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1.
Front Pharmacol ; 13: 814198, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35559254

RESUMO

Objective: Background incidence rates are routinely used in safety studies to evaluate an association of an exposure and outcome. Systematic research on sensitivity of rates to the choice of the study parameters is lacking. Materials and Methods: We used 12 data sources to systematically examine the influence of age, race, sex, database, time-at-risk, season and year, prior observation and clean window on incidence rates using 15 adverse events of special interest for COVID-19 vaccines as an example. For binary comparisons we calculated incidence rate ratios and performed random-effect meta-analysis. Results: We observed a wide variation of background rates that goes well beyond age and database effects previously observed. While rates vary up to a factor of 1,000 across age groups, even after adjusting for age and sex, the study showed residual bias due to the other parameters. Rates were highly influenced by the choice of anchoring (e.g., health visit, vaccination, or arbitrary date) for the time-at-risk start. Anchoring on a healthcare encounter yielded higher incidence comparing to a random date, especially for short time-at-risk. Incidence rates were highly influenced by the choice of the database (varying by up to a factor of 100), clean window choice and time-at-risk duration, and less so by secular or seasonal trends. Conclusion: Comparing background to observed rates requires appropriate adjustment and careful time-at-risk start and duration choice. Results should be interpreted in the context of study parameter choices.

2.
Lancet Infect Dis ; 2022 May 13.
Artigo em Inglês | MEDLINE | ID: mdl-35576963

RESUMO

BACKGROUND: There are few data on the incidence of thrombosis among COVID-19 cases, with most research concentrated on hospitalised patients. We aimed to estimate the incidence of venous thromboembolism, arterial thromboembolism, and death among COVID-19 cases and to assess the impact of these events on the risks of hospitalisation and death. METHODS: We conducted a distributed network cohort study using primary care records from the Netherlands, Italy, Spain, and the UK, and outpatient specialist records from Germany. The Spanish database was linked to hospital admissions. Participants were followed up from the date of a diagnosis of COVID-19 or positive RT-PCR test for SARS-CoV-2 (index date) for 90 days. The primary study outcomes were venous thromboembolic events, arterial thromboembolic events, and death, all over the 90 days from the index date. We estimated cumulative incidences for the study outcomes. Multistate models were used to calculate adjusted hazard ratios (HRs) for the association between venous thromboembolism or arterial thromboembolism occurrence and risks of hospitalisation or COVID-19 fatality. FINDINGS: Overall, 909 473 COVID-19 cases and 32 329 patients hospitalised with COVID-19 on or after Sept 1, 2020, were studied. The latest index dates across the databases ranged from Jan 30, 2021, to July 31, 2021. Cumulative 90-day incidence of venous thromboembolism ranged from 0·2% to 0·8% among COVID-19 cases, and up to 4·5% for those hospitalised. For arterial thromboembolism, estimates ranged from 0·1% to 0·8% among COVID-19 cases, increasing to 3·1% among those hospitalised. Case fatality ranged from 1·1% to 2·0% among patients with COVID-19, rising to 14·6% for hospitalised patients. The occurrence of venous thromboembolism in patients with COVID-19 was associated with an increased risk of death (adjusted HRs 4·42 [3·07-6·36] for those not hospitalised and 1·63 [1·39-1·90] for those hospitalised), as was the occurrence of arterial thromboembolism (3·16 [2·65-3·75] and 1·93 [1·57-2·37]). INTERPRETATION: Risks of venous thromboembolism and arterial thromboembolism were up to 1% among COVID-19 cases, and increased with age, among males, and in those who were hospitalised. Their occurrence was associated with excess mortality, underlying the importance of developing effective treatment strategies that reduce their frequency. FUNDING: European Medicines Agency.

3.
J Bone Miner Res ; 2022 May 17.
Artigo em Inglês | MEDLINE | ID: mdl-35579494

RESUMO

While oral bisphosphonates (BP) are commonly used, there is conflicting evidence for their safety in the elderly. Safety concerns might trump BP use in older patients with complex health needs. Our study evaluated the safety of BP, focussing on severe acute kidney injury (AKI), gastrointestinal ulcer (GI ulcer), osteonecrosis of the jaw (ONJ) and femur fractures. We used UK primary care data (CPRD GOLD), linked to hospital (HES inpatient) and ONS mortality data. We included all patients aged >65 with complex health needs and no BP use in the year before study start (01/01/2010). Complex health needs were defined in three cohorts: an electronic frailty index score ≥3 (frailty cohort), ≥1 unplanned hospitalisation/s (hospitalisation cohort); and prescription of ≥10 different medicines in 2009 (polypharmacy cohort). Incidence rates were calculated for all outcomes. Subsequently, all individuals who experienced AKI or GI ulcer anytime during follow-up were included for Self-Controlled Case Series (SCCS) analyses. Incidence rate ratios (IRR) were estimated separately for AKI and GI ulcer, comparing event rates between BP-exposed and unexposed time windows. No SCCS were conducted for ONJ and femur fractures. We identified 94,364 individuals in the frailty cohort, as well as 78,184 and 95,621 persons in the hospitalisation and polypharmacy cohorts. Of those, 3,023, 1,950 and 2,992 individuals experienced AKI and 1,403, 1,019 and 1,453 had GI ulcer/s during follow-up, respectively. Age-adjusted SCCS models found evidence of increased risk of AKI associated with BP use (frailty cohort: IRR 1.65 [95%CI 1.25-2.19]), but no association with GI ulcers (frailty cohort: IRR 1.24 [95%CI 0.86-1.78]). Similar results were obtained for the hospitalisation and polypharmacy cohorts. Our study found a 50-65% increased risk of AKI associated with BP use in elderly patients with complex health needs. Future studies should further investigate the risk-benefit of BP use in these patients. This article is protected by copyright. All rights reserved.

