1,721,032 research outputs found
Describing the participants in a study
No full textThis paper reviews the use of descriptive statistics to describe the participants included in a study. It discusses the practicalities of incorporating statistics in papers for publication in Age and Aging, concisely and in ways that are easy for readers to understand and interpret
Reduced sway during dual task balance performance among people with stroke at 6 and 12 months after discharge from hospital
No full textBackground: cognitive motor interference has been linked to poor recovery and falls. Little is known about recovery of dual-task balance ability poststroke. Methods: in this experimental study, postural sway was examined while standing on a force plate in preferred stance, with feet together, and with eyes closed, at 6 and 12 months postdischarge from hospital. Sway was assessed in isolation and while participants performed a cognitive (shopping list) task. Results: seventy-six people with stroke (mean age 67 years; range, 21-91 years) took part. Fifty-four completed both assessments. When compared with the single task, sway during the dual-task condition was significantly lower in both the medial lateral (ML) and anterior posterior (AP) directions (both P < .0001). Sway in both directions was influenced by the difficulty of the balance task (both P < .0001). There was a trend of reduced sway at the 12-month assessment compared with the 6-month assessment: significant only in the ML direction (P = .0056). Repeat fallers swayed more than non—repeat fallers, with increases of 48% and 44% in the ML (P = .0262) and AP (P = .0134) directions, respectively. No significant variation in the dual-task reduction in sway was found: the dual-task effect was remarkably consistent over all the conditions tested, particularly in the AP direction. Conclusions: sway decreased under dual-task conditions and changed as the difficulty of the balance task changed. Stroke fallers swayed more than nonfallers and there was evidence of a reduction in sway over time, particularly in the ML directio
The analysis of continuous outcomes in multi-centre trials with small centre sizes
No full textThe standard analysis of clinical trials stratified by centre is to include centres as fixed effects, but if many centres contribute small numbers of patients, this approach results in a loss of power. Assuming no treatment by centre interaction, we used simulation to examine power and coverage of confidence intervals from three approaches to the analysis of continuous outcome in multi-centre trials: ignoring centres, including centres as fixed effects, and including them as random effects. The simulation incorporated eight sizes of centre effects; randomization in blocks of size 2 or 4; and two sample sizes, namely 100 and 200 patients per treatment arm in a parallel groups design. All simulated data sets included many centres with few subjects. The three different approaches were unbiased and had similar coverage. Fixed effects analysis was less powerful, particularly when centre effects were small. Incorporating block randomization with larger block size increased non-orthogonality in the design, contributing to loss of power. Where centre effects are small and recruitment in many centres is low, the approaches of ignoring centres or incorporating them as random effects have better performance than the traditional fixed effects analysis
Predicting fallers in a community-based sample of people with Parkinson's disease
No full textBACKGROUND: The risk of people with Parkinson's disease (PD) falling is greater than that of the general population but to date, disease-specific predictors of falling have not been identified. OBJECTIVES: To identify one or more features, which would predict individuals at risk of falling during a 3-month prospective follow-up study. METHOD: A battery of standardised tests administered in the home and the laboratory with a 3-month follow-up telephone interview. RESULTS: Sixty-three people with PD were recruited from GP practices. Eleven interview variables and six gait laboratory variables were used with subsamples (55 and 44 subjects, respectively) to fit predictive models for identifying future fallers. The number of falls in the previous year was the most important variable, without exception, to be selected as a predictor in various logistic regression models. A history of two or more falls had a sensitivity of 86.4% (95% CI 67.3-96.2%) and a specificity of 85.7% (95% CI 71.2-94.2%) in predicting falling in the next 3 months. CONCLUSION: Healthcare workers should be asking their patients with PD regularly and carefully about falling, and should consider instigating programmes of fall management for patients with PD who have fallen two or more times in the previous 12 months
Comparative study of mortality rates and cardiac dysrhythmias in post-marketing surveillance studies of sertindole and two other atypical antipsychotic drugs, risperidone and olanzapine
No full textSertindole (Serdolect), an atypical antipsychotic, was voluntarily suspended in the European Union in 1998 following regulatory concerns over reports of serious cardiac dysrhythmias and sudden unexpected deaths. The reported causes of death, their frequency, prolongation of the rate corrected QT interval (QTc) and cardiac dysrhythmias in patients prescribed sertindole were compared with those for patients treated with two other atypical antipsychotics. All patients in England, prescribed atypical antipsychotics by general practitioners during each drug's immediate post-marketing period, were identified using an observational cohort technique, prescription-event monitoring. Mortality rates in the sertindole cohort were compared with those in a comparator cohort using standardized mortality ratios and incidence rate ratios. Cardiovascular events were reviewed and followed up to identify cases of prolongation of QTc interval. There was no statistically significant difference in mortality rates between sertindole and the comparator cohort, although confidence intervals (CI) were wide due to small numbers in the sertindole cohort. A much smaller number of patients were prescribed sertindole than the other antipsychotics. Six cases of prolongation of QTc interval were identified in 462 patients (1.3%, 95% CI 0.5 - 2.8) treated with sertindole and one with unspecified electrocardiogram changes in the comparator cohort of 16 542 patients. This study contributes to the understanding of the occurrence of prolongation of QTc interval during clinical use of sertindole, the incidence of which was similar to that in clinical trials. Although no statistically significant difference was shown in mortality rates between sertindole and comparator cohort, the sertindole cohort was too small to rule out an association between the use of this drug and cardiovascular deaths
