中医药大规模临床研究的数据核查

当前我国中医药临床研究质量普遍偏低,其提供的有关中医药有效性和安全性的证据强度较弱。研究过程中缺乏科学管理,尤其在数据管理环节存在较多问题,是导致中医药研究水平较低的原因之一。因此,加强临床研究过程中的数据管理,对提高中医药临床研究质量十分必要。本文结合国家科技攻关计划项目的具体实践,介绍了数据管理中的核查环节,以供参考。     

The National Clinical Audit of Falls and Bone Health—secondary prevention of falls and fractures: a physiotherapy perspective

Objective

To establish current physiotherapy practice in the secondary management of falls and fragility fractures compared with national guidance.

Design

Web-based national clinical audit.

Participants

Acute trusts (n = 157) and primary care trusts (n = 146) in England, Wales and Northern Ireland.

Results

Data were collected on 5642 patients with non-hip fragility fractures and 3184 patients with a hip fracture. Those patients who were bedbound or who declined assessment or rehabilitation were excluded from the analysis. Results indicate that of those with non-hip fractures, 28% received a gait and balance assessment, 22% participated in an exercise programme, and 3% were shown how to get up from the floor. For those with a hip fracture, the results were 68%, 44% and 7%, respectively.

Conclusions

Physiotherapists have a significant role to play in the secondary prevention of falls and fractures. However, along with managers and professional bodies, more must be done to ensure that clinical practice reflects the evidence base and professional standards.     

The use of audit in acute pain services: a UK perspective

Clinical audit aims to improve the quality of patient care. It identifies, from research evidence, the best treatment for patients, measures current practice and then attempts to improve any deficiencies in order to improve the quality of clinical care. This review will outline the successive steps required to implement the clinical audit, identify the barriers to change, highlight examples of well-conducted acute pain audit and introduce the concept of measuring quality within acute pain services. In addition, the role of clinical audit in national clinical effectiveness strategies will be explored. Recent changes in the law restricting access to patients’ confidential data may have a profound bearing on audit, epidemiological research and ultimately clinical governance and the future implications for large-scale investigative audit will be discussed.     

Audit and Re-audit of the CSP Core Standards of Physiotherapy Practice

The third edition of the Core Standards of PhysiotherapyPractice has been piloted in eight sites, representing the whole breadth of the physiotherapy profession. Part of the pilot involved auditing patient records and soliciting patient feedback using a questionnaire, both in two stages. The first audit was carried out before physiotherapists had knowledge of the content of the new standards. The re-audit was carried out after a period of awareness-raising and implementation of any changes arising from the first audit. All audit criteria including the patient feedback were specifically generated from the standards.Significant and important improvements were reported from the patient record audits, especially in the standards relating to recording of patients' expectations, patients' goals, and use of outcome measures.The patient feedback questionnaire showed a consistently high level of achievement but less real change between the two audits. Some issues around consent improved, as did privacy. Performance against some criteria deteriorated, although not significantly, for example patients' perceptions of the effectiveness of treatment. Documentation in patient records has shown important improvements as a result of the new standards. Feedback from patients suggests little change in conformance with those standards and criteria more appropriately measured by patients.Audit is a useful tool for disseminating and implementing national standards when carried out in partnership with physiotherapy managers.     

Introducing delirium screening in a cardiothoracic critical care unit

Aim: To share an experience of introducing Delirium scoring into a Cardiothoracic Critical Care Unit and the lessons learnt. Background: Delirium has serious consequences leading to increased length of stay in hospital, the possible development of dementia with the associated need for long‐term care and even death. It is therefore vital that the Critical Care nurses are able to prevent, recognize and manage delirium. Data sources and methods: 108 patients who were admitted over a 6 week period were audited and their delirium score, documentation and treatment plans were reviewed. Results: 21% of patients experienced delirium during their stay on Cardiothoracic Critical Care and hypoactive delirium was the most prevalent subtype. Of the three patients who stayed more than 20 days on critical care all suffered with delirium at some point during their stay. Documentation of delirium by both Nursing and Medical staff occurred in less than 50% of patients. Conclusions: The introduction of delirium scoring and audit of its practice has highlighted the incidence of delirium in critically ill patients and has resulted in;

• Improved quality of care by development of a delirium care bundle
• Improved recognition of delirium
• Instigation of practices to prevent and treat delirium

     

Improving clinical practice in stroke through audit: results of three rounds of National Stroke Audit

