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PubMed2000

Toward more rational prediction of outcome in patients with high-grade subarachnoid hemorrhage.

OBJECTIVE: Accurate outcome prediction after high-grade subarachnoid hemorrhage remains imprecise. Several clinical grading scales are in common use, but the timing of grading and changes in grade after admission have not been carefully evaluated. We hypothesized that these latter factors could have a significant impact on outcome prediction. METHODS: Fifty-six consecutive patients with altered mental status after subarachnoid hemorrhage, who were managed at a single institution, were studied retrospectively. On the basis of prospectively assessed elements of the clinical examination, each patient was graded at admission, at best before treatment, at worst before treatment, immediately before treatment, and at best within 24 hours after treatment of the aneurysm using the Glasgow Coma Scale (GCS), the World Federation of Neurological Surgeons (WFNS) scale, and the Hunt and Hess scale. Outcome at 6 months was determined using a modification of the Glasgow Outcome Scale validated against the Karnofsky scale. All grades and clinical and radiographic data collected were compared among good and poor outcome groups. Multivariate analyses were then performed to determine which grading scale, which time of grading, and which other factors were correlated with and contributed significantly to outcome prediction. RESULTS: A good outcome was achieved in 24 (43%) of 56 patients. Our study also had a 32% mortality rate. With the Hunt and Hess scale, only the worst pretreatment grade was significantly correlated with outcome. However, with the GCS and the WFNS scale, grading at all pretreatment times was significantly correlated with outcome, although outcome was best predicted before treatment, regardless of the scale used, if grading was performed at the patient's clinical worst. Multivariate analysis revealed that the best predictor of outcome was WFNS grade at clinical worst before treatment. Used alone, a WFNS Grade 3 at worst pretreatment predicted a 75% favorable outcome, and a WFNS Grade 5 at worst pretreatment predicted an 87% poor outcome. No significant correlation was found between direction or magnitude of change in grade and outcome. Age was found to be significantly correlated with outcome, but it was only an independent factor in outcome prediction when used in conjunction with the Hunt and Hess scale and not with the WFNS scale and the GCS. CONCLUSION: Timing of grading is an important factor in outcome prediction that needs to be standardized. This study suggests that the patient's worst clinical grade is most predictive of outcome, especially when the patient is assessed using the WFNS scale or the GCS.

Adult↗

PubMed2004

Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles.

CONTEXT: Selective reporting of outcomes within published studies based on the nature or direction of their results has been widely suspected, but direct evidence of such bias is currently limited to case reports. OBJECTIVE: To study empirically the extent and nature of outcome reporting bias in a cohort of randomized trials. DESIGN: Cohort study using protocols and published reports of randomized trials approved by the Scientific-Ethical Committees for Copenhagen and Frederiksberg, Denmark, in 1994-1995. The number and characteristics of reported and unreported trial outcomes were recorded from protocols, journal articles, and a survey of trialists. An outcome was considered incompletely reported if insufficient data were presented in the published articles for meta-analysis. Odds ratios relating the completeness of outcome reporting to statistical significance were calculated for each trial and then pooled to provide an overall estimate of bias. Protocols and published articles were also compared to identify discrepancies in primary outcomes. MAIN OUTCOME MEASURES: Completeness of reporting of efficacy and harm outcomes and of statistically significant vs nonsignificant outcomes; consistency between primary outcomes defined in the most recent protocols and those defined in published articles. RESULTS: One hundred two trials with 122 published journal articles and 3736 outcomes were identified. Overall, 50% of efficacy and 65% of harm outcomes per trial were incompletely reported. Statistically significant outcomes had a higher odds of being fully reported compared with nonsignificant outcomes for both efficacy (pooled odds ratio, 2.4; 95% confidence interval [CI], 1.4-4.0) and harm (pooled odds ratio, 4.7; 95% CI, 1.8-12.0) data. In comparing published articles with protocols, 62% of trials had at least 1 primary outcome that was changed, introduced, or omitted. Eighty-six percent of survey responders (42/49) denied the existence of unreported outcomes despite clear evidence to the contrary. CONCLUSIONS: The reporting of trial outcomes is not only frequently incomplete but also biased and inconsistent with protocols. Published articles, as well as reviews that incorporate them, may therefore be unreliable and overestimate the benefits of an intervention. To ensure transparency, planned trials should be registered and protocols should be made publicly available prior to trial completion.

Clinical Protocols↗

PubMed2002

Is global outcome predictable in the rehabilitation of patients with musculoskeletal disorders? A pilot study.

