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Validation of the complexity and treatment outcome components of the index of complexity, outcome, and need (ICON).

Occlusal indexes objectively quantify malocclusions. The index of complexity, outcome and treatment need (ICON) is a new index developed to measure several aspects of occlusion and treatment outcome. The purpose of this study was to test the validity of the ICON in measuring orthodontic complexity, outcome, and degree of improvement. Fifteen orthodontists evaluated 100 pairs of pretreatment and posttreatment study models for complexity, outcome, and degree of improvement. A calibrated examiner used ICON to score the casts. One month later, a random subset of 40 study casts was rescored by raters and the examiner for reliability testing. A simple kappa statistic was used to assess agreement between the scores from the expert panel and from the ICON examiner. Interrater agreement was moderate for complexity (kappa =.50), slight for outcome (kappa =.18), and poor for degree of improvement (kappa =.04). Reliability of the calibrated examiner was kappa =.90 for pretreatment and kappa =.83 for posttreatment casts. Agreement between the raters and the ICON scores was moderate for complexity (kappa =.52) and outcome (kappa =.50) and fair for degree of improvement (kappa =.27). ICON is valid for assessing cases for complexity and outcome. However, lack of agreement among the raters for degree of improvement and between the ICON-based evaluations and the orthodontists' evaluation of degree of improvement suggests that this component should be reexamined.

Dental Health Surveys↗

Outcomes research in advanced practice nursing selecting an outcome.

APNs should investigate outcomes that will enhance patient care and contribute to building nursing knowledge and science; however, APNs should also consider addressing and including into their daily activities outcomes that are of interest to governmental, accreditation, and not-for-profit groups. APNs can accomplish this in a number of ways within the numerous roles from which they practice. APNs practicing as clinical nurse specialists can incorporate these outcomes into hospital based quality improvement or management activities in which they already routinely initiate or participate. Additionally, in their roles as role model or educator they can provide their professional nursing colleagues with a clear understanding of these outcomes and their importance to patient care and the institution's success. And finally, in their role as acute care nurse practitioners, APNs can seek to measure and benchmark their own performance on many of these measures. Active participation in measuring, reporting, and improving the outcomes addressed within this article will help ensure that all patients achieve a minimum consistent level of quality outcomes. Of equal importance, however, is that by being active partners in achieving these outcomes, APNs will further enhance recognition of the vital role nursing plays in improving the quality of care provided to all Americans by our healthcare system.

Accreditation↗

Emergency Medical Services Outcomes Project (EMSOP) II: developing the foundation and conceptual models for out-of-hospital outcomes research.

Development of methodologically acceptable outcomes models for emergency medical services (EMS) is long overdue. In this article, the Emergency Medical Services Outcomes Project proposes a conceptual framework that will provide a foundation for future EMS outcomes research. The "Episode of Care Model" and the "Out-of-Hospital Unit of Service Model" are presented. The Episode of Care Model is useful in conditions in which interventions and outcomes, especially survival and major physiologic dysfunction, are linked in a time-dependent manner. Conditions such as severe trauma, anaphylaxis, airway obstruction, respiratory arrest, and nontraumatic cardiac arrest are amenable to this methodology. The Out-of-Hospital Unit of Service Model is essentially a subunit of the Episode of Care Model. It is valuable for evaluating conditions that have minimal-to-moderate therapeutic time dependency. This model should be used when studying outcomes limited to the out-of-hospital interval. An example of this is pain management for injuries sustained in motor vehicle crashes. These models can be applied to a wide spectrum of conditions and interventions. With the scrutiny of health care expenditures ever increasing, the identification of clinical interventions that objectively improve patient outcome takes on growing importance. Therefore, the development, dissemination, and use of meaningful methodologies for EMS outcomes research is key to the future of EMS system development and maintenance.

Aftercare↗

Choice of clinical outcomes in randomized trials of heart failure therapies: disease-specific or overall outcomes?

