Investigation of the effect of Interleukin-1 receptor antagonist (IL-1ra) on markers of inflammation in non-ST elevation acute coronary syndromes (The MRC-ILA-HEART Study)

Background

Point of care testing (PoCT) may be a useful adjunct in the management of chronic conditions in general practice (GP). The provision of pathology test results at the time of the consultation could lead to enhanced clinical management, better health outcomes, greater convenience and satisfaction for patients and general practitioners (GPs), and savings in costs and time. It could also result in inappropriate testing, increased consultations and poor health outcomes resulting from inaccurate results. Currently there are very few randomised controlled trials (RCTs) in GP that have investigated these aspects of PoCT.

Design/Methods

The Point of Care Testing in General Practice Trial (PoCT Trial) was an Australian Government funded multi-centre, cluster randomised controlled trial to determine the safety, clinical effectiveness, cost effectiveness and satisfaction of PoCT in a GP setting. The PoCT Trial covered an 18 month period with the intervention consisting of the use of PoCT for seven tests used in the management of patients with diabetes, hyperlipidaemia and patients on anticoagulant therapy. The primary outcome measure was the proportion of patients within target range, a measure of therapeutic control. In addition, the PoCT Trial investigated the safety of PoCT, impact of PoCT on patient compliance to medication, stakeholder satisfaction, cost effectiveness of PoCT versus laboratory testing, and influence of geographic location.

Discussion

The paper provides an overview of the Trial Design, the rationale for the research methodology chosen and how the Trial was implemented in a GP environment. The evaluation protocol and data collection processes took into account the large number of patients, the broad range of practice types distributed over a large geographic area, and the inclusion of pathology test results from multiple pathology laboratories. The evaluation protocol developed reflects the complexity of the Trial setting, the Trial Design and the approach taken within the funding provided. The PoCT Trial is regarded as a pragmatic RCT, evaluating the effectiveness of implementing PoCT in GP and every effort was made to ensure that, in these circumstances, internal and external validity was maintained.

Trial Registration

12612605000272695     

The National QAAMS Program – A Practical Example of PoCT Working in the Community

The Quality Assurance for Aboriginal and Torres Strait Islander Medical Services (QAAMS) Program is the largest and longest-standing national point-of-care testing (PoCT) program in Australia. With a focus on PoCT for diabetes management, it now operates in 115 Indigenous medical services and has been funded continuously by the Australian Government for 11 years. A recent independent evaluation of the QAAMS Program concluded that the program continues to meet best practice standards for Indigenous healthcare, diabetes management and PoCT.     

i-STAT – Combining Chemistry and Haematology in PoCT

Point-of-care testing (PoCT) is traditionally considered a branch or offshoot of clinical chemistry. The appearance on the market of small, light, inexpensive, multi-purpose, point-of-care analysers, which combine a number of widely differing analytes, has to some degree upset this paradigm. Such analysers, however, are invaluable in some clinical settings.Specialties other than clinical chemistry may have differing views on traditional test management, particularly with regard to quality control (QC), quality assurance (QA), and training. These views must be considered when designing an overall PoCT management plan. Test management issues should be resolved by taking the view that it is a ‘point-of-care’ test, and by looking at the specific test technology and method involved, rather than by just assuming it is a ‘haematology’ or a ‘chemistry’ test.Clinical users of a combined PoCT system are principally interested in the generation of good quality results. To avoid confusion, any advice given to clinical staff regarding their analysers should be clear, concise, and above all else, consistent.     