4.
Drug Saf ; 45(5): 493-510, 2022 May.
Artigo em Inglês | MEDLINE | ID: mdl-35579813

RESUMO

Increasing availability of electronic health databases capturing real-world experiences with medical products has garnered much interest in their use for pharmacoepidemiologic and pharmacovigilance studies. The traditional practice of having numerous groups use single databases to accomplish similar tasks and address common questions about medical products can be made more efficient through well-coordinated multi-database studies, greatly facilitated through distributed data network (DDN) architectures. Access to larger amounts of electronic health data within DDNs has created a growing interest in using data-adaptive machine learning (ML) techniques that can automatically model complex associations in high-dimensional data with minimal human guidance. However, the siloed storage and diverse nature of the databases in DDNs create unique challenges for using ML. In this paper, we discuss opportunities, challenges, and considerations for applying ML in DDNs for pharmacoepidemiologic and pharmacovigilance studies. We first discuss major types of activities performed by DDNs and how ML may be used. Next, we discuss practical data-related factors influencing how DDNs work in practice. We then combine these discussions and jointly consider how opportunities for ML are affected by practical data-related factors for DDNs, leading to several challenges. We present different approaches for addressing these challenges and highlight efforts that real-world DDNs have taken or are currently taking to help mitigate them. Despite these challenges, the time is ripe for the emerging interest to use ML in DDNs, and the utility of these data-adaptive modeling techniques in pharmacoepidemiologic and pharmacovigilance studies will likely continue to increase in the coming years.

5.
BMJ Open ; 12(4): e052816, 2022 Apr 06.
Artigo em Inglês | MEDLINE | ID: mdl-35387809

RESUMO

INTRODUCTION: Osteoarthritis (OA) is one of the leading chronic conditions in the older population. People with OA are more likely to have one or more other chronic conditions than those without. However, the temporal associations, clusters of the comorbidities, role of analgesics and the causality and variation between populations are yet to be investigated. This paper describes the protocol of a multinational study in four European countries (UK, Netherlands, Sweden and Spain) exploring comorbidities in people with OA. METHODS AND ANALYSIS: This multinational study will investigate (1) the temporal associations of 61 identified comorbidities with OA, (2) the clusters and trajectories of comorbidities in people with OA, (3) the role of analgesics on incidence of comorbidities in people with OA, (4) the potential biomarkers and causality between OA and the comorbidities, and (5) variations between countries.A combined case-control and cohort study will be conducted to find the temporal association of OA with the comorbidities using the national or regional health databases. Latent class analysis will be performed to identify the clusters at baseline and joint latent class analysis will be used to examine trajectories during the follow-up. A cohort study will be undertaken to evaluate the role of non-steroidal anti-inflammatory drugs (NSAIDs), opioids and paracetamol on the incidence of comorbidities. Mendelian randomisation will be performed to investigate the potential biomarkers for causality between OA and the comorbidities using the UK Biobank and the Rotterdam Study databases. Finally, a meta-analyses will be used to examine the variations and pool the results from different countries. ETHICS AND DISSEMINATION: Research ethics was obtained according to each database requirement. Results will be disseminated through the FOREUM website, scientific meetings, publications and in partnership with patient organisations.


Assuntos
Osteoartrite do Joelho , Osteoartrite , Analgésicos , Estudos de Casos e Controles , Estudos de Coortes , Estudos Transversais , Registros Eletrônicos de Saúde , Humanos , Osteoartrite/epidemiologia , Osteoartrite do Joelho/epidemiologia
6.
Nat Commun ; 13(1): 1639, 2022 03 23.
Artigo em Inglês | MEDLINE | ID: mdl-35322045

