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Results for “Randomised Controlled Trial”

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PubMed2002

A randomised controlled trial of clinics in secondary schools for adolescents with asthma.

AIM: To compare a nurse-led clinic in schools versus care in general practice for adolescents with asthma. DESIGN OF STUDY: Randomised controlled trial in four schools; parallel observational study in two schools. SETTING: Six comprehensive schools. METHOD: In the randomised trial, pupils were invited to attend asthma review at a nurse-led clinic either in school, or in general practice. The parallel observational study compared pupils invited to practice care within and outside the randomised trial. Primary outcome measures were attendance for asthma review, symptom control, and quality of life. Secondary outcomes were knowledge, attitudes, inhaler technique, use of steroids, school absence, peak flow rate, preference for future care, health service utilisation, and costs. RESULTS: School clinic pupils were more likely to attend an asthma review than those randomised to practice care (90.8% versus 51.0% overall [P < 0.001, not consistent across schools]). No differences were observed in symptom control (P = 0.42) or quality of life (P = 0.63). Pupils attending school clinics had greater knowledge of asthma (difference = +0.38, 95% CI = 0.19 to 0.56), more positive attitudes (difference = +0.21, 95% CI = 0.05 to 0.36), and better inhaler technique (P < 0.001, not consistent across all schools). No differences were observed in school absence or peak flow rate. A majority (63%) of those who had received care at school preferred this model in future. Median costs of providing care at school and at the practice were 32.10 Pounds and 19.80 Pounds, respectively. No differences were observed between the groups in the observational comparison on any outcome. CONCLUSIONS: The schools asthma clinic increased uptake of asthma reviews. There were improvements in various process measures, but not in clinical outcomes.

Absenteeism↗

PubMed2003

A systematic review of randomised controlled trials evaluating the effect of mother/baby skin-to-skin care on successful breast feeding.

OBJECTIVE: to examine the effects of early skin-to-skin contact between mother and baby on the initiation and duration of breast feeding. REVIEW METHODS SEARCH STRATEGY: electronic databases--the Cochrane Library, MEDLINE,CINAHL and EMBASE. References of studies were examined to identify additional trials and contact was made with researchers in the field. Study selection criteria: randomised or quasi-randomised controlled trials in any language in which skin-to-skin contact between mothers and their healthy full-term newborn babies was compared to routine contact. Primary outcomes were success of first breast feed and duration of breast feeding. Secondary outcomes included, baby temperature and behaviour. STUDY-QUALITY ASSESSMENT: validity of included studies was assessed using criteria defined by the Cochrane Collaboration. Application of inclusion criteria, validity assessment and data extraction were carried out independently by two reviewers with a third reviewer to resolve differences. FINDINGS: seven randomised controlled trials were identified. Five studies assessed duration of breast feeding with mixed results. None of the studies assessed the success of the first breast-feeding experience. Study quality was variable with methods of randomisation and blinding of assessment unclear in four of the five studies providing relevant results. CONCLUSIONS: the findings of this systematic review fail to support the current initiatives to implement changes in clinical practice to include skin-to-skin contact. Methodological flaws within the included studies prohibit firm conclusions being reached with regard to the effect of skin-to-skin contact on the duration of breast feeding, timing of first breast feed or baby physiological factors. The review highlights the need for further primary research to assess the effect of skin-to-skin contact on the breast-feeding experience.

Breast Feeding↗

PubMed1994

Obtaining data from randomised controlled trials: how much do we need for reliable and informative meta-analyses?

Many randomised controlled trials compare treatments that will produce only moderate differences in outcome, but these differences can be clinically important. However, they are difficult to assess reliably and require a large amount of randomised evidence. This can be achieved through large prospective randomised trials which will accrue future patients, the meta-analysis of results from randomised trials involving patients from the past, or--ideally--both. The techniques require that all possible biases are minimised, and in meta-analyses this can best be achieved by ensuring that all of the randomised evidence--both trials and participants in those trials--is included. The meta-analysis of individual patient data has been described as the gold standard for this approach. It will remove many of the problems associated with relying solely on published data and some of the problems arising from a reliance on aggregate data, and will also add to the analyses that can be performed. Such projects, however, require considerable time and effort.