Integrating PoCT into Clinical Care

In South Australia, the Integrated Cardiovascular Clinical Network SA (iCCnet SA) is the provider which enacts the recommendations and policies of the state-wide cardiac clinical network working parties in rural and remote areas by developing appropriate clinical tools.Pathology tests play a significant role in contributing to best practice for patient diagnosis and management. As most South Australian country hospitals do not have timely access to pathology results, point-of-care testing (PoCT) for troponin and N-terminal pro-brain natriuretic peptide (NT-proBNP) has been integrated into clinical pathways for the management of possible acute coronary syndrome (ACS) and suspected heart failure patients respectively. Compared with control hospitals of similar size and resources, preliminary results from an iCCnet SA regional hospital showed improved patient outcomes for ACS: 30-day readmission rates were reduced from 10.4% to 4.2% (p = 0.03) and there was a corresponding trend in the reduction of in-hospital death rates from 15.8% to 9.8% (p = 0.1).The establishment of iCCnet SA has improved outcomes for rural patients presenting to hospital with symptoms suggestive of ACS by facilitating the uptake of evidence-based acute cardiac care. Implementation of PoCT equipment into clinical care requires a systematic approach that engages all stakeholders involved in patient care. Provider clinical networks, such as iCCnet SA, provide a structure for effective working relationships between health professionals. PoCT has been critical to the success of the network, but it needs to be implemented within an integrated system of care to produce optimal outcomes.     

The Evidence to Support Point-of-Care Testing

Point-of-care testing (PoCT) is now possible in many areas of clinical medicine. This review examines the evidence for its application in four areas: self-monitoring; community testing primarily in the pharmacy; general practice; and the emergency department. In all of these areas except pharmacy, randomised controlled trials of PoCT versus central laboratory testing have been performed, with the results of some of these trials supporting the use of PoCT. Aside from providing evidence, these trials and other observational studies have provided valuable information about how PoCT should be conducted. In particular they have shown that adoption of the technology is often insufficient to achieve a benefit and in some cases a change of care process is also required.     

A pragmatic cluster randomized controlled trial of early intervention for chronic obstructive pulmonary disease by practice nurse-general practitioner teams: Study Protocol

ABSTRACT: BACKGROUND: Chronic Obstructive Pulmonary Disease (COPD) is a leading cause of disability, hospitalization, and premature mortality. General practice is well placed to diagnose and manage COPD, but there is a significant gap between evidence and current practice, with a low level of awareness and implementation of clinical practice guidelines. Under-diagnosis of COPD is a world-wide problem, limiting the benefit that could potentially be achieved through early intervention strategies such as smoking cessation, dietary advice, and exercise. General practice is moving towards more structured chronic disease management, and the increasing involvement of practice nurses in delivering chronic care. DESIGN: A pragmatic cluster randomised trial will test the hypothesis that intervention by a practice nurse-general practitioner (GP) team leads to improved health-related quality of life and greater adherence with clinical practice guidelines for patients with newly-diagnosed COPD, compared with usual care. Forty general practices in greater metropolitan Sydney Australia will be recruited to identify patients at risk of COPD and invite them to attend a case finding appointment. Practices will be randomised to deliver either practice nurse-GP partnership care, or usual care, to patients newly-diagnosed with COPD. The active intervention will involve the practice nurse and GP working in partnership with the patient in developing and implementing a care plan involving (as appropriate), smoking cessation, immunisation, pulmonary rehabilitation, medication review, assessment and correction of inhaler technique, nutritional advice, management of psycho-social issues, patient education, and management of co-morbidities. The primary outcome measure is health-related quality of life, assessed with the St George's Respiratory Questionnaire 12 months after diagnosis. Secondary outcome measures include validated disease-specific and general health related quality of life measures, smoking and immunisation status, medications, inhaler technique, and lung function. Outcomes will be assessed by project officers blinded to patients' randomization groups. DISCUSSION: This study will use proven case-finding methods to identify patients with undiagnosed COPD in general practice, where improved care has the potential for substantial benefit in health and healthcare utilization. The study provides the capacity to trial a new model of team-based assessment and management of newly diagnosed COPD in Australian primary care. Trial registration ACTRN12610000592044\     

General Practitioners’ Experiences of,and Responses to,Uncertainty in Prostate Cancer Screening: Insights from a Qualitative Study

