A Comprehensive Assessment Tool for Patient Registry Software Systems: The CIPROS Checklist^[*]

 

 Buy Article Permissions and Reprints

Summary

Background: Patient registries are an important instrument in medical research. Often their structure is complex and their implementation uses composite software systems to meet the wide spectrum of challenges.

Objectives: For the implementation of a registry, there is a wide range of commercial, open source, and self-developed systems available and a minimal standard for the critical appraisal of their architecture is needed.

Methods: We performed a systematic review of the literature to define a catalogue of relevant criteria to construct a minimal appraisal standard.

Results: The CIPROS list is developed based on 64 papers which were found by our systematic review. The list covers twelve sections and contains 72 items.

Conclusions: The CIPROS list supports developers to assess requirements on existing systems and strengthens the reporting of patient registry software system descriptions. It can be a first step to create standards for patient registry software system assessments.

^* Supplementary online material published on our website www.methods-online.com

• References

• 1 Mathis-Edenhofer S, Piso B. Formen medizinischer Register - Definitionen, ausgewählte methodische Aspekte und Qualität der Forschung mit Registern.. Wiener Medizinische Wochenschrift 2011; 161/23-24 580-590.
  PubMedGoogle Scholar
• 2 Anazawa T, Miyata H, Gotoh M.. Cancer registries in Japan: National Clinical Database and site-specific cancer registries. Int J Clin Oncol 2014. (Epub ahead of print.).
  Google Scholar
• 3 Register in der Medizin. Available: http://www.arztbibliothek.de/themenschwerpunkt/themen-von-a-z/medizinregister (Accessed: Dec 14, 2014).
  PubMed
• 4 Gliklich RE, Dreyer NA. eds. Registries for Evaluating Patient Outcomes: A User’s Guide. Second Edition. Rockville, AHRQ Publication No. 10-EHC049 2010
  Google Scholar
• 5 Arts DG, De Keizer NF, Scheffer GJ. Defining and improving data quality in medical registries: a literature review, case study, and generic framework.. J Am Med Inform Assoc 2002; 9: 600-611.
  CrossrefPubMedGoogle Scholar
• 6 Solomon DJ, Henry RC, Hogan JG. et al. Evaluation and implementation of public health registries.. Public Health Rep 1991; 106: 142-150.
  PubMedGoogle Scholar
• 7 Müller D, Augustin M, Banik N, Baumann W, Bestehorn K, Kieschke J, Lefering R, Maier B, Mathis S, Rustenbach SJ, Sauerland S, Semler SC, Stausberg J, Sturm H, Unger C, Neugebauer EAM. Memorandum Register für die Versorgungsforschung.. Das Gesundheitswesen 2010; 72: 824-839.
  Article in Thieme ConnectPubMedGoogle Scholar
• 8 Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, Gøtzsche PC, Lang T. CONSORT GROUP (Consolidated Standards of Reporting Trials). The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med 2001; 134: 663-694.
  CrossrefPubMedGoogle Scholar
• 9 Lindörfer D, Müller TH. Integration und Analyse von Patienten mit Chronischer Myeloischer Leukämie (CML) in 25 Europäischen Ländern mit webbasierter elektronischer Datenerfassung. In: Schmücker P, Elsässer K-H, Hayna S. (Hrsg.) Tagungsband der 55. GMDS Jahrestagung 2010, Mannheim 2010
  Google Scholar
• 10 National Cancer Institute The caBIG program has been retired. Available: https://cabig.nci.nih.gov/ (Accessed: Dec 14, 2014).
  PubMedGoogle Scholar
• 11 National Cancer Institute National Cancer Informatics Program. . Available: http://cbiit.nci.nih.gov/ncip (Accessed Dec 14, 2014).
  PubMedGoogle Scholar
• 12 TMF e.V. Available: http://www.tmf-ev.de/ (Accessed: Dec 14, 2014).
  PubMed
• 13 Lindoerfer D, Mansmann U. CIPROS - A checklist with items for a patient registry software system.. Stud Health Technol Inform 2014; 205: 161-165.
  PubMedGoogle Scholar
• 14 Lindoerfer D, Mansmann U.. A proposal of Checklist Items for evaluating a Patient Registry Software System. In: Nußbeck SY, Wolff S, Rienhoff O. (Hrsg.). Tagungsband der 59. GMDS Jahrestagung 2014, Göttingen 2014
  Google Scholar
