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1.
Int J Equity Health ; 23(1): 34, 2024 Feb 21.
Artículo en Inglés | MEDLINE | ID: mdl-38383380

RESUMEN

BACKGROUND AND AIMS: Sepsis is a serious and life-threatening condition caused by a dysregulated immune response to an infection. Recent guidance issued in the UK gave recommendations around recognition and antibiotic treatment of sepsis, but did not consider factors relating to health inequalities. The aim of this study was to summarise the literature investigating associations between health inequalities and sepsis. METHODS: Searches were conducted in Embase for peer-reviewed articles published since 2010 that included sepsis in combination with one of the following five areas: socioeconomic status, race/ethnicity, community factors, medical needs and pregnancy/maternity. RESULTS: Five searches identified 1,402 studies, with 50 unique studies included in the review after screening (13 sociodemographic, 14 race/ethnicity, 3 community, 3 care/medical needs and 20 pregnancy/maternity; 3 papers examined multiple health inequalities). Most of the studies were conducted in the USA (31/50), with only four studies using UK data (all pregnancy related). Socioeconomic factors associated with increased sepsis incidence included lower socioeconomic status, unemployment and lower education level, although findings were not consistent across studies. For ethnicity, mixed results were reported. Living in a medically underserved area or being resident in a nursing home increased risk of sepsis. Mortality rates after sepsis were found to be higher in people living in rural areas or in those discharged to skilled nursing facilities while associations with ethnicity were mixed. Complications during delivery, caesarean-section delivery, increased deprivation and black and other ethnic minority race were associated with post-partum sepsis. CONCLUSION: There are clear correlations between sepsis morbidity and mortality and the presence of factors associated with health inequalities. To inform local guidance and drive public health measures, there is a need for studies conducted across more diverse setting and countries.


Asunto(s)
Sepsis , Humanos , Factores de Riesgo , Femenino , Embarazo , Factores Socioeconómicos , Etnicidad , Inequidades en Salud , Disparidades en el Estado de Salud
2.
BMC Health Serv Res ; 23(1): 367, 2023 Apr 14.
Artículo en Inglés | MEDLINE | ID: mdl-37060063

RESUMEN

BACKGROUND: Overprescribing of antibiotics is a major concern as it contributes to antimicrobial resistance. Research has found highly variable antibiotic prescribing in (UK) primary care, and to support more effective stewardship, the BRIT Project (Building Rapid Interventions to optimise prescribing) is implementing an eHealth Knowledge Support System. This will provide unique individualised analytics information to clinicians and patients at the point of care. The objective of the current study was to gauge the acceptability of the system to prescribing healthcare professionals and highlight factors to maximise intervention uptake. METHODS: Two mixed-method co-design workshops were held online with primary care prescribing healthcare professionals (n = 16). Usefulness ratings of example features were collected using online polls and online whiteboards. Verbal discussion and textual comments were analysed thematically using inductive (participant-centred) and deductive perspectives (using the Theoretical Framework of Acceptability). RESULTS: Hierarchical thematic coding generated three overarching themes relevant to intervention use and development. Clinician concerns (focal issues) were safe prescribing, accessible information, autonomy, avoiding duplication, technical issues and time. Requirements were ease and efficiency of use, integration of systems, patient-centeredness, personalisation, and training. Important features of the system included extraction of pertinent information from patient records (such as antibiotic prescribing history), recommended actions, personalised treatment, risk indicators and electronic patient communication leaflets. Anticipated acceptability and intention to use the knowledge support system was moderate to high. Time was identified as a focal cost/ burden, but this would be outweighed if the system improved patient outcomes and increased prescribing confidence. CONCLUSION: Clinicians anticipate that an eHealth knowledge support system will be a useful and acceptable way to optimise antibiotic prescribing at the point of care. The mixed method workshop highlighted issues to assist person-centred eHealth intervention development, such as the value of communicating patient outcomes. Important features were identified including the ability to efficiently extract and summarise pertinent information from the patient records, provide explainable and transparent risk information, and personalised information to support patient communication. The Theoretical Framework of Acceptability enabled structured, theoretically sound feedback and creation of a profile to benchmark future evaluations. This may encourage a consistent user-focused approach to guide future eHealth intervention development.