RESUMO

Small trials have suggested that heterologous vaccination with first-dose ChAdOx1 and second-dose BNT162b2 may generate a better immune response than homologous vaccination with two doses of ChAdOx1. In this cohort analysis, we use linked data from Catalonia (Spain), where those aged <60 who received a first dose of ChAdOx1 could choose between ChAdOx1 and BNT162b2 for their second dose. Comparable cohorts were obtained after exact-matching 14,325/17,849 (80.3%) people receiving heterologous vaccination to 14,325/149,386 (9.6%) receiving homologous vaccination by age, sex, region, and date of second dose. Of these, 464 (3.2%) in the heterologous and 694 (4.8%) in the homologous groups developed COVID-19 between 1st June 2021 and 5th December 2021. The resulting hazard ratio (95% confidence interval) is 0.66 [0.59-0.74], favouring heterologous vaccination. The two groups had similar testing rates and safety outcomes. Sensitivity and negative control outcome analyses confirm these findings. In conclusion, we demonstrate that a heterologous vaccination schedule with ChAdOx1 followed by BNT162b2 was more efficacious than and similarly safe to homologous vaccination with two doses of ChAdOx1. Most of the infections in our study occurred when Delta was the predominant SARS-CoV-2 variant in Spain. These data agree with previous phase 2 randomised trials.


Assuntos
COVID-19 , SARS-CoV-2 , Idoso , /uso terapêutico , COVID-19/epidemiologia , COVID-19/prevenção & controle , /uso terapêutico , Humanos , Vacinação/efeitos adversos , Vacinação/métodos
7.
BMJ ; 376: e068373, 2022 03 16.
Artigo em Inglês | MEDLINE | ID: mdl-35296468

RESUMO

OBJECTIVE: To study the association between covid-19 vaccines, SARS-CoV-2 infection, and risk of immune mediated neurological events. DESIGN: Population based historical rate comparison study and self-controlled case series analysis. SETTING: Primary care records from the United Kingdom, and primary care records from Spain linked to hospital data. PARTICIPANTS: 8 330 497 people who received at least one dose of covid-19 vaccines ChAdOx1 nCoV-19, BNT162b2, mRNA-1273, or Ad.26.COV2.S between the rollout of the vaccination campaigns and end of data availability (UK: 9 May 2021; Spain: 30 June 2021). The study sample also comprised a cohort of 735 870 unvaccinated individuals with a first positive reverse transcription polymerase chain reaction test result for SARS-CoV-2 from 1 September 2020, and 14 330 080 participants from the general population. MAIN OUTCOME MEASURES: Outcomes were incidence of Bell's palsy, encephalomyelitis, Guillain-Barré syndrome, and transverse myelitis. Incidence rates were estimated in the 21 days after the first vaccine dose, 90 days after a positive test result for SARS-CoV-2, and between 2017 and 2019 for background rates in the general population cohort. Indirectly standardised incidence ratios were estimated. Adjusted incidence rate ratios were estimated from the self-controlled case series. RESULTS: The study included 4 376 535 people who received ChAdOx1 nCoV-19, 3 588 318 who received BNT162b2, 244 913 who received mRNA-1273, and 120 731 who received Ad26.CoV.2; 735 870 people with SARS-CoV-2 infection; and 14 330 080 people from the general population. Overall, post-vaccine rates were consistent with expected (background) rates for Bell's palsy, encephalomyelitis, and Guillain-Barré syndrome. Self-controlled case series was conducted only for Bell's palsy, given limited statistical power, but with no safety signal seen for those vaccinated. Rates were, however, higher than expected after SARS-CoV-2 infection. For example, in the data from the UK, the standardised incidence ratio for Bell's palsy was 1.33 (1.02 to 1.74), for encephalomyelitis was 6.89 (3.82 to 12.44), and for Guillain-Barré syndrome was 3.53 (1.83 to 6.77). Transverse myelitis was rare (<5 events in all vaccinated cohorts) and could not be analysed. CONCLUSIONS: No safety signal was observed between covid-19 vaccines and the immune mediated neurological events of Bell's palsy, encephalomyelitis, Guillain-Barré syndrome, and transverse myelitis. An increased risk of Bell's palsy, encephalomyelitis, and Guillain-Barré syndrome was, however, observed for people with SARS-CoV-2 infection.


Assuntos
Paralisia de Bell/epidemiologia , Vacinas contra COVID-19/administração & dosagem , COVID-19/prevenção & controle , Encefalomielite/epidemiologia , Síndrome de Guillain-Barré/epidemiologia , Mielite Transversa/epidemiologia , SARS-CoV-2/imunologia , Adulto , Idoso , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Dados de Saúde Coletados Rotineiramente , Espanha , Reino Unido , Vacinação/efeitos adversos
10.
BMJ Open ; 12(2): e050949, 2022 02 16.
Artigo em Inglês | MEDLINE | ID: mdl-35172995

