Patient suitability and outcome in short-term individual psychotherapy.

The effects of short-term (time-limited), dynamically oriented individual therapy and the patient characteristic quality of object relations (QOR) were studied in a controlled clinical trial involving 8 experienced therapists and 144 psychiatric outpatients. A comprehensive set of outcome scores was monitored at 5-month intervals including a follow-up assessment. A strong treatment effect that was maintained at follow-up was found. The effect was evident in terms of statistical significance, effect size, and clinical significance. Evidence for an additive effect of the combination of treatment and QOR was also found. The best results were attained by high QOR therapy patients, and the worst results were attained by low QOR control patients. The results were suggestive of an optimal match between type of patient and type of therapy. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Treatment of septicaemia in the newborn infant: choice of initial antimicrobial drugs and the role of exchange transfusion

The therapeutic success of antibiotics used at the beginning of treatment and the effect of exchange transfusion in cases of septicaemia were tested in 22 newborn infants. The clinical course of these patients was compared with the outcome of 11 newborn infants who received antibiotic treatment without exchange transfusion. The following results were obtained: 1) All 6 patients initially receiving antibiotics, which were ineffective in vitro, died. In this group of patients the incidence of septic organ involvements (meningitis, ventriculitis, peritonitis) was significantly increased. 2) Following exchange transfusion, an impressive clinical improvement was consistently observed. 3) In patients who had initially received effective antibiotics and exchange transfusion, the lethality was significantly lower than in patients without exchange transfusion. 4) Our bacteriological findings show that continuous monitoring of cultures from blood, CSF and stool is necessary to choose the most effective antibiotic in the prevailing nosocomical circumstances.     

Benchmarking the effectiveness of psychotherapy treatment for adult depression in a managed care environment: A preliminary study.

This preliminary study evaluated the effectiveness of psychotherapy treatment for adult clinical depression provided in a natural setting by benchmarking the clinical outcomes in a managed care environment against effect size estimates observed in published clinical trials. Overall results suggest that effect size estimates of effectiveness in a managed care context were comparable to effect size estimates of efficacy observed in clinical trials. Relative to the 1-tailed 95th-percentile critical effect size estimates, effectiveness of treatment provided in this setting was observed to be between 80% (patients with comorbidity and without antidepressants) and 112% (patients without comorbidity concurrently on antidepressants) as compared to the benchmarks. Because the nature of the treatments delivered in the managed care environment were unknown, it was not possible to make conclusions about treatments. However, while replications are warranted, concerns that psychotherapy delivered in a naturalistic setting is inferior to treatments delivered in clinical trials appear unjustified. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Clinical validation of the Chinese Personality Assessment Inventory.

The clinical validity of the Chinese Personality Assessment Inventory (CPAI; F. M. Cheung, K. Leung, et al., 1996) was examined in 2 studies involving a group of 167 male prisoners in Hong Kong and a group of 339 psychiatric patients in China. Elevated scores on the clinical scales were obtained for the clinical samples. Logistic regression analyses confirmed that the CPAI scales were useful in differentiating between male prisoners and the Hong Kong male normative sample and between psychiatric patients and a random sample of normal adults in China. Multivariate analyses of variance results showed significant differences on the CPAI clinical scales and personality scales among subgroups of psychiatric patients with diagnoses of bipolar, schizophrenic, and neurotic disorders. The usefulness of an indigenous personality inventory is discussed. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Effect of the presentation of results from clinical trials on the intention to prescribing: relativity of the relative risk

OBJECTIVE: To determine if the methods of reporting results of clinical trials affects the physician views on prescribing. DESIGN: Analysis of responses, from a convenience sample of primary care physicians, of one teaching exercise on prescribing intention which showed 5 different methods of reporting results: relative risk reduction (RRR), absolute risk reduction, the percent of event free patients, the number needed to treat (NNT) and RRR and mortality. SETTING: Curses of clinical management in Valencia and Barcelona. RESULTS: The willingness to prescribe was significantly influenced by the way in which data were presented, being major when they were showed as RRR and minor when mortality was added. CONCLUSIONS: The method of reporting trial results has an important influence on the prescribing intention. The reporting of clinical trial results, and their abstracts or citations, should be include the NNT and negative results, for avoiding a subjective bias of treatment effect magnification.     

