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Results for “Randomised controlled trials as topic”

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At least 937 records · Page 52Linked to original sources
PubMed1997

Comparing two methods of follow up in a multicentre randomised trial.

AIMS: To evaluate a parental questionnaire as a means of providing outcome measures for a multicentre randomised controlled trial of treatment for post-haemorrhagic ventricular dilatation. METHODS: The parents of 88 survivors were sent a questionnaire before a paediatric assessment at the age of 30 months. The parents' responses to individual questions taken mainly from the Griffiths' mental development scales and their perception of the child's ability to see and hear were compared with the paediatric findings. A model, based on the parents' responses to particular questions, allowed the categorisation of the children as normal, impaired, moderately or severely disabled; this was compared with similar categorisation based on the full paediatric assessment. RESULTS: Agreement on items concerning gross motor function ranged between 81 and 99%, concerning dressing between 77 and 80%, concerning feeding between 91 and 99%, and concerning language between 85 and 93%. Similar proportions of children were identified as disabled by the parents (60%) and by the paediatrician (66%). Of 29 children who had developmental quotients less than 70, parents identified 28 as disabled, 18 of them as severely disabled. They were not so good at identifying children with impairments without functional loss. CONCLUSIONS: Further work is required but there is sufficient encouragement from the results to pursue this methodology further for use in comparing groups in randomised trials.

Cerebrospinal Fluid Shunts↗
PubMed2001

Results of an intervention study to improve communication about randomised clinical trials of cancer therapy.

We report results from an intervention study to improve communication during consultations about randomised clinical trials of cancer therapy. Patients, eligible for a trial, completed questionnaires about information preferences and attitudes to trials prior to seeing their doctors, who were either shown these questionnaires (intervention) or not (control). Fifteen doctors participated and invited 265 patients to join one of 40 different randomised clinical trials. Most patients (77.4%) agreed to trial entry and this was predicted by the Patient's Attitudes to Trials questionnaire with an 80.4% accuracy. Accrual, length of consultation, doctor and patient satisfaction were not associated with the intervention. Further research to explore the potential use of written interventions to facilitate communication and accrual to randomised clinical trials is recommended.

Adult↗
PubMed1998

Screening for prostate cancer: the current position.

Prostate cancer is a significant and increasing health problem in the UK and elsewhere, and there is considerable interest in the potential for screening. Of the currently available screening tests, measurement of serum levels of prostate specific antigen appears the most promising. However, despite evidence that screening can detect asymptomatic early stage disease, there is, as yet, no evidence that mortality from prostate cancer can be reduced. There are concerns that screening may result in considerable over-diagnosis of non-progressive or slowly developing disease, and the effectiveness of radical treatment of localised disease, which itself will cause some morbidity, remains a subject of debate. Population screening should not currently be recommended. Randomised controlled trials are in progress to assess the effectiveness of screening, but these will take many years to produce results.

Biomarkers, Tumor↗
PubMed2000

Do presenters to paediatric meetings get their work published?

BACKGROUND: Research presented to a scientific meeting is inaccessible to clinicians, unless it is also published in a cited journal. AIMS: To assess the publication rate of studies presented to two UK national paediatric meetings: the Paediatric Research Society (PRS) and the British Paediatric Association (BPA). METHODS: A Medline search in December 1999 for the first authors of all plenary abstracts presented in 1996. If not found, authors contacted by postal questionnaire. RESULTS: Information was obtained on 88/89 presentations. Twenty five of 48 PRS and 31 of 40 BPA studies were published in Medline listed journals. The major reason for non-publication was that they had not been submitted (PRS 15/48, BPA 6/40). Some authors were still hoping to do so (PRS 7, BPA 2). Other reasons were: publication in other forms (theses, book chapters, non-Medline journals) (PRS 5, BPA 2), or still being reviewed (PRS 3, BPA 1). Ten of 11 randomised, controlled trials were published, but only 20 of 37 observational studies were submitted and published. CONCLUSION: Presenters to paediatric meetings need help in submitting and publishing their work.

Child↗
PubMed2001

Autologous serum eyedrops for dry eyes and epithelial defects: clinical and in vitro toxicity studies.

