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https://www.readbyqxmd.com/read/28515198/post-authorisation-passive-enhanced-safety-surveillance-of-seasonal-influenza-vaccines-protocol-of-a-pilot-study-in-england
#1
Simon de Lusignan, Gaël Dos Santos, Ana Correa, François Haguinet, Ivelina Yonova, Florence Lair, Rachel Byford, Filipa Ferreira, Karen Stuttard, Tom Chan
AIM: To pilot enhanced safety surveillance of seasonal influenza vaccine meeting the European Medicines Agency (EMA) requirement to rapidly detect a significant increase in the frequency or severity of adverse events of interest (AEIs), which may indicate risk from the new season's vaccine. STUDY DESIGN: A prospective passive enhanced safety surveillance combining data collection from adverse drug reaction (ADR) cards with automated collection of pseudonymised routinely collected electronic health record (EHR) data...
May 17, 2017: BMJ Open
https://www.readbyqxmd.com/read/28330491/orchestrating-differential-data-access-for-translational-research-a-pilot-implementation
#2
Marco Brandizi, Olga Melnichuk, Raffael Bild, Florian Kohlmayer, Benedicto Rodriguez-Castro, Helmut Spengler, Klaus A Kuhn, Wolfgang Kuchinke, Christian Ohmann, Timo Mustonen, Mikael Linden, Tommi Nyrönen, Ilkka Lappalainen, Alvis Brazma, Ugis Sarkans
BACKGROUND: Translational researchers need robust IT solutions to access a range of data types, varying from public data sets to pseudonymised patient information with restricted access, provided on a case by case basis. The reason for this complication is that managing access policies to sensitive human data must consider issues of data confidentiality, identifiability, extent of consent, and data usage agreements. All these ethical, social and legal aspects must be incorporated into a differential management of restricted access to sensitive data...
March 23, 2017: BMC Medical Informatics and Decision Making
https://www.readbyqxmd.com/read/28235748/the-effect-of-the-general-data-protection-regulation-on-medical-research
#3
John Mark Michael Rumbold, Barbara Pierscionek
BACKGROUND: The enactment of the General Data Protection Regulation (GDPR) will impact on European data science. Particular concerns relating to consent requirements that would severely restrict medical data research have been raised. OBJECTIVE: Our objective is to explain the changes in data protection laws that apply to medical research and to discuss their potential impact. METHODS: Analysis of ethicolegal requirements imposed by the GDPR...
February 24, 2017: Journal of Medical Internet Research
https://www.readbyqxmd.com/read/28219100/-current-developments-of-the-interdisciplinary-subject-rehabilitation-physical-medicine-naturopathic-treatment-in-the-german-medical-faculties-results-of-the-dgrw-faculty-survey-in-2015
#4
S Schmidt, C Bergelt, R Deck, G Krischak, M Morfeld, M Michel, S R Schwarzkopf, K Spyra, S Walter, W Mau
To ascertain the current development of the rehabilitation-related medical teaching in the interdisciplinary subject Rehabilitation, Physical Medicine, Naturopathic Treatment (Q12) regarding its execution, content, exams and evaluation of teaching at the Medical Faculties the German Society of Rehabilitation Science conducted another faculty survey in 2015. Representatives of all degree courses of human medicine in German Universities (n=41) received a pseudonymised standardised questionnaire in summer 2015...
February 2017: Die Rehabilitation
https://www.readbyqxmd.com/read/28059689/an-integrated-health-neighbourhood-framework-to-optimise-the-use-of-ehr-data
#5
Siaw-Teng Liaw, Simon De Lusignan
 General practice should become the hub of integrated health neighbourhoods (IHNs), which involves sharing of information to ensure that medical homes are also part of learning organisations that use electronic health record (EHR) data for care, decision making, teaching and learning, quality improvement and research. The IHN is defined as the primary and ambulatory care services in a locality that relates largely to a single hospital-based secondary care service provider and is the logical denominator and unit of comparison for the optimal use of EHR data and health information exchange (HIE) to facilitate integration and coordination of care...
