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Analysis Plan Submission Form

Date submitted: 24 February 2013 at 12:04:33
Date approved:

Analysis Plan Title: Aspirin Use in Diabetic Patients: Cross-sectional Study
Investigator‘s Name: Silom Jamulitrat ([email protected])
Contact Address:
Department of Community Medicine, Faculty of MedicinePrince of Songkla University, Hat Yai, Songkla 90110 Phone :0894684673URL : http://medinfo.psu.ac.th
Rationale/Background:
Antiplatelet therapy, primarily with 75–325 mg aspirin daily, is recommended toprevent cardiovascular events in diabetes [1–3]. These recommendations are based onevidence that antiplatelet therapy significantly reduces the risk of cardiovascularevents without an excessive risk of adverse effects [4–9]. Historically, the majority ofthis evidence was generated from studies enrolling patients without diabetes, butsince diabetes was considered a “coronary risk equivalent”[10] these conclusions wereextended to diabetic patients. Recently, 2 clinical trials examined the use of ≤100 mgaspirin daily for primary prevention of cardiovascular events in diabetic patients[11,12]. Along with a diabetic subgroup analysis of the Primary Prevention Program,these studies concluded that ≤100 mg aspirin daily does not significantly lower therisk of death or a primary cardiovascular event [8,11,12]. Moreover, data fromobservational studies suggest primary prevention with low dose aspirin may beassociated with more harm than benefit [13,14]. In light of such studies, the role ofaspirin for preventing cardiovascular events in diabetes is being questioned [15,16]Indeed, six meta-analyses published since 2009 have not found any significant benefitfor aspirin in primary prevention of cardiovascular events in diabetes [16–21]One possible explanation for the apparent lack of benefit is aspirin resistance [22].
Diabetes is associated with numerous biochemical abnormalities, including elevatedplatelet reactivity [23,24] Indeed, diabetic patients have a lower response to aspirincompared to the general population [25–27]. Although the exact mechanisms are notclear, a subgroup analysis of the Aspirin-Induced Platelet Effect (ASPECT) studydemonstrated that diabetic patients exhibited a significantly lower rate of resistancewhen given >100 mg daily compared with a lower (and more commonly used) dose of 81 mg daily [28,29]. Moreover, the Antithrombotic Trialists’ (ATT) Collaborationreported that <75 mg aspirin daily was not associated with a significantly lower risk ofvascular events, while 75–1500 mg aspirin daily was [5]. However, this dose-responserelationship was examined in a group of high risk patients regardless of diabetesstatus.
The frequenncy of aspirin use among diabetic patients, stratified demographic andclinical data would give us the clues regarding the decision made by the physians. Objective:
To detemine the fequency of aspirin use among diabetic patients
Dataset to be used:
Dataset Name: Data DM/HT