Complications of spongiosa harvesting of the ilial crest. A retrospective analysis of 1,191 cases

We analyzed retrospectively 1191 cases of bone graft harvesting of the iliac crest which had been performed at our hospital between 1982 and 1991. There was an operative revision rate of 2.8%. For further study, we analyzed the clinical reports of all autograft (iliac crest) donors in a representative year (1991) and re-examined all those who still had symptoms. A total of 104 grafts were taken from 97 patients. Of these, 18 developed postoperative complications (19.6%), such as hematoma, which could usually be treated with local procedures such as aspiration. The rate of hematoma tended to be lower in those patients who had received a local coagulant, but this was not significant. Of the patients 55% still had problems 1 year after operation at the time of re-examination, but in most cases they were minor, for example, local irritation or discomfort. Serious problems developed in those patients who had a palpable defect of the iliac crest. We advise using local coagulants to decrease the rate of postoperative complications, although we cannot statistically prove the effect. When large grafts are harvested, the iliac crest should be reconstructed for better long-term results.     

Effect of ion implantation of TMA archwires on the rate of orthodontic sliding space closure

OBJECTIVE: A previous study of botulinum toxin type F (BTX-F) treatment for torticollis had shown a dose of 520 MU to be effective, but for a much shorter duration than is usual with botulinum toxin type A (BTX-A). The objective was to assess the effect of a higher dose of BTX-F. METHODS: Four of the previously treated patients, plus an additional patient, were treated with a higher dose of 780 MU BTX-F. All were secondary nonresponders to BTX-A due to neutralising antibodies. A test injection of 40 MU BTX-F was also given into the extensor digitorum brevis muscle (EDB), to examine the time course of the biological effect of the toxin electrophysiologically. Patients were followed up at two, four, eight, and 12 weeks. RESULTS: All patients reported subjective improvement lasting from seven to 11 (mean 8.6) weeks accompanied by a significant reduction in mean clinical severity scores at two weeks. Four patients had pain which was substantially reduced. The electrophysiological studies confirmed biological sensitivity to the toxin in all patients, showing a significant change beginning at two weeks and returning to baseline at 12 weeks. The time course of this effect paralleled roughly that of the clinical response. The four patients who had previously received 520 MU BTX-F reported that the response was better and longer in duration with 780 MU. Dysphagia was more common than reported with the lower dose. CONCLUSION: Better results are possible with higher doses of BTX-F but the duration of benefit is still shorter than with BTX-A, seemingly due to a shorter duration of neuromuscular junction blockade.     

Vegetarian diet for patients with rheumatoid arthritis: can the clinical effects be explained by the psychological characteristics of the patients?

In a controlled, single blind clinical trial we have demonstrated recently a beneficial effect of fasting and vegetarian diet in RA. In the present study we compared 53 patients who participated in this clinical trial with 71 other RA patients with regard to some psychological parameters. The patients who participated in the clinical trial differed significantly from other RA patients. Firstly, they had a higher internal score and a lower chance score on the Multi-dimensional Health Locus of Control Scale (MHLCS). Secondly, their belief in the effect of ordinary medical treatment, evaluated by a 10-cm visual analogue scale, was lower, and their belief in the effect of 'alternative', unconventional forms of treatment was higher. Of the patients who were randomized to a vegetarian diet, there was no significant difference between diet responders and diet non-responders with regard to the MHLCS scores. But, diet responders had a significantly lower belief in the effect of ordinary medical treatment compared with diet non-responders. The psychological distress imposed on the patients by changing from an omnivorous diet to a vegetarian diet was monitored during the clinical trial by means of the General Health Questionnaire. Throughout the clinical trial, this variable favoured the vegetarians compared with the omnivorous and the diet responders vs the diet non-responders. We conclude, firstly, that patients with certain psychological characteristics were selected to the clinical trial; secondly, that the MHLCS scores could not explain the clinical improvement, but it may have been influenced by the patients' beliefs in ordinary and 'alternative' forms of treatment; and thirdly, that dietary treatment decreased psychological distress.     

Effects of dopamine synthesis inhibition on WAIS Comprehension.

