Everyday Clinical Care Research Articles

On the Evaluation of Intervention Outcome Risks for Patients With Ischemic Heart Disease

Risk is defined in the Oxford Pocket American Dictionary of Current English as “a chance or possibility of danger, loss, injury, etc.”1 The evaluation of clinical risk and benefit is a mainstay of all clinical investigation in medicine. More recently, it is slowly becoming a component of everyday clinical care. In this issue of Circulation , Singh et al2 potentially advance the evaluation of risk in the domain of ischemic heart disease. Article p 356 Because procedural mortality has been such an important outcome in the surgical revascularization of coronary artery disease, the assessment of preoperative risk has been an important focus of attention for many years. Large US regional and national databases, such as the Northern New England Cardiovascular Disease Study Group,3 the New York State cardiac surgery database,4 and the Society of Thoracic Surgeons’ National Cardiac Database (STS NCD),5 have developed relatively sophisticated multivariable models to predict mortality risk across the entire spectrum of coronary artery bypass grafting (CABG) patients. Similar risk models have been developed outside the United States, most notably from the European Cardiac Surgery database.6 Model performance has been tested and continually refined within these databases. Over the years, it has become clear that a core group of preoperative risk factors and conditions contribute a majority of the inherent mortality risk in these models. This has led to the concept that specific risk models can be applied to other CABG data sets. Nashef et al7 tested the performance of the EuroSCORE model against a cohort of STS CABG patients. In general, these risk-prediction models achieve the best fit when applied to the database systems from which they were derived. In the United States, the STS NCD has documented a substantial increase in the predicted risk of mortality over …

Validation of a Tool to Measure and Promote Clinical Teamwork

Human factors and teamwork are major contributors to sentinel events. A major limitation to improving human factors and teamwork is the paucity of objective validated measurement tools. Our goal was to develop a brief tool that could be used to objectively evaluate teamwork in the field during short clinical team simulations and in everyday clinical care. A pilot validation study. Standardized videos were created demonstrating poor, average, and excellent teamwork among an obstetric team in a common clinical scenario (shoulder dystocia). Three evaluators all trained in Crew Resource Management, and unaware of assigned teamwork level, independently reviewed videos and evaluated teamwork using the Clinical Teamwork Scale (CTS). Statistical analysis included calculation of the Kappa statistic and Kendall coefficient to evaluate agreement and score concordance among raters, and Interclass Correlation Coefficient (ICC) to evaluate interrater reliability. The reliability of the tool was further evaluated by estimating the variance of each component of the tool based on generalizability theory. There was substantial agreement (Kappa 0.78) and score concordance (Kendall coefficient 0.95) among raters, and excellent interrater reliability (interclass correlation coefficient 0.98). The highest percentage of variance in scores among raters was because of rater/item interaction. The CTS was developed to efficiently measure key clinical teamwork skills during simulation exercises and in everyday clinical care. It contains 15 questions in 5 clinical teamwork domains (communication, situational awareness, decision-making, role responsibility, and patient friendliness). It is easy to use and has construct validity with median ratings consistently corresponding with the intended teamwork level. The CTS is a brief, straightforward, valid, reliable, and easy-to-use tool to measure key factors in teamwork in simulated and clinical settings.

The Lowering of Vascular Atherosclerotic Risk (LOVAR) Program: An Approach to Modifying Cerebral, Cardiac, and Peripheral Vascular Disease

More than 1 million US citizens die of cerebral, cardiac, and peripheral vascular disease (collectively, CVD) each year. Basic science and clinical outcome research aimed at reducing the burden of this illness is widespread, but the knowledge gleaned from controlled trials has not fully translated into everyday clinical practice and care of patients with CVD and their inherent risk factors. The Lowering of Vascular Atherosclerotic Risk (LOVAR) program was a 5-year observational study that evaluated the feasibility of a high-intensity multidisciplinary program of risk factor reduction in a population with known symptoms of CVD. The population comprised patients with documented clinically symptomatic cerebral, cardiac, or peripheral vascular disease and at least two modifiable risk factors for stroke, myocardial infarction, or peripheral vascular occlusive disease. Final outcomes were evaluated by comparing primary and secondary end points and quality of life. A total of 271 patients were enrolled in the intervention group, and 242 were enrolled in the standard care group (control). At 3 years, significant improvements in several risk factors were seen in the intervention group, with no significant improvements for the control group. The rate of patient retention was 95% at 3 years, and overall rates of physician and patient satisfaction were high. We believe that the Lowering of Vascular Atherosclerotic Risk program is generalizable to a sufficiently motivated population targeted as high risk for vascular disease.