Asunto(s)
Antibacterianos , Personal de Salud , Humanos , Antibacterianos/uso terapéutico , Comunicación , Registros Médicos , Atención Primaria de Salud
3.
Rheumatology (Oxford) ; 61(4): 1448-1458, 2022 04 11.
Artículo en Inglés | MEDLINE | ID: mdl-34255815

RESUMEN

OBJECTIVES: Clinical trials have shown that low-dose glucocorticoid therapy in patients with RA reduces bone loss in hands or hip, but the effect on osteoporotic fractures is not yet clear. Therefore, we investigated the use of low-dose oral glucocorticoids and risk of osteoporotic fractures among patients with RA. METHODS: This was a cohort study including patients with RA aged 50+ years from the Clinical Practice Research Datalink between 1997 and 2017. Exposure to oral glucocorticoids was stratified by the most recent prescription in current (<6 months), recent (7-12 months) and past (>1 year) use, and average daily and cumulative doses. Risk of incident osteoporotic fractures (including hip, vertebrae, humerus, forearm, pelvis and ribs) was estimated by time-dependent Cox proportional-hazards models, adjusted for lifestyle parameters, comorbidities and comedications. Secondary analyses assessed osteoporotic fracture risk with a combination of average daily and cumulative doses of oral glucocorticoids. RESULTS: Among 15 123 patients with RA (mean age 68.8 years, 68% females), 1640 osteoporotic fractures occurred. Current low-dose oral glucocorticoid therapy (≤7.5 mg prednisolone equivalent dose/day) in patients with RA was not associated with overall risk of osteoporotic fractures (adjusted hazard ratio 1.14, 95% CI 0.98, 1.33) compared with past glucocorticoid use, but was associated with an increased risk of clinical vertebral fracture (adjusted hazard ratio 1.59, 95% CI 1.11, 2.29). Results remained unchanged regardless of a short-term or a long-term use of oral glucocorticoids. CONCLUSION: Clinicians should be aware that even in RA patients who receive low daily glucocorticoid doses, the risk of clinical vertebral fracture is increased.


Asunto(s)
Artritis Reumatoide , Fracturas Osteoporóticas , Fracturas de la Columna Vertebral , Anciano , Artritis Reumatoide/inducido químicamente , Artritis Reumatoide/complicaciones , Artritis Reumatoide/tratamiento farmacológico , Estudios de Cohortes , Femenino , Glucocorticoides/uso terapéutico , Humanos , Masculino , Fracturas Osteoporóticas/inducido químicamente , Fracturas Osteoporóticas/epidemiología , Factores de Riesgo , Fracturas de la Columna Vertebral/inducido químicamente , Fracturas de la Columna Vertebral/epidemiología
4.
Br J Clin Pharmacol ; 88(12): 5183-5201, 2022 12.
Artículo en Inglés | MEDLINE | ID: mdl-35701368

RESUMEN

AIM: Pragmatic clinical trials (PCTs) are randomized trials implemented through routine clinical practice, where design parameters of traditional randomized controlled trials are modified to increase generalizability. However, this may introduce statistical challenges. We aimed to identify these challenges and discuss possible solutions leading to best practice recommendations for the design and analysis of PCTs. METHODS: A modified Delphi method was used to reach consensus among a panel of 11 experts in clinical trials and statistics. Statistical issues were identified in a focused literature review and aggregated with insights and possible solutions from experts collected through a series of survey iterations. Issues were ranked according to their importance. RESULTS: Twenty-seven articles were included and combined with experts' insight to generate a list of issues categorized into participants, recruiting sites, randomization, blinding and intervention, outcome (selection and measurement) and data analysis. Consensus was reached about the most important issues: risk of participants' attrition, heterogeneity of "usual care" across sites, absence of blinding, use of a subjective endpoint and data analysis aligned with the trial estimand. Potential issues should be anticipated and preferably be addressed in the trial protocol. The experts provided solutions regarding data collection and data analysis, which were considered of equal importance. DISCUSSION: A set of important statistical issues in PCTs was identified and approaches were suggested to anticipate and/or minimize these through data analysis. Any impact of choosing a pragmatic design feature should be gauged in the light of the trial estimand.


Asunto(s)
Proyectos de Investigación , Humanos , Consenso
5.
Ann Rheum Dis ; 80(4): 423-431, 2021 04.
Artículo en Inglés | MEDLINE | ID: mdl-33310727

RESUMEN

BACKGROUND: Patients with rheumatoid arthritis (RA) commonly use oral glucocorticoids (GCs) and proton pump inhibitors (PPIs), both associated with osteoporotic fractures. We investigated the association between concomitant use of oral GCs and PPIs and the risk of osteoporotic fractures among patients with RA. METHODS: This was a cohort study including patients with RA aged 50+ years from the Clinical Practice Research Datalink between 1997 and 2017. Exposure to oral GCs and PPIs was stratified by the most recent prescription as current use (<6 months), recent use (7-12 months) and past use (>1 year); average daily and cumulative dose; and duration of use. The risk of incident osteoporotic fractures (including hip, vertebrae, humerus, forearm, pelvis and ribs) was estimated by time-dependent Cox proportional-hazards models, statistically adjusted for lifestyle parameters, comorbidities and comedications. RESULTS: Among 12 351 patients with RA (mean age of 68 years, 69% women), 1411 osteoporotic fractures occurred. Concomitant current use of oral GCs and PPIs was associated with a 1.6-fold increased risk of osteoporotic fractures compared with non-use (adjusted HR: 1.60, 95% CI: 1.35 to 1.89). This was statistically different from a 1.2-fold increased osteoporotic fracture risk associated with oral GC or PPI use alone. Most individual fracture sites were significantly associated with concomitant use of oral GCs and PPIs. Among concomitant users, fracture risk did not increase with higher daily dose or duration of PPI use. CONCLUSIONS: There was an interaction in the risk of osteoporotic fractures with concomitant use of oral GCs and PPIs. Fracture risk assessment could be considered when a patient with RA is co-prescribed oral GCs and PPIs.


