Abstract:
BACKGROUND:The Epidemiologic Registry of Cystic Fibrosis (ERCF) was a multicentre, longitudinal follow-up project of cystic fibrosis patients enrolled at some 200 centres in nine European countries between 1994 and 1999. PURPOSE:We aimed to assess and improve the quality of a subset of data from the ERCF relating to seven English centres (1184 patients), prior to using the data for a long-term cost-effectiveness analysis of dornase alfa (Pulmozyme). Specifically we wanted to assess the completeness and accuracy of the data and the comparability of cases across centres. METHODS:We used a subset of ERCF data relating to seven UK cystic fibrosis (CF) centres. Following initial data editing, key variable data from a sample of patients from five centres were subjected to a detailed verification of ERCF data against original data sources available in the centres. Disagreements between ERCF reports and original data sources were identified and corrected in the study dataset. In addition, centre staff were questioned about relevant clinical and recording practices. RESULTS:Thanks to detailed routine data checking procedures on key variables operated by the ERCF, the rates of disagreement between ERCF data and original data as identified in our verification process on the assessed variables are generally low (0.4-3.7%). Some outcome variables (deaths, hospitalisations) seem to be under-reported by some centres. Episodes of pulmonary exacerbation are difficult to identify and also to verify. Twenty-four patients were registered twice (consecutively in two different centres). There were some differences between centres in their interpretation of recording rules. CONCLUSIONS:Researchers seeking to use disease registry data should consider detailed data quality review processes. Apart from data accuracy, reliable definitions of both critical events as well as their timing are important. The degree of under-reporting, particularly of outcome variables, should be estimated. Information on local clinical and reporting practices is necessary to interpret multi-centre data. Data protection issues may limit the possibilities for detailed data quality assessments of secondary data, as does the accessibility of original data for verification purposes. Our experiences and recommendations may be valuable for those intending to use disease registry data as well as those devising and operating such registries.
journal_name
Pharmacoepidemiol Drug Safjournal_title
Pharmacoepidemiology and drug safetyauthors
Strobl J,Enzer I,Bagust A,Haycox A,Smyth R,Ashby D,Walley Tdoi
10.1002/pds.804keywords:
subject
Has Abstractpub_date
2003-09-01 00:00:00pages
467-73issue
6eissn
1053-8569issn
1099-1557journal_volume
12pub_type
杂志文章,多中心研究abstract:PURPOSE:This paper introduces an improved tool for designing matched-pairs randomized trials. The tool allows the incorporation of clinical and other knowledge regarding the relative importance of variables used in matching and allows for multiple types of missing data. The method is illustrated in the context of a clu...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3260
更新日期:2012-05-01 00:00:00
abstract::Sixteen pathologically confirmed and 14 suspected cases of a new disease entity, fibrosing colonopathy, have been described in the UK and the US in children with cystic fibrosis since 1991. The patterns of use of pancreatic enzyme supplements in cases were compared with use in controls and in the market, in the 2 year...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/(SICI)1099-1557(199709/10)6:5<347::AID-PDS
更新日期:1997-09-01 00:00:00
abstract:PURPOSE:To identify and quantify risk factors associated with preterm birth, stratified by gestational age at birth. METHODS:Three case-control analyses were done. Controls were pregnancies of > or =37 weeks of gestational age at birth. Cases were defined as: <28, 28-32, 33- <37 weeks of gestational age at birth respe...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1575
更新日期:2008-06-01 00:00:00
abstract:PURPOSE:Type 2 diabetes is associated with increased cardiovascular risk. The comparative effectiveness of statin plus fibrate combination therapy and statin monotherapy in reducing risk of cardiovascular disease in real-world settings is unknown. METHODS:A retrospective database analysis was performed using a large m...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3261
更新日期:2012-05-01 00:00:00
abstract::The current medical care environment has created expectations that exceed its capabilities, one effect of which has been an increasing awareness of lapses in the quality of healthcare, including medical errors. As more new therapies reach clinical application, the expectations on the part of the public are unlikely to...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.699
更新日期:2002-06-01 00:00:00
abstract:PURPOSE:The objectives of this study were to characterize the validity of algorithms to identify AF from electronic health data through a systematic review of the literature and to identify gaps needing further research. METHODS:Two reviewers examined publications during 1997-2008 that identified patients with atrial ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,评审
doi:10.1002/pds.2317
更新日期:2012-01-01 00:00:00
abstract:PURPOSE:We evaluated national outpatient antimicrobial prescription trends in relation to the first United States case of inhalational anthrax due to the intentional delivery of Bacillus anthracis (B. anthracis) spores. METHODS:We queried IMS HEALTH's National Prescription Audit Plus7 database for two 6-month periods ...
