Analysis Plan Submission Form

Transcription

1 Analysis Plan Submission Form DMHT : Analysis Plan # Date submitted: 03 January 2014 at 15:19:09 Date approved: Analysis Plan Title: Achievement of metabolic goals among different health insurance schemes in Thai type 2 diabetes patients Investigator s Name: Tada Kunavisarut (kunavisarut@gmail.com) Contact Address: Division of endocrinology and metabolism, Siriraj Hospital Department of Medicine, Faculty of Medicine, Mahidol University, Bangkok, Thailand Rationale/Background: Type 2 diabetes mellitus is a common and chronic disease. It can cause micro- and macro-vascular complications. Many professional organizations, including Thai endocrine society, develop diabetes guidelines and goals of each metabolic parameter. The latest Thai diabetes guideline have been published in 2011 and distributed to primary and secondary care physicians in all region of Thailand. Mortality and morbidity rates in type 2 diabetes patients have fallen considerably over the past decades. Patients can achieve the goals with complex drug regimens and new medications and lead to declining in cardiovascular complications. Medicines consume 25-65% of total spending on health in developing countries (1). Therefore, access to medications and adherence to medications are essential for optimizing outcomes. According World health organization, Universal Health Coverage is defined as ensuring that all people can use the promotive, preventive, curative, rehabilitative and palliative health services they need, of sufficient quality to be effective, while also ensuring that the use of these services does not expose the user to financial hardship(2).in Thailand, the universal coverage policy has been started in There are three main types of health insurance schemes: 1) Civil Servant Medical Benefit (CSMB); 2) Social Security (SS); 3) Universal Coverage (UC). Regarding to the Health and welfare survey in 2004 (HWS2004) report, 10 %, 11% and almost 80% of Thai population using CSMB, SS and UC for their health coverage respectively(3).expanding health insurance coverage increased access to medicines in primary care especially chronic disease such as diabetes and hypertension(1). However, there are differences in the drug list in each scheme. UC uses the National List of Essential Medicines (NLEM) which most of them are lower cost medicines (eg. generic products, and products that are manufactured by Thailand s Government Pharmaceutical organization). SS uses their own drug lists, while the patients who have CSMB can uses almost all medications including originator

2 brand products. Objective: The objective of this study is to compare the metabolic controls in Thai type 2 diabetes patients using different three main health insurance schemes. Dataset to be used: Dataset Name: Data DM/HT pid, hosp, opd, sex, age, occ, region, type, type_8x, dm_ht, weight, high, dmdiag, dmdate, dmpcu, dmldate, b91, b91date, b92, b92date, b92na, b9na, b10, b10date, b10na, b11, b11date, b11na, b12, b12date, b12na, b13, b13date, b13na, b14, b14date, b14na, b15, b15date, b16a, b16b, b16date, b16c, b171, b171date, b171na, b172, b172date, b172na, b173, b173date, b173na, b174, b174date, b174na, ldldm, b17d, b1811, b1812, b181date, b1821, b1822, b182date, b19, b19a, b19an2x, b19b, b19date, b20a, b20b1, b20b2, b20b3, b20b4, b21a, b21b1, b21b2, b21b3, b22a, b22adate, b22b1, b22b2, b22b3, b22b4a, b22b4b1, b22b4b2, b22b4c1, b22b4c2, b23, b24a, b24b1, b24b2, b24b3, b25a, b25b, b25c, b26a, b26b1, b26b2, b26b3, b31n3, b32, b33, b33date, b34, htdiag, htdate, htpcu, htldate, c3611, c3612, c361date, c3621, c3622, c362date, c37, c38, c38date, c39a, c39b, c39date, c40a1, c40a2, c40adate, c40b1, c40b2, c40bdate, c40c1, c40c2, c40cdate, c40d1, c40d2, c40ddate, c40e1, c40e2, c40edate, c40f1, c40f2, c40g1, c40g2, ldlht, c40i1, c40i2, c40j1, c40j2, c40k1, c40l1, c40l2n31, c40l2n32, c40l2n33, sbp, dbp, ldl_c, chol, tg, ldl, lipid, bp, bp_dn, bp_ht, alb_mg, type_h, hosp_bkk, bed_gr, bed_gr_bkk, type_new, type_gr Primary outcome descriptions: Goal for DM: Goal for DM with HT

3 Primary outcome variable: Dataset Data DM/HT: sbp, dbp, ldl_c, chol, ldl, lipid, bp Materials and Methods: Study design A national cross-sectional survey was conducted by Thailand National Health Security Office (NHSO) and the Thailand Medical Research Network to assess on quality of care among patients diagnosed with type 2 diabetes and hypertension visiting Ministry of Public Health and Bangkok Metropolitan Administration Hospitals between 2010 and Data were collected from medical records by enrolling 174,578 patients from 602 hospitals across Thailand. This study included total xx,xxxx samples. Statistical Analysis Results are presented as mean and standard deviation (SD) for continuous variables and percentage for categorical variables. Analysis of variance and Chi-square test were used for comparisons, when appropriate.statistical analyses were performed using SPSS version Statistical significant was defined as p-value<0.05. Mock Tables and Figures: I.Demographic data Diabetes Demographic data UC (n= ) CSMB (n= ) SS (n= ) Age (yrs) Mean (SD) Gender Male Female BMI (kg/m2) Mean (SD) Underweight Normal Overweight Obesity Duration of diabetes (years) Smoking history Currently smoke Ex-smoke

4 Never smoke SBP (mmhg) DBP (mmhg) FPG (mg/dl) HbA1C (%) Total cholesterol (mg/dl) Triglyceride (mg/dl) HDL (mg/dl) LDL (mg/dl) *NON-HDL (mg/dl) Serum creatinine Anti-platelet Rx -yes -no Microalbuminuria -positive -negative Hypoglycemic agents -oral hypoglycemic agents -Insulin -Oral hypoglycemic agents with insulin -Life style modification * NON-HDL= Total Cholesterol-HDL Diabetes with hypertension Demographic data UC (n= ) CSMB (n= ) SS (n= ) Age (yrs) Mean (SD) Gender Male Female BMI (kg/m2) Mean (SD) Underweight Normal Overweight

5 Obesity Duration of diabetes (years) Smoking history Currently smoke Ex-smoke Never smoke SBP (mmhg) DBP (mmhg) FPG (mg/dl) HbA1C (%) Total cholesterol (mg/dl) Triglyceride (mg/dl) HDL (mg/dl) LDL (mg/dl) NON-HDL (mg/dl) Serum creatinine Anti-platelet Rx -yes -no Microalbuminuria -positive -negative Hypoglycemic agents -oral hypoglycemic agents -Insulin -Oral hypoglycemic agents with insulin -Life style modification * NON-HDL= Total Cholesterol-HDL II. Achieve Goal data Diabetes Goal UC (n= ) CSMB (n= ) SS (n= )

6 * NON-HDL= Total Cholesterol-HDL Diabetes with hypertension Goal UC (n= ) CSMB (n= ) SS (n= ) References: 1. Quick JD. Ensuring access to essential medicines in the developing countries: a framework for action. Clinical pharmacology and therapeutics Apr;73(4): PubMed PMID: HWS. National statistical office Mock Abstract: