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At least 19 recordsLinked to original sources

Flow cytometric DNA analysis of neuroblastoma. Correlation with histology and clinical outcome.

Clinical and histologic features of 38 cases of neuroblastoma were compared with data obtained by flow cytometric DNA analysis. Favorable clinical outcome was associated with an aneuploid stem line (P less than 0.01) and a low percentage of tumor cells in the S, G2, and M phases of the cell cycle (P less than 0.005). These favorable cytometric features were also associated with a favorable clinical stage (1, 2, 4s), and histologic evidence of Schwann's cell and ganglion cell differentiation. Consideration of cytometric data improved the sensitivity, specificity, and predictive efficiency of a current system for histologic grading of neuroblastoma.

Child↗

Incidence of additional genetic changes in the TEL and AML1 genes in DCOG and COALL-treated t(12;21)-positive pediatric ALL, and their relation with drug sensitivity and clinical outcome.

Clinical heterogeneity within t(12;21) or TEL/AML1-positive ALL (25% of childhood common/preB ALL) indicates that additional genetic changes might contribute to outcome. We studied the relation between additional genetic changes in TEL(ETV6) and AML1(RUNX1) (FISH), drug sensitivity (MTT assay) and clinical outcome in 143 DCOG and COALL-treated t(12;21)-positive ALL patients. Additional genetic changes in TEL and AML1 were present in 83% of the patients, and consisted of (partial) deletion of the second TEL gene (70%), an extra AML1 gene (23%) or an extra der(21)t(12;21) (10%). More than one additional change was observed in 20%. Disease-free survival (pDFS) of DCOG patients without additional genetic changes (4 years pDFS +/- s.e. 53 +/- 17%) and of those with an extra der(21)t(12;21) (60 +/- 22%) is poorer than that of compared to patients with other additional genetic changes in TEL or AML1 (79 +/- 6%; P-trend = 0.02). This was mainly due to the occurrence of early relapses within 2.5 years after the first diagnosis. Similar observations were found in the COALL cohort, albeit not significant owing to limited follow-up. Multivariate analysis including age, WBC and genetic abnormalities in TEL and/or AML1 showed that especially, in vitro resistance to prednisolone (hazard ratio 5.78, 95% CI 1.45-23.0; P=0.01) is an independent prognostic factor in DCOG- and COALL-treated t(12;21)-positive ALL.

Antineoplastic Combined Chemotherapy Protocols↗

The Multiple Sclerosis Functional Composite Measure (MSFC): an integrated approach to MS clinical outcome assessment. National MS Society Clinical Outcomes Assessment Task Force.

Clinical outcome assessment in Multiple Sclerosis (MS) is challenging due to the diversity and fluctuating nature of MS symptoms. Traditional clinical scales such as the EDSS are inadequate in their assessment of key clinical dimensions of MS (e.g. , cognitive function), and they have psychometric limitations as well. Based on analyses of pooled data from natural history studies and from placebo groups in clinical trials, the National MS Society's Clinical Outcomes Assessment Task Force recently proposed a new multidimensional clinical outcome measure, the MS Functional Composite (MSFC). The MSFC comprises quantitative functional measures of three key clinical dimensions of MS: leg function/ambulation, arm/hand function, and cognitive function. Scores on component measures are converted to standard scores (z-scores), which are averaged to form a single MSFC score. Preliminary analyses confirm that: (1) the three clinical dimensions of the MSFC are relatively independent; (2) the MSFC is sensitive to clinical changes over 1- and 2-year intervals; and (3) the MSFC has acceptable criterion validity (i.e., predicts both concurrent and subsequent EDSS change). The advantages and potential limitations of incorporating quantitative functional outcome measures such as the MSFC into collaborative databases are discussed.

Clinical Trials as Topic↗

Research fundamentals: selection and development of clinical outcome measures.

Clinical outcomes measure patient health or well-being. The choice of an outcome measure for use in a clinical trial or study is complex. It is even more difficult when no appropriate outcome measure exists, necessitating the development of a novel one. The ideal clinical outcome should be credible, comprehensive, sensitive to change, accurate, biologically sensible, and feasible. This paper describes the attributes of clinical outcomes and illustrates how to develop novel outcomes, using as an example the authors' experience in developing a wound cosmesis outcome measure.

Humans↗

Renal allograft biopsies with borderline changes: predictive factors of clinical outcome.