Bias↗

PubMed2005

A randomised controlled trial of biopsy forceps and cannula aspiration for transcervical chorionic villus sampling.

OBJECTIVE: This trial compared two instruments for transcervical chorionic villus sampling (CVS). DESIGN: Randomised controlled trial. SETTING: Regional university prenatal diagnosis and treatment centre. POPULATION: Two hundred women were randomised at 10(+0)-12(+6) weeks of gestation to transcervical CVS using cannula aspiration (CA) or biopsy forceps (BF). METHODS: Women undergoing indicated CVS signed informed consent. Randomisation after decision to perform transcervical CVS. MAIN OUTCOME MEASURES PRIMARY OUTCOME: the rise in maternal serum alpha-fetoprotein (alpha-FP). SECONDARY OUTCOMES: (i) placental trauma (fetomaternal haemorrhage [FMH]); (ii) laboratory, procedure, and cytogenetic results and pregnancy outcomes; (iii) patient and operator satisfaction; and (iv) economic analyses. Analyses were performed by intention to treat. RESULTS: The -FP rise did not differ between groups; there was no other evidence of placental trauma. BF were better tolerated by women, provided culturable tissue, after fewer instrument passes, with greater ease and in less time. BF were associated with cost savings. CONCLUSIONS: Unlike -FP, other markers of FMH were unaltered, questioning the reliability of alpha-FP as an indicator of FMH. Compared with CA, transcervical BF caused comparable placental trauma, appeared to be similarly effective and safe and were preferred by operators and patients.

Biopsy, Needle↗

PubMed2005

Integrated versus non-integrated management and care for clients with co-occurring mental health and substance use disorders: a qualitative systematic review of randomised controlled trials.

The purpose of this paper is to conduct a qualitative review of randomised controlled trials in relation to the treatment of adults with co-occurring mental health and substance use disorder (MH/SUD). In particular, integrated approaches are compared with non-integrated approaches to treatment. Ten articles were identified for inclusion in the review. The findings are equivocal with regard to the superior efficacy of integrated approaches to treatment, although the many limitations of the studies need to be considered in our understanding of this finding. Clearly, this is an extremely challenging client group to engage and maintain in intervention research, and the complexity and variability of the problems render control particularly difficult. The lack of available evidence to support the superiority of integration is discussed in relation to these challenges. Much remains to be investigated with regard to integrated management and care for people with co-occurring and MH/SUD, particularly for specific combinations of dual diagnosis and giving consideration to the level of inter-relatedness between the disorders.

Adult↗

PubMed1999

The impact of patient treatment preferences on the interpretation of randomised controlled trials.

Reliable information about aggregate main treatment effects in cancer research comes from randomised controlled trials (RCTs). The possibility of important interactions, such as between treatment preferences and their effects, is necessarily subordinated in the quest for evidence about main treatment effects. If patient preferences can influence the effectiveness of treatments, for which there is some indirect evidence, then those estimates of the treatment's main organic effects from unblind RCTs might be wrong. RCTs clearly disallow patient choice and it is, therefore, important to know the extent of any preference effects in order to interpret the RCT evidence. It may be important to know whether they exist, and where and by how much they affect outcome. It is argued that measuring these effects reliably is methodologically difficult, and will require massive trials each directed at measuring one particular preference effect. Such effects have a slightly fanciful image, particularly in cancer treatment, and may be transient. Given the current uncertainties about their true nature and plausible biological mechanisms, the accumulated evidence is unlikely to provide sufficient justification for investing in such trials, given other current priorities.

