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PubMed2005

Validation of a male-specific, 12-locus fluorescent short tandem repeat (STR) multiplex.

Y chromosome-specific short tandem repeat (Y-STR) analysis has become another widely accepted tool for human identification. The PowerPlex Y System is a fluorescent multiplex that includes the 12 loci: DYS19, DYS385a/b, DYS389I/II, DYS390, DYS391, DYS392, DYS393, DYS437, DYS438 and DYS439. This panel of markers incorporates the 9-locus European minimal haplotype (EMH) loci recommended by the International Y-STR User Group and the 11-locus set recommended by the Scientific Working Group on DNA Analysis Methods (SWGDAM). Described here are inter-laboratory results from 17 developmental validation studies of the PowerPlex Y System and include the following results: (a) samples distributed between laboratories and commercial standards produced expected and reproducible haplotypes; (b) use of common amplification and detection instruments were successfully demonstrated; (c) full profiles were obtained with standard 30 and 32 cycle amplification protocols and cycle number (24-28 cycles) could be modified to match different substrates (such as direct amplification of FTA paper); (d) complete profiles were observed with reaction volumes from 6.25 to 50 microL; (e) minimal impact was observed with variation of enzyme concentration; (f) full haplotypes were observed with 0.5-2x primer concentrations; however, relative yield between loci varied with concentration; (g) reduction of magnesium to 1mM (1.5 mM standard) resulted in minimal amplification, while only partial loss of yield was observed with 1.25 mM magnesium; (h) decreasing the annealing temperature by 2-4 degrees C did not generate artifacts or locus dropout and most laboratories observed full amplification with the annealing temperature increased by 2 degrees C and significant locus dropout with a 4 degrees C increase in annealing temperature; (i) amplification of individual loci with primers used in the multiplex produced the same alleles as observed with the multiplex amplification; (j) all laboratories observed full amplification with >or = 125 pg of male template with partial and/or complete profiles observed using 30-62.5 pg of DNA; (k) analysis of < or = 500 ng of female DNA did not yield amplification products; (l) the minor male component of a male/female mixture was observed with < or =1200-fold excess female DNA with the majority of alleles still observed with 10,000-fold excess female; (m) male/male mixtures produced full profiles from the minor contributor with 10-20-fold excess of the major contributor; (n) average stutter for each locus; (o) precision of sizing were determined; (p) human-specificity studies displayed amplification products only with some primate samples; and (q) reanalysis of 102 non-probative casework samples from 65 cases produced results consistent with original findings and in some instances additional identification of a minor male contributor to a male/female mixture was obtained. In general, the PowerPlex Y System was shown to have the sensitivity, specificity and reliability required for forensic DNA analysis.

Animals↗

PubMed2005

Validation of male-specific, 12-locus fluorescent short tandem repeat (STR) multiplex.

Animals↗

PubMed2006

Sport participation and physical activity in adolescent females across a four-year period.

PURPOSE: To determine the odds of engaging in future moderate-to-vigorous physical activity (MVPA) and vigorous physical activity (VPA) in adolescent female sport participants. A secondary purpose was to compare activity levels of three groups of girls, those who played sports at three time points, those who dropped out, and those who did not participate in sports. METHODS: Data were collected at three time points, eighth, ninth, and 12th grades, in 429 adolescent girls across the state of South Carolina. Demographic, sport participation and physical activity (PA) data were collected using surveys. Odds ratios were calculated to determine the association between sport participation and future PA behavior. PA was also compared for three sport participation groups (nonparticipants, dropouts, or three-year participants) using analysis of variance. RESULTS: For MVPA, ninth grade participants were more likely to be active in 12th grade (OR = 1.74 [1.13, 2.67]), and eighth and ninth grade participants more likely to be active in 12th grade than nonparticipants (OR = 1.54 [confidence interval 1.01, 2.35]). For VPA, sport participants had higher odds of being active at all future time points. Three-year participants were significantly more vigorously active than nonparticipants and dropouts at all three time points (p < .01). CONCLUSIONS: Adolescent girls who participate in sports in eighth, ninth, and 12th grades are more likely to be vigorously active in 12th grade. These findings are novel in providing evidence that sport participation contributes to overall vigorous physical activity during late adolescence, when overall physical activity is known to decline precipitously.