journal_title:Pharmacoepidemiology and drug safety
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doi:10.1002/pds.828
更新日期:2003-04-01 00:00:00
abstract:PURPOSE:To investigate the association between socioeconomic position and use of lipid-lowering drugs and ACE-inhibitors after an acute myocardial infarction (AMI) when simultaneously considering participation in the national quality register RIKS-HIA (Register of Information and Knowledge about Swedish Heart Intensive...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1917
更新日期:2010-04-01 00:00:00
abstract:PURPOSE:The objective of this study was to determine the fraction of variance in patient-level medication adherence accounted for by prescribers and pharmacies. METHODS:We used prescription drug claims paid between January 2010 and July 2011 to a national pharmacy benefits manager to define implementation during persi...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4025
更新日期:2016-07-01 00:00:00
abstract:PURPOSE:To study the association between antibiotic use in early pregnancy and the risk of isolated orofacial clefts. METHODS:We conducted a cohort study of 806,011 live births in Denmark from 1996 through September 2008. Individual-level information on prescribed antibiotics during pregnancy, orofacial cleft diagnosi...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.2179
更新日期:2012-03-01 00:00:00
abstract:BACKGROUND AND AIMS:Epidemiologic studies on a potential chemopreventive effect of statin therapy have yielded conflicting results. We sought to clarify whether long-term statin therapy has a chemopreventive effect on the risk of colorectal cancer (CRC) in a large, population-representative cohort. METHODS:A nested ca...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1599
更新日期:2008-09-01 00:00:00
abstract:PURPOSES:(1) Measure the prevalence of herbal product (HP) use, alone, and concomitantly with prescribed medications during pregnancy, (2) identify the most frequently consumed HP during gestation and (3) determine predictors of HP use at the beginning of pregnancy, and during the third trimester. METHODS:A questionna...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,评审
doi:10.1002/pds.1731
更新日期:2009-06-01 00:00:00
abstract::Meloxicam (Mobic((R))) was introduced in the UK in 1996 as a nonsteroidal anti-inflammatory drug (NSAID). To help evaluate the postmarketing experience with meloxicam in the UK, we used the General Practitioners Research Database (GPRD) to characterize the baseline risk of an upper gastrointestinal (GI) event among ne...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/(SICI)1099-1557(200003/04)9:2<113::AID-PDS
更新日期:2000-03-01 00:00:00
abstract:PURPOSE:The aim of the present study was to determine whether community pharmacists recommend appropriate medications and give valid information to pregnant women. METHODS:A total of 163 community pharmacists randomly selected in the Midi-Pyrénées area were interviewed by means of an open questionnaire. Ten scenarios ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.954
更新日期:2004-10-01 00:00:00
abstract:PURPOSE:Opioid analgesic use in chronic non-cancer pain (CNCP) is increasingly prevalent, but the benefits and risks are inadequately understood. In France, tramadol is one of the most used prescription opioids, but studies on its misuse liability in CNCP are still lacking. The aim was to assess the incidence of tramad...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4056
更新日期:2016-09-01 00:00:00
abstract:PURPOSE:To evaluate the impact of 2 policy changes on quetiapine dispensing in Australia: removal of prior authorisation for prescribing (policy 1: July 2007) and removal of repeat prescriptions for 25-mg quetiapine (policy 2: January 2014). METHODS:We performed an interrupted time series analysis using Pharmaceutical...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4408
更新日期:2018-04-01 00:00:00
abstract:PURPOSE:This study mainly aimed at describing the prevalence of psychotropic medication consumption in the Spanish elderly population between the years 1993 and 2003. METHODS:Descriptive, cross-sectional study covering the Spanish population aged 65 years and over, using data drawn from the 1993 and 2003 Spanish Natio...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1344
更新日期:2007-04-01 00:00:00
abstract:PURPOSE:We systematically review the cross-national drug utilization studies performed in Latin America (LA) in order to analyze the methods applied and assess the validity of the data to ensure the comparability. METHODS:A systematic search in Medline, Embase, and BIREME was performed. Drug utilization studies includ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,评审
doi:10.1002/pds.3896
更新日期:2016-01-01 00:00:00
