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Does the Dundee Step Test predict outcome in treated hypertension? A sub-study protocol for the ASCOT trial. Anglo-Scandinavian Cardiac Outcome Trial.

Treated hypertensive subjects may remain five times more likely to die of cardiac and cerebrovascular diseases than normotensive subjects with equivalent resting blood pressure (BP) levels. Research evidence suggests that exercise BP is a better predictor of end-organ damage and mortality than resting BP, and data from our centre show that a significant proportion of treated hypertensives have uncontrolled BP during a 5-min Dundee Step Test. The prognostic usefulness of exercise BP has yet to be translated into clinical practice because of the lack of a suitable technique. The Dundee Step Test is being evaluated in the ASCOT (Anglo-Scandinavian Cardiac Outcome Trial) study, a 5-year follow-up multicentre, multinational trial comparing the effect of newer (amlodipine and perindopril) and older (bendroflumethiazide and atenolol) antihypertensive agents stratified according to cholesterol levels on cardiac outcome. If the value of the Dundee Step Test is proven, then it may be adopted into routine clinical practice for the assessment of exercise BP. This may result in the improved management of hypertension with a subsequent reduction in morbidity and mortality. The publication of this study protocol is meant to be a statement of on-going research which may stimulate interest among those with an interest in this area of research. Journal of Human Hypertension (2000) 14, 75-78.

Adult↗

Defining the nursing contribution to patient outcome: lessons from a review of the literature examining nursing outcomes, skill mix and changing roles.

A review of the evidence to define the nursing contribution to patient outcome is presented. The review relies on work related to nursing sensitive outcomes, skill mix and changing roles. Methodological difficulties associated with these studies are highlighted. Areas requiring further research are discussed. It is suggested that experimental evidence is not always appropriate, when attempting to describe nursing activity. The authors advocate that new methodologies, in particular practitioner-centred research, are needed to unpack the nature of nursing.

Diagnosis-Related Groups↗

Vascular access results from the Dialysis Outcomes and Practice Patterns Study (DOPPS): performance against Kidney Disease Outcomes Quality Initiative (K/DOQI) Clinical Practice Guidelines.

BACKGROUND: The Kidney Disease Outcomes Quality Initiative Guidelines for Vascular Access in hemodialysis patients recommend native arteriovenous (AV) fistulae over AV grafts or catheters for permanent vascular access. They recommend letting fistulae mature > or =1 month before cannulation. METHODS: The Dialysis Outcomes and Practice Patterns Study (DOPPS) provides an unparalleled means to examine vascular access practice patterns and guidelines internationally, with particular attention to associations with mortality risk. RESULTS: Most patients in Europe and Japan dialyze through AV fistulae and very few use AV grafts; in the United States, more patients use grafts than fistulae. Patients who receive nephrologic care for over 30 days before starting dialysis have significantly higher chances of commencing via AV fistula. Medical directors of dialysis facilities in the United States commonly prefer grafts; in Europe and Japan, most prefer fistulae. In the United States, there is a relatively long average time between fistula creation and cannulation but significantly worse fistula survival than that seen in Europe. Tunneled catheters pose a higher mortality risk than permanent accesses and are associated with increased risk of failure of a subsequent fistula. The percentage of prevalent patients in the DOPPS countries using catheters has increased in recent years. DOPPS data suggest that performance in some countries falls short of practices achieved in other countries. AV fistula use is low in the United States but has been improving. The trend of increasing use of catheters in most countries is discouraging. CONCLUSION: The DOPPS will continue to monitor practice trends and explore whether greater application of guidelines will lead to fewer access complications and improved longevity for hemodialysis patients.

Arteriovenous Shunt, Surgical↗

Anemia management for hemodialysis patients: Kidney Disease Outcomes Quality Initiative (K/DOQI) guidelines and Dialysis Outcomes and Practice Patterns Study (DOPPS) findings.

BACKGROUND: After recombinant human erythropoietin was introduced into routine nephrologic practice, specific clinical guidelines were developed to optimize the quality of anemia management for patients with chronic kidney disease. METHODS: The Dialysis Outcomes and Practice Patterns Study (DOPPS), an international investigation providing patient- and facility-level data on hemodialysis practice, was developed to provide information on various aspects of current practices in hemodialysis management, including treatment of renal anemia. RESULTS: Hemoglobin concentration is strongly associated with both morbidity and mortality in hemodialysis patients. Although some improvements can be documented in anemia management practices in the years after the publication of international guidelines, wide variations in anemia management are still observed among countries. CONCLUSION: Many efforts are still needed to allow a greater proportion of patients to reach the recommended hemoglobin concentrations. Significantly improved outcomes may therefore be expected by a more widespread reaching of the recommended hemoglobin levels. The results of the DOPPS point to the difficulties in implementing clinical guidelines in the everyday management of individual patients. In specific circumstances, a well-designed observational study may offer credible information and serve as a basic instrument for monitoring the implementation of clinical guidelines in typical clinical practice.

