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1.
Pharmacoepidemiol Drug Saf ; 33(1): e5707, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-37786242

RESUMO

PURPOSE: Nearly all apremilast users captured in Clinical Practice Research Datalink (CPRD) Aurum have only one prescription, which is inconsistent with its prescribing pattern. The goal of this study was to assess capture of apremilast prescriptions in CPRD Aurum by comparison to CPRD GOLD and general practitioner (GP) questionnaires. METHODS: We compared the number of apremilast prescriptions for patients in Aurum to (1) those in GOLD and (2) those reported by the GPs via questionnaire responses. RESULTS: There were 441 Aurum patients with an apremilast prescription (424 [96%] in England) and 341 GOLD patients (11 [3%]) in England). In Aurum 91% of all patients (and 96% of English patients) had only one apremilast prescription while in GOLD 29% of all patients (and 82% of English patients) had only one prescription. We received questionnaire responses from GPs for 50 of 390 (13%) patients participating in Aurum who had 57 total apremilast exposed months captured in Aurum. GPs reported 8 (16%) patients with only one prescription and a median of 4 (range 1-35) apremilast prescriptions per patient, yielding 463 total months of apremilast exposure. CONCLUSIONS: CPRD Aurum captures only one apremilast prescription for most recorded users, though questionnaire responses indicated most patients received multiple prescriptions. Researchers using any UK GP database should be aware of potential for significant exposure misclassification of apremilast and other treatments classified as specialist or shared care by local Area Prescribing Committees.


Assuntos
Medicina Geral , Prescrições , Talidomida/análogos & derivados , Humanos , Reino Unido , Inglaterra
2.
Pharmacoepidemiol Drug Saf ; 32(1): 73-77, 2023 01.
Artigo em Inglês | MEDLINE | ID: mdl-36251264

RESUMO

PURPOSE: While several studies have assessed quality and completeness of recording acute medical events in Clinical Practice Research Datalink (CPRD) Aurum, evaluation of additional chronic conditions is warranted. METHODS: We selected patients with a first diagnosis of rheumatoid arthritis (RA) coded in their CPRD Aurum record between 2005 and 2019. We assessed quality of RA diagnosis by evaluating additional information in the patient record that would corroborate the diagnosis. We report recording of diagnoses, prescriptions, labs, and referrals expected to be present based on NICE guidelines for RA management. RESULTS: There were 53 083 patients with a first recorded RA diagnosis during the study period: 43606 (82%) patients had RA drug treatments in their record, 7596 (14%) had supporting codes without drug treatment, and 1881 (4%) patients had only a RA diagnoses recorded in their medical record with no supporting codes or RA treatments. Patients with RA diagnosis only were more likely to be first diagnosed in the earliest time period of study. Labs for diagnosing and monitoring RA were most common among patients with RA treatment. Analgesic and glucocorticoid prescriptions were common in all study patients but were highest among patients with RA treatment. Among patients with RA diagnosis only, the overwhelming majority had only one RA diagnosis recorded (76%). CONCLUSIONS: Our findings suggest that codes expected for monitoring and treatment of RA are routinely recorded in CPRD Aurum. These results support previous assessments, which found data recorded in CPRD Aurum to be of good quality for use in research.


Assuntos
Artrite Reumatoide , Humanos , Bases de Dados Factuais , Reino Unido/epidemiologia , Artrite Reumatoide/diagnóstico , Artrite Reumatoide/tratamento farmacológico , Artrite Reumatoide/epidemiologia , Prontuários Médicos , Encaminhamento e Consulta
3.
Rheumatology (Oxford) ; 60(4): 1926-1931, 2021 04 06.
Artigo em Inglês | MEDLINE | ID: mdl-33159794

