Journal Club

埼玉医科大学　総合医療センター　内分泌・糖尿病内科Department of Endocrinology and Diabetes,

Saitama Medical Center, Saitama Medical University

松田　昌文Matsuda, Masafumi

2012 年 10 月 18 日　 8:30-8:55８階　医局

Reed M, Huang J, Graetz I, Brand R, Hsu J, Fireman B, Jaffe M.Outpatient electronic health records and the clinical care and outcomes of patients with diabetes mellitus.Ann Intern Med. 2012 Oct 2;157(7):482-9.

Simmons RK, Echouffo-Tcheugui JB, Sharp SJ, Sargeant LA, Williams KM, Prevost AT, Kinmonth AL, Wareham NJ, Griffin SJ.Screening for type 2 diabetes and population mortality over 10 years (ADDITION-Cambridge): a cluster-randomised controlled trial.Lancet. 2012 Oct 3. pii: S0140-6736(12)61422-6.

Ann Intern Med. 2012;157:482-489.

Drs. Reed and Huang and Ms. Graetz: Division of Research, Kaiser Permanente, 2000 Broadway, 3rd Floor, Oakland, CA 94612. Dr. Brand: University of California, San Francisco, Department of Epidemiology & Biostatistics, 185 Berry Street, Suite 5700, San Francisco, CA 94107. Dr. Hsu: Mongan Institute for Health Policy, Massachusetts General Hospital, Department of Health Care Policy, Harvard Medical School, 50 Staniford Street, 9th Floor, Boston, MA 02114. Mr. Fireman: Division of Research, Kaiser Permanente, 2000 Broadway, 2nd Floor, Oakland, CA 94612. Dr. Jaffe: Endocrinology and Internal Medicine, Kaiser South San Francisco Medical Center, 1200 El Camino Real, South San Francisco, CA 94080.

Background: Physicians can receive federal payments for meaningful use of complete certified electronic health records (EHRs). Evidence is limited on how EHR use affects clinical care and outcomes. Objective: To examine the association between use of a commercially available certified EHR and clinical care processes and disease control in patients with diabetes.

Design: Quasi-experimental design with outpatient EHR implementation sequentially across 17 medical centers. Multivariate analyses adjusted for patient characteristics, medical center, time trends, and facility-level clustering. Setting: Kaiser Permanente Northern California, an integrated delivery system. Patients: 169 711 patients with diabetes mellitus. Intervention: Use of a commercially available certified EHR. Measurements: Drug treatment intensification and hemoglobin A1c (HbA1c) and low-density lipoprotein cholesterol (LDL-C) testing and values.

From: Outpatient Electronic Health Records and the Clinical Care and Outcomes of Patients With Diabetes Mellitus

Staggered EHR implementation by medical center: quasi-experimental study with concurrent controls.This figure shows the schedule of staggered outpatient EHR implementation across all study medical centers during the study period (2004–2009; dark shade) and the number of study patients at each medical center. After implementation, the EHR completely replaced the paper medical chart and a limited patchwork of preexisting nonintegrated health information technology tools. Use of those early health information technology tools was limited because paper-based alternatives were still in use. EHR = electronic health record.

Figure Legend:

Ann Intern Med. 2012;157(7):482-489. doi:10.7326/0003-4819-157-7-201210020-00004

169 711 patients with diabetes mellitus

From: Outpatient Electronic Health Records and the Clinical Care and Outcomes of Patients With Diabetes Mellitus

Ann Intern Med. 2012;157(7):482-489. doi:10.7326/0003-4819-157-7-201210020-00004

EHR implementation order: relationship between mean HbA1c value in preimplementation period and order of EHR implementation, by medical center.Mean HbA1c values for the 17 medical centers, ordered by the date of their EHR implementation. A linear regression analysis with the mean HbA1c level among all patients in the diabetes registry in 2004 as the dependent variable and order of EHR implementation as the predictor yields a coefficient of 0.00006371 (P = 0.61), indicating that the order of implementation of EHR was not associated with preimplementation diabetes care quality. EHR = electronic health record; HbA1c = hemoglobin A1c.

Figure Legend:

Results: Use of an EHR was associated with statistically significant improvements in treatment intensification after HbA1c values of 9% or greater (odds ratio, 1.10 [95% CI, 1.05 to 1.15]) or LDL-C values of 2.6 to 3.3 mmol/L (100 to 129 mg/dL) (odds ratio, 1.06 [CI, 1.00 to 1.12]); increases in 1-year retesting for HbA1c and LDL-C levels among all patients, with the most dramatic change among patients with the worst disease control (HbA1c levels 9% or LDL-C ≧levels 3.4 mmol/L [ 130 mg/dL]); and decreased 90- day ≧ ≧retesting among patients with HbA1c levels less than 7% or LDL-C levels less than 2.6 mmol/L ( ＜ 100 mg/dL). The EHR was also associated with statistically significant reductions in HbA1c and LDL-C levels, with the largest reductions among patients with the worst control (0.06-mmol/L [2.19-mg/dL] reduction among patients with baseline LDL-C levels 3.4 ≧mmol/L [ 130 mg/dL]; ≧ P ＜ 0.001).

Limitation: The EHR was implemented in a setting with strong baseline performance on cardiovascular care quality measures. Conclusion: Use of a commercially available certified EHR was associated with improved drug treatment intensification, monitoring, and physiologic control among patients with diabetes, with greater improvements among patients with worse control and less testing in patients already meeting guideline-recommended glycemic and lipid targets. Primary Funding Source: National Institute of Diabetes and Digestive and Kidney Diseases.