A previous study has shown that parkinsonian patients treated with levodopa had decreased scores over time on the Comprehension subtest of the WAIS, whereas scores on all other 10 subtests of the WAIS increased. It was hypothesized that if levodopa treatment, which increases dopamine activity in the brain, is directly related to an apparent deleterious effect on the WAIS Comprehension, then a drug such as alpha-methylparatyrosine (AMPT), which decreases dopamine activity, might have an augmenting effect on this subtest. A therapeutic trial of AMPT in a group of 9 19–35 yr old chronic schizophrenic patients provided an opportunity to test this hypothesis. Comprehension scores improved significantly with AMPT. Other clinical rating instruments failed to show any changes. Implications of using a psychometric instrument to assess specific, but clinically obscured, drug effects on intellectual functioning are discussed. (19 ref) (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Placebo-controlled trial of flosequinan in moderate heart failure. The possible importance of aetiology and method of analysis in the interpretation of the results of heart failure trials

One hundred-thirty five patients with moderate heart failure, recruited from 18 centres, were included in a double blind, placebo controlled study to evaluate the effects of flosequinan on symptom limited tread-mill exercise tolerance. Fifteen patients in the placebo group were withdrawn from the study compared with 14 from the group given flosequinan. New York Heart Association classification was improved at week 16 in the flosequinan group relative to those randomised to placebo (P < 0.01). Depending how the other results are analysed flosequinan either appeared to have no effect on symptom limited exercise tolerance in those who completed the study; a suggestion of superiority if an analysis at endpoint is used (P = 0.09), or, if a covariate analysis at endpoint is used, then a significant improvement can be demonstrated (P = 0.04). Subset analysis suggests that the aetiology of the heart failure and the dose of diuretics used might have a major effect on the response to treatment. The best way of analysing clinical trials in heart failure is not clear as the results can be profoundly influenced by the way data from withdrawn patients are handled. The aetiology and diuretic requirement of patients may influence their response to treatment.     

The interpretation of scores from the EORTC quality of life questionnaire QLQ-C30

While quality of life (QOL) assessment is becoming more common, interpreting the results remains problematic. This paper demonstrates an approach to developing clinically-based interpretations for QOL outcomes, using the QLQ-C30 as an example. The results from 14 published QLQ-C30 studies which group patients by performance status, weight loss, toxicity, extent or severity of disease are collated. Groups with lower clinical status generally have worse QOL. The largest differences are between performance status groups, and the smallest differences are between groups of patients with local disease and those with metastases. The physical and role scores have the largest ranges of means across patient groups, and show the largest differences between clinical groups, while the cognitive and emotional scores have the smallest ranges of means and differences. Sicker groups have larger score standard deviations than healthier groups. Relatively large and small means and differences, and corresponding effect sizes, are presented. Collectively, the results provide a sense of the relative sizes of means and of differences, and of the types of clinical groups which give rise to them, thereby providing clinically-based benchmarks by which to interpret QLQ-C30 results.     

Meniere's disease. A neuropsychological study

A neuro-psychological study is described comprising 19 patients with Meniere's Disease who were participating in an experimental lithium therapy programme. The patients evidenced an organic dysfunction which is not entirely periphearl. The interpretation of the results are not incompatible with an attempt to reconcile neuro-psychological and psycho-somatic viewpoints regarding etiological aspects of Meniere's Disease. An evaluation of the lithium effect was performed.     

Disorders of muscle tonus and their treatment with sirdalud in patients in the early recovery period of ischemic stroke

The paper presents the results of clinical and neurophysiologic study of muscular tonus in 94 patients aged 42-70 years in early recovery after ischemic stroke. Selective role of spasticity was estimated in clinical pattern of motor disorders in groups of the patients with different disorders of muscular tonus with the same degree of paresis. Efficiency of antispastic preparation sirdalud was analyzed in 28 patients from this group. Sirdalud in daily dose of 6-12 mg in patients with prevalence of a spasticity in a clinical picture of the paresis and with either moderate or manifested degree of paresis of the extremities has significant antispastic effect without any decrease of muscular strength, which, in turn, increases the degree of restoration of motor functions.     

Osteoma of the long bones and the spine. A study of eleven patients and a review of the literature

The clinical features, radiographic and histopathological findings, treatment, and results are described for eleven patients who were managed for an extracranial osteoma at our medical center between 1980 and 1993. Ten of the patients were initially seen because of dull, aching bone pain that had been present for two weeks to thirty years. Radiographs demonstrated single or multiple homogeneous, well defined, radiodense foci with smooth round or lobulated margins. The histopathological features consistently included uniformly dense, compact, cortical-like, mature lamellar bone. The preoperative diagnosis was unclear for all patients, and osteoma was rarely considered in the differential diagnosis. For four patients, a tentative diagnosis of osteosarcoma was made, and a wide excision was carried out in two of these patients. Marginal excision with less than three millimeters of normal tissue around the lesion was performed in most patients. None of the osteomas recurred, and ten patients had relief of the pain. Awareness of the clinical, radiographic, and histopathological features of osteoma, as described, is valuable for making a differential diagnosis and for distinguishing osteomas from other lesions.     