RESUMO

OBJECTIVES: People with PsA are at increased risk of cardiovascular disease. The objective of this study was to quantify the risk of myocardial infarction (MI), stroke and revascularizations in people with apremilast-treated PsA compared with patients receiving other PsA treatments. METHODS: We conducted a cohort study of 68 678 patients with PsA treated with apremilast, TNF inhibitor (TNF-i) biologics, IL-17 or -12/23 biologics, conventional DMARDs or CS in the United States MarketScan database. Cohort entry was date of first study drug after 21 March 2014. Cases were patients with MI, stroke or revascularization. We calculated incidence rates (IRs) and incidence rate ratios for each outcome by exposure. RESULTS: We identified 292 MI, 151 stroke and 475 revascularizations cases. IRs for MI were lowest for users of TNF-i biologics [1.4 per 1000 person-years (PY)] and similar for all other treatments, including apremilast, ranging from 1.8 to 3.8 per 1000 PY. IRs were similar for all treatments for both stroke (0.1-1.6 per 1000 PY) and revascularization (3.1-5.1 per 1000 PY). IRs for apremilast were 2.5 per 1000 PY for MI, 1.6 per 1000 PY for stroke and 3.3 per 1000 PY for revascularization. CONCLUSION: In patients with treated PsA, IRs of MI, stroke and revascularization were low for all systemic treatments evaluated. Although the number of events was small, apremilast exposure did not signal potential acute cardiovascular harm and was not associated with a material increase in the risk of these serious cardiac events.


Assuntos
Corticosteroides/uso terapêutico , Anti-Inflamatórios não Esteroides/uso terapêutico , Antirreumáticos/uso terapêutico , Artrite Psoriásica/tratamento farmacológico , Fatores Biológicos/uso terapêutico , Infarto do Miocárdio/etiologia , Acidente Vascular Cerebral/etiologia , Talidomida/análogos & derivados , Corticosteroides/efeitos adversos , Anti-Inflamatórios não Esteroides/efeitos adversos , Antirreumáticos/efeitos adversos , Fatores Biológicos/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/induzido quimicamente , Intervenção Coronária Percutânea/estatística & dados numéricos , Fatores de Risco , Acidente Vascular Cerebral/induzido quimicamente , Talidomida/efeitos adversos , Talidomida/uso terapêutico
4.
Pharmacoepidemiol Drug Saf ; 29(11): 1456-1464, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-32986901

RESUMO

PURPOSE: The Clinical Practice Research Datalink (CPRD) now provides a new medical record database, CPRD Aurum. This is the second of several studies being undertaken to assess the quality of CPRD Aurum data for research. METHODS: We included patients aged 20+, with at least one lab test result of any type from a random sample of 50 000 patients in CPRD Aurum. We assessed whether diagnosis codes for type 2 diabetes, hyperlipidemia, and iron deficiency or unspecified anemia were accompanied by supporting codes including lab results and treatments (correctness) and whether lab results, treatments, or other codes indicate a missing diagnosis record (completeness). RESULTS: Among 37 502 patients in CPRD Aurum, correctness of type 2 diabetes, hyperlipidemia, and anemia diagnoses was high (99%, 93%, and 97%, respectively). Completeness was only high for type 2 diabetes (94%-98%); completeness for hypercholesterolemia and anemia diagnoses was modest even when the presence of treatments and lab results indicated the conditions were likely present (51%-59% and 58%-70%, respectively). CONCLUSIONS: Our findings indicate that for studies of type 2 diabetes, hyperlipidemia, and iron deficiency or unspecified anemia, the diagnosis code is likely to be correct where present. However, a significant proportion of cases of hyperlipidemia or anemia will be missed if only diagnosis codes are used to select patients with these conditions. Researchers should consider using treatments, supporting codes, and, when available, lab data to supplement diagnosis codes and enhance case capture when including these conditions in studies using CPRD Aurum.


Assuntos
Confiabilidade dos Dados , Diabetes Mellitus Tipo 2 , Gerenciamento de Dados , Bases de Dados Factuais , Diabetes Mellitus Tipo 2/diagnóstico , Diabetes Mellitus Tipo 2/epidemiologia , Humanos , Reino Unido
5.
Pharmacoepidemiol Drug Saf ; 29(9): 1134-1140, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32222005

RESUMO

PURPOSE: The Clinical Practice Research Datalink (CPRD) now provides a new medical record database, CPRD Aurum. This is the first of several studies being undertaken to assess the quality and completeness of CPRD Aurum data for research endeavors. METHODS: We identified patients with a pulmonary embolism (PE) diagnosis from a random sample of 50 000 patients in CPRD Aurum and compared the diagnoses using data from Hospital Episode Statistics (HES). We calculated the proportion of PE cases recorded in CPRD Aurum who also had a PE diagnosis recorded in HES. We also evaluated completeness by identifying all PE diagnoses in HES and calculating the proportion also present in CPRD Aurum. RESULTS: The study included 781 PE patients: 580 had a PE in CPRD Aurum, 632 had a PE in HES, and 431 had a PE in both. The proportion of patients with anticoagulated PE in CPRD Aurum confirmed by HES was 76.8%. The completeness of primary hospitalized PE HES events compared to CPRD Aurum was 79.1%. In most instances, there was a plausible explanation for the presence of a PE in only one of the two data sources. CONCLUSIONS: The results of this study are reassuring and suggest that the correctness (eg, quality, accuracy) and completeness of diagnosis information in CPRD Aurum are promising with respect to serious acute conditions that require medical attention. Evaluation of other data elements will provide additional insight into this new data resource and its utility for medical research.