BACKGROUND: There are different views regarding the appropriateness of using cause-specific events or all events as the primary outcome of clinical trials. METHODS: This is a methodologic essay in which we discuss the pros and cons of the 2 approaches and provide illustrative examples. RESULTS: Our preference is the use of cause-specific outcomes (as long as they can be classified with reasonable reproducibility and without bias) because they are more likely to be sensitive to change, less likely to lead to spurious conclusions by random variations in categories of outcomes that are unlikely to be affected by treatment, and relatively free from confounding. Overall benefit-risk ratios can be derived by examining the impact of treatment on various categories of outcomes and then developing a general judgment. Such an approach will also allow judgments to be made regarding generalizability of results across various groups of patients who are at differing risks for an event. CONCLUSIONS: In general, cause-specific outcomes sensitive to the effects of a treatment are to be preferred as the principal outcome in trials of heart failure, as long as they are biologically sensible and can be classified without bias. Other outcomes, not expected to be affected, should also be reported separately.

Bias↗

Outcome following onset of juvenile idiopathic inflammatory arthritis: I. frequency of different outcomes.

OBJECTIVE: To determine the outcome, following the onset of juvenile idiopathic inflammatory arthritis, in terms of remission of disease activity, loss of function and structural damage based on a review of the available published data. METHODS: Electronic databases were searched for major studies publishing outcome data in the past 10 yr in juvenile idiopathic arthritis, juvenile rheumatoid arthritis and juvenile chronic arthritis, and 21 studies were selected. The proportions of children in the different categories of the outcomes of interest are described. Data were stratified where possible by disease subtype. RESULTS: There were major differences between the studies reviewed in terms of study design, case selection and the results obtained. In general, children with systemic- or polyarticular-onset disease were much less likely to go into remission than those with oligoarticular onset, although the remission rates in the latter group ranged from 36 to 84%. Several different approaches were used to assess functional outcome but the pattern of results between the different subgroups was the same as with remission. Similarly, children with polyarticular disease in all the cohorts reviewed were substantially more likely to have erosive radiological damage on follow-up. The rates of individual outcomes, even within a subgroup, varied considerably between studies and this does not appear to be explained solely by differences in methodology. CONCLUSIONS: There remains a considerable lack of clarity in the prognosis following onset of juvenile idiopathic arthritis for the major outcomes considered, although those with oligoarthritis at presentation have the best outcome. The ability to offer accurate prognosis is particularly important to both reassure parents and guide treatment at disease onset. To achieve this, large definitive prospective studies will be required.

Adolescent↗

Outcomes measurement requires nursing to shift to outcome-based practice.

The measurement of outcomes to demonstrate the effectiveness of nursing care delivered is essential. This article will outline the history of outcomes measurement in nursing, the definition and levels of outcomes, the differentiation between process interventions and outcome statements, and the monitoring of outcomes at the staff nurse and case manager levels. Care management methodologies to assist in outcome management will be discussed. In the end, the development of nursing knowledge and innovation in care strategies and advanced clinical decision making is dependent on the measurement of intermediate and end result outcomes.

Case Management↗

Simplifying outcome measurement: evaluation of instruments for measuring outcome after fusion surgery for chronic low back pain.

STUDY DESIGN: A comparative evaluation of outcome instruments and global assessment was performed. OBJECTIVE: To test patient global assessment as a substitute for the use of more comprehensive outcome instruments in treatment trials of chronic low back pain. SUMMARY OF BACKGROUND DATA: Treatment outcome can be measured with pain scales and functional instruments. In the absence of a gold standard, the patient him- or herself is the basic reference for outcome, for which the instruments give a more or less exact measurement. Global assessment, which is a retrospective recording, may overestimate improvement as a result of recall or motivational bias. METHODS: In this study, 294 patients treated for chronic low back pain were evaluated with a visual analog scale for back pain, the Oswestry Disability Index, the Million Score and general function score for disease-specific disability, and the Zung Depression Scale for depressive symptoms. The correlation between the pretreatment and posttreatment scores for the outcome instruments (Delta scores) and the global assessment scores was calculated; effect sizes were compared; sensitivity and specificity with receiver operating characteristics (ROC) curves were estimated; and associations of global assessment with pretreatment and posttreatment scores were determined. RESULTS: All the Delta scores showed significant correlations with patient global assessment and with each other. The effect size of global assessment tended to be greater than that of the outcome instruments. The specificity and sensitivity of the disability instruments and pain scale were approximately 75%, whereas they were lower for depression. The associations between global assessment and outcome instrument scores did not produce evidence that global assessment was biased. CONCLUSION: Patient global assessment is a valid and responsive descriptor of overall effect in randomized controlled trials of treatment for chronic low back pain.

Chronic Disease↗

Implementation of an institutional program to improve clinical and financial outcomes of mechanically ventilated patients: one-year outcomes and lessons learned.

OBJECTIVE: To determine the effect of an institutional approach to the care of patients requiring mechanical ventilation for longer than three consecutive days in five adult intensive care units (ICU) on clinical and financial outcomes. DESIGN: A multidisciplinary team was selected from five adult ICUs to design the approach. Planning occurred from August 1999 to September 2000. The process was called outcomes management (OM) and included an evidence-based clinical pathway, protocols for weaning and sedation use, and the selection of four advanced practice nurses (called outcomes managers) to manage and monitor the program. SETTING: The project was completed in a 550-bed mid-Atlantic academic medical center. The ICUs included the following: coronary care, medical ICU, neuroscience ICU, surgical trauma ICU, and thoracic cardiovascular ICU. PATIENTS: The sample included 595 pre-OM patients and 510 post-OM patients mechanically ventilated for greater than three consecutive days. INTERVENTIONS: Full implementation of the OM approach occurred in March 2001. Retrospective baseline (18 months pre-OM) and prospective (12 months OM) clinical and financial data were compared. MEASUREMENTS AND MAIN RESULTS: Statistically significant differences in clinical outcomes were demonstrated in the managed patients compared with those managed before the institutional approach. Outcomes include ventilator duration (median days declined from ten to nine; p =.0001), ICU length of stay (median days declined from 15 to 12; p =.0008), hospital length of stay (median days declined from 22 to 20; p =.0001), and mortality rate (declined from 38% to 31%, p =.02). More than 3,000,000 US dollars cost savings were realized in the OM group. CONCLUSIONS: This institutional approach to the care of patients ventilated >3 days improved all clinical and financial outcomes of interest. To date, few similar initiatives have demonstrated similar results. The approach and lessons learned in this process improvement project may be helpful to other institutions attempting to improve outcomes in this vulnerable population.

Academic Medical Centers↗

Outcome expectancies, functional outcomes, and expectancy fulfillment for patients with shoulder problems.

OBJECTIVES: This study was conducted to evaluate the relationship among patient outcome expectancies, perceived shoulder function changes, and perceptions of expectancy fulfillment. METHODS: Patients (n = 199) treated for shoulder problems at one orthopedic surgeon's office completed a baseline survey comprised of measures of outcome expectancies, shoulder function, health status, and demographics. At 1 month, 2 months, and 3 months, patients completed a mailed follow-up survey comprised of all baseline measures except demographic variables. At 3 months, a measure of expectancy fulfillment was added. A general linear modeling approach was used to assess the significance and effect size of 1) outcome expectancies on changes in shoulder function; and (2) outcome expectancies, shoulder function changes, and their interaction on perceptions of expectancy fulfillment. RESULTS: Outcome expectancies significantly predicted changes in shoulder function and accounted for 10% of the variance in functional improvement. The improvement difference between patients with high expectancies compared with those with low expectancies was clinically relevant (4.57 points), as it was greater than the minimal clinically important difference (3.02 points). Outcome expectancies and shoulder function changes significantly predicted patients' perceptions of fulfilled expectancies, but their interaction was not statistically significant. CONCLUSIONS: Results highlight the importance of patient expectancy in medical encounters. The findings suggest the need for interventions targeting patient expectancies such as including discussions about expectancy in patient-physician negotiations of therapeutic plans. Results also underscore the need for the development of better measures of outcome expectancies and expectancy fulfillment.

Adolescent↗

Outcome of corneal transplantation: can a prioritisation system predict outcome?

