Assessment of digital vascular structure and function in response to bosentan in patients with systemic sclerosis-related Raynaud's phenomenon.
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Adult↗
Biomedical subjects
A Vail
Publications and source records attributed to A Vail.
Interventions for apraxia of speech following stroke.
BACKGROUND: Apraxia of speech is a communication disorder that can affect stroke patients. Several different intervention strategies are undertaken by speech and language therapists working with this patient group. OBJECTIVES: To assess whether therapeutic interventions improve functional speech in stroke patients with apraxia of speech and which individual therapeutic interventions are effective. SEARCH STRATEGY: We searched the Cochrane Stroke Group Trials Register (searched May 2004). In addition, we searched the following databases: the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 4, 2003); MEDLINE (1966 to April 2004); EMBASE (1980 to April 2004); CINAHL (1982 to April 2004); PsycINFO (1974 to April 2004); the National Research Register (searched April 2004); and Current Controlled Trials Register (searched May 2004). We reviewed reference lists of relevant articles and contacted authors and researchers in an effort to identify published and unpublished trials. SELECTION CRITERIA: We sought to include randomised controlled trials of non-drug interventions for adults with apraxia of speech following a stroke where the primary outcome was functional speech at six months follow up. DATA COLLECTION AND ANALYSIS: One author searched the titles, abstracts and keywords. Two authors examined the abstracts that might meet the inclusion criteria. Four authors were available to assess trial quality and to extract data from eligible studies. MAIN RESULTS: No trials were identified. AUTHORS' CONCLUSIONS: There is no evidence from randomised trials to support or refute the effectiveness of therapeutic interventions for apraxia of speech. There is a need for high quality randomised trials to be undertaken in this area.
Apraxias↗
Reflective consideration of postoperative endophthalmitis as a quality marker.
PURPOSE: To study the incidence of acute postoperative presumed infectious endophthalmitis (PIE) in a UK district general hospital over a 10-year period. Consideration of such departmental healthcare-associated infection frequency rates as part of reflective and comparative quality practice in the light of local concerns. METHODS: Hospital-based retrospective case series: 12 831 cataract extraction operations from 01/01/1995 to 31/12/2004 were studied. All cases of PIE within 6 weeks of cataract surgery were ascertained and investigated in a standardised format. PIE incidence rate per 1000 cataract surgical procedures was contrasted with the existing literature. RESULTS: Seven isolated PIE cases occurred following phacoemulsification. None followed extra-capsular extractions. The PIE rate was 0.55 [95% CI; 0.22 to 1.12] cases per 1000 cataract extractions, or one PIE case within 6 weeks of surgery in every 1833 [95% CI; 893 to 4545] cataract operations undertaken. Five cases were culture positive. Details of PIE cases are presented. CONCLUSION: PIE incidence rates in our department are slightly lower than reported case series in similar settings. Whether this is due to a variety of preventive measures deployed locally and/or methods of case ascertainment in published studies is problematic and is discussed. Departmental benchmarking data is important in relation to rare, but critical, patient safety incidents. Collection and monitoring of endophthalmitis outcomes is of merit and may inform patient choice. Surgical site infection surveillance systems of relevance are discussed. Implications for making healthcare safer, including reflective practice are, discussed in relation to cataract care.
Aged↗
Differences between brain and rectal temperatures during routine critical care of patients with severe traumatic brain injury.
Theoretical models suggest that small differences only exist between brain and body temperature in health. Once the brain is injured, brain temperature is generally regarded to rise above body temperature. However, since reports of the magnitude of the temperature gradient between brain and body vary, it is still not clear whether conventional body temperature monitoring accurately predicts brain temperature at all times. In this prospective, descriptive study, 20 adults with severe primary brain trauma were studied during their stay in the neurointensive care unit. Brain temperature ranged from 33.4 to 39.9 degrees C. Comparisons between paired brain and rectal temperature measurements revealed no evidence of a systematic difference [mean difference -0.04 degrees C (range -0.13 to 0.05 degrees C, 95% CI), p = 0.39]. Contrary to popular belief, brain temperature did not exceed systemic temperature in this relatively homogeneous patient series. The mean values masked inconsistent and unpredictable individual brain-rectal temperature differences (range 1.8 to -2.9 degrees C) and reversal of the brain-body temperature gradient occurred in some patients. Brain temperature could not be predicted from body temperature at all times.