BACKGROUND: The results of three rounds of National Stroke Audit in England, Wales and Northern Ireland are compared. METHODS: Audit of the organization of stroke services and retrospective case-note audit of up to 40 consecutive cases admitted per hospital over a 3-month period was conducted in each of 1998, 1999 and 2001/02. The changes in the organizational, case-mix and process results of the hospitals that had participated in all three rounds were analysed. RESULTS: 60% of all eligible trusts from England, Wales and Northern Ireland took part in all three audits in 1998, 1999 and 2001/02. Total numbers of cases were 4996, 4841 and 5152, respectively. Case-mix variables were similar over the three rounds. Mortality at 7 and 30 days fell by 3% and 5%, respectively. The proportion of hospitals with a stroke unit rose from 48% to 77%. The proportion of patients spending most of their stay in a stroke unit rose from 17% in 1998 to 26% in 1999 and 29% in 2001/02. Improvements achieved in process standards of care between 1998 and 1999 (median change was a gain of 9%) failed to improve further by 2001/02 (median change was 0%). In all three rounds process standards of care tended to be better in stroke units. CONCLUSIONS: Three rounds of national audit of stroke care have shown standards of care on stroke units were notably higher than on general wards. Slowing in the rise of the proportion managed on stroke units mirrors the slow down in improvement to overall national standards of care. To further improve outcomes and national standards of stroke care a much higher proportion of patients needs to be managed in stroke units.     

Audit as a learning tool in postgraduate emergency medicine training

Objective: Educational activities for emergency medicine trainees need to be clinically focused, relevant, and ideally have the capacity to change practice and patient outcomes. It is proposed that the use of audit methods in educational sessions may address these learning needs. The aims of this project were to involve emergency medicine trainees in undertaking audits of ED patient care, and to evaluate the use of this technique in fulfilling training needs. Methods: Trainees were given clinical topics on which to develop a presentation at weekly education sessions within the ED. This presentation included a brief clinical audit concerning an aspect of the same topic. The audit question addressed one of the issues identified as standard of care in the trainee presentation and investigated our department's level of compliance with that standard. At the end of a 6‐month period, a questionnaire was given to all trainees involved, either as presenters or attendees at an audit presentation. Results: Trainees performing audits reported that this method was most useful for demonstrating the limitations of coding, giving a greater appreciation of poor documentation in medical records, and improving their presentation skills. Most trainees attending audit based presentations reported that this educational method gave them a greater appreciation of systems based practice, actually changed their clinical practice, and was more useful than traditional lectures. Conclusions: Audit should be a key component of emergency medicine education. Trainees perceive the technique as useful addressing a number of training needs in a clinical context.     

Audit,guidelines and standards: Clinical governance for hip fracture care in Scotland

Purpose: To report on experience of national-level audit, guidelines and standards for hip fracture care in Scotland.

Methods: Scottish Hip Fracture Audit (from 1993) documents case-mix, process and outcomes of hip fracture care in Scotland. Evidence-based national guidelines on hip fracture care are available (1997, updated 2002). Hip fracture serves as a tracer condition by the health quality assurance authority for its work on older people, which reported in 2004.

Results: Audit data are used locally to document care and support and monitor service developments. Synergy between the guidelines and the audit provides a means of improving care locally and monitoring care nationally. External review by the quality assurance body shows to what extent guideline-based standards relating to A&E care, pre-operative delay, multidisciplinary care and audit participation are met

Conclusion: Three national-level initiatives on hip fracture care have delivered: Reliable and large-scale comparative information on case-mix, care and outcomes; evidence-based recommendations on care; and nationally accountable standards inspected and reported by the national health quality assurance authority. These developments are linked and synergistic, and enjoy both clinical and managerial support. They provide an evolving framework for clinical governance, with casemix-adjusted outcome assessment for hip fracture care as a next step.     

Audit, guidelines and standards: Clinical governance for hip fracture care in Scotland

Purpose: To report on experience of national-level audit, guidelines and standards for hip fracture care in Scotland.

Methods: Scottish Hip Fracture Audit (from 1993) documents case-mix, process and outcomes of hip fracture care in Scotland. Evidence-based national guidelines on hip fracture care are available (1997, updated 2002). Hip fracture serves as a tracer condition by the health quality assurance authority for its work on older people, which reported in 2004.

Results: Audit data are used locally to document care and support and monitor service developments. Synergy between the guidelines and the audit provides a means of improving care locally and monitoring care nationally. External review by the quality assurance body shows to what extent guideline-based standards relating to A&E care, pre-operative delay, multidisciplinary care and audit participation are met

Conclusion: Three national-level initiatives on hip fracture care have delivered: Reliable and large-scale comparative information on case-mix, care and outcomes; evidence-based recommendations on care; and nationally accountable standards inspected and reported by the national health quality assurance authority. These developments are linked and synergistic, and enjoy both clinical and managerial support. They provide an evolving framework for clinical governance, with casemix-adjusted outcome assessment for hip fracture care as a next step.     

Audit in transfusion practice

Given the growing concern for the safety, cost and adequacy of blood supply, there is an increasing need for appropriate blood product utilization. Despite a number of consensus guidelines for the transfusion of allogeneic blood products, inappropriate blood transfusion continues. We discuss the quality assurance process for improvement in transfusion therapy including audit of blood transfusion. Audits identify areas of problems in transfusion practice which can be corrected by education of doctors, formulation of practice guidelines and algorithms. To improve the effectiveness of the audit programmes, the frequency of audits has to be maintained and there should be continual reinforcement of policies.     

