2017 Fiscal Year Annual Research Report
フィリピンの結核治療における低栄養と糖尿病への栄養介入法の構築に向けた観察研究
| Project/Area Number |
17H04662
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| Research Institution | Nagasaki University |
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Principal Investigator |
コックス シャーロン 長崎大学, 熱帯医学・グローバルヘルス研究科, 教授 (80750140)
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| Co-Investigator(Kenkyū-buntansha) |
柳原 克紀 長崎大学, 医歯薬学総合研究科(医学系), 教授 (40315239)
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| Project Period (FY) |
2017-04-01 – 2020-03-31
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| Keywords | tuberculosis / malnutrition / diabetes / immune function |
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| Outline of Annual Research Achievements |
Study site selection is nearly complete, with 8 sites identified from three regions in the Philippines and national and local ethical and official approvals nearly complete and the study has been endorsed by the Dept of Health and the National TB Programme. The head of the National TB Programme is a local investigator. S Cox was invited to participate in the 12th National TB Programme Coordinator meeting in the WPRO region, hosted by WPRO WHO Office in March 2018.
Two new PhD student projects (1 x student accepted on Nagasaki/London school of Hygiene & Tropical Medicine, UK Joint PhD; 1 x student accepted by TMGH, Nagasaki, both to start in Oct 2018) have been incorporated into the study design submitted for ethical approvals. All equipment has been purchased and installed and laboratory protocols are in place. Local staff recruitment of clinical research nurse data collectors has started and will continue into May including completion of all local staff training
Recruitment is now planned to start in June 2018, pending ability to hire replacement supervisory research staff - please see below.
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| Current Status of Research Progress |
Current Status of Research Progress
4: Progress in research has been delayed.
Reason
The start of patient enrolment and data collection is delayed by 6 months due to research staff availability (1 research assistant went on maternity leave and Assistant Professor Laura White resigned in October 17) and difficulties in hiring replacements. Lack of staff also caused delays in preparing all the documentation required for approvals, which was greatly increased due to recent changes in local ethical committee requirements and processes, plus more delays in reviewing due to internal process changes and fewer review meetings.
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| Strategy for Future Research Activity |
Cebu has been added as an extra site, due to planned sites in Manila being unable to participate due to other activities. Activities from June - March 2019 will include enrolment of TB patients initiating a new TB-DOTs course of treatment at the 8 different TB DOTS clinics. Data collection at enrolment will include sputum sample collection, TB disease information from their NTP cards, anaemia and diabetes screening from finger prick samples and anthropometry. 250 bacteriologically confirmed patients will be selected for a venous blood sample for testing of immune responses using Quantiferon GoldPlus kits. Follow up data collection of anthropometry and drug adherence by the research study nurses will occur at monthly visits to the study TB DOTS clinics or at their barangay health post. TB patients who are diagnosed with diabetes will have HbA1C re-assessed at 3-montly intervals. Data collection on patient costs has been added to the protocol to be completed by a PhD student. Also drug-resistant TB patients enrolled on the new 9 month -shorter course regiment, which is being rolled out nationally, managed by local TB DOTS clinics, rather than at centralised Programmatic Management of Drug Resistant TB centres, are now being included, as this will allow us to compare nutritional status, diabetes and TB outcomes between drug sensitive and drug resistant TB patients and evaluate the effect of this new regimen on total patient costs.
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