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Breast cancer metastasis burden in sentinel nodes analysed using one-step nucleic acid amplification predicts axillary nodal status
© 2015 Elsevier Ltd. Background: In breast cancer patients undergoing sentinel lymph node biopsy (SLNB) analysis using one-step nucleic acid amplification (OSNA), clarity is required as to the risk factors for non-sentinel lymph node (NSLN) involvement upon axillary lymph node dissection (ALND). This study aims to identify these factors, including categorising by extent of sentinel node positivity: solitary positive node (solitary), multiple nodes with some positive (multiple incomplete positive), or multiple nodes all of which are positive (multiple all positive). Methods: We conducted a cohort study using prospectively collected data on 856 SLNBs analysed using OSNA, from patients with cT1-3 clinically node-negative invasive breast cancer. ALND was performed for 289 positive SLNBs. Results: NSLN metastases were identified in 73 (25.3%) ALNDs. Significant factors for NSLN involvement on multivariate analysis were: SLNB macrometastases (cytokeratin-19 mRNA count >5000 copies/μl) (adj.OR = 3.01; 95% CI, 1.61-5.66; p = 0.0006), multiple all positive vs. multiple incomplete positive SLNB (adj.OR = 2.92; 95% CI, 1.38-6.19; p = 0.0050), and undergoing mastectomy (adj.OR = 1.89; 95% CI, 1.00-3.55; p = 0.0486). Amongst multiple incomplete positive SLNBs, an 8.8% NSLN risk was identified when only micrometastases were present. Conclusion: Extent of sentinel lymph node positivity measured using OSNA predicts NSLN metastasis risk, aiding decisions surrounding axillary treatment.
Outcome Measurement in Adult Auditory Rehabilitation: A Scoping Review of Measures Used in Randomized Controlled Trials
© 2015 Wolters Kluwer Health, Inc. This review documented the range and nature of reported outcome measures in the context of adult auditory rehabilitative research. Design: A scoping review conducted as a part of the development of a systematic review of the effect of interventions to improve hearing aid use. The authors searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled Trials; PubMed; EMBASE; CINAHL; Web of Science; Cambridge Scientific Abstracts; ICTRP; and additional sources for published and unpublished randomized control trials. The date of the search was November 6, 2013. Outcomes were grouped using a framework suggested by the Cochrane Effective Practice and Organization of Care group. Results: Patient outcomes included adherence to hearing aid use, daily hours of aid use, hearing handicap, hearing aid benefit, quality of life, and communication and psychological outcome. Satisfaction and speech perception were frequent secondary outcomes. There was diversity in measures used to report patient outcomes. Outcome categories other than patient health status and behavior were rarely reported. The timing of outcome measurement was often short term (>12 weeks), with a relative lack of evidence on long-term outcomes (<1 year). Conclusions: This review has highlighted considerable diversity in patient-reported outcome measurements in randomized control trials in the context of adult auditory rehabilitation. In addition, there are gaps in the literature with respect to measurement of other outcome types of potential interest to stakeholders, including policymakers and commissioners. Long-term outcome assessment is rare.
Minimally disruptive medicine is needed for patients with multimorbidity: Time to develop computerised medical record systems to meet this requirement
Copyright © 2015 The Author(s). Background Minimally disruptive medicine (MDM) is proposed as a method for more appropriately managing people with multiple chronic disease. Much clinical management is currently single disease focussed, with people with multimorbidity being managed according to multiple single disease guidelines. Current initiatives to improve care include education about individual conditions and creating an environment where multiple guidelines might be simultaneously supported. The patientcentred medical home (PCMH) is an example of the latter. However, educational programmes and PCMH may increase the burden on patients. Problem The cumulative workload for patients in managing the impact of multiple disease-specific guidelines is only relatively recently recognised. There is an intellectual vacuum as to how best to manage multimorbidity and how informatics might support implementing MDM. There is currently no alternative to multiple singlecondition- specific guidelines and a lack of certainty, should the treatment burden need to be reduced, as to which guideline might be 'dropped'. Action The best information about multimorbidity is recorded in primary care computerised medical record (CMR) systems and in an increasing number of integrated care organisations. CMR systems have the potential to flag individuals who might be in greatest need. However, CMR systems may also provide insights into whether there are ameliorating factors that might make it easier for them to be resilient to the burden of care. Data from such CMR systems might be used to develop the evidence base about how to better manage multimorbidity. Conclusions There is potential for these information systems to help reduce the management burden on patients and clinicians. However, substantial investment in research-driven CMR development is needed if we are to achieve this.