• 15 Sherman S, Shats O, Fleissner E, Bascom G, Yiee K, Copur M, Crow K, Rooney J, Mateen Z, Ketcham MA, Feng J, Sherman A, Gleason M, Kinarsky L, Silva-Lopez E, Edney J, Reed E, Berger A, Cowan K. Multicenter breast cancer collaborative registry.. Cancer Inform 2011; 10: 217-226.
  PubMedGoogle Scholar
• 16 Deserno TM, Haak D, Brandenburg V, Deserno V, Classen C, Specht P.. Integrated Image Data and Medical Record Management for Rare Disease Registries. A General Framework and its Instantiation to the German Calciphylaxis Registry. J Digit Imaging 2014
  Google Scholar
• 17 Messiaen C, Le Mignot L, Rath A, Richard JB, Dufour E, Ben Said M, Jais JP, Verloes A, Le Merrer M, Bodemer C, Baujat G, Gerard-Blanluet M, Bourdon-Lanoy E, Salomon R, Ayme S, Landais P. CEMARA: a Web dynamic application within a N-tier architecture for rare diseases.. Stud Health Technol Inform 2008; 136: 51-56.
  PubMedGoogle Scholar
• 18 Singh SK, Malik A, Firoz A, Jha V. CDKD: a clinical database of kidney diseases.. BMC Nephrol 2012; 13: 23.
  CrossrefPubMedGoogle Scholar
• 19 Natter MD, Quan J, Ortiz DM, Bousvaros A, Ilowite NT, Inman CJ, Marsolo K, McMurry AJ, Sandborg CI, Schanberg LE, Wallace CA, Warren RW, Weber GM, Mandl KD. An i2b2-based, generalizable, open source, self-scaling chronic disease registry.. J Am Med Inform Assoc 2013; 20 (01) 172-179.
  CrossrefPubMedGoogle Scholar
• 20 Holzner B, Giesinger JM, Pinggera J, Zugal S, Schöpf F, Oberguggenberger AS, Gamper EM, Zabernigg A, Weber B, Rumpold G. The Computer-based Health Evaluation Software (CHES): a software for electronic patient-reported outcome monitoring.. BMC Med Inform Decis Mak 2012; 12: 126.
  CrossrefPubMedGoogle Scholar
• 21 Lanzola G, Parimbelli E, Micieli G, Cavallini A, Quaglini S. Data quality and completeness in web stroke registry as the basis for data and process mining.. J Healthc Eng 2014; 5 (02) 163-184.
  CrossrefPubMedGoogle Scholar
• 22 Plotnicki L, Kohl CD, Höcker B, Krupka K, Rahmel A, Pape L, Hoyer P, Marks SD, Webb NJ, Söylemezoglu O, Topaloglu R, Szabo AJ, Seeman T, Marlies Cornelissen EA, Knops N, Grenda R, Tönshoff B.. The CERTAIN Registry: a novel, web-based registry and research platform for pediatric renal transplantation in Europe.. Transplant Proc 2013; 45: 1414-1417.
  CrossrefPubMedGoogle Scholar
• 23 Steurbaut K, De Backere F, Keymeulen A, De Leenheer M, Smets K, De Turck F. NEOREG: design and implementation of an online Neonatal Registration System to access, follow and analyse the data of newborns with congenital cytomegalovirus infection.. Inform Health Soc Care 2013; 38 (03) 223-235.
  CrossrefPubMedGoogle Scholar
• 24 Sanderson G, Ariyaratne TV, Wyss J, Looi V. A global patient outcomes registry: Cochlear paediatric implanted recipient observational study (Cochlear™ P-IROS).. BMC Ear Nose Throat Disord 2014; 14: 10.
  CrossrefPubMedGoogle Scholar
• 25 Xie F, Zhang D, Wu J, Zhang Y, Yang Q, Sun X, Cheng J, Chen X. Design and implementation of the first nationwide, web-based Chinese Renal Data System (CNRDS).. BMC Med Inform Decis Mak 2012; 12: 11.
  CrossrefPubMedGoogle Scholar
• 26 France DJ, Miles P, Cartwright J, Patel N, Ford C, Edens C, Whitlock JA. A chemotherapy incident reporting and improvement system. Jt Comm J Qual Saf 2003; 29 (04) 171-180.
  PubMedGoogle Scholar
• 283a Erratum in: Jt Comm J Qual Saf 2003; 29 (05) 209.
  PubMed
• 27 Zargaran E, Schuurman N, Nicol AJ, Matzopoulos R, Cinnamon J, Taulu T, Ricker B, Garbutt Brown DR, Navsaria P, Hameed SM. The electronic Trauma Health Record: design and usability of a novel tablet-based tool for trauma care and injury surveillance in low resource settings.. J Am Coll Surg 2014; 218 (01) 41-50.
  CrossrefPubMedGoogle Scholar
• 28 Teng JE, Thomson DR, Lascher JS, Raymond M, Ivers LC. Using Mobile Health (mHealth) and Geospatial Mapping Technology in a Mass Campaign for Reactive Oral Cholera Vaccination in Rural Haiti.. PLoS Negl Trop Dis 2014; 8 (07) e3050.
  CrossrefPubMedGoogle Scholar
• 29 Gillies MC, Walton R, Liong J, Arnold JJ, McAllister I, Morlet N, Hunyor A, Guymer R, Keeffe J, Essex R, Herrera-Bond A, Glastonbury B, Simpson JM, Barthelmes D.. Efficient capture of high-quality data on outcomes of treatment for macular diseases: the fight retinal blindness! Project.. Retina 2014; 34 (01) 188-195.
