English term (edited): practices (en este contexto)

Rita, según entiendo yo el término "práctica" o "prácticas" se refieren a las prácticas médicas

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Note added at 13 mins (2007-11-05 22:28:29 GMT)
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Rita lo siguiente lo saqué recién del sitio que dejo al final de esta nota.

The General Practice Research Database (GPRD) is the world's largest computerised database of anonymised longitudinal patient records from general practice

http://www.gprd.com/home/

PDF] La UK General Practice Research Database (Base de Datos para la ... File Format: PDF/Adobe Acrobat - View as HTML
Research Database (GPRD) (Base de Datos para Investigación en Medicina. General), pertenece al UK Department of Health (Departamento de Salud del ...
www.bifap.org/docs/Strom.pdf - Similar pages
Sigo buscando..

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Note added at 11 hrs (2007-11-06 09:24:33 GMT)
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Need a definition in English first before it can be properly translated:

General Practice Research Database

The General Practice Research Database (GPRD) is the world's largest database of anonymised longitudinal medical records from primary care. It contains comprehensive observational data from real-life


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Note added at 11 hrs (2007-11-06 09:25:45 GMT)
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good number of databases have been developed in theUnited States and in Europe allowing the conduct ofpharmacoepidemiological studies, though specialmention should be made of the British GPRD (GeneralPractice Research Database)(6-8), which computeraccumulates information from close to 2000 primarycare doctors. The salient feature of the GPRD is its"integral" nature, since it contains data relating toprescription, diseases and clinical problems, and resultsof complementary tests, requiring no link to otherdatabases (i.e., record-linkage) in order to gather theinformation required for epidemiological studies – the
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Salvador-Rosa A, Moreno-Pérez JC, Sonego D, García-Rodríguez LA and de Abajo-Iglesias FJThe BIFAP Project: Database for Pharmacoepidemiological Research in Primary CareRESEARCH PROJECT131| Aten Primaria 2002. December. 30 (10): 655-661 |655latter being the field where the GPRD has undoubtedlybeen most useful. The GPRD contains informationcorresponding to 35 million person-years, and hasallowed the publication of over 200 studies in scientificjournals – including particularly studies of ADRs (9-11), as well as studies addressing the possible benefitsof drugs in routine clinical practice (drugefficacy)(12,13).Clinical information and primary careThe organization of the national health care system inSpain is similar to that found in Great Britain. In oursetting, primary care is usually the entry point to thehealth care system, and is also a common destinationfor those patients initially seen outside primary care.The primary care setting is also the level at which anenormous number of health problems are resolved.Within the context of the primary care team, the doctors– both general practitioners and pediatricians – are theprofessionals who are closest to integrally knowing theclinical particulars of their patients. The longitudinalcare they provide, the great number of diagnoses andtreatments involved, their normalizing function inrelation to patient access to other parts of the system,their general view of health problems, and theconfidence they frequently establish with their patientsall place these doctors in a privileged position forattempting to gather the information generated by thisand other health care settings or levels. On the otherhand, primary care doctors extend over 80% of allprescriptions made in the Spanish National HealthSystem. The fact that part of these prescriptionscorrespond to prescriptions originally made by otherdoctors also gives an idea of the important flow ofinformation between other health care levels and theprimary care setting. Based on these considerations, itmay be stated that primary care doctors are undoubtedlybest positioned to conduct a complete prospectiveregistry of health problems, therapeutic interventions,preventive activities and clinical events. In global terms,the information these professionals deal with habituallycan be considered particularly adequate forpharmacoepidemiological research (14), since suchinformation a priori contains all the elements requiredfor such research: prescriptions, symptoms anddiagnoses, demographic data, anthropometricalinformation, exploratory