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| Name | Class |
|---|---|
| Institute of Health Economics, Canada | OTHER |
| Roche Pharma AG | INDUSTRY |
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The objective of this study is to assess the effects of using HRQL measures in the clinical care of pre- and post-lung transplant patients.
The hypotheses are that the inclusion of HRQL measures, the Health Utilities Index System Mark 2(HUI2) and Mark 3 (HUI3), in routine clinical care of pre- and post-lung transplant patients, will: 1) improve patient-clinician communication;2) affect patient management; 3) improve patients' HRQL.
Recently there has been increasing interest in the use of health-related quality of life (HRQL) measures in routine clinical practice. Traditionally, patient care has been based on laboratory results, medical history, and signs and symptoms diagnosed by clinicians. The inclusion of HRQL measures in routine practice may provide important and often otherwise missing information, revealing the impact of the disease or its treatment on the patient's physical, emotional and social well-being, and may assist in patient management. HRQL assessments may assist in changing the medical paradigm from a disease-centered approach to a patient-centered one.
Several studies in mental health and oncology discuss the application of HRQL measures in clinical practice. Taenzer et al (2000) and Detmar et al. (2002) provide evidence that using HRQL measures improves patient-clinician communication. Velikova et al (2004) detected impacts on communication and the emotional well-being of patients.
Using a framework based on these previous studies and the methods for the health technology assessment of diagnostic technologies (Guyatt et al. 1986), we will assess the effects of including HRQL assessments in the routine clinical care of patients undergoing solid organ transplantation (lung).
We expect that the routine use of HRQL measures in clinical practice will affect patient-clinician communication, patient management, and patient outcome.
Lung transplantation trades a fatal disease (end-stage pulmonary disease) for a chance at prolonged survival and improved quality of life, albeit with immunosuppression. In this context, generic preference-based measures such as HUI2 and HUI3 are preferred to specific measures, because they measure a broader range of health dimensions, including pain, ambulation and emotional issues that are expected to be relevant. Preference-based measures provide scores on the conventional 0.00 (dead) to 1.00 (perfect health) scale that allows for the integration of morbidity and mortality effects and calculation of quality adjusted life years (QALYs) and health-adjusted life expectancy (HALE).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HUI score card | Behavioral | Patients completed the HUI2 and HUI3 before the encounter with the clinician, the result was graphically represented in the HUI score card. Clinicians used the HUI score card as an extra tool to help them in the management of the patients |
| Measure | Description | Time Frame |
|---|---|---|
| Communication Score | Each clinician-patient encounter was audio tape-recorded. The content of the tape-recordings was examined and results recorded on the communication form by three blinded raters. This form tallies the number of issues discussed. The number of issues is summed to produce a communication score. The issues discussed included health attributes included in the HUI2 and HUI3: ambulation, self-care, anxiety, depression, cognitive problems, pain (type and frequency), vision, hearing speech and dexterity problems. | Baseline and end of study (6 months) |
| Management Composite | Changes in clinical management were recorded in the chart review form. The number of referrals to other healthcare providers, tests ordered (X-rays, blood test, bronchoscopies) and changes in medication (reduction or increase dosage, addition or discontinuation) were summed to produce the management composite. | At baseline and end of study (6 months) |
| EuroQol, EQ-5D. | Generic preference-based measure. EQ-5D consists of two sections: a 100-point visual analog scale (VAS) and a descriptive system that contains five attributes (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) with three levels per attribute ("no problem", "some problems" and "extreme problems").Using the US scoring function EQ-5D index scores range from -0.11 (all-worst health state, worse than dead), to 0.00 (dead) to 1.00 (perfect health). The EQ-5D is easy to complete, valid and reliable. | At baseline and end of study (6 months). |
| Measure | Description | Time Frame |
|---|---|---|
| The Hospital Anxiety and Depression Scale,HADS. Completed at Baseline and End of the Study. | HADS is a self-complete mental health measure. The scale consists of 14 items, seven of which assess anxiety and seven which assess depression. Each item is on a four point scale and the scores are added to give a total ranging from 0 to 21 for anxiety and 0 to 21 for depression. Higher scores indicate more severe anxiety or depression. A cut-point of 8 or 9 indicates mild burden for the two scales; 11 or 12 indicates severe . All the patients completed HADS at baseline and at the end of the study. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David H Feeny, PhD | Professor Economics, University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta Hospital | Edmonton | Alberta | Canada |
Pre-transplant patients were censored out of the study once they had the lung transplant.