  CrossrefPubMedGoogle Scholar
• 30 da Silva KR, Costa R, Crevelari ES, Lacerda MS, de Moraes Albertini CM, Filho MM, Santana JE, Vissoci JR, Pietrobon R, Barros JV.. Glocal clinical registries: pacemaker registry design and implementation for global and local integration - methodology and case study.. PLoS One 2013; 8 (07) e71090.
  CrossrefPubMedGoogle Scholar
• 31 Prasser F, Kohlmayer F, Lautenschläger R, Kuhn KA. ARX - A Comprehensive Tool for Anonymizing Biomedical Data.. AMIA Annual Symposium Proceedings 2014 2014; 984-993.
  PubMedGoogle Scholar
• 32 Sherman S, Shats O, Ketcham MA, Anderson MA, Whitcomb DC, Lynch HT, Ghiorzo P, Rubinstein WS, Sasson AR, Grizzle WE, Haynatzki G, Feng J, Sherman A, Kinarsky L, Brand RE. PCCR: Pancreatic Cancer Collaborative Registry.. Cancer Inform 2011; 10: 83-91.
  PubMedGoogle Scholar
• 33 Ko GT, So WY, Tong PC, Le Coguiec F, Kerr D, Lyubomirsky G, Tamesis B, Wolthers T, Nan J, Chan J.. From design to implementation - the Joint Asia Diabetes Evaluation (JADE) program: a descriptive report of an electronic web-based diabetes management program.. BMC Med Inform Decis Mak 2010; 10: 26.
  CrossrefPubMedGoogle Scholar
• 34 Pang X, Kozlowski N, Wu S, Jiang M, Huang Y, Mao P, Liu X, He W, Huang C, Li Y, Zhang H. Construction and management of ARDS/sepsis registry with REDCap.. J Thorac Dis 2014; 6 (09) 1293-1299.
  PubMedGoogle Scholar
• 35 Wang Y, Tao Z, Cross PK, Le LH, Steen PM, Babcock GD, Druschel CM, Hwang SA. Development of a web-based integrated birth defects surveillance system in New York State.. J Public Health Manag Pract 2008; 14 (06) E1-E10.
  PubMedGoogle Scholar
• 36 Ergonomic requirements for office work with visual display terminals (VDTs) - Part 11: Guidance on usability (ISO 9241-11:1998) Available at: http://www.it.uu.se/edu/course/homepage/acsd/vt09/ISO9241part11.pdf (Accessed July 14, 2015).
  PubMed
• 37 Hira AY, Lopes TT, de Mello AN, Filho VO, Zuffo MK, de Deus Lopes R. Establishment of the Brazilian telehealth network for paediatric oncology.. J Telemed Telecare 2005; 11 Suppl (Suppl. 02) S51-52.
  CrossrefPubMedGoogle Scholar
• 38 O’Reilly DJ, Bowen JM, Sebaldt RJ, Petrie A, Hopkins RB, Assasi N, MacDougald C, Nunes E, Goeree R.. Evaluation of a chronic disease management system for the treatment and management of diabetes in primary health care practices in Ontario: an observational study.. Ont Health Technol Assess Ser 2014; 14 (03) 1-37.
  PubMedGoogle Scholar
• 39 Silveira P, Rodríguez C, Casati F. et al. On the Design of Compliance Governance Dashboards for Effective Compliance and Audit Management. In: Dan A, Gittler F, Toumani F. editors. Service-Oriented Computing. ICSOC/ServiceWave 2009 Workshops. Vol. 6275 Berlin, Heidelberg: Springer; 2010: 208-217.
  Google Scholar
• 40 Workman TA., Rockville MD. Agency for Healthcare Research and Quality (US); 2013 Sep. Engaging Patients in Information Sharing and Data Collection: The Role of Patient-Powered Registries and Research Networks [Internet]. . Available at: http://www.ncbi.nlm.nih.gov/books/NBK164514/ (Accessed: Dec 14, 2014).
  PubMedGoogle Scholar
• 41 Gliklich R, Levy D, Karl J. et al. Registry of Patient Registries (RoPR): project overview.. Rockville, MD: Agency for Healthcare Research and Quality; 2012
  Google Scholar
• 42 Bellgard M, Beroud C, Parkinson K, Harris T, Ayme S, Baynam G, Weeramanthri T, Dawkins H, Hunter A.. Dispelling myths about rare disease registry system development.. Source Code Biol Med 2013; 8 (01) 21.
  CrossrefPubMedGoogle Scholar
• 43 Schendel DE, Bresnahan M, Carter KW, Francis RW, Gissler M, Grønborg TK, Gross R, Gunnes N, Hornig M, Hultman CM, Langridge A, Lauritsen MB, Leonard H, Parner ET, Reichenberg A, Sandin S, Sourander A, Stoltenberg C, Suominen A, Surén P, Susser E.. The International Collaboration for Autism Registry Epidemiology (iCARE): multinational registry-based investigations of autism risk factors and trends.. J Autism Dev Disord 2013; 43 (011) 2650-2663.
  CrossrefPubMedGoogle Scholar

• Supplementary Material