Definition of prognostic factors for outcome quality is of increasing interest in rehabilitation medicine. The main question of this pilot study in 552 patients was whether global outcome could be predicted by a team-based chief physician specialized in physical medicine and rehabilitation (PMR), and whether other predictive factors would exist (ICIDH-2 levels, pain, working incapacity). Little data is available about the possibility of global prediction of prognosis in the rehabilitation of patients with musculoskeletal disorders. All 552 patients met each member of the rehabilitation team and key data from each patient was discussed at the rehabilitation conference within the first 2 days. On entry to the study, a chief physician specialized in PMR assessed the patient's key data, which was structured according to ICIDH-2 (ICF) and assessed quantitatively on a scale from zero to ten. Second, the PMR physician rated the expected global prognosis on the basis of ICIDH-2 and other key data, and in respect to the defined rehabilitation goals (see Table 2). At the same time, the patient and an assistant doctor (AD) assessed pain scores (VAS 0-10) and the actual working incapacity (%). These assessments were completed within the first 3 days and were repeated before discharge. Assessment of outcome was rated by both, separately, according to the above-mentioned scale. Different regression models were calculated, searching for significant differences between the numerous variables. In the regression models, the best predictor for outcome was the PMR physician assessment. Complete and good correspondence between prediction and outcome was obtained in 71.4% (42.1% and 29.3%, respectively) in the descriptive model. Quantitatively assessed ICIDH-2 levels, pain at entrance and working incapacity at entrance were not predictive factors for global outcome. The global outcome was rated as very good/good in 79.0% of cases by patient and in 75.1% cases by the AD, as moderate in 13.9% of cases by the patient and 18.4% of cases by the AD, and as poor/worsening in 7.1% of cases by the patient and in 6.5% of cases by the AD. Rating of outcome by the patient and the AD gave complete and good correspondence in 87.6% and no correspondence in only 2.6% of cases. Pain could be reduced highly significantly (P<0.001). There was a highly significant degree of correlation between quality of outcome and pain relief (outcome 'very good' and 'good', P<0.001; 'moderate', P=0.003; 'poor/worsening', not significant). Partial or complete reduction of working incapacity could be reached in 30% of the patients. This had no statistical influence on global outcome; neither did persistent working incapacity. Prediction of global outcome by a team-based PMR assessment seems to be a useful semiquantitative method with high predictive value. The method, including the critical point of validation, is currently being extensively discussed. Prediction is an integral process based on the high information grade of a multiprofessional rehabilitation team, the ICIDH-2 structures, the definition of rehabilitation goals, the knowledge and experience in bio-psycho-social medicine and the application of common sense. Rating of global outcome by the patient/AD is an integrative process as well. Pain relief is an important and very strong factor, with a high degree of influence on global outcome in musculoskeletal rehabilitation, probably by improving quality of life. Working incapacity is no reason for refusing patients rehabilitation and both improvement of working capacity and persistence of working incapacity, has no statistical influence on global outcome. Finally, the extent of the four ICIDH-2 levels, especially negative contextual factors, were not predictive, that is, they had no significant influence on global outcome in this study. In conclusion, prediction of global outcome by a team-based chief physician specialized in PMR is of high predictive value, practicable and useful for rehabilitation processes, quality assurance, insurance companies and health policies. To our knowledge, this is the first published study on this topic.

Adolescent↗

PubMed1995

Why it is important to demonstrate linkages between outcomes of care and processes and structures of care.

This first article of the supplement describes the rationale for the Department of Veterans Affairs Cooperative Study, Processes, Structures, and Outcomes in Cardiac Surgery, which was designed to demonstrate statistically and clinically meaningful linkages between processes and structures of care and the outcomes of that care. United States health care is in an era of great enthusiasm for the use of health care outcomes to assess and improve quality of care. An important reason for this enthusiasm is the concern that processes and structures of care, which traditionally have been selected arbitrarily without valid linkages to favorable outcomes, may not result in the desired outcomes of care. Furthermore, health care outcomes are intrinsic to the definition of quality of care and should be relatively free of preconceived biases about how care should be provided. However, the limitations to outcomes-directed quality improvement have been inadequately recognized. These limitations include the following: (1) mortality, the most commonly used outcome, is usually sufficiently rare, resulting in inadequate statistical power; (2) nonfatal outcomes are much more difficult to measure reliably; (3) outcomes may not be measurable for an extended period of time after the care episode, making linkage to quality improvement inefficient; and (4) patients often desire good processes of care as well as favorable outcomes. A review of the literature found relatively few reports linking processes and structures of care to favorable outcomes. Significant relationships between processes of care and outcomes have been reported for several medical conditions (congestive heart failure, acute myocardial infarction, pneumonia, and stroke) when the patient has been considered the unit of analysis. However, there is a paucity of published meaningful process-outcome or structure-outcome linkages for surgical conditions or for any conditions when the hospital has been the focus of analysis. The authors concluded that quality improvement will proceed most efficiently and effectively if all three elements of Donabedian's quality triad (processes, structures, and outcomes) are used and if the processes and structures chosen have been demonstrated to be associated with desired outcomes of care.