Anemia↗

Outcomes after percutaneous coronary interventions in patients with CKD: improved outcome in the stenting era.

BACKGROUND: Percutaneous coronary intervention (PCI) with stenting reduces adverse events in the general population compared with balloon angioplasty. The benefit of stents in high-risk patients normally excluded from clinical trials has not been well studied. Outcomes after PCIs in patients with chronic kidney disease (CKD) before and after widespread use of stents were compared. METHODS: All patients undergoing PCIs at our center within 2 periods selected for high and low stent use were included. Demographic, kidney and cardiac function, and PCI data were collected. Kaplan-Meier curves were constructed, and Cox proportional hazards analysis was used to assess the effect of high stent use on major adverse cardiac event, a composite of cardiac revascularization, myocardial infarction, or death 3 years after PCI. RESULTS: A total of 1,879 patients (780 patients, low stent use; 1,099 patients, high stent use; 18% and 94.1% stent use, respectively) with a mean age of 63 years, 73% men, and 26% of patients with a glomerular filtration rate less than 60 mL/min were included. At baseline, there was a greater prevalence of severe CKD, cardiac risk factors, and cardiovascular disease in the high-stent-use cohort. Major adverse cardiac events were reduced in the contemporary cohort (hazard ratio, 0.61; 95% confidence interval, 0.52 to 0.72); this benefit extended across all stages of kidney function. CONCLUSION: Patients with CKD undergoing PCI in the stenting era show improved outcomes. Additional studies are needed to determine optimal revascularization strategies in patients with CKD.

Aged↗

[The Knee Injury and Osteoarthritis Outcome Score--a multifunctional questionnaire to measure outcome in knee arthroplasty].

AIM: It was the purpose of this investigation to create a German version of the Knee Injury and Osteoarthritis Outcome Score (KOOS) and to test its appropriateness in patients with advanced gonarthritis. METHOD: Reliability (test-retest reliability, internal consistency), validity (convergent construct validity and divergent construct validity), sensitivity to change as well as practicability and acceptance of this questionnaire were tested in 90 patients. RESULTS: The test-retest reliability was acceptably high for all subscales, it ranged between r = 0.65 and 0.78 and the questionnaire showed a high internal consistency in almost all of the subscales. The comparison to the results of the questionnaire "Short Form-12" (SF-12) as well as to the patients self-assessment of health status showed high concordance in nearly all subscales, however it was only moderate for the symptom scale. Furthermore the KOOS was able to show significant differences between patients and healthy controls. When testing the sensitivity to change, the KOOS could demonstrate significant improvements within 3 months and the instrument has shown to be practicable with a high acceptance by the patients. CONCLUSION: With the German version of the Knee Injury and Osteoarthritis Outcome Score a multidimensional instrument is available now to measure health status as well as therapeutic effects in patients with knee problems. Modifying the subscale "symptoms" could further optimize this questionnaire in patients with advanced gonarthritis.

Adolescent↗

Hospital outcomes management: the Care Continuum and Health Outcomes Project.

The Care Continuum and Health Outcomes Project is part of a national initiative to build an outcomes management approach in health care. This paper examines the baseline performance of the study. In 1995-96, 7154 Australian Capital Territory hospital inpatients were selected to take part in a five-wave survey over six months. In addition to the survey, the project involved the unit record linkage of routine data collections. A total of 5668 people (79%) agreed to participate in the survey, with 85% of these people agreeing to release their Medicare data. There were significant variations in participation rates between hospitals and wards. Factors contributing to these variations included patient socioeconomic status, disease type and illness severity. In conclusion, the success in establishing the project indicates that it is possible to conduct a broad scientific study within the health system, and that there are strong implications that ongoing scientific evaluations can be embedded within routine clinical practice.

Adult↗

Outcomes after detoxification for heroin dependence: findings from the Australian Treatment Outcome Study (ATOS).

