Data quality and clinical audit

Clinical audit has an increasingly important role in the quality of care being offered to patients. Only good-quality data can enable valid conclusions to be drawn, which in turn enable changes to be made for the better. More and more patient data are held on NHS computer systems, and increasingly these data are being used to facilitate the audit process. The quality of any such data needs to meet the highest standards. This article briefly defines the audit cycle and goes on to consider a typical data model. The various elements of the data model are defined, the understanding of which should enable individuals to avoid pitfalls in data collection and ensure that the data they collect for clinical audit are of the highest quality.     

Data quality and clinical audit

Clinical audit has an increasingly important role in the quality of care being offered to patients. Only good-quality data can enable valid conclusions to be drawn, which in turn enable changes to be made for the better. More and more patient data are held on NHS computer systems, and increasingly these data are being used to facilitate the audit process. The quality of any such data needs to meet the highest standards. This article briefly defines the audit cycle and goes on to consider a typical data model. The various elements of the data model are defined, the understanding of which should enable individuals to avoid pitfalls in data collection and ensure that the data they collect for clinical audit are of the highest quality.     

Data quality and clinical audit

Clinical audit has an increasingly important role in the quality of care being offered to patients. Only good-quality data can enable valid conclusions to be drawn, which in turn enable changes to be made for the better. More and more patient data are held on NHS computer systems, and increasingly these data are being used to facilitate the audit process. The quality of any such data needs to meet the highest standards. This article briefly defines the audit cycle and goes on to consider a typical data model. The various elements of the data model are defined, the understanding of which should enable individuals to avoid pitfalls in data collection and ensure that the data they collect for clinical audit are of the highest quality.     

Testing quality improvement interventions

The quality of health care is in drastic need of improvement. Surgeons are key players in the health care delivery system, and as such, they should be involved by leading or participating in the improvements that should take place. This article posits some suggestions as to how surgeons can participate in the efforts to make the health care provided to patients better and make the system a better place to work for surgeons and for other health professionals. Participation in quality improvement (QI) initiatives has the potential to bring much personal satisfaction for surgeons who help the process to move forward, even though it takes some effort and even forces them to learn some new skills and attitudes to what can be accomplished by QI teams. This article provides a methodologic guide to conducting and evaluating QI research.     

Quality assurance in day case surgery: closing the audit loop

Following recommendations made after a quality assurance initiative at Addenbrooke's Day Surgery Unit, Cambridge, a further audit was undertaken some months later. Many improvements were noted but certain areas gave cause for concern, e.g. an increase in the number of cancellations and little improvement in the adoption of better day case anaesthetic techniques. Re-audit is regarded as an essential exercise although care should be taken not to collect too much data. In future small audit projects will be undertaken and an education programme established to ensure that positive changes are indeed made as a result of audit findings.     

Issues of consent and privacy affecting the functioning of ASERNIP-S

The Australian Safety and Efficacy Register for New Interventional Procedures - Surgical (ASERNIP-S) undertakes horizon scanning, systematic reviews and audits. By disseminating information derived from these processes, ASERNIP-S aims to improve the quality of health care. In the present article, we discuss some of the legal and ethical issues surrounding the collection of identified data for the purposes of audit. The individual's right to privacy is considered as well as the benefits of improving the quality of surgical health care.     

Guidelines for surgical audit in Australia and New Zealand

Surgical audit is an important part of the process to measure performance, reduce clinical risk and improve quality of care. Recognizing this, the Royal Australasian College of Surgeons established a Surgical Audit Taskforce as a subcommittee of the Board of Continuing Professional Standards. This study aims to review the recommendations of the Taskforce for data collection and peer review. The minimum data for whole-practice, continuing audit have been defined. The method of data collection, devices and databases are personal choices for the individual surgeon. However, there are many benefits of developing an electronic surgical audit, and these include facilitating comparison and sharing of audit data between units. Surgical audits should not only report on work carried out but also ensure that outcomes include key performance indicators such as major complications, readmissions, reoperations, transfers, incident reports, complaints and mortalities. Effective clinical governance demands that issues raised by audit need to be documented and reported together with recommendations for improvement. Surgeons should be proactive in helping to find and implement solutions to the issues arising from surgical audit.     