Cardiac Surgical Procedures↗

PubMed2006

What is the appropriate outcome for studies of treatments for out-of-hospital cardiac arrest?

BACKGROUND: A good outcome following out-of-hospital medical care for cardiac arrest is survival to hospital discharge. Because a large number of patients are required to detect a minimum clinically important difference in survival, an intermediate outcome such as hospital admittance is commonly used. For an intermediate outcome to be a useful surrogate, the survival rate conditional on achieving the intermediate outcome should not depend upon the field treatment. If so, an advantage of the intermediate outcome may be a smaller sample size. However, recent trials demonstrate that survival conditional on admittance may depend upon the field treatment. Even if the resources are available to power a study for survival, is survival the right outcome? For example, no increase in survival and a large increase in admittance could be considered a bad result, as it represents a substantial waste of resources. Similarly no increase in mortality and a decrease in admittance should be considered a good result, as it represents a substantial cost savings without any sacrifice of life. Both admittance and survival are important outcomes and need to be considered jointly, that is, as a bivariate outcome. METHODS: Cost-effectiveness concepts are used to distinguish between a good and bad (bivariate) outcome. Simulations are conducted to compare the impact of the univariate and the bivariate outcomes in a variety of trial scenarios. A table of sample sizes is computed for the bivariate outcome across a range of trial scenarios. RESULTS: The bivariate outcome outperforms both univariate outcomes for most alternatives. The required sample size for the joint outcome of admittance and survival may be substantially, over 50%, less than that for the survival outcome alone. CONCLUSION: Use of the bivariate outcome could provide more informed decision making about resuscitation strategies and at less cost then the current gold standard of hospital survival.

Cardiopulmonary Resuscitation↗

PubMedDate not supplied

Connecting stuttering management and measurement: V. Deduction and induction in the development of stuttering treatment outcome measures and stuttering treatments.

BACKGROUND: The development of evidence-based practice, which is increasingly popular in stuttering treatment, is closely linked to the development of outcome measures. AIMS: Two approaches to the development of stuttering treatment outcome measures are outlined. The first is the deductive, top-down approach, where the development of specific outcome measures is guided by a priori general conceptualizations of the nature of the disorder. A competing approach to the development of stuttering treatment outcome measures is outlined. This is the inductive, or bottom up approach. This approach uses Baer's (1988, 1990) notion of specific complaints of clients as the starting point to develop inductive statements for use as general guidance for developing treatment outcome measures. MAIN CONTRIBUTION: It is argued that the deductive approach to development of outcome measures has limitations. It is overly prescriptive, generating numerous and increasingly complex outcome measures that are potentially confusing for clinicians. Further, it is arbitrary and fragile, being linked to conceptualizations and theories about stuttering, which, by necessity, are limited themselves. Further, the development of numerous outcome measures is not compatible with the conduct of randomized controlled trials, which allow a maximum of two primary outcome measures. In contrast, the inductive approach to the development of outcome measures has in its favour that it is empirically driven rather than arbitrary, and that it facilitates a yoking of the development of clinical outcomes and the clinical methods to attain those outcomes. The approach is unlikely to lead to the development of fruitless treatment methods. Further, the approach is parsimonious to the extent that it is likely to produce few guiding generalities for treatment outcome assessment -- perhaps as few as two in the case of adults and one in the case of preschoolers. This is well suited to the use of the randomized controlled trial as a source of evidence for treatment efficacy. CONCLUSIONS: One inductive statement that can be used to guide the development of outcome measures is that the ill effects of stuttered speech could be troubling for those who seek clinical help. The other is that those who seek clinical help are likely to experience speech-related anxiety. Together, these sources of information provide sound guidance for the development of outcome measures relating to stuttered speech and speech-related anxiety, and guidance for the development of treatments to offset those ill effects of the condition. Until another outcome measure can be derived from inductive processes, those treatment developments should serve all the needs of those who stutter and the clinicians who provide those needs.