Adolescent↗

PubMed2004

Efficacy and safety of extended-release, once-daily tramadol in chronic pain: a randomized 12-week clinical trial in osteoarthritis of the knee.

The efficacy and safety of a once-daily extended-release formulation of tramadol hydrochloride (tramadol ER) was evaluated in patients with moderate to severe chronic pain of osteoarthritis (OA). This was a randomized, double-blind, placebo-controlled, parallel-group, 12-week study. Eligible patients with radiographically confirmed OA of the knee meeting the American College of Rheumatology diagnostic criteria, defined by knee pain and presence of osteophytes, plus at least age >50 years, morning stiffness <30 minutes in duration, and/or crepitus, entered a 2-7 day washout period during which all analgesics were discontinued. When pain at the index knee joint reached > or =40 mm (0-100 mm VAS), patients were randomized to tramadol ER or placebo. Tramadol ER was initiated at 100 mg QD and increased to 200 mg QD by the end of 1 week of treatment. After the first week, further increases to tramadol ER 300 mg or 400 mg QD were allowed. Outcome measures included Arthritis Pain Intensity Visual Analogue Scale (VAS), Western Ontario and McMaster Universities Arthritis Scale (WOMAC) Pain, Stiffness, Physical Function VAS subscales, Patient and Physician Global Assessment of Therapy, Sleep, dropouts due to insufficient therapeutic effect, and adverse events. Two hundred forty-six patients were randomized (tramadol ER 124, placebo 122). There were no baseline differences between the two treatments. The mean age was 61 years, mean duration of OA 12.9 years, and the mean tramadol ER dose was 276 mg QD. All efficacy outcome measures favored tramadol ER over placebo. On the primary outcome variable of average change from baseline in Arthritis Pain Intensity VAS over 12 weeks, tramadol ER was superior to placebo (least squares mean change from baseline: 30.4 mm vs. 17.7 mm, P < 0.001). Significant differences from placebo were evident at week 1, the first post-treatment visit. Similarly, outcomes on the WOMAC Pain, Stiffness and Physical Function subscales, the WOMAC Composite Scale, dropouts due to insufficient therapeutic effect, Patient and Physician Global Assessment of Therapy, and Sleep were all significantly better with tramadol ER than placebo (P < 0.001 to < 0.05). Treatment with tramadol ER results in statistically significant and clinically important and sustained improvements in pain, stiffness, physical function, global status, and sleep in patients with chronic pain. A once-a-day formulation of tramadol has the potential to provide patients increased control over the management of their pain, fewer interruptions in sleep and improved compliance.

Aged↗

PubMed2026

Foot exercise plus education versus brief advice for the treatment of plantar heel pain (FEET Trial): a feasibility randomised controlled trial.

BACKGROUND: Despite foot muscle strengthening being a target of exercise interventions for plantar heel pain (PHP) no study has measured foot muscle outcomes, and existing research is limited by a lack of control (no treatment) comparisons. OBJECTIVES: To determine the feasibility of conducting a randomised controlled trial and investigate the acceptability and credibility of comprehensive progressive foot exercise and education compared to brief advice for PHP. DESIGN: Randomised parallel group feasibility trial. METHOD: People with PHP were randomised (1:1 concealed allocation) to receive either foot exercise plus education or brief advice for twelve weeks. Primary outcomes included willingness to enrol, recruitment rate, adherence, logbook completion, dropout rate, early withdrawal reasons, adverse events, additional treatments sought, and credibility/expectancy. RESULTS: Twenty people with PHP (16 women; age 50 ± 9 years; body mass index = 30.7 ± 4.6 kg/m2) were recruited over 15 weeks (1.3 participants per week). Primary outcomes were willingness to enrol (80%), adherence (physiotherapy sessions attended: foot exercise plus education 85%, brief advice 100%; home exercise program: 62% daily sessions completed, 72% thrice weekly sessions completed), logbook completion (foot exercise plus education 75%, brief advice 90%), dropout rate (15%), and additional treatments sought (69%). There were no intervention-related adverse events, and credibility scores were higher for foot exercise plus education. CONCLUSIONS: This study confirms feasibility and acceptability of a protocol comparing foot exercise plus education with brief advice in individuals with PHP, generating key insights to inform future trial design.

Humans↗

PubMed2005

Improvement of the image quality of T1-weighted anatomical brain scans.