Use of national surgical quality improvement program data as a catalyst for quality improvement

BACKGROUND: Semiannually, the National Surgical Quality Improvement Program (NSQIP) provides its participating sites with observed-to-expected (O/E) ratios for 30-day postoperative mortality and morbidity. At each reporting period, there is typically a small group of hospitals with statistically significantly high O/E ratios, meaning that their patients have experienced more adverse events than would be expected on the basis of the population characteristics. An important issue is to determine which actions a surgical service should take in the presence of a high O/E ratio. STUDY DESIGN: This article reviews case studies of how some of the Department of Veterans Affairs and private-sector NSQIP participating sites used the clinically rich NSQIP database for local quality improvement efforts. Data on postoperative adverse events before and after these local quality improvement efforts are presented. RESULTS: After local quality improvement efforts, wound complication rates were reduced at the Salt Lake City Veterans Affairs medical center by 47%, surgical site infections in patients undergoing intraabdominal surgery were reduced at the University of Virginia by 36%, and urinary tract infections in vascular patients were reduced at the Massachusetts General Hospital by 74%. At some sites participating in the NSQIP, notably the Massachusetts General Hospital and the University of Virginia, the NSQIP has served as the basis for surgical service-wide outcomes research and quality improvement programs. CONCLUSIONS: The NSQIP not only provides participating sites with risk-adjusted surgical mortality and morbidity outcomes semiannually, but the clinically rich NSQIP database can also serve as a catalyst for local quality improvement programs to significantly reduce postoperative adverse event rates.     

Implementing Major Trauma Audit in Ireland

BackgroundThere are 27 receiving trauma hospitals in the Republic of Ireland. There has not been an audit system in place to monitor and measure processes and outcomes of care. The National Office of Clinical Audit (NOCA) is now working to implement Major Trauma Audit (MTA) in Ireland using the well-established National Health Service (NHS) UK Trauma Audit and Research Network (TARN).AimsThe aim of this report is to highlight the implementation process of MTA in Ireland to raise awareness of MTA nationally and share lessons that may be of value to other health systems undertaking the development of MTA.MethodsThe National Trauma Audit Committee of the Royal College of Surgeons in Ireland, consisting of champions and stakeholders in trauma care, in 2010 advised on the adaptation of TARN for Ireland. In 2012, the Emergency Medicine Program endorsed TARN and in setting up the National Emergency Medicine Audit chose MTA as the first audit project. A major trauma governance group was established representing stakeholders in trauma care, a national project co-ordinator was recruited and a clinical lead nominated. Using Survey Monkey, the chief executives of all trauma receiving hospitals were asked to identify their hospital's trauma governance committee, trauma clinical lead and their local trauma data co-ordinator. Hospital Inpatient Enquiry systems were used to identify to hospitals an estimate of their anticipated trauma audit workload.ResultsThere are 25 of 27 hospitals now collecting data using the TARN trauma audit platform. These hospitals have provided MTA Clinical Leads, allocated data co-ordinators and incorporated MTA reports formally into their clinical governance, quality and safety committee meetings. There has been broad acceptance of the NOCA escalation policy by hospitals in appreciation of the necessity for unexpected audit findings to stimulate action.ConclusionMajor trauma audit measures trauma patient care processes and outcomes of care to drive quality improvement at hospital and national level. MTA will facilitate the strategic development of trauma care in Ireland by monitoring processes and outcomes and the effects of changes in trauma service provision.     

Defining high quality health care

Most health care quality improvement efforts target measures of health care structures, processes, and/or outcomes. Structural measures examine relatively fixed aspects of health care delivery such as physical plant and human resources. Process measures, the focus of the largest proportion of quality improvement efforts, assess specific transactions in clinical-patient encounters, such as use of appropriate surgical antibiotic prophylaxis, which are expected to improve outcomes. Outcome measures, which comprise quality of life endpoints as well as morbidity and mortality, are of greatest interest to clinicians and patients, but entail the greatest complexity, as the majority of variance in outcomes is attributable to patient and environmental factors that may not be readily modifiable. Selecting among structure, process, and outcome measures for quality improvement efforts generally will be dictated by the specific clinical situation for which improvement is desired.One aspect of health care quality that has received a great deal of attention in recent years is the relationship between surgical volume and health outcomes. Volume, an inherent characteristic of a health care facility or provider, is generally considered a structural measure of quality. Many studies have demonstrated a positive association between volume and outcomes, and policymakers in the private and public sectors have begun to consider volume in certification and reimbursement decisions. The volume-outcome association is not without controversy, however. Most studies in the field are limited by the nature of the administrative data on which they are based, and some studies have found that variation in quality within volume quantiles exceeds differences between quantiles. Moreover, regionalization driven by a focus on volume may exert adverse effects on access to care.The movement for health care quality improvement faces substantial methodological, clinical, financial, and political challenges. Despite these challenges, it is a movement that is gaining momentum, and the emphasis on quality in health care delivery is likely only to increase in the future. It is crucial, therefore, that physicians assume increasing leadership roles in efforts to define, measure, report, and improve quality of care.     