October 4, 2016: Journal of Innovation in Health Informatics
https://www.readbyqxmd.com/read/27764135/linking-data-for-mothers-and-babies-in-de-identified-electronic-health-data
#6
Katie Harron, Ruth Gilbert, David Cromwell, Jan van der Meulen
OBJECTIVE: Linkage of longitudinal administrative data for mothers and babies supports research and service evaluation in several populations around the world. We established a linked mother-baby cohort using pseudonymised, population-level data for England. DESIGN AND SETTING: Retrospective linkage study using electronic hospital records of mothers and babies admitted to NHS hospitals in England, captured in Hospital Episode Statistics between April 2001 and March 2013...
2016: PloS One
https://www.readbyqxmd.com/read/27751180/legal-assessment-tool-lat-an-interactive-tool-to-address-privacy-and-data-protection-issues-for-data-sharing
#7
Wolfgang Kuchinke, Christian Krauth, René Bergmann, Töresin Karakoyun, Astrid Woollard, Irene Schluender, Benjamin Braasch, Martin Eckert, Christian Ohmann
BACKGROUND: In an unprecedented rate data in the life sciences is generated and stored in many different databases. An ever increasing part of this data is human health data and therefore falls under data protected by legal regulations. As part of the BioMedBridges project, which created infrastructures that connect more than 10 ESFRI research infrastructures (RI), the legal and ethical prerequisites of data sharing were examined employing a novel and pragmatic approach. METHODS: We employed concepts from computer science to create legal requirement clusters that enable legal interoperability between databases for the areas of data protection, data security, Intellectual Property (IP) and security of biosample data...
July 7, 2016: BMC Medical Informatics and Decision Making
https://www.readbyqxmd.com/read/27729352/evolution-of-primary-care-databases-in-uk-a-scientometric-analysis-of-research-output
#8
Paraskevas Vezyridis, Stephen Timmons
OBJECTIVE: To identify publication and citation trends, most productive institutions and countries, top journals, most cited articles and authorship networks from articles that used and analysed data from primary care databases (CPRD, THIN, QResearch) of pseudonymised electronic health records (EHRs) in UK. METHODS: Descriptive statistics and scientometric tools were used to analyse a SCOPUS data set of 1891 articles. Open access software was used to extract networks from the data set (Table2Net), visualise and analyse coauthorship networks of scholars and countries (Gephi) and density maps (VOSviewer) of research topics co-occurrence and journal cocitation...
October 11, 2016: BMJ Open
https://www.readbyqxmd.com/read/27616950/effect-of-named-accountable-gps-on-continuity-of-care-protocol-for-a-regression-discontinuity-study-of-a-national-policy-change
#9
Therese Lloyd, Adam Steventon
INTRODUCTION: Increasing continuity of care has been identified as a strategy to improve patient outcomes, but previous studies of integrated care have tended to focus on pilot areas, which limit their generalisability and the ability to determine in which contexts integrated care was most successful. OBJECTIVE: This study protocol describes a quantitative evaluation of a reform in England that introduced named, accountable general practitioners for all National Health Service (NHS) patients aged 75 years or over...
2016: International Journal of Integrated Care
https://www.readbyqxmd.com/read/27518117/-incidence-of-knee-injuries-numbers-for-outpatient-and-inpatient-care-in-germany
#10
O Schneider, H-P Scharf, T Stein, S Knapstein, C Hermann, J Flechtenmacher
BACKGROUND: Musculoskeletal illnesses and injuries are among the most common ailments in the Federal Republic of Germany. In 2008 they generated costs of nearly 29 billion euros. Figures about their incidence and prevalence are necessary for a demand-oriented planning of future patient-centred care. METHOD: Pseudonymised data of 3.8 million people insured by AOK Baden-Württemberg between 2008 and 2013 were evaluated. The diagnoses were assigned to nine injury groups...
December 2016: Der Orthopäde
https://www.readbyqxmd.com/read/27504235/health-related-quality-of-life-for-young-people-receiving-dialectical-behaviour-therapy-dbt-a-routine-outcome-monitoring-pilot
#11
M Swales, R A B Hibbs, L Bryning, R P Hastings
PURPOSE: Adults presenting with borderline personality disorder (BPD) score poorly on measures of health related quality of life (HRQoL). Little is known about HRQoL in adolescents with BPD type presentations and how treatment impacts quality of life. Our primary aim was to use routinely collected quality-of-life outcome measures pre and post-treatment in dialectical behaviour therapy (DBT) for adolescents to address this gap. Secondary aims were to benchmark these data against EuroQol 5 dimensions (EQ-5D™) outcomes for clients treated in clinical trials and to assess the potential of the EQ-5D™ as a benchmarking tool...