The clinical outcome and appropriate management for patients showing 'borderline changes' on allograft biopsy after renal transplantation is still controversial. In an attempt to identify predictive factors of clinical outcome of patients with such lesions, we reviewed the clinical course of 91 patients with borderline changes. Multivariate analysis revealed significant and independent effects of histological stage (i + t < or = or > 2) and time to borderline changes (< or = or > 3 months after transplant) on serum creatinine levels at 1 year from borderline changes episodes (respectively, p = 0.04 and p = 0.02) and only a significant effect of time to borderline changes on serum creatinine levels at 2 years (p = 0.005). Renal function at 1 year and 2 years as 5- and 8-year graft survival were not significantly different in the group of patients treated with antirejection therapy (T group, n = 49) compared with the untreated group (UT group, n = 42). This study strongly suggests that borderline changes with histological score (i + t) > 2 and late episodes of borderline changes should be considered to be of poor prognosis.

Adult↗

Using discrete choice experiments to go beyond clinical outcomes when evaluating clinical practice.

BACKGROUND: This study builds on the results of a randomized controlled trial concerned with examining the effect of reducing waiting times on the health status of patients referred for non-urgent rheumatology opinion. No difference in clinical outcomes was found between a 'fast-track' and 'ordinary' appointment system. This suggests that rationing by waiting times is not detrimental to health. However, such an approach ignores the value patients attach to reducing waiting time. OBJECTIVES: To estimate the monetary value of reducing waiting time, as well as changes in duration of appointment and the introduction of a pain management service, in the provision of rheumatology services. METHODS: Discrete choice experiment (DCE). SETTING: The main outpatient clinic of the rheumatology service for the Lothian and Borders region. SUBJECTS: 262 patients who had received a specialist rheumatology opinion--73 had received fast-track treatment, 65 standard care and 124 were non-trial patients. RESULTS: A response rate of 71% was achieved. Patients valued a 9-week reduction in waiting time at 131 pounds sterling. However, the introduction of a pain management service was valued at 209 pounds sterling. Thus, the latter is of more value to respondents. Evidence was also found of the internal consistency and theoretical validity of the DCE approach. CONCLUSIONS: The reduction of waiting times is a central plank of NHS policy. Whilst a reduction in waiting time is of value, a pain management service is of more benefit than a 9-week reduction in waiting time. DCE were shown to be a potentially useful technique for valuing different aspects of health care interventions.

Clinical Medicine↗

Middle cerebral artery occlusion: correlation of computed tomography and angiography with clinical outcome.

The clinical outcome of 40 cases with middle cerebral artery (MCA) occlusion was examined in relation to the site of occlusion and the findings on computed tomography (CT). Patients were treated conservatively without surgery. A few had decompressive craniotomy when necessary. Outcome in 7 (18%) was good, in 6 (15%) moderate, and in 15 (38%) severe; 12 (30%) died by the follow-up at 3 months. In cases with occlusion at the origin of the MCA, hypodensity on CT scan was usually localized to the basal ganglia, presumably because of collateral circulation through the anterior cerebral arteries; the outcome in these patients was not always favorable. Cases with occlusion of the trunk or branch vessels always showed marked CT hypodensity, and clinical outcome was poor. To assess quantitatively the extent of collateral circulation, the conduction time of contrast medium from the intracranial siphon (IC) to the insular portion of the MCA (M2) through the anterior cerebral arteries was calculated on serial carotid angiograms obtained within 24 hours after stroke onset. An IC-M2 time of 5 seconds was a critical indicator of whether extensive CT hypodensity would develop (the rule of 5 seconds). Furthermore, this method predicted the appearance and extent of infarction before CT revealed hypodensity. The significance of acute reconstructive surgery is also discussed.

Aged↗

Overcoming interface problems in computerized monitoring of clinical outcomes.

Monitoring clinical outcome and its cost can improve the quality and efficiency of health care, and computers offer a cost-effective way to collect such data routinely. We report the development of a new computer system, including the initial requirements specified and experience with introducing a pilot system and then a commercially developed system in several sites. Problems met when designing, implementing, and operating the system are described, together with solutions to the problems. Costs and benefits of the system are assessed, and rules to follow in introducing computerized monitoring of clinical outcomes are suggested.

Anxiety Disorders↗

Influence of molecular characteristics on clinical outcome in human immunodeficiency virus-associated non-Hodgkin's lymphoma: identification of a subgroup with favorable clinical outcome.