Humans↗

PubMed2006

Financial considerations in the conduct of multi-centre randomised controlled trials: evidence from a qualitative study.

BACKGROUND: Securing and managing finances for multicentre randomised controlled trials is a highly complex activity which is rarely considered in the research literature. This paper describes the process of financial negotiation and the impact of financial considerations in four UK multicentre trials. These trials had met, or were on schedule to meet, recruitment targets agreed with their public-sector funders. The trials were considered within a larger study examining factors which might be associated with trial recruitment (STEPS). METHODS: In-depth semi-structured telephone interviews were conducted in 2003-04 with 45 individuals with various responsibilities to one of the four trials. Interviewees were recruited through purposive and then snowball sampling. Interview transcripts were analysed with the assistance of the qualitative package Atlas-ti. RESULTS: The data suggest that the UK system of dividing funds into research, treatment and NHS support costs brought the trial teams into complicated negotiations with multiple funders. The divisions were somewhat malleable and the funding system was used differently in each trial. The fact that all funders had the potential to influence and shape the trials considered here was an important issue as the perspectives of applicants and funders could diverge. The extent and range of industry involvement in non-industry-led trials was striking. Three broad periods of financial work (foundation, maintenance, and resourcing completion) were identified. From development to completion of a trial, the trialists had to be resourceful and flexible, adapting to changing internal and external circumstances. In each period, trialists and collaborators could face changing costs and challenges. Each trial extended the recruitment period; three required funding extensions from MRC or HTA. CONCLUSION: This study highlights complex financial aspects of planning and conducting trials, especially where multiple funders are involved. Recognition of the importance of financial stability and of the need for appropriate training in this area should be paralleled by further similar research with a broader range of trials, aimed at understanding and facilitating the conduct of clinical research.

Journal Article↗

PubMed2005

Barriers to Australian physicians' and paediatricians' involvement in randomised controlled trials.

OBJECTIVE: To compare attitudes of Australian physicians and paediatricians about treatment and randomised controlled trial (RCT) participation. DESIGN AND PARTICIPANTS: A cross-sectional survey using the validated "Physician Orientation Profile" (POP), with 250 physicians and 250 paediatricians surveyed. OUTCOME MEASURES: Five indices - primary allegiance, decision making under uncertainty, professional activities, perceived rewards, and peer-group influence - with scores for each participant ranging along a continuum from clinician-oriented to research-oriented and expressed as a number between 0 and 1. RESULTS: Overall response rate was 60%, with 135 physicians (54%) and 165 paediatricians (66%) responding. Paediatricians and physicians were similar in their attitudes to RCT participation, being generally clinician-oriented rather than research-oriented and less inclined to participate in RCTs when there is uncertainty about the best treatment. Most assign limited time to research, with 26.9% not currently involved in research and 31.5% having no experience of RCT participation. Doctors perceive few rewards and little peer-group influence regarding trial participation. Independent predictors of favourable attitudes to trial participation (based on POP scores) were the presence of allocated research time (0.37 for no allocated research time v 0.61 for > 70% research time; P < 0.0001), previous experience enrolling a patient in an RCT (0.40 for no experience v 0.46 for experience; P < 0.0001), and articles published in the past 12 months (0.40 for no publications v 0.55 for > 3 publications; P < 0.0001). CONCLUSIONS: This study highlights the minor importance of research for most Australian physicians. Research plays only a small role in their professional activities, and the importance of research participation is not recognised. They are clinician-oriented in their attitudes to RCT participation. To encourage greater involvement in trials among physicians in Australia, clinical research needs to be restructured in a primarily clinically oriented setting with dedicated research time.

Adult↗

PubMed2005

Vitamin C supplementation in very preterm infants: a randomised controlled trial.