Assuntos
Coleta de Dados/métodos , Bases de Dados Factuais/estatística & dados numéricos , Registros Eletrônicos de Saúde/estatística & dados numéricos , Sistemas de Informação Hospitalar/estatística & dados numéricos , Embolia Pulmonar/epidemiologia , Humanos , Embolia Pulmonar/diagnóstico , Reino Unido/epidemiologia
6.
BMC Cancer ; 19(1): 1040, 2019 Nov 04.
Artigo em Inglês | MEDLINE | ID: mdl-31684896

RESUMO

BACKGROUND: The longevity for people with intellectual disability (ID) has significantly increased in developed countries during the past decades. Consequently, the incidence of cancer is expected to increase in this group. The aim of the present study was to investigate the prescription of pain medication in older cancer patients with intellectual disability (ID) compared to older patients in the general population, surviving or living with a cancer diagnosis. METHODS: This Swedish national registry-based study, included people with ID aged 55 years or older in 2012, and alive at the end of that year (ID cohort, n = 7936). For comparisons, we used a referent cohort, one-to-one matched with the general population by year of birth and sex (gPop cohort, n = 7936). People with at least one diagnosis of cancer during 2002-2012 were identified using the Swedish National Patient Register, resulting in 555 cancer patients with ID and 877 cancer patients from the general population. These two cohorts of cancer patients were compared with respect to prescription of pain medication for the period 2006-2012. Outcome data were aggregated so that each patient was categorized as either having or not having at least one prescription of each investigated drug group during the study period, and relative risks (RRs) for prescription were estimated for prescription in the ID cohort vs the gPop cohort. RESULTS: Cancer patients with ID were less likely than cancer patients in the gPop cohort to have at least one prescription of COX inhibitors (RR 0.61) and weak opioids (RR 0.63). They were, however, more likely to be prescribed paracetamol (RR 1.16), antidepressants (RR 2.09), anxiolytics (RR 2.84), and "other hypnotics, sedatives, and neuroleptics" (RR 1.39). No statistically significant differences between the two cohorts were found for strong opioids, antiepileptics, tricyclic antidepressants, or hypnotics and sedatives. CONCLUSION: In the studied cohort of older people surviving or living with cancer, prescriptions for pain-treatment was less common in patients with ID compared to the general population. These results may suggest that pain is not sufficiently treated among cancer patients with ID, a situation that most likely would compromise the quality of life in this group.


Assuntos
Analgésicos/uso terapêutico , Prescrições de Medicamentos/estatística & dados numéricos , Deficiência Intelectual/epidemiologia , Neoplasias/epidemiologia , Dor/tratamento farmacológico , Sistema de Registros/estatística & dados numéricos , Idoso , Idoso de 80 Anos ou mais , Sobreviventes de Câncer , Estudos de Coortes , Feminino , Humanos , Deficiência Intelectual/tratamento farmacológico , Masculino , Pessoa de Meia-Idade , Neoplasias/tratamento farmacológico , Suécia/epidemiologia
7.
Br J Clin Pharmacol ; 85(5): 949-959, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30682225