T1-weighted anatomical brain scans are routinely used in neuroimaging studies, for example, as anatomical reference for functional data and in brain morphometry studies. Subject motion can degrade the quality of these images. An additional problem is the occurrence of signal dropouts in the case of long echo times and low receiver bandwidths. These problems are addressed in two different studies. In the first study, it is shown that the high scalp signal, which results from the low T1 value of fat, may cause a typical ringing artefact in the presence of head motion. This problem may be enhanced if phased array coils are used for signal reception due to their increased sensitivity in the peripheral head regions. It is shown that this artefact can be avoided by combining certain fat suppression techniques that reduce the scalp signal. In the second study, it is shown that signal dropout affects mainly the orbitofrontal cortex and the temporal lobes, and that a bandwidth of 100 Hz/pixel should be chosen for the investigation of these areas to avoid signal losses while maintaining an acceptable signal-to-noise ratio. Experimental results are based on the MDEFT sequence but can be applied to other T1-weighted sequences like FLASH and MP-RAGE. Furthermore, the presented methods for improving the image quality can be combined with other artefact reduction techniques.

Adipose Tissue↗

PubMed2000

Efficacy of newer medications for treating depression in primary care patients.

PURPOSE: Several medications have recently been introduced for the treatment of depression. We reviewed the literature to summarize their efficacy in the treatment of depression in adult patients in primary care settings. METHODS: We searched the literature published from 1980 to January 1998 using the Cochrane Collaboration Depression Anxiety and Neurosis Group's specialized registry of 8,451 clinical trials, references from trials and 46 pertinent meta-analyses, and consultation with experts. We included randomized controlled trials of at least 6 weeks' duration that measured clinical outcomes and compared one of 32 newer medications with another newer antidepressant, an older antidepressant, a placebo, or a psychosocial intervention for the treatment of depressed patients in primary care settings. The primary outcome was response rate, defined as the proportion of patients experiencing a 50% or greater improvement in depressive symptoms. RESULTS: There were 28 randomized controlled trials involving 5,940 adult primary care patients with major depression, depression requiring treatment, dysthymia, or mixed anxiety depression. Newer agents, including selective serotonin re-uptake inhibitors, serotonin norepinephrine inhibitors, reversible inhibitors of monoamine oxidase, and dopamine antagonists, were usually compared with tricyclic agents. Average response rates were 63% for newer agents, 35% for placebo, and 60% for tricyclic agents. Newer agents were significantly more effective than placebo [risk ratio = 1.6; 95% confidence interval (CI), 1.2 to 2.1), but similar to tricyclic agents (risk ratio = 1.0; 95% CI, 0.9 to 1.1). Response rates were similar in the different types of depressive disorders, except that two small trials in frail older patients showed no significant effects of newer agents compared with placebo. Dropout rates as a result of adverse effects were 8% with newer agents and 13% with tricyclic agents (P <0.05). CONCLUSIONS: In primary care settings, newer antidepressants are more effective than placebo and have similar efficacy compared with tricyclic agents in the acute treatment of depression. Dropout rates as a result of adverse effects are lower with newer compared with tricyclic agents. Future studies should compare the effectiveness of different therapies among primary care patients with less severe depression and greater medical and psychiatric comorbidity.

Antidepressive Agents, Second-Generation↗

PubMed2000

Early versus delayed inpatient stroke rehabilitation: a matched comparison conducted in Italy.

OBJECTIVE: To assess the specific influence of onset-admission interval (OAI) on rehabilitation results. DESIGN: A case-control study in consecutive stroke inpatients, enrolled in homogeneous subgroups, matched for age (within 1 year) and Barthel Index (BI) score at admission, and different for OAI to the rehabilitation ward. The short OAI group began rehabilitation treatment within the first 20 days from stroke, medium OAI group between days 21 and 40, and long OAI between days 41 and 60. SETTING: Rehabilitation hospital. PATIENTS: One hundred forty-five patients with sequelae of first stroke. MAIN OUTCOME MEASURES: Efficiency (average increase in BI per day), effectiveness (proportion of potential improvement achieved during rehabilitation) of treatment, and percentage of low- and high-response patients, calculated on BI, were evaluated. Odds ratios (ORs) of dropouts and of poor and excellent therapeutic response were also quantified. RESULTS: The short OAI subgroup had significantly higher effectiveness of treatment than did the medium (p < .05) and the long OAI groups (p < .005). Beginning treatment within the first 20 days was associated with a significantly high probability of excellent therapeutic response (OR = 6.11; 95% confidence interval [CI], 2.03-18.36), and beginning later was associated with a similar risk of poor response (OR = 5.18; 95% CI, 1.07-25.00). On the other hand, early intervention was associated with a five times greater risk of dropout than that of patients with delayed start of treatment (OR = 4.99; 95% CI, 1.38-18.03). The three subgroups were significantly (p < .05) different regarding the percentage of low and high responders. CONCLUSION: Our results showed a strong association between OAI and functional outcome.

