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PubMed2006

Pharmacogenetics of drug-induced arrhythmias: a feasibility study using spontaneous adverse drug reactions reporting data.

PURPOSE: The bottleneck in pharmacogenetic research on rare adverse drug reactions (ADR) is retrieval of patients. Spontaneous reports of ADRs may form a useful source of patients. We investigated the feasibility of a pharmacogenetic study, in which cases were selected from the database of a spontaneous reporting system for ADRs, using drug-induced arrhythmias as an example. METHODS: Reports of drug-induced arrhythmias to proarrhythmic drugs were selected from the database of the Netherlands Pharmacovigilance Centre (1996-2003). Information on the patient's general practitioner (GP) was obtained from the original report, or from another health care provider who reported the event. GPs were contacted and asked to recruit the patient as well as two age, gender and drug matched controls. Patients were asked to fill a questionnaire and provide a buccal swab DNA sample through the mail. DNA samples were screened for 10 missense mutations in 5 genes associated with the congenital long-QT (LQT) syndrome (KCNQ1, KCNH2, SCN5A, KCNE1, KCNE2). RESULTS: We identified 45 eligible cases, 29 GPs could be contacted of which seven were willing to participate. Four cases and five matched controls could be included in the study, giving an overall participation rate of 9% (4/45). The main reason for GPs not being willing to participate was lack of time. Variants were identified in KCNH2, SCN5A and KCNE1. CONCLUSIONS: Spontaneous reporting systems for ADRs may be used for pharmacogenetic research. The methods described, however, need to be improved to increase participation and international collaboration may be required.

Adult↗
PubMed2005

Impact analysis of signals detected from spontaneous adverse drug reaction reporting data.

This paper describes a new method of prioritising signals of potential adverse drug reactions (ADRs) detected from spontaneous reports that is called impact analysis. This is an interim step between signal detection and detailed signal evaluation. Using mathematical screening tools, large numbers of signals may now be detected from spontaneous ADR databases. Regulatory authorities need to rapidly prioritise them and focus on those that are most likely to require significant action. Using two scores ranging from one to 100, each with three input variables, signals may be categorised in terms of the strength of evidence (E) and the potential public health impact (P). In a two-by-two figure with empirically derived cut-off points of ten (the logarithmic mean) for each score, signals are placed in one of four categories (A-D) that are ranked according to their priority (A being the highest and D the lowest). A sensitivity analysis is then performed that tests the robustness of the categorisation in relation to each of the six input variables. A computer program has been written to facilitate the process and reduce error. Further work is required to test the feasibility and value of impact analysis in practice.

Adverse Drug Reaction Reporting Systems↗
PubMed1998

Limitations and strengths of spontaneous reports data.

US Food and Drug Administration (FDA) monitoring of the continued safety of marketed medical products depends greatly on spontaneous reporting of serious adverse events by health professionals. Despite its inherent limitations, the national postmarketing surveillance system provides vital information of clinical importance.

Adverse Drug Reaction Reporting Systems↗
PubMed2006

Epidemiology and heritability of astigmatism in Norwegian twins: an analysis of self-reported data.

PURPOSE: To describe the occurrence and heritability of astigmatism in a population-based sample of Norwegian twins. METHODS: Self-reported history of astigmatism based on questionnaire responses was used to estimate the prevalence and incidence rates of astigmatism from birth through 31 years in 8,045 twins. Kaplan-Meier analysis and log-binomial regression were used to study the conditional and relative risk of astigmatism in twin pairs by sex and zygosity. Tetrachoric correlations and structural equation models were applied to estimate the genetic and environmental sources of variations in liability for astigmatism. RESULTS: Altogether 21.1% of males and 29.3% of females (p < 0.001) reported a positive history of astigmatism. Estimated incidence rates peaked in both sexes in the group aged 16-19 years and then decreased. Both conditional and relative risks of developing astigmatism were considerably higher in monozygotic than in dizygotic twins if a cotwin reported a positive history of astigmatism. The best-fitting biometrical model suggested that additive genetic, dominant genetic, and individual environmental effects explained 9% (95% CI: 0-40), 54% (95% CI: 20-69), and 38% (95% CI: 31-45) of the variation in the liability to astigmatism, respectively. No differences in heritability of astigmatism between the genders were found. CONCLUSIONS: The prevalence of self-reported astigmatism in twins is comparable with previous findings from Norway. Our results suggest considerable genetic contribution to the development of astigmatism in young adult Norwegian twins mainly due to dominant genetic effects, which are similar in both males and females.

Adolescent↗
PubMed2006

[Profile of acute poisoning in Italy. Analysis of the data reported by Poison Centres].