Clinical trials versus registries in coronary revascularization: which are more relevant?

Clinical decision-making in coronary artery disease relies heavily on evidence-based medicine. Data from randomized controlled trials constitute the highest order of evidence and remain the standard for comparisons between therapies. While comprehensive, observational databases lack the scientific rigor of randomized controlled trials, they represent a more accurate accounting of everyday clinical care. Which data are more relevant to clinical practice?. At least 11 randomized controlled trials and three meta-analyses comparing coronary artery bypass grafting and percutaneous coronary intervention exist, which all largely show no difference in death or myocardial infarction between the two treatments but more repeat revascularization with percutaneous coronary intervention. All these studies, however, are subject to the biases of trial design, which impact the external validity of the results. Analyses of four observational databases show a survival advantage in multivessel disease with coronary artery bypass grafting. Although these are reflective of real world clinical practice, they are subject to 'treatment bias', some of which can be corrected by risk adjustment. Information from both randomized controlled trials and outcomes databases is necessary to determine appropriate strategy for individual patients. Reliance on data solely from either source is insufficient. It is incumbent on the treating physician to know not only the results of published studies, but also the limitations of that information.

How should we report neonatal outcomes?

The aim of neonatal care is to achieve long-term survival free of handicap. There is a need for standardised datasets linking perinatal care to outcome at 2 years corrected age for all babies who have gone through neonatal intensive care. Realistically this can only happen if all the data are collected by the units caring for the babies. This has not been possible previously using routinely collected data because of the poor quality of such information. Recent improvements in neonatal data collection along with the development of standardised neonatal and follow-up datasets make it possible that this could now be achieved from routine data collected as part of everyday clinical care. It is important that further links with maternity and child health systems are developed. The National Neonatal Audit Project, funded by the Department of Health, will hopefully develop the infrastructure to allow the storage, analysis and rapid reporting of pooled neonatal and follow-up data.

Praxistest: Empfehlung zur Lymphödemdiagnostik nach Brustkrebs in der Nachsorge und Rehabilitation

Fragestellung: Zur Vereinheitlichung und Verbesserung der Diagnostik und Therapie des Lymphödems bei Frauen nach Brustkrebs wurde eine systematische Handlungsempfehlung (Leitlinie) formuliert, die die ärztliche Befunderhebung und Erfassung der krankheitsspezifischen Lebensqualität einschließt. Grundvoraussetzung für die Implementierung ist, dass diese Befunderhebungen im Alltag anwendbar sind. Dieser Fragestellung geht der Praxistest nach. Methode: In 5 Praxen und 1 Rehabilitationsklinik in einem ländlichen Versorgungsgebiet in Hessen wurde die Handlungsempfehlung zur Lymphödemdiagnostik über einen Zeitraum von 6 Wochen in der klinischen Routine eingesetzt. Alle Patientinnen mit Mammakarzinom, die sich in diesem Zeitraum in den teilnehmenden Einrichtungen vorstellten, wurden empfehlungskonform untersucht. Die ärztliche Befunderhebung wurde, im der Handlungsempfehlung beigefügten Dokumentationsbogen, für die Bereiche Anamnese (6 Aspekte), Funktionsprüfung (2-Tests), Umfangsmessungen (seitengetrennt 2 Messpunkte), differenzierte ärztliche Beurteilung nach der Internationalen Klassifikation der Funktionsfähigkeit, Behinderung und Gesundheit (ICF) erfasst. Alle Patientinnen füllten den EORTC‐QLQ‐30 + BR23 Lebensqualitätsfragebogen aus. Alle beteiligten Ärzte wurden nach der Testphase mittels eines Evaluationsbogens zur Praxistauglichkeit und ihren Erfahrungen befragt. Ergebnisse: 11 Ärzte und 72 Patientinnen nahmen teil. 26 Patientinnen (36 %) wiesen ein Lymphödem auf. 64 % der Lymphödempatientinnen zeigten auffällige Befunde bezüglich Funktionsstörungen und Beschwerden im Armbereich bei der Lebensqualitätsmessung. Alle Ärzte beurteilten das Lymphödem-Diagnostikinstrument als praxistauglich. Als aufwendig und zeitintensiv wurden „Umfangsmessungen“ und „differenzierte Beurteilung“ bewertet. Schlussfolgerung: Der Praxistest zeigte, dass die systematische Statuserhebung in der Diagnostik des Lymphödems bei Mammakarzinom in der klinischen Routine einsetzbar ist. Die identifizierten Anwendungsbarrieren könnten überwunden werden, indem die zeitaufwendigen Umfangsmessungen an nicht ärztliches Personal vor der Konsultation delegiert werden, und der ärztliche Kenntnisstand zur ICF-Anwendung durch Fort- und Weiterbildungsmaßnahmen angehoben wird. Die Auswirkungen der Handlungsempfehlung auf die Versorgungsqualität und die Validität der diagnostischen Entscheidungsregeln sind durch eine, die weitere Implementierung begleitende wissenschaftliche Evaluierung zu prüfen.

