough Swedish to answer questionnaires.'}, 'identificationModule': {'nctId': 'NCT03822533', 'briefTitle': 'A Cost-efficiency Analysis of Primary Assessors for Patients With Knee Pain in Primary Care', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Vastra Gotaland Region'}, 'officialTitle': 'A Cost-efficiency Analysis of Physiotherapist or Physicians as Primary Assessors for Patients With Knee Pain in Primary Care', 'orgStudyIdInfo': {'id': '115841healthecon'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Physiotherapist as primary assessor', 'description': '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.\n\nPatients can seek a physician anytime after the first assessment with the physiotherapist.', 'interventionNames': ['Other: Physiotherapist as primary assessor']}, {'type': 'OTHER', 'label': 'Physician as primary assessor', 'description': '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.\n\nPatients can seek a physiotherapist anytime after the first assessment with the physician.', 'interventionNames': ['Other: Physician as primary assessor']}], 'interventions': [{'name': 'Physiotherapist as primary assessor', 'type': 'OTHER', 'description': 'Physiotherapist diagnose and treat the patient.', 'armGroupLabels': ['Physiotherapist as primary assessor']}, {'name': 'Physician as primary assessor', 'type': 'OTHER', 'description': 'Physician diagnose and treat the patient.', 'armGroupLabels': ['Physician as primary assessor']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vänersborg', 'state': 'VastraGotaland', 'country': 'Sweden', 'facility': 'Närhälsan Vänersborg Rehabmottagning', 'geoPoint': {'lat': 58.38075, 'lon': 12.3234}}, {'city': 'Brålanda', 'state': 'Västra Götaland County', 'country': 'Sweden', 'facility': 'Medpro Clinic Brålanda-Torpa Vårdcentral', 'geoPoint': {'lat': 58.56344, 'lon': 12.34923}}, {'city': 'Lilla Edet', 'state': 'Västra Götaland County', 'country': 'Sweden', 'facility': 'Medpro Clinic Lilla Edet Vårdcentral', 'geoPoint': {'lat': 58.13333, 'lon': 12.13333}}, {'city': 'Lilla Edet', 'state': 'Västra Götaland County', 'country': 'Sweden', 'facility': 'Närhälsan Lilla Edets Rehabmottagning', 'geoPoint': {'lat': 58.13333, 'lon': 12.13333}}, {'city': 'Trollhättan', 'state': 'Västra Götaland County', 'country': 'Sweden', 'facility': 'Capio Läkarhus Hjortmossen', 'geoPoint': {'lat': 58.28365, 'lon': 12.28864}}, {'city': 'Trollhättan', 'state': 'Västra Götaland County', 'country': 'Sweden', 'facility': 'Närhälsan Trollhättan Rehabmottagning', 'geoPoint': {'lat': 58.28365, 'lon': 12.28864}}, {'city': 'Trollhättan', 'state': 'Västra Götaland County', 'country': 'Sweden', 'facility': 'Primapraktiken', 'geoPoint': {'lat': 58.28365, 'lon': 12.28864}}, {'city': 'Vänersborg', 'state': 'Västra Götaland County', 'country': 'Sweden', 'facility': 'Medpro Clinic Torpa Vårdcentral', 'geoPoint': {'lat': 58.38075, 'lon': 12.3234}}, {'city': 'Vänersborg', 'state': 'Västra Götaland County', 'country': 'Sweden', 'facility': 'Vårdcentralen Nordstan', 'geoPoint': {'lat': 58.38075, 'lon': 12.3234}}], 'overallOfficials': [{'name': 'Lena Nordeman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Närhälsan Research and development center Södra Älvsborg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vastra Gotaland Region', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}