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Outcomes management: an interdisciplinary approach to improving patient outcomes.

Outcomes management provides a means for interdisciplinary collaboration in improving patient outcomes. The benefits of an outcomes management program are numerous, including decreasing healthcare costs, decreasing the length of stay, improving clinical outcomes, improving system processes, and fostering outcomes research. The outcomes manager is responsible for the development, implementation, and evaluation of an outcomes management program. One of the functions of an outcomes manager is developing collaborative practice teams to serve as vehicles of change through their analysis of outcomes data and the identification of best practice patterns. Interdisciplinary collaboration is a key component of an outcomes management program. Without an atmosphere os shared responsibility among disciplines for outcomes noted in a patient population, and recognition of individual expertise regarding care, efforts to produce change will move very slowly, if at all, and optimal improvements in care will be forfeited.

Costs and Cost Analysis↗

Identifying outcomes from the nursing outcomes classification as indicators of quality of care in Korea: a modified delphi study.

BACKGROUND: The evaluation of patient outcomes as a measure of quality control of patient care is being adopted in Korean hospitals. Since nursing care contributes to the bulk of patient care, it is important to identify nursing-sensitive patient outcomes, hereafter referred to as 'nursing outcomes', that will be useful in the evaluation of nursing care. OBJECTIVE: This study was conducted to identify nursing outcomes included within the Nursing Outcomes Classification (NOC) that are most sensitive for the evaluation of nursing care in Korean hospitals as well as being observable and measurable. DESIGN: Delphi technique modified for this study was used to gain a consensus from Korean nursing experts. SETTINGS: Participants were recruited from general hospitals in Korea. PARTICIPANTS: Two hundred and thirty nurses working for Quality Improvement (QI) and Continuous Quality Improvement (CQI) programmes were chosen as the nurse experts for this study. METHODS: Three rounds of data collection from all participants was undertaken. In the first data collection, the sensitivity of 260 NOC nursing outcomes (Johnson, et al., 2000. Iowa Outcomes Projects: Nursing Outcomes Classification (NOC). C.V. Mosby, St. Louis) was examined, and more highly nursing sensitive ones were selected. In the second and third data collection phases, nursing outcomes which are most useful for the evaluation of nursing care were selected. RESULTS: Vital Signs Status, Knowledge: Infection Control, Pain Control, Safety Behavior: Fall Prevention, and Infection Status were identified as the five most useful nursing outcomes for the evaluation of nursing care in hospitals. CONCLUSIONS: The nursing outcomes identified highly useful for the evaluation of nursing care in this study can be used effectively for the quality management of nursing care in Korea.

Adult↗

A comparative evaluation of substance abuse treatment: II. Linking proximal outcomes of 12-step and cognitive-behavioral treatment to substance use outcomes.

This study examines the linkages in the treatment process chains that are thought to underlie two prevalent approaches to substance abuse treatment, traditional 12-Step treatment and cognitive-behavioral treatment. The focus is on the "proximal outcomes" specified by the two treatment approaches and their relation to "ultimate" substance use outcomes assessed at a 1-year follow-up. A total of 2687 men who received treatment in 15 Department of Veterans Affairs substance abuse treatment programs were assessed at treatment entry, at or near discharge, and at a 1-year follow-up. Based on the results of factor analyses, composite proximal outcomes variables were constructed to assess 12-Step cognitions, 12-Step behaviors, cognitive-behavioral beliefs, substance-specific coping, and general coping. Correlation analyses indicated that some of the proximal outcome composites assessed at treatment discharge were linked to 1-year outcomes, but the relationships were weak (r = .09 to .15). At follow-up, the cross-sectional relationships between the proximal outcome composites and two substance use outcomes were stronger, but still modest in magnitude (r = .16 to .39). The weak predictive findings suggest some mechanism is needed to sustain treatment-induced change on proximal outcomes so that positive ultimate outcomes can be achieved more frequently. In this regard, participation in continuing care was associated with enhanced maintenance of treatment gains on proximal outcomes. However, the modest cross-sectional relationships between proximal and substance use outcomes at follow-up suggest that the theories on which 12-Step and cognitive-behavioral substance abuse treatments are based are not sufficiently comprehensive.