BACKGROUND: In 1995 a prioritisation system for patients waiting for corneal transplantation surgery was adopted in British Columbia. In 1997 a routine outcome assessment programme was adopted. The authors sought to determine the outcomes of corneal transplant surgery in the province of British Columbia and to evaluate if they were associated with waiting list prioritisation. METHODS: Since May 1997 all patients who receive a corneal transplant are enrolled in the Eye Bank of British Columbia (EBBC) outcome assessment programme. Each patient fills out a visual function assessment (VFA) questionnaire before and 12 months after surgery. Data on visual acuity, pain, demographics, and other ocular complications are collected from both patients and surgeons before and after operation. RESULTS: 269 patients were enrolled in the programme between May 1997 and April 1998. 12 month follow up showed that visual acuity improved in 69.9% of patients, while it remained the same in 20.8%, and got worse in 5.9%. Overall, at follow up 16.6% of patients had intermittent pain and 5.0% had constant pain. 78.6% of patients who experienced intermittent or constant pain before surgery reported no pain at follow up. Visual function improved in 72.4% of patients, remained the same in 4.1%, and worsened in 23.5%. 88% of patients improved in at least one of the three outcome categories. Patients who had the greatest improvement had been assigned the highest priority for surgery. The 11% of patients who did not improve in any of the three categories (visual acuity, pain, or visual function) were more likely to have a preoperative visual acuity better than 20/60, most likely to have old trauma or Fuchs' dystrophy as their primary diagnosis, and to have had fewer points in the EBBC priority scoring system. CONCLUSION: The finding that patients who had a high preoperative priority score were more likely to have a good outcome suggests that the priority system was accurately identifying patients at greatest need for surgery. These findings also suggest that outcome from corneal transplant surgery is best measured as a combination of clinical indices and patient derived indices. A routine outcome assessment programme and prioritisation system can assist surgeons and eye banks in better case selection and in anticipating both objective and subjective improvement following surgery.

Aged↗

In pursuit of patient-centred outcomes: a qualitative evaluation of the 'Measure Yourself Medical Outcome Profile'.

OBJECTIVES: To ascertain the ability of a patient-generated outcome measure, the 'Measure Yourself Medical Outcome Profile' (MYMOP), to reflect the outcomes of consultations which patients consider are most important, as derived from qualitative interviews. METHODS: A qualitative study using a constant comparative method to analyse semistructured interviews which were then compared with the results of MYMOP questionnaires. A variable-orientated analysis was used to develop themes and a case-orientated analysis was used to develop narrative summaries called vignettes from the interviews. The MYMOP questionnaire was completed by the interviewees (n = 20), a minimum to twice and a maximum of nine times over a four-month period. The scores were displayed on individual MYMOP charts. For each individual, the outcome as measured by MYMOP was compared with the outcome data from the qualitative interviews. The interviewees were attending a variety of complementary practitioners in primary care. RESULTS: The treatment effects which people described were encompassed by five themes: reduction in symptoms; reduction in disability; reduction in, or avoidance of, medication; gaining control and improving coping skills; and securing support and hope through the patient-practitioner relationship. The vignettes demonstrated how individuals identified and valued these various effects and weighed them up in evaluating the overall benefit of the treatment. Their MYMOP charts were able to measure some effects better than others. CONCLUSIONS: The treatment effects, as quantified using MYMOP, accorded with those described by most patients at interview, but some important limitations were identified with MYMOP, particularly an underplaying of the importance of medication avoidance or medication reduction in this patient group. This dimension is lacking in most outcome questionnaires and has been included in a new version of MYMOP. This study also showed that qualitative interview data can help in evaluating the ability of outcome questionnaires to measure the treatment effects that particular patient groups consider most important.

Adolescent↗

Evaluation of the reliability and validity of nursing outcomes classification patient outcomes and measures.

One hundred sixty-nine of the Nursing Outcomes Classification (NOC) patient outcomes were tested for interrater reliability, criterion validity, and sensitivity. In 10 field sites, ranging from hospitals to home care, pairs of nurses rated the outcome measures for 5 to 130 patients. Inter-class correlations were greater than or equal to 0.70 for 63 outcomes. Pearson's correlations with criterion measures were greater than or equal to 0.60 for 40 outcomes and from 0.39 to 0.60 for 43 additional ones. Change scores for 99 outcomes ranged from 0 to 2.0 from first to second and second to third rating. Most NOC measures demonstrated good inter-rater reliability, substantial criterion validity, and sensitivity to change. More testing and thorough training of nurses using NOC outcomes are needed.

