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1.
Pharmacoepidemiol Drug Saf ; 30(12): 1643-1652, 2021 12.
Artículo en Inglés | MEDLINE | ID: mdl-34418227

RESUMEN

PURPOSE: Anaphylaxis (ANA) is an important adverse drug reaction. We examined positive predictive values (PPV) and other test characteristics of ICD-10-GM code algorithms for detecting ANA as used in a multinational safety study (PASS). METHODS: We performed a cross-sectional study on routine data from a German academic hospital (2004-2019, age ≥ 18). Chart review was used for case verification. Potential cases were identified from the hospital administration system. The main outcome required at least one of the following: any type of specific in-hospital code (T78.2, T88.6, and T80.5) OR specific outpatient code in combination with a symptom code OR in-hospital non-specific code (T78.4, T88.7, and Y57.9) in combination with two symptom codes. PPV were calculated with 95% confidence interval. Sensitivity analyses modified type of codes, unit of analysis, verification criteria and time period. The most specific algorithm used only primary codes for ANA (numbers added in brackets). RESULTS: Four hundred and sixteen eligible cases were evaluated, and 78 (37) potential ANA cases were identified. PPV were 62.8% (95% CI 51.1-73.5) (main) and 77.4% (58.9-90.4) (most specific). PPV from all modifications ranged from 12.9% to 80.6%. The sensitivity of the main algorithm was 66.2%, specificity 91.5%, and negative predictive value 92.6%. Corresponding figures for the most specific algorithm were 32.4%, 98.0%, and 87.0%. CONCLUSIONS: The PPV of the main algorithm seems of acceptable validity for use in comparative safety research but will underestimate absolute risks by about a third. Restriction to primary discharge codes markedly improves PPV to the expense of reducing sensitivity.


Asunto(s)
Anafilaxia , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Algoritmos , Anafilaxia/diagnóstico , Anafilaxia/epidemiología , Estudios Transversales , Bases de Datos Factuales , Hospitales , Humanos , Clasificación Internacional de Enfermedades
2.
BMC Fam Pract ; 21(1): 270, 2020 12 17.
Artículo en Inglés | MEDLINE | ID: mdl-33334312

RESUMEN

BACKGROUND: There is wide variation in clinical practice for the early detection of prostate cancer, not least because of the ongoing debate about the benefits of prostate-specific antigen (PSA) testing. In this study, we aimed to assess the approaches, attitudes, and knowledge of general practitioners (GPs) regarding PSA testing in primary care in the Netherlands, particularly regarding recommendations for prostate cancer. METHODS: Questionnaire surveys were sent to 179 GPs in the north-east of the Netherlands, of which 65 (36%) were completed and returned. We also surveyed 23 GPs attending a postgraduate train-the-trainer day (100%). In addition to demographic data and practice characteristics, the 31-item questionnaire covered the attitudes, clinical practice, adherence to PSA screening recommendations, and knowledge concerning the recommendations for prostate cancer early detection. Statistical analysis was limited to the descriptive level. RESULTS: Most GPs (95%; n = 82) stated that they had at least read the Dutch GP guideline, but just half (50%; n = 43) also stated that they knew the content. Almost half (46%; n = 39) stated they would offer detailed counseling before ordering a PSA test to an asymptomatic man requesting a test. Overall, prostate cancer screening was reported to be of minor importance compared to other types of cancer screening. CONCLUSIONS: Clinical PSA testing in primary care in this region of the Netherlands seems generally to be consistent with the relevant guideline for Dutch GPs that is restrictive to PSA testing. The next step will be to further evaluate the effects of the several PSA testing strategies.