idrun, pid, hosp, hosp_new, opd, opd_6x, opd_6x_fz, sex, age, occ, occ_12x,occ_12x_fz, region, region_fz, region_4x, type, type_8x, type_8x_fz, dm_ht,weight, weight_na, weight_na_fz, high, high_na, high_na_fz, dmdiag, dmdiag_fz,dmdate, dmdate_fz, dmna, dmna_fz, dmpcu, dmpcu_fz, dmldate, dmldate_fz,b91, b91_fz, b91date, b91date_fz, b92, b92_fz, b92date, b92date_fz, b92na,b92na_fz, b9na, b9na_fz, b10, b10_fz, b10date, b10date_fz, b10na, b10na_fz,b11, b11_fz, b11date, b11date_fz, b11na, b11na_fz, b12, b12_fz, b12date,b12date_fz, b12na, b12na_fz, b13, b13_fz, b13date, b13date_fz, b13na,b13na_fz, b14, b14_fz, b14date, b14date_fz, b14na, b14na_fz, b15, b15_fz,b15date, b15date_fz, b15na, b15na_fz, b16a, b16a_fz, b16b, b16b_fz, b16date,b16date_fz, b16c, b171, b171_fz, b171date, b171date_fz, b171na, b171na_fz,b172, b172_fz, b172date, b172date_fz, b172na, b172na_fz, b173, b173_fz,b173date, b173date_fz, b173na, b173na_fz, b174, b174_fz, b174date,b174date_fz, b174na, b174na_fz, ldldm, ldldm_fz, b17d, b17d_fz, b1811,b1811_fz, b1812, b1812_fz, b181date, b181date_fz, b1821, b1821_fz, b1822,b1822_fz, b182date, b182date_fz, b19, b19_fz, b19a, b19a_fz, b19an2x,b19an3x, b19b, b19b_fz, b19date, b19date_fz, b20a, b20a_fz, b20b1, b20b1_fz,b20b2, b20b2_fz, b20b3, b20b3_fz, b20b4, b20b4_fz, b21a, b21a_fz, b21b1,b21b1_fz, b21b2, b21b2_fz, b21b2x, b21b3, b21b3_fz, b21b3x, b22a, b22a_fz,b22adate, b22adate_fz, b22b1, b22b1_fz, b22b2, b22b2_fz, b22b3, b22b3_fz,b22b4a, b22b4a_fz, b22b4b1, b22b4b1_fz, b22b4b2, b22b4b2_fz, b22b4c1,b22b4c1_fz, b22b4c2, b22b4c2_fz, b23, b23_fz, b24a, b24a_fz, b24b1, b24b1_fz,b24b2, b24b2_fz, b24b3, b24b3_fz, b24b4, b24b4_fz, b24b4x, b24b5, b24b5_fz,b24date, b24date_fz, b25a, b25a_fz, b25date, b25date_fz, b25b, b25b_fz, b25c,b25c_fz, b26a, b26a_fz, b26b1, b26b1_fz, b26b2, b26b2_fz, b26b3, b26b3_fz,b26b4, b26b4_fz, b27, b27_fz, b27date, b27date_fz, b28a1, b28a1_fz,b28a1date, b28a1date_fz, b28a2, b28a2_fz, b28b1, b28b1_fz, b28b1date,b28b1date_fz, b28b2, b28b2_fz, b28c1, b28c1_fz, b28c1date, b28c1date_fz,b28c2, b28c2_fz, b28d1, b28d1_fz, b28d1date, b28d1date_fz, b28d2, b28d2_fz,b29, b29_fz, b29date, b29date_fz, b30, b30_fz, b31n1, b31n1_fz, b31n2,b31n2_fz, b31n3, b31n3_fz, b31b, b31b_fz, b32, b32_fz, b33, b33_fz, b33date, b33date_fz, b34, b34_fz, b34n4x, b35n1, b35n1_fz, b35n1_2gr, b35n2, b35n2_fz,b35n2_2gr, b35n3, b35n3_fz, b35n3_2gr, b35n4, b35n4_fz, b35n4_2gr, b35n5,b35n5_fz, b35n5_2gr, b35n6, b35n6_fz, b35n6_2gr, b35n7, b35n7_fz, b35n7_2gr,b35n8, b35n8_fz, b35n8_2gr, b35n9, b35n9_fz, b35n9_2gr, b35n10, b35n10_fz,b35n10_2gr, b35n11, b35n11_fz, b35n11_2gr, b35n12, b35n12_fz, b35n12_2gr,b35n13, b35n13_fz, b35n13_2gr, b35n14, b35n14_fz, b35n14_2gr, b35n15,b35n15_fz, b35n15_2gr, b35n16, b35n16_fz, b35n16_2gr, htdiag, htdiag_fz,htdate, htdate_fz, htna, htna_fz, htpcu, htpcu_fz, htldate, htldate_fz, c3611,c3611_fz, c3612, c3612_fz, c361date, c361date_fz, c3621, c3621_fz, c3622,c3622_fz, c362date, c362date_fz, c37, c37_fz, c38, c38_fz, c38date, c38date_fz,c39a, c39a_fz, c39b, c39b_fz, c39date, c39date_fz, c40a1, c40a1_fz, c40a2,c40a2_fz, c40adate, c40adate_fz, c40b1, c40b1_fz, c40b2, c40b2_fz, c40bdate,c40bdate_fz, c40c1, c40c1_fz, c40c2, c40c2_fz, c40cdate, c40cdate_fz, c40d1,c40d1_fz, c40d2, c40d2_fz, c40ddate, c40ddate_fz, c40e1, c40e1_fz, c40e2,c40e2_fz, c40edate, c40edate_fz, c40f1, c40f1_fz, c40f2, c40f2_fz, c40fdate,c40fdate_fz, c40g1, c40g1_fz, c40g2, c40g2_fz, c40gdate, c40gdate_fz, ldlht,ldlht_fz, c40g3, c40g3_fz, c40h1, c40h1_fz, c40h2, c40h2_fz, c40hdate,c40hdate_fz, c40h3, c40h3_fz, c40i1, c40i1_fz, c40i2, c40i2_fz, c40