An algorithm to improve diagnostic accuracy in diabetes in computerised problem orientated medical records (POMR) compared with an established algorithm developed in episode orientated records (EOMR)
Copyright © 2015 The Author(s). Background An algorithm that detects errors in diagnosis, classification or coding of diabetes in primary care computerised medial record (CMR) systems is currently available. However, this was developed on CMR systems that are episode orientated medical records (EOMR); and do not force the user to always code a problem or link data to an existing one. More strictly problem orientated medical record (POMR) systems mandate recording a problem and linking consultation data to them. Objective To compare the rates of detection of diagnostic accuracy using an algorithm developed in EOMR with a new POMR specific algorithm. Method We used data from The Health Improvement Network (THIN) database (N = 2,466,364) to identify a population of 100,513 (4.08%) patients considered likely to have diabetes. We recalibrated algorithms designed to classify cases of diabetes to take account of that POMR enforced coding consistency in the computerised medical record systems [In Practice Systems (InPS) Vision] that contribute data to THIN. We explored the different proportions of people classified as having type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) and with diabetes unclassifiable as either T1DM or T2DM. We compared proportions using chi-square tests and used Tukey's test to compare the characteristics of the people in each group. Results The prevalence of T1DM using the original EOMR algorithm was 0.38% (9,264/2,466,364), and for T2DM 3.22% (79,417/2,466,364). The prevalence using the new POMR algorithm was 0.31% (7,750/2,466,364) T1DM and 3.65% (89,990/2,466,364) T2DM. The EOMR algorithms also left more people unclassified 11,439 (12%), as to their type of diabetes compared with 2,380 (2.4%), for the new algorithm. Those people who were only classified by the EOMR system differed in terms of older age, and apparently better glycaemic control, despite not being prescribed medication for their diabetes (p < 0.005). Conclusion Increasing the degree of problem orientation of the medical record system can improve the accuracy of recording of diagnoses and, therefore, the accuracy of using routinely collected data from CMRs to determine the prevalence of diabetes mellitus; data processing strategies should reflect the degree of problem orientation.
Improving the measurement of longitudinal change in renal function: Automated detection of changes in laboratory creatinine assay
Copyright © 2015 The Author(s). Introduction Renal function is reported using the estimates of glomerular filtration rate (EGFR). However, EGFR values are recorded without reference to the particular serum creatinine (SCr) assays used to derive them, and newer assays were introduced at different time points across the laboratories in the United Kingdom. These changes may cause systematic bias in EGFR reported in routinely collected data, even though laboratory-reported EGFR values have a correction factor applied. Design An algorithm to detect changes in SCr that in turn affect EGFR calculation method was developed. It compares the mapping of SCr values on to EGFR values across a time series of paired EGFR and SCr measurements. Setting Routinely collected primary care data from 20,000 people with the richest renal function data from the quality improvement in chronic kidney disease trial. Results The algorithm identified a change in EGFR calculation method in 114 (90%) of the 127 included practices. This change was identified in 4736 (23.7%) patient time series analysed. This change in calibration method was found to cause a significant step change in the reported EGFR values, producing a systematic bias. The EGFR values could not be recalibrated by applying the Modification of Diet in Renal Disease equation to the laboratory reported SCr values. Conclusions This algorithm can identify laboratory changes in EGFR calculation methods and changes in SCr assay. Failure to account for these changes may misconstrue renal function changes over time. Researchers using routine EGFR data should account for these effects.
Using routinely collected health data for surveillance, quality improvement and research: Framework and key questions to assess ethics and privacy and enable data access
Copyright © 2015 The Author(s). Background The use of health data for public health, surveillance, quality improvement and research is crucial to improve health systems and health care. However, bodies responsible for privacy and ethics often limit access to routinely collected health data. Ethical approvals, issues around protecting privacy and data access are often dealt with by different layers of regulations, making approval processes appear disjointed. Objective To create a comprehensive framework for defining the ethical and privacy status of a project and for providing guidance on data access. Method The framework comprises principles and related questions. The core of the framework will be built using standard terminology definitions such as ethics- related controlled vocabularies and regional directives. It is built in this way to reduce ambiguity between different definitions. The framework is extensible: principles can be retired or added to, as can their related questions. Responses to these questions should allow data processors to define ethical issues, privacy risk and other unintended consequences. Results The framework contains three steps: (1) identifying possible ethical and privacy principles relevant to the project; (2) providing ethics and privacy guidance questions that inform the type of approval needed; and (3) assessing case-specific ethics and privacy issues. The outputs from this process should inform whether the balance between public interests and privacy breach and any ethical considerations are tipped in favour of societal benefits. If they are then this should be the basis on which data access is permitted. Tightly linking ethical principles to governance and data access may help maintain public trust.