Asunto(s)
Artritis Reumatoide , Fracturas Osteoporóticas , Anciano , Artritis Reumatoide/complicaciones , Artritis Reumatoide/tratamiento farmacológico , Artritis Reumatoide/epidemiología , Estudios de Cohortes , Femenino , Glucocorticoides/uso terapéutico , Humanos , Masculino , Fracturas Osteoporóticas/inducido químicamente , Fracturas Osteoporóticas/epidemiología , Inhibidores de la Bomba de Protones/efectos adversos , Factores de Riesgo
6.
Pharmacoepidemiol Drug Saf ; 28(2): 179-186, 2019 02.
Artículo en Inglés | MEDLINE | ID: mdl-30264875

RESUMEN

PURPOSE: To quantify misclassification in glucocorticoid (GC) exposure defined using UK primary care prescription data. METHODS: A cross-sectional study including patients with rheumatoid arthritis prescribed oral GCs in the past 2 years. Glucocorticoid exposure based on electronic prescription records was compared with participant-reported GC use captured using a paper diary. Prescription data (containing information about prescriptions issued but no dispensing information) was provided by the Clinical Practice Research Datalink. The following variables were defined: current use and dose of oral GCs and if (and when) participants had received a GC injection. For oral GCs, self-reported use was taken to represent "true" exposure. A dataset representing a hypothetical population was generated to assess the impact of the misclassification found for current use. RESULTS: A total of 67 of 78 study participants (86%) were correctly classified as currently on/off oral GCs; 32/38 (84.2%) participants reporting current GC use and 35/40 (87.5%) participants not reporting current use were correctly classified. Estimated values of current dose were imprecise (correlation coefficient 0.46). Concordance between reported and prescribed GC injections was poor (kappa statistic 0.14). Misclassification bias was demonstrated in the hypothetical population: For "true" relative risks of 1.5, 4, and 9, the "observed" relative risks were 1.33, 2.48, and 3.58, respectively. CONCLUSIONS: Misclassification of current use of oral GCs was low but sufficient to lead to significant bias. Researchers should take care to assess the likely impact of exposure misclassification on their analyses.


Asunto(s)
Exactitud de los Datos , Prescripciones de Medicamentos/estadística & datos numéricos , Prescripción Electrónica/estadística & datos numéricos , Glucocorticoides/administración & dosificación , Atención Primaria de Salud/estadística & datos numéricos , Administración Oral , Anciano , Estudios Transversales , Diarios como Asunto , Relación Dosis-Respuesta a Droga , Inglaterra , Femenino , Glucocorticoides/efectos adversos , Humanos , Masculino , Persona de Mediana Edad , Prednisolona/administración & dosificación , Prednisolona/efectos adversos , Autoinforme/estadística & datos numéricos
7.
BMC Fam Pract ; 20(1): 172, 2019 12 10.
Artículo en Inglés | MEDLINE | ID: mdl-31823739

RESUMEN

BACKGROUND: Antimicrobial resistance (AMR) is high on the UK public health policy agenda, and poses challenges to patient safety and the provision of health services. Widespread prescribing of antibiotics is thought to increase AMR, and mostly takes place in primary medical care. However, prescribing rates vary substantially between general practices. The aim of this study was to understand contextual factors related to general practitioners' (GPs) antibiotic prescribing behaviour in low, high, and around the mean (medium) prescribing primary care practices. METHODS: Qualitative semi-structured interviews were conducted with 41 GPs working in North-West England. Participants were purposively sampled from practices with low, medium, and high antibiotic prescribing rates adjusted for the number and characteristics of patients registered in a practice. The interviews were analysed thematically. RESULTS: This study found that optimizing antibiotic prescribing creates tensions for GPs, particularly in doctor-patient communication during a consultation. GPs balanced patient expectations and their own decision-making in their communication. When not prescribing antibiotics, GPs reported the need for supportive mechanisms, such as regular practice meetings, within the practice, and in the wider healthcare system (e.g. longer consultation times). In low prescribing practices, GPs reported that increasing dialogue with colleagues, having consistent patterns of prescribing within the practice, supportive practice policies, and enough resources such as consultation time were important supports when not prescribing antibiotics. CONCLUSIONS: Insight into GPs' negotiations with patient and public health demands, and consistent and supportive practice-level policies can help support prudent antibiotic prescribing among primary care practices.