RESUMO

AIMS: To estimate the relative, absolute and attributable risk of non-traumatic tendon rupture, at various sites, associated with use of fluoroquinolones, with and without concomitant corticosteroids. METHODS: We conducted cohort and nested case-control studies among fluoroquinolone users in the United Kingdom Clinical Practice Research Datalink Gold. We estimated the excess risk (cohort analysis) and odds ratios (ORs) (case control) of tendon rupture by fluoroquinolone (current, recent and past use versus unexposed) and corticosteroid (current versus unexposed) use. RESULTS: Among 740 926 patients with a fluoroquinolone prescription, 3957 cases of tendon rupture were identified. The excess risk due to current fluoroquinolone use was low: any tendon rupture 3.73 (95% confidence interval, CI, 2.08-5.39) per 10 000 person-years (PY) and Achilles tendon rupture 2.91 (1.71-4.11) per 10 000 PY. The excess risk of any tendon rupture was much higher for current concomitant fluoroquinolone and corticosteroid use versus corticosteroids alone: 21.2 (11.3-31.2) per 10 000 PY. In the case-control, OR (95% CI) among current fluoroquinolone users versus unexposed patients was elevated: any tendon rupture 1.60 (1.22-2.09), Achilles tendon 2.71 (1.76-4.17) and bicep tendon 1.53 (0.85-2.73). The risk of any tendon rupture was higher among women (OR 2.27 [1.54-3.34]), patients aged 60+ (OR 2.42 [1.74-3.37]), and concomitant corticosteroid use (OR 6.64 [3.99-11.1]). CONCLUSIONS: Fluoroquinolones increase the risk of Achilles tendon rupture and, to a lesser extent, bicep tendon rupture, but the attributable risk is low. The risk is materially increased with concomitant use of corticosteroids.


Assuntos
Tendão do Calcâneo/lesões , Antibacterianos/efeitos adversos , Fluoroquinolonas/efeitos adversos , Glucocorticoides/efeitos adversos , Traumatismos dos Tendões/epidemiologia , Adulto , Estudos de Casos e Controles , Quimioterapia Combinada/efeitos adversos , Quimioterapia Combinada/métodos , Feminino , Seguimentos , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Razão de Chances , Estudos Prospectivos , Medição de Risco , Fatores de Risco , Fatores Sexuais , Traumatismos dos Tendões/induzido quimicamente , Reino Unido/epidemiologia
8.
Soc Psychiatry Psychiatr Epidemiol ; 54(8): 937-944, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-30903237

RESUMO

PURPOSE: To describe demographic and diagnostic profiles in a national cohort of older people with intellectual disability (ID) who were prescribed antipsychotics. METHODS: Using national registers, we identified people with ID who were 55 + years in 2012 (n = 7936), as well as a subcohort with complete information on demographic factors (sex, year of birth, severity of ID, presence of behavior impairment, and residence in special housing; n = 1151). Data regarding diagnoses and prescription of antipsychotics were added for the time period 2006-2012. The potential effects of demographic factors and diagnoses on the prescription of sedating and less-sedating antipsychotics, respectively, were assessed in separate models by estimating the relative risks (RRs) of prescription. RESULTS: Of the demographic factors, severe/profound ID (RR 1.17), behavior impairment (RR 1.34), and living in special housing (RR 1.25) were associated with prescription of sedating antipsychotics, whereas only behavior impairment (RR 1.42) was associated with prescription of less-sedating antipsychotics. For both sedating and less-sedating antipsychotics, the diagnoses with the largest association (i.e., highest relative risk) were schizophrenia (RR 2.17 for sedating and RR 1.81 for less-sedating) and ID (RR 1.84 and RR 1.68, respectively), followed by disorders of psychological development (for sedating antipsychotics, RR 1.57) and organic mental disorders (for less-sedating antipsychotics, RR 1.55). CONCLUSIONS: The associations between prescription of antipsychotics and demographic factors and non-psychotic diagnoses, respectively, suggest that older people with ID may be prescribed antipsychotic medication without thorough psychiatric diagnosing. If so, there is a need for improving the abilities of health care professionals to properly diagnose and manage psychiatric illness in this population.


Assuntos
Antipsicóticos/uso terapêutico , Prescrições de Medicamentos/estatística & dados numéricos , Deficiência Intelectual/tratamento farmacológico , Transtornos Neurocognitivos/epidemiologia , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Demografia , Feminino , Habitação/estatística & dados numéricos , Humanos , Prescrição Inadequada , Deficiência Intelectual/psicologia , Masculino , Pessoa de Meia-Idade , Transtornos Neurocognitivos/tratamento farmacológico , Sistema de Registros , Esquizofrenia/tratamento farmacológico , Esquizofrenia/epidemiologia
10.
Ann Intern Med ; 160(2): 111-21, 2014 Jan 21.
Artigo em Inglês | MEDLINE | ID: mdl-24592496