As part of the Australian Treatment Outcome Study (ATOS), 177 (88%) heroin users entering detoxification (DTX) and 66 (83%) heroin users not in treatment (NT) were interviewed at baseline and 3 months to examine drug use, risk-taking, overdose, crime and psychopathology outcomes. The majority (76%) of the DTX group had entered additional treatment at 3 months, mainly further detoxification, and 54% were currently in treatment, mainly maintenance and residential rehabilitation. There were reductions in heroin use and other drug use in those entering detoxification. Forty-two per cent were abstinent at 3 months compared to 20% in the NT group. There were also reductions in crime among those entering DTX, and less marked reductions in the NT group. Psychopathology showed less change. Detoxification may, in some part, function as a gateway to further treatment and those entering DTX showed modest but significant improvements across drug use and crime at 3 months.

Adult↗

Combining summaries of binary outcomes with those of continuous outcomes in a meta-analysis.

We present a methodology for combining trials some of which report continuous outcome measures and others binary outcomes created by a dichotomy of the continuous measurement. This was motivated by a series of controlled clinical trials investigating the effect of prophylactic use of oxytocics on postpartum blood loss during labor. Data were available in the form of summary statistics from published papers. The log-odds ratio is used as a common measure of treatment difference across all trials. We discuss the general applicability of this approach.

Female↗

Measuring general practice-based primary care: generic outcomes. Welsh Primary Care Outcomes Group.

Increasing attention is being paid to the measurement of outcomes in primary care. However, many of the methods proposed are measures based on readily collectable data or standardized population measures of health status. These may interest population scientists but are unlikely to satisfy most primary-care clinicians. The reason for this dissonance is that the population measures do not reflect the complex and personal nature of primary care. Quality measures are needed that have validity to clinicians and patients. An alternative classification is proposed which is based more formally on the functions of primary care. This would appear to provide a framework which is more likely to be valued by those who provide primary care. The need for further research and testing of some outcome measures is identified.

Clinical Competence↗

Methodological and statistical considerations for threats to internal validity in pediatric outcome data: response shift in self-report outcomes.

OBJECTIVE: To examine conceptual models of response shift, research design, and internal validity issues in the context of longitudinal outcome research using self-report measures such as pediatric quality of life. METHODS: Growth modeling was introduced and illustrated using a previously published data set (Clay, Wood, Frank, Hagglund, & Johnson, 1995) of adjustment in children with juvenile rheumatoid arthritis, diabetes, and healthy controls. RESULTS: Demonstrations revealed that growth modeling may detect response shift and may also model the time and shape of the response shift. CONCLUSIONS: Growth modeling provides one avenue to investigate response shift, thereby addressing an important threat to internal validity in longitudinal outcome research such as quality of life in children with chronic illness.

Adolescent↗

Maternal and neonatal outcomes in pregestational and gestational diabetes mellitus, and the influence of maternal obesity and weight gain: the DEPOSIT study. Diabetes Endocrine Pregnancy Outcome Study in Toronto.

We prospectively studied pregnancy outcome in 428 women with gestational diabetes mellitus (DM) and 196 women with pregestational DM, with particular reference to the influence of maternal obesity and excessive weight gain. These were consecutive singleton pregnancies delivered in our institution over 5 years. After controlling for multiple risk factors, including maternal BMI and pregnancy weight gain, women with pregestational DM were at increased risk (compared to those with gestational DM) for Caesarean delivery (OR 3.6, 95%CI 2.3-5.6), shoulder dystocia or cephalopelvic disproportion (OR 2.2, 95%CI 1.3-3.6), and gestational hypertension or toxaemia (OR 3.0, 95%CI 1.7-5.4). The offspring of these women were also at increased risk for admission to the neonatal intensive care unit (OR 4.0, 95%CI 2.3-6.8), large-for-gestational-age birthweight (OR 3.5, 95%CI 2.2-5.6), and preterm birth before 37 weeks (OR 3.8, 95%CI 2.5-5.9). Maternal obesity, and, to a lesser degree, excessive weight gain, were also independent risk factors for all these adverse maternal and neonatal outcomes, regardless of the type of DM, except for shoulder dystocia/cephalopelvic disproportion.

Adult↗

Patterns of care outcome survey: national outcome data for six disease sites.

This paper reports the results of the PCS Outcome Surveys for radiation therapy treatment in six disease sites: cervix, Hodgkin's disease, seminoma of the testis, anterior two-thirds of tongue and floor of mouth, larynx and prostate. The survey reflects data obtained for patients treated in 1973. Results for early stages of disease are generally favorable in cancer of the cervix, prostate, testis, larynx and Hodgkin's disease. Control of disease in anterior two-thirds of tongue and floor of mouth was less favorable, but data suggest that more aggressive radiation therapy may contribute to better outcome for this site.