Asunto(s)
Antibacterianos/uso terapéutico , Toma de Decisiones Conjunta , Médicos Generales/psicología , Negociación , Relaciones Médico-Paciente , Pautas de la Práctica en Medicina , Inglaterra , Femenino , Humanos , Entrevistas como Asunto , Masculino , Investigación Cualitativa
9.
Pharmacoepidemiol Drug Saf ; 27(2): 239-242, 2018 02.
Artículo en Inglés | MEDLINE | ID: mdl-28924986

RESUMEN

PURPOSE: To describe a novel observational study that supplemented primary care electronic health record (EHR) data with sample collection and patient diaries. METHODS: The study was set in primary care in England. A list of 3974 potentially eligible patients was compiled using data from the Clinical Practice Research Datalink. Interested general practices opted into the study then confirmed patient suitability and sent out postal invitations. Participants completed a drug-use diary and provided saliva samples to the research team to combine with EHR data. RESULTS: Of 252 practices contacted to participate, 66 (26%) mailed invitations to patients. Of the 3974 potentially eligible patients, 859 (22%) were at participating practices, and 526 (13%) were sent invitations. Of those invited, 117 (22%) consented to participate of whom 86 (74%) completed the study. CONCLUSIONS: We have confirmed the feasibility of supplementing EHR with data collected directly from patients. Although the present study successfully collected essential data from patients, it also underlined the requirement for improved engagement with both patients and general practitioners to support similar studies.


Asunto(s)
Bases de Datos Factuales , Registros Electrónicos de Salud/organización & administración , Participación del Paciente/métodos , Atención Primaria de Salud/organización & administración , Corticoesteroides/análisis , Insuficiencia Suprarrenal/inducido químicamente , Insuficiencia Suprarrenal/diagnóstico , Insuficiencia Suprarrenal/epidemiología , Artritis Reumatoide/tratamiento farmacológico , Diarios como Asunto , Inglaterra , Estudios de Factibilidad , Glucocorticoides/efectos adversos , Humanos , Saliva/química
10.
Pharmacoepidemiol Drug Saf ; 27(7): 781-788, 2018 07.
Artículo en Inglés | MEDLINE | ID: mdl-29667263

RESUMEN

PURPOSE: Real-world data for observational research commonly require formatting and cleaning prior to analysis. Data preparation steps are rarely reported adequately and are likely to vary between research groups. Variation in methodology could potentially affect study outcomes. This study aimed to develop a framework to define and document drug data preparation and to examine the impact of different assumptions on results. METHODS: An algorithm for processing prescription data was developed and tested using data from the Clinical Practice Research Datalink (CPRD). The impact of varying assumptions was examined by estimating the association between 2 exemplar medications (oral hypoglycaemic drugs and glucocorticoids) and cardiovascular events after preparing multiple datasets derived from the same source prescription data. Each dataset was analysed using Cox proportional hazards modelling. RESULTS: The algorithm included 10 decision nodes and 54 possible unique assumptions. Over 11 000 possible pathways through the algorithm were identified. In both exemplar studies, similar hazard ratios and standard errors were found for the majority of pathways; however, certain assumptions had a greater influence on results. For example, in the hypoglycaemic analysis, choosing a different variable to define prescription end date altered the hazard ratios (95% confidence intervals) from 1.77 (1.56-2.00) to 2.83 (1.59-5.04). CONCLUSIONS: The framework offers a transparent and efficient way to perform and report drug data preparation steps. Assumptions made during data preparation can impact the results of analyses. Improving transparency regarding drug data preparation would increase the repeatability, reproducibility, and comparability of published results.


Asunto(s)
Glucocorticoides/efectos adversos , Glucocorticoides/uso terapéutico , Hipoglucemiantes/efectos adversos , Hipoglucemiantes/uso terapéutico , Farmacoepidemiología/métodos , Algoritmos , Artritis Reumatoide/tratamiento farmacológico , Enfermedades Cardiovasculares/inducido químicamente , Interpretación Estadística de Datos , Bases de Datos Factuales , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Humanos , Reproducibilidad de los Resultados , Proyectos de Investigación , Factores de Riesgo
11.
J Antimicrob Chemother ; 72(9): 2636-2646, 2017 09 01.
Artículo en Inglés | MEDLINE | ID: mdl-28859440

