"Summary measure" statistic for assessing the outcome of treatment trials in relapsing-remitting multiple sclerosis

OBJECTIVE: The relation of temperamental dimensions to somatization and panic disorders in women was investigated. METHOD: Eighteen patients with both panic and somatization disorders, 41 patients with panic disorder only, and 22 control subjects were compared on the Tridimensional Personality Questionnaire. RESULTS: The patients with somatization and panic disorders had significantly higher Novelty Seeking values than both the patients with panic only and the control subjects. The only significant correlation was between the number of symptoms of somatization disorder and Novelty Seeking. The presence of other psychiatric conditions, comorbid with panic disorder in the patient group, did not affect significantly the temperamental variables. CONCLUSIONS: A temperamental disposition characterized by extraversion, impulsivity, as well as frequent exploratory activity and pursuit of novel and pleasurable activities may help differentiate women with both somatization and panic disorders from women with panic disorder only.     

The Thematic Apperception Test as an outcome measure in psychotherapy research.

Correlated 2 measures of the TAT—the presence of depressive themes and the ratings of story endings—with other indicators of depression (MMPI and Beck Depression Inventory) or with ratings of improvement. 129 psychiatric hospital patients, aged 20–65 yrs, served as Ss. Results support the potential use of the TAT as an outcome measure in the treatment of depressions. (18 ref) (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Clinical trials and tribulations: implementation processes in schizophrenia research outcome

This article focuses on an area in clinical drug trials for new antipsychotic medications for the treatment of schizophrenia which has not received sufficient attention in the literature: the day-to-day implementation tasks performed by research staff which have potential effects on study results. Implementation tasks are viewed as dynamic processes involving interactions among research and nonresearch staff, patients, families, and pharmaceutical company staff. Research-related demands and possible sources of stress for all participants in the process, such as recruiting and maintaining patients in studies, are discussed. Suggestions are offered for increasing the ease of participation. Further investigation is called for in several areas including variability in the effectiveness of research teams and in the rarely discussed interactions between site staff and pharmaceutical company personnel, as they may affect research outcomes. It is posited that increased knowledge about implementation processes in schizophrenia drug development is needed to more fully understand study results and to enhance patients' and their families' willingness to participate.     

An evaluation of the effect of pentoxifylline on sperm function and treatment outcome of male-factor infertility: a preliminary study

OBJECTIVE: Our objective was to study the effect of pentoxifylline (PF) on fertilization rates in couples with previous failure of fertilization and male-factor infertility and to determine the predictive value of conventional semen analysis parameters in selecting the couples who would benefit from the elective use of PF in IVF. DESIGN: This prospective controlled study was conducted in an assisted conception METHODS: Sixty-nine couples with previous failed IVF cycle, who had a low fertilization rate and/or male-factor infertility, were recruited to the study. Multiple follicular development was induced using the same protocol of human menopausal gonadotropin and gonadotropin releasing hormone analogue in both cycles. The oocytes were inseminated with spermatozoa treated with PF. The fertilization rates in the PF cycle were compared to the reference cycle based on semen analysis parameters and previous fertilization rates. RESULTS: In couples with male infertility, the fertilization rate improved significantly, from 17 to 50% in PF cycles (P < 0.001). A significant improvement in fertilization rate was also demonstrated in couples with previous poor fertilization, < 30% (P < 0.01), particularly in those with a very low fertilization rate, < 20% (P < 0.001). Although there was an overall improvement in fertilization rates in couples with male-factor infertility, there was no cutoff value in sperm motility that would make a significant difference in the impact of PF on fertilization rates. CONCLUSION: Couples with poor fertilization rates in vitro benefit with a significant improvement in fertilization by the elective use of PF. The improvement is most significant in couples with previous complete failure of fertilization and poor fertilization rates, < 30%.     

Infarct volume as a surrogate or auxiliary outcome measure in ischemic stroke clinical trials. The RANTTAS Investigators

Post-translational control of Escherichia coli ribosome on newly synthesised polypeptide leading to its active conformation (protein folding) has been shown in the case of the enzyme beta-galactosidase. As expected, antibiotics chloramphenicol and lincomycin, which bind to 23S rRNA/50S subunit and kasugamycin and streptomycin which interact with the 30S subunit instantaneously inhibited protein synthesis when they were added to the growing cells. The increase in beta-galactosidase activity, though stopped immediately after the addition of chloramphenicol and lincomycin, went on considerably in the presence of streptomycin and kasugamycin even after the stoppage of protein synthesis.     