Patient-reported short-term and long-term physical and psychologic symptoms: results of the continuous hyperfractionated accelerated [correction of acclerated] radiotherapy (CHART) randomized trial in non-small-cell lung cancer. CHART Steering Committee

PURPOSE: The randomized multicenter trial of continuous hyperfractionated accelerated radiotherapy (CHART) versus conventional radiotherapy for patients with non-small-cell lung cancer (NSCLC) showed a significant survival benefit to CHART (29% v 20% at 2 years, P=.004). However, an assessment of the effect on physical and psychologic symptoms is vital to balance the costs and benefits of the two treatments. METHODS: A total of 356 patients in the United Kingdom completed the Rotterdam Symptom Checklist (RSCL) and the Hospital Anxiety and Depression Scale (HADS) at 10 time points. The principal aim of the analyses was to keep the methods simple, so as to allow the presentation and interpretation of the results to be as clear as possible. This was achieved by (1) considering individual symptoms rather than symptom subscales or domains, (2) assessing short-term effects (up to 3 months) and long-term effects (at 1 and 2 years) separately, and (3) for the short-term analyses, (a) splitting the data randomly into an exploratory data set and a confirmatory data set, and (b) using two different methods of analysis: a subject-specific approach, which used the area under the curve (AUC) as a summary measure, and a group-based method, which plotted the percent of patients with moderate or severe symptoms over time. RESULTS: The results indicate that apart from CHART causing transient pain on swallowing and heartburn, there was little difference between the regimens in the short or long-term. CONCLUSION: Combining the results of the patient-assessed symptom comparisons with the clinical results indicates that CHART confers a major benefit without serious morbidity.     

Operator volume and outcome of patients undergoing coronary stent placement

OBJECTIVES: The aim of this study was to assess the relation between operator experience in coronary stent placement procedures and the clinical outcome of patients. BACKGROUND: The results of coronary balloon angioplasty are closely related to the experience of the operator performing the procedure. Data on the effect of operator experience on the results after coronary stent placement are missing. METHODS: The study included 3,409 consecutive patients undergoing coronary stent placement for the management of coronary artery disease. A composite end point of cardiac death, myocardial infarction and aortocoronary bypass surgery during the first 30 days after the intervention, was the primary end point and the procedural failure was the secondary end point of the study. RESULTS: Adverse clinical outcome occurred in 2.99% of the 3,409 patients undergoing coronary stent placement. Procedural failure was recorded in 2.08% of the patients. Operator volumes above 483 procedures were associated with a risk-adjusted adverse outcome rate of 1.70%+/-1.28%, which is significantly lower than the overall rate of 2.99%. Operator yearly volumes of under 90 procedures were associated with a risk-adjusted adverse outcome rate of 4.59%+/-1.17%, which is significantly higher than the overall rate of 2.99%. The operator experience was an independent predictor even after adjusting for the effect of other risk factors. The analysis demonstrated that an experience of at least 100 procedures is required to obtain better outcome even in patients with simple coronary lesions and that operators should perform at least 70 procedures annually to expect a better outcome in patients with both simple and complex coronary lesions. CONCLUSIONS: Operator experience is a significant and independent predictor of the outcome of patients undergoing coronary stent placement. An experience of at least 100 procedures and an annual volume of at least 70 procedures are required to ensure a significantly better outcome after coronary stent implantation.     

Revision of the Brief Visuospatial Memory Test: Studies of normal performance, reliability, and validity.

There is an increasing demand for alternate-form neuropsychological tests that can be used in clinical trials with little risk of direct practice effect. Although the Brief Visuospatial Memory Test ( BVMT ) includes six equivalent alternate forms, its administration is limited to an immediate and 25-min delayed free-recall trial. We now present a revised version of the BVMT called the Brief Visuospatial Memory Test—Revised (BVMT-R) that includes three learning trials, a 25-min delayed recall trial, and a delayed yes/ no recognition task. A new scoring system, which accounts for the location of test stimuli as well as the accuracy of recall, is also introduced. Using these new administration and scoring procedures, we administered the BVMT-R to 261 neuropsychiatric patients and 456 normal healthy adults. The results indicated that the test has excellent interform reliability, and the construct and criterion-related validity of the test were supported in studies using clinical samples. Although the BVMT-R is not without its limitations, the test's brevity and alternate-form capacity make it a valuable instrument for serial neuropsychological assessments. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

A review on the clinical applications of the Chinese MMPI.