2016: SpringerPlus
https://www.readbyqxmd.com/read/27441823/-which-back-pain-patients-benefit-from-multidisciplinary-pain-management-a-comparative-cost-analysis-using-claims-data-of-statutory-health-insurance
#12
S Behrendt, H Kulas, U Marschall, M Steffens, G Schiffhorst, H-H Bleß
Aim: Multidisciplinary pain therapy (MPT) is considered as best practice for treating patients with chronical back pain. Several studies showed the cost effectiveness of interdisciplinary treatment. The aim of the present study is to identify patient characteristics that, under condition of MMT, can be associated with favourable cost trajectories after intervention. We assume that an improved health status leads to less health care utilisation. Furthermore, we aim at identifying those patients with back pain without MPT for whom we can expect favourable cost trajectories...
July 21, 2016: Das Gesundheitswesen
https://www.readbyqxmd.com/read/27357194/regional-variation-of-patient-behaviour-and-reasons-for-consultation-in-the-general-practice-of-northern-germany-protocol-for-an-observational-study
#13
Ingmar Schäfer, Heike Hansen, Nadine Pohontsch, Laura Bole, Hans-Otto Wagner, Miriam Führ, Dagmar Lühmann, Martin Scherer
INTRODUCTION: Inappropriate supply and an increasing demand on the healthcare system have been of concern for health policy in Germany for at least 15 years. In the primary care setting, this especially relates to an undersupply of general practitioners (GPs) in the countryside. In addition, there seem to be other regional differences, for example, a difference in accessing primary and secondary care between rural and urban areas. Despite these findings, regional differences in health services have not been studied extensively in Germany...
June 29, 2016: BMJ Open
https://www.readbyqxmd.com/read/27203791/effects-of-the-german-skin-cancer-screening-programme-on-melanoma-incidence-and-indicators-of-disease-severity
#14
F Trautmann, F Meier, A Seidler, J Schmitt
BACKGROUND: In Germany a nationwide melanoma screening programme for adults aged ≥ 35 years was introduced in July 2008. Evidence on utilization and effects is limited. OBJECTIVES: To examine the uptake and effects of the German nationwide screening programme. METHODS: This analysis is based on pseudonymized outpatient routine data of a German health insurance company covering data of > 2 million individuals from Saxony for the years 2005-2012...
November 2016: British Journal of Dermatology
https://www.readbyqxmd.com/read/27142361/improving-care-and-research-electronic-data-trust-antwerp-icaredata-a-research-database-of-linked-data-on-out-of-hours-primary-care
#15
Annelies Colliers, Stefaan Bartholomeeusen, Roy Remmen, Samuel Coenen, Barbara Michiels, Hilde Bastiaens, Paul Van Royen, Veronique Verhoeven, Philip Holmgren, Bernard De Ruyck, Hilde Philips
BACKGROUND: Primary out-of-hours care is developing throughout Europe. High-quality databases with linked data from primary health services can help to improve research and future health services. METHODS: In 2014, a central clinical research database infrastructure was established (iCAREdata: Improving Care And Research Electronic Data Trust Antwerp, www.icaredata.eu ) for primary and interdisciplinary health care at the University of Antwerp, linking data from General Practice Cooperatives, Emergency Departments and Pharmacies during out-of-hours care...
May 4, 2016: BMC Research Notes
https://www.readbyqxmd.com/read/26856942/the-management-and-outcomes-of-fingolimod-first-dose-cardiac-monitoring-in-uk-patients-with-relapsing-remitting-multiple-sclerosis
#16
Joe Datt, Laura Baldock, Emily Pull, Bryn Webber
BACKGROUND: Patients initiated on Gilenya (fingolimod) require cardiovascular monitoring for 6h after the first dose. Novartis has engaged an independent provider (Regent's Park Heart Clinics [RPHC]) to provide a first dose observation (FDO) service to UK neurologists. OBJECTIVES: To describe routinely-documented clinical observations (heart rate [HR], blood pressure [BP], cardiac rhythm [CR]) and outcomes from the RPHC fingolimod FDO service. METHODS: Pseudonymised data (clinical observations pre-dose and for 6h after the first dose and any requirement for extended monitoring) were collected retrospectively from RPHC records for the first 850 RPHC FDO episodes (undertaken Jul-2012 to Jan-2015)...