BACKGROUND/AIMS: Autologous serum drops have been reported to be beneficial in keratoconjunctivitis sicca (KCS) and persistent epithelial defects (PED). A clinical pilot study was carried out to examine these potential uses and in vitro toxicity testing on corneal epithelial cell cultures was performed to compare the effect of serum drops with unpreserved hypromellose (hydroxypropylmethylcellulose 0.3%). METHODS: Patients with KCS and PED, unresponsive to conventional treatment were recruited. Patients were examined before treatment, at 1 and 2 weeks after initiation, and then 2 weekly until treatment ceased. Symptoms were assessed at each visit. Clinical examination included Schirmer's test without anaesthesia, rose bengal staining, and fluorescein staining. Epithelial defects were measured with the slit beam. In the laboratory, cultured human corneal epithelial cells were exposed to serum drops and hypromellose, and their viability evaluated with fluorescent viability staining (Calcein AM ethidium homodimer) and an ATP assay. RESULTS: Autologous serum was used in 15 eyes of 13 patients with PED and 11 eyes of nine patients with KCS. In two patients serum drops were started after penetrating keratoplasty (PK). The PKs were performed for perforations secondary to PEDs. Of the 15 eyes with PED, nine healed at a mean of 29 days and six failed. The mean duration of PED before the use of serum drops was 48.2 days. Of the 11 eyes with KCS, six had improved subjective scores and fluorescein scores, and five had improved rose bengal scores after the use of serum drops. For the two patients who used serum eyedrops post-PK, there was a stable and intact epithelium at 1 week. Cessation of serum drops during the postoperative period led to deterioration in the subjective and objective scores in both patients. One developed a PED that responded to reinstitution of serum drops. The morphology and ATP levels of cultured epithelial cells exposed to serum were better maintained than those exposed to hypromellose. CONCLUSION: Autologous serum drops are useful for PED and KCS. This effect may be related to a number of active factors in serum including growth factors, fibronectin, vitamin A, and anti-proteases. In vitro toxicity testing demonstrated that serum drops have reduced toxicity compared with unpreserved hypromellose. Currently regulatory restrictions in the UK have prevented the establishment of a prospective randomised controlled trial examining the efficacy of autologous serum drops for the management of this group of ocular surface disorders.

Administration, Topical↗
PubMed2001

Sedation for children requiring wound repair: a randomised controlled double blind comparison of oral midazolam and oral ketamine.

OBJECTIVE: To compare the efficacy of oral ketamine (10 mg/kg) with oral midazolam (0.7 mg/kg) in providing sedation for suturing of lacerations. METHOD: Prospective, randomised, double blinded trial with consecutive, concealed recruitment of 59 children aged 1 to 7 with wounds requiring local anaesthetic (LA) injection or topical LA with an anxiety score greater than one. RESULTS: Tolerance to LA injection was better with ketamine (p=0.029) and tolerance to procedure after LA injection showed a trend towards being improved with ketamine (p=0.067). There was no difference in tolerance to LA application or procedure in children receiving topical LA. Time to reach a sedation score of less than four was faster with ketamine (medians 20 versus 43 minutes, p=0.001) but times from dosing to discharge (medians 105 and 110 minutes) were similar. Inconsolable agitation was reported with midazolam in six cases. Dysphoria was not noted with ketamine. Vomiting was more common with ketamine but not significantly so (six versus two, p = 0.14). Oxygen desaturations were noted in both groups. Ataxia after discharge was seen in four patients, two in each group. Thirty six per cent of children showed new behavioural disturbances in the two weeks after discharge, more commonly in the midazolam group (p=0.048). CONCLUSIONS: At these doses tolerance to LA injection was better in children receiving ketamine, with fewer behavioural changes noted in the first two weeks. Midazolam at this dose caused dysphoric reactions, which may have affected the results. Continuous pulse oximetry monitoring is required when using these drugs. Vomiting and prolonged ataxia occurred in a few patients.

Administration, Oral↗
PubMed2005

Oxytocin receptor antagonists for inhibiting preterm labour.