Twenty-six studies on the clinical applications of the Chinese version of the Minnesota Multiphasic Personality Inventory (MMPI) in China are reviewed. The results show that the basic scales are able to differentiate between normals and psychiatric patients, including schizophrenics, manics, depressives, and neurotics. Distinctive profiles were obtained for the different diagnostic groups, similar to the clinical patterns observed in the United States. The average T scores for Scales F, 2, and 8, which were high among Chinese normals, were further elevated among the patient groups. When the Chinese norm was applied, the T scores on the clinical scales fell under 70 for all patient groups. The Chinese researchers suggested a cutoff value of 60 for the Chinese norm. Concordance between MMPI profiles and clinical diagnoses was high for the schizophrenics and moderate for the other patient groups. The results support the clinical applications of the Chinese MMPI in China. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Clinical outcome in diffuse large B-cell lymphoma is dependent on the relationship between different cell-cycle regulator proteins

PURPOSE: The goal of this work was to perform a comprehensive exploration of the relationship between the clinical outcome of diffuse large B-cell lymphoma (DLBCL) and the expression of a panel of tumor suppressor and oncogenic proteins, which includes some cell-cycle regulator proteins involved in the p53 pathway. PATIENTS AND METHODS: To this end, we collected the clinical data of 141 patients with DLBCL and immunohistochemically analyzed diagnostic tumoral tissue from each patient for the presence of Ki67 (MIB1, Immuno-tech, Marseille, France), bcl2, p53, p21/WAF1, MDM2, and retinoblastoma (Rb) proteins. RESULTS: The results show that several proteins are associated with some of the clinical traits analyzed. Multivariate analysis showed that an extended overall survival (OS) time was associated with low growth fraction, high Rb protein, and low MDM2 expression, as well as with known clinical parameters. The probability of inducing a complete remission (CR) was only associated with clinical parameters, although univariate study showed that a low growth fraction was associated with a higher probability of inducing a CR. Univariate study of disease-free survival (DFS) showed that tumors with high bcl2 expression and nodal origin have a shorter DFS time, although multivariate study only confirmed the adverse effect of bcl2 expression. CONCLUSION: Taking all these results into consideration, it seems that although the overall outcome for patients with DLBCL is decided by a combination of different clinical and biologic variables, the expression of some of these cell-cycle regulator proteins appears to be specifically associated with the different clinical features of tumors.     

Capacity of the clinical picture to characterize low back pain relieved by facet joint anesthesia. Proposed criteria to identify patients with painful facet joints

STUDY DESIGN: Prospective randomized study to compare the efficacy of facet joint injection with lidocaine and facet joint injection with saline in two groups of patients with low back pain, with and without clinical criteria that were determined in a previous study to implicate the facet joint as the primary source of the pain. OBJECTIVES: To assess the efficacy of single facet joint anesthesia versus placebo (saline injections) and to determine clinical criteria that are predictive of significant relief of LBP after injection. SUMMARY OF BACKGROUND DATA: There is no syndrome that discriminates between lower back pain caused by facet joint and that caused by other structures. Single or double facet joint anesthesia, and single photon emission computed tomography are expensive and time-consuming procedures for selecting patients in controlled clinical trials with large populations. METHODS: Results of a previous study showed that seven clinical characteristics were more frequent in patients who responded to facet joint anesthesia than in those who did not. In the current study, a group of 43 patients with lower back pain who met at least five criteria were compared with 37 patients who met fewer criteria. Patients randomly received injection of either lidocaine or saline into the lower facet joints. The result was considered positive if more than 75% pain relief was determined by visual analog scale. The patient, the radiologist, and the investigator were blinded. An analysis of variance was used to seek an interaction between clinical group effect and injection effect, and logistic regression analysis to select the best set of variables that would be predictive of minimum pain relief of 75% after the injection. RESULTS: There was a significant interaction between clinical group and injection effect (P = 0.003). In patients with back pain, lidocaine provided greater lower-back pain relief than saline (P = 0.01). Lidocaine also-provided greater pain relief in the back pain group than in the nonpain group (P = 0.02). The presence of five among seven variables (age greater than 65 years and pain that was not exacerbated by coughing, not worsened by hyperextension, not worsened by forward flexion, not worsened when rising from flexion, not worsened by extension-rotation, and well-relieved by recumbency), always including the last item, distinguished 92% of patients responding to lidocaine injection and 80% of those not responding in the lidocaine group. CONCLUSIONS: A set of five clinical characteristics can be used in randomized studies to select lower back pain that will be well relieved by facet joint anesthesia. These characteristics should not, however, be considered as definite diagnostic criteria of lower back pain originating from facet joints.