Information relative to about 400 000 cases of human intoxications, registered by nine Italian Poison Centres between 1991 and 1998 is presented. Data have been collected and elaborated in the framework of an European project on improving the prevention and treatment of acute human poisoning (90/C 329/EEC Resolution). Sex, age group, etiological agent, place and circumstances of poisoning and risk estimation are the parameters analyzed for the characterization of this phenomenon. The following conclusions can be summarized from the overall picture. There is a slight prevalence of males over females (50.0% against 45.7%); 1-4 year age group presents the highest risk (37.0%), followed by 20-49 group (25.8%); drugs and household products are the prevalent causes of intoxications (37.4% and 26.0%, respectively); home is the place where 84.9% of accidents occur. Poisoning is accidental in 73.5% of the cases whilst suicides represent 18.7%. However, the outcome is positive in almost all cases and fatal accidents are not reported in the present casuistry.

Accidents↗
PubMed2003

Incomplete data reporting in studies of emergency department patients with potential acute coronary syndromes using troponins.

OBJECTIVES: A multidisciplinary panel of experts is developing standardized reporting criteria for risk stratification studies of emergency department (ED) patients with potential acute coronary syndromes (ACS). The authors assessed the need for such criteria by reviewing published studies to determine whether these core criteria currently are being reported. METHODS: Studies published during 2000-2001 in eight journals representing emergency medicine, cardiology, and general medicine that evaluated the cardiac troponins for risk stratification of ED patients with chest pain were identified by a systematic MEDLINE review. Two raters independently analyzed each study with a structured tool. The presence or absence of 47 core criteria in eight major reporting categories, which were determined by expert consensus, was abstracted from the articles. When the two raters disagreed, discrepancies were resolved by consensus. Data are presented as percent frequency of occurrence with 95% confidence intervals. RESULTS: Twenty-two articles met inclusion criteria. The two reviewers had a median of 7.5 initial discrepancies per article (interquartile range = 6 to 10) but achieved consensus on all. The median of the percent of articles reporting the core criteria within each major reporting category is shown [table: see text]. CONCLUSIONS: Many of the 47 items considered core criteria by the expert committee writing standardized reporting guidelines for risk stratification studies of potential ACS patients were not reported often in major cardiology and emergency medicine journals. There seems to be a need for standardized reporting guidelines because important information is not currently being reported.

Acute Disease↗
PubMed2005

Colon cancer in Luxembourg: a national population-based data report, 1988-1998.

BACKGROUND: Over the last two decades time trends in incidence rates of colorectal cancer, changes in the proportions of stage at diagnosis and changes in the anatomic sub-site distribution of colon cancers have been reported in some European countries. In order to determine a strategy for early detection of colon cancer in the Grand-Duchy of Luxembourg, all consecutive colon adenocarcinomas diagnosed during the period 1988-1998 at a nation-wide level were reviewed. METHODS: The population-based data of the national Morphologic Tumour Registry report all new high-grade adenomas (i.e. high-grade intraepithelial adenomatous neoplasias) and all consecutive new invasive adenocarcinomas of the colon diagnosed in the central department of pathology. Attention has been focused on variations in incidence, stage, anatomical site distribution and survival rates. Rectal cancers were excluded. RESULTS: Over the study period, 254 new colonic high-grade adenomas and 1379 new invasive adenocarcinomas were found; the crude incidence rates of colon adenocarcinomas grew steadily by 30%. Comparing the two 5-year periods 1988-1992 and 1994-1998, the crude incidence rates of high-grade adenomas (stage 0) rose by 190%, that of stage I cases by 14.3%, stage II cases 12.9% and stage III cases 38.5%, whereas the crude incidence rates of stage IV cases decreased by 11.8%. The high-grade adenoma/adenocarcinoma ratio increased. The right-sided colonic adenocarcinomas in elderly patients (>69 years) increased by 76%. The observed survival rates correlated with tumour stages. The overall observed 5-year survival rate (stage I-IV) was 51 +/- 3% (95% confidence interval). CONCLUSION: The increasing incidence rates of colon adenocarcinomas, the persistence of advanced tumour stages (stage III), the mortality rates which remain stable, and the changing trends in the age- and sub-site distribution underline the need for preventive measures at the age of 50 in asymptomatic patients to reduce mortality from colo(rectal) cancer.

Adenocarcinoma↗
PubMed2007

Reporting data on homeopathic treatments (RedHot): a supplement to CONSORT.

When homeopathy is tested in clinical trials, understanding and appraisal is likely to be improved if published reports contain details of prescribing strategies and treatments. An international Delphi panel was convened to develop consensus guidelines for reporting homeopathic methods and treatments. The panel agreed 28 treatment- and provider-specific items that supplement the Consolidated Standards of Reporting Trials (CONSORT) Statement items 2, 3, 4 and 19. The authors recommend these for adoption by authors and journals when reporting trials of homeopathy.

Consensus↗
PubMed2006

Reporting data on homeopathic treatments (RedHot): a supplement to CONSORT*.