Adaptation, Psychological↗

Costs of measuring outcomes of acute hospital care in a longitudinal outcomes measurement system.

It is widely acknowledged that the measurement of outcomes of care and the comparison of outcomes over time within health care providers and risk-adjusted comparisons among providers are important parts of improving quality and cost-effectiveness of care. However, few studies have assessed the costs of measuring outcomes of care. We sought to evaluate the personnel and financial resources spent for a prospective assessment of outcomes of acute hospital care by health professionals in internal medicine. The study included 15 primary care hospitals participating in a longitudinal outcomes measurement program and 2005 patients over an assessment period with an average duration of 6 months. Each hospital project manager participated in a previously-tested structured 30-minute telephone interview. Outcome measures include time spent by the individual job titles in implementing and running the outcomes measurement program. Job-title-specific times were used to calculate costs from the hospitals' perspective. One-time costs (2132 +/- 1352 Euros) and administrative costs (95 +/- 97 Euros per week) varied substantially. Costs per patient were fairly stable at around 20 Euros. We estimated that the total cost for each hospital to assess outcomes of care for accreditation (10 tracer diagnoses over 6 months) would be 9700 Euros and that continuous monitoring of outcomes (5 tracer diagnoses) would cost 12,400 Euros per year. This study suggests that outcomes of acute hospital care can be assessed with limited resources and that standardized training programs would reduce variability in overall costs. This study should help hospital decision makers to estimate the necessary funding for outcomes measurement initiatives.

Hospital Costs↗

Expanding the roles of outpatient pharmacists: effects on health services utilisation, costs, and patient outcomes.

BACKGROUND: In recent years pharmacists' roles have expanded from simply packaging and dispensing medications to working with other health care professionals and the public. OBJECTIVES: To assess the effects of expanding outpatient pharmacists' roles on health services utilisation, the costs of health services, and patient outcomes. SEARCH STRATEGY: We searched the Cochrane Effective Practice and Organisation of Care Group specialised register, MEDLINE, EMBASE, Pharmline, International Pharmaceutical Abstracts and reference lists of articles up to December 1995. We also searched the published abstracts of three meetings and hand searched five journals and two bibliographies. SELECTION CRITERIA: Randomised trials, controlled clinical trials, controlled before-and-after studies and interrupted time series analyses of interventions comparing 1. Pharmacist services targeted at patients versus services delivered by other health professionals; 2. Pharmacist services targeted at patients versus no intervention; 3. Pharmacist services targeted at health professionals versus services delivered by other health professionals; and 4. Pharmacist services targeted at health professionals versus no intervention. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and assessed study quality. MAIN RESULTS: Fourteen studies were included involving more than 1991 patients. In the one study identified for comparison 1 the relative changes in professional outcome measures ranged from a 24% increase in clinic visits to a 16% decrease in hospital admissions. Relative differences in patient outcome measures were not statistically significant. Seven studies were identified for comparison 2. Four measured process of care and demonstrated decreases in health services utilisation from -67% for hospital admissions to -564% for total ambulatory care visits, as well as decreases in the numbers and costs of drugs compared to control patients. Five measured patient outcomes and consistently reported improvements in the targeted patient condition. In the one study identified for comparison 3 the intervention delivered by the pharmacist was less successful than that delivered by physician counsellors in decreasing inappropriate antibiotic prescribing. All six studies identified for comparison 4 demonstrated that the pharmacist intervention produced the intended effect on physician prescribing practices. These studies did not measure patient outcomes. REVIEWER'S CONCLUSIONS: The limited number of studies analysed support the expanded roles of pharmacists in patient counselling and physician education. However, doubts about the generalisability of the studies, the poorly defined nature of the interventions tested, and the lack of studies including cost assessments and patient outcome data indicate that more rigorous research is needed to document the effects of outpatient pharmacist interventions.