The relationship between clinical and molecular characteristics of 45 treated individuals with histologically-documented human immunodeficiency virus (HIV)-associated B-cell non-Hodgkin's lymphoma was examined to determine whether differences in molecular features of lymphoma were associated with differences in clinical outcome. Tissue specimens from these tumors were evaluated for evidence of Ig heavy-chain gene rearrangements using both Southern blot analysis and reverse transcriptase polymerase chain reaction (RT-PCR). Lymphomas were also evaluated for the presence of Epstein-Barr virus (EBV) DNA sequences and c-myc gene rearrangements. Twenty-five lymphomas were characterized as polyclonal and 20 as monoclonal. PCR amplification of expressed Ig variable (V)-region genes confirmed polyclonality in three extensively studied polyclonal lymphomas. The median CD4 count was significantly higher in the group with polyclonal disease (277/microL) than in the group with monoclonal disease (123/microL), P = .04. The complete response rate to therapy was significantly higher in patients with polyclonal disease (78%) and CD4 greater than 200/microL (81%) than in those with monoclonal disease (31%) and CD4 less than 200/microL (33%). CD4 count, clonality, and presence of EBV DNA sequences were the most important predictors of survival. Both Kaplan-Meier and Cox proportional hazards analyses showed a markedly prolonged survival in those patients with both CD4 > or = 200/microL and polyclonal disease. Histologically the polyclonal lymphomas were high grade in appearance and contained prominent macrophages. All seven surviving patients were in this group. Median survival for those individuals whose tumors contained EBV sequences was only 3.2 months (range, 0.4 to 19.5), whereas those with EBV- tumors survived for a median of 9.0 months (range, 0.7 to 65.2), P = .0007. These data indicate that molecular features of HIV-associated lymphomas may be important predictors of clinical outcome. These characteristics define a distinct subset of patients with polyclonal EBV- tumors and CD4 counts greater than 200/microL that appear to have a less aggressive clinical course.

Antineoplastic Combined Chemotherapy Protocols↗

[Monocondylar fractures of the femur. Therapeutic strategy and clinical outcome].

Twenty-nine unicondylar fractures of the distal femur were treated at the Trauma Center "Bergmannsheil", University of Bochum, Germany, between 1981 and 1994. All patients sustained their injuries from severe direct trauma. There were 16 lateral condylar fractures, 7 medial condylar fractures and 6 tangential posterior ("Hoffa-type") fractures. Twenty-eight closed injuries and 1 grade IIIB open fracture injuries to the skeleton. All fractures were treated with open reduction and internal fixation with screws within 8 h of admission. Postoperative management consisted of early continuous passive motion and minimal weight-bearing for 6-8 weeks, progressing to full weight-bearing. The mean follow-up was 68 months (18-120). The therapeutic outcome (clinical result, radiographs) was rated by the Neer score. Twenty-seven patients were available for follow-up examination. Of these, 23 were rated as excellent. 3 achieved satisfactory results, and 1 had an unsatisfactory result. All patients who did not achieve an excellent outcome had had accompanying injuries. Open reduction and internal screw fixation of unicondylar femur fractures provided overall excellent long-term results. The therapeutic outcome was significantly affected by associated injuries of the skeleton.

Adolescent↗

Biological parameters in major depression: effects of paroxetine, viloxazine, moclobemide, and electroconvulsive therapy. Relation to early clinical outcome.

BACKGROUND: Clinical and pharmacologic studies report a relative or absolute serotonergic deficiency in major depression; however, the variability of clinical characteristics of illness has led to controversial results. In the present work, we looked for a possible relationship between i) biochemical values that indirectly reflect aminergic neurons activity and clinical characteristics and ii) their evolution and the early clinical outcome under antidepressive therapies (ATs). METHODS: Platelet serotonin content, platelet monoamine oxydase activity, and urinary biopterins were measured in 27 depressed patients before and during four different ATs (paroxetine, viloxazine, moclobemide, or electroconvulsive therapy). Depressive symptomatology and its evolution under ATs were quantified using three clinical rating scales. RESULTS: A severe symptomatology, high serotonin (5-HT) platelet content, and high or low urinary B could represent risk factors leading to a smaller or delayed response to an AT. Furthermore, the early improvement under ATs was negatively correlated to pretreatment 5-HT platelet content. CONCLUSIONS: Determination of 5-HT level could be useful in the choice of an AT.