Alterstraumazentren von der Idee bis zur Umsetzung

The geriatric trauma working party, a subgroup of the German Society of Trauma Surgery (Deutsche Gesellschaft für Unfallchirurgie, DGU), focuses on the challenges of geriatric fractures, which are steadily increasing due to demographic changes. Inherent comorbidities implicate perioperative complications leading to loss of mobility and endangered independence followed by an increased burden on the social services. An interdisciplinary approach is required. The geriatric trauma working party defined criteria for interdisciplinary treatment and comprehensive care as well as early rehabilitation in interdisciplinary geriatric fracture centers. By passing an independent audit process these centers can achieve certification as a geriatric trauma center DGU (AltersTraumaZentrum DGU). Certified centers can participate in a recently established geriatric fracture registry which includes an internationally consented data set. Audit and registry enable centers to acquire an international benchmark, ensure permanent improvement in quality and allow participation in health services research.     

Evidence-based medical quality management in dialysis--Part I: Routine implementation of QiN, a German quality management system

Increasing medical complexity, centrifugal forces of medical subspecialization and growing economic constraints are the key reasons for the introduction of quality management into routine care processes such as dialysis. Adequate quality assurance and improvement must be implemented in order to supply medical staff, care providers, and patients with the necessary information on critical issues of clinical management of dialysis patients. QiN (Quality in Nephrology), the quality management program of the largest German dialysis provider, is outlined here as a practicable example. The first of 2 parts provides information on the structure, implementation of QiN and achieved clinical improvement in routine care. The second part (quotation) analyzes longitudinal data in order to differentiate whether observed improvements during more than 5 years of QiN can be ascribed to the intervention (application of QiN) or whether they are due to other factors such as generally improved medical knowledge.     

The case for restraint in spinal surgery: does quality management have a role to play?

Most quality improvement efforts in surgery have focused on the technical quality of care provided, rather than whether the care was indicated, or could have been provided with a safer procedure. Because risk is inherent in any procedure, reducing the number of unnecessary operations is an important issue in patient safety. In the case of lumbar spine surgery, several lines of evidence suggest that, in at least some locations, there may be excessively high surgery rates. This evidence comes from international comparisons of surgical rates; study of small area variations within countries; increasing surgical rates in the absence of new indications; comparisons of surgical outcomes between geographic areas with high or low surgical rates; expert opinion; the preferences of well-informed patients; and increasing rates of repeat surgery. From a population perspective, reducing unnecessary surgery may have a greater impact on complication rates than improving the technical quality of surgery that is performed. Evidence suggests this may be true for coronary bypass surgery in the US and hysterectomy rates in Canada. Though similar studies have not been done for spine surgery, wide geographic variations in surgical rates suggest that this could be the case for spine surgery as well. We suggest that monitoring geographic variations in surgery rates may become an important aspect of quality improvement, and that rates of repeat surgery may bear special attention. Patient registries can help in this regard, if they are very complete and rigorously maintained. They can provide data on surgical rates; offer post-marketing surveillance for new surgical devices and techniques; and help to identify patient subgroups that may benefit most from certain procedures.     

Evaluating quality in clinical care

Defining and maintaining quality is essential to surgical practice. It is only through structured approaches to assessing outcomes that we can ensure that optimal care is delivered. This article will define quality in healthcare and discuss assessment models with reference to pertinent surgical literature. National initiatives are discussed with a critical appraisal of their role and effectiveness. We discuss the aim of quality improvement initiatives and comment on reporting of outcomes. The difficult question of how to maintain quality during a crisis, such as an infectious disease pandemic, is addressed.     

Preclinical care of trauma patients in air rescue. Results of the medical quality management for patients with severe head injury and polytrauma in the years 2000 and 2001