Ambulatory Care↗

Early Glasgow Outcome Scale scores predict long-term functional outcome in patients with severe traumatic brain injury.

Patients sustaining severe traumatic brain injury (TBI) have variable long-term outcomes. We examined the association between Glasgow Outcome Scale (GOS) assessed at 3 months and long-term outcomes at 12 months after TBI. We studied 159 patients with severe, closed traumatic brain injuries (Glasgow Coma Scale [GCS] <or= 8) who were treated at an academic medical center and survived for a minimum of 3 months after TBI. Demographics and admission clinical data and GOS at 3 and 12 months were analyzed. Multivariate logistic regression was used to asses the relationship between 3-month GOS, demographics, and clinical data and a poor outcome, defined as GOS 1-3 assessed at 12 months after injury. The patient population was predominantly male (77%), with a median age of 30 years and a median admission GCS of 6. The logistic regression model showed that the GOS at 3 months was the best predictor of 12-month outcomes (odds ratio = 15.22, p < 0.001). The presence of prolonged hypotension, diffuse axonal injury (DAI), and fixed and dilated pupils on admission were also significant independent predictors of poor 12-month outcome (for all, p <or= 0.047). The adjusted logistic model showed a steep gradient of long-term recovery potential depending upon GOS at 3 months, ranging from an 89.4% chance of poor outcome for patients with a GOS of 2, to a 0.11% chance of poor outcome for those with a GOS of 5. The 3-month GOS is a powerful independent predictor of long-term outcome for patients with severe TBI. Prolonged hypotension, DAI, and the presence of fixed and dilated pupils were also independent predictors of poor outcome.

Adolescent↗

The effect of clustering of outcomes on the association of procedure volume and surgical outcomes.

BACKGROUND: A large body of literature documents associations between the volume of cases a hospital or surgeon treats and clinical outcomes. Most of these studies have used conventional statistical methods that do not recognize the fact that hospitals or surgeons with similar volumes may have very different outcomes because of systematic differences in processes of care, a phenomenon that exaggerates the true statistical significance of the effect of volume on outcome. OBJECTIVE: To describe methods to assess the degree of this "clustering" of outcomes and to explore the impact of available statistical techniques that correct for clustering. DESIGN: Reanalysis of 3 previously published volume-outcome studies. SETTING: Medicare beneficiaries 65 years of age or older undergoing surgery for colon, prostate, or rectal cancer in the population defined by the Surveillance, Epidemiology, and End Results cancer registries during 1992 to 1996. PATIENTS: 3 data sets were analyzed to assess the impact of surgeon volume on outcomes: 1) 24 166 colectomies performed by 2682 surgeons, 2) 10 737 prostatectomies performed by 999 surgeons, and 3) 2603 rectal resections performed by 1141 surgeons. MEASUREMENTS: Volume-outcome trends were analyzed by a conventional method (logistic regression) and corrected for clustering. Two widely used statistical methods for analyzing clustered data, a random-effects model and generalized estimating equations, were used and compared, and the degree of clustering was presented graphically. RESULTS: Substantial clustering was observed in the analyses involving morbidity end points. The 2 statistical techniques produced noticeably different results in some analyses. CONCLUSIONS: The presence of clustering represents variations in outcomes among providers with similar volumes. Thus, in volume-outcome studies, the degree of clustering of outcomes should be characterized because it may provide insight into variations in quality of care.

Clinical Competence↗

The Outcomes of Cancer Outcomes Research: focusing on the National Cancer Institute's quality-of-care initiative.