Abbreviated Injury Scale↗
Interleukin-6 and acute ischaemic stroke.
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Acute Disease↗
A randomised phase II study of interleukin-1 receptor antagonist in acute stroke patients.
OBJECTIVES: The cytokine interleukin (IL)-1 mediates ischaemic brain damage in rodents. The endogenous, highly selective, IL-1 receptor antagonist (IL-1ra) protects against ischaemic cerebral injury in a range of experimental settings, and IL-1ra causes a marked reduction of cell death when administered peripherally or at a delay in transient cerebral ischaemia. We report here the first randomised, double blind, placebo controlled trial of recombinant human IL-1ra (rhIL-1ra) in patients with acute stroke. METHODS: Patients within 6 hours of the onset of symptoms of acute stroke were randomised to rhIL-1ra or matching placebo. Test treatment was administered intravenously by a 100 mg loading dose over 60 seconds, followed by a 2 mg/kg/h infusion over 72 h. Adverse events and serious adverse events were recorded for up to 3 months, serial blood samples were collected for biological markers up to 3 months, and 5-7 day brain infarct volume was measured by computed tomography. RESULTS: No adverse events were attributed to study treatment among 34 patients randomised. Markers of biological activity, including neutrophil and total white cell counts, C reactive protein, and IL-6 concentrations, were lower in rhIL-1ra treated patients. Among patients with cortical infarcts, clinical outcomes at 3 months in the rhIL-1ra treated group were better than in placebo treated. CONCLUSIONS: These data suggest that rhIL-1ra is safe and well tolerated in acute stroke. In addition, rhIL-1ra exhibited biological activity that is relevant to the pathophysiology and clinical outcome of ischaemic stroke. Our findings identify rhIL-1ra as a potential new therapeutic agent for acute stroke.
Acute Disease↗
Common statistical errors in the design and analysis of subfertility trials.
BACKGROUND: The quality of clinical trials has received increasing attention with the growth of evidence-based medicine and systematic reviews. We aimed to identify whether errors and omissions commonly encountered when undertaking Cochrane reviews in this field are still passing peer review. METHODS: We undertook a review of trials published in 2001 by two major journals. We selected from Medline only trials in which authors compared pregnancy rates under two interventions by allocating women to different groups. RESULTS: We identified 39 trials meeting our criteria. Six trials were fatally flawed by design, either by inappropriate use of a cross-over design or by systematic allocation described by the authors as 'random'. Only six reports claimed to apply the intention-to-treat principle, and the principle was misunderstood by four of these. Only five trials reported live birth rates sufficiently to allow valid meta-analysis. Most trials (82%) included at least one 'unit of analysis' error. CONCLUSIONS: We selected simple trials from respected journals, assuming that our sample would represent trials of highest methodological quality in the field. Nevertheless, the standards of design, analysis and reporting of many subfertility trials are not sufficient to allow reliable interpretation of results, or inclusion in meta-analyses.
Clinical Trials as Topic↗
Ten year follow up of ulcerative colitis patients with and without low grade dysplasia.
BACKGROUND AND AIMS: Low grade dysplasia (LGD) is believed to predispose to colorectal cancer (CRC), and proctocolectomy has been advocated when this is identified. Between 1978 and 1990, 160 patients with longstanding extensive ulcerative colitis (UC) were recruited for annual colonoscopic surveillance and 40 developed LGD at some stage. We report the outcome of this cohort 10 years after the original study ended. METHODS: Retrospective cohort study and histopathological review of the original diagnoses of LGD. The outcome of 158/160 (98.8%) patients was established in 2000. RESULTS: Of the 128 patients still alive and with an intact colon at the end of 1990, two were not traceable, 29 had LGD, and 97 had no dysplasia (controls). After 10 years, high grade dysplasia (HGD) or CRC developed in 3/29 LGD (10%) and in 4/97 controls (4.0%). Kaplan-Meier analysis from 1991 to death or colectomy did not show a statistically significant difference between the two groups (log rank test p=0.63). Histopathological review demonstrated the unreliability of LGD diagnosis. Agreement between pathologists was uniformly poor: kappa <0.4 for all comparisons. CONCLUSION: LGD diagnosis is not sufficiently reliable to justify prophylactic colectomy. Conservative management of established LGD cases should not be ruled out.
