Estimation of Patient Accrual Rates in Clinical Trials Based on Routine Data from Hospital Information Systems

被引：16

作者：

Dugas, M. ^{[1
]}

Amler, S. ^{[1
]}

Lange, M. ^{[2
]}

Gerss, J. ^{[1
]}

Breill, B. ^{[1
]}

Koepcke, W. ^{[1
]}

机构：

[1] Univ Munster, Dept Med Informat & Biomath, D-48149 Munster, Germany

[2] Univ Klinikum Munster, IT Ctr, Munster, Germany

来源：

METHODS OF INFORMATION IN MEDICINE | 2009年 / 48卷 / 03期

关键词：

Patient accrual rate; hospital information system; clinical trial; HIGH-DOSE CYTARABINE; PROLONGED MAINTENANCE; MITOXANTRONE; RECRUITMENT; INDUCTION;

D O I：

10.3414/ME0582

中图分类号：

TP [自动化技术、计算机技术];

学科分类号：

0812 ;

摘要：

Background: Delayed patient recruitment is a common problem in clinical trials. According to the literature, only about a third of medical research studies recruit their planned number of patients within the time originally specified. Objectives: To provide a method to estimate patient accrual rates in clinical trials based on routine data from hospital information systems (HIS). Methods: Based on inclusion and exclusion criteria for each trial, a specific HIS report is generated to list potential trial subjects. Because not all information relevant for assessment of patient eligibility is available as coded HIS items, a sample of this patient list is reviewed manually by study physicians. Proportions of matching and non-matching patients are analyzed with a Chi-squared test. An estimation formula for patient accrual rate is derived from this data. Results: The method is demonstrated with two datasets from cardiology and oncology. HIS reports should account for previous disease episodes and eliminate duplicate persons. Conclusion: HIS data in combination with manual chart review can be applied to estimate patient recruitment for clinical trials.

引用

页码：263 / 266

页数：4

共 16 条

[1] Double induction containing either two courses or one course of high-dose cytarabine plus mitoxantrone and postremission therapy by either autologous stem-cell transplantation or by prolonged maintenance for acute myeloid leukemia [J].

Büchner, T ;

Berdel, WE ;

Schoch, C ;

Haferlach, T ;

Serve, HL ;

Kienast, J ;

Schnittger, S ;

Kern, W ;

Tchinda, J ;

Reichle, A ;

Lengfelder, E ;

Staib, P ;

Ludwig, WD ;

Aul, C ;

Eimermacher, H ;

Balleisen, L ;

Sauerland, MC ;

Heinecke, A ;

Wöermann, B ;

Hiddemann, W .

JOURNAL OF CLINICAL ONCOLOGY, 2006, 24 (16) :2480-2489

[2] 6-thioguanine, cytarabine, and daunorubicin (TAD) and high-dose cytarabine and mitoxantrone (HAM) for induction, TAD for consolidation, and either prolonged maintenance by reduced monthly TAD or TAD-HAM-TAD and one course of intensive consolidation by sequential HAM in adult patients at all ages with de novo acute myeloid leukemia (AML):: A randomized trial of the German AML cooperative group [J].

Büchner, T ;

Hiddemann, W ;

Berdel, WE ;

Wörmann, B ;

Schoch, C ;

Fonatsch, C ;

Löffler, H ;

Haferlach, T ;

Ludwig, WD ;

Maschmeyer, G ;

Staib, P ;

Aul, C ;

Grüneisen, A ;

Lengfelder, E ;

Frickhofen, N ;

Kern, W ;

Serve, HL ;

Mesters, RM ;

Sauerland, MC ;

Heinecke, A .

JOURNAL OF CLINICAL ONCOLOGY, 2003, 21 (24) :4496-4504

[3]

Campbell MK, 2007, HEALTH TECHNOL ASSES, V11

[4] Practical considerations for estimating clinical trial accrual periods: Application to a multi-center effectiveness study [J].

Carter R.E. ;

Sonne S.C. ;

Brady K.T. .

BMC Medical Research Methodology, 5 (1)

[5] APPLYING RESULTS OF RANDOMIZED TRIALS TO CLINICAL-PRACTICE - IMPACT OF LOSSES BEFORE RANDOMIZATION [J].

CHARLSON, ME ;

HORWITZ, RI .

BRITISH MEDICAL JOURNAL, 1984, 289 (6454) :1281-1284

[6] The use of confidence or fiducial limits illustrated in the case of the binomial. [J].

Clopper, CJ ;

Pearson, ES .

BIOMETRIKA, 1934, 26 :404-413

[7] PLANNING PATIENT RECRUITMENT - FANTASY AND REALITY [J].

COLLINS, JF ;

WILLIFORD, WO ;

WEISS, DG ;

BINGHAM, SF ;

KLETT, CJ .

STATISTICS IN MEDICINE, 1984, 3 (04) :435-443

[8]

Dorda W, 2002, METHOD INFORM MED, V41, P89

[9] Workflow to improve patient recruitment for clinical trials within hospital information systems -: a case-study [J].

Dugas, Martin ;

Lange, Matthias ;

Berdel, Wolfgang E. ;

Mueller-Tidow, Carsten .

TRIALS, 2008, 9 (1)

[10] Outcome parameters for trials in atrial fibrillation: executive summary [J].

Kirchhof, Paulus ;

Auricchio, Angelo ;

Bax, Jeroen ;

Crijns, Harry ;

Camm, John ;

Diener, Hans-Christoph ;

Goette, Andreas ;

Hindricks, Gerd ;

Hohnloser, Stefan ;

Kappenberger, Lukas ;

Kuck, Karl-Heinz ;

Lip, Gregory Y. H. ;

Olsson, Bertil ;

Meinertz, Thomas ;

Priori, Silvia ;

Ravens, Ursula ;

Steinbeck, Gerhard ;

Svernhage, Elisabeth ;

Tijssen, Jan ;

Vincent, Alphons ;

Breithardt, Guenter .

EUROPEAN HEART JOURNAL, 2007, 28 (22) :2803-2817

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