OBJECTIVE: To determine whether regulating vitamin C (ascorbic acid: AA) intake to achieve higher or lower plasma concentrations was associated with improved clinical outcome. DESIGN: A double blind, randomised controlled trial. SETTING: Neonatal intensive care unit at Christchurch Women's Hospital. PATIENTS: Infants with birth weight <1500 g or gestation <32 weeks, admitted to the unit within 48 hours of birth. INTERVENTION: Infants were randomised to one of three protocols with regard to AA supplementation for the first 28 days of life: group LL received low supplementation throughout; group LH received low until day 10 and then high: group HH received high throughout. MAIN OUTCOME MEASURES: Primary outcome measures were oxygen requirement at 28 days and 36 weeks postmenstrual age, total days supplemental oxygen, and retinopathy of prematurity. AA concentrations were measured at study entry (day 2), and days 10, 21, and 28. RESULTS: A total of 119 infants were enrolled over 24 months (mean gestation 28.4 weeks; birth weight 1161 g). Six infants died, and these had significantly higher AA concentrations before randomisation than surviving infants (116 micromol/l (95% confidence interval 90 to 142) v 51 micromol/l (45 to 58), p<0.0001). There were no significant differences in primary outcomes between the groups. However, the proportion of surviving infants with an oxygen requirement at 36 weeks postmenstrual age in group HH (19%) was half that in group LL (41%) (p=0.06). CONCLUSIONS: In a randomised controlled trial, no significant benefits or harmful effects were associated with treatment allocation to higher or lower AA supplementation throughout the first 28 days of life.

Ascorbic Acid↗

PubMed2004

Effect of joint crisis plans on use of compulsory treatment in psychiatry: single blind randomised controlled trial.

OBJECTIVE: To investigate whether a form of advance agreement for people with severe mental illness can reduce the use of inpatient services and compulsory admission or treatment. DESIGN: Single blind randomised controlled trial, with randomisation of individual patients. The investigator was blind to allocation. SETTING: Eight community mental health teams in southern England. PARTICIPANTS: 160 people with an operational diagnosis of psychotic illness or non-psychotic bipolar disorder who had experienced a hospital admission within the previous two years. INTERVENTION: The joint crisis plan was formulated by the patient, care coordinator, psychiatrist, and project worker and contained contact information, details of mental and physical illnesses, treatments, indicators for relapse, and advance statements of preferences for care in the event of future relapse. MAIN OUTCOME MEASURES: Admission to hospital, bed days, and use of the Mental Health Act over 15 month follow up. RESULTS: Use of the Mental Health Act was significantly reduced for the intervention group, 13% (10/80) of whom experienced compulsory admission or treatment compared with 27% (21/80) of the control group (risk ratio 0.48, 95% confidence interval 0.24 to 0.95, P = 0.028). As a consequence, the mean number of days of detention (days spent as an inpatient while under a section of the Mental Health Act) for the whole intervention group was 14 compared with 31 for the control group (difference 16, 0 to 36, P = 0.04). For those admitted under a section of the Mental Health Act, the number of days of detention was similar in the two groups (means 114 and 117, difference 3, -61 to 67, P = 0.98). The intervention group had fewer admissions (risk ratio 0.69, 0.45 to 1.04, P = 0.07). There was no evidence for differences in bed days (total number of days spent as an inpatient) (means 32 and 36, difference 4, -18 to 26, P = 0.15 for the whole sample; means 107 and 83, difference -24, -72 to 24, P = 0.39 for those admitted). CONCLUSIONS: Use of joint crisis plans reduced compulsory admissions and treatment in patients with severe mental illness. The reduction in overall admission was less. This is the first structured clinical intervention that seems to reduce compulsory admission and treatment in mental health services.

Adult↗

PubMed2006

Fibrates in the prevention of cardiovascular disease in patients with type 2 diabetes mellitus: meta-analysis of randomised controlled trials.