The recruitment started July 2005. Patients were recruited at the out patient clinic University of Alberta Hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | HUI2 and HUI3 Completion Without Feedback to Clinicians. | Patients in the control arm completed the HUI2 and HUI3 but the results were not fed back to clinicians. |
| FG001 | HUI2 and HUI3 Completion and Feedback to Clinicians | Patients in the intervention arm completed the HUI2 and HUI3 and results were fedback to clinicians before the encounter with the patient at every clinic visit. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HUI2 and HUI3 Completion Without Feedback to Clinicians. | Patients in the control arm completed the HUI2 and HUI3 but the results were not fed back to clinicians. |
| BG001 | HUI2 and HUI3 Completion and Feedback to Clinicians |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Communication Score | Each clinician-patient encounter was audio tape-recorded. The content of the tape-recordings was examined and results recorded on the communication form by three blinded raters. This form tallies the number of issues discussed. The number of issues is summed to produce a communication score. The issues discussed included health attributes included in the HUI2 and HUI3: ambulation, self-care, anxiety, depression, cognitive problems, pain (type and frequency), vision, hearing speech and dexterity problems. | Traditional analysis of covariance, ANCOVA was conducted to explore the difference between control and intervention groups at 6 months adjusting for baseline scores and transplant status. ITT was conducted and missing values were imputed using the LOCF. | Posted | Mean | Standard Deviation | Mean number of issues discussed | Baseline and end of study (6 months) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HUI2 and HUI3 Completion Without Feedback to Clinicians. | Patients in the control arm completed the HUI2 and HUI3 but the results were not fed back to clinicians. |
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Randomizing patients instead of clinicians lead to sensitizing effects. EQ-5D is a generic preference-based measure, a specific measure should have been used to maximize responsiveness.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maria Jose Santana | Lung transplant program, University of Alberta Hospital | 780-441-1661 | msantana@ualberta.ca |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D011658 | Pulmonary Fibrosis |
| D006976 | Hypertension, Pulmonary |
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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|
| Baseline and end of study (6 months) |
| Death |
|
Patients in the intervention arm completed the HUI2 and HUI3 and results were fedback to clinicians before the encounter with the patient at every clinic visit.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Patients in the control arm completed the HUI2 and HUI3 but the results were not fed back to clinicians. |
| OG001 | HUI2 and HUI3 Completion and Feedback to Clinicians | Patients in the intervention arm completed the HUI2 and HUI3 and results were fedback to clinicians before the encounter with the patient at every clinic visit. |
|
|
|
| Secondary | The Hospital Anxiety and Depression Scale,HADS. Completed at Baseline and End of the Study. | HADS is a self-complete mental health measure. The scale consists of 14 items, seven of which assess anxiety and seven which assess depression. Each item is on a four point scale and the scores are added to give a total ranging from 0 to 21 for anxiety and 0 to 21 for depression. Higher scores indicate more severe anxiety or depression. A cut-point of 8 or 9 indicates mild burden for the two scales; 11 or 12 indicates severe . All the patients completed HADS at baseline and at the end of the study. | 47 observation were imputed by LOCF and analyzed as ITT. | Posted | Mean | Standard Deviation | mean anxiety and depression | Baseline and end of study (6 months) |
|
|
|
|
| Primary | Management Composite | Changes in clinical management were recorded in the chart review form. The number of referrals to other healthcare providers, tests ordered (X-rays, blood test, bronchoscopies) and changes in medication (reduction or increase dosage, addition or discontinuation) were summed to produce the management composite. | Analysis was conducted using ITT, with 47 observations carried forward. | Posted | Mean | Standard Deviation | mean management composite | At baseline and end of study (6 months) |
|
|
|
|
| Primary | EuroQol, EQ-5D. | Generic preference-based measure. EQ-5D consists of two sections: a 100-point visual analog scale (VAS) and a descriptive system that contains five attributes (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) with three levels per attribute ("no problem", "some problems" and "extreme problems").Using the US scoring function EQ-5D index scores range from -0.11 (all-worst health state, worse than dead), to 0.00 (dead) to 1.00 (perfect health). The EQ-5D is easy to complete, valid and reliable. | To compare two independent means for a parallel trial design, 100 patients in each group were needed to detect a clinically important difference (CID) in EQ-5D index score (CID = 0.10, SD = 0.25) with a 5% probability of Type I error, two-sided-test and 80% power. ITT was conducted for 213 recruited patients. 47 records were imputed using LOCF. | Posted | Mean | Standard Deviation | mean EQ-5D index score | At baseline and end of study (6 months). |
|
|
|
|
| 0 |
| 105 |
| 0 |
| 105 |
| EG001 | HUI2 and HUI3 Completion and Feedback to Clinicians | Patients in the intervention arm completed the HUI2 and HUI3 and results were fedback to clinicians before the encounter with the patient at every clinic visit. | 0 | 108 | 0 | 108 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017563 | Lung Diseases, Interstitial |
| D005355 | Fibrosis |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| End-of-Study Anxiety |
|
| End-of-Study Depression |
|
| 0.55 |
| 95 |
| Superiority or Other (legacy) |