Adrenergic Uptake Inhibitors↗

Imatinib in Philadelphia chromosome-positive chronic phase CML patients: molecular and cytogenetic response rates and prediction of clinical outcome.

Previous clinical trials with the tyrosine kinase inhibitor imatinib in chronic-phase Philadelphia chromosome-positive chronic myelogenous leukemia (CML) resulted in 95% of hematologic and 60% major cytogenetic remissions in patients who failed a previous interferon-alpha-containing regimen. In an identical clinical trial setting with 39 chronic-phase CML patients we achieved comparable cytogenetic response rates after a median follow up of 30.1 weeks, with an almost identical toxicity profile. In order to identify predictive markers for the therapeutical use of imatinib, we monitored apart from standard hematology parameters bcr/abl fusion transcripts by quantitative real-time fluorescence RT-PCR. As previous investigations demonstrated that the plasma protein alpha-1 acid glycoprotein might inactivate circulating levels of free imatinib by protein binding with high affinity, we assessed plasma alpha-1 acid glycoprotein concentrations in our study cohort as well. Median bcr/abl fusion transcripts declined gradually over the entire treatment period and became significantly lowered at month 3 after initiation of imatinib therapy. Further, we observed elevated pretreatment levels of alpha-1 acid glycoprotein in patients who relapsed with leukemia, whereas initial bcr/abl mRNA copy numbers were not of predictive value. In addition, we provide data showing molecular response to this therapy in the vast majority of patients. Finally, our results support the hypothesis, that initially elevated plasma levels of alpha-1 acid glycoprotein might serve as a predictive marker for the clinical outcome of treatment with imatinib.

Adult↗

Shifting to a new paradigm to measure clinical outcomes.

Most clinical outcomes monitoring systems have relied on paper- and pencil-driven forms and/or interviews to collect information. The following article outlines some methodological and logistical problems inherent in these approaches, as well as describing the implementation of a ground-breaking new effort in how outcomes data are collected and analyzed. This computer-assisted interview approach can be less costly, provide more accurate information, allow for a broader range of questions to be addressed and even lead to a new paradigm for outcomes management programs--one that is practical in real-world settings and offers clinicians instant norms. Decision-makers in behavioral healthcare organizations can use the principles described here to develop systems tailored to their organizations' specific needs.

Ambulatory Care Information Systems↗

The influence of experience and specialty certifications on clinical outcomes for patients with low back pain treated within a standardized physical therapy management program.

STUDY DESIGN: Secondary analysis of a randomized trial. OBJECTIVES: To examine the influence of experience and specialty certification on outcomes for patients with low back pain receiving a standardized manipulation or stabilization exercise intervention program. BACKGROUND: Little research has examined the impact of therapist-related factors on the outcomes of clinical care for patients with low back pain. It is assumed that therapists with more clinical experience or specialty certification will achieve better clinical outcomes; however, few studies have examined this hypothesis. METHODS AND MEASURES: One hundred thirty-one participants in a randomized trial were included (70 randomized to receive manipulation, 61 stabilization). All subjects completed an Oswestry Disability Questionnaire at baseline, and after 1 and 4 weeks of treatment. Therapists were categorized based on total years of experience, years of experience with manual therapy, and specialty certification status. Two-way repeated-measures analyses of covariance were performed within each intervention group to examine the effects of the therapist characteristics on outcomes. Hierarchical linear regression models were used to examine the relative effects of therapist characteristics and intervention on clinical outcomes. RESULTS: Thirteen therapists participated (average 6.0 years of experience [standard deviation, 4.01, 4 (30.8%) with specialty certification). A significant interaction between time and specialty certification status (P = .04) was detected for subjects receiving the manipulation intervention. No significant interactions were detected in the stabilization group. The regression models found that the intervention group significantly contributed to explaining clinical outcomes, but that therapist characteristics did not. CONCLUSIONS: With the standardized protocol utilized in this study, it appears that the therapist-related factors of increased experience and specialty certification status do not result in an improvement in patients' disability associated with low back pain.

Adult↗

Genetic polymorphism and clinical outcome: identification of individuals at risk of a poor clinical outcome.

Susceptibility and outcome in complex disorders such as asthma and cancer appear to be determined, at least in part, by genetic polymorphism. However, while our ability to identify new allelic variants and study them in case and control populations has greatly improved, considerable difficulties remain in elucidating how many genes determine particular clinical phenotypes. This is because most studies have concentrated on study of single genes in relatively small study groups. The important issues of gene-gene interactions (epistasis) and high-risk subgroups have not yet been adequately addressed. We now describe a general approach, using patients with head and neck cancers as an example. Our purpose is to demonstrate candidate gene selection, statistical approaches, and identification of patient subgroups.