RESUMEN

Background: Flucloxacillin is an established cause of liver injury. Despite this, there are a lack of published data on both the strength of association after adjusting for potential confounders, and the absolute incidence among different subgroups of patients. Objectives: To assess the relative and absolute risks of liver injury following exposure to flucloxacillin and identify subgroups at potentially increased risk. Methods: A cohort study between 1 January 2000 and 1 January 2012 using the UK Clinical Practice Research Datalink, including 1 046 699 people with a first prescription for flucloxacillin (861 962) or oxytetracycline (184 737). Absolute risks of experiencing both symptom-defined (jaundice) and laboratory-confirmed liver injury within 1-45 and 46-90 days of antibiotic initiation were estimated. Multivariable logistic regression was used to estimate 1-45 day relative effects. Results: There were 183 symptom-defined cases (160 prescribed flucloxacillin) and 108 laboratory-confirmed cases (102 flucloxacillin). The 1-45 day adjusted risk ratio for laboratory-confirmed injury was 5.22 (95% CI 1.64-16.62) comparing flucloxacillin with oxytetracycline use. The 1-45 day risk of laboratory-confirmed liver injury was 8.47 per 100 000 people prescribed flucloxacillin (95% CI 6.64-10.65). People who received consecutive flucloxacillin prescriptions had a 1-45 day risk of jaundice of 39.00 per 100 000 (95% CI 26.85-54.77), while those aged >70 receiving consecutive prescriptions had a risk of 110.57 per 100 000 (95% CI 70.86-164.48). Conclusions: The short-term risk of laboratory-confirmed liver injury was >5-fold higher after a flucloxacillin prescription than an oxytetracycline prescription. The risk of flucloxacillin-induced liver injury is particularly high within those aged >70 and those who receive multiple flucloxacillin prescriptions. The stratified risk estimates from this study could help guide clinical care.


Asunto(s)
Antibacterianos/efectos adversos , Enfermedad Hepática Inducida por Sustancias y Drogas/epidemiología , Floxacilina/efectos adversos , Hígado/efectos de los fármacos , Adulto , Factores de Edad , Anciano , Antibacterianos/administración & dosificación , Antibacterianos/uso terapéutico , Estudios de Cohortes , Femenino , Floxacilina/administración & dosificación , Floxacilina/uso terapéutico , Humanos , Incidencia , Hígado/patología , Masculino , Persona de Mediana Edad , Vigilancia de la Población , Prescripciones , Factores de Riesgo , Reino Unido/epidemiología
12.
Ann Rheum Dis ; 76(10): 1723-1730, 2017 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-28684558

RESUMEN

OBJECTIVES: To examine the association between the use of statins and the risk of systemic lupus erythematosus (SLE) with focus on describing the patterns of risks over time. SETTING: A population-based cohort study using the UK Clinical Practice Research Datalink. PARTICIPANTS: All patients aged 40 years or older who had at least one prescription of statins during the period 1995-2009 were selected and matched by age, sex, practice and date of first prescription to non-users. The follow-up period of statin users was divided into periods of current, recent and past exposure, with patients moving among these three exposure categories over time. Current statin users were also stratified into ≤1 year or >1 year of use. MAIN OUTCOME MEASURES: Time-dependent Cox models were used to calculate HRs of SLE, adjusted for disease history and previous drug exposure. RESULTS: We included 1 039 694 patients, of whom 519 847 were statin users. Current statin users did not have an increased risk of developing SLE among patients aged ≥40 years (HRadjusted 0.75, 95% CI 0.53 to 1.07). Current statin users who continued the therapy for >1 year had a 38% lower risk of developing SLE (HRadjusted 0.62, 95% CI 0.42 to 0.93). When more specific definitions for SLE were used, this latter finding, however, was not observed. CONCLUSIONS: Our findings showed no effect of statins on the risk of developing SLE among patients aged ≥40 years. Further research is needed to study the long-term effects of statins on SLE.


Asunto(s)
Inhibidores de Hidroximetilglutaril-CoA Reductasas/uso terapéutico , Lupus Eritematoso Sistémico/epidemiología , Adulto , Anciano , Anciano de 80 o más Años , Estudios de Casos y Controles , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Modelos de Riesgos Proporcionales , Estudios Prospectivos , Factores de Riesgo , Reino Unido/epidemiología
13.
Am J Epidemiol ; 184(1): 58-66, 2016 Jul 01.
Artículo en Inglés | MEDLINE | ID: mdl-27317693

RESUMEN

Previous observational studies on statins have shown variable results based on the methodology used. Our objective was to study the association between statins and orthopedic implant failure and to explore the influence of methodological differences in study design. Our study base consisted of patients with a primary total joint replacement in Denmark and the United Kingdom (n = 189,286; 1987-2012). We used 4 study designs: 1) case-control (each patient with revision surgery matched to 4 controls), 2) time-dependent cohort (postoperative statin use as a time-varying exposure variable), 3) immortal time cohort (misclassifying the time postoperatively before statin use), and 4) time-exclusion cohort (excluding the time postoperatively before statin use). Cox proportional hazards models and logistic regression were used to estimate incidence rate ratios. In the time-dependent cohort design, statin use was associated with a decreased risk of revision surgery (adjusted incidence rate ratio (IRR) = 0.90, 95% confidence interval (CI): 0.85, 0.96), which was similar to our case-control results (IRR = 0.87, 95% CI: 0.81, 0.93). In contrast, both time-fixed cohort designs yielded substantially lower risk estimates (IRR = 0.36 (95% CI: 0.34, 0.38) and IRR = 0.65 (95% CI: 0.63, 0.68), respectively). We discourage the use of time-fixed cohort studies, which may falsely suggest protective effects. The simple choice of how to classify exposure can substantially change results from biologically plausible to implausible.