BACKGROUND: To assess the impact of outcomes research, the Agency for Healthcare Policy and Research has proposed a four-level typology that successively distinguishes between research that (1) adds to the knowledge base only, (2) affects practice policies, (3) influences the delivery of care, and (4) leads to changes in health outcomes. The agency has concluded that outcomes research to date has made substantial contributions at level 1, but has had little impact at levels 2 to 4. OBJECTIVE: To describe the National Cancer Institute's emerging agenda in cancer outcomes research, focusing on how it has been shaped early on to support the institute's quality of care initiative and noting whether each new project represents outcomes research at level 1, 2, 3, or 4. RESULTS: Cancer outcomes research describes, interprets, and predicts the impact of various influences, especially (but not exclusively) interventions on endpoints that matter to decision makers. The institute's projects to improve the scientific quality of final endpoint measures, strengthen the methodologic and empirical basis for quality of care analysis, and enhance the application of health-related quality-of-life measures in clinical trials represent level 1 applications of outcomes research. Collaborative projects with federal agencies to translate evidence into practice and a new public and private effort to identify core measures of cancer quality represent level 2 and level 3 outcomes research. CONCLUSION: The stage has been set for carrying out a balanced portfolio of level 1 to 3 outcomes research projects in cancer, with the ultimate (level 4) aim of improving cancer-related health outcomes.

Clinical Trials as Topic↗

Differences in 4-year health outcomes for elderly and poor, chronically ill patients treated in HMO and fee-for-service systems. Results from the Medical Outcomes Study.

OBJECTIVE: To compare physical and mental health outcomes of chronically ill adults, including elderly and poor subgroups, treated in health maintenance organization (HMO) and fee-for-service (FFS) systems. STUDY DESIGN: A 4-year observational study of 2235 patients (18 to 97 years of age) with hypertension, non-insulin-dependent diabetes mellitus (NIDDM), recent acute myocardial infarction, congestive heart failure, and depressive disorder sampled from HMO and FFS systems in 1986 and followed up through 1990. Those aged 65 years and older covered under Medicare and low-income patients (200% of poverty) were analyzed separately. SETTING AND PARTICIPANTS: Offices of physicians practicing family medicine, internal medicine, endocrinology, cardiology, and psychiatry, in HMO and FFS systems of care. Types of practices included both prepaid group (72% of patients) and independent practice association (28%) types of HMOs, large multispecialty groups, and solo or small, single-specialty practices in Boston, Mass, Chicago, Ill, and Los Angeles, Calif. OUTCOME MEASURES: Differences between initial and 4-year follow-up scores of summary physical and mental health scales from the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) for all patients and practice settings. RESULTS: On average, physical health declined and mental health remained stable during the 4-year follow-up period, with physical declines larger for the elderly than for the nonelderly (P<.001). In comparisons between HMO and FFS systems, physical and mental health outcomes did not differ for the average patient; however, they did differ for subgroups of the population differing in age and poverty status. For elderly patients (those aged 65 years and older) treated under Medicare, declines in physical health were more common in HMOs than in FFS plans (54% vs 28%; P<.001). In 1 site, mental health outcomes were better (P<.05) for elderly patients in HMOs relative to FFS but not in 2 other sites. For patients differing in poverty status, opposite patterns of physical health (P<.05) and for mental health (P<.001) outcomes were observed across systems; outcomes favored FFS over HMOs for the poverty group and favored HMOs over FFS for the nonpoverty group. CONCLUSIONS: During the study period, elderly and poor chronically ill patients had worse physical health outcomes in HMOs than in FFS systems; mental health outcomes varied by study site and patient characteristics. Current health care plans should carefully monitor the health outcomes of these vulnerable subgroups.

Adult↗

Reconsidering "between-group psychotherapy outcome research and basic science:" applications to child and adolescent psychotherapy outcome research.