In a retrospective study of mission data of ADAC Air Rescue of the years 2000 and 2001 the quality of preclinical care of 1,946 patients with severe head injuries and 1,878 polytraumatized patients was examined. The actual preclinical care of these patients was compared with a catalogue of eleven thesis-like recommendations. These recommendations were previously derived from corresponding publications of national and international specialist companies and were introduced in a binding manner by the senior doctors of the participating air rescue centres.The results of the study show that 73.3% of the severe head injuries were preclinically intubated and 94.4% were supplied with oxygen, 82.2% were analgosedated. 94.8% could be delivered to the hospital of destination. 65.9% had a systolic blood pressure of >120 mmHg upon admission to the hospital. 71.4% of severe head injury victims were equipped with a cervical support, 23.3% had the blood pressure documented. 47.3% reached the hospital of destination in less than 60 minutes.Among polytraumatic patients the intubation was performed in 75.7%, the supply with oxygen in 90.7%, 88.6% of the patients were analgosedated. 78.7% of patients suffering from concomitant head injuries were provided with a cervical support and only 22.8% had a blood sugar measurement documented. A concomitant severe thorax trauma was treated by a thorax drainage in 59.2%. 35.6% of the polytraumata reached the hospital of destination in less than 60 minutes.The work describes the preclinical patient care of severe head injuries and polytraumata, pointing out deficits and presenting optimization possibilities, particularly in the area of training. Furthermore, the work shows the concept of the medical quality management in an air rescue enterprise. The total evaluation of all air rescue centres participating in data collection forms the basis of an external quality comparison. The data evaluation of a single station makes regional strengths and weaknesses visible, deficits can be proven and proposals for optimization be developed. The presentation of the time history of data yields continuous standard information on the state of the patient care at the relevant air rescue location and enables the analysis of improvement concepts based on the updated data.     

Impact of a peri‐operative quality improvement programme on postoperative pulmonary complications

Postoperative pulmonary complications are common, with a reported incidence of 2–40%, and are associated with adverse outcomes that include death, longer hospital stay and reduced long‐term survival. Enhanced recovery is now a standard of care for patients undergoing elective major surgery. Despite the high prevalence of pulmonary complications in this population, few elements of enhanced recovery specifically address reducing these complications. In 2013, a prevalence audit confirmed a postoperative pulmonary complication rate of 16/83 (19.3%) in patients undergoing elective major surgery who were admitted to critical care postoperatively. A quality improvement team developed and implemented ERAS+, an innovative model of peri‐operative care combining elements of enhanced recovery with specific measures aimed at reducing pulmonary complications. ERAS+ was introduced in June 2014, with full implementation in September 2014. Patients were screened during full ERAS+ implementation and again one year following implementation. Following ERAS+ implementation, postoperative pulmonary complications reduced to 24/228 (10.5%). Sustained improvement was evident one year after implementation, with a pulmonary complication rate of 16/183 (8.7%). Median (IQR [range]) length of hospital stay one year after implementation of ERAS+ also improved from 12 (9–15 [4‐101]) to 9 (5.5–10.5 [3‐81]) days. The ERAS+ pathway is applicable to patients undergoing elective major surgery and appears effective in reducing postoperative pulmonary complications.     

A decade's experience with quality improvement in cardiac surgery using the Veterans Affairs and Society of Thoracic Surgeons national databases

OBJECTIVE: To review the Department of Veteran Affairs (VA) and the Society of Thoracic Surgeons (STS) national databases over the past 10 years to evaluate their relative similarities and differences, to appraise their use as quality improvement tools, and to assess their potential to facilitate improvements in quality of cardiac surgical care. SUMMARY BACKGROUND DATA: The VA developed a mandatory risk-adjusted database in 1987 to monitor outcomes of cardiac surgery at all VA medical centers. In 1989 the STS developed a voluntary risk-adjusted database to help members assess quality and outcomes in their individual programs and to facilitate improvements in quality of care. METHODS: A short data form on every veteran operated on at each VA medical center is completed and transmitted electronically for analysis of unadjusted and risk-adjusted death and complications, as well as length of stay. Masked, confidential semiannual reports are then distributed to each program's clinical team and the associated administrator. These reports are also reviewed by a national quality oversight committee. Thus, VA data are used both locally for quality improvement and at the national level with quality surveillance. The STS dataset (217 core fields and 255 extended fields) is transmitted for each patient semiannually to the Duke Clinical Research Institute (DCRI) for warehousing, analysis, and distribution. Site-specific reports are produced with regional and national aggregate comparisons for unadjusted and adjusted surgical deaths and complications, as well as length of stay for coronary artery bypass grafting (CABG), valvular procedures, and valvular/CABG procedures. Both databases use the logistic regression modeling approach. Data for key processes of care are also captured in both databases. Research projects are frequently carried out using each database. RESULTS: More than 74,000 and 1.6 million cardiac surgical patients have been entered into the VA and STS databases, respectively. Risk factors that predict surgical death for CABG are very similar in the two databases, as are the odds ratios for most of the risk factors. One major difference is that the VA is 99% male, the STS 71% male. Both databases have shown a significant reduction in the risk-adjusted surgical death rate during the past decade despite the fact that patients have presented with an increased risk factor profile. The ratio of observed to expected deaths decreased from 1.05 to 0.9 for the VA and from 1.5 to 0.9 for the STS. CONCLUSION: It appears that the routine feedback of risk-adjusted data on local performance provided by these programs heightens awareness and leads to self-examination and self-assessment, which in turn improves quality and outcomes. This general quality improvement template should be considered for application in other settings beyond cardiac surgery.     

