Using Health-related Quality of Life (HRQL) in Routine Clinical Care
An Assessment of the Effects of the Use of Measures of Health-related Quality of Life in Routine Clinical Care:an Application to Lung Transplantation.
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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).
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Alberta
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Edmonton, Alberta, Canadá
- University of Alberta Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- pre-lung transplant:subjects who are included on the waiting list and are being seen at the out-patient clinic
- post-lung transplant subjects.
Exclusion Criteria:
- younger than 18 years of age
- diagnosed as being cognitively impaired
- unable to complete questionnaires in English
Plan de estudios
¿Cómo está diseñado el estudio?
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Control
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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
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Communication Score
Periodo de tiempo: Baseline and end of study (6 months)
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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.
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Baseline and end of study (6 months)
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Management Composite
Periodo de tiempo: At baseline and end of study (6 months)
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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.
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At baseline and end of study (6 months)
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EuroQol, EQ-5D.
Periodo de tiempo: At baseline and end of study (6 months).
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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.
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At baseline and end of study (6 months).
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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The Hospital Anxiety and Depression Scale,HADS. Completed at Baseline and End of the Study.
Periodo de tiempo: Baseline and end of study (6 months)
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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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Baseline and end of study (6 months)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: David H Feeny, PhD, Professor Economics, University of Alberta
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Digestivo
- Procesos Patológicos
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Enfermedades de las vías respiratorias
- Enfermedades pulmonares
- Infantil, Recién Nacido, Enfermedades
- Enfermedades Genéticas Congénitas
- Enfermedades pancreáticas
- Hipertensión
- Fibrosis
- Enfermedades Pulmonares Obstructivas
- Enfermedad Pulmonar Obstructiva Crónica
- Fibrosis pulmonar
- Fibrosis quística
- Hipertensión Pulmonar
Otros números de identificación del estudio
- IHE-188
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