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research:comparison_of_combination_treatment_in_hypertension [2017/04/16 08:56] burculantonija |
research:comparison_of_combination_treatment_in_hypertension [2017/08/07 08:42] (current) scyou [Discussion] |
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- | ====== Large-scale modeling of patients with thyroid conditions ====== | + | ====== Comparison of combination treatment in hypertension ====== |
<WRAP box justify round> | <WRAP box justify round> | ||
- | **Objective:** //Characterisation of non-cancerous thyroid disorder population and sources of variation within treatment pathways// | + | **Objective:** The goal of this protocols is conducting comparative effectiveness research to establish evidences for optimal anti-hypertensive combination strategies among patients without cardiovascular outcome from various databases across world. |
- | **Rationale:** //There are an estimated 200 million people worldwide who suffer from some form of thyroid disease according to the Thyroid Foundation of Canada. Women are 5-8 times more likely to develop it than men. 5-10 % of pregnancies end up with postpartum thyroiditis. Over 12 % of the US population has some type of a thyroid condition. As a result, synthetic thyroid hormone is the top prescribed medication in USA with more than 20 million prescriptions per month. Patients who suffer from the symptoms of the disease often spend years un- or misdiagnosed. Depending on the type of the condition symptoms include, among others, anxiety, weight gain or loss, depression and brain fog. Patients can suffer from symptoms of the disease even though their thyroid stimulating hormone (TSH) values are within the reference ranges. Currently, the treatment for any type of a thyroid condition includes the process of testing different drug combinations and doses for a period of time until the optimal one is found. | + | **Rationale:** High blood pressure is the leading global burden of death and disability. Extensive evidences support the beneficial effects in tight control of blood pressure. Since monotherapy is often insufficient or slow to reach blood pressure target quickly, combination therapy is recommended as the first-line treatment for selected patients with hypertension by the recent guideline to reduce cardiovascular risk. Retrospective observational studies and meta-analysis have suggested that initial combination hypertensive treatment confers decreased risk for cardiovascular events than monotherapy. Only a few randomized clinical trials, however, have directly compared the effects of different regimens of combination. In addition to limited number of evidences from head-to-head comparison, baseline high risk for cardiovascular outcome and previous history of anti-hypertensive medication of participants also make the findings from RCTs difficult to apply to clinical practice. To the best of our knowledge, real-world comparative effectiveness research comparing the various regimens of combination treatment in patients with essential hypertension has not been conducted until now. |
- | To conclude, patients with a thyroid dysfunction would benefit from looking into treatment variations occurring due to the heterogeneous and drug and dose-sensitive nature of their disease. | + | |
- | // | + | |
- | **Project Lead(s):** //Antonija Burcul, Frank DeFalco, Jill Hardin// | ||
- | **Coordinating Institution(s):** //// | + | **Project Lead(s):** |
+ | Seng Chan You, MD, Ajou University, Korea | ||
+ | Sungjae Jung, BE, Ajou University, Korea | ||
+ | Sungha Park, MD, Yonsei university College of Medicine, Korea | ||
+ | Rae Woong Park, MD, PhD, Ajou University, Korea | ||
+ | |||
+ | **Coordinating Institution(s):** Ajou University, Korea | ||
** Additional Participants:** // | ** Additional Participants:** // | ||
- | Dr. med. Ivette Engel-Bicik, Switzerland, | ||
- | Dr. med. Maria Tulpan, USA, | ||
- | Dr. med. Kent Holfort, USA | ||
// | // | ||
- | **Full Protocol:** //[[https://github.com/OHDSI/StudyProtocolSandbox/raw/master/HypertensionCombination/documents/HTN_combi_protocol_ver0.3(17.1.2).docx|Word doc for the protocol]] // | + | **Full Protocol:** [[https://github.com/OHDSI/StudyProtocolSandbox/blob/master/HypertensionCombination/documents/HTN_combi_protocol_ver1.1.docx|Word doc for the protocol]] |
**Initial Proposal Date:** Sep 2016 | **Initial Proposal Date:** Sep 2016 | ||
- | **Launch Date:** 16 Jan 2017 // // | + | **Launch Date:** 7 Aug 2017 |
**Study Closure Date: // //** | **Study Closure Date: // //** | ||
- | **Results Submission:** //<method of sumission, [[mailto:applegna@gmail.com|Email]]>// | + | **Results Submission:** Via Google Drive |
</WRAP> | </WRAP> | ||
===== Requirements ===== | ===== Requirements ===== | ||
- | **CDM:** //V5 only// | + | **CDM:** V5 or over |
- | **Table Accessed:** //person, drug_exposure, drug_era, death, condition_occurrence, measurement, procedure_occurrence, visit_occurrence// | + | **Table Accessed:** person, drug_exposure, drug_era, death, condition_occurrence, procedure_occurrence, visit_occurrence |
**Database Dialects:** SQL Server, Postgres, Oracle | **Database Dialects:** SQL Server, Postgres, Oracle | ||
- | **Software:** //R// | + | **Software:** R |
===== Code ===== | ===== Code ===== | ||
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===== Discussion ===== | ===== Discussion ===== | ||
- | //Post a thread letting everyone know about this new proposed study at [[http://forums.ohdsi.org/c/researchers]]// | + | //[[http://forums.ohdsi.org/c/researchers]]// |
===== Datasets Run ===== | ===== Datasets Run ===== |