Aged↗

Patient outcomes and pathology practice: An introduction to the College of American Pathologists Conference XXXIV on Molecular Pathology: Role in Improving Patient Outcome.

This article provides an abbreviated conceptual framework for viewing general issues of outcomes research and management and consideration of the emerging interest in patient-referenced outcomes in medicine and pathology. Specific issues addressed are the reasons for increased interest in outcomes research within the past decade; a review of the current language of outcomes management and research; a critique of the advantages and weaknesses of contemporary outcomes analysis and research methods; a summary of the responses of government, regulatory and accreditation organizations, medical societies, and the College of American Pathologists to the outcomes movement; and, in conclusion, a discussion of opportunities provided through outcomes management for enhanced involvement by pathologists in the care of patients.

Humans↗

Outcomes of patients with hypertension and non-insulin dependent diabetes mellitus treated by different systems and specialties. Results from the medical outcomes study.

OBJECTIVE: To compare the outcomes of patients with hypertension and non-insulin-dependent diabetes mellitus (NIDDM) who were cared for in three different systems of care and by generalist and subspecialist physicians. DESIGN: An observational study with follow-up at three periods: (1) a 2-year study of 532 patients with hypertension and 170 patients with NIDDM who had entrance and exit histories, physical examinations, and laboratory tests; (2) a 4-year follow-up of 1044 patients with hypertension and 317 patients with NIDDM based on patient-reported functional status; and (3) 7-year mortality for 1296 patients with hypertension and 424 patients with NIDDM. SETTING AND PARTICIPANTS: Patients sampled from health maintenance organizations, large multispecialty groups, and solo or single-specialty group practices in Boston, Mass, Los Angeles, Calif, and Chicago, Ill. Patients were designated as belonging to one of three systems of care: fee for service; prepaid patients in solo or small single-specialty groups or in large multispecialty group practices, referred to as independent practice associations; and staff-model health maintenance organizations. The principal providers were family practitioners, general internists, cardiologists, or endocrinologists. MAIN OUTCOME MEASURES: Physiological, functional, and mortality. For hypertension, we measured blood pressure and stroke incidence. For NIDDM, we measured blood pressure, glycosylated hemoglobin level, visual function, vibration sense, ulcers and infections in the feet, and albumin excretion rate. Functional outcomes were assessed using the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36). Mortality was assessed for the 7 years following the entrance examination. RESULTS: We found no evidence that any one system of care or physician specialty achieved consistently better 2-year or 4-year outcomes than others for patients with NIDDM or hypertension. Endocrinologists appeared to achieve better foot-ulcer and infection outcomes for patients with NIDDM, particularly when compared with family practitioners. However, no other specialist differences were found in any individual measures for either condition. Moreover, no adjusted mortality differences among systems or among physicians specialties were observed in the 7-year follow-up period. CONCLUSION: No meaningful differences were found in the mean health outcomes for patients with hypertension or NIDDM, whether they were treated by different care systems or by different physician specialists. Although prepaid medicine relies more heavily on generalist physicians than does fee for service, there is no evidence from these analyses that the quality of care of moderately ill patients with these two common disease was adversely affected. These findings must be viewed in light of the historically higher costs of fee-for-service medicine and of subspecialty physician practice.

Analysis of Variance↗

Breast cancer outcome and predictors of outcome: are there age differentials?

Several questions were addressed regarding breast cancer outcome, predictors of outcome, and young age at diagnosis. Is there evidence that outcome is worse in younger women compared with other age groups? Do younger patients have a greater frequency of adverse prognostic factors? If younger age is associated with a poor outcome, is it an intrinsic independent adverse predictor, or is the outcome worse due to poor prognostic factor profiles? Several methods were used to answer these questions and applied to those reports in which age categories were carefully defined: 1) detailed review of population-based breast cancer outcome literature, 2) synthesis of published cooperative group and single institution univariate and multivariate analyses, and 3) a new analysis of the 8738-patient San Antonio database. Overall, epidemiologic studies suggested that younger women have the worst survival outcome, when matched with similarly staged older cohorts. Univariate trends analyses confirmed that younger women more often had more positive lymph nodes, larger tumors, and negative steroid hormone receptors. Significantly more cancers in women less than 35 years of age had high S-phase fractions and abnormal expression of p53. Multivariate modeling confirmed that young age was an independent adverse predictor when a few standard factors were considered in the model, but other descriptors such as tumor grade or high S-phase fraction were more important when available. These data support the conclusion that "young age" serves as a surrogate for a greater frequency of adverse prognostic factor profiles and suggest important questions for future study.