Placental implantation on the amniotic sheet: effect on pregnancy outcome

PURPOSE: To assess pregnancy outcome in patients with amniotic sheets and to determine whether outcome is affected by placental implantation on the amniotic sheet. MATERIALS AND METHODS: Sonograms obtained during the 2nd and 3rd trimesters were reviewed in 157 patients with amniotic sheets to confirm the presence of an amniotic sheet and to determine the relationship of the placenta to the amniotic sheet. The cesarean section rate, gestational age at birth, birth weight, birth weight percentile, and Apgar score 1 minute after birth were recorded in patients in whom the postnatal follow-up data were available. Data were compared with overall data obtained at the authors' institution during the same period. RESULTS: The placenta appeared implanted on the amniotic sheet in 41 (26.1%) of the 157 patients. In the 120 patients with amniotic sheets and follow-up data, the cesarean section rate was 32.5% compared with 21.5% overall. The mean gestational age at birth was slightly lower than that overall (38.2 vs 39.0 weeks, P < .001), but the birth weight percentile was similar (48.6% vs 50.0%, P = .58). No statistically significant differences were found in postnatal follow-up data between pregnancies with placental implantation on and in those without implantation on the amniotic sheet. CONCLUSION: Pregnancy outcome is similar in patients with and in those without placental implantation on the amniotic sheet.     

Maternal nutrition and the outcome of pregnancy. A renaissance in research

Research over the past decade indicates that aspects of maternal nutrition may play a greater role in immediate and long-term health of offspring than was thought previously. The effects of nutritional exposures on outcomes likely depend primarily on the timing of insults during pregnancy and may not have to be severe to have a long-term impact on health. If the rate of change in knowledge of the effects of maternal nutritional exposures on outcomes continues at its current pace, work initiated in the past decade may well be looked back upon as representing the renaissance of maternal nutrition research.     

Acquiescent response set as a measure of acquiescence: Further evidence.

This study reconfirms evidence that acquiescent response set (ARS) does not reflect an underlying personality tendency to conform or acquiesce as assumed in the literature. ARS scores derived from 3 additional types of instruments failed to correlate with acquiescence to simulated judgments of others in an Aschlike conformity situation. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Interpretation of prospective trials in hypertension: do treatment guidelines accurately reflect current evidence?

OBJECTIVE: To review the findings of prospective controlled trials of antihypertensive treatment and determine whether the evidence they have provided is embodied satisfactorily in current national and international guidelines for hypertension management. MANAGEMENT GUIDELINES: Conventional guidelines all advise prompt treatment of moderate-to-severe hypertension and treatment of even mild hypertension in subjects with cardiovascular disease, target organ damage or diabetes, and in the elderly; and treatment of isolated systolic hypertension in the elderly. All acknowledge that evidence for efficacy and safety of treatment is strongest for thiazide diuretics and beta-blockers. UNCOMPLICATED MILD HYPERTENSION: Conventional guidelines all emphasize the importance of long-term blood pressure, measured over some months, for treatment decisions. However the blood pressure for routine treatment varies from 160/100 mmHg (British Hypertension Society) to 140/90 mmHg (Joint National Committee V). This dictates very large differences in the number of patients to be treated to prevent a cardiovascular disease event and in the proportion of the population to be treated, yet the reasons for these differences are not explicit. None of the conventional guidelines is entirely satisfactory. The more conservative British Hypertension Society policy may leave untreated some middle-aged men who ought to be treated. The more aggressive Joint National Committee V policy will lead to treatment of some young subjects who have only a remote chance of benefit, at very high cost, and possibly with adverse harm-benefit consequences. RISK-BASED GUIDELINES: Guidelines developed in New Zealand target absolute cardiovascular disease risk in mild hypertension and have the potential to correct this shortcoming of conventional guidelines. However they require further consideration as regards the number needed to treat which is acceptable to well-informed patients, the appropriate estimate of relative cardiovascular disease risk reduction by treatment in mild hypertension, the pattern of treatment which will emerge and their acceptability in ordinary practice. CONCLUSION: Comparative evaluation will be needed to determine whether the outcome is better with conventional guidelines, which are simple but at the expense of accuracy, or with risk-targeted guidelines, which are more accurate but at the expense of simplicity.     