RESUMO

OBJECTIVES: To investigate the perceptions and experiences of people with specific immune-mediated inflammatory diseases during the process of switching from Humira to biosimilar adalimumab. DESIGN: Cross-sectional survey. SETTING: An anonymised, self-administered, web-based survey. PARTICIPANTS: The participants were drawn from members and non-members of either the National Rheumatoid Arthritis Society, the National Axial Spondyloarthritis Society, Crohn's and Colitis UK, or Psoriasis Association. Birdshot Uveitis Society and Olivia's Vision also signposted to the survey links. RESULTS: A total of 899 people living with various immune mediated inflammatory diseases participated in this survey. Thirty-four per cent of respondents reported poor overall satisfaction with their biosimilar adalimumab after the switch, associated with complaints related to the switching process including lack of shared decision making, scarcity of information provided by or signposted to by the department instigating the switch as well as lack of training with the new injection device. Where training with the new device had been provided, there were significantly reduced reports of pain when injecting the new biosimilar (OR 0.20, 95% CI 0.07 to 0.55), side effects (OR 0.17, 95% CI 0.06 to 0.47) and difficulty in using the new injection device (OR 0.25, 95% CI 0.15 to 0.41). Self-reported side effects were reduced by (OR 0.13, 95% CI 0.05 to 0.38) when written information was provided by healthcare professionals and by (OR 0.15, 95% CI 0.05 to 0.42) with provision of verbal information. Difficulty in using the new injection device was also reduced by provision of satisfactory information such as written documents (OR 0.38, 95% CI 0.23 to 0.63) or by verbal communication with healthcare professionals (OR 0.45, 95% CI 0.27 to 0.73). Finally, provision of satisfactory written or verbal information was associated with a reduction in any negative perception regarding symptom control with the new biosimilar by (OR 0.05, 95% CI 0.004 to 0.57) and by (OR 0.15, 95% CI 0.03 to 0.84), respectively. CONCLUSIONS: Patient reported experiences of the process of switching from originator to biosimilar emphasise the importance of clear communication, training and information in order to optimise perception and maximise achievable outcomes with the new treatment.


Assuntos
Medicamentos Biossimilares , Doença de Crohn , Adalimumab/uso terapêutico , Medicamentos Biossimilares/uso terapêutico , Doença de Crohn/tratamento farmacológico , Estudos Transversais , Humanos , Reino Unido
11.
BMC Med Res Methodol ; 22(1): 35, 2022 01 30.
Artigo em Inglês | MEDLINE | ID: mdl-35094685

RESUMO

BACKGROUND: We investigated whether we could use influenza data to develop prediction models for COVID-19 to increase the speed at which prediction models can reliably be developed and validated early in a pandemic. We developed COVID-19 Estimated Risk (COVER) scores that quantify a patient's risk of hospital admission with pneumonia (COVER-H), hospitalization with pneumonia requiring intensive services or death (COVER-I), or fatality (COVER-F) in the 30-days following COVID-19 diagnosis using historical data from patients with influenza or flu-like symptoms and tested this in COVID-19 patients. METHODS: We analyzed a federated network of electronic medical records and administrative claims data from 14 data sources and 6 countries containing data collected on or before 4/27/2020. We used a 2-step process to develop 3 scores using historical data from patients with influenza or flu-like symptoms any time prior to 2020. The first step was to create a data-driven model using LASSO regularized logistic regression, the covariates of which were used to develop aggregate covariates for the second step where the COVER scores were developed using a smaller set of features. These 3 COVER scores were then externally validated on patients with 1) influenza or flu-like symptoms and 2) confirmed or suspected COVID-19 diagnosis across 5 databases from South Korea, Spain, and the United States. Outcomes included i) hospitalization with pneumonia, ii) hospitalization with pneumonia requiring intensive services or death, and iii) death in the 30 days after index date. RESULTS: Overall, 44,507 COVID-19 patients were included for model validation. We identified 7 predictors (history of cancer, chronic obstructive pulmonary disease, diabetes, heart disease, hypertension, hyperlipidemia, kidney disease) which combined with age and sex discriminated which patients would experience any of our three outcomes. The models achieved good performance in influenza and COVID-19 cohorts. For COVID-19 the AUC ranges were, COVER-H: 0.69-0.81, COVER-I: 0.73-0.91, and COVER-F: 0.72-0.90. Calibration varied across the validations with some of the COVID-19 validations being less well calibrated than the influenza validations. CONCLUSIONS: This research demonstrated the utility of using a proxy disease to develop a prediction model. The 3 COVER models with 9-predictors that were developed using influenza data perform well for COVID-19 patients for predicting hospitalization, intensive services, and fatality. The scores showed good discriminatory performance which transferred well to the COVID-19 population. There was some miscalibration in the COVID-19 validations, which is potentially due to the difference in symptom severity between the two diseases. A possible solution for this is to recalibrate the models in each location before use.