In this issue: Time to replace doctors' judgement with computers
Copyright © 2015 The Author(s). Informaticians continue to rise to the challenge, set by the English Health Minister, of trying to replace doctors' judgement with computers. This issue describes successes and where there are barriers. However, whilst there is progress this tends to be incremental and there are grand challenges to be overcome before computers can replace clinician. These grand challenges include: (1) improving usability so it is possible to more readily incorporate technology into clinical workflow; (2) rigorous new analytic methods that make use of the mass of available data, 'Big data', to create real-world evidence; (3) faster ways of meeting regulatory and legal requirements including ensuring privacy; (4) provision of reimbursement models to fund innovative technology that can substitute for clinical time and (5) recognition that innovations that improve quality also often increase cost. Informatics more is likely to support and augment clinical decision making rather than replace clinicians.
A simple clinical coding strategy to improve recording of child maltreatment concerns: An audit study
Copyright © 2015 The Author(s). Background Recording concerns about child maltreatment, including minor concerns, is recommended by the General Medical Council (GMC) and National Institute for Health and Clinical Excellence (NICE) but there is evidence of substantial under-recording. Aim To determine whether a simple coding strategy improved recording of maltreatment-related concerns in electronic primary care records. Design and Setting Clinical audit of rates of maltreatment-related coding before January 2010-December 2011 and after January-December 2012 implementation of a simple coding strategy in 11 English family practices. The strategy included encouraging general practitioners to use, always and as a minimum, the Read code 'Child is cause for concern'. A total of 25,106 children aged 0-18 years were registered with these practices. We also undertook a qualitative service evaluation to investigate barriers to recording. Method Outcomes were recording of 1) any maltreatment-related codes, 2) child protection proceedings and 3) child was a cause for concern. Results We found increased recording of any maltreatment-related code (rate ratio 1.4; 95% CI 1.1-1.6), child protection procedures (RR 1.4; 95% CI 1.1-1.6) and cause for concern (RR 2.5; 95% CI 1.8-3.4) after implementation of the coding strategy. Clinicians cited the simplicity of the coding strategy as the most important factor assisting implementation. Conclusion This simple coding strategy improved clinician's recording of maltreatment- related concerns in a small sample of practices with some 'buy- in'. Further research should investigate how recording can best support the doctor-patient relationship.
Journal of innovation in health informatics: Building on the 20-year history of a BCS Health peer review journal
Copyright © 2015 The Author(s). After 20-years as Informatics in Primary Care the journal is renamed Journal of Innovation in Health Informatics. The title was carefully selected to reflect that: (1) informatics provides the opportunity to innovate rather than simply automates; (2) implementing informatics solutions often results in unintended consequences, and many implementations fail and benefits and innovations may go unrecognised; (3) health informatics is a boundary spanning discipline and is by its very nature likely to give rise to innovation. Informatics is an innovative science, and informaticians need to innovate across professional and discipline boundaries.
Unleashing the power of e-Health requires the development of an evidence base for interventions that improve care
The two leading articles in this issue of Informatics in Primary Care describe the importance of creating the right evidence base if we are to Unleash the Power of e-Health. Policy needs to promote well-thought-out developments that are evidence based, have the right theoretical underpinnings and are carefully modelled to see where and how they might fit into the (very human) process of health care delivery and most importantly affect health outcomes. To inform this debate, we need to be clear about what we mean by e-Health and the evidence base, their origins and definitions (Boxes 1 and 2).
Physician associates and GPs in primary care: A comparison
© British Journal of General Practice. Background: Physician associates [PAs] (also known as physician assistants) are new to the NHS and there is little evidence concerning their contribution in general practice. Aim: This study aimed to compare outcomes and costs of same-day requested consultations by PAs with those of GPs. Design and setting: An observational study of 2086 patient records presenting at same-day appointments in 12 general practices in England. Method: PA consultations were compared with those of GPs. Primary outcome was re-consultation within 14 days for the same or linked problem. Secondary outcomes were processes of care. Results: There were no significant differences in the rates of re-consultation (rate ratio 1.24, 95% confidence interval [CI] = 0.86 to 1.79, P = 0.25). There were no differences in rates of diagnostic tests ordered (1.08, 95% CI = 0.89 to 1.30, P = 0.44), referrals (0.95, 95% CI = 0.63 to 1.43, P = 0.80), prescriptions issued (1.16, 95% CI = 0.87 to 1.53, P = 0.31), or patient satisfaction (1.00, 95% CI = 0.42 to 2.36, P = 0.99). Records of initial consultations of 79.2% (n = 145) of PAs and 48.3% (n = 99) of GPs were judged appropriate by independent GPs (P<0.001). The adjusted average PA consultation was 5.8 minutes longer than the GP consultation (95% CI = 2.46 to 7.1; P<0.001); cost per consultation was GBP £6.22, (US$10.15) lower (95% CI = -7.61 to -2.46, P<0.001). Conclusion: The processes and outcomes of PA and GP consultations for same-day appointment patients are similar at a lower consultation cost. PAs offer a potentially acceptable and efficient addition to the general practice workforce.