Adult↗
How practical are recommendations for dietary control in phenylketonuria?
In patients with phenylketonuria, blood phenylalanine concentration during childhood is the major determinant of cognitive outcome. Guidelines provide age-related recommendations for treatment. To ascertain the extent to which these aims are achievable, we audited results from four centres for the years 1994-2000. The median proportion of samples with phenylalanine concentrations above those recommended was less than 30% for those younger than age 10 years but almost 80% for those aged 15 years and older. Similarly, the median frequency of blood sampling, expressed as a proportion of that recommended, was more than 80% for patients younger than 10 years but less than 50% by age 15 years. Our results indicate the difficulty of maintaining control in phenylketonuria, especially in older rather than younger children.
Adolescent↗
Prospective, placebo-controlled trial of 5 vs 10 days of oral prednisolone in acute adult asthma.
BACKGROUND: The optimal duration of oral steroid treatment in the management of acute adult asthma is unclear. We prospectively studied the effect of 5 vs. 10 days of oral prednisolone in patients with acute asthma requiring hospital admission. METHODS: Each patient received 40 mg of enteric-coated prednisolone daily for 5 days, followed by 5 days of 40 mg prednisolone daily (n=24) or placebo (n=20). All were given their usual inhaled asthma therapy including inhaled corticosteroids. Patients kept PEF and symptom diaries for 21 days. RESULTS: For the 5-day treatment group mean (95% CI) early morning PEF was 6 (-47,+36) l/min lower to day 21 (P=0.78). There was no evidence of differences in other PEF measures (morning post-bronchodilator, evening or worst of day). One patient in each group had an exacerbation requiring further oral steroids during the 21-day observation period. Asthma symptom scores were worse in the 5-day group on days 6-21 but the significance of this finding was uncertain, as a difference had emerged by day 5 (prior to trial entry). CONCLUSIONS: It may be possible to reduce the standard steroid course to 5 days in acute adult asthma, provided all patients receive inhaled steroids and a personal asthma management plan.
Acute Disease↗
Clinical medication review by a pharmacist of patients on repeat prescriptions in general practice: a randomised controlled trial.
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Aged↗
Prospective application of Bayesian monitoring and analysis in an "open" randomized clinical trial.
We describe the prospective application of Bayesian monitoring and analysis in an ongoing large multi-centre, randomized trial in which interim results are released to investigators. Substantial variability in prior opinion led us to reject the use of elicited clinical priors for monitoring, in favour of archetypal prior distributions representing reasonable scepticism and enthusiasm. Likelihoods for odds ratios for different covariate values are derived from a logistic regression model, which allows us to incorporate information from prognostic factors without resorting to specialized software. Priors, likelihoods and posterior distributions are regularly reported to both an independent Data Monitoring Committee and the trial investigators.
Bayes Theorem↗
Randomised controlled trial of clinical medication review by a pharmacist of elderly patients receiving repeat prescriptions in general practice.
OBJECTIVE: To determine whether a pharmacist can effectively review repeat prescriptions through consultations with elderly patients in general practice. DESIGN: Randomised controlled trial of clinical medication review by a pharmacist against normal general practice review. SETTING: Four general practices. PARTICIPANTS: 1188 patients aged 65 or over who were receiving at least one repeat prescription and living in the community. INTERVENTION: Patients were invited to a consultation at which the pharmacist reviewed their medical conditions and current treatment. MAIN OUTCOME MEASURES: Number of changes to repeat prescriptions over one year, drug costs, and use of healthcare services. RESULTS: 590 (97%) patients in the intervention group were reviewed compared with 233 (44%) in the control group. Patients seen by the pharmacist were more likely to have changes made to their repeat prescriptions (mean number of changes per patient 2.2 v 1.9; difference=0.31, 95% confidence interval 0.06 to 0.57; P=0.02). Monthly drug costs rose in both groups over the year, but the rise was less in the intervention group (mean difference 4.72 pound sterling per 28 days, - 7.04 pound sterling to - 2.41 pound sterling); equivalent to 61 pound sterling per patient a year. Intervention patients had a smaller rise in the number of drugs prescribed (0.2 v 0.4; mean difference -0.2, -0.4 to -0.1). There was no evidence that review of treatment by the pharmacist affected practice consultation rates, outpatient consultations, hospital admissions, or death rate. CONCLUSIONS: A clinical pharmacist can conduct effective consultations with elderly patients in general practice to review their drugs. Such review results in significant changes in patients' drugs and saves more than the cost of the intervention without affecting the workload of general practitioners.