RESUMO

BACKGROUND: Previous systematic reviews of implantable cardioverter defibrillators (ICDs) used for primary prevention of sudden cardiac death (SCD) concluded that ICDs are less effective in women and the elderly. PURPOSE: To examine ICD effectiveness for primary prevention of SCD across subgroups by sex, age, New York Heart Association class, left ventricular ejection fraction, heart failure, left bundle branch block, QRS interval, time since myocardial infarction, blood urea nitrogen level, and diabetes. DATA SOURCES: MEDLINE and the Cochrane Central Register of Controlled Trials through 3 September 2013 with no language restriction. STUDY SELECTION: Researchers screened articles for studies comparing ICD versus no ICD for primary prevention. DATA EXTRACTION: Data were extracted about study design, patients, interventions, mortality and SCD outcomes, subgroup characteristics, and subgroup effects. Quality of subgroup analyses was determined by consensus. Relative odds ratios comparing subgroup effects were calculated, and random-effects model meta-analyses were conducted on these ratios. DATA SYNTHESIS: Meta-analysis of 14 studies showed a decrease in deaths and SCDs due to ICD treatment. Ten studies provided subgroup analyses. Nine studies compared ICD versus no ICD, whereas one compared cardiac resynchronization therapy plus a defibrillator versus no ICD. Within-study interaction tests and across-study meta-analyses yielded weak evidence that did not show differences for all-cause mortality in subgroups by sex, age, and QRS interval. The evidence was indeterminate for other evaluated subgroups because of a paucity of data. LIMITATION: Many subgroup analyses were underpowered, which may have resulted in false-negative findings. CONCLUSION: Weak evidence fails to show differences for all-cause mortality in subgroups of sex, age, and QRS interval. Evidence is indeterminate for all-cause mortality in the other subgroups and for SCD. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.


Assuntos
Morte Súbita Cardíaca/prevenção & controle , Desfibriladores Implantáveis , Prevenção Primária , Fatores Etários , Causas de Morte , Feminino , Humanos , Masculino , Fatores de Risco , Fatores Sexuais
11.
Clin Epidemiol ; 15: 1207-1218, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-38126003

RESUMO

Purpose: To report distribution of codes associated with a rheumatoid arthritis (RA) diagnosis recorded in Clinical Practice Research Datalink (CPRD) Aurum compared to the previously validated CPRD GOLD database as a critical step toward making decisions about CPRD Aurum's suitability for medical research. Patients and Methods: We analyzed the distribution of codes for RA diagnoses, labs, and treatments in the new CPRD Aurum database, compared to the CPRD GOLD database by selecting relevant indicators of RA diagnosis, treatment, and clinical care. We included all patients in England in CPRD Aurum and CPRD GOLD with an incident diagnosis code for RA on or after 1 January 2005 and at least two years recorded data before first RA diagnosis. Results: We found 53,083 and 18,167 patients with a new diagnosis code for RA in CPRD Aurum and CPRD GOLD, respectively. In both databases approximately 67% were female with similar mean ages at first diagnosis. There were few differences in RA-related recording patterns between the two data sources. Before first RA diagnosis, CPRD Aurum patients had more RA-specific labs and other supporting clinical codes. After diagnosis, CPRD Aurum patients had more RA diagnoses coded and more often had 10+ general RA labs than patients in CPRD GOLD. More CPRD GOLD patients had 10+ prescriptions for conventional disease-modifying antirheumatic drugs (cDMARD) compared to CPRD Aurum. Otherwise, the distribution of drugs used to treat RA was similar between databases. The standardized incidence of RA was similar between databases. Conclusion: Overall, among patients with a diagnosis code for RA, recording of diagnoses, prescription drugs, and labs were similar between CPRD Aurum and CPRD GOLD. Slight differences were found for a few variables, but overall, we found consistency between the databases. In addition, standardized incidence of RA was similar between databases.

12.
Clin Epidemiol ; 15: 1219-1222, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-38126004

RESUMO

Ongoing evaluation of any electronic health data source is critical to assess suitability for its use in medical research. In addition, familiarity with a data source's history and recording practices is important for making informed data source selection, study design choices, and interpretation of results. In this commentary, the authors discuss three studies that assessed different aspects of the quality and completeness of information contained in Clinical Practice Research Datalink (CPRD) Aurum compared to the well-established CPRD GOLD and to other linked data sources, with the aim to describe insights gained through these data quality assessments. Our findings support the view that CPRD Aurum and GOLD are both valuable tools for studies based on information recorded in primary care but should not be used without critical consideration of strengths and limitations. Further, use of linked data should be considered for some studies, after taking into account all relevant factors.