Asunto(s)
Prótesis de Cadera , Inhibidores de Hidroximetilglutaril-CoA Reductasas/uso terapéutico , Prótesis de la Rodilla , Extremidad Inferior/cirugía , Falla de Prótesis , Reoperación , Adulto , Anciano , Estudios de Casos y Controles , Estudios de Cohortes , Factores de Confusión Epidemiológicos , Dinamarca , Femenino , Humanos , Modelos Logísticos , Masculino , Persona de Mediana Edad , Modelos de Riesgos Proporcionales , Medición de Riesgo , Reino Unido
14.
Calcif Tissue Int ; 99(3): 243-9, 2016 09.
Artículo en Inglés | MEDLINE | ID: mdl-27099132

RESUMEN

We aimed to characterize incident users of alendronate from Denmark and Spain, and investigate their eligibility for participation in the pivotal Fracture Intervention Trial (FIT). This is an international cross-sectional study, where the data were obtained from the SIDIAP database (Sistema d'Informació per al Desenvolupament de l'Investigació en Atenció Primària) from Catalonia (Spain) and the Danish Health Registries (DHR). This study included patients who were incident users of alendronate, ≥40 years old with no history of Paget's disease. Our measurements were the proportion of incident users of alendronate who were not eligible to participate in FIT. 14,316 and 21,221 subjects initiated alendronate in 2006-2007 (SIDIAP) and 2005-2006 (DHR), respectively. SIDIAP and DHR alendronate user cohorts had 2347 (16.4 %) and 5275 (24.9 %) subjects aged >80 years old, reported 9 (0.1 %) and 91 (0.4 %) diagnoses of myocardial infarction, 423 (3 %) and 368 (1.7 %) of erosive gastro-intestinal disease, 200 (1.4 %) and 1109 (5.2 %) of dyspepsia, and 349 (2.4 %) and 149 (0.7 %) of metabolic bone disease, all of which were exclusion criteria in FIT. Men [3818 (26.7 %) in SIDIAP and 3885 (18.3 %) in DHR] and glucocorticoid users [1229 (8.6 %) in SIDIAP and 4716 (22.2 %) in DHR] were also excluded from the FIT trial. Overall, 3447 (35.4 %) SIDIAP and 6228 (44.5 %) (when not considering men and glucocorticoid users) DHR of incident alendronate users would have been excluded from FIT. One in two real-life users of alendronate exhibited one or more clinical characteristics that would have led to them being excluded from the FIT trial.


Asunto(s)
Alendronato/efectos adversos , Índice de Masa Corporal , Fracturas Óseas/etiología , Glucocorticoides/efectos adversos , Adulto , Anciano de 80 o más Años , Alendronato/administración & dosificación , Estudios de Cohortes , Estudios Transversales , Femenino , Glucocorticoides/administración & dosificación , Humanos , Masculino , Persona de Mediana Edad , Selección de Paciente , Ensayos Clínicos Controlados Aleatorios como Asunto
15.
Acta Oncol ; 55(7): 851-8, 2016 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-27150973

RESUMEN

BACKGROUND: This study was aimed to assess the risk of breast cancer associated with exposure to insulin glargine in women with type 2 diabetes and evaluate whether the pattern of risk concurs with the hypothesized trend of an increase in risk with longer duration of use, taking into account previous cumulative exposure to other types of insulin. METHODS: We performed a restrospective cohort study (2002-2013) in the Clinical Practice Research Datalink among adult female patients with a first ever insulin prescription (n = 12 468). Time-dependent exposure measures were used to assess associations with duration of use of: (1) other insulin types before glargine was first prescribed (i.e. among switchers); and (2) of glargine during follow-up. Analyses were performed separately for insulin-naïve glargine users and patients switched to glargine. Cox proportional hazards models were used to derive p-trends, hazard ratios (HR) and 95% confidence intervals (CI) for breast cancer associated with glargine use. RESULTS: During 66 151 person years, 186 breast cancer cases occurred; 76 in glargine users (3.0/1000 years) and 110 in users of other insulins (2.7/1000 years). Among insulin-naïve women, no association with cumulative glargine use was observed (p-trend = 0.91), even after ≥5 years (HR = 1.06, 95% CI 0.48-2.33). Among switchers, a linear trend with years of prior exposure to other insulins was found (p-trend = 0.02). An increased risk was observed in glargine users with extensive (>3 years) past exposure to other insulins (HR = 3.17, 95% CI 1.28-7.84). A non-significant trend with cumulative glargine exposure was found among switchers (p-trend = 0.24). CONCLUSIONS: Exposure to glargine was not associated with an increased breast cancer risk in insulin-naïve patients. Exposure to other insulins prior to the start of glargine appears to be relevant when studying breast cancer risk associated with glargine use.