A controlled trial of the effectiveness of drug treatment & testing orders (DTTO) with standard care
No full text
Mechanical methods of reducing blood transfusion in cardiac surgery: randomised controlled trial
No full textObjective:
To assess the effectiveness of two mechanical methods of blood conservation in reducing the need for allogeneic red blood cells or coagulation products during cardiac surgery.Design: Randomised controlled trial.Setting:
Regional cardiac centre in a teaching hospital in Southampton.Participants:
263 adults aged 18-80 years undergoing elective coronary artery bypass surgery entered the study, of whom 252 completed the trial. All patients received routine perioperative care. Patients were allocated to one of three treatment groups: intraoperative cell salvage, intraoperative cell salvage with acute perioperative normovolaemic haemodilution, or no mechanical blood conservation. There were 84 patients in each group.Main outcome measures:
Numbers of patients who received allogeneic blood or coagulation products, and the mean number of units of blood transfused per patient.Results:
Of the patients in the intraoperative cell salvage group, 26 were given a transfusion of allogeneic blood, compared with 43 in the control group (odds ratio 0.43 (95% confidence interval 0.23 to 0.80)). The mean number of units of allogeneic blood transfused per patient in the intraoperative cell salvage group was 0.68 units (SD=1.55), compared with 1.07 (1.56) units in the control group. 32 of the patients in the intraoperative cell salvage group were given any blood product, compared with 47 in the control group (odds ratio 0.47 (0.25 to 0.89); P=0.019). Combining acute perioperative normovolaemic haemodilution with intraoperative cell salvage conferred no additional benefits.Conclusions:
An intraoperative cell salvage device should be used in elective coronary artery bypass grafting. Pharmacological strategies may achieve further reductions in blood transfusions. Yet further reductions in blood transfusions could be achieved if the lower safe limit of haemoglobin concentration in patients undergoing cardiac surgery were known
A community-dwelling sample of people with Parkinson's disease: characteristics of fallers and non-fallers
No full textBackground: people with Parkinson's disease often fall. Objectives: to report the frequency of falls and characteristics of fallers and non-fallers in a community-based sample of people with Parkinson's disease. Method: we administered a battery of standardized tests in the home and the laboratory. Results: we recruited 63 people with Parkinson's disease through general practices. Forty (64%, 95% confidence interval 51–74%) had fallen in the previous 12 months. Many factors associated with falling in the general population were associated with Parkinson's disease fallers (e.g. use of multiple medication and greater physical disability). Fallers were more likely to be depressed and anxious than non-fallers. Condition-specific factors associated with falling included greater disease severity (although there were exceptions) and more marked response to levodopa treatment, including more dyskinesia and on–off phenomena. Fallers took more steps to complete a test of mobility. They also had a shorter functional reach and greater postural sway whilst completing a dual task than non-fallers. Conclusion: this community-based study confirms the high risk of falling in Parkinson's disease. Our results suggest that disease-specific factors contribute to the increased risk and that there is scope for specific therapeutic interventions
An investigation into the feasibility of comparing three management options (augmentation, conservative and water) for nulliparae with dystocia in the first stage of labour
No full textObjective: to evaluate the feasibility of a randomised controlled trial (RCT) examining the effect of three options (augmentation, conservative and water) for the management of dystocia in nulliparae. The main objectives were to explore the feasibility of trial procedures in the clinical environment, consent rates and acceptability of the management options to women, local incidence of dystocia in nulliparae and the size of the subsequent study.Design: a two part study: a pilot, RCT with follow-up through to delivery with postnatal maternal surveys, and a case review of nulliparae with dystocia.Setting: a large maternity unit in the South of England in May–July 1997 inclusive.Participants: nulliparae with dystocia in the first stage of labour who had an otherwise uncomplicated obstetric background.Interventions: women in the pilot RCT received one of three management options: labouring in a waterbirth pool, conservative management or augmentation of labour, which is the standard management of women with dystocia condition in the Unit.Findings: it is feasible to conduct an RCT of management of dystocia in the Unit. Seventy per cent (95% confidence interval 47% to 87%) of women approached agreed to participate. Conservative management was the least acceptable option to women and has been dropped from the subsequent trial. The audit provided some idea of possible differences in operative delivery and epidural rates depending on augmentation or not. A sample of 220 women should be large enough to detect moderate changes and will require a 2-year recruitment period.Conclusions: a subsequent trial is feasible and is now underway. It has the potential to provide information enabling women and practitioners to have a greater choice of care options in the presence of dystocia, or provide a good basis for an even larger trial
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