Genetic Predisposition to Disease↗

Rationale, development, and clinical outcomes of a multidisciplinary amiodarone clinic.

OBJECTIVES: To review the rationale and development of a multidisciplinary amiodarone clinic, and document the clinical outcomes resulting from its implementation. METHODS: A clinic was established to provide an ambulatory setting in which patients receiving amiodarone could be followed according to published guidelines by a multidisciplinary team of cardiovascular health care specialists. Patients receiving amiodarone were referred to the clinic by their primary physicians. A data base containing each patient's medical history, current drug therapy, and baseline laboratory values was developed during the initial visit. Liver function tests, thyroid function tests, and chest radiographs were performed every 6 months, and pulmonary function tests were scheduled on an annual basis. Dosage adjustments were performed in select patients. RESULTS: Since November 1996, 60 patients have been referred to the amiodarone clinic. Mean length of follow-up before and after referral was 16.3+/-25.5 and 9.2+/-5.5 months, respectively. Laboratory tests were performed according to accepted guidelines in 14 (23%) patients before referral compared with 54 (90%) patients after enrollment (p<0.001). Previously unrecognized adverse events were detected in 21 (35%) patients, including pulmonary fibrosis, QT prolongation, liver enzyme elevation, hypothyroidism, hyperthyroidism, and asthma exacerbation. Amiodarone was discontinued in six patients, four of whom had suspected pulmonary toxicity. The dose of amiodarone was adjusted in 29 (48.4%) patients. CONCLUSION: Many patients receiving amiodarone are not being followed according to published recommendations. Implementation of a specialized, multidisciplinary amiodarone clinic improves outcomes by monitoring for early detection of drug-related toxicities and by facilitating proper dosage modifications.

Adult↗

Clinical outcomes and satisfaction of patients of clinical nurse specialists in psychiatric-mental health nursing.

Survey research was conducted to examine clinical outcomes and satisfaction of patients of psychiatric mental health clinical nurse specialists (CNSs). Patients who had terminated from outpatient psychotherapy with 6 CNSs in 1993 were mailed a questionnaire (N = 223). Follow-ups by mail yielded a response rate of 45% (n = 100). The questionnaires included the Profile of Mood States-Short Form ([POMS-SF]; McNair, Lorr, & Droppleman, 1992). Quality of Life Function ([QOL]; Lehman, 1991), and Patient Satisfaction Scale (Baradell, 1994). Paired difference t-tests were used to evaluate clinical outcomes. Percentages were used to report satisfaction, and Pearson correlations were used to examine the relationship between clinical outcomes and patient satisfaction. The mean age for respondents was 37 years; 82% were female. Diagnoses included depression (46%), adjustment disorders (34%), anxiety (10%), and other (10%). Patients reported significant improvement in all clinical symptoms: anxiety, depression, anger, confusion, fatigue and vigor. Patients reported significant improvement in all domains of QOL: family, social, and job. Patients reported a very high level of satisfaction with the care provided. The more clinical improvement the patients reported, the more satisfied they were with the care provided. If nurses are to be included in a reformed health care delivery system in the future, additional research is essential.

Adolescent↗

Magnetic resonance imaging of injuries to the ankle joint: can it predict clinical outcome?

OBJECTIVE: To predict clinical outcome after ankle sprains on the basis of magnetic resonance (MR) findings. DESIGN AND PATIENTS: Twenty-nine consecutive patients (mean age 32.9 years, range 13-60 years) were examined clinically and with MR imaging both after trauma and following standardized conservative therapy. Various MR abnormalities were related to a clinical outcome score. RESULTS: There was a tendency for a better clinical outcome in partial, rather than complete, tears of the anterior talofibular ligament and when there was no fluid within the peroneal tendon sheath at the initial MR examination (P = 0.092 for either abnormality). A number of other MR features did not significantly influence clinical outcome, including the presence of a calcaneofibular ligament lesion and a bone bruise of the talar dome. CONCLUSION: Clinical outcome after ankle sprain cannot consistently be predicted by MR imaging, although MR imaging may be more accurate when the anterior talofibular ligament is only partially torn and there are no signs of injury to the peroneal tendon sheath.

Adolescent↗