Aged↗

PubMed1999

Pattern of neuronal loss in the rat hippocampus following experimental cardiac arrest-induced ischemia.

The pattern of neuronal loss in the rat hippocampus following 10-min-long cardiac arrest-induced global ischemia was analyzed using the unbiased, dissector morphometric technique and hierarchical sampling. On the third day after ischemia, the pyramidal layer of sector CA1 demonstrated significant (27%) neuronal loss (P<0.05). At this time, no neuronal loss was observed in other cornu Ammonis sectors or the granular layer of the dentate gyrus. On the 14th postischemic day, further neuronal loss in the sector CA1 pyramidal layer was noticed. At this time, this sector contained 31% fewer pyramidal neurons than on the third day (P<0.05) and 58% fewer than in the control group (P<0.01). On the 14th day, neuronal loss in other hippocampal subdivisions also was observed. The pyramidal layer of sector CA3 contained 36% fewer neurons than in the control group (P<0.05), whereas the granular layer of the dentate gyrus contained 40% fewer (P<0.05). The total number of pyramidal neurons in sector CA2 remained unchanged. After the 14th day, no significant alterations in the total number of neurons were observed in any subdivision of the hippocampus until the 12th month of observation. Unbiased morphometric analysis emphasizes the exceptional susceptibility of sector CA1 pyramidal neurons to hypoxia/ischemia but also demonstrates significant neuronal loss in sector CA3 and the dentate granular layer, previously considered 'relatively resistant'. The different timing of neuronal dropout in sectors CA1 and CA3 and the dentate gyrus may implicate the existence of region-related properties, which determine earlier or later reactions to ischemia. However, the hippocampus has a unique, unidirectional system of intrinsic connections, whereby the majority of dentate granular neuron projections target the sector CA3 pyramidal neurons, which in turn project mostly to sector CA1. As a result, the early neuronal dropout in sector CA1 may result in retrograde transynaptic degeneration of neurons in other areas. The lack of neuronal loss in sector CA2 can be explained by the resistance of this sector to ischemia/hypoxia and the fact that this sector is not included in the major chain of intrahippocampal connections and hence is not affected by retrograde changes.

Animals↗

PubMed2001

Identifying and separating the effects of practice and of cognitive ageing during a large longitudinal study of elderly community residents.

In protracted longitudinal studies of cognitive changes in old age volunteers must be repeatedly tested. Even with intervals of several years between assessment, this raises the possibility that improvements due to practice mask other changes. This problem is much more acute in brief studies of cognitive changes associated with progressive pathologies such as Alzheimer's disease or the effects of clinical interventions. Both types of study also encounter problems of selective dropout of frail and less able individuals leaving relatively 'elite' survivors. An analysis of data from repeated testing at 2-3 years intervals on the AH4 (1) intelligence test is presented to illustrate how a random effects model can be used to identify and disassociate age-related changes and practice effects at the population level, after effects of selective dropout and of background demographical variables have been taken into consideration. This analysis also provides some new, substantive empirical findings. Age-related changes are relatively slight between 49 and 70 years but much more marked between 70 and 80 years. Even with assessment points, several years apart the population average effect of practice is large relative to that of age-related change. Variation between individuals increases as samples age, providing the first clear evidence from a longitudinal study for marked individual differences in trajectories of cognitive ageing.

Age Factors↗

PubMed1999

Reasons for discontinuing intracavernous injection therapy with prostaglandin E1 (alprostadil).