Anxiety↗

PubMed2005

Effectiveness of routine reporting to identify minor and serious adverse outcomes in surgical patients.

OBJECTIVE: To assess the effectiveness of routine reporting to identify surgical adverse outcomes in comparison with retrospective medical record review. DESIGN: Independent assessment of two methods applied to one sample. Surgeons and surgical residents routinely reported all adverse outcomes for patients in their care during admission. A trained research assistant, blinded to the surgeons' reporting data, retrospectively reviewed the medical records of selected patients and registered all adverse outcomes identified from paper or electronic patient records. SETTING: Dutch university hospital. STUDY SAMPLE: A 5% sample of patients (N = 150) discharged in 2002 was taken; oversampling of patients undergoing reoperations, sick patients (ASA >or=3), and those undergoing technically complex surgery was done to increase the yield of adverse outcomes. MAIN OUTCOME MEASURES: The number of adverse outcomes identified by each method was compared with the total number identified by either method. This was done both for all adverse outcomes and for serious adverse outcomes. RESULTS: Routine reporting identified fewer adverse outcomes than medical record review (62.5% v 78.2%). Complete agreement was achieved in only 40.7% of adverse outcomes. Routine reporting identified slightly more serious adverse outcomes (84.8% v 79.5% of the total), but this difference was not statistically significant. Extrapolating these results to the total number of admissions in 2002, routine reporting underestimated the annual adverse outcome incidence by 1.8% (increasing from 14.5% to 16.3%) and the incidence of serious adverse outcomes by 0.3% (increasing from 6.9% to 7.2%). CONCLUSIONS: Neither method identified all adverse outcomes. Routine reporting underestimated the incidence of minor events but was as accurate as record review in identifying serious adverse outcomes.

Adult↗

PubMed2005

Reporting success rate at 12 months after percutaneous treatment for peripheral arterial disease: the impact of outcome criteria.

OBJECTIVE: The objectives of our study were to assess the influence of varying outcome criteria on the success rate at 12 months after percutaneous intervention for peripheral arterial disease and to suggest a reporting method that can be used in studies that report results of interventions as measured by parameters of daily clinical practice. MATERIALS AND METHODS: The outcomes of 1,411 consecutive procedures in 1,583 limbs recorded in a multicenter registry involving six hospitals were analyzed. Six sets of outcome criteria were evaluated: one based on symptomatic change, three based on ankle-brachial index (ABI) measurements, and two based on combining the symptomatic and ABI outcome measures. Agreement among the outcome measures was compared using the kappa statistic. RESULTS: The ABI outcome measures alone showed good agreement (kappa = 0.74-0.94). The symptomatic outcome measures yielded a substantially higher 12-month success rate than the ABI outcome measures (difference, 18-24%) and the agreement was only fair (kappa = 0.52-0.60). The agreement between symptomatic outcome and ABI outcome measures was poor in patients with a pretreatment ABI measurement at rest of more than 0.90 (kappa = 0.20). Combining symptomatic outcome and the ABI outcome measures with the logical operator "OR" showed good agreement with the symptomatic outcome measures alone (kappa = 0.97) and using "AND" showed good agreement with the ABI outcome measures alone (kappa = 0.87). CONCLUSION: In patients with a pretreatment ABI measurement at rest of more than 0.90, classifying procedures using a criterion based on improvement in ABI measurements with more than 0.10 is inaccurate and underestimates the actual success rate at 12 months after percutaneous intervention. Furthermore, combining subjective improvement in symptoms and improvement in ABI measurements does not yield more information than reporting these outcome measures separately. Therefore, we suggest that improvement in symptoms and improvement in ABI measurements should be reported separately to indicate the 12-month success rate of percutaneous interventions for peripheral arterial disease.

Blood Pressure Determination↗

PubMed2001

Outcomes and patient-based hearing status in conductive hearing loss.