January 2016: Multiple Sclerosis and related Disorders
https://www.readbyqxmd.com/read/26801463/patient-characteristics-associated-with-risk-of-first-hospital-admission-and-readmission-for-acute-exacerbation-of-chronic-obstructive-pulmonary-disease-copd-following-primary-care-copd-diagnosis-a-cohort-study-using-linked-electronic-patient-records
#17
L C Hunter, R J Lee, I Butcher, C J Weir, C M Fischbacher, D McAllister, S H Wild, N Hewitt, R M Hardie
OBJECTIVES: To investigate patient characteristics of an unselected primary care population associated with risk of first hospital admission and readmission for acute exacerbation of chronic obstructive pulmonary disease (AECOPD). DESIGN: Retrospective open cohort using pseudonymised electronic primary care data linked to secondary care data. SETTING: Primary care; Lothian (population approximately 800,000), Scotland. PARTICIPANTS: Data from 7002 patients from 72 general practices with a COPD diagnosis date between 2000 and 2008 recorded in their primary care record...
2016: BMJ Open
https://www.readbyqxmd.com/read/26547084/validation-and-application-of-a-core-set-of-patient-relevant-outcome-domains-to-assess-the-effectiveness-of-multimodal-pain-therapy-vapain-a-study-protocol
#18
MULTICENTER STUDY
Ulrike Kaiser, Christian Kopkow, Stefanie Deckert, Rainer Sabatowski, Jochen Schmitt
INTRODUCTION: Multimodal pain therapy (MPT) has been established accounting for biopsychosocial consideration in diagnostic and therapy. MPT seems to be effective, but comparability of studies is limited due to diversity of study designs and outcome measurements. The presented study aims to develop a core outcome set consisting of a minimum of outcome measures deemed necessary for medical and therapeutic decision-making, which must be measured in all clinical trials and non-randomised intervention studies...
November 6, 2015: BMJ Open
https://www.readbyqxmd.com/read/26297363/data-linkage-errors-in-hospital-administrative-data-when-applying-a-pseudonymisation-algorithm-to-paediatric-intensive-care-records
#19
MULTICENTER STUDY
Gareth Hagger-Johnson, Katie Harron, Tom Fleming, Ruth Gilbert, Harvey Goldstein, Rebecca Landy, Roger C Parslow
OBJECTIVES: Our aim was to estimate the rate of data linkage error in Hospital Episode Statistics (HES) by testing the HESID pseudoanonymisation algorithm against a reference standard, in a national registry of paediatric intensive care records. SETTING: The Paediatric Intensive Care Audit Network (PICANet) database, covering 33 paediatric intensive care units in England, Scotland and Wales. PARTICIPANTS: Data from infants and young people aged 0-19 years admitted between 1 January 2004 and 21 February 2014...
August 21, 2015: BMJ Open
https://www.readbyqxmd.com/read/26069072/socioeconomic-deprivation-independently-predicts-painful-diabetic-neuropathy-in-type-2-diabetes
#20
S G Anderson, R P Narayanan, N S Malipatil, H Roberts, G Dunn, A H Heald
OBJECTIVE: Painful peripheral neuropathy in people with type 2 diabetes is a disabling complication. We explored associations of this condition with socioeconomic deprivation. RESEARCH DESIGN AND METHODS: The Townsend index of socioeconomic deprivation was examined in the pseudonymised GP records of 15388 (44.1% female) individuals with type 2 diabetes in the Cheshire county of England, and related to prevalence of drug treated painful diabetic neuropathy. We also analysed prescription trends with respect to pharmacotherapy for neuropathy pain relief...
July 2015: Experimental and Clinical Endocrinology & Diabetes
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