Using quality indicators in anaesthesia: feeding back data to improve care

After recent UK policy developments, considerable attention has been focused upon how clinical specialties measure and report on the quality of care delivered to patients. Defining the right indicators alone is insufficient to close the feedback loop. This narrative review aims to describe and synthesize a diverse body of research relevant to the question of how information from quality indicators can be fed back and used effectively to improve care. Anaesthesia poses certain challenges in the identification of valid outcome indicators sensitive to variations in anaesthetic care. Metrics collected during the immediate post-anaesthetic recovery period, such as patient temperature, patient-reported quality of recovery, and pain and nausea, provide potentially useful information for the anaesthetist, yet this information is not routinely fed back. Reviews of the effects of feeding back performance data to healthcare providers suggest that this may result in small to moderate positive effects upon outcomes and professional practice, with stronger effects where feedback is integrated within a broader quality improvement strategy. The dominant model for use of data within quality improvement is based upon the industrial process control approach, in which care processes are monitored continuously for process changes which are rapidly detectable for corrective action. From this review and experience of implementing these principles in practice, effective feedback from quality indicators is timely, credible, confidential, tailored to the recipient, and continuous. Considerable further work is needed to understand how information from quality indicators can be fed back in an effective way to clinicians and clinical units, in order to support revalidation and continuous improvement.     

Improving the outcomes of carotid endarterectomy: results of a statewide quality improvement project

OBJECTIVE: The purpose of this study was to establish the statewide outcomes for carotid endarterectomy (CEA) and to facilitate improvement in outcomes through feedback, peer discussion, and ongoing process and outcome measurement. METHODS: The Medicare Part A claims files were used to identify all Medicare patients undergoing CEA in Iowa during two 12-month time periods (January 1994-December 1994 and June 1995-May 1996). Medical record abstraction was used to obtain surgical indications, perioperative care process, and outcome information. Confidential reports were provided to each hospital (N = 30) where the procedure was performed. Surgeons performing the procedure (N = 79) were invited to meetings to discuss care process variation and outcomes. Voluntary participation was solicited in a standardized program of ongoing hospital-based data collection of CEA process and outcome data. RESULTS: The statewide combined stroke or mortality rate decreased from 7.8% in 1994 to 4.0% in the 1995 to 1996 time period (P <.001). Fourteen hospitals, accounting for 74% of the statewide cases, participated in ongoing data collection. The combined stroke or mortality rate in these hospitals decreased significantly (P <.05) over time from 6.5% (1994) to 3.7% (1995-1996) to 1.8% (June 1997-May 1998). The use of intraoperative assessment of the operative site (20% in 1994, 46% in 1997-1998) and patch angioplasty (14% in 1994, 30% in 1997-1998) increased significantly during this time in the participating hospitals. CONCLUSIONS: Confidential feedback of outcome and process data for CEA may lead to change in perioperative care processes and improved outcomes. Standardized community-based outcome analysis should become routine for CEA to ensure that optimum results are being achieved.     

A new approach to clinical research: Integrating clinical care,quality reporting,and research using a wound care network‐based learning healthcare system

The disparity between ideal evidence from randomized controlled trials and real‐world evidence in medical research has prompted the United States Food and Drug Administration to consider the use of real‐world data to better understand safety and effectiveness of new devices for a broader patient population and to prioritize real‐world data in regulatory decision making. As the healthcare system transitions from volume‐ to value‐based care, there is a growing need to harness the power of real‐world data to change the paradigm for wound care clinical research and enable more generalizable clinical trials. This paper describes the implementation of a network‐based learning healthcare system by a for‐profit consortium of wound care clinics that integrates wound care management, quality improvement, and comparative effectiveness research, by harnessing structured real‐world data within a purpose‐built electronic health record at the point of care. Centers participating in the consortium submit their clinical data and quality measures to a qualified clinical data registry for wound care, enabling benchmarking of their data across this national network. The common definitional framework of the purpose‐built electronic health record and the 21 wound‐specific quality measures help to standardize the potential sources of bias in real‐world data, making the consortium data useful for comparative effectiveness research. This consortium can transform wound care clinical research and raise the standards of care, while helping physicians achieve success with the Merit‐Based Incentive Payment System.