Asunto(s)
Médicos Generales , Neoplasias de la Próstata , Detección Precoz del Cáncer , Humanos , Masculino , Tamizaje Masivo , Países Bajos , Pautas de la Práctica en Medicina , Antígeno Prostático Específico , Neoplasias de la Próstata/diagnóstico
3.
Pharmacoepidemiol Drug Saf ; 28(10): 1344-1352, 2019 10.
Artículo en Inglés | MEDLINE | ID: mdl-31373108

RESUMEN

PURPOSE: Acute liver injury (ALI) is an important adverse drug reaction. We estimated the positive predictive values (PPVs) of ICD-10-GM codes of ALI used in an international postauthorisation safety study (PASS). METHODS: Analyses used routine data (2007 to 2016, adults) from a German academic hospital in a cross-sectional design. Two algorithms from the PASS were applied to extract potential cases from the hospital information system: specific end point (A) (discharge diagnosis of liver disease-specific codes) and less specific end point (B) (discharge and outpatient-specific and nonspecific codes suggestive of liver injury). ALI cases were confirmed on the basis of plasma liver enzyme activity elevation. Secondary analysis was performed following exclusion of cases with known cancer, chronic liver, biliary and pancreatic disease, heart failure, and alcohol-related disorders, as applied in the PASS. RESULTS: On the basis of ICD codes: outcome A, 154 cases (143 with case notes and lab data for case verification); outcome B, 485 cases (357 with case notes and lab data). ALI was confirmed in 71 outcome A cases, PPV of 49.7% (95% confidence interval [CI], 41.2%-58.1%), and 100 outcome B cases, PPV of 28.0% (95% CI, 23.4%-33.0%). Applying exclusion criteria increased PPV (95% CI) to 62.7% (50.0%-74.2%) for outcome A and 45.7% (37.2%-54.3%) for outcome B. CONCLUSIONS: In safety studies on hepatotoxicity based on routine data using ICD-10-GM discharge codes and when validation of potential cases is not feasible, only the more specific codes should be used to describe ALI, and competing diagnoses for liver injury should be excluded to avoid substantial misclassification.


Asunto(s)
Enfermedad Hepática Inducida por Sustancias y Drogas/epidemiología , Codificación Clínica/estadística & datos numéricos , Clasificación Internacional de Enfermedades , Farmacoepidemiología/métodos , Adulto , Enfermedad Hepática Inducida por Sustancias y Drogas/diagnóstico , Enfermedad Hepática Inducida por Sustancias y Drogas/etiología , Estudios Transversales , Bases de Datos Factuales/estadística & datos numéricos , Femenino , Alemania/epidemiología , Hospitales/estadística & datos numéricos , Humanos , Masculino , Registros Médicos/estadística & datos numéricos
4.
Front Oncol ; 11: 691197, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-34150662

RESUMEN

BACKGROUND: In 2020, around 1.4 million new prostate cancer (PCa) cases were recorded worldwide. Early detection of PCa by prostate-specific antigen (PSA) screening remains debated, leading to different specialist-specific recommendations in PCa guidelines. This study aimed to assess attitudes toward and use of PSA testing among urologists in Germany and general practitioners (GPs) in Lower Saxony (Germany). METHODS: A nationwide questionnaire was sent to urologists via the mailing lists of the Professional Association of German Urologists and the German Urological Society. A version of the questionnaire for GPs was sent to email addresses via the Association of Statutory Health Insurance Physicians Lower Saxony. The online questionnaires covered use of PSA testing, information communication, handling of test results, and handling of/knowledge about national and international guidelines and recommendations on early detection of PCa. Statistical analysis was performed at a descriptive level. RESULTS: In total, 432 of 6,568 urologists (6.6%) and 96 of 1,579 GPs (6.1%) participated in this survey. Urologists and GPs differed in their attitudes and approaches toward PSA testing. Most urologists (86.8%, n=375) judged the test as "very meaningful" or "meaningful", compared with 52.1% (n=50) of GPs. Almost two-thirds of the urologists (64.4%, n=278) viewed the PCa mortality reduction by PSA testing as proven, compared with one-fifth of GPs (20.8%, n=20). Almost 80% of male urologists (79.9%, n=291) indicated that they would undergo a PSA test in the future (again), compared with 55.1% of male GPs (n=38). In addition, 56.3% (n=243) of urologists stated that "considerably more than half" or "almost all" men aged 45 years or older received a PSA test, compared with 19.8% (n=19) of GPs. CONCLUSIONS: Urologists are more convinced about the PSA test than GPs. PSA testing is therefore used more often in urological settings, although the preselected patient population must be considered. In accordance with specialist-specific recommendations, GPs show a more reserved approach toward PSA testing. Instead of focusing on different attitudes and recommendations on PSA testing, the exchange between specialist groups should be improved to achieve a consistent approach to PSA testing.