Asunto(s)
Neoplasias de la Mama/inducido químicamente , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Hipoglucemiantes/efectos adversos , Insulina Glargina/efectos adversos , Adulto , Anciano , Anciano de 80 o más Años , Neoplasias de la Mama/epidemiología , Estudios de Cohortes , Femenino , Estudios de Seguimiento , Humanos , Persona de Mediana Edad , Modelos de Riesgos Proporcionales , Estudios Retrospectivos , Factores de Riesgo , Reino Unido/epidemiología
16.
Pharmacoepidemiol Drug Saf ; 25 Suppl 1: 88-102, 2016 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-27038355

RESUMEN

PURPOSE: Results from observational studies on the same exposure-outcome association may be inconsistent because of variations in methodological factors, clinical factors or health care systems. We evaluated the consistency of results assessing the association between antidepressant use and the risk of hip/femur fractures in three European primary care databases using two different study designs. METHODS: Cohort and nested case control studies were conducted in three European primary care databases (Spanish BIFAP, Dutch Mondriaan and UK THIN) to assess the association between use of antidepressants and hip/femur fracture. A common protocol and statistical analysis plan was applied to harmonize study design and conduct between data sources. RESULTS: Current use of antidepressants was consistently associated with a 1.5 to 2.5-fold increased risk of hip/femur fractures in all data sources with both designs, with estimates for SSRIs generally higher than those for TCAs. In general, risk estimates in Mondriaan, the smallest data source, were higher compared to the other data sources. This difference may be partially explained by an interaction between SSRI and age in Mondriaan. Adjustment for GP-recorded lifestyle factors and matching on general practice had negligible impact on adjusted relative risk estimates. CONCLUSION: We found a consistent increased risk of hip/femur fracture with current use of antidepressants across different databases and different designs. Applying similar pharmacoepidemiological study methods resulted in similar risks for TCA use and some variation for SSRI use. Some of these differences may express real (or natural) variance in the exposure-outcome co-occurrences.


Asunto(s)
Antidepresivos/efectos adversos , Fracturas de Cadera/etiología , Farmacoepidemiología/normas , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Estudios de Casos y Controles , Femenino , Fémur/lesiones , Humanos , Masculino , Persona de Mediana Edad , Estudios Observacionales como Asunto , Farmacoepidemiología/estadística & datos numéricos , Factores de Riesgo
17.
Pharmacoepidemiol Drug Saf ; 24(5): 468-77, 2015 May.
Artículo en Inglés | MEDLINE | ID: mdl-25410590

RESUMEN

PURPOSE: Prior event rate ratio (PERR) adjustment method has been proposed to control for unmeasured confounding. We aimed to assess the performance of the PERR method in realistic pharmacoepidemiological settings. METHODS: Simulation studies were performed with varying effects of prior events on the probability of subsequent exposure and post-events, incidence rates, effects of confounders, and rate of mortality/dropout. Exposure effects were estimated using conventional rate ratio (RR) and PERR adjustment method (i.e. ratio of RR post-exposure initiation and RR prior to initiation of exposure). RESULTS: In the presence of unmeasured confounding, both conventional and the PERR method may yield biased estimates, but PERR estimates appear generally less biased estimates than the conventional method. However, when prior events strongly influence the probability of subsequent exposure, the exposure effect from the PERR method was more biased than the conventional method. For instance, when the effect of prior events on the exposure was RR = 1.60, the effect estimate from the PERR method was RR = 1.13 and from the conventional method was RR = 2.48 (true exposure effect, RR = 2). In all settings, the variation of the estimates was larger for the PERR method than for the conventional method. CONCLUSION: The PERR adjustment method can be applied to reduce bias as a result of unmeasured confounding. However, only in particular situations, it can completely remove the bias as a result of unmeasured confounding. When applying this method, theoretical justification using available clinical knowledge for assumptions of the PERR method should be provided.