data, and the results ofcomplementary tests.Computerization of primary careThe computerization of clinical visits and histories isincreasingly common in primary care (15-18). Theusefulness of this practice need not be limited tohealthcare, administrative or management tasks but canalso be extended to other activities – including of coursepharmacoepidemiological research in large populationgroups. Based on these premises, the BIFAP Project(Database for Pharmacoepidemiological Research inPrimary Care / Base de datos para la InvestigaciónFarmacoepidemiológica en Atención Primaria) hasbeen created.The BIFAP ProjectDefinitionThe BIFAP Project has been developed to determinewhether it is feasible in Spain to establish a publicdatabase containing anonymous clinical information(i.e., without personal identifying data) facilitated byprimary care doctors of the Spanish National HealthSystem who habitually make use of computers todocument patient information. The database willlikewise be named BIFAP, and if viable it will bedestined to the conduction of pharmacoepidemiologicalstudies, following due validation as an informationsource.ObjectivesThe aim of the project is to create a qualitypharmacoepidemiological research tool essentiallyintended for the conduction of two types of study:– Drug safety studies attempting to test causalassociation hypotheses, including those specificallyintended to assess drug-related “alarm signals”,particularly those generated by the Spanishpharmacovigilance system.–Studies of drug efficacy under habitual conditionsof use (the broad population base of the BIFAPwould contribute to this).the information afforded by the BIFAP will only beusable for epidemiological research – never to eitherindividually or collectively evaluate aspects relating tothe professional activities or costs generated by thecollaborating doctors.JustificationApart from the considerations made in the Introduction,other reasons exist for attempting to establish a primarycare database in Spain - considering that others alreadyexist in other countries - and use it forpharmacoepidemiological research:a) it is always desirable to have the possibility ofcontrasting the same hypothesis using differentinformation sources; b) some drugs are marketed onlyin Spain or are only relevantly used in Spain; c) theeffects of drugs should be assessed under theirconditions of use, which may not be the same as inother countries; and d) the effects of drugs varyaccording to genetic and environmental factors, whichin turn may differ in terms of the population involved.
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Salvador-Rosa A, Moreno-Pérez JC, Sonego D, García-Rodríguez LA and de Abajo-Iglesias FJThe BIFAP Project: Database for Pharmacoepidemiological Research in Primary CareRESEARCH PROJECT131| Aten Primaria 2002. December. 30 (10): 655-661 |655Pilot phaseThe pilot phase was started in January 2000 and isexpected to extend to the end of 2003. Up until June2002, the following steps have been taken: a) a teamhas been established, composed ofpharmacoepidemiologists, primary care doctors andcomputer technicians; b) the BIFAP Data ProcessingCenter (DPC)(located in the Pharmacoepidemiologyand Pharmacovigilance Division of the SpanishMedicines Agency) has been equipped with the requiredtechnical means; c) authorization has been requestedfrom the different Autonomous Communities forstarting the project; d) information on the project hasbegun to be distributed to doctors and health carecenters; e) an evaluation has been made of the softwareprograms of greatest implantation in the NationalHealth Care System in terms of the possibility ofdeveloping a specific data exportation module (theprograms must at least allow the coded recording ofhealth problems according to the InternationalClassification of Primary Care, the InternationalClassification of Diseases – Ninth Edition (ICD-9), orposterior version of both; of the prescribed drugsaccording to the National Pharmaceutical ProductCodes; and of the complementary data and observationsof each process); f) a data exportation module has beendeveloped, compatible with the OMI-AP program in itsversions 4 and 5, and tests have been made of the latter- with satisfactory results. The functions of the moduleare (Fig. 1): to extract the information of interest (Table1), generate non-identifying patient codes(dissociation), and encrypt the data; g) the databasestructure has been created; and h) a registry guide hasbeen edited for OMI-AP using collaborating doctors,the function of which is to provide recommendationsconcerning different aspects of the registry (e.g., theassignment of dates, the coding of processes andprescriptions, the inactivation of duplicate