BACKGROUND: Preterm birth, defined as birth before 37 completed weeks, is the single most important cause of perinatal mortality and morbidity in high-income countries. Oxytocin receptor antagonists have been proposed as effective tocolytic agents for women in preterm labour to postpone the birth, with fewer side-effects than other tocolytic agents. OBJECTIVES: To assess the effects on maternal, fetal and neonatal outcomes of tocolysis with oxytocin receptor antagonists for women with preterm labour compared with placebo or no intervention and compared with any other tocolytic agent. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (September 2004), CENTRAL (The Cochrane Library, Issue 3, 2004), MEDLINE (1965 to June 2004), EMBASE (1988 to June 2004). SELECTION CRITERIA: Randomised trials of oxytocin receptor antagonists for tocolysis in the management of women in labour between 20 and 36 weeks' gestation. DATA COLLECTION AND ANALYSIS: Two authors independently evaluated methodological quality and extracted trial data. We sought additional information from trial authors. MAIN RESULTS: Six trials (1695 women) were included. Compared with placebo, atosiban did not reduce incidence of preterm birth or improve neonatal outcome. In one trial (583 infants), atosiban was associated with an increase in infant deaths at 12 months of age compared with placebo (relative risk (RR) 6.15; 95% confidence intervals (CI) 1.39 to 27.22). However, this trial randomised significantly more women to atosiban before 26 weeks' gestation. Use of atosiban resulted in lower infant birthweight (weighted mean difference -138.31 gm; 95% CI -248.76 to -27.86) and more maternal adverse drug reactions (RR 4.02; 95% CI 2.05 to 7.85, 2 trials, 613 women).Compared with betamimetics, atosiban increased the numbers of infants born under 1500 gm (RR 1.96; 95% CI 1.15 to 3.35, 2 trials, 575 infants). Atosiban was associated with fewer maternal drug reactions requiring treatment cessation (RR 0.04; 95% CI 0.02 to 0.11, number needed to treat 6; 95% CI 5 to 7, 4 trials, 1035 women). AUTHORS' CONCLUSIONS: This review failed to demonstrate the superiority of atosiban over betamimetics or placebo in terms of tocolytic efficacy or infant outcomes. The finding of an increase in infant deaths in one placebo controlled trial warrants caution. A recent Cochrane review suggests that calcium channel blockers (mainly nifedipine) are associated with better neonatal outcome and fewer maternal side-effects than betamimetics. However, a randomised comparison of nifedipine with placebo is not available. Further well-designed randomised controlled trials of tocolytic therapy are needed. Such trials should incorporate a placebo arm.

Albuterol↗
PubMed2006

Epidemiological studies on adverse effects of prenatal ultrasound--which are the challenges?

A large number of foetuses are scanned on a routine basis and although it is generally assumed that prenatal ultrasound is safe; very few studies have in fact focused on possible adverse effects in humans. The epidemiological tools when studying possible adverse effects of prenatal ultrasound are randomised controlled trials and observational studies such as cohort and case-control studies. There are advantages and disadvantages with all study designs. In this review, some of the challenges that have to be met are discussed based on experiences from a randomised controlled trial, cohort studies and an ongoing case-control study.

Epidemiologic Methods↗
PubMed2002

Association between competing interests and authors' conclusions: epidemiological study of randomised clinical trials published in the BMJ.

OBJECTIVE: To assess the association between competing interests and authors' conclusions in randomised clinical trials. DESIGN: Epidemiological study of randomised clinical trials published in the BMJ from January 1997 to June 2001. Financial competing interests were defined as funding by for profit organisations and other competing interests as personal, academic, or political. STUDIES: 159 trials from 12 medical specialties. MAIN OUTCOME MEASURES: Authors' conclusions defined as interpretation of extent to which overall results favoured experimental intervention. Conclusions appraised on 6 point scale; higher scores favour experimental intervention. RESULTS: Authors' conclusions were significantly more positive towards the experimental intervention in trials funded by for profit organisations alone compared with trials without competing interests (mean difference 0.48 (SE 0.13), P=0.014), trials funded by both for profit and non-profit organisations (0.30 (SE 0.10), P=0.003), and trials with other competing interests (0.45 (SE 0.13), P=0.006). Other competing interests and funding from both for profit and non-profit organisations were not significantly associated with authors' conclusions. The association between financial competing interests and authors' conclusions was not explained by methodological quality, statistical power, type of experimental intervention (pharmacological or non-pharmacological), type of control intervention (for example, placebo or active drug), or medical specialty. CONCLUSIONS: Authors' conclusions in randomised clinical trials significantly favoured experimental interventions if financial competing interests were declared. Other competing interests were not significantly associated with authors' conclusions.

Analysis of Variance↗