13.
Clin Epidemiol ; 15: 1193-1206, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-38126002

RESUMO

Purpose: To evaluate the new Clinical Practice Research Datalink (CPRD) Aurum database, we estimated 'correctness' (ie accuracy, validity) and 'completeness' (ie presence, missingness) of malignant breast cancer diagnoses recorded in CPRD Aurum compared to external linked data sources: Hospital Episode Statistics (HES) Admitted Patient Care (APC), HES Outpatient (OP), and Cancer Registry (CR), and to the previously validated CPRD GOLD. Methods: Linkage-eligible, female patients with incident malignant breast cancer diagnosis recorded in at least one study data source were selected. Correctness was the proportion of malignant breast cancer cases recorded in CPRD Aurum or GOLD who also had a diagnosis recorded in HES APC/OP (2004-2019) or CR (2004-2016). Completeness was estimated by identifying all malignant breast cancer diagnoses in HES APC/OP or CR and calculating the proportion with a concordant diagnosis in CPRD Aurum or GOLD. Results: Compared to HES APC/OP, there were 85,659 and 31,452 eligible patients in CPRD Aurum and GOLD, respectively. Correctness estimates were high (CPRD Aurum 83.5%, GOLD 81.7%). Compared to CR, there were 70,190 and 29,597 eligible patients in CPRD Aurum and GOLD, respectively: correctness was 89.1% for CPRD Aurum and 88.2% for GOLD. Completeness estimates for CPRD Aurum and GOLD were high (>90%). Diagnoses were recorded in CPRD Aurum within -7 to 74 days of those in the linked sources. Reasons for discordant diagnostic coding included presence of treatment or other clinical codes only, diagnosis coded after end of follow-up, non-malignant breast cancer in linked data, and administrative codes in lieu of diagnostic codes. Conclusion: These results indicate that correctness and completeness of malignant breast cancer diagnoses in CPRD Aurum were high and similar to CPRD GOLD. This provides confidence in use of CPRD Aurum for research purposes. Where complete case capture is important, researchers should consider linkage to HES APC or CR.

14.
Clin Epidemiol ; 15: 1183-1192, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-38126005

RESUMO

Purpose: To evaluate the presence of data elements related to diagnosis and treatment of malignant breast cancer in CPRD Aurum compared to those in the previously validated CPRD GOLD. Methods: Females in CPRD Aurum or GOLD with a first-time code for malignant breast cancer, mastectomy, or ≥1 prescription for tamoxifen or aromatase inhibitors (2004-2019) were selected. We compared the presence of the codes for breast cancer diagnosis, surgeries (mastectomy, lumpectomy), tamoxifen and aromatase inhibitor prescriptions, radiation, chemotherapy, and supporting clinical codes (suspected breast cancer, lump symptoms, biopsy, lumpectomy, cancer care, referral/visit to specialist, palliative care). Age standardized incidence rates of breast cancer diagnosis in CPRD Aurum and GOLD were calculated. Results: There were 131,936 eligible patients in CPRD Aurum and 69,102 patients in GOLD. A similar proportion of patients in CPRD Aurum and GOLD had codes for breast cancer diagnosis, mastectomy, drug prescriptions, lump, biopsy, lumpectomy, chemotherapy, and cancer and palliative care coded in their electronic record during follow-up. However, suspected breast cancer, radiation, and referral/visits to specialists were coded more frequently in patients in CPRD Aurum compared to GOLD. Age-standardized incidence rates were similar for CPRD Aurum and GOLD. Conclusion: Overall, there was consistency between data elements related to malignant breast cancer recorded in CPRD Aurum and GOLD, particularly for the most informative clinical details. These findings provide reassurance that breast cancer information recorded in CPRD Aurum is generally comparable to that recorded in the previously validated CPRD GOLD and support the use of CPRD Aurum for breast cancer research.