Audit of nasal fracture management in accident and emergency in a district general hospital

RATIONALE: Nasal fractures are a common occurrence in accident and emergency and dealt with by inexperienced senior house officers. This can lead to inappropriate X-rays being performed, no proper documentation of septal haematomas and often no follow-up with a specialist team leading to in some cases complex cosmetic surgery whereas simple manipulation may have sufficed. METHOD: We report an ambispective audit carried out on nasal fracture management in a busy district general hospital over a 6-month period. RESULTS: 46 patients were seen 24 in the first 3 months and 22 the next three. 10 had nasal X-ray performed initially on audit. Nine had no documentation of septal haematoma and seven had no follow-up arranged. After appropriate education and the setting up of a department protocol based on best practice, the next cycle was repeated. Two nasal X-rays were performed looking for foreign bodies, all patients had appropriate documentation of septal haematoma and appropriate follow-up. CONCLUSION: Appropriate education and implementation of departmental guidelines can result in more effective and efficient use of resources when dealing with nasal fractures in accident and emergency.     

The Nursing and Midwifery Content Audit Tool (NMCAT): a short nursing documentation audit tool

johnson m., jefferies d. & langdon r. (2010) Journal of Nursing Management
The Nursing and Midwifery Content Audit Tool (NMCAT): a short nursing documentation audit tool Background The Nursing and Midwifery Content Audit Tool (NMCAT) was developed to monitor the quality of nursing documentation. Methods A health care record audit was conducted on 200 records. Using a time-sampling approach, recent nursing documentation was examined. Inter-rater reliability was determined at 85% agreement between two raters. Results The NMCAT criteria relating to the recording of the patients’ health status, use of objective information and logical presentation were met to a high level. The patients’ response to treatment or nursing interventions including medications requires attention. The recording of events immediately after they have occurred was limited. The structure of the sentences and language used, restricted the readability of the documentation. The widespread use of local abbreviations, often connected together to form the text, was problematic. Conclusions The present study provides new audit solutions based on time-sampling approaches and focused evidence-based criteria. The use of language support software and writing coaches to improve the presentation of nursing documentation is recommended. Implications for Nursing Management The NMCAT is a time-efficient tool available to managers for monitoring the quality of nursing documentation, either at a unit level or across health facilities to demonstrate compliance with quality standards.     

The Total Health Care Audit System: a systematic methodology for clinical practice evaluation and development in NHS provider organizations

Writing in Medical Education in 1982, Fowkes (1982) noted the lack of general agreement within the medical profession on methods of audit, a deficiency previously articulated by Shaw (1980) and later emphasized by McIntyre (1985). More recently, a study by Black & Thompson (1993) of consultant and junior medical staff in four London district general hospitals revealed that 'many doctors did not understand how to undertake audit', and major research by both Hopkins (1993, 1994) and Buttery et al. (1994) described a multiplicity of methodological deficiencies in the general approaches to audit adopted by clinicians since the promulgation of the White Paper definition in 1989. Soundness of methodological approach is fundamental to securing the success of clinical audit within Provider organizations and is thus central to the generation of measurable improvements in the quality of clinical care being delivered to patients. It is therefore disturbing that methodological deficiencies may still be observed in general approaches to audit (Buttery et al. 1994), with no author yet recommending a formal system for critical inquiry into clinical practice. It was the recognition of the unsatisfactory nature of this situation which led us to develop a system aimed at assessing, in a critical fashion, the quality of the totality of care dispensed within NHS provider organizations. The system is presented here for the first time.     

Reliability and validity of the Intercollegiate Stroke Audit Package

The aim of this study was to assure the validity and reliability of the Intercollegiate Stroke Audit Package as used in the National Sentinel Audit of Stroke. The Intercollegiate Working Party for Stroke, which included most stakeholders, including patients, devised the audit standards. These were submitted to a formal consensus (modified Delphi) survey before the audit questions were developed and piloted for validity and reliability. Following the pilot, Help Booklets were developed to promote the involvement of all disciplines as auditors in the national sentinel audit of stroke and ensure inter-rater reliability. During the national audit each Trust was asked to double rate the first five cases with auditors of different disciplines working independently. A total of 886 case notes were double-rated in 184 separate sites (median 5, range 1-5 per site). Trusts used auditors from different disciplines in 77% of cases. After excluding the 'No answer' cases the kappa score for items ranged from 0.49 to 0.87 (median 0.70, IQR 0.63-0.78). Very good agreement was found for seven of the 45 items, good agreement for 30 items, and moderate agreement for eight items. This large study, across a range of hospital sites and involving many disciplines, demonstrates that careful piloting of audit tools, with use of clear instructions to auditors, promotes the reliability of data.