Response bias in below-chance performance: Computation of the parametric measure !b.

We argue that conceptual problems arise with the parametric measure β when above- and below-chance data are aggregated or compared. Depending on the interpretation of β as a likelihood-ratio measure or an indicator of strictness or bias toward signal or noise, the original formula for β should be retained or modified. The response bias measure β can be retained only if it is interpreted as a likelihood-ratio measure. If it is interpreted as an indicator of strictness or bias toward signal or noise, the original formula has to be modified. One possible modified formula is suggested here. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Spontaneous ambulatory activity as a quantifiable outcome measure for osteoarthritis of the knee

OBJECTIVE: Quantifiable outcome measures for disabling diseases such as osteoarthritis (OA) of the knee are necessary in order to compare the impact of different interventions competing for financial resources. Current subjective and questionnaire data are not satisfactory for such study. In this study, we examine the potential of the direct measurement of ambulatory activity as such a measure. POPULATION: Patients with X-ray evidence of OA of the knee recruited to studies of anti-inflammatory agents (n = 29). Patients with OA of the knee awaiting knee replacement surgery (n = 28). METHODS: Comparison of various standard measures with total energy output data from an activity monitor. RESULTS: Spearman rho correlations of ambulatory energy output (number of steps x average amplitude of steps) correlated with other measures. Correlation with physician's opinion was greater than with patient's opinion (r = 0.4 and 0.2, respectively). There was no correlation with visual analogue pain scale or OA severity index. Correlation with scales of the Nottingham Health Profile questionnaire were not significant either for mobility (r = - 0.15) or for pain (r = - 0.13). There was, however, a significant correlation between poor sleep and increased activity (r = 0.34, P < 0.05). Correlation with Kellgren X-ray grade was significant (r = - 0.45, P = 0.01). Patients recruited to anti-inflammatory studies were 69% more active than those awaiting replacement surgery. CONCLUSION: The monitoring of ambulatory activity shows some construct and discriminant validity, and is worthy of further study.     

Assessing the effects of cooperation bias and attrition in behavioral genetic research using data-weighting

Because twins and adoptees are a rare resource, they are often studied repeatedly over a period of many years. Differential attrition, and in some studies initial cooperation bias, have the potential to lead to serious biases to estimates of genetic and environmental parameters. Since non-response is often influenced by multiple binary or categorical sociodemographic variables, maximum-likelihood methods are not easily adapted to adjust for such effects. In this brief note we illustrate the use of data-weighting to assess the likely effects of cooperation bias or attrition both on measures of mean or prevalence, and on twin pair correlations or concordances, using data from the Australian twin panel 1981 survey and alcohol challenge studies. Participants in the alcohol challenge study were on average younger, more socially nonconforming, heavier drinkers, more likely to be unmarried, and less likely to report their religion as Other Protestant. Reweighting the alcohol challenge sample to have the same distribution on these variables as the Australian twin panel 1981 survey respondents confirmed that individuals who would feel very intoxicated after a challenge dose of alcohol were underrepresented in the study. However, pairwise data-weighting indicated that this cooperation bias was leading to only a slight underestimation of the importance of genetic effects on subjective intoxication.     

The effect of female age and ovarian reserve on pregnancy rate in male infertility: treatment of azoospermia with sperm retrieval and intracytoplasmic sperm injection