15.
Drug Saf ; 45(11): 1403-1411, 2022 11.
Artigo em Inglês | MEDLINE | ID: mdl-36151359

RESUMO

INTRODUCTION: This real-world safety analysis was requested by the European Medicines Agency following approval of apremilast, an oral treatment for psoriasis or psoriatic arthritis. OBJECTIVE: We aimed to compare incidence rates of adverse events of special interest identified a priori, in patients receiving apremilast with those receiving other systemic treatments for psoriasis or psoriatic arthritis. METHODS: This 5-year cohort study was conducted in Clinical Practice Research Datalink GOLD between January 2015 and June 2020. Incidence rates of adverse events of special interest were estimated for four matched cohorts: apremilast-exposed and three matched non-apremilast cohorts (oral only, injectable only, and oral and injectable psoriasis or psoriatic arthritis treatments). RESULTS: The apremilast-exposed cohort included 341 patients and the three non-apremilast cohorts included 4981 patients. There were no incident cases of vasculitis, hematologic malignancy, non-melanoma skin malignancy, treated depression, treated anxiety, or suicidal behaviors in the apremilast-exposed cohort during the follow-up. Similar incidence rates of all-cause mortality, major adverse cardiac events, tachyarrhythmias, and solid malignancies were recorded in the apremilast and non-apremilast cohorts. The incidence rate (95% confidence interval) per 1000 person-years of opportunistic and serious infections in the apremilast-exposed cohort (64 [40-102])) was similar to incidence rates in the oral (50 [42-60]) and oral and injectable non-apremilast cohorts (57 [47-69]), while the incidence rates were lower in the injectable treatment-only cohort (20 [10-41]). Limitations include small numbers of apremilast-exposed patients and potential exposure misclassification partly owing to missing information on biologic and other specialty treatment use. CONCLUSIONS: No new apremilast safety signals were identified in this study. These results provide evidence that the long-term safety of apremilast in psoriasis and psoriatic arthritis in a real-world setting is comparable to that reported in clinical trials.


Assuntos
Artrite Psoriásica , Produtos Biológicos , Psoríase , Anti-Inflamatórios não Esteroides/efeitos adversos , Artrite Psoriásica/tratamento farmacológico , Produtos Biológicos/uso terapêutico , Estudos de Coortes , Humanos , Psoríase/induzido quimicamente , Psoríase/tratamento farmacológico , Talidomida/análogos & derivados , Reino Unido/epidemiologia
17.
Clin Epidemiol ; 14: 641-652, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35535332

RESUMO

Background: Assessments of strengths and limitations of new data sources are critical for making decisions about suitability for specific research questions. For some studies, it is necessary to capture a drug's indication for use. Objective: To assess the presence of indications for prescription use in Clinical Practice Research Datalink (CPRD) Aurum (January 1988-June 2021) by describing the proportion of men in CPRD Aurum who had a recorded indication for use of prescriptions for 5-alpha reductase inhibitors (5-ARI), alpha blockers (AB), or tadalafil, which have multiple indications. Methods: From a random sample of 154 practices of CPRD Aurum data, we selected 85,597 male patients with a prescription for a 5-ARI, an AB, or tadalafil. Among these patients, we described presence of codes indicating whether the patient had benign prostatic hyperplasia, hypertension, erectile dysfunction, or alopecia using three indication definitions: narrow (specific diagnoses recorded within one year before and up to 90 days after the prescription), broad (specific diagnoses or supporting clinical codes in the time period described above), and widest (diagnoses or supporting codes recorded at any time before the prescription and up to 90 days after the prescription). Results: Using the narrow indication definition limited to diagnoses only, 39,861 (46.6%) patients' records contained an indication for use. The broad definitions, which additionally included supporting codes, captured indications for 62,912 (73.5%) patients and the widest definition, which additionally included supporting codes and all available data before the first prescription date, captured indications for 71,478 (83.5%) patients. Indications were present more often for prescriptions in 2005 and later (85.9%). Conclusion: The findings of this assessment suggest that CPRD Aurum can be used for studies that require information on treatment indications for BPH and potentially for treatments of other chronic diseases managed in the primary care setting.

18.
Acta Crystallogr D Biol Crystallogr ; 67(Pt 3): 167-75, 2011 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-21358047