OBJECTIVE: To assess the impact of lipid lowering treatment with fibrates on cardiovascular endpoints in patients with type 2 diabetes mellitus. METHODS: MEDLINE (from inception to November 2005) and the Cochrane Controlled Trials Register (including Issue 3, 2005) were searched for randomised controlled trials comparing therapy with fibrates to placebo in patients with type 2 diabetes mellitus. Electronic searches were supplemented by manual searching of reference lists, reviews, conference abstracts and specialist journals. Incidence rate ratios (IRRs) were estimated using a fixed effects model. The primary endpoint was the IRR for coronary heart disease (CHD) events (a combination of non fatal myocardial infarction and death due to CHD). Secondary endpoints included: (1) death due to CHD; (2) fatal and non fatal myocardial infarction; and (3) fatal and non fatal stroke. RESULTS: Eight trials and 12 249 patients with type 2 diabetes were included in the analyses. A total of 924 CHD events (418 and 506 in the treatment and placebo groups, respectively) occurred during a follow up of 60 395 person-years (30 106 and 30 289 in treatment and placebo groups). The combined IRR for CHD events was 0.84 (95% confidence interval [CI] 0.74-0.96, p = 0.008). The numbers needed to treat (NNTs) to prevent one CHD event over 10 years were nine and 26 for patients with and without pre-existing CHD, respectively. IRRs for death due to CHD, myocardial infarction and stroke were 0.96 (95% CI 0.77-1.20, p = 0.73), 0.88 (95% CI 0.69-1.12, p = 0.30) and 0.87 (95% CI 0.73-1.05, p = 0.14), respectively. Larger benefits were found when restricting the analysis to trials that were not confounded by unequal provision of additional lipid-lowering therapy. CONCLUSIONS: Fibrates are associated with a substantial reduction of CHD events, but their exact role in lipid lowering treatment of patients with type 2 diabetes mellitus remains to be defined.

Cardiovascular Diseases↗

PubMed1996

Adjuvant progestagen therapy for the treatment of endometrial cancer: review and meta-analyses of published randomised controlled trials.

OBJECTIVE: To assess the efficacy of adjuvant progestagen therapy for the treatment of endometrial cancer. DESIGN: Computerised literature review by MEDLINE backed up by a manual search of 16 journals published before January 1995, to identify relevant published randomised controlled trials. Trials were classified according to methodological quality criteria. Odds ratios and 95% confidence intervals (CIs) were calculated where data allowed. SETTING: Institute of Epidemiology and Health Service Research, University of Leeds. SUBJECTS: Patients presenting with endometrial cancer. INTERVENTION: Adjuvant progestagen therapy. OUTCOMES: Death (overall, cancer related and intercurrent) and relapse. RESULTS: Six randomised controlled trials comparing adjuvant progestagen with no adjuvant therapy in the treatment of endometrial cancer were identified in the literature prior to January, 1995. Three trials had an acceptable method of randomisation. Meta-analysis demonstrated that overall survival was not improved by adjuvant progestagen therapy and may even have been adversely affected. Furthermore, this treatment was not associated with any reduction in relapse or death from endometrial cancer. CONCLUSION: Current evidence does not support use of adjuvant progestagen therapy in the primary treatment of endometrial cancer.

Chemotherapy, Adjuvant↗

PubMed2003

Randomised controlled trial of site specific advice on school travel patterns.

AIMS: To evaluate the effect of site specific advice from a school travel coordinator on school travel patterns. METHODS: Cluster randomised controlled trial of children attending 21 primary schools in the London boroughs of Camden and Islington. A post-intervention survey measured the proportion of children walking, cycling, or using public transport for travel to school, and the proportion of parents/carers very or quite worried about traffic and abduction. The proportion of schools that developed and implemented travel plans was assessed. RESULTS: One year post-intervention, nine of 11 intervention schools and none of 10 control schools had travel plans. Proportions of children walking, cycling, or using public transport on the school journey were similar in intervention and control schools. The proportion of parents who were very or quite worried about traffic danger was similar in the intervention (85%) and control groups (87%). However, after adjusting for baseline and other potential confounding factors we could not exclude the possibility of a modest reduction in parental concern about traffic danger as a result of the intervention. CONCLUSIONS: Having a school travel coordinator increased the production of school travel plans but there was no evidence that this changed travel patterns or reduced parental fears. Given the uncertainty about effectiveness, the policy of providing school travel coordinators should only be implemented within the context of a randomised controlled trial.