Aged↗
The design features and practicalities of conducting a pragmatic cluster randomized trial of obesity management in primary care.
The aim of this paper is to describe the design features and practicalities of conducting a cluster randomized trial of obesity management in primary care. The aim of the trial is to assess the effectiveness of an obesity management educational intervention delivered to staff within primary care practices (unit of randomization) in terms of change in body weight of their patients (unit of analysis) at one year. The design features which merit particular attention in this cluster randomized trial include standardization of intervention, sample size considerations, recruitment of patients prior to randomization of practices, method of randomization to balance control and intervention practices with respect to practice and patient level characteristics, and blinding of outcome assessment. The practical problems (and our solutions) associated with implementing these design features, particularly those that result in a time delay between baseline data collection, randomization and intervention, are discussed.
Adolescent↗
"No thank you": why elderly patients declined to participate in a research study.
OBJECTIVES: To compare the population consenting for a study of the effectiveness of a pharmacist-run medication review clinic with the population not consenting for patients aged over 65 years old with respect to age, sex and number of repeat medicines. To explore the reasons why some patients declined to consent to the study. METHODS: Letters were sent to 2,403 patients aged 65 and over and taking at least one repeat medicine from 4 general practices. If no reply was received to a second letter they were followed up by telephone. If they declined to consent they were asked for their reasons. Data for consenting and non-consenting patients was collected on the stratification factors: age, sex and number of repeat medicines. Multiple logistic regression was used to assess the association of each factor with consent rates. RESULTS: Consenting patients were dissimilar to non-consenting patients. Patients were less likely to consent if they were older, OR (95% CI) = 0.54 (0.46, 0.64), or female, OR (95% CI) = 0.74 (0.63, 0.88). Patients were more likely to consent if on 5 or more repeat medicines: OR (95% CI) = 1.3 (1.1, 1.5). Ten broad categories of reasons why patients did not wish to participate were identified from the patient interviews. CONCLUSIONS: Patients were less likely to give their consent if they were elderly, female and on fewer repeat medicines. A number of administrative and behavioural factors were identified which reduced the chances of informed consent being given. These factors need to be addressed to maximise numbers of consenting patients in medication review studies.
Aged↗
Mortality at 12 and 24 months after stroke may be associated with depressive symptoms at 1 month.
BACKGROUND AND PURPOSE: Previous studies have reported mood symptoms after stroke to be a risk factor for later mortality. The purpose of the study was to examine whether mood symptoms at 1 month after stroke may be a risk factor for mortality at 12 and 24 months. METHODS: As a cohort within a randomized controlled trial, 448 hospital patients were seen at 1 month after stroke and were randomized into a trial of psychological therapy. Follow-up was at 12 and 24 months. Mood symptoms were assessed by the Present State Examination and the General Health Questionnaire (GHQ)-28. Measures of disability before and after stroke and of cognitive impairment after stroke were also taken at 1 month. Mortality was determined at 12 and 24 months after stroke. RESULTS: In logistic regression analyses, mortality at 12 months was associated unifactorally with scoring on the GHQ-D subscale (odds ratio [OR] 2.4, 95% CI 1.3 to 4.5) and scoring in the highest quartile of the GHQ (OR 3.1, 95% CI 1.1 to 8.8). In multiple logistic regression analyses, only GHQ-D remained a significant predictor after controlling for other known predictors. At 24 months, scoring on GHQ-D (OR 2.4, 95% CI 1.4 to 4.1) and in the highest GHQ quartile (OR 2.2, 95% CI 1.0 to 4.8) was significantly associated with mortality in unifactoral analyses. Scoring on the GHQ-D remained a predictor of mortality after controlling for other variables. Psychiatric disorder, such as major depression (according to International Classification of Diseases, 10th Revision), was not statistically significantly associated with increased mortality at 12 or 24 months. CONCLUSIONS: Mood symptoms on a self-reported rating scale were associated with 12- and 24-month mortality after stroke, after adjustment for factors associated with stroke severity. The result is in keeping with other evidence that depressive symptoms are a risk factor for death from vascular disease.