histories, theexistence of imaginary patient histories – often used toperform registry tests and afford training in computeruse – and so on), which increase the consistency andvalidity of the information recorded while preservingmaximum program flexibility.The development of the BIFAP Project is supervised bya scientific committee with representation by theprincipal scientific societies in the field of primary care,and including general practitioners, primary carepediatricians, specialists in bioethics, specialists inprimary care computerization, andpharmacoepidemiologists. Their tasks are to supervisedevelopment of the project, provide counseling onspecific aspects, contribute suggestions, and ensureadhesion to legislation and to current recommendationsin matters of data protection.Doctor collaborationIn the year 2001, recruitment of the collaboration ofgeneral practitioners and primary care pediatriciansstarted in those Autonomous Communities for whichauthorization had been obtained. The aim is to ensurethe cooperation of 300-500 doctors (a figure consideredto be convenient for the BIFAP validation studies; seebelow). Collaboration is of an individual and voluntarynature (with prior approval from the correspondingdirecting or management body). The essentialrequirements for cooperating in the pilot phase are: a)habitual registration of patient information with theOMI-AP program; and b) foreseeable workplacestability. The collaborating doctors will receive formalacknowledgement as such.None of the activities implied in such collaboration willpose a significant added workload for those doctorswith minimal skills in using a computer in theconsulting room. These activities are the following(those activities which must be carried out by thecollaborating doctor in person are shown in boldface;depending on the contents, other team doctors,residents, primary care computer technicians oradministrative personnel may participate in the rest ofactivities):Activities related to data transmission to the DPC:– Installation of the exportation module.– Periodic exportations (every 2-3 months). Theinitiation of each exportation session will require theuse of a secret code established by the collaboratingdoctor.– Submission to the DPC of the files generated in theexportation process. The transmissions can be madeelectronically or by mail (using a computer disc or otherappropriate support). The project information flow isrepresented in Figure 1.Following of the guide by cooperating doctors:The aim is to ensure a sufficient registration level in thecourse of the first 6 months. It is advisable to promoteadhesion to the guide by the substituting doctors andresidents who attend the same quota of patients. Thedifferent types of data to be recorded are specified inTable 1.Activities related to BIFAP validation to beconducted during the pilot phase (Fig. 2)(See alsothe section: “BIFAP validation”):– Photocopy or print-out of admission reports, specialistreports and complementary tests performed (filed onpaper or computer) in small patient samples (to thiseffect, the DPC will supply the individual dissociationcodes of the patients selected). The identity of the
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Salvador-Rosa A, Moreno-Pérez JC, Sonego D, García-Rodríguez LA and de Abajo-Iglesias FJThe BIFAP Project: Database for Pharmacoepidemiological Research in Primary CareRESEARCH PROJECT139| Aten Primaria 2002. December. 30 (10): 655-661 |659File relatingdissociatedPrimary CareCenterPC databasePatientdissociationCompression+encryptingPhysician: JoséRodríguezCHN (*) Patient: 15True CHN: 15Dissociated CHN: 3JKL23File relatingdissociated patientsto real patientsProcessed file*CHN: clinical history numberTransfer fileSubmissionExportationmoduleProcessing of clinicaldataDissociated physician: 4G7BJHPatient CHN: GF54DF54F2ndpatientdissociationPhysiciandissociationDissociated CHN: 3JKL232nddissociated CHN:Physician: José RodríguezDissociated physician:File relatingDissociatedphysicians tocollaboratingphysiciansDecompression+decryptingTransfer filepatients todouble-dissociatedpatientsFIGURE1.Information flow in the BIFAP Project and example of the dissociation procedure.TABLE1.BIFAP information1. Administrative data (admission/discharge dates) and demographic particulars (sex and date of birth)2. Morbidity eventsDiseases/symptoms leading to patient consultationStarting date of first diagnosis of chronic and recurrent illnessesSignificant results of complementary testsIndications of the prescribed medication, and reasons for changing the dose or suspending the medicationEvents or disorders giving rise to admission, referral to the Emergency Service or to a specialist, and essentialdata derived from the latter (new diagnoses, interventions, results of specialized tests, etc.)3. Prescriptions4. Pregnancy and its outcome5. Deaths and their causes6. Other data of clinical or epidemiological interest (vaccinations, height, weight, toxic habits)
