Contribution of Four Pulmonary Function Tests to Diagnosis in the Primary Care.
Contribution of Four Pulmonary Function Tests to Diagnosis in Patients With Respiratory Symptoms in the Primary Care.
調査の概要
状態
条件
詳細な説明
Background Pulmonary function tests are routinely used for the diagnosis of respiratory conditions. Few studies have been conducted, assessing the use of the pulmonary function tests and their contribution to the diagnosis in patients with respiratory symptoms. A recent study in 33 chest services from Belgian hospitals have shown that each of the four common pulmonary function tests (spirometry, lung volume, airway resistance and diffusing capacity) contributes significantly to the final diagnosis made by pulmonologists in new patients with respiratory symptoms.
Primary care physicians however treat the majority of patients with respiratory symptoms and often use a symptom-based approach to make a diagnosis (2). Diagnostic spirometry remains largely underused in primary care and is probably mainly performed in the care of patients with asthma and chronic obstructive pulmonary disease (COPD). Drawbacks of home spirometry also include poorly performed tests and incorrect interpretation of the results (3). In addition, primary care physicians have no access to the three other common pulmonary function tests that contribute independently to the diagnosis of respiratory diseases (1).
Since 2015, our chest service localized in the center of Brussels offers a direct and open access to the lung function laboratory to all the patients referred by their general practitioners. The four common tests are performed in their patients with respiratory symptoms but no clear diagnosis and the patients are not evaluated by the chest physicians. A protocol is however performed with potential advice for additional diagnostic tests (provocation tests, exhaled NO measurement, ergospirometry, imaging,…).
In the present study, we will assess the contribution of the four common pulmonary function tests to diagnosis in patients with respiratory symptoms in the primary care.
Methods Prospective single center cohort study. Adult patients, aged more than 18 years, presenting to the general practitioner with respiratory symptoms but without a clear diagnosis and referred by them for pulmonary function tests will be enrolled in the study. Patients will be excluded if they had diagnosed respiratory disease at our institution and if they are not able to perform pulmonary function testing.
The patients will not be seen or examined by a pulmonologist of the chest service. They will return to the referring family physician for further treatment.
Before lung function testing, the patients will be asked to fill in a questionnaire, including short questions about their medical history and respiratory medications, previous referrals to a pulmonologist, symptoms and comorbidities.
All patients, regardless of the suspected respiratory condition, will also be asked to complete the COPD assessment test (CAT test) to better quantify their symptoms.
The tests (spirometry, plethysmography, airway resistance measurement, diffusion capacity measurement) will then be performed by a qualified lung function lab technician. Interpretation of the results will be made by a pulmonologist. The protocol will be given to the patient or sent to the referring family physician and may also include proposals for additional diagnostic tests.
In second time, one month later, the general practitioner will be contacted by one of the investigators to receive more information about the final diagnosis based on all the investigations done and treatment.
The collected data will be processed in a database and analyzed anonymously. The primary outcome will be the increase in the proportion of diagnosis afforded by the four tests in comparison with spirometry alone. Secondary outcomes will be the proportion of patients without clear diagnosis, time to lung function tests and time to diagnosis.
Statistical analysis The present study is mainly descriptive and no hypothesis can be made on the contribution of additional lung function tests to the final diagnosis in a population of patients from general practitioners. The present study will include 100 patients with respiratory symptoms but no clear diagnosis.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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Brussels、ベルギー、1000
- 募集
- CHU St Pierre
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コンタクト:
- Maria Gabrovska, M.D.
- 電話番号:00325353368
- メール:maria_gabrovska@stpierre-bru.be
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コンタクト:
- Vincent Ninane, M.D., PhD
- 電話番号:00325354276
- メール:vincent_ninane@stpierre-bru.be
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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
サンプリング方法
調査対象母集団
- all patients, send by a general practitioner to our lung function lab
- adults patients (older than 18 years and younger than 80 years), both sexes
- not followed by a pulmonologist
- no previous diagnosis and established treatment
説明
Inclusion Criteria:
- all subjects: 18 or older than 18 years old and younger than 80 years old
- send by a general practitioner for a lung function test
Exclusion Criteria:
- subjects, younger than 18 years old
- not able to perform the lung function tests
- incomplete lung function tests
- disease already diagnosed
- already follow up by a pulmonologist
- preoperative test
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
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1 cohort
adult patients of both sexes (>18 and <80 years) with no previous diagnosis or follow up by a pulmonologist, send by a general practitioner to the lung function lab
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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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number of cases in which the four lung function tests are contributing to the final diagnosis
時間枠:at study completion
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number of cases in which the four lung function tests are contributing to the final established diagnosis compared to spirometry alone
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at study completion
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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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number of cases in which additional tests were performed
時間枠:at study completion
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number of cases in which additional tests were needed to establish the correct final diagnosis, after the performance of the four lung function tests
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at study completion
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changes in treatment after the four lung function tests
時間枠:at study completion
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changes in treatment, prescribed by the primary physician, after the performance of the four lung function tests
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at study completion
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協力者と研究者
捜査官
- 主任研究者:Vincent Ninane, M.D., PhD、CHU St Pierre
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
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 (実際)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
呼吸器疾患の臨床試験
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