When homeopathy is tested in clinical trials, understanding and appraisal are likely to be improved if published reports contain details of prescribing strategies and treatments. An international Delphi panel was convened to develop consensus guidelines for reporting homeopathic methods and treatments. The panel agreed 28 treatment- and provider-specific items that supplement the CONSORT (Consolidated Standards of Reporting Trials) Statement items 2, 3, 4 and 19. The authors recommend these for adoption by authors and journals when reporting trials of homeopathy.

Delphi Technique↗
PubMed2003

Rectal cancer in Luxembourg : a national population-based data report, 1988-1998.

BACKGROUND: Morphologic criteria which might help to support the need for a preventive strategy for early detection of rectal cancer were analysed. Population-based data on rectal adenomas with high-grade dysplastic changes (n = 199) and invasive adenocarcinomas (n = 912) registered by the national Morphologic Tumour Registry (MTR) and diagnosed in a central department of pathology in Luxembourg between 1988 and 1998 were considered. METHODS: The analysis concerned time trends in frequency, crude incidence, tumour-stage, the rectal "high-grade" adenoma/invasive adenocarcinoma-ratio and the survival rates. Histopathological tumour-stage parameters (UICC/AJCC, 1997) in a consecutive series of 641 resected rectal cancers and their relationship with the observed patient survival are investigated. RESULTS: The majority of invasive adenocarcinomas are diagnosed at a late stage (i.e. Stage II and III) into contrast with the highly significant increase (355 %) in frequency of rectal high-grade adenomas (Stage 0). During the two-time periods 1988-1992 and 1994-1998 Stage I and Stage IV-cases decreased by 11 % and 47 % respectively. Tumour-stage correlates with prognosis. The rectal high-grade adenoma / invasive adenocarcinoma-ratio improved significantly over the last five years. CONCLUSION: Over the study period, there has been a highly significant rise in the incidence of resected rectal adenomas with high-grade intraepithelial neoplasia. The ratio of early tumours to invasive cancers has risen while the numbers of colonoscopies and rectoscopies remained unchanged respectively decreased. As the number of advanced tumour-stages remained stable, mass-screening procedures focusing on the fifty to sixty age group should be reinforced.

Adenocarcinoma↗
PubMed1991

Measurement issues in evaluating physicians' practice patterns using hospital billing and surgeon's self-report data.

The availability of computerized case mix data, which merge medical records information and patient billing data, provide opportunity for measuring physician-specific practice patterns. However, the validity of physician comparisons is a concern when total patient charges are measured at two points in time. In this physician-initiated multicenter study, comparisons using samples of uncomplicated, baseline cases, as determined from medical records chart reviews of five surgical procedures at three institutions, demonstrated a statistically significant reduction in average length of stay (ALOS) from 0.8 to 2.8 in seven of the 15 studies while total patient charges increased in 11 of the studies from one to 29 per cent. Billing data were useful in measuring ALOS and the frequency of specific laboratory tests ordered and then comparing these to physicians' self-report practice.

Ancillary Services, Hospital↗
PubMed1986

Enzyme activity in human gingival crevicular fluid: considerations in data reporting based on analysis of individual crevicular sites.

Using a reproducible approach to collection, processing and analysis of gingival crevicular fluid (GCF), this study examined 284 fluid samples from individual crevicular sites for the presence of the enzymes lactate dehydrogenase (LDH), B-glucuronidase (BG) and arylsulfatase (AS). 88 of the sites were from periodontally healthy individuals (probing depth 1-3 mm), while 98 sites from patients with periodontitis were examined before and 2 weeks after scaling and root planing (probing depths 1-3 mm, 4-6 mm and 7-10 mm). This study demonstrated the sensitivity of the enzyme assays. When GCF was collected with a 30-s insertion of the filter strip, 90% of the sites from the control subjects demonstrated LDH activity, 85% demonstrated BG activity and 73% demonstrated AS activity. For the 1-3 mm sites from the patients with periodontitis, 100% of sites from which fluid was collected demonstrated LDH and BG activity, and 90% of sites had AS activity before therapy. After therapy, 100% of sites demonstrated LDH activity, 90% had BG activity and 83% had AS activity. All sites in the 4-6 mm and 7-10 mm categories demonstrated activity of all 3 enzymes. The data were analyzed in terms of enzyme activity/30-s sample and as concentration of enzyme in a standard volume of GCF. Enzyme activity/30-s sample was a different and possibly more sensitive indicator of periodontal pathology than standard clinical parameters. There was a disassociation between clinical parameters and the data for enzyme analysis when it was reported as concentration.

Adult↗
PubMed1996

[Health report data in the management of chronic psychiatric patients].

Reforming mental health care in the Federal Republic of Germany was clearly impeded by a lack of health care data which would allow for a precise description of the state of the reorganisational process. Since these deficits are not a specific problem of mental health care, the need for a national health report providing health care statistics from all medical disciplines is widely recognised and has led to appropriate political initiatives. The difficulties in interpreting mental health care statistics of restricted validity and the resulting dangers will be discussed by means of examples, and the need for a special health report in mental health care is justified.

Chronic Disease↗