Supportive Therapy for Schizophrenia

Background Supportive therapy is often used in everyday clinical care and in evaluative studies of other treatments. Objectives To review the effects of supportive therapy compared with standard care, or other treatments in addition to standard care for people with schizophrenia. Search methods For this update, we searched the Cochrane Schizophrenia Group's register of trials (November 2012). Selection criteria All randomised trials involving people with schizophrenia and comparing supportive therapy with any other treatment or standard care. Data collection and analysis We reliably selected studies, quality rated these and extracted data. For dichotomous data, we estimated the risk ratio (RR) using a fixed-effect model with 95% confidence intervals (CIs). Where possible, we undertook intention-to-treat analyses. For continuous data, we estimated the mean difference (MD) fixed-effect with 95% CIs. We estimated heterogeneity (I2 technique) and publication bias. We used GRADE to rate quality of evidence. Main results Four new trials were added after the 2012 search. The review now includes 24 relevant studies, with 2126 participants. Overall, the evidence was very low quality. We found no significant differences in the primary outcomes of relapse, hospitalisation and general functioning between supportive therapy and standard care. There were, however, significant differences favouring other psychological or psychosocial treatments over supportive therapy. These included hospitalisation rates (4 RCTs, n = 306, RR 1.82 CI 1.11 to 2.99, very low quality of evidence), clinical improvement in mental state (3 RCTs, n = 194, RR 1.27 CI 1.04 to 1.54, very low quality of evidence) and satisfaction of treatment for the recipient of care (1 RCT, n = 45, RR 3.19 CI 1.01 to 10.7, very low quality of evidence). For this comparison, we found no evidence of significant differences for rate of relapse, leaving the study early and quality of life. When we compared supportive therapy to cognitive behavioural therapy CBT), we again found no significant differences in primary outcomes. There were very limited data to compare supportive therapy with family therapy and psychoeducation, and no studies provided data regarding clinically important change in general functioning, one of our primary outcomes of interest. Authors' conclusions There are insufficient data to identify a difference in outcome between supportive therapy and standard care. There are several outcomes, including hospitalisation and general mental state, indicating advantages for other psychological therapies over supportive therapy but these findings are based on a few small studies where we graded the evidence as very low quality. Future research would benefit from larger trials that use supportive therapy as the main treatment arm rather than the comparator.

A Pilot Study to Test the Use of a Checklist in a Tertiary Intensive Care Unit as a Method of Ensuring Quality Processes of Care

This pilot study aimed to test the use of a checklist as a method of ensuring that certain processes of care are performed routinely and systematically in a tertiary intensive care unit. The pilot involved the development of a process indicator checklist, its implementation and review. The checklist contained 16 items sourced from the literature or deemed important by local clinicians. Checklists were completed on the morning round for all adult patients admitted to the unit for approximately one month. Baseline and evaluation surveys were conducted with medical staff to assess both the benefits and shortcomings of using the checklist. Results demonstrated good compliance in completing the checklist (81%) and that when checked, certain aspects of care were not always delivered when appropriate. At the conclusion of the study the majority of medical staff believed that care in the intensive care unit actually improved with the use of the checklist, and all thought that it assisted in ensuring that good quality care was delivered. The checklist is a useful tool that can be readily applied to facilitate best practice and quality in everyday clinical care, ultimately leading to better health outcomes for patients.