BackgroundProstate-specific antigen (PSA) testing for prostate cancer is controversial. There are unresolved tensions and disagreements amongst experts, and clinical guidelines conflict. This both reflects and generates significant uncertainty about the appropriateness of screening. Little is known about general practitioners’ (GPs’) perspectives and experiences in relation to PSA testing of asymptomatic men. In this paper we asked the following questions: (1) What are the primary sources of uncertainty as described by GPs in the context of PSA testing? (2) How do GPs experience and respond to different sources of uncertainty?MethodsThis was a qualitative study that explored general practitioners’ current approaches to, and reasoning about, PSA testing of asymptomatic men. We draw on accounts generated from interviews with 69 general practitioners located in Australia (n = 40) and the United Kingdom (n = 29). The interviews were conducted in 2013–2014. Data were analysed using grounded theory methods. Uncertainty in PSA testing was identified as a core issue.FindingsAustralian GPs reported experiencing substantially more uncertainty than UK GPs. This seemed partly explainable by notable differences in conditions of practice between the two countries. Using Han et al’s taxonomy of uncertainty as an initial framework, we first outline the different sources of uncertainty GPs (mostly Australian) described encountering in relation to prostate cancer screening and what the uncertainty was about. We then suggest an extension to Han et al’s taxonomy based on our analysis of data relating to the varied ways that GPs manage uncertainties in the context of PSA testing. We outline three broad strategies: (1) taking charge of uncertainty; (2) engaging others in managing uncertainty; and (3) transferring the responsibility for reducing or managing some uncertainties to other parties.ConclusionOur analysis suggests some GPs experienced uncertainties associated with ambiguous guidance and the complexities of their situation as professionals with responsibilities to patients as considerably burdensome. This raises important questions about responsibility for uncertainty. In Australia in particular they feel insufficiently supported by the health care system to practice in ways that are recognisably consistent with ‘evidence based’ professional standards and appropriate for patients. More work is needed to clarify under what circumstances and how uncertainty should be communicated. Closer attention to different types and aspects of the uncertainty construct could be useful.     

Verification of quantitative analytical methods in medical laboratories

BackgroundGlobally, all medical laboratories seeking accreditation should meet international quality standards to perform certain specific tests. Quality management program provides disciplines targeted to ensure that quality standards have been implemented by a laboratory in order to generate correct results. The hallmark of the accreditation process is method verification and quality assurance. Before introducing a new method in your laboratory, it is important to assess certain performance characteristics that reflect the concept of method verification.MethodsIn this review, we illustrated how to verify the performance characteristics of a new method according to the recent guidelines. It includes an assessment of precision, trueness, analytical sensitivity, detection limits, analytical specificity, interference, measuring range, linearity, and measurement uncertainty.ConclusionsAlthough the presence of several updated guidelines used to determine the performance characteristics of new methods in clinical chemistry laboratories, the real practice raised several concerns with the application of these guidelines which in need for further consideration in the upcoming updates of these guidelines.     

Setting standards based on patients' views on access and continuity: secondary analysis of data from the general practice assessment survey

ObjectivesTo examine patients'' views on access and continuity in general practice to derive quality standards.DesignSecondary analysis of data from general practice research studies and routine quality assessment activities undertaken by practices and primary care trusts.SettingGeneral practice.ParticipantsGeneral practice patients.ResultsSatisfactory standards of access were next day appointments with general practitioners and a 6-10 minute wait for consultations to begin. A satisfactory level of continuity was seeing the same general practitioner “a lot of the time.” Standards varied with the analytic method used and by sociodemographic group.ConclusionsStandards expected by patients in primary care can be derived from linked report-assessment pairs. Patients may have expectations of access that are in excess of government targets. Patients also have high expectations of continuity of care. It is unclear the degree to which such standards are reliable or valid, how conflicts between access and continuity should be resolved, or how these standards relate to other priorities of patients such as high quality interpersonal care.

