The Consolidated Standards of Reporting Trials (CONSORT) statement was developed to improve the reporting of randomised controlled trials. It was initially published in 1996 and focused on the reporting of parallel group randomised controlled trials.

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The statement includes a checklist of items that should be included in the trial report. These items are evidence based whenever possible and are regularly reviewed. 3 The statement also recommends including a flow diagram to show the flow of participants from group assignment through to the final analysis.The CONSORT statement focused on reporting parallel group randomised trials in which individual participants are randomly assigned to study groups. However, in some situations it is preferable to randomly assign groups of individuals (such as families or medical practices) rather than individuals. Reasons include the threat of contamination of some interventions (such as dietary interventions) if individual randomisation is used.4 5 Also, in certain settings randomisation by group may be the only feasible method of conducting a trial.6 Trials with this design are variously known as field trials, community based trials, place based trials, or (as in this paper) cluster randomised trials. 7 In an earlier discussion paper we considered the implications of the CONSORT statement for the reporting of cluster randomised trials.8 Here we present updated guidance, based on the 2001 revision of the CONSORT statement. 2 Methodological issues in cluster randomised trialsCompared with individually randomised trials, cluster randomised trials are more complex to design, require more participants to obtain equivalent statistical power, and require more complex analysis. The methodological issues in cluster randomised trials have been widely discussed.7 9 In brief, observations on individuals in the same cluster tend to be correlated (nonindependent), and so the effective sample size is less than the total number of individual participants.The reduction in effective sample size depends on average cluster size and the degree of correlation within clusters, known as the intracluster (or intraclass) correlation coefficient ( ). The intracluster correlation coefficient is the proportion of the total variance of the outcome that can be explained by the variation between clusters. To retain power, the sample size should be multiplied by 1+(m − 1) , called the design effect, where m is the average cluster size. Hayes and Bennett describe a related coefficient of variation, k, between clusters 10 and Connelly considers an economic approach.11 Software is available to adjust for the intracluster correlation coefficient in an analysis. 12The conduct of cluster randomised controlled trials may also differ from that of trials that randomise individuals. For instance, clusters are usually randomised all at once (or in batches) rather than one at a time. After randomisation, individuals in the clusters may be approached for consent, which raises the possibility of post-randomisation selection bias, 4 or they may not, which raises ethical concerns. 14An expanded explanation of the methods of cluster randomised trials is available on the CONSORT website (www. consort_statement.org). Quality of reporting of cluster trialsSurveys of published ...

Background: A commonly reported problem with the conduct of multicentre randomised controlled trials (RCTs) is that recruitment is often slower or more difficult than expected, with many trials failing to reach their planned sample size within the timescale and funding originally envisaged. The aim of this study was to explore factors that may have been associated with good and poor recruitment in a cohort of multicentre trials funded by two public bodies: the UK Medical Research Council (MRC) and the Health Technology Assessment (HTA) Programme.

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Non-UK purchasers will have to pay a small fee for post and packing. For European countries the cost is £2 per monograph and for the rest of the world £3 per monograph.You can order HTA monographs from our Despatch Agents:-fax (with credit card or official purchase order) -post (with credit card or official purchase order or cheque) -phone during office hours (credit card only).Additionally the HTA website allows you either to pay securely by credit card or to print out your order and then post or fax it. Contact details are as follows: Payment methods Paying by chequeIf you pay by cheque, the cheque must be in pounds sterling, made payable to Direct Mail Works Ltd and drawn on a bank with a UK address. Paying by credit cardThe following cards are accepted by phone, fax, post or via the website ordering pages: Delta, Eurocard, Mastercard, Solo, Switch and Visa. We advise against sending credit card details in a plain email.Paying by official purchase order You can post or fax these, but they must be from public bodies (i.e. NHS or universities) within the UK.We cannot at present accept purchase orders from commercial companies or from outside the UK. How do I get a copy of HTA on CD?Please use the form on the HTA website (www.hta.ac.uk/htacd.htm). Or contact Direct Mail Works (see contact details above) by email, post, fax or phone. HTA on CD is currently free of charge worldwide.The website also provides information about the HTA Programme and lists the membership of the various committees. HTA NIHR Health Technology Assessment ProgrammeT he Health Technology Assessment (HTA) programme, now part of the National Institute for Health Research (NIHR), was set up in 1993. It produces high-quality research information on the costs, effectiveness and broader impact of health technologies for those who use, manage and provide care in the NHS. 'Health technologies' are broadly defined to include all interventions used to promote health, prevent and treat disease, and improve rehabilitation and long-term care, rather than settings of care. The research findings from the HTA Programme directly influence decision-making bodies such as the National Institute for Health and Clinical Excellence (NICE) and the National Screening Committee (NSC). HTA findings also help to improve the quality of clinical practice in the NHS indirectly in that they form a key component of the 'National Knowledge Service'. The HTA Programme is needs-led in that it fills gaps in the evidence needed by the NHS. There are three routes to the start of projects. First is the commissioned route. Suggestions for research are actively sought from people working in the NHS, the public and consumer groups and professional bodies such as royal colleges and NHS trusts. These suggestions are carefully prioritised by panels of independent experts (including NHS service users). The HTA Programme then commissions the research by competitive tender. Secondly, the HTA Programme provides grants for clinical trials for researchers who identify research questions. ...

Objectives To test the hypothesis that nurse led follow-up programmes are effective and cost effective in improving quality of life after discharge from intensive care.Design A pragmatic, non-blinded, multicentre, randomised controlled trial.Setting Three UK hospitals (two teaching hospitals and one district general hospital).Participants 286 patients aged ≥18 years were recruited after discharge from intensive care between September 2006 and October 2007.Intervention Nurse led intensive care follow-up programmes versus standard care.Main outcome measure(s) Health related quality of life (measured with the SF-36 questionnaire) at 12 months after randomisation. A cost effectiveness analysis was also performed.Results 286 patients were recruited and 192 completed one year follow-up. At 12 months, there was no evidence of a difference in the SF-36 physical component score (mean 42.0 (SD 10.6) v 40.8 (SD 11.9), effect size 1.1 (95% CI −1.9 to 4.2), P=0.46) or the SF-36 mental component score (effect size 0.4 (−3.0 to 3.7), P=0.83). There were no statistically significant differences in secondary outcomes or subgroup analyses. Follow-up programmes were significantly more costly than standard care and are unlikely to be considered cost effective.Conclusions A nurse led intensive care follow-up programme showed no evidence of being effective or cost effective in improving patients' quality of life in the year after discharge from intensive care. Further work should focus on the roles of early physical rehabilitation, delirium, cognitive dysfunction, and relatives in recovery from critical illness. Intensive care units should review their follow-up programmes in light of these results.Trial registration ISRCTN 24294750