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Salvador-Rosa A, Moreno-Pérez JC, Sonego D, García-Rodríguez LA and de Abajo-Iglesias FJThe BIFAP Project: Database for Pharmacoepidemiological Research in Primary CareRESEARCH PROJECT139| Aten Primaria 2002. December. 30 (10): 655-661 |659InvestigatorCannot identify physiciansCannot identify patients(individualizes patients through second dissociated code)BIFAP Data Processing Center (DPC)Cannot identify patients(can relate second dissociation code to first dissociation code of each patient)Can identify physicians (communication with them is essential d uring the collaboration period)PhysicianThe only subject capable of identifying the patients belonging to his/her personal quota, based on the first dissociation code (essential for BIFAP validation)PatientsFIGURE2Code communication chain and identityprotection in the BIFAP Project.patient will only be accessible to the collaboratingdoctor, since the module allows the latter to reassociatethis code with the corresponding clinical case number(the use of this application also requires a secret code).–Inscription of the dissociated patient code in thecopies of reports.–Document anonymity (photocopies or print-outs).This will consist of the elimination of allidentifying data – either direct (patient first andlast name/s) or indirect (name of the doctors incharge of the reports, hospital, locality, etc.).–Submission to the DPC of the anonymous reports(See the section: “Validation”).Data protection in the BIFAP ProjectThe mechanisms guaranteeing data anonymity andconfidentiality are the following: a) data exportationdoes not include identifying information (Fig. 1); b)double code dissociation is performed, at origin anddestination, assigning a random code to each patient,and generating a dissociated code for each doctor atdestination (Fig.s 1 and 2); c) high-level encrypting isperformed at origin to reinforce data security (Fig. 1);d) the DPC follows a series of internal security normsthat affect both physical and logical safety and theprocedures of data use; and e) the identity of thecollaborating doctors is not made known to thirdpersons (with the obligate exception of thecorresponding directory/managerial bodies).Controls prior to data loading in BIFAPThe data reaching the DPC will be subjected toautomatized controls to verify that the information isminimally coherent from the qualitative andquantitative perspective, taking population indicatorsand mean values of the data received as reference. Inaddition, the controls will entail the generation ofreports to be distributed individually to eachcollaborator to specify which areas of the recordingprocess are adequate, which can be improved, andwhich are defective. These reports of course will beexclusively addressed to the corresponding doctor. Theaim of such reports is to ensure a feedback mechanismto secure adequate recording performance and maintainsuch performance where already achieved.BIFAP validationThe database validation studies will be conducted bythe BIFAP Project investigators, once the aggregatedinformation has covered a period of at least 6-12months. These validation studies will comprisecorrelation of the BIFAP registries with anonymouscopies of clinical reports (Fig. 2)(See the section“Doctor collaboration”), in samples of patients selectedby disease or medication code. A concordance ofdiagnoses and prescribed drugs of over 90% will beconsidered adequate. For those centers working“without papers”, an alternative validation strategy willbe established.BIFAP feasibility and perspectivesOnly if at the end of the pilot phase a sufficient numberof collaborating doctors has been secured and it isconcluded that the BIFAP is effectively valid forpharmacoepidemiological research will it make sense tomaintain the database as a permanent source ofinformation. In such a case, the collaborating doctorswill be requested to accept a stable cooperationcommitment, and the initiative will be left open for theincorporation of other software and new collaboratingdoctors – with the aim of gradually increasing theirnumber. A figure of 2000 collaborating doctors isconsidered convenient to efficiently investigate the rareeffects or effects of infrequently prescribed drugs.On the other hand, if in future BIFAP becomesestablished as a research tool, it will be obligate todefine a series of standardized operative proceduresrelating to the use and provision of data to theinvestigators. These procedures will include scientific