Borkovec and Miranda (1996) proposed that the purpose of controlled outcome studies is to increase our understanding of the change mechanisms associated with psychotherapy, and they suggested several ways that between-group outcome research establishes cause-and-effect relationships. Child psychotherapy outcome research presents special challenges for the issues raised by Borkovec and Miranda and four of these are discussed herein: (a) the multitude of influences on children and adolescents that affect their functioning and therapy outcomes, (b) accurately defining the referral problem, (c) identifying appropriate outcome measures and reliable informants of change in child and adolescent treatment, and (d) considering developmental processes that influence therapeutic effectiveness. It is suggested that transporting clinical trials methods to natural settings is of limited value in identifying cause-and-effect relationships, and an alternative methodology is proposed for advancing child therapy outcome research. This approach advocates developing a profile of the underlying causes that predict psychopathology and therapy outcome for individual children in real clinical settings and then aggregating the data for youth with similar profiles and outcomes. These data can then be used to generate hypotheses about what interventions work for specific children, and investigators can employ prospective studies of therapy outcome for youth with similar profiles.

Adolescent↗

One-year outcome in early aneurysm surgery: prediction of outcome.

Predictors of one-year outcome were studied in patients treated for ruptured intracranial aneurysm. A total of 929 patients, who were treated conservatively or surgically, and 839 patients as a part of this population who were surgically treated, were randomly divided into two groups in order to create predictive models by logistic regression and to validate them. The models were derived from two-thirds of these two patient groups and the remaining one-thirds were used for validation. The pre-operative variables of both conservatively and surgically treated patients were studied by Model A. The pre-operative Grade (Hunt and Hess), age, and the presence of vasospasm on angiography were the three most important predictors of the one-year outcome (Glasgow Outcome Scale 1-2/3-5). Model B consisted of pre- and per-operative, and Model C pre-, per-, and post-operative variables collected from the surgically treated group. The pre-operative Grade, ligation of a major vessel and age were the three most powerful determinants of outcome in Model B. In Model C high Grade, post-operative CT-hypodensities and ligation of a major vessel were most closely associated with poor outcome. Model A, based on pre-operative data, most accurately predicted good outcome. All the 59 patients in the validation sample (n = 310) who were predicted to have a less than 5% probability of poor outcome had a favourable outcome (positive and negative predictive value 100%). Model C determined that 22 of 280 patients would have a more than 80% probability of poor outcome.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗

Responsiveness of the Michigan Hand Outcomes Questionnaire and physical measurements in outcome studies of distal radius fracture treatment.

PURPOSE: Outcomes study of distal radius fracture (DRF) treatment has been hampered by an uncertainty regarding the most appropriate outcomes assessment tool to evaluate the effectiveness of treatment. This study aimed to measure the responsiveness of the Michigan Hand Outcomes Questionnaire (MHQ) and physical measurements to assess the value of these outcomes tools for DRF studies. METHODS: Forty-seven patients prospectively completed the MHQ and physical testing at 3 months and 6 months (period 1) after open reduction and internal fixation of unstable DRFs. Thirty-seven patients prospectively completed the MHQ and physical testing at 6 months and 1 year after open reduction and internal fixation (period 2). Responsiveness to clinical change within each period was calculated with standardized response means (SRMs). RESULTS: In period 1, all domains of the MHQ except aesthetics significantly improved. The SRMs were large for the overall score and for the work domain. The SRMs were medium for the pain, function, and activities of daily living domains. In period 1, the grip strength, pinch strength, and active wrist range of motion measurements significantly improved and had large SRMs. In period 2, the grip- and pinch-strength tests significantly improved and the SRMs were medium, whereas the active wrist range of motion had a small SRM. CONCLUSIONS: Unlike other conditions such as carpal tunnel syndrome, for which the outcomes questionnaire is the most responsive measure, in DRF treatment both the MHQ and physical tests are responsive in measuring outcomes and should be reported for outcomes studies of DRFs. The MHQ and physical tests can be used for outcomes research related to DRF with the advantage of also being useful for assessing and comparing outcomes for other hand disorders.

Activities of Daily Living↗

Memory and intelligence outcome following surgery for intractable temporal lobe epilepsy: relationship to seizure outcome and evaluation using a customized neuropsychological battery.