Assuntos
COVID-19 , Influenza Humana , Pneumonia , Teste para COVID-19 , Humanos , Influenza Humana/epidemiologia , SARS-CoV-2 , Estados Unidos
12.
J Asthma ; : 1-11, 2022 Feb 11.
Artigo em Inglês | MEDLINE | ID: mdl-35012410

RESUMO

Objective: Large international comparisons describing the clinical characteristics of patients with COVID-19 are limited. The aim of the study was to perform a large-scale descriptive characterization of COVID-19 patients with asthma.Methods: We included nine databases contributing data from January to June 2020 from the US, South Korea (KR), Spain, UK and the Netherlands. We defined two cohorts of COVID-19 patients ('diagnosed' and 'hospitalized') based on COVID-19 disease codes. We followed patients from COVID-19 index date to 30 days or death. We performed descriptive analysis and reported the frequency of characteristics and outcomes in people with asthma defined by codes and prescriptions.Results: The diagnosed and hospitalized cohorts contained 666,933 and 159,552 COVID-19 patients respectively. Exacerbation in people with asthma was recorded in 1.6-8.6% of patients at presentation. Asthma prevalence ranged from 6.2% (95% CI 5.7-6.8) to 18.5% (95% CI 18.2-18.8) in the diagnosed cohort and 5.2% (95% CI 4.0-6.8) to 20.5% (95% CI 18.6-22.6) in the hospitalized cohort. Asthma patients with COVID-19 had high prevalence of comorbidity including hypertension, heart disease, diabetes and obesity. Mortality ranged from 2.1% (95% CI 1.8-2.4) to 16.9% (95% CI 13.8-20.5) and similar or lower compared to COVID-19 patients without asthma. Acute respiratory distress syndrome occurred in 15-30% of hospitalized COVID-19 asthma patients.Conclusion: The prevalence of asthma among COVID-19 patients varies internationally. Asthma patients with COVID-19 have high comorbidity. The prevalence of asthma exacerbation at presentation was low. Whilst mortality was similar among COVID-19 patients with and without asthma, this could be confounded by differences in clinical characteristics. Further research could help identify high-risk asthma patients.[Box: see text]Supplemental data for this article is available online at https://doi.org/10.1080/02770903.2021.2025392 .

13.
Int J Cancer ; 150(5): 782-794, 2022 03 01.
Artigo em Inglês | MEDLINE | ID: mdl-34655476

RESUMO

The relationship between cancer and coronavirus disease 2019 (COVID-19) infection and severity remains poorly understood. We conducted a population-based cohort study between 1 March and 6 May 2020 describing the associations between cancer and risk of COVID-19 diagnosis, hospitalisation and COVID-19-related death. Data were obtained from the Information System for Research in Primary Care (SIDIAP) database, including primary care electronic health records from ~80% of the population in Catalonia, Spain. Cancer was defined as any primary invasive malignancy excluding non-melanoma skin cancer. We estimated adjusted hazard ratios (aHRs) for the risk of COVID-19 (outpatient) clinical diagnosis, hospitalisation (with or without a prior COVID-19 diagnosis) and COVID-19-related death using Cox proportional hazard regressions. Models were estimated for the overall cancer population and by years since cancer diagnosis (<1 year, 1-5 years and ≥5 years), sex, age and cancer type; and adjusted for age, sex, smoking status, deprivation and comorbidities. We included 4 618 377 adults, of which 260 667 (5.6%) had a history of cancer. A total of 98 951 individuals (5.5% with cancer) were diagnosed, and 6355 (16.4% with cancer) were directly hospitalised with COVID-19. Of those diagnosed, 6851 were subsequently hospitalised (10.7% with cancer), and 3227 died without being hospitalised (18.5% with cancer). Among those hospitalised, 1963 (22.5% with cancer) died. Cancer was associated with an increased risk of COVID-19 diagnosis (aHR: 1.08; 95% confidence interval [1.05-1.11]), direct COVID-19 hospitalisation (1.33 [1.24-1.43]) and death following hospitalisation (1.12 [1.01-1.25]). These associations were stronger for patients recently diagnosed with cancer, aged <70 years, and with haematological cancers. These patients should be prioritised in COVID-19 vaccination campaigns and continued non-pharmaceutical interventions.


Assuntos
Teste para COVID-19/métodos , COVID-19/mortalidade , Adolescente , Adulto , Idoso , Feminino , História do Século XXI , Hospitalização , Humanos , Masculino , Pessoa de Meia-Idade , SARS-CoV-2 , Espanha/epidemiologia , Adulto Jovem
14.
J Allergy Clin Immunol Pract ; 10(1): 257-266.e8, 2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-34571200