Caring for Dying People of Different Faiths

Ten years since last revision, Caring for Dying People of Different Faiths has been extended to encompass African and Afro-Caribbean, Japanese and humanist beliefs and customs. Although written for nurses it makes valuable reading for all health professionals caring for dying patients. Most of us will die in hospital, receiving care from professionals from a wide spectrum of faiths, beliefs and cultural backgrounds—just as now we provide care to a very diverse patient population. We would not expect those caring for us in the future to make assumptions about our beliefs and wishes, and the same applies to our patients today. The beliefs of those from any particular religious group also vary widely, even amongst family groups. Given this, what can this book hope to achieve? First, by sketching the background to a range of religions and philosophies, and the implications for dying and death, this book has the potential to widen our conceptions of how others cope and find meaning at the end of life. Such understanding may make sense of some of the choices patients make, or the expectations of their families, that may at times appear strange or incomprehensible to us. Similarly, it may cast light on the attitudes and approaches of our professional colleagues. Broadening our awareness in this way has the potential to enhance the decision-making process regarding end-of-life care, and enable us to seek appropriate support for patients and their carers at this time. The implications of certain religious beliefs for medical treatment decisions are outlined, and it is emphasized that the remit for religious and spiritual care extends well beyond the hospital chaplain and our nursing colleagues. Secondly, with its practical focus the book offers concrete examples of the physical care and rituals that patients and families may expect during the terminal phase, at the time of death, and through into the bereavement period. Getting such details right at this highly sensitive and significant time is crucial. A delay in burial due to the unavailability of a death certificate, for example, or the failure to handle a body after death according to particular religious requirements (including routine nursing care), may cause profound and lasting distress. I strongly recommend this book to all professionals caring for dying patients. It promises to increase awareness and insight for everyday clinical care, and is a useful introduction for those wishing to explore more theoretical aspects. Beyond this, it is of specific interest to physicians for two reasons. First, a greater understanding of the beliefs of dying people of different faiths aids those medical decisions at the end of life which are so dependent upon individual goals and preferences. Secondly, no matter how good clinical care has been for however long, difficulties and undue distress during the period of dying will be the memories that remain with those close to the patient, and even a little knowledge can enhance a fitting end.

Relating quality-of-life scores to future sentinel clinical events and health care utilization

INTRODUCTION: Quality-of-life (QOL) measures are increasingly being used in everyday clinical practice. To date, patient reports of functioning and wellbeing have been used most often in clinical practice settings at the group level for research purposes rather than at the individual patient level for clinical decision making. Disappointing results of implementation studies and the failure of payers to reimburse functional health assessment have slowed adoption of patientbased measures in everyday clinical care. SIGNIFICANCE: For clinical decisionmaking and patient care purposes, it will be important for methodologists to develop cut points that declare QOL scores as positive or negative, within normal or abnormal ranges, or above or below decision thresholds. For example, a score of 52 on the Medical Outcomes Study Short Form-20 Health Survey (SF20) and the 36-item survey (SF-36) Mental Health Index-5 scale has been found to indicate a positive screen for depression. This is a useful benchmark for score interpretation and decision-making purposes. Because the training and mindset of clinicians may not prepare them to interpret QOL information, QOL researchers need to present their information in ways familiar to clinicians-that is, as both dichotomous data (with logically determined and clinically sensible cut scores) and continuous data, as occurs with many clinical tests. OBJECTIVE: In this study, we use one of the largest and oldest electronic medical record systems-the Regenstrief Medical Record System-to explore the association between QOL scores and sentinel clinical events and health care utilization over a lo-year period. METHODS: This study is a secondary data analysis of 1049 patients who were at least 75 years old or at least 50 years old with serious underlying disease (eg, cancer, ischemic heart disease, chronic heart failure, chronic obstructive pulmonary disease, cerebrovascular disease, chronic renal failure, or chronic liver failure). In 1992, the 1049 patients completed the SF-36. In 2002,

Computer aids to mental health care.

Computer systems are being used increasingly to aid the assessment and self-treatment of mental health problems in adults. Systems vary hugely in the extent to which they meet all patients' assessment and therapy needs and save clinicians' time. Hardly any single system 1) performs every task required from initial screening to the end of follow-up, 2) works 100% independently of contact with a clinician or technician, and 3) is widely available and supported. Most systems use desk- or laptop computers. Some now use palmtop (hand-held) computers. A few employ computerized phone interviews (interactive voice response), usually from home. Virtual reality as a tool is embryonic. Computer aids save time in screening and outcome-tracking in a wide variety of problems. Computer aids to treatment have had promising outcomes in phobic, anxiety, panic, and obsessive-compulsive disorders, nonsuicidal depression, obesity, and smoking cessation. Some systems are installed in a few places as part of everyday clinical care. A growing number should soon be robust enough to ease the lives of many patients, practitioners, and researchers if use of the systems is carefully integrated into normal clinical practice.