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Salvador-Rosa A, Moreno-Pérez JC, Sonego D, García-Rodríguez LA and de Abajo-Iglesias FJThe BIFAP Project: Database for Pharmacoepidemiological Research in Primary CareRESEARCH PROJECT141| Aten Primaria 2002. December. 30 (10): 655-661 |661and ethical revision by an independent committee of theproposed studies involving the mentioned data. Amongthese conditions, it is expected that the actualcollaborating doctors will be among the end-users of thedatabase. In sum, these professionals are central to theBIFAP Project, which hopes to make a databaseavailable to public health and the scientific communityfor conducting quality pharmacoepidemiological studieswith important time and resource savings.References(Bibliography)1. Jick H, García Rodríguez LA, Pérez-Gutthann S.Principles of epidemiological research on adverse andbeneficial drug effects. Lancet 1998;352:1767-70.2. De Abajo FJ, Montero D, Cachá A.Pharmacovigilance: goals and strategies. Methods FindExp Clin Pharmacol 2000;22:405-7.3. Madurga M, De Abajo FJ, Martín-Serrano G,Montero D. El Sistema Español de Farmacovigilancia.En: Grupo IFAS, editores. Nuevas perspectivas de lafarmacovigilancia en España y en la Unión Europea.Madrid: Jarpyo, 1998; p. 37-61.4. Arnáiz JA, Carné X, Riba N, Codina C, Ribas J,TrillaA. The use of evidence in pharmacovigilance. Casereports as the reference source for drug withdrawals.Eur J Clin Pharmacol 2001;57:89-91.5. Gardner JS, Park BJ, Stergachis A. AutomatedDatabases in Pharmacoepidemiological Studies. En:Hartzema AG, Porta MS,Tilson HH, editores.Pharmacoepidemiology. 3rd ed. Cincinate: HarveyWhitney Books Company, 1998; p. 368-88.6. Jick H, Jick SS, Derby L. Validation of informationrecorded on a general practitioner based computeriseddata resource in the United Kingdom. BMJ1991;302:766-8.7. García Rodríguez LA, Pérez Gutthann S. Use of theUK General Practice Research Database forpharmacoepidemiology. Br J Clin Pharmacol1998;45:419-25.8. García Rodríguez LA, Pérez-Guthann S, Jick S. TheUK General Practice Research Database. En: Strom BL,editor. Pharmacoepidemiology, 3rd ed. Chichester: JohnWiley & Sons, Ltd., 2000; p. 375-85.9. García Rodríguez LA, Stricker BH, Zimmermann HJ.Risk of acute liver injury associated with thecombination of amoxicillin and clavulanic acid. ArchIntern Med 1996;156:1327-32.10. De Abajo FJ, García Rodríguez LA. Risk ofventricular arrhythmias associated with nonsedatingantihistamine drugs. Br J Clin Pharmacol 1999;47:307-13.11. De Abajo FJ, García Rodríguez LA, Montero D.Association between selective serotonin reuptakeinhibitors and upper gastrointestinal bleeding:population based case-control study. BMJ1999;319:1106-9.12. García Rodríguez LA, Ruigómez A. Secondaryprevention of upper gastrointestinal bleeding associatedwith maintenance acid-suppressing treatment in patientswith peptic ulcer bleed. Epidemiology 1999;10:228-32.13. García Rodríguez LA, Huerta Álvarez C. Reducedrisk of colorectal cancer among long-term users ofaspirin and nonaspirin nonsteroidal antiinflammatorydrugs. Epidemiology 2001;12: 88-93.14. Gómez de la Cámara A. La investigación enatención primaria. El ensayo clínico y los estudiosobservacionales de productos farmacéuticos. AtenPrimaria 1999;24:431-5.15. Grupo de trabajo sobre informatización de lasemFYC. Informatización en la atención primaria (I).Aten Primaria 2000;26:488-507.16. Grupo de trabajo sobre informatización de lasemFYC. La informatización de atención primaria (yII). Aten Primaria 2000;26:559-76.17. Grupo de trabajo sobre informatización de lasemFYC. El desafío de la informatización en atenciónprimaria [editorial]. Aten Primaria 2000;26:437-8.18. Gérvas J. Pérez Fernández M. La historia clínicaelectrónica en atención primaria. Fundamento clínico,teórico y práctico. Semergen 2000;26:17-32.How to contact:Further details on the project can be found at thefollowing website: www.bifap.orgDoctors interested in participating in the BIFAP Projectcan request the exportation module and registry guideby contacting Dr. Antonio Salvador via e-mail([email protected]), telephone (91 596 78 88), fax(91 596 78 91), or conventional mail:Data Processing Center-BIFAPSpanish Medicines AgencyDivision of Pharmacoepidemiology andPharmacovigilanceCtra. Majadahonda-Pozuelo, km 228220 Majadahonda (Madrid), Spain

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Note added at 11 hrs (2007-11-06 09:27:30 GMT)
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Apologies: I did not mean to send you all these pages of references.

In answer to your question:

General Practices = los médicos [de familia] que trabajan en Atención Primaria.