Factors other than spermatozoa could be the major determinant of the success of assisted reproduction treatment in cases of male infertility. Our aim was to evaluate the effect of the wife's age and ovarian reserve on assisted reproduction success rates in the most severe type of male infertility, i.e. azoospermia. A total of 249 consecutive couples suffering from male infertility caused by azoospermia underwent microsurgical epididymal sperm aspiration (MESA) or testicular sperm extraction (TESE) with intracytoplasmic sperm injection (ICSI). Of these men, 186 had irreparable obstructive azoospermia, and 63 had non-obstructive azoospermia due to testicular failure. Neither the pathology, the source, the quantity, nor the quality of spermatozoa had any effect on fertilization or pregnancy rates. Maternal age and ovarian reserve (number of eggs) had no effect on fertilization or embryo cleavage, but did dramatically affect the embryo implantation, pregnancy and delivery rates. Wives of azoospermic men who were in their 20s had a 46% live delivery rate per cycle, wives aged 30-36 years had a 34% live delivery rate per cycle, wives aged 37-39 years had a 13% live delivery rate per cycle, and wives > or = 40 years had only a 4% live delivery rate per cycle. The number of eggs retrieved also affected pregnancy and delivery rate, but to a lesser extent than age. In virtually all cases of obstructive azoospermia, and in 62% of cases with non-obstructive azoospermia caused by germinal failure, sufficient spermatozoa could be retrieved to perform ICSI, with normal fertilization and embryo cleavage. However, the pregnancy rate and the live delivery rate were dependent strictly on the age of the wife, and on her ovarian reserve. Unfortunately, exaggerated claims of high pregnancy rates can thus easily be made by manipulating, in a very simple way, selection for female factors.     

Laparoscopic treatment of interstitial pregnancy using the harmonic scalpel

OBJECTIVE: To evaluate a laparoscopic technique of cornual resection using the harmonic scalpel. METHODS: Four patients with unruptured interstitial pregnancies were treated laparoscopically using the harmonic scalpel at Ioannina University Hospital. RESULTS: There were no failures in the technique in any of our patients. CONCLUSION: Our study suggests that interstitial pregnancies of a maximum gestational age of 7-8 weeks and sac diameter less than 4-5 cm may be treated laparoscopically.     

The causal generalization paradox: The case of treatment outcome research.

Data from psychological experiments pose a causal generalization paradox. Unless the experimental results have some generality, they contribute little to scientific knowledge. Yet, because most experiments use convenience samples rather than probability-based samples, there is almost never a formal justification, or set of rigorous guidelines, for generalizing the study's findings to other populations. This article discusses the causal generalization paradox in the context of outcome findings from experimental evaluations of psychological treatment programs and services. In grappling with the generalization paradox, researchers often make misleading (or at least oversimplified) assumptions. The article analyzes 10 such assumptions, including the belief that a significant experimental treatment effect is likely to be causally generalizable and the belief that the magnitude of a significant experimental effect provides a sound effect size estimate for causal generalization. The article then outlines 10 constructive strategies for assessing and enhancing causal generality. They include strategies involving the scaling level of outcome measures, variable treatment dosages, effectiveness designs, multiple measures, corroboration from observational designs, and the synthesis of multiple studies. Finally, the article's discussion section reviews the conditions under which causal generalizations are justified. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

An empirical study of the effect of the control rate as a predictor of treatment efficacy in meta-analysis of clinical trials

If the control rate (CR) in a clinical trial represents the incidence or the baseline severity of illness in the study population, the size of treatment effects may tend to very with the size of control rates. To investigate this hypothesis, we examined 115 meta-analyses covering a wide range of medical applications for evidence of a linear relationship between the CR and three treatment effect (TE) measures: the risk difference (RD); the log relative risk (RR), and the log odds ratio (OR). We used a hierarchical model that estimates the true regression while accounting for the random error in the measurement of and the functional dependence between the observed TE and the CR. Using a two standard error rule of significance, we found the control rate was about two times more likely to be significantly related to the RD (31 per cent) than to the RR (13 per cent) or the OR (14 per cent). Correlations between TE and CR were more likely when the meta-analysis included 10 or more trials and if patient follow-up was less than six months and homogeneous. Use of weighted linear regression (WLR) of the observed TE on the observed CR instead of the hierarchical model underestimated standard errors and overestimated the number of significant results by a factor of two. The significant correlation between the CR and the TE suggests that, rather than merely pooling the TE into a single summary estimate, investigators should search for the causes of heterogeneity related to patient characteristics and treatment protocols to determine when treatment is most beneficial and that they should plan to study this heterogeneity in clinical trials.     

Further evidence on the ego strength scale as a measure of psychological health.

This study was designed to see if the difference between undergraduates and mental patients obtained by Taft (1957) on the ES Scale represents a difference between college and noncollege populations. Therapy and nontherapy groups in a university setting were compared on the ES scale and results similar to that of Taft were obtained. There was also a trend for self-referred counselees to obtain higher scores on the ES scale than those earned by referred counselees. (PsycINFO Database Record (c) 2010 APA, all rights reserved)