OBJECTIVES: To clarify the reasons why experience with self-injection therapy for erectile dysfunction shows high dropout rates. METHODS: We studied 86 patients 36 to 76 years old who had been on home treatment for at least 3 months. Sixty-nine patients (80%) were continuing to use injections, and 17 (20%) had discontinued the treatment. Patients were evaluated by interview and clinical examination. RESULTS: Patients still in the program used one injection every 2 weeks, and those who had given up treatment had used one injection in 3 weeks (P = 0.31). They were in the program for 39+/-27 and 16+/-22 months (P = 0.002), respectively, and had used 50 (95% confidence interval [CI] 21 to 91) versus 12 (95% CI 4 to 20) injections, respectively (P<0.0001). Injections producing unsatisfactory penile rigidity, prolonged erections, hematoma at injection site, corporal fibrosis, secondary penile deviation, and mean estimated duration of a pharmacoinduced erection showed no significant differences. Patient satisfaction (P = 0.02), estimated partner satisfaction (P = 0.02), increase in self-esteem (P = 0.01), and negligible effort in performing injections (P = 0.001) all showed significantly better results for those still in the program. CONCLUSIONS: Reasons for dropout from self-injection therapy are not based on objective side effects and discomfort. Patients leaving the program are less motivated, less satisfied with the quality of pharmacoinduced sexuality, consider the effort to perform injections to be substantial, and have not achieved improved self-esteem.

Adult↗

PubMed2001

Family preservation and family support programs: child maltreatment outcomes across client risk levels and program types.

OBJECTIVES: This study evaluated client-level outcomes among an entire statewide group of Family Preservation and Family Support (FPFS) programs funded under PL 103-66. METHOD: A total of 1,601 clients (primarily low income, moderate to high risk with no current involvement in the child protection system) were assessed and followed over time for future child maltreatment events reported to Child Protective Services. The study compared program completers with program dropouts, compared recipients of more lengthy full-service programs with recipients of one-time services, and examined the effects of program duration, intensity, service site (center-based vs. home based) and service model/content. Effects were modeled using survival analysis and variable-exposure Poisson hierarchical models, controlling for initial client risk levels and removing failure events because of surveillance bias. Changes in lifestyle, economic and risk factors were also examined. RESULTS: A total of 198 (12.2%) participants had at least one defined failure event over a median follow-up period of 1.6 years. Controlling for risk and receipt of outside services, program completers did not differ from program dropouts or from recipients of one-time services, and there was no relationship between program intensity or duration and outcomes. Program types designed to help families meet basic concrete needs and programs using mentoring approaches were found to be more effective than parenting and child development oriented programming, and center-based services were found to be more effective than home-based services, especially among higher risk parents. CONCLUSIONS: The findings did not support the effectiveness of these services in preventing future maltreatment cases, and raised questions about a number of common family support assumptions regarding the superiority of home-visiting based and parent training services. A number of possible reasons for this are explored.

Adolescent↗

PubMedDate not supplied

Stress management for patients with heart disease: a pilot study.

OBJECTIVE: To conduct a feasibility study on stress management for patients with heart disease; more specifically, to test the availability of patients, determine dropout rates, and investigate the sensitivity to change of a large number of psychologic and biologic stress indexes. DESIGN: Random assignment, two-group clinical trial. SETTING: Pacific Northwest university-affiliated teaching hospital. PATIENTS: Forty-five patients with heart disease (mean age 56 years), who either had a myocardial infarction or coronary bypass surgery. OUTCOME MEASURES: Hostility, subjective distress, resting electrocardiogram, resting blood pressure and blood pressure reactivity to a psychologic stressor, and blood lipid, cortisol, and catecholamine levels. INTERVENTION: Patients were randomly assigned to either (1) exercise rehabilitation (ER) and an 8-week stress management (SM) program (ER + SM) or (2) ER only. Although the recruitment rate was satisfactory, 67% of patients assigned to the control condition and 40% of the SM subjects were not available for posttesting. RESULTS: Computed effect sizes indicated that blood pressure reactivity to a psychologic challenge was reduced after treatment in the ER + SM group but not in ER group. The ER + SM group showed improvement in perceived health status and had clinically meaningful reductions in triglyceride levels, whereas the ER group did not. The ER group had a reduction in high-density lipoproteins, whereas the high-density lipoprotein levels of the ER + SM group did not change. CONCLUSIONS: Patients randomly assigned to a control condition may be less willing to participate in time-consuming and invasive posttests than treated patients. Reducing the invasiveness of measurement may increase cost-effectiveness and reduce the dropout rate under controlled conditions. Blood pressure reactivity to a psychologic stress test and changes in serum lipid levels may be sensitive and cost-effective measures to include in future studies of cardiac rehabilitation.

Adult↗

PubMed2000

The effect of new and continuing prescription drug use on cost: a longitudinal analysis of chronic and seasonal utilization.

OBJECTIVE: To provide basic information about 2 factors contributing to rising prescription drug costs--utilization trends and product selection. BACKGROUND: Prescription drug costs have risen sharply in recent years, and continued growth is expected. There is little consensus about appropriate cost-management strategies, in part because quantitative data on the causes and implications of increased drug costs are lacking. METHODS: This study followed 463,820 continuously enrolled adult (> or = 18 years of age on January 1, 1996) utilizers of 15 chronic or seasonal therapeutic classes for 2.5 years (January 1996 through June 1998) using a pharmacy benefit manager's multiple-payer claims database. Outcome measures included (1) change in utilization rate, (2) relationship between new use and utilization growth, (3) stability of the treated population (ie, mostly long-term use vs high rates of turnover), and (4) product mix changes (ie, cost per dispensed day for 1996 vs 1997 and for new vs continuing users, controlling for inflation). RESULTS: Of the 463,820 utilizers, 97% were commercially insured and 3% enrolled in Medicare risk plans; 40% were enrolled in managed care and the remainder covered by indemnity insurance. Rates of growth and turnover varied substantially by class. The highest 2-year utilization rate change was 66.7% for antihyperlipidemic agents; change was < 10% in only 3 classes. Across classes, an average of 38.7% of 1997 users were new (ie, no use in 1996) and an average of 34.0% of 1996 users were dropouts (ie, no use in 1997). Utilization growth depended heavily on treatment continuation; classes with high dropout rates (eg, antirheumatic, antiasthmatic) did not have high growth rates, even with high rates of new use. In most classes, costs were not higher for new than for continuing users. In some classes, however (eg, antipsychotic, antidiabetic), both new and continuing users increased their use of newer, more expensive products. CONCLUSIONS: Because factors underlying rising prescription drug costs vary by therapeutic class, cost-containment strategies should address these differences. Further research is needed to assess the clinical and economic costs and benefits of rapid growth in the utilization of certain therapeutic classes.

Adult↗

PubMed2003

The effect of anemia treatment on selected health-related quality-of-life domains: a systematic review.

BACKGROUND: Anemia is a reduction in the oxygen-carrying capacity of red blood cells that results in a variety of symptoms, including dyspnea, headaches, light-headedness, and fatigue. Although anemia has been associated with reduced health-related quality of life (HRQoL), its treatment has not yet been consistently shown to improve HRQoL. OBJECTIVE: This systematic review of the literature was conducted to determine whether the treatment of anemia improves HRQoL domains, regardless of the type of underlying disease. METHODS: Data for this review were drawn from the clinical trial databases from 2 previous systematic literature reviews of erythropoiesis-stimulating protein treatment for renal insufficiency- and cancer-related anemia, both spanning the period January 1, 1980, through December 31, 2001. MEDLINE, Cancerlit, and Current Contents/Clinical Medicine were searched using the combined terms erythropoietin, kidney failure, neoplasms, and anemia. The reference lists of all identified articles were searched manually for additional relevant papers. The review included prospective studies that reported both HRQoL and hematocrit (Hct) in patients with cancer or renal insufficiency who received treatment for anemia with an erythropoiesis-stimulating protein. HRQoL was categorized by domain (overall, energy/fatigue, physical, activity); changes in HRQoL domains were expressed as effect sizes and meta-analyzed, as were correlation coefficients. The effects on HRQoL of dropout rate, study duration, baseline Hct, and change in Hct were examined in meta-regression analyses. RESULTS: Sixteen studies each were identified in patients with renal insufficiency (N = 2253) and patients with cancer (N = 10,695). The treated groups included 11,710 patients, and the control groups included 1238 patients. The baseline Hct in all treated groups averaged 26.0%: 28.3% in the group with cancer and 24.4% in the group with renal insufficiency. The mean improvement in Hct from baseline to the end of treatment was 8.3% (range, 1.0%-16.5%) in treated patients and 1.0% (range, 0.0%-3.3%) in controls. The Hct changes were similar in treated patients with cancer and treated patients with renal insufficiency, as was the HRQoL effect size (0.43). Dropout rate and study duration were not significant predictors of HRQoL changes, but change in Hct was a significant predictor in both conditions. Meta-analysis of the correlation coefficients, adjusting for HRQoL domains, showed a consistent and significant positive correlation between change in Hct and change in HRQoL (P < 0.001). CONCLUSION: The consistency in both direction and magnitude of effect across many studies and thousands of patients supports the hypothesis that treatment of anemia with erythropoiesis-stimulating protein improves selected HRQoL domains in patients with renal insufficiency- or cancer-related anemia.

Anemia↗

PubMedDate not supplied

Risperidone versus haloperidol: I. Meta-analysis of efficacy and safety.

Haloperidol is widely considered a reference standard in antipsychotic therapy and is commonly used in comparative studies of the efficacy and safety of antipsychotic medication. Comparative clinical trials have shown that the novel antipsychotic agent risperidone tends to have greater efficacy (i.e., clinical response defined as a > or = 20% reduction in total scores on the Positive and Negative Syndrome Scale) than haloperidol in patients with chronic schizophrenia and poses less risk of extrapyramidal symptoms (EPS). We used DerSimonian and Laird's random-effects model to analyze pooled patient data from available randomized, double-masked, comparative trials of risperidone and haloperidol in patients with schizophrenia treated for at least 4 weeks at recommended doses. The purpose of the analysis was to determine whether there are significant overall differences in the rates of patient clinical response, prescription of anticholinergic agents, and treatment dropout. Six of the nine trials revealed in a literature search met all criteria for inclusion in the meta-analysis. The meta-analysis showed that in patients with chronic schizophrenia, risperidone therapy is associated with significantly higher response rates, significantly less prescribing of anticholinergic medication, and significantly lower treatment dropout rates than haloperidol. These results demonstrate the greater treatment efficacy associated with risperidone compared with haloperidol and suggest both a lower incidence of EPS and improved treatment compliance.

Antipsychotic Agents↗

PubMed1994

Long-term treatment of alcoholic liver disease with propylthiouracil. Part 2: Influence of drop-out rates and of continued alcohol consumption in a clinical trial.

Although propylthiouracil has previously been shown to reduce the risk of mortality in alcoholic liver disease by 60%, generalized use of propylthiouracil for this condition has not occurred. Additional data are therefore presented on four aspects to provide a better assessment of its therapeutic effectiveness. First, the characteristics and the prognosis of dropouts were virtually identical in both the drug and placebo groups. Also the methodology and analysis employed, were designed to control for dropouts, thus providing an accurate interpretation of the outcome. Secondly, since 97% of the patients continued to drink, abstinence was not a precondition for the beneficial effect of propylthiouracil. However, the beneficial effect was observed most clearly in those patients who continued to drink at lower levels, whereas lower level drinking per se did not afford protection in placebo patients. Thirdly, serious side effects or clinical hypothyroidism occurred extremely rarely in these patients, many of whom have now received propylthiouracil for over 4 years. Fourthly, we discuss why the outcome in long-term clinical trials in alcoholic liver disease cannot be compared with effects observed in clinical trials lasting only a few weeks. Journal of Hepatology.

Clinical Trials as Topic↗

PubMed1997

Familial and socioeconomic influences on children's well-being: an examination of preschool children in Kenya.

As patterns of family formation change, it is important to know how children's lives are affected by their parents' marital and socioeconomic circumstances. Using data from the 1993 Kenya Demographic and Health Survey, this study shows that children of never married and formerly married mothers have significantly higher probabilities of polio dropout and acute undernutrition than those of monogamously married mothers. The number of male household members of working age greatly enhances the chances of full immunization and the nutritional status of children whose mothers were previously married. For children of never married mothers, the benefits of residing with males of working age are largely a function of ethnicity. The results also show that, although children are not disadvantaged nutritionally when their fathers have more than one wife, polygyny is associated with a higher probability of polio dropout and lower probability of full immunization than monogamy. Higher socioeconomic status is associated with a greater probability of full immunization and a lower probability of malnutrition but socioeconomic factors do not explain the effects of mothers' marital status. The findings underscore the complex realities of family interaction and the importance of the broader social context in accounting for variations in child welfare across diverse marital situations.

Child Welfare↗