5.
Front Oncol ; 11: 681006, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-34123851

RESUMEN

BACKGROUND: Prostate cancer (PCa) is the most frequent cancer among men in Europe. Differences in PCa incidence around the world can be partly explained by variations in recommendations for prostate-specific antigen (PSA), particularly for early detection. For example, the PSA testing policy is more conservative in the Netherlands than in Germany. To better understand the relationship between PSA testing recommendations and PCa incidence, stage distribution, and mortality, we compared these variables over time between Lower Saxony in northwestern Germany and the neighboring province of Groningen in the Netherlands. METHODS: Population data, tumor stage- and age group-specific PCa incidence (ICD-10 C61) and mortality rates for Lower Saxony and Groningen were obtained from the Lower Saxony Epidemiological Cancer Registry, the Netherlands Comprehensive Cancer Organization, and Statistics Netherlands for 2003-2012. Incidence and mortality rates per 100,000 person-years were age-standardized (ASR, old European standard). Trends in age-standardized incidence rates (ASIR) and mortality rates (ASMR) for specific age groups were assessed using joinpoint regression. RESULTS: The mean annual PCa ASIR between 2003 and 2012 was on average 19.9% higher in Lower Saxony than in Groningen (120.5 vs. 100.5 per 100,000), while the mean annual ASMR was on average 24.3% lower in Lower Saxony than in Groningen (21.5 vs. 28.4 per 100,000). Between 2003 and 2012, the average annual percentage change (AAPC) in PCa incidence rates did not change significantly in either Lower Saxony (-1.8%, 95% CI -3.5, 0.0) or Groningen (0.2%, 95% CI -5.0, 5.7). In contrast, the AAPC in mortality rate decreased significantly during the same time period in Lower Saxony (-2.5%, 95% CI -3.0, -2.0) but not in Groningen (0.1%, 95% CI -2.4, 2.6). CONCLUSIONS: Higher PCa incidence and lower PCa-related mortality was detected in Lower Saxony than in Groningen. Although recommendations on PSA testing may play a role, the assessed data could not offer obvious explanations to the observed differences. Therefore, further investigations including data on the actual use of PSA testing, other influences (e.g., dietary and ethnic factors), and better data quality are needed to explain differences between the regions.

6.
Cancer Manag Res ; 11: 3079-3097, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31114352

RESUMEN

Background: Prostate cancer (PCa) is the most frequent cancer and the third leading cause of cancer death among German men. One option for PCa early detection is prostate-specific antigen (PSA) testing, which is still under debate regarding its risk benefits. Besides recommendations on the early PCa detection, daily practice on PSA testing varies in, for example, information communication and usage of the test. This pilot study assessed potential differences between general practitioners (GPs) and urologists in handling PSA testing and guidelines on early detection of PCa. Methods: 172 GPs belonging to the teaching network of the University of Oldenburg in Lower Saxony and Bremen and 128 practicing urologists were included in the online survey focusing on PSA testing. The questionnaire covered 43 questions on topics as the usage of the test, information communication, handling of test results and handling of/knowledge about national and international guidelines on PCa. Wether PSA testing is used in accordance with guidelines was also explored in four standardized case scenarios. Statistical analysis was done at a descriptive level. Results: In total, 65 doctors participated in the survey (response proportion: 21.7%, n=65; 27.9%, n=48 [GPs]; 13.2%, n=17 [urologists]). Results of 41 GPs and 14 urologists were analyzed. The PSA test was judged as useful by all urologists, while almost half of the GPs valued the test as ambivalent or not useful. Urologists showed a more proactive approach of informing men on PSA testing. Regarding guidelines and recommendations on PSA testing, GPs were less familiar with them compared to the urologists. Doctors of both specialties did not always treat men in consistence with the guidelines. This was partially in contradiction to their self-appraisal. Conclusion: This pilot study is highlighting differences in PSA testing practices between GPs and urologists in Germany. Urologists showed a more proactive approach. For further verification, we plan a more comprehensive study covering several German states.

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