The main objectives of this prospective study were to (1) assess memory and intelligence outcome following surgery for intractable temporal lobe epilepsy, (2) correlate this with seizure outcome and side of surgery, and (3) perform (1) and (2) using an indigenously developed battery customized to the Indian population. Prior to use in our epilepsy surgery program, the test-retest and interexaminer variance reliability of this battery had been established in both normal and cognitively compromised populations. The memory scores were overall rather than material-specific. The battery was administered to right-handed adults undergoing surgery for intractable temporal lobe epilepsy without any evidence of opposite temporal lobe abnormality, both presurgery and postsurgery at a mean follow-up of 8 months. Twenty-five consecutive patients were included; 13 underwent right and 12 underwent left temporal surgery. Seizure outcome was assessed using Engel's classification. Among 13 patients who underwent right temporal surgery, although 4 patients with poor seizure outcome had insignificant changes in scores, 7 of 9 patients with good seizure outcome exhibited considerable (> 20% over preoperative) improvement in their memory and intelligence scores. Statistical analysis using Student's t test and the Mann-Whitney test revealed that the patients who underwent right temporal surgery with good seizure outcome had significant improvement in both memory (P = 0.007) and intelligence (P = 0.043) scores compared with those with poor seizure outcome. In contrast, patients who underwent left temporal surgery had no significant change in cognitive scores irrespective of seizure outcome. Cognitive improvement seems to occur in patients with good seizure outcome following nondominant temporal lobe surgery for intractable epilepsy with no evidence of pathology in the opposite temporal lobe. The same finding was not observed in patients undergoing left temporal surgery.

Adolescent↗

The importance of gender on outcome after major trauma: functional and psychologic outcomes in women versus men.

BACKGROUND: Outcome after major trauma is an increasingly important focus of injury research. The effect of gender on functional and psychological outcomes has not been examined. The Trauma Recovery Project is a large, prospective, epidemiologic study designed to examine multiple outcomes after major trauma, including quality of life, functional outcome, and psychological sequelae such as depression and early symptoms of acute stress reaction. The specific objectives of the present report are to examine gender differences in short- and long-term functional and psychological outcomes in the Trauma Recovery Project population. METHODS: Between December 1, 1993, and September 1, 1996, 1,048 eligible trauma patients triaged to four participating trauma center hospitals in the San Diego Regionalized Trauma System were enrolled in the study. The enrollment criteria for the study included age 18 years and older, admission Glasgow Coma Scale score of 12 or greater, and length of stay greater than 24 hours. Quality of life was measured after injury using the Quality of Well-being scale, a sensitive index to the well end of the functioning continuum (range, 0 = death to 1.000 = optimum functioning). Depression was assessed using the Center for Epidemiologic Studies Depression scale and early symptoms of acute stress reaction were assessed using the Impact of Events scale. Patient outcomes were assessed at discharge and at 6, 12, and 18 months after discharge. RESULTS: Functional outcome was significantly worse at each follow-up time point in women (n = 313) versus men (n = 735). Quality of Well-being scale scores were markedly and significantly lower at 6-month follow-up in women compared with those in men (0.606 vs. 0.646, p < 0.0001). This association persisted at 12-month (0.637 vs. 0.6685, p < 0.0001) and 18-month (0.646 vs. 0.6696, p < 0.0001) follow-up. Women were also significantly more likely to be depressed at all follow-up time points (discharge odds ratio [OR] = 1.4, p < 0.05; 6-month follow-up OR = 2.2, p < 0.01; 12-month follow-up OR = 2.0, p < 0.01; 18-month follow-up OR = 2.2, p < 0.01) and to have early symptoms of acute stress reaction at discharge (OR = 1.4, p < 0.05). These differences remained significant and independent after adjusting for injury severity, mechanism, age, and sociodemographic factors. CONCLUSION: Women are at risk for markedly worse functional and psychological outcomes after major trauma than men, independent of injury severity and mechanism. Gender differences in short- and long-term trauma outcomes have important implications for future studies of recovery from trauma.