OBJECTIVES/HYPOTHESIS: To study hearing status and quality of life outcomes in patients with conductive hearing loss (CHL), and to develop a prognostic disease severity staging system for use in future clinical outcomes studies in CHL. STUDY DESIGN: Clinical outcomes research study in three stages: 1) Prospective development and psychometric validation of a disease-specific hearing status outcomes instrument for CHL. 2) Prospective observational outcomes study of patient-based hearing status and quality of life (QOL) outcomes after treatment of CHL. 3) Development of a prognostic disease-severity staging system to stratify patients into groups of similar treatment outcome. METHODS: Psychometric instrument validation: assessment of test-retest reliability, internal consistency reliability, content, construct and criterion validity, and responsiveness to change. Statistical assessment of the impact of CHL on patient-based hearing status and QOL, and the change in hearing status and QOL after treatment. Using data from the prospective study and multivariate regression, identification of pretreatment independent variables, which predict good outcome after treatment, and development of a severity staging system. RESULTS: Test-retest reliability (r >0.70) and internal consistency reliability (alpha >0.70) were adequate for both subscales of the hearing status instrument. Construct validity was demonstrated by adequate convergent/divergent validity with other health status instruments on multi-item multitrait correlation matrixes. Criterion validity was demonstrated using audiometric threshold data. Responsiveness to change was demonstrated using the standardized response mean after treatment (SRM = 0.40 and 0.61 for the two subscales). Emotional hearing status and social/situational hearing status improved significantly after treatment of CHL: emotional score, 31.1 to 56.6 (P < .001); social/situational score, 56.7 to 63.7 (P = .01). Mean QOL subscale scores for patients with CHL were not significantly different from healthy populations, and global QOL scores did not change significantly after treatment of CHL. Using proportional improvement in emotional hearing status as an outcome, we identified several pretreatment factors that predicted good outcome (i.e., larger proportional improvement): level of pretreatment emotional hearing status, presence of sensorineural component of HL, and etiology of CHL (otosclerosis vs. all other causes). Some hypothesized predictive independent factors, such as bilateral HL, audiometric threshold level, pretreatment functional status, employment status, age, and duration of HL, were not identified as significant predictors of outcome in the multivariate analysis. We constructed a prognostic disease severity staging system in which the three predictor variables were each given a score of 0 or 1, and these three scores were added to obtain the disease stage (stage 0, 1, 2, or 3). Higher disease stage indicated more severe disease or a lower proportional improvement in emotional hearing status after treatment. This staging system appropriately stratified patients into groups of similar outcome after treatment (P = .02) and has significant potential use for future outcomes research on CHL. CONCLUSIONS: We have developed and validated a patient-based hearing status outcomes instrument for use in CHL. We have measured hearing status and quality of life outcomes after treatment of CHL, and we have developed a prognostic disease severity staging system that predicts the improvement in emotional hearing status after treatment of CHL.

Adaptation, Physiological↗

PubMed2005

Identifying outcome reporting bias in randomised trials on PubMed: review of publications and survey of authors.

OBJECTIVE: To examine the extent and nature of outcome reporting bias in a broad cohort of published randomised trials. DESIGN: Retrospective review of publications and follow up survey of authors. Cohort All journal articles of randomised trials indexed in PubMed whose primary publication appeared in December 2000. MAIN OUTCOME MEASURES: Prevalence of incompletely reported outcomes per trial; reasons for not reporting outcomes; association between completeness of reporting and statistical significance. RESULTS: 519 trials with 553 publications and 10,557 outcomes were identified. Survey responders (response rate 69%) provided information on unreported outcomes but were often unreliable--for 32% of those who denied the existence of such outcomes there was evidence to the contrary in their publications. On average, over 20% of the outcomes measured in a parallel group trial were incompletely reported. Within a trial, such outcomes had a higher odds of being statistically non-significant compared with fully reported outcomes (odds ratio 2.0 (95% confidence interval 1.6 to 2.7) for efficacy outcomes; 1.9 (1.1 to 3.5) for harm outcomes). The most commonly reported reasons for omitting efficacy outcomes included space constraints, lack of clinical importance, and lack of statistical significance. CONCLUSIONS: Incomplete reporting of outcomes within published articles of randomised trials is common and is associated with statistical non-significance. The medical literature therefore represents a selective and biased subset of study outcomes, and trial protocols should be made publicly available.

Bias↗

PubMedDate not supplied

Comparing professional and patient outcomes for the same episode of care.

Following an acute hospital admission, patients' perceptions of the acceptability of their own outcomes were compared with professionally derived outcomes of care developed for the same patients by nurses. Professional opinion was obtained from the Nursing Practice--Casemix and Outcomes Project undertaken by the Sydney Metropolitan Teaching Hospitals Nursing Consortium, where patient outcomes were classified by nurses into three groups: Outcomes Acceptable; Outcomes Not Acceptable but Justified and Outcomes Not Acceptable and Not Justified. Fifteen male patients in the present study discussed their outcomes following recent orthopaedic surgery at a series of focus groups organised according to the three outcome categories. Findings from the study showed the majority of patients were satisfied with their outcomes. Patient agreement with nurses regarding the acceptability of outcomes was highest for patients from the Outcomes Acceptable group and lowest for those from the Outcomes Not Acceptable and Not Justified group. This work is significant in that it is one of the first nursing studies to compare outcomes developed by practitioners for a particular group of patients with actual outcomes experienced by the same group of patients.