Message糖尿病（ DM ）の患者約 17 万人を対象に、生涯健康医療電子記録（ EHR ）と治療および疾患コントロールの関連を準実験計画法で検討。 EHR 利用は治療の強化と有意に関連し、 HbA1c または LDL-C 高値の患者で検査回数増加、低値の患者で検査回数減少が見られた。また、 HbA1c および LDL-Cの低下とも有意に関連した。

つまり　電子カルテは　よい！

MRC Epidemiology Unit, Cambridge, UK (R K Simmons PhD, J B Echouff o-Tcheugui PhD, S J Sharp MSc, L A Sargeant PhD, Prof N J Wareham PhD, S J Griffi n DM); Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, UK (K M Williams PhD, Prof A T Prevost PhD, Prof A L Kinmonth MD); and King’s College London, Department of Primary Care and Public Health Sciences, London, UK (A T Prevost)

www.thelancet.com Published online October 4, 2012 http://dx.doi.org/10.1016/S0140-6736(12)61422-6

Background The increasing prevalence of type 2 diabetes poses a major public health challenge. Population-based screening and early treatment for type 2 diabetes could reduce this growing burden. However, uncertainty persists around the benefits of screening for type 2 diabetes. We assessed the effect of a population-based stepwise screening programme on mortality.

Methods In a pragmatic parallel group, cluster-randomised trial, 33 general practices in eastern England were randomly assigned by the method of minimisation in an unbalanced design to: screening followed by intensive multifactorial treatment for people diagnosed with diabetes (n=15); screening plus routine care of diabetes according to national guidelines (n=13); and a no-screening control group (n=5). The study population consisted of 20 184 individuals aged 40–69 years (mean 58 years), at high risk of prevalent undiagnosed diabetes, on the basis of a previously validated risk score. In screening practices, individuals were invited to a stepwise programme including random capillary blood glucose and glycated haemoglobin (HbA1c) tests, a fasting capillary blood glucose test, and a confirmatory oral glucose tolerance test. The primary outcome was all-cause mortality. All participants were flagged for mortality surveillance by the England and Wales Office of National Statistics. Analysis was by intention-to screen and compared all-cause mortality rates between screening and control groups. This study is registered, number ISRCTN86769081.

Figure 2: ADDITION-Cambridge trial profile

RC=screening followed by routine care of patients with screen-detected diabetes according to national guidelines. *IT=screening followed by intensive treatment of patients with screen-detected diabetes.

In the first stage of randomisation, 33 recruited practices were allocated (1:3:3) to one of three groups: no screening (control; five practices), screening followed by intensive treatment of patients with screen-detected diabetes (IT; 15 practices), and screening plus routine care of patients with screendetected diabetes (RC; 13 practices). These practices are included in the main trial analysis of screening versus control presented here.

The need to achieve the required sample size of patients with screen-detected diabetes for the treatment trial warranted the uneven randomisation ratio with a disproportionate number of screening practices and a second stage of randomisation. 27 practices were subsequently randomly assigned (1:1) to IT (n=14) and RC (n=13).

The final group allocation after the two stages of randomisation included 28 practices to IT, 27 to RC, and five to control (no screening).

Our sample was representative of the eastern England population, since up to 99% of people in the UK are registered with a general practice. However, participating practices served less deprived areas than the average English practice. Caution should therefore be exercised in extrapolation of our results to more socioeconomically disadvantaged communities in which the disease risk might be higher although attendance for screening is likely to be lower.

Findings Of 16 047 high-risk individuals in screening practices, 15 089 (94%) were invited for screening during 2001–06, 11 737 (73%) attended, and 466 (3%) were diagnosed with diabetes. 4137 control individuals were followed up. During 184 057 person-years of follow up (median duration 9 ・ 6 years [IQR 8 ・ 9–9 ・ 9]), there were 1532 deaths in the screening practices and 377 in control practices (mortality hazard ratio [HR] 1 ・06, 95% CI 0 ・ 90–1 ・ 25). We noted no significant reduction in cardiovascular (HR 1 ・ 02, 95% CI 0 ・ 75–1 ・ 38), cancer (1 ・ 08, 0 ・ 90–1 ・ 30), or diabetes-related mortality (1 ・ 26, 0 ・75–2 ・ 10) associated with invitation to screening.

Interpretation In this large UK sample, screening for type 2 diabetes in patients at increased risk was not associated with a reduction in all-cause, cardiovascular, or diabetes-related mortality within 10 years. The benefits of screening might be smaller than expected and restricted to individuals with detectable disease. Funding Wellcome Trust; UK Medical Research Council; National Health Service research and development support; UK National Institute for Health Research; University of Aarhus, Denmark; Bio-Rad.

Message国で糖尿病（ DM ）高リスク者 2 万 184 人を対象に、 2 型糖尿病検診の死亡率への影響をクラスター無作為化試験で検討（ ADDITION-Cambridge 試験）。中央値9.6 年の追跡の結果、検診群に対する非検診群の死亡ハザード比は 1.06 だった。検診と関連する心血管疾患、癌、糖尿病関連死の有意な低下は見られなかった。

… ほとんどの国民が家庭医に登録されているので　検診に有効性は？