What is already known on this topic

Standards are increasingly being set for the provision of health servicesSurveys and consultation exercises before the NHS plan helped set the standard for a maximum waiting time of 48 hours for appointments to see general practitionersThe optimal methods by which patients should be involved in setting standards and the utility of such standards are unclear

What this study adds

Satisfactory standards of access were next day appointments, a 6-10 minute wait for consultations to begin, and seeing the same general practitioner a lot of the timePatients may have expectations for access to primary care in excess of current government targets     

Continuing medical education in Europe: NVVC,CVOI, ESC,UEMS and EBAC

The European Board for Accreditation in Cardiology (EBAC) is a joint initiative of the European Society of Cardiology (ESC) and the Cardiology Section of the Union of European Medical Specialists or Union Européenne des Médecins Spécialistes (UEMS). EBAC operates independently from these parent organisations. The ESC is the highest cardiovascular scientific authority in Europe and the most important provider of Continuing Medical Education (CME) in cardiology. The UEMS officially represents the European medical specialists at the European Union (EU). The UEMS consists of different mono-specialist sections, among which the Cardiology Section. The recognition of the importance of CME and the need for quality standards and quality control led the UEMS to establish the European Accreditation Council for CME (EACCME) in January 2000. CME activities that seek European accreditation have to comply with the regulations of this council. As a consequence of the establishment of EACCME, the mono-specialist sections of the UEMS together with the different European scientific societies started to create accreditation boards with the aim to assess international CME activities in accordance with the regulations of UEMS and EACCME. EBAC was founded in 2000. EBAC accreditation is complimentary to national CME accreditation. The Netherlands Society of Cardiology (Nederlandse Vereniging voor Cardiologie, NVVC) and its Institute for CME, the Netherlands Institute for Continuing Cardiovascular Education (Cardio-Vasculair Onderwijs Instituut, CVOI) formally recognise EBAC accreditation and Attendance Certificates.     

General practice and pandemic influenza: a framework for planning and comparison of plans in five countries

Background

Although primary health care, and in particular, general practice will be at the frontline in the response to pandemic influenza, there are no frameworks to guide systematic planning for this task or to appraise available plans for their relevance to general practice. We aimed to develop a framework that will facilitate planning for general practice, and used it to appraise pandemic plans from Australia, England, USA, New Zealand and Canada.

Methodology/Principal Findings

We adapted the Haddon matrix to develop the framework, populating its cells through a multi-method study that incorporated the peer-reviewed and grey literature, interviews with general practitioners, practice nurses and senior decision-makers, and desktop simulation exercises. We used the framework to analyse 89 publicly-available jurisdictional plans at similar managerial levels in the five countries. The framework identifies four functional domains: clinical care for influenza and other needs, public health responsibilities, the internal environment and the macro-environment of general practice. No plan addressed all four domains. Most plans either ignored or were sketchy about non-influenza clinical needs, and about the contribution of general practice to public health beyond surveillance. Collaborations between general practices were addressed in few plans, and inter-relationships with the broader health system, even less frequently.

Conclusions

This is the first study to provide a framework to guide general practice planning for pandemic influenza. The framework helped identify critical shortcomings in available plans. Engaging general practice effectively in planning is challenging, particularly where governance structures for primary health care are weak. We identify implications for practice and for research.     

Study protocol of a mixed-methods evaluation of a cluster randomized trial to improve the safety of NSAID and antiplatelet prescribing: data-driven quality improvement in primary care

ABSTRACT: BACKGROUND: Trials of complex interventions are criticized for being 'black box', so the UK Medical Research Council recommends carrying out a process evaluation to explain the trial findings. We believe it is good practice to pre-specify and publish process evaluation protocols to set standards and minimize bias. Unlike protocols for trials, little guidance or standards exist for the reporting of process evaluations. This paper presents the mixed-method process evaluation protocol of a cluster randomized trial, drawing on a framework designed by the authors.Methods/designThis mixed-method evaluation is based on four research questions and maps data collection to a logic model of how the data-driven quality improvement in primary care (DQIP) intervention is expected to work. Data collection will be predominately by qualitative case studies in eight to ten of the trial practices, focus groups with patients affected by the intervention and quantitative analysis of routine practice data, trial outcome and questionnaire data and data from the DQIP intervention. DISCUSSION: We believe that pre-specifying the intentions of a process evaluation can help to minimize bias arising from potentially misleading post-hoc analysis. We recognize it is also important to retain flexibility to examine the unexpected and the unintended. From that perspective, a mixed-methods evaluation allows the combination of exploratory and flexible qualitative work, and more pre-specified quantitative analysis, with each method contributing to the design, implementation and interpretation of the other.As well as strengthening the study the authors hope to stimulate discussion among their academic colleagues about publishing protocols for evaluations of randomized trials of complex interventions.Data-driven quality improvement in primary care trial registrationClinicalTrials.gov: NCT01425502.     

