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.
調査の概要
詳細な説明
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).
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Alberta
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Edmonton、Alberta、カナダ
- University of Alberta Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
コホートと介入
グループ/コホート |
介入・治療 |
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コントロール
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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
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Communication Score
時間枠：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
時間枠：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.
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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The Hospital Anxiety and Depression Scale,HADS. Completed at Baseline and End of the Study.
時間枠：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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協力者と研究者
スポンサー
捜査官
- 主任研究者：David H Feeny, PhD、Professor Economics, University of Alberta
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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