Patients' online access to their electronic health records and linked online services: A systematic review in primary care
©British Journal of General Practice. Background: Online access to medical records by patients can potentially enhance provision of patient-centred care and improve satisfaction. However, online access and services may also prove to be an additional burden for the healthcare provider. Aim: To assess the impact of providing patients with access to their general practice electronic health records (EHR) and other EHR-linked online services on the provision, quality, and safety of health care. Design and setting: A systematic review was conducted that focused on all studies about online record access and transactional services in primary care. Method: Data sources included Medline, Embase, CINAHL, Cochrane Library, EPOC, DARE, King's Fund, Nuffield Health, PsycINFO, OpenGrey (1999-2012). The literature was independently screened against detailed inclusion and exclusion criteria; independent dual data extraction was conducted, the risk of bias (RoB) assessed, and a narrative synthesis of the evidence conducted. Results: A total of 176 studies were identified, 17 of which were randomised controlled trials, cohort, or cluster studies. Patients reported improved satisfaction with online access and services compared with standard provision, improved self-care, and better communication and engagement with clinicians. Safety improvements were patient-led through identifying medication errors and facilitating more use of preventive services. Provision of online record access and services resulted in a moderate increase of e-mail, no change on telephone contact, but there were variable effects on face-to-face contact. However, other tasks were necessary to sustain these services, which impacted on clinician time. There were no reports of harm or breaches in privacy. Conclusion: While the RoB scores suggest many of the studies were of low quality, patients using online services reported increased convenience and satisfaction. These services positively impacted on patient safety, although there were variations of record access and use by specific ethnic and socioeconomic groups. Professional concerns about privacy were unrealised and those about workload were only partly so.
Journal of Innovation in Health Informatics: Building on the 20-year history of a BCS Health peer review journal
Copyright © 2015 The Author(s). After 20-years as Informatics in Primary Care the journal is renamed Journal of Innovation in Health Informatics. The title was carefully selected to reflect that: (1) informatics provides the opportunity to innovate rather than simply automates; (2) implementing informatics solutions often results in unintended consequences, and many implementations fail and benefits and innovations may go unrecognised; (3)health informatics is a boundary spanning discipline and is by its very nature likely to give rise to innovation. Informatics is an innovative science, and informaticians need to innovate across professional and discipline boundaries.
Low effectiveness of seasonal influenza vaccine in preventing laboratory-confirmed influenza in primary care in the United Kingdom: 2014/15 mid–season results
In 2014/15 the United Kingdom experienced circulation of influenza A(H3N2) with impact in the elderly. Midseason vaccine effectiveness (VE) shows an adjusted VE of 3.4% (95% CI: −44.8 to 35.5) against primary care consultation with laboratory-confirmed influenza and −2.3% (95% CI: −56.2 to 33.0) for A(H3N2). The low VE reflects mismatch between circulating viruses and the 2014/15 northern hemisphere A(H3N2) vaccine strain. Early use of antivirals for prophylaxis and treatment of vulnerable populations remains important.
An evaluation of audiology service improvement documentation in England using the chronic care model and content analysis
Objective: Implementation of the chronic care model (CCM) is associated with improved outcomes for patients. It follows that any proposed policy or implementation plan that maps highly onto the CCM is more likely to lead to improved outcomes. The aim of this study was to compare long-term condition (LTC) policy documents and audiology quality standard documents with the CCM and to highlight the need for further research in service implementation and clinical outcome. Design: We carried out a keyword-in-context content analysis of relevant documents. Study sample: Documents relating to health department policy on LTCs, audiology service improvement initiatives in England and the CCM. Results: This analysis shows that current audiology implementation documents in England map poorly onto the CCM compared to health policy documents relating to the management of LTCs. The biggest discrepancies occur in self-management support, delivery system design, and decision support. These elements are supported by the best evidence of potential improvements in clinical outcome. Conclusions: Our content analysis of audiology service quality improvement documents in England suggests they compare poorly to some elements of the CCM. We discuss the implications this might have for future research. © 2014 British Society of Audiology, International Society of Audiology, and Nordic Audiological Society.
Effective pseudonymisation and explicit statements of public interest to ensure the benefts of sharing Health data for research, quality improvement and Health Service management outweigh the risks
This journal strongly supports the sharing of data to support research and quality improvement. However, this needs to be done in a way that ensures the benefts vastly outweigh the risks, and vitally using methods which are inspire both public and professional confdences - robust pseudonymisation is needed to achieve this. The case for using routine data for research has already been well made and probably also for quality improvement; however, clearer mechanisms are needed of how we test that the public interest is served. Ensuring that the public interest is served is essential if we are to maintain patients' and public's trust, especially in the English National Health Service where the realpolitik is that patients can opt out of data sharing. Copyright © 2014 The Author(s).