Adult↗

PubMed2002

What outcomes matter to patients: a physician-researcher point of view.

BACKGROUND: During the last quarter of the 20th century, it became feasible to measure and take into account the patient's subjective preferences for health states and various outcomes. This has become increasingly relevant in the treatment of cancer, where patients are confronted with a life-threatening illness and may have varied treatment choices and outcomes. OBJECTIVES: To provide a framework for examining the outcomes that matter to patients from a clinician-researcher perspective. Considerations include the heterogeneity of the cancer patient population, the influence of the setting of care on patient outcomes, the range of outcomes that are often considered by patients and researchers, and possible study designs that should be considered to measure outcomes that are important to patients. The outcomes that matter to patients can broadly be classified into disease-focused and patient-focused outcomes. CONCLUSIONS: There are many challenges in the measurement of patient-focused outcomes, including consensus on what are the most important outcomes and the methods for their measurement. In addition, it is often difficult to integrate disease-focused and patient-focused outcomes in the same setting, particularly for use in clinical decision making. We need to develop some key strategies to enhance patient outcomes including (1) emphasis on evidence-based treatments whenever possible, as the best way of improving disease-focused outcomes; (2) the inclusion of patient preferences when different treatment alternatives provide equivalent disease-focused outcomes; and (3) the provision of adequate time for communication about disease-focused and patient-focused outcomes, with emphasis on the training of clinicians to facilitate these discussions.

Adult↗

PubMed1996

Outcomes of cancer treatment for technology assessment and cancer treatment guidelines. American Society of Clinical Oncology.

In 1993, the Health Services Research Committee of the American Society of Clinical Oncology (ASCO) charged an Outcomes Working Group with defining the outcomes of adult and pediatric cancer treatment to be used for technology assessment and development of cancer treatment guidelines. The Working Group defined by consensus outcomes for technology assessment and guideline development, focusing on cancer treatments. The Working Group considered a variety of perspectives on outcomes, including those of patients, physicians, clinical investigators, ASCO, and policy makers. Because ASCO's guidelines will define what constitutes the best treatment and not whether that treatment should be paid for, the Working Group gave higher priority to the clinical and clinical research perspectives than to the health policy perspective. Survival is the most important outcome of cancer treatment. An improvement in at least disease-free survival is a prerequisite for recommending adjuvant therapy. In the case of metastatic cancer, treatment can be recommended even without an improvement in survival, if it improves quality of life. Quality of life includes global quality of life, as well as its physical, psychologic, and social dimensions. To be an outcome of cancer treatment, quality-of-life measures must be sensitive to clinically meaningful changes produced by treatment; evaluations must control for placebo effects and determinants of quality of life not related to cancer or its treatment. Toxicity, both short and long term, is vitally important, with the latter being particularly critical in children. The value of cancer outcomes like tumor response (eg, complete or partial response) and biomarkers (eg, CA-125) for technology assessment and guideline development depends on their ability to predict patient outcomes (survival and quality of life) or to influence decisions about treatment. Complete response is an important outcome when it predicts survival. Progression is important because it signals the need to change or stop treatment. Cost-effectiveness is an especially important outcome to consider when the benefits of treatment are modest or the costs are high. Patient outcomes (eg, survival and quality of life) should receive higher priority than cancer outcomes (eg, response rate), but both types of outcomes are important in technology assessment and guideline development. Multiple outcomes should be considered because no single outcome adequately describes the results of cancer treatment. In general, there is no minimum benefit above which treatments are justified; rather, benefits should be balanced against toxicity and cost.

Adult↗

PubMed2001

[Psychopathology and outcome in first-admission schizophrenia: a 13-year follow-up study at a medical school hospital].