A systematic approach for prioritizing multiple management actions for invasive species

The successful management and eradication of invasive species is often constrained by insufficient or inconsistent funding. Consequently, managers are usually forced to select a subset of infested areas to manage. Further, managers may be unaware of the most effective methods for identifying priority areas and so are unable to maximize the effectiveness of their limited resources. To address these issues, we present a spatially explicit decision method that can be used to identify actions to manage invasive species while minimizing costs and the likelihood of reinvasion. We apply the method to a real-world management scenario, aimed at managing an invasive aquatic macrophyte, olive hymenachne (Hymenachne amplexicaulis), which is one of the most threatening invasives in tropical Australia, affecting water quality, freshwater biodiversity, and fisheries.     

JCI认证特点解析及体会

通过对JCI认证的理念、认证的特点和评审标准的充分理解和体会,分析了JCI认证对我国医院管理和医疗质量提高的积极促进作用,同时也指出医院在认证过程中存在的问题,为医院真正实现JCI认证的目的提供建议。     

Foreword: International Standards for Native Seeds in Ecological Restoration

Restoration practitioners must increasingly incorporate seed procurement models and seed use planning early in project development, despite insufficient guidance about what are reasonable expectations for the sourcing and use of native seeds. This special issue presents a series of articles examining each key step in the native seed supply chain, and provides a framework for the “standards” that need to be applied to native seed batches if the native seed supply chain is to achieve the levels of reliability and transparency required. These Standards provide seed buyers, end users, and funding bodies with a level of confidence and reliability in the sourcing of quality native seeds, and a pathway toward global best practice in native seed use.     

Voluntary accreditation of cellular therapies: Foundation for the Accreditation of Cellular Therapy (FACT)

Voluntary accreditation of cells, tissues, and cellular and tissue-based products intended for human transplantation is an important mechanism for improving quality in cellular therapy. The Foundation for the Accreditation of Cellular Therapy (FACT) has developed and implemented programs of voluntary inspection and accreditation for hematopoietic cellular therapy, and for cord blood banking. These programs are based on the standards of the clinical and laboratory professionals of the American Society of Blood and Marrow Transplantation (ASBMT), the International Society for Cellular Therapy (ISCT), and NETCORD. FACT has collaborated with European colleagues in the development of the Joint Accreditation Committee in Europe (jACIE). FACT has published standards documents, a guidance manual, accreditation checklists, and inspection documents; and has trained as inspectors over 300 professionals active in the field. All inspectors have a minimum of 5 years' experience in the area they inspect. Since the incorporation of FACT in 1996, 215 hematopoietic progenitor cell facilities have applied for FACT accreditation. Of these facilities, 113 are fully accredited; the others are in the process of document submission or inspection. Significant opportunities and challenges exist for FACT in the future, including keeping standards and guidance materials current and relevant, recruiting and retaining expert inspectors, and establishing collaborations to develop standards and accreditation systems for new cellular products. The continuing dialogue with the Food and Drug Administration (FDA) is also important to ensure that they are aware of the accomplishments of voluntary accreditation, and keep FACT membership alerted to FDA intentions for the future. Other potential avenues of communication and cooperation with FDA and other regulatory agencies are being investigated and evaluated.     