RESUMO

dUTPases are housekeeping enzymes which catalyse the hydrolysis of dUTP to dUMP in an ion-dependent manner. Bacillus subtilis has both a genomic and an SPß prophage homotrimeric dUTPase. Here, structure determination of the prophage apoenzyme and of its complexes with dUDP and dUpNHpp-Mg(2+) is described at 1.75, 1.9 and 2.55 Šresolution, respectively. The C-terminal extension, which carries the conserved motif V, is disordered in all three structures. Unlike all other trimeric dUTPases for which structures are available, with the exception of the Bacillus genomic enzyme, the aromatic residue covering the uridine and acting as the Phe-lid is close to motif III in the sequence rather than in motif V. This is in spite of the presence of an aromatic amino acid at the usual Phe-lid position in motif V. The alternative position of the Phe-lid requires a reconsideration of its role in the catalytic cycle of the enzyme. In the dUpNHpp-Mg(2+) complex a water can be seen at the position expected for nucleophilic attack on the α-phosphate, in spite of motif V being disordered. Differences in the active site between the free enzyme and the dUDP and dUpNHpp-Mg(2+) complexes shows that the triphosphate moiety needs to be in the gauche conformation to trigger the conformational changes that can be seen in both B. subtilis dUTPases.


Assuntos
Bacillus subtilis/química , Bacillus subtilis/virologia , Nucleotídeos/química , Prófagos/química , Domínios e Motivos de Interação entre Proteínas , Pirofosfatases/química , Sequência de Aminoácidos , Animais , Sequência Conservada , Cristalografia por Raios X , Humanos , Modelos Moleculares , Dados de Sequência Molecular , Nucleotídeos/metabolismo , Prófagos/metabolismo , Ligação Proteica , Estrutura Quaternária de Proteína , Pirofosfatases/metabolismo , Alinhamento de Sequência , Especificidade por Substrato
19.
Int J Nurs Stud Adv ; 3: 100027, 2021 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-38746736

RESUMO

Objectives: The recovery after tonsil surgery is often troublesome for children and caregivers often feel insecure regarding optimal post-operative care for their children at home.The aim was to study what the current literature reports regarding the effect of post-operative telephone counselling and Internet support on pain and recovery after paediatric tonsil surgery. Method: A systematic literature review was conducted where only randomised clinical trials were included. Outcome measures: Primary outcome measure was pain after surgery. Secondary outcomes also included nausea, anxiety, children's knowledge, use of analgesics, fluid intake and health care service use. Results: Only four studies fulfilled the inclusion criteria. The studies were heterogeneous, rendering a meta-analysis impossible. The results of the included studies showed a possible positive effect on postoperative pain, as well as level of anxiety, use of analgesics, fluid intake and health care service use. However, the studies were few with few included participants. Conclusion: There were indications, but no definitive evidence supporting the positive effect of telephone counselling or Internet-based support on pain and recovery after tonsil surgery in children. More research is needed to further examine these effects.ClinicalTrials.gov 12/03/2017 (NCT03292068).

20.
Curr Med Res Opin ; 37(9): 1563-1571, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-34241571

RESUMO

OBJECTIVE: To provide the epidemiology of skin events occurring during long-term administration of medications delivered by continuous subcutaneous infusion pump (CSIP) systems as background rates for the development of novel CSIP treatments to use in community-based settings. METHODS: Using a United Kingdom general practice database, we conducted a study to assess the rates of skin events among new users of apomorphine and insulin delivered by CSIP in patients with Parkinson's disease or diabetes, respectively. Skin events included skin infections, skin nodules/localized swelling, dermatitis/eczema, urticaria/erythema, and rash/other non-specific skin eruptions. RESULTS: Five hundred and fifty-seven adults (age 30+) were included in this descriptive cohort. The median duration of CSIP use was 17 months among 255 apomorphine users and 41 months among 302 insulin users. By 60 months, ∼40% of both cohorts experienced skin events. Repeated skin events occurred in 11% of the apomorphine cohort and 14% of the insulin cohort at any time during follow-up. The overall skin event rate in the apomorphine cohort was 17 per 1000 person-months (PM) and 13 per 1000 PM in the insulin cohort. The most common skin events in both cohorts were infection and rash/unspecified skin eruptions. The highest rates of skin events occurred soon after apomorphine CSIP initiation (36 per 1000 PM in weeks 1-2 and 50 per 1000 PM in weeks 3-4), with lower rates after 4 weeks. Insulin CSIP users' skin event rates were consistent over the treatment duration. CONCLUSIONS: Clinically important skin events are common during long-term administration of medications by CSIP.


Assuntos
Doença de Parkinson , Preparações Farmacêuticas , Adulto , Antiparkinsonianos/uso terapêutico , Apomorfina/uso terapêutico , Humanos , Infusões Subcutâneas , Insulina/uso terapêutico , Sistemas de Infusão de Insulina , Doença de Parkinson/tratamento farmacológico
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