RESUMO

BACKGROUND: Evidence suggests adults with atopic eczema have increased fracture risk. However, it is unclear whether oral corticosteroids explain the association. OBJECTIVE: To assess to what extent oral corticosteroids mediate the relationship between atopic eczema and fractures. METHODS: We conducted a cohort study using English primary care (Clinical Practice Research Datalink) and hospital admissions (Hospital Episode Statistics) records (1998-2016) including adults (18 years old and older) with atopic eczema matched (age, sex, and general practice) with up to 5 adults without atopic eczema. We used Cox regression to estimate hazard ratios (HRs) for specific major osteoporotic fractures (hip, spine, pelvis, or wrist) and for any-site fracture comparing individuals with atopic eczema with those without, adjusting for 6 different definitions of time-updated oral corticosteroid use (ever any prescription, ever high-dose, and recent, cumulative, current, or peak dose). RESULTS: We identified 526,808 individuals with atopic eczema and 2,569,030 without. We saw evidence of an association between atopic eczema and major osteoporotic fractures (eg, spine HR 1.15, 99% CI 1.08-1.22; hip HR 1.11, 99% CI 1.08-1.15) that remained after additionally adjusting for oral corticosteroids (eg, cumulative corticosteroid dose: spine HR 1.09, 99% CI 1.03-1.16; hip HR 1.09, 99% CI 1.06-1.12). Fracture rates were higher in people with severe atopic eczema than in people without even after adjusting for oral corticosteroids (eg, spine HR [99% CI]: confounder-adjusted 2.31 [1.91-2.81]; additionally adjusted for cumulative dose 1.71 [1.40-2.09]). CONCLUSIONS: Our findings suggest that little of the association between atopic eczema and major osteoporotic fractures is explained by oral corticosteroid use.


Assuntos
Dermatite Atópica , Adolescente , Corticosteroides/uso terapêutico , Adulto , Estudos de Coortes , Dermatite Atópica/tratamento farmacológico , Dermatite Atópica/epidemiologia , Humanos , Fatores de Risco
15.
Hip Int ; 32(3): 371-378, 2022 May.
Artigo em Inglês | MEDLINE | ID: mdl-33601915

RESUMO

AIM: To assess revision rates and postoperative mortality in patients undergoing hip arthroplasty (HA) for inflammatory arthritis compared to hip osteoarthritis (OA). METHODS: The analysis was conducted among cases of HA that were recorded in the National Joint Registry for England and Wales (NJR) between April 2003 and December 2012 and linked to Office for National Statistics mortality records. Procedures were identified where the indication for surgery was listed as seropositive rheumatoid arthritis (RA), ankylosing spondylitis (AS), other inflammatory arthritis (otherIA), or OA. 5-year revision risk and 90-day postoperative mortality according to indication were compared using Cox regression models adjusted for age, sex, American Society of Anaesthesiologists (ASA) grade, year of operation, implant type, and surgical approach. RESULTS: The cohort included 1457 HA procedures conducted for RA, 615 for AS, 1000 for otherIA, and 183,108 for OA. When compared with OA, there was no increased revision risk for any form of inflammatory arthritis (adjusted HRs: RA: 0.93 (0.64-1.35); AS: 1.14 (0.73-1.79); otherIA: 1.08 (0.73-1.59)). Postoperative 90-day mortality was increased for RA when compared with OA (adjusted HR: 2.86 (1.68-4.88)), but not for AS (adjusted HR: 1.56 (0.59-4.18)) or otherIA (adjusted HR: 0.64 (0.16-2.55)). CONCLUSIONS: The revision risk in HA performed for all types of inflammatory arthritis is similar to that for HA performed for OA. The 3-fold increased risk of 90-day mortality in patients with RA compared with OA highlights the need for active management of associated comorbidities in RA patients during the perioperative period.


Assuntos
Artroplastia de Quadril , Artroplastia do Joelho , Espondilite Anquilosante , Artroplastia de Quadril/efeitos adversos , Artroplastia do Joelho/efeitos adversos , Humanos , Sistema de Registros , Reoperação , Espondilite Anquilosante/cirurgia , País de Gales/epidemiologia
16.
J Gerontol A Biol Sci Med Sci ; 77(1): 148-154, 2022 01 07.
Artigo em Inglês | MEDLINE | ID: mdl-33885746

RESUMO

BACKGROUND: Frail subjects are at increased risk of adverse outcomes. We aimed to assess their risk of falls, all-cause mortality, and fractures. METHOD: We used a retrospective cohort study using the Sistema d'Informació per al Desenvolupament de l'Investigació en Atenció Primària database (>6 million residents). Subjects aged 75 years and older with ≥1 year of valid data (2007-2015) were included. Follow-up was carried out from (the latest of) the date of cohort entry up to migration, end of the study period or outcome (whichever came first). The eFRAGICAP classified subjects as fit, mild, moderate, or severely frail. Outcomes (10th revision of the International Classification of Diseases) were incident falls, fractures (overall/hip/vertebral), and all-cause mortality during the study period. Statistics: hazard ratios (HRs), 95% CI adjusted (per age, sex, and socioeconomic status), and unadjusted cause-specific Cox models, accounting for competing risk of death (fit group as the reference). RESULTS: A total of 893 211 subjects were analyzed; 54.4% were classified as fit, 34.0% as mild, 9.9% as moderate, and 1.6% as severely frail. Compared with the fit, frail had an increased risk of falls (adjusted HR [95% CI] of 1.55 [1.52-1.58], 2.74 [2.66-2.84], and 5.94 [5.52-6.40]), all-cause mortality (adjusted HR [95% CI] of 1.36 [1.35-1.37], 2.19 [2.16-2.23], and 4.29 [4.13-4.45]), and fractures (adjusted HR [95% CI] of 1.21 [1.20-1.23], 1.51 [1.47-1.55], and 2.36 [2.20-2.53]) for mild, moderate, and severe frailty, respectively. Severely frail had a high risk of vertebral (HR of 2.49 [1.99-3.11]) and hip fracture (HR [95% CI] of 1.85 [1.50-2.28]). Accounting for competing risk of death did not change results. CONCLUSION: Frail subjects are at increased risk of death, fractures, and falls. The eFRAGICAP tool can easily assess frailty in electronic primary care databases in Spain.