BACKGROUND: The course and outcome of 'dementia praecox' have attracted considerable attention since it was first described. However, studies in which schizophrenic patients have been followed for more than ten years are rare. In this study, the course and outcome of first-admission schizophrenic patients in Jichi Medical School Hospital was investigated. METHOD: The subjects were 62 schizophrenic patients, 29 females and 33 males (the mean age at first hospitalization was 25.2 +/- 7.4 years), who were 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 thirteen years. The social outcome was measured using Eguma's Social Adjustment Scale. The subjects were divided into two groups according to Eguma's Scale: a favorable outcome group and an unfavorable outcome group. The following data were obtained from clinical records and analyzed: sex, family history of mental disorders, educational background, job experience, marital status, age at first contact to a psychiatrist, age at first hospitalization, type of onset, subtype of schizophrenia (paranoid, catatonic, hebephrenic types) and symptoms at the time of first hospitalization. Symptoms at the time of first hospitalization included delusions, hallucinations, disorders of ego consciousness, thought disorders, emotional disturbances, lack of spontaneity, catatonic symptoms, hypochondriac-cenestopathic symptoms, disorganized behavior, and suicide attempts. RESULT: Fifty-six of the 62 patients were followed-up. Six patients could not be contacted. Nine of the 56 patients follow-up were dead; two had died suddenly and seven had committed suicide. Forty-seven patients were alive, eight of which were not under psychiatric treatment, while 39 patients were receiving treatment (33 as outpatients, 6 as inpatients). The 47 patients who were still living were divided into two groups: 22 were included in the favorable outcome group, and 25 in the unfavorable outcome group. No significant differences in premorbid status were found. The unfavorable outcome group had an earlier age at first contact and age at first admission than the favorable outcome group. In the favorable outcome group, acute onset was more common than chronic onset. A comparison of psychopathological symptoms at the time of first hospitalization between the favorable and unfavorable outcome groups revealed significant differences in lack of spontaneity and hypochondriac-cenestopathic symptoms. No significant differences were found for any other symptoms. In the favorable outcome group, paranoid type was more common than hebephrenic type. DISCUSSION: Lack of spontaneity may reflect negative symptomatology, which has been suggested to be a predictor of an unfavorable outcome. While hypochondriac-cenestopathic symptoms may reflect an insufficient psychic container for the body, which has been hypothesized to work as an enabler of body image or imaginary body and an enabler of ego function as well. CONCLUSION: First-admission schizophrenic patients followed up after a mean period of thirteen years, and of this group data could be obtained on 90% of them. Two symptoms (a lack of spontaneity and hypochondriac-cenestopathic symptoms) present at the time of first hospitalization were observed more frequently in the unfavorable outcome group than in the favorable outcome group.

Adolescent↗

PubMed1995

Research issues related to optimal oral health outcomes.

Patient outcomes form one part of the classic triad used to define quality of care: structure, process, and outcome. Outcomes research in dentistry should focus on global questions such as: What difference does dental care make to a patient? Do patients derive perceptible benefits from their dental care? What dental treatments work the best? Like programs or other courses of action, treatment outcomes are considered on three levels: the policy level, which asks, "Are we doing the right things for our target population, given our resources?" program evaluation, in which specific program objectives are set in terms of achievement or maintenance of certain rates and measures; and the individual patient level, in which specific physiologic, psychological, and sociological measures are used to determine individual treatment outcomes. Each level of evaluation can use treatment outcomes or oral health status measures as evaluation criteria. Clinicians routinely face the challenge of providing "appropriate" care to older veterans--a concept that considers the accuracy of risk assessment and diagnosis as well as treatment outcomes (such as the relative effectiveness and cost-effectiveness of alternative treatment strategies, together with the short- and longer-term physiologic and psychological results). Outcomes research is even more challenging when considering its application in older populations whose physical, social, and psychological health are increasingly interrelated and variable with age. Thus, outcomes research, and particularly research on the appropriateness of care, must consider the values and preferences (utility) of those outcomes for older veterans and their families. Optimal oral health outcomes can be achieved through invigorated oral health services research to better understand patients' preferences related to dental treatment decisions, to define oral health outcomes incorporating these preferences, and to assess the effectiveness of the current dental delivery system and its various components, including the appropriate mix of dental providers and allied health personnel, emerging technologies, and innovative prevention and health promotion strategies. An administrative structure and incentives should be established to support dental health services and outcomes research within the Department of Veterans Affairs (VA). A dental service network with an oversight board could be established to evaluate issues related to treatment outcomes. Alternatively, a Geriatric Research Education and Clinical Center devoted to the improvement of the quality of VA dental care and the oral health care delivery system could be established.

Aged↗

PubMed2003

Correlation of visual and refractive outcomes between eyes after same-session bilateral laser in situ keratomileusis surgery.