Clinical Trials as Topic↗

Developing an outcome-based multidisciplinary care planning tool: process and outcomes.

Multidisciplinary care planning is required for patients in acute care settings. A task force was charged by the Vice President of Patient Care to develop and implement a multidisciplinary care planning tool. This article outlines the process used and includes examples of the tool and outcomes to date. This major change project resulted in the development of a successful tool, a successful Joint Commission on Accreditation of Healthcare Organization survey, and new opportunities for outcome-based care planning.

Critical Pathways↗

Modified system outcome score and outcome index--method of monitoring patient care in a special care area.

A scoring system intended both to assess mortality risk and permit surveillance, evaluation, and comparison of medical care was developed in our surgical ICU. Five simple clinical indices of organ system failure were selected and weighted according to their statistically validated relationship to mortality, resulting in a daily System Outcome Score (SOS). Cluster analysis was used to divide the creation data set of 2,777 patients into suitable groupings of scores to predict mortality; the clustering was confirmed for reproducibility with a validation set of an additional 2,860 patients. Based on this validation of the scoring system, two computer-controlled patient care surveillance techniques were developed. The first involved the definition of three unfavorable SOS patterns evolving during the course of a patient's admission. Detection of one or more of these patterns, described by the acronym SDL, permits review of the care administered to the specific patient generating the pattern. A global assessment of care is achieved with the Outcome Index (OI), which relates overall mortality risk in the ICU to the actual mortality rate over a given time period. Effectiveness of care can then be compared between different time periods within the one unit or between different units with similar patient mix. The overall system offers the potential for a surveillance-based quality assurance system with widespread applicability.

Hospital Information Systems↗

Outcome prediction models on admission in a medical intensive care unit: do they predict individual outcome?

Prospectively acquired data from 941 patients staying greater than 24 h in a medical ICU were analyzed to determine the relevance of scoring on ICU admission by the following methods of outcome prediction: Acute Physiology and Chronic Health Evaluation (APACHE II), Simplified Acute Physiology Score (SAPS), and Mortality Prediction Model (MPM). Analysis was performed separately for all patients (group A) and for a subsample (group B), obtained by excluding coronary care patients. Calculation of risk and classification of patients were carried out as recommended in the literature for MPM, APACHE II, and SAPS. In group A, sensitivities (correct prediction of hospital mortality) were 44.7%, 51.1%, and 21.2% and specificities (correct prediction of survival) were 84.5%, 85.4%, and 96.8%, respectively; overall correct classification rates were 73.3%, 75.8%, and 75.6%. In group B, sensitivities were slightly higher, but total correct classification rates did not reach group A levels. Goodness-of-fit testing showed low levels of fit for all methods in both groups. Application of APACHE II to diagnostic subgroups, using disease-adapted risk calculations, revealed marked inconsistencies between the estimated risk and the observed mortality. We conclude that the estimation of risk on admission by the three methods investigated might be helpful for global comparisons of ICU populations, although the lack of disease specificity reduces their applicability for severity grading of a given illness. The inaccuracy of these methods makes them ineffective for predicting individual outcome; thus, they provide little advantage in clinical decision-making.

Female↗

The eight-item treatment-outcome post-traumatic stress disorder scale: a brief measure to assess treatment outcome in post-traumatic stress disorder.

This preliminary report describes a new brief interview based assessment of post-traumatic stress disorder using an 8-item treatment-outcome post-traumatic stress disorder scale (TOP-8). The TOP-8 was developed from a larger post-traumatic stress disorder evaluation scale based on items which occurred frequently in the population and which responded substantially to treatment across time. The 8 resultant items were drawn from all three symptom clusters for post-traumatic stress disorder, and showed an improved ability to detect drug versus placebo differences in comparison with the original scale. The eight-item treatment-outcome post-traumatic stress disorder scale also correlated significantly with a self-rated measure of post-traumatic stress disorder and distinguished at a highly significant level between responders and non-responders on an independently judged Clinical Global Impressions measure. The results of this study are discussed and future directions suggested.

Adult↗

Outcomes measurement. Multidisciplinary approaches and patient outcomes after stroke.

Synergism is an apt description for the powerful results that can occur when multidisciplinary approaches are used. Studies have documented that multidisciplinary teams produce improved patient outcomes in selected patient groups, including recent studies of patients with strokes. Multidisciplinary teams in patient care are still far from being the normative model of care delivery. In the interest of better patient care and outcomes, it is time for health care professionals to actively engage in multidisciplinary approaches, because the sum of our collaborative efforts is greater than our individual disciplinary parts.

Cerebrovascular Disorders↗