Assuntos
Fragilidade , Fraturas do Quadril , Acidentes por Quedas , Idoso , Estudos de Coortes , Idoso Fragilizado , Fragilidade/epidemiologia , Humanos , Estudos Retrospectivos
17.
Osteoporos Int ; 33(1): 123-137, 2022 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-34392386

RESUMO

We estimated and characterized the imminent fracture risk (1-2 years) of high-risk fracture patients through a multinational (UK, Spain, Denmark) cohort study. Older individuals with newly diagnosed osteoporosis and individuals who had a fracture while on treatment with a bisphosphonate were at a high risk of imminent fracture. PURPOSE: To characterize and estimate 1- to 2-year fracture risk in high-risk fracture patients. METHODS: Multi-cohort study in (database/study period) UK (CPRD/1995-2017), Spain (SIDIAP/2006-2016) and Denmark (DHR/1995-2016) including individuals ≥ 50 years old in NDO (newly diagnosed osteoporosis), OFx (incident osteoporotic fracture), BP (incident oral bisphosphonates use) or FWOT (fracture while on treatment with bisphosphonates). Outcomes (ICD-10/READ): hip, clinical spine, non-hip, non-spine and hip/humerus/distal forearm fracture. FOLLOW-UP: from cohort entry until death, migration/transfer or end of the study. STATISTICS: baseline characteristics and incidence rate (IR per 1000 persons). RESULTS (1-YEAR IR): NDO included 69,899 (UK), 37,901 (Spain) and 158,191 (Denmark) individuals. Spanish-IR was lowest for hip (4.7), clinical spine (2.5) and major osteoporotic fracture (MOF) (17.3) and highest in Denmark (74.2, 26.0 and 120.1, respectively). OFx included 83,514 (UK), 51,044 (Spain) and 509,551 (Denmark) individuals. IR in Denmark was highest for hip (24.1) and MOF (47.2), in Spain was highest for the clinical spine (9.4) and lowest for hip (9.5) and in the UK was lowest for the clinical spine (2.8) and MOF (20.7). BP included 148,507 (UK), 52,037 (Spain) and 204,010 (Denmark) individuals. Spanish-IR was lowest for hip (5.0) and MOF (21.1) and highest in Denmark (20.3 and 48.6, respectively). FWOT included 28,930 (UK), 1,865 (Spain) and 31,882 (Denmark) individuals. Clinical spine-IR was highest for Spain (12.0). Hip-IR was lowest for Spain (7.6) and highest for Denmark (33.6). Comparing young subjects, those who have FWOT started with an increased fracture rate. CONCLUSION: OFx and FWOT individuals experience higher re-fracture incidence rates than those with osteoporosis with or without treatment.


Assuntos
Fraturas do Quadril , Osteoporose , Fraturas por Osteoporose , Estudos de Coortes , Fraturas do Quadril/epidemiologia , Fraturas do Quadril/etiologia , Humanos , Incidência , Pessoa de Meia-Idade , Osteoporose/complicações , Osteoporose/epidemiologia , Fraturas por Osteoporose/epidemiologia , Fraturas por Osteoporose/etiologia , Fatores de Risco
18.
Arthritis Care Res (Hoboken) ; 74(3): 392-402, 2022 03.
Artigo em Inglês | MEDLINE | ID: mdl-33002322

RESUMO

OBJECTIVE: To estimate the costs of primary hip and knee replacement in individuals with osteoarthritis up to 2 years postsurgery, compare costs before and after the surgery, and identify predictors of hospital costs. METHODS: Patients age ≥18 years with primary planned hip or knee replacements and osteoarthritis in England between 2008 and 2016 were identified from the National Joint Registry and linked with Hospital Episode Statistics data containing inpatient episodes. Primary care data linked with hospital outpatient records were also used to identify patients age ≥18 years with primary hip or knee replacements between 2008 and 2016. All health care resource use was valued using 2016/2017 costs, and nonparametric censoring methods were used to estimate total 1-year and 2-year costs. RESULTS: We identified 854,866 individuals undergoing hip or knee replacement. The mean censor-adjusted 1-year hospitalization costs for hip and knee replacement were £7,827 (95% confidence interval [95% CI] 7,813, 7,842) and £7,805 (95% CI 7,790, 7,818), respectively. Complications and revisions were associated with up to a 3-fold increase in 1-year hospitalization costs. The censor-adjusted 2-year costs were £9,258 (95% CI 9,233, 9,280) and £9,452 (95% CI 9,430, 9,475) for hip and knee replacement, respectively. Adding primary and outpatient care, the mean total hip and knee replacement 2-year costs were £11,987 and £12,578, respectively. CONCLUSION: There are significant costs following joint replacement. Revisions and complications accounted for considerable costs and there is a significant incentive to identify best approaches to reduce these.