Impact of nurse practitioners on workload of general practitioners: randomised controlled trial

Objective To examine the impact on general practitioners'' workload of adding nurse practitioners to the general practice team.Design Randomised controlled trial with measurements before and after the introduction of nurse practitioners.Setting 34 general practices in a southern region of the Netherlands.Participants 48 general practitioners.Intervention Five nurses were randomly allocated to general practitioners to undertake specific elements of care according to agreed guidelines. The control group received no nurse.Main outcome measures Objective workload, derived from 28 day diaries, included the number of contacts per day for each of three conditions (chronic obstructive pulmonary disease or asthma, dementia, cancer), by type of consultation (in practice, telephone, home visit), and by time of day (surgery hours, out of hours). Subjective workload was measured by using a validated questionnaire. Outcomes were measured six months before and 18 months after the intervention.Results The number of contacts during surgery hours increased in the intervention group compared with the control group (P < 0.06), particularly for patients with chronic obstructive pulmonary disease or asthma (P < 0.01). The number of consultations out of hours declined slightly in the intervention group compared with the control group, but this difference did not reach significance. No significant changes became apparent in subjective workload.Conclusion Adding nurse practitioners to general practice teams did not reduce the workload of general practitioners, at least in the short term. This implies that nurse practitioners are used as supplements, rather than substitutes, for care given by general practitioners.     

Counsellors in English and Welsh general practices: their nature and distribution.

OBJECTIVE--To establish the prevalence of counselling services in English and Welsh general practices and factors associated with their distribution; to describe qualifications, working arrangements, and case mix of "counsellors." DESIGN--Postal questionnaire and telephone interview survey of a sample of about one in 20 general practitioners in England and Wales. SETTING--English and Welsh general practices. SUBJECTS--1880 general practitioners of whom 1542 (82%) completed questionnaires. MAIN OUTCOME MEASURES--Prevalence and distribution of practice counselling services; counsellors'' qualifications and funding; types of patients referred. RESULTS--586 counsellors were distributed among 484 of the 1542 practices. Three types of counsellor predominated: community psychiatric nurses (187); "practice counsellors" (145); and clinical psychologists (95). Practice characteristics which independently predicted the presence of a counsellor were for community psychiatric nurses four or more partners (odds = 1.72, 95% confidence interval 1.18 to 2.26); for practice counsellors stress clinic (odds = 2.22; 1.83 to 2.61), training practice (odds = 1.70; 1.24 to 2.16), and health region (chi 2 = 55.94; df = 14; p < 0.001); and for clinical psychologists list size of > or = 10,500 (odds = 1.79; 1.09 to 2.49), training practice (odds = 1.78; 1.31 to 2.25), health region (chi 2 = 48.31; df = 14; p < 0.001). 197 counsellors had training in counselling. The qualifications of 85 were unknown to the general practitioner. The principal source of funding was the district health authority for community psychiatric nurses (150) and clinical psychologists (58) and the family health services authority for practice counsellors (76). All counsellors were referred a wide range of problems. CONCLUSIONS--Counselling services are wide-spread in general practice, but a high proportion of counsellors lack qualifications, and many may be referred problems outside their knowledge.     

Cost effectiveness analysis of a randomised trial of acupuncture for chronic headache in primary care

Objective To evaluate the cost effectiveness of acupuncture in the management of chronic headache.Design Cost effectiveness analysis of a randomised controlled trial.Setting General practices in England and Wales.Participants 401 patients with chronic headache, predominantly migraine.Interventions Patients were randomly allocated to receive up to 12 acupuncture treatments over three months from appropriately trained physiotherapists, or to usual care alone.Main outcome measure Incremental cost per quality adjusted life year (QALY) gained.Results Total costs during the one year period of the study were on average higher for the acupuncture group (£403; $768; €598) than for controls (£217) because of the acupuncture practitioners'' costs. The mean health gain from acupuncture during the one year of the trial was 0.021 quality adjusted life years (QALYs), leading to a base case estimate of £9180 per QALY gained. This result was robust to sensitivity analysis. Cost per QALY dropped substantially when the analysis incorporated likely QALY differences for the years after the trial.Conclusions Acupuncture for chronic headache improves health related quality of life at a small additional cost; it is relatively cost effective compared with a number of other interventions provided by the NHS.