Asunto(s)
Sistemas de Registro de Reacción Adversa a Medicamentos/estadística & datos numéricos , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Modelos Teóricos , Farmacoepidemiología/métodos , Sesgo , Simulación por Computador , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/etiología , Humanos , Método de Montecarlo , Farmacoepidemiología/estadística & datos numéricos
18.
Stroke ; 45(7): 2066-71, 2014 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-24903985

RESUMEN

BACKGROUND AND PURPOSE: The aim of this study was to evaluate whether the remote introduction of electronic decision support tools into family practices improves risk factor control after first stroke. This study also aimed to develop methods to implement cluster randomized trials in stroke using electronic health records. METHODS: Family practices were recruited from the UK Clinical Practice Research Datalink and allocated to intervention and control trial arms by minimization. Remotely installed, electronic decision support tools promoted intensified secondary prevention for 12 months with last measure of systolic blood pressure as the primary outcome. Outcome data from electronic health records were analyzed using marginal models. RESULTS: There were 106 Clinical Practice Research Datalink family practices allocated (intervention, 53; control, 53), with 11 391 (control, 5516; intervention, 5875) participants with acute stroke ever diagnosed. Participants at trial practices had similar characteristics as 47,887 patients with stroke at nontrial practices. During the intervention period, blood pressure values were recorded in the electronic health records for 90% and cholesterol values for 84% of participants. After intervention, the latest mean systolic blood pressure was 131.7 (SD, 16.8) mm Hg in the control trial arm and 131.4 (16.7) mm Hg in the intervention trial arm, and adjusted mean difference was -0.56 mm Hg (95% confidence interval, -1.38 to 0.26; P=0.183). The financial cost of the trial was approximately US $22 per participant, or US $2400 per family practice allocated. CONCLUSIONS: Large pragmatic intervention studies may be implemented at low cost by using electronic health records. The intervention used in this trial was not found to be effective, and further research is needed to develop more effective intervention strategies. CLINICAL TRIAL REGISTRATION URL: http://www.controlled-trials.com. Current Controlled Trials identifier: ISRCTN35701810.


Asunto(s)
Registros Electrónicos de Salud , Evaluación de Resultado en la Atención de Salud , Ensayos Clínicos Controlados Aleatorios como Asunto , Accidente Cerebrovascular/prevención & control , Anciano , Anciano de 80 o más Años , Registros Electrónicos de Salud/estadística & datos numéricos , Medicina Familiar y Comunitaria/estadística & datos numéricos , Femenino , Humanos , Masculino , Evaluación de Resultado en la Atención de Salud/estadística & datos numéricos , Ensayos Clínicos Controlados Aleatorios como Asunto/economía , Ensayos Clínicos Controlados Aleatorios como Asunto/normas , Ensayos Clínicos Controlados Aleatorios como Asunto/estadística & datos numéricos , Accidente Cerebrovascular/economía , Accidente Cerebrovascular/fisiopatología , Accidente Cerebrovascular/terapia , Reino Unido
20.
Br J Clin Pharmacol ; 78(3): 649-59, 2014 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-24602118

RESUMEN

AIM: The aim was to evaluate clinical risk factors associated with myotoxicity in statin users. METHODS: This was a cohort study of patients prescribed a statin in UK primary care practices contributing to the Clinical Practice Research Datalink. Outcomes of interest were creatine phosphokinase (CPK) concentrations and clinical records of rhabdomyolysis. RESULTS: The cohort comprised 641,703 statin users. Simvastatin was most frequently prescribed (66.3%), followed by atorvastatin (24.4%). CPK was measured in 127,209 patients: 81.4% within normal range and 0.7% above four times ULN CPK compared with normal CPK (OR 1.28, 95% CI 1.01, 1.60). Rosuvastatin users had higher risk of >four times ULN CPK (OR 1.62, 95% CI 1.22, 2.15) as did patients with larger daily doses of other statin types. A recent clinical record of myalgia was associated with an increased OR of >four times ULN CPK (OR 1.73, 95% CI 1.37, 2.18). In patients who were rechallenged to statins and had repeat CPK measurements after >four times ULN CPK abnormalities, 54.8% of the repeat CPK values were within normal range, 32.1% between one to three times and 13.0% >four times ULN. CONCLUSIONS: The frequencies of substantive CPK increases and rhabdomyolysis during statin treatment were low, with highest risks seen in those on large daily doses or interacting drugs and on rosuvastatin. CPK measurements appeared to have been done in a haphazard manner and better guidance is needed.


Asunto(s)
Creatina Quinasa/metabolismo , Fluorobencenos/efectos adversos , Inhibidores de Hidroximetilglutaril-CoA Reductasas/efectos adversos , Pirimidinas/efectos adversos , Rabdomiólisis/inducido químicamente , Sulfonamidas/efectos adversos , Anciano , Anciano de 80 o más Años , Estudios de Cohortes , Citocromo P-450 CYP3A/efectos de los fármacos , Citocromo P-450 CYP3A/metabolismo , Bases de Datos Factuales , Relación Dosis-Respuesta a Droga , Interacciones Farmacológicas , Femenino , Fluorobencenos/administración & dosificación , Humanos , Inhibidores de Hidroximetilglutaril-CoA Reductasas/administración & dosificación , Masculino , Persona de Mediana Edad , Atención Primaria de Salud , Pirimidinas/administración & dosificación , Rabdomiólisis/epidemiología , Factores de Riesgo , Rosuvastatina Cálcica , Sulfonamidas/administración & dosificación , Reino Unido/epidemiología
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