Adult↗

Critical care outcomes: linking structures, processes, and organizational and clinical outcomes.

BACKGROUND: Organizational structure and process are thought to affect patient care outcomes beyond the effects of expert clinical care. OBJECTIVES: To test the hypothesis that a discretionary pattern of organizational structure and process factors is predictive of critical care unit performance, ie, desirable patient and organizational outcomes. METHODS: Quality-of-care patient and organizational outcomes were evaluated in 25 critical care units. A single value representing each critical care unit's euclidian distance from a theoretically ideal pattern of discretionary function was determined and correlated with unit-level measures of outcomes (standardized mortality ratio, severity-adjusted length of stay, patient satisfaction, quality of nursing care, and nursing retention). RESULTS: Distance from the ideal-type discretionary pattern predicted organizational but not clinical outcomes. Units closer to the ideal-type pattern had higher RN retention, and were viewed as better places to work, with higher-quality care by both nurses and physicians. Objectively measured quality of care, patient satisfaction, severity-adjusted mortality, and length of stay were not consistently related to better-structured units. CONCLUSIONS: With experienced critical care practitioners, unit-level structure and process factors were better predictors of organizational outcomes than of clinical outcomes.

APACHE↗

Assessing the contributions of S-O and R-O associations to differential-outcome matching through outcome reversals.

Pigeons were trained on symbolic matching with 2 samples, 2 pairs of comparisons, and different outcomes for the correct responses within each comparison pair. For one group, the 2 samples were also associated with different outcomes, whereas for another group, they were not. When the response-outcome (R-O) relations for one pair were subsequently reversed, the group trained with differential sample-outcome (S-O) associations was significantly disrupted in its performance on both reversed- and nonreversed-outcome trials. By contrast, the group trained with just differential R-O associations was disrupted only on reversed-outcome trials. These results were replicated when the outcomes on the initially nonreversed trials were then reversed. The findings indicate that differential S-O associations, when present, have a stronger influence on matching performances than differential R-O associations. They are also consistent with hierarchical and configural models of discriminative control.

Animals↗

Major clinical outcomes in adults undergoing thoracic aortic surgery requiring deep hypothermic circulatory arrest: quantification of organ-based perioperative outcome and detection of opportunities for perioperative intervention.

OBJECTIVE: The purpose of this study was to describe clinical outcome after adult thoracic aortic surgery requiring standardized deep hypothermic circulatory arrest (DHCA), to determine mortality and length of stay, neurologic outcome, cardiorespiratory outcome, and hemostatic and renal outcome after DHCA. DESIGN: Retrospective and observational. SETTING: Cardiothoracic operating rooms and intensive care unit (ICU). PARTICIPANTS: All adults requiring thoracic aortic repair with DHCA. INTERVENTIONS: None. The study was observational. MAIN RESULTS: The cohort size was 110. All patients received an antifibrinolytic. The mortality rate was 8.2%. The mean length of stay was 6.8 days (ICU) and 14.0 days (hospital). The incidence of stroke was 8.1% and postoperative delirium was 10.9%. The rate of postoperative atrial fibrillation was 43.6%; 19.1% required postoperative mechanical ventilation longer than 72 hours. Chest tube drainage was 931 mL for the first 24 hours. Postoperative dialysis was required in 1.8% of patients. Renal dysfunction occurred in 40% to 50% of patients, depending on the definition. CONCLUSIONS: The protocol for DHCA at the authors' institution is associated with superior or equivalent perioperative outcomes to those reported in the literature. This study identified the need for further quantification of the clinical outcomes after DHCA in order to prioritize outcome-based hypothesis-driven prospective intervention in DHCA.

Aged↗