Bicycling↗

PubMed2006

Laparoscopic versus open colposuspension--results of a prospective randomised controlled trial.

OBJECTIVE: To compare the effectiveness and cost effectiveness of open and laparoscopic colposuspension in the treatment of stress urinary incontinence. DESIGN: A randomised controlled trial. Women were randomised between March 1999 and February 2002 and were seen for assessment at 6, 12 and 24 months, postoperatively. SETTING: Women were recruited from six gynaecology units in the UK. POPULATION: Women with proven stress urinary incontinence requiring surgery. METHODS: Open abdominal retropubic colposuspension or laparoscopic colposuspension. MAIN OUTCOME MEASURES: Primary outcomes were subjective (satisfaction with outcome) and objective (negative 1-hour pad test). Secondary outcomes were operative and postoperative morbidity and quality of life. The study was powered to demonstrate noninferiority, i.e. that the absolute cure rate of laparoscopic colposuspension was no more than 15% below that of open colposuspension. RESULTS: A total of 291 women were randomised, with 24-month data on subjective and objective outcomes in 88 and 82.5%, respectively. The intention-to-treat analysis indicated no significant difference in cure rates between open and laparoscopic surgery. The objective cure rates for open and laparoscopic were 70.1 and 79.7%, respectively. Subjective cure rates by satisfaction were lower than objective cure; 54.6 and 54.9%, respectively, and there was considerable nonconcordance both ways. CONCLUSIONS: Laparoscopic colposuspension is not inferior to open colposuspension in terms of curing stress urinary incontinence.

Female↗

PubMed2004

Methodological issues in assessing health-related quality of life of colorectal cancer patients in randomised controlled trials.

Although health-related quality of life (HRQOL) is increasingly reported as an important endpoint in cancer clinical trials, questions still remain about the quality of its reporting. The aim of this study was to evaluate the level of reporting of HRQOL in randomised controlled trials (RCTs) of colorectal cancer (CRC). A systematic literature search from 1980 to March 2003 was undertaken on a number of databases. Identified eligible studies were selected and then evaluated on a broad set of HRQOL predetermined criteria by four reviewers. Thirty-one randomised controlled trials involving 9683 colorectal cancer patients were identified. Nearly all studies dealt with metastatic patients and principally compared different chemotherapy regimens. The HRQOL tool most often used was the European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), which was used in 48% of the studies. Some methodological limitations were identified: 39% of the RCTs did not report HRQOL compliance at baseline and 52% did not give details on missing data. A rationale for using a specific HRQOL measure was given in only 10% of the studies. Whilst HRQOL assessment is a potential valuable source of information in understanding the impact of colorectal cancer, a number of methodological shortcomings have to be further addressed in future studies.

Colorectal Neoplasms↗

PubMed2003

To blow or not to blow: a randomised controlled trial of compression-only and standard telephone CPR instructions in simulated cardiac arrest.