Adult↗

Psychopathology and outcome of first-admission schizophrenic patients: hypochondriac-cenestopathic symptoms as predictors of an unfavorable outcome.

The outcome of first-admission schizophrenic patients at Jichi Medical School Hospital was investigated to identify outcome predictors of schizophrenia among the symptoms at the time of the first hospitalization. The subjects were 62 schizophrenic patients, 29 females and 33 males, consecutively discharged from the Department of Psychiatry, Jichi Medical School Hospital, between June 1983 and May 1988. The mean interval between first admission and follow-up was 13 years. Eguma's Social Adjustment Scale was used to measure social outcome. The subjects were divided into two groups according to their rating on Eguma's Scale; a favorable outcome group and an unfavorable outcome group. Information on premorbid status and psychopathology at the time of the first hospitalization was obtained from clinical records and analyzed by comparing them between the two groups. Of the 62 patients, 56 were followed-up. Nine of the 56 patients followed-up had died. While 47 patients were alive; 39 were receiving psychiatric treatment and eight were not. The 47 patients who were still living were divided into two groups; a favorable outcome group (n = 22), and an unfavorable outcome group (n = 25). No significant differences in premorbid status were found. Comparison of psychopathology at the time of the first hospitalization between the outcome groups revealed significant differences in lack of spontaneity and hypochondriac-cenestopathic symptoms. Lack of spontaneity may reflect negative symptomatology, while hypochondriac-cenestopathic symptoms may reflect a serious disturbance of ego function. There is a strong possibility that evaluation of body-related symptoms in schizophrenia will be helpful in predicting outcome.

Activities of Daily Living↗

Previous pregnancy outcome is an important determinant of subsequent pregnancy outcome in women with systemic lupus erythematosus.

Women with systemic lupus erythematosus (SLE) have increased adverse pregnancy outcomes. The reasons for these problems include maternal disease, clinical or serologic activity, medication use, and residual organ impairment from prior disease flares. In retrospective studies, pregnancy data are often treated cross-sectionally, with births rather than mothers as the unit of analysis. Multiple pregnancies from the same mother may be highly correlated with each other. In an unmatched retrospective study, the first two pregnancy outcomes in lupus patients with anticardiolipin antibody (anti-CL IgG or IgM isotype) (cases N = 47) and without anticardiolipin antibody (controls, N = 125) were assessed according to birth order. A good outcome was defined as a full-term (> 38 weeks) live birth without neonatal complications. All other pregnancy outcomes were considered adverse outcomes. Therapeutic abortions and ectopic or molar pregnancies were excluded. Both cases and controls with an adverse outcome in their first pregnancy had at least a 50% chance of another adverse outcome in their second pregnancy. Cases with a late miscarriage (fetal loss at 14 to 20 weeks' gestation) in their first pregnancy had the highest risk, 80%, of an adverse outcome in their second pregnancy. Both previous pregnancy loss and anti-CL antibody status should be considered in the analysis of pregnancy outcomes in women with SLE.

Antibodies, Anticardiolipin↗

The problem with measuring patient perceptions of outcome with existing outcome measures in foot and ankle surgery.

Quality outcome measures are the cornerstone of clinical research. A review of outcome measures used in foot and ankle surgery research reveals that the issues of validity, reliability and responsiveness of outcome measures have not been addressed. Most reports in the literature have attempted to evaluate patient perceptions of outcome following foot surgery. Underlying the many difficulties with these outcome measures is a lack of understanding of what patients perceive to be important in terms of outcome. Consequently none of the existing outcome measures can claim to be valid measures of patient perceptions of outcome, as there has been no research uncovering these perceptions. In addition, measures of general health status and quality of life in relation to outcome of foot and ankle surgery have been largely ignored to date.

Ankle↗