UMIN-CTR Clinical Trial
| Recruitment status | Terminated |
| Unique ID issued by UMIN | UMIN000042096 |
| Receipt No. | R000048043 |
| Scientific Title | Diagnostic accuracy and adverse events of bronchial and intranasal challenge tests for NSAIDs-exacerbated respiratory disease: A systematic review and meta-analysis |
| Date of disclosure of the study information | 2020/10/15 |
| Last modified on | 2021/01/12 (Ver. 2) |
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| Basic information | ||
| Public title | Diagnostic accuracy and adverse events of bronchial and intranasal challenge tests for NSAIDs-exacerbated respiratory disease: A systematic review and meta-analysis | |
| Acronym | Diagnostic accuracy and adverse events of bronchial and intranasal challenge tests for NSAIDs-exacerbated respiratory disease: A systematic review and meta-analysis | |
| Scientific Title | Diagnostic accuracy and adverse events of bronchial and intranasal challenge tests for NSAIDs-exacerbated respiratory disease: A systematic review and meta-analysis | |
| Scientific Title:Acronym | Diagnostic accuracy and adverse events of bronchial and intranasal challenge tests for NSAIDs-exacerbated respiratory disease: A systematic review and meta-analysis | |
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| Condition | ||
| Condition | NSAIDs-exacerbated respiratory disease | |
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| Classification by malignancy | Others | |
| Genomic information | NO | |
| Objectives | |
| Narrative objectives1 | This systematic review aimed to evaluate the diagnostic accuracy and adverse events of inhalational challenge tests including bronchial and nasal challenge tests. |
| Basic objectives2 | Others |
| Basic objectives -Others | Evaluating sensitivity and specificity as well as the number of adverse reactions. |
| Trial characteristics_1 | |
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| Assessment | |
| Primary outcomes | Sensitivity and specificity |
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| Base | |
| Study type | Others,meta-analysis etc |
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| Gender | Male and Female | |||
| Key inclusion criteria | First, we will include the prospective or retrospective cohort studies, case-control studies, case series, and case reports describing aspirin inhalation challenge tests (bronchial or nasal challenge tests) for NERD in the review of adverse events.
Second, AS and HS will independently select the articles from include articles in adverse events review for systematic review and meta-analysis of diagnostic accuracy. Inclusion criteria for diagnostic test accuracy review will be prospective or retrospective cohort studies, and case-control studies assessing the accuracy of aspirin or ketorolac inhalational challenge tests for differentiating NERD and non-NERD patients. Exclusion criteria of diagnostic test accuracy review will be case series, case reports, review articles, and animal studies. |
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| Key exclusion criteria | Mentioned above. | |||
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| Organization | Ichinomiyanishi Hospital | ||||||
| Division name | Department of respiratory medicine | ||||||
| Zip code | 491-0001 | ||||||
| Address | 1 Kaimeihira Chinomiya, Aichi, Japan, 494-0001 | ||||||
| TEL | 080-3807-4960 | ||||||
| akihirokun8@gmail.com | |||||||
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| Organization | Ichinomiyanishi Hospital | ||||||
| Division name | Department of respiratory medicine | ||||||
| Zip code | 491-0001 | ||||||
| Address | 1 Kaimeihira Chinomiya, Aichi, Japan, 494-0001 | ||||||
| TEL | 080-3807-4960 | ||||||
| Homepage URL | |||||||
| akihirokun8@gmail.com | |||||||
| Sponsor | |
| Institute | Ichinomiyanishi Hospital |
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| Funding Source | |
| Organization | We obtained funding from Systematic Review Workshop Peer Support Group (SRWS-PSG) (https://community.camp-fire.jp/projects/view/187310). |
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| Category of Funding Organization | Other |
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| Organization | Not applicable |
| Address | Not applicable |
| Tel | Not applicable |
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| Secondary IDs | |
| Secondary IDs | NO |
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| URL releasing protocol | |
| Publication of results | Unpublished |
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| Recruitment status | Terminated | ||||||
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| Other related information | For diagnostic test accuracy review, we will evaluate bronchial and intranasal aspirin challenge tests as a role of a replacement of oral aspirin challenge tests in specialized centers among patients who are suspected of NERD based on history and physical examination. We will extract the study information and evaluate the quality of the included studies using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool.
Diagnostic accuracy of inhalation challenge tests will be evaluated with separate three categories; lysine-aspirin bronchial challenge tests, lysine-aspirin intranasal challenge tests, and ketorolac intranasal challenge tests. We will illustrate forest plots and hierarchical summary operating characteristic (HSROC) curves to summarize the diagnostic yield of inhalation challenge tests. Besides, we used a fixed specificity of 93% and calculate the point estimation of sensitivity using HSROC parameters. We used a fixed specificity of 93% because oral aspirin challenge tests had 93% of specificity for diagnosing NERD and we expect bronchial and intranasal challenge tests as similar add-on tests. The overall quality evidence will be assessed using the GRADE approach. |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000048043 |