Aged↗
Difficulties with anonymous shortlisting of medical school applications and its effects on candidates with non-European names: prospective cohort study.
OBJECTIVE: To assess the feasibility of anonymous shortlisting of applications for medical school and its effect on those with non-European names. DESIGN: Prospective cohort study. SETTING: Leeds school of medicine, United Kingdom. SUBJECTS: 2047 applications for 1998 entry from the United Kingdom and the European Union. INTERVENTION: Deletion of all references to name and nationality from the application form. MAIN OUTCOME MEASURES: Scoring by two admissions tutors at shortlisting. RESULTS: Deleting names was cumbersome as some were repeated up to 15 times. Anonymising application forms was ineffective as one admissions tutor was able to identify nearly 50% of candidates classed as being from an ethnic minority group. Although scores were lower for applicants with non-European names, anonymity did not improve scores. Applicants with non-European names who were identified as such by tutors were significantly less likely to drop marks in one particular non-academic area (the career insight component) than their European counterparts. CONCLUSIONS: There was no evidence of benefit to candidates with non-European names of attempting to blind assessment. Anonymising application forms cannot be recommended.
Cohort Studies↗
Androgens versus placebo or no treatment for idiopathic oligo/asthenospermia.
BACKGROUND: Oligo-astheno-teratospermia (sperm of low concentration, reduced motility and increased abnormal morphology) of unknown cause is common and the need for treatment is felt by patients and doctors alike. As a result, a variety of empirical, non-specific treatments have been used in an attempt to improve semen characteristics and fertility. Androgens have been suggested as a treatment because its binding proteins maintain a maintain a high intratesticular level testosterone essential for spermatogenesis and because the epididymis and seminal vesicles affect the seminal constitution and sperm motility and are also androgen-dependent. However exogenous testosterone was found to exert negative feedback on the pituitary-gonadal axis and thereby to suppress FSH and LH secretion. Spermatogenesis was thus adversely affected. Nevertheless androgens are used for the treatment of male infertility either for a putative direct "stimulatory" or "rebound" therapy. The stimulatory androgens used are mesterolone and testosterone undecanoate which, it is postulated, in a form and dosage that does not influence pituitary gonadotrophin secretion, either have a direct stimulatory effect on spermatogenesis or influence sperm transport and maturation though an effect on the epididymis, ductus deferens and seminal vesicles. Other androgens have been used to produce a rebound effect. These androgens are administered to suppress gonadotrophin secretion and spermatogenesis. After androgen therapy is discontinued there is a surge of FSH and LH and spermatogenesis is recommenced. Because of their different proposed mechanisms of action, stimulatory and rebound androgen therapy are analysed separately in the comparisons. This review considers the available evidence of the effect of androgens for idiopathic oligo and/or asthenospermia. OBJECTIVES: The objective of this review was to assess the effect of androgen treatment of men among couples where failure to conceive has been attributed to idiopathic oligo- and/or asthenospermia. SEARCH STRATEGY: The Cochrane Subfertility Review Group specialised register of controlled trials was searched". SELECTION CRITERIA: Randomised trials of mesterolone or testosterone undecanoate versus placebo or no treatment (stimulatory therapy), or testosterone enanthate or testosterone undecanoate versus placebo or no treatment (rebound therapy) in couples where subfertility is attributed to male factor. DATA COLLECTION AND ANALYSIS: Eligibility and trial quality were assessed. MAIN RESULTS: Eleven trials involving 930 patients were included. For stimulatory therapy, androgens had little effect on endocrinal outcomes and sperm parameters. The rate of pregnancy after androgens with stimulatory effect compared to no treatment or placebo was also similar (odds ratio 1.10, 95% confidence interval 0.75 to 1.61). In rebound therapy, no difference was found in sperm parameters. The pregnancy rate after androgens with rebound effect also showed no difference compared to no treatment or placebo (odds ratio 1.60, 95% confidence interval 0.42 to 6.16). Adverse effects such as headaches and exanthema were reported. REVIEWER'S CONCLUSIONS: There is not enough evidence to evaluate the use of androgens for male subfertility. [This abstract has been prepared centrally.]
Androgens↗