idate,c40idate_fz, c40j1, c40j1_fz, c40j2, c40j2_fz, c40jdate, c40jdate_fz, c40k1,c40kdate, c40kdate_fz, c40k21, c40k21_fz, c40k22, c40k22_fz, c40k23,c40k23_fz, c40k24, c40k24_fz, c40k25, c40k25_fz, c40k25n, c40k25n_fz,c40k26, c40k26_fz, c40k26n, c40k26n_fz, c40l1, c40l1_fz, c40ldate, c40ldate_fz,c40l2, c40l2_fz, c40l2n31, c40l2n31_fz, c40l2n32, c40l2n32_fz, c40l2n33,c40l2n33_fz, c40l2n34, c40l2n34_fz, c40l2n34x, c40l2n34x_fz, c40l2n35,c40l2n35_fz, c40n1, c40n1_fz, c40n1_2gr, c40n2, c40n2_fz, c40n2_2gr, c40n3,c40n3_fz, c40n3_2gr, c40n4, c40n4_fz, c40n4_2gr, c40n5, c40n5_fz, c40n5_2gr,c40n6, c40n6_fz, c40n6_2gr, c40n7, c40n7_fz, c40n7_2gr, c40n8, c40n8_fz,c40n8_2gr, c40n9, c40n9_fz, c40n9_2gr, c40n10, c40n10_fz, c40n10_2gr,c40n11, c40n11_fz, c40n11_2gr, c40n12, c40n12_fz, c40n12_2gr, c40n13,c40n13_fz, c40n13_2gr, c40n14, c40n14_fz, c40n14_2gr, c40n15, c40n15_fz,c40n15_2gr, c40n16, c40n16_fz, c40n16_2gr, c40n17, c40n17_fz, c40n17x,c40n17x_fz, record, date_rec, audit, date_audit, pro, hosp2, area, type_hosp,n_hosp, age_gr, type_t1, dm, ht, fpg_gr_l, fpg_gr_lc, fpg_gr_bl, fpg_gr_blc, dtx_gr,hb1c_gr, sbp, dbp, ldl_c, chol, tg, ldl, lipid, bp, bp_dn, bp_ht, bp_c, pp, b20_g,micro_yn, b22b4b, b22b4c, alb_mg, alb_g, alb_24, alb_ab, feet, cad_dm,kidney_dm, cvd_dm, follow, fpg_ht, sum_comobid, cad_ht, cvd_ht, kidney_ht,sum_exam, type_h, hosp_bkk, lipid_ht, b21a_total, bed, random_gr, bed_gr,bed_gr_bkk, bmi, bmi_gr, dtx_gr2, hdl, hdlfm, feet_gr, hb1c_gr3, feet_yn,feet_gr3, labht, labht_gr, b20a_new, bmi_gr_risk, time, b28a2_new, type_new,type_gr, filter__
Primary outcome descriptions:
Percentage of diabetic patients precribed with aspirin, stratified by demographic andclinical data Primary outcome variable:
Materials and Methods:
Study design: Crossectional survey during January to December 2011 Setting: Eight hundred and thirty hospitals in Universal Coverage Network of Thailand Target population: Patient with diagnosis of diabetes mellitus type 2 attending thehospitals for at least 12 months, age 20 years or over, sign inform consent.
Exclusion criteria:- -Type 1 diabetes mellitus- The patients of subspecialty clinic- The patient underwent experiment project- Miss medical record- Loss to follow up Sampling technique:-Proportional to size, stratified cluster sampling from 25 referralcenters, 69 general hospitals, 736 community hospitals, 539 smalll district hospitals,131 medium-size district hospitals, 66 large district hospital.
Statistical analysis: Frequency of aspirin use will be described in term of percentagewith corresponding 95%confidence interval calculated by binomial exact statistic.
Correlation between aspirin use and dichotous variables will be determine bydifference between two proportion and statistical significant will be evaluated by meanof Pearson or McNemar chi-square according to unconditional or conditional datarespectively. The relationship between aspirin use and and ordinal data will be definedby mean of Wilcoxon ranksum test or Mann Whithney test. Tne correlation betweendose of aspirin and continuous variables will analyzed by regression analysis Mock Tables and Figures:
References:
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Mock Abstract:

Source: http://www.damus.in.th/damus/files/plan_41_1_160_571425187.pdf