Assuntos
Artroplastia de Quadril/economia , Artroplastia do Joelho/economia , Osteoartrite do Quadril/cirurgia , Osteoartrite do Joelho/cirurgia , Idoso , Idoso de 80 Anos ou mais , Artroplastia de Quadril/mortalidade , Artroplastia de Quadril/estatística & dados numéricos , Artroplastia do Joelho/mortalidade , Artroplastia do Joelho/estatística & dados numéricos , Estudos de Coortes , Feminino , Custos Hospitalares/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-Idade , Osteoartrite do Quadril/epidemiologia , Osteoartrite do Joelho/epidemiologia , Complicações Pós-Operatórias/economia , Atenção Primária à Saúde/economia , Sistema de Registros
19.
Clinicoecon Outcomes Res ; 14: 249-264, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35492806

RESUMO

Purpose: To assess the cost-effectiveness of a Fracture Liaison Service (FLS) compared with standard care for the secondary prevention of fragility fractures in Spain. Methods: Patients with osteoporosis and an initial fragility fracture who were candidates to initiate osteoporosis treatment (mean age 65 years, 90.7% female) were included in the model. Disease progression was simulated with a Markov model through seven health states (with and without osteoporosis treatment, subsequent hip, vertebral, forearm and humerus fracture, and death). A time horizon of 10 years and a 6-month duration per cycle was set. Clinical, economic, and quality of life parameters were estimated from the literature and Spanish clinical practice. Resource use and treatment patterns were validated by an expert panel. The Spanish National Health System (SNS) perspective was adopted, taking direct costs (€; 2020) into account. Effectiveness was measured in life-years gained (LYG) and quality-adjusted life years gained (QALYs). A discount rate of 3% was applied to costs and outcomes. The uncertainty of the parameters was assessed using deterministic, scenario and probabilistic sensitivity analyses (1000 iterations). Results: Setting up a FLS for the secondary prevention of fragility fractures in Spain would provide better osteoporosis treatment initiation and persistence. This would reduce subsequent fragility fractures, disutilities and deaths. FLS would have greater clinical benefits (0.008 and 0.082 LYG and QALY gained per patient, respectively) and higher costs (€563.69 per patient) compared with standard care, leading to an incremental cost-utility ratio of €6855.23 per QALY gained over the 10 years horizon. The sensitivity analyses showed limited dispersion of the base case results, corroborating their robustness. Conclusion: From the SNS perspective and considering Spanish willingness-to-pay thresholds, the introduction of FLS for the secondary prevention of fragility fractures would be a cost-effective strategy.

20.
Bone ; 154: 116177, 2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-34508880

RESUMO

Osteogenesis imperfecta (OI) is a rare inherited connective tissue disorder with considerable clinical and genetic heterogeneity. The clinical hallmark of OI is liability to fractures due to reduced bone strength. Pregnancy and lactation are periods of increased calcium demand resulting in a decrease in maternal bone mineral density (BMD). This self-controlled case series evaluates fracture risk 12- and 19-months prior to conception compared to a period of 12- and 19 months following childbirth in women with OI. This study is based on data from the Danish National Patient Register collected between 1995 and 2018. Modified Poisson models were fitted to estimate Incidence Rate Ratio in the post/pre-pregnancy period/s, adjusted by parity and age. The 12-month observation group included 111 women with 205 pregnancies, and the 19-month observation 108 women with 197 pregnancies. We calculated fracture rates (IR) of 48.78 [95%CI 18.55-79.01] per 1000 person years 12 months prior to conception, and of 27.87 [95%CI 10.60-45.14] in the 12 months post-delivery. Comparing pre- and post-pregnancy period we found an incidence rate ratio (IRR) of 1.00 [95%CI 0.42-2.40]. When adjusting for parity and age at delivery no significant change in the IRR was noted. In the 19 months observation-period, the IR per 1000 person years prior to conception was 74.84 [95%CI 44.25-105.43] and the IR postpartum was 36.86 [95%CI 17.55-56.17], leading to an IRR of 0.61 [95%CI 0.31-1.18]. We could not identify any increased risk of fractures when comparing fracture rates during pregnancy and 12 or 19 months postpartum to fracture rates 12 or 19 months prior to conception.


Assuntos
Conservadores da Densidade Óssea , Fraturas Ósseas , Osteogênese Imperfeita , Densidade Óssea , Dinamarca/epidemiologia , Difosfonatos , Feminino , Fraturas Ósseas/epidemiologia , Fraturas Ósseas/etiologia , Humanos , Osteogênese Imperfeita/complicações , Osteogênese Imperfeita/epidemiologia , Gravidez
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