PURPOSE: To determine whether between-eye refractive and visual outcomes after same-session laser in situ keratomileusis (LASIK) surgery are correlated, and to determine whether suboptimal visual and refractive outcomes in one eye are predictive of poor results in the fellow eye. DESIGN: Observational case series. METHODS: Retrospective chart review. A total of 484 eyes of 242 patients met inclusion criteria of having undergone same-day LASIK surgery and having 3-month refractive and visual acuity outcomes. Statistical comparisons of outcomes were performed, including between-eye Pearson correlation analysis and logistic regression models for predicting second-eye outcome. Main outcome measures were 1-month, 3-month, and 6-month uncorrected visual acuity and manifest refraction. RESULTS: Refractive outcomes at 1, 3, and 6 months between first (right) and second eyes were not found to be significantly different. No difference in uncorrected or best spectacle-corrected visual acuity was observed between first and second eyes Refractive outcomes of spherical equivalent, sphere, and cylinder and visual outcomes of uncorrected and best spectacle-corrected visual acuity were highly correlated between the two eyes. Analysis of cases with suboptimal outcomes (> or =1 diopter from intended correction or uncorrected acuity equal to or worse than 20/40) suggests that a poor refractive or visual outcome in the first eye increases the risk of a poor outcome in the second eye by approximately 20-fold. CONCLUSIONS: Retrospective analysis of refractive and visual outcomes from patients undergoing same-session bilateral LASIK demonstrates a high correlation of refractive and visual outcome between the eyes.

Adult↗

PubMedDate not supplied

Validity and community-health-nursing sensitivity of six outcomes for community health nursing with older clients.

A survey research design was used to assess the importance, sensitivity to nursing interventions, and content validity of six client outcomes from the Nursing Outcomes Classification (NOC)). Outcomes relevant for elderly community residents and caregivers were included in a questionnaire mailed to American Nurses Credentialing Center-certified expert community health nurses. Two hundred thirty-nine experts rated specific indicators of the six outcomes for their importance in determining the outcomes and the contribution of nursing to their achievement. Outcomes also were rated for their importance for community health nursing clients and responsiveness to community health nursing intervention. Results strongly support the content validity and nursing sensitivity of outcomes and specific indicators. Experts judged all six outcomes to be important and 90% of indicators as important in determining the outcome. All outcomes and 78% of indicators were judged to be responsive to community health nursing intervention. Recommendations include the testing of NOC outcomes in community health nursing clinical practice and inclusion in community health nursing curricula. Areas for further research include development and validation of community-level outcomes, validation of outcomes with rural and home health nursing experts, and exploration of the community health nursing-sensitivity of one study outcome.

Activities of Daily Living↗

PubMed2000

Factors influencing the reporting of adverse perioperative outcomes to a quality management program.

UNLABELLED: Quality management programs have used several data reporting sources to identify adverse perioperative outcomes. We compared reporting sources and identified factors that might improve data capture. Adverse perioperative outcomes between January 1, 1992, and December 31, 1994, were reported to the Department of Anesthesiology Quality Management program by anesthesiologists, hospital chart reviewers, and other hospital personnel using incident reports. The reports were compared for preoperative health status, severity of outcome, and associated human error. Subsequently, personnel representing the various sources were surveyed regarding factors that might affect their reporting of adverse outcomes. Of 37,924 anesthetics, 734 (1. 9%) adverse outcomes were reported, 519 (71%) of which were identified by anesthesiologists, 282 (38%) by chart reviewers, and 67 (9.1%) by incident report. There was no statistically significant difference in reporting rates by anesthesiologists according to preexisting disease, severity of outcome, or presence of human error. Thirteen cases involving human error, however, resulted in disabling patient injury, with a higher rate of self-reporting for these cases (92%, P < 0.05). Rates of reporting by chart reviewers varied (P < 0.05) according to severity of patient illness and severity of outcome. Incident reports identified only 67 adverse outcomes (9.1%), but included a significantly higher percentage of the adverse outcomes involving human error (23.3%, P < 0.05). Twenty attending anesthesiologists, 15 resident anesthesiologists, 29 operating room nurses, 19 postanesthesia care unit nurses, and 6 hospital chart reviewers responded to the survey. Only the potential to improve quality of patient care influenced or strongly influenced a decision by all groups to report an adverse outcome to a peer review process. Physician self-reporting is a more reliable method of identifying adverse outcomes than either medical chart review or incident reporting. IMPLICATIONS: Physician self-reporting is a more reliable method of identifying adverse outcomes than either medical chart review or incident reporting. Reporting by chart reviewers is biased both by the severity of outcome and severity of patient illness, whereas incident reports tend to focus on human error. All groups feel compelled to report adverse outcomes when the data may result in improved patient care.

Adverse Drug Reaction Reporting Systems↗