This randomised controlled trial used a manikin model of cardiac arrest to compare skill performance in untrained lay persons randomised to receive either compression-only telephone CPR (Compression-only tel., n=29) or standard telephone CPR instructions (Standard tel., n=30). Performance was evaluated during standardised 10 min cardiac arrest simulations using a video recording and data from a laptop computer connected to the training manikin. A number of subjects in both groups did not open the airway. More than 75% in the Standard tel. group failed to deliver two effective initial rescue breaths, and only 17% provided an adequate inflation volume for subsequent breaths, delivering a median of only five inflations during the entire scenario. Most subjects in both groups gave chest compressions that were too shallow and at an inappropriately rapid rate. Hand position was also poor, but was worse in the group given simplified instructions. There was a significant delay to first compression in both groups, although this interval was shortened by over a minute when ventilations were eliminated from the telephone instruction algorithm (245 vs. 184 s, P<0.001). Over two-and-a-half times as many chest compressions were delivered during an average ambulance response time with compression-only telephone directions compared with standard CPR (461 vs. 186, P<0.001). These variables may be critical in predicting survival from out-of-hospital cardiac arrest. Further research is necessary to establish if modifications to scripted telephone instructions can remedy the identified performance deficiencies. Eliminating instructions for rescue breaths from scripted telephone directions will have little impact on the ventilation of most patients. Research is required to determine if the consequent reduction in the delay to starting chest compressions and the significant increase in the number of compressions delivered can increase survival from out-of-hospital cardiac arrest.

Adult↗

PubMed2006

[Patients' assessments of acute psychiatric day hospital and inpatient care. Analyses of open questions within the context of a randomised controlled trial].

OBJECTIVE: Within the context of the EDEN-study, a multi-centre randomised controlled trial comparing acute psychiatric day hospital with inpatient care, patients' assessments of treatment as well as their setting-preferences for future treatment have been studied. METHOD: Patients' assessments were collected using the Clients' Scale for Assessment of Treatment (CAT). The quantitative content analysis refers to the answers to the open questions of the CAT by all day hospital patients and inpatients in the Dresden project centre who completed the questionnaire one week after admission and again at discharge. RESULTS: Day hospital patients as well as inpatients assessed their treatment altogether as pleasant and effective. Interpersonal contact to the staff and other patients was evaluated as sound and helpful. Differences between the settings appeared primarily with regard to criticisms: Day hospital patients were mainly dissatisfied with their daily routine, inpatients criticized particularly structural conditions such as premises and food. In case of a hospital readmission, the majority of the patients would prefer that setting they had been randomised to within the EDEN-study. However, a tendency to prefer treatment in the day hospital was found. CONCLUSIONS: Acute mentally ill patients provide a substantially favourable assessment of both day hospital and inpatient care. Particularly the criticism of the day hospital patients contains important information for improving the quality of psychiatric care.

Acute Disease↗

PubMed2000

Nebulised steroid in the treatment of croup: a systematic review of randomised controlled trials.

BACKGROUND: Croup is one of the commonest respiratory complaints among children. There is growing evidence that steroids may be an effective treatment. AIM: To assess the effectiveness of treatment with nebulised steroid for children with croup. METHOD: Systematic review of randomised controlled trials comparing administration of nebulised steroid with placebo. Trials were identified from searches of three bibliographic databases, the Cochrane Controlled Trials Register, correspondence with the manufacturers of nebulised steroid, and one round of manual citation searching. RESULTS: Eight randomised controlled trials were identified including 574 children with mild to severe croup. Overall, the mean age was 25.2 months and 72% of children were male. All trials were hospital-based and of good methodological quality, with adequate concealment of treatment allocation and blind outcome assessment. Children treated with nebulised steroid were significantly more likely to show an improvement in croup score by five hours (combined relative risk = 1.48, 95% confidence interval [CI] = 1.27 to 1.74) and significantly less likely to need hospital admission after attending the emergency department (combined relative risk = 0.56, 95% CI = 0.42 to 0.75) than the placebo group. The funnel plot indicated the presence of publication bias, with smaller studies showing the larger effects, but this could also be owing to less pronounced effects in studies of older children with milder croup. CONCLUSIONS: Nebulised steroids are effective in the treatment of children attending hospital departments with croup. A meta-analysis based on individual patient data could clarify to what extent the effect depends on age and severity of disease. New trials are needed to define the indications for, and effectiveness of, steroid treatment of croup in the community.

Anti-Inflammatory Agents↗