abstract:BACKGROUND AND AIMS:Non-adherence is considered a major barrier to better outcomes of diabetes care. A relationship has been established between polypharmacy and patients' adherence. This study aims to investigate the occurrence of polypharmacy and non-adherence in general practice, their mutual relationship and the as...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,随机对照试验
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更新日期:2009-11-01 00:00:00
abstract:PURPOSE:This study aimed to validate a predefined algorithm for osteonecrosis of the jaw (ONJ) among cancer patients in the Danish National Registry of Patients and to assess the nature of clinical information recorded in medical charts of ONJ patients. METHODS:We identified potential ONJ cases recorded in 2005-2010 a...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3786
更新日期:2015-07-01 00:00:00
abstract:PURPOSE:The Centers for Medicare & Medicaid Services claims comprise an administrative database of beneficiary-specific clinical information. This study evaluates the impacts of (i) claim information updates (claims adjudication) and (ii) delay in claim processing (claims delay) on real-time evaluation of health servic...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.2143
更新日期:2011-07-01 00:00:00
abstract:PURPOSE:Breast cancer is the most common cancer in women worldwide. We attempted to investigate the association between the risk of breast cancer and use of captopril and other antihypertensive medication. METHODS:We performed a cohort study with a nested case-control analysis using the General Practitioner Research D...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.910
更新日期:2004-08-01 00:00:00
abstract:PURPOSE:Estimating drug effectiveness and safety among older adults in population-based studies using administrative health care claims can be hampered by unmeasured confounding as a result of frailty. A claims-based algorithm that identifies patients likely to be dependent, a proxy for frailty, may improve confounding...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3719
更新日期:2015-01-01 00:00:00
abstract:OBJECTIVE:This study describes the use of psychotropic drugs in a sample of eight Italian psychiatric hospitals. METHODS:A cross-sectional approach was used to collect information about sociodemographic and clinical characteristics of the inpatient population, and about medications prescribed. Prescribing behaviour in...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/(SICI)1099-1557(199908/09)8:5<331::AID-PDS
更新日期:1999-08-01 00:00:00
abstract:PURPOSE:Because health insurance claims lack clinical information, comparative effectiveness research studies that rely on these data may be challenging to interpret and may result in biased inference. We conducted an exploratory study to determine if medical information contained in patient charts could offer clinical...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1988
更新日期:2010-08-01 00:00:00
abstract:PURPOSE:A case-control study is the most powerful design to test the risk of specific congenital malformations associated with a specific drug. However, malformation registries often lack non-malformed controls. For the Dutch EUROCAT, we collected a non-malformed control group: the 'Healthy Pregnant'. The aim of this s...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.2254
更新日期:2011-11-01 00:00:00
abstract::We review the concept of time-dependent confounding by using the example in paper "Comparative effectiveness of individual angiotensin receptor blockers on risk of mortality in patients with chronic heart failure" by Desai et al. and illustrate how to adjust for it by using inverse probability of treatment weighting t...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 评论,杂志文章
doi:10.1002/pds.2306
更新日期:2012-03-01 00:00:00
abstract:PURPOSE:The use of granulocyte colony-stimulating factor (G-CSF) in the treatment of non-chemotherapy drug- induced agranulocytosis is controversial. We aimed at assessing the effect of G-CSF on the duration of agranulocytosis. METHODS:To assess the effect of G-CSF on the duration of agranulocytosis, a Cox proportiona...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1542
更新日期:2008-03-01 00:00:00
abstract:PURPOSE:Lack of control for time-varying exposures can lead to substantial bias in estimates of treatment effects. The aim of this study is to provide an overview and guidance on some of the available methodologies used to address problems related to time-varying exposure and confounding in pharmacoepidemiology and oth...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,评审
doi:10.1002/pds.4372
更新日期:2018-02-01 00:00:00
abstract:PURPOSE:To evaluate the internet way of feedback to prescribing physicians, providing data on antimicrobial use and to assess the applicability of the DU90% (i.e. Drug Utilisation 90%--the number of drugs accounting for 90% of the volume of usage in defined daily doses, (DDDs)) methodology in the hospital setting. MET...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.898
更新日期:2004-07-01 00:00:00