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CONSORT 2010
Editorial
Liz Wager
CONSORT 2010
Published Online March 24, 2010 DOI:10.1016/S01406736(10)60456-4 See Comment page 1144 See Online for webappendix
For more on CONSORT see http:// www.consort-statement.org For reporting guidelines for all studies see http://www.equatornetwork.org
3 years ago in January, 2007, a group of experts in trial design gathered in a wooden lodge in Montebello, Canada, to discuss what revisions were needed to the CONSORT (Consolidated Standards of Reporting Trials) guidelines. Two and a half days later, these statisticians, trial methodologists, researchers, and journal editors emerged into the deep snow and biting winds with the principles for what was then called CONSORT III established. Some celebrated with a sleigh ride pulled by huskies; others began the long refinement and consultation process, culminating in what is now published as CONSORT 2010. The first CONSORT statement was published in 1996, and revised in 2001. The aim then, and now, was to improve how trials are reported so that they can be accurately assessed by readers, editors, and reviewers. Some success has been achieved—the reporting of some trials is excellent. But complete and clear information on all aspects of all trials is missing, still, from many reported studies, despite CONSORT having been around for 14 years. For this journal, since 1996, editors have asked authors of all published trials to adhere to CONSORT
guidelines, with varying degrees of success. From now, authors will be asked to conform to the CONSORT 2010 Statement (see webappendix), which in practice means completing a 25-item checklist and submitting a flow diagram to show the enrolment, allocation, followup, and analysis phases for the trial participants. New in CONSORT 2010 are sub-items or full items to clarify trial design, any changes to the methods or outcome measures after the trial began, encouragement to present both relative and absolute effect sizes, and registration, funding, and protocol information. Important changes in CONSORT 2010, compared with the previous version, are summarised in panel 1 in the accompanying Comment, which also discusses why mention of how the success of masking might have been evaluated is no longer required. Ken Schulz, Doug Altman, and David Moher have successfully led the CONSORT Group to this latest reincarnation of the guidelines. It is now down to authors and editors to ensure that CONSORT 2010 is diligently implemented. ■ The Lancet
Improving quality of care in the NHS
Getty Images
UK hospital standards are in the spotlight after previous high-profile inquiries uncovering shocking cases of the neglect of patients and poor hygiene standards at MidStaffordshire, Basildon and Thurrock, and Tameside National Health Service (NHS) trusts. Scrutiny intensified after a BBC radio programme last week drew attention to an apparently disproportionate number of deaths in 25 NHS hospital trusts in England. The documentary highlighted work by Sir Brian Jarman, emeritus professor at Imperial College School of Medicine. Jarman, who was previously a member of the inquiry into the deaths of children receiving heart surgery at Bristol Royal Infirmary, used the hospital standardised mortality ratio and the number of mortality alerts for particular procedures to estimate that 4600 more patients died than would be normally expected in 2007–08 in the 25 trusts. Although a death rate that is higher than expected does not necessarily indicate that clinical standards are unsatisfactory, it does suggest that tighter scrutiny of patients’ care is needed. 1136
Fortunately, some measures that might address the issues are already in place. From April 1, 2010, all NHS trusts in England must register with the Care Quality Commission (CQC), the independent regulator of all health and adult social care in England, to legally treat patients. Trusts will be visited by inspectors at least once every 2 years under a new system to scrutinise standards, and the CQC will fine, prosecute, or close down trusts failing to meet benchmarks. These measures are a vast improvement on the previous CQC regulatory system, which relied on hospitals completing self-assessments on standards and in which only about a fifth of all hospitals were inspected per year. For some trusts, registration under the new system is conditional on improvements being made in areas such as infection control and use of unregistered nursing agencies. Such improvements to independent oversight are welcome, but continuous monitoring and enforceable penalties are essential to bring all trusts up to the level to which the NHS aspires and the public expects. ■ The Lancet www.thelancet.com Vol 375 April 3, 2010
Liz Wager
CONSORT 2010
Published Online March 24, 2010 DOI:10.1016/S01406736(10)60456-4 See Comment page 1144 See Online for webappendix
For more on CONSORT see http:// www.consort-statement.org For reporting guidelines for all studies see http://www.equatornetwork.org
3 years ago in January, 2007, a group of experts in trial design gathered in a wooden lodge in Montebello, Canada, to discuss what revisions were needed to the CONSORT (Consolidated Standards of Reporting Trials) guidelines. Two and a half days later, these statisticians, trial methodologists, researchers, and journal editors emerged into the deep snow and biting winds with the principles for what was then called CONSORT III established. Some celebrated with a sleigh ride pulled by huskies; others began the long refinement and consultation process, culminating in what is now published as CONSORT 2010. The first CONSORT statement was published in 1996, and revised in 2001. The aim then, and now, was to improve how trials are reported so that they can be accurately assessed by readers, editors, and reviewers. Some success has been achieved—the reporting of some trials is excellent. But complete and clear information on all aspects of all trials is missing, still, from many reported studies, despite CONSORT having been around for 14 years. For this journal, since 1996, editors have asked authors of all published trials to adhere to CONSORT
guidelines, with varying degrees of success. From now, authors will be asked to conform to the CONSORT 2010 Statement (see webappendix), which in practice means completing a 25-item checklist and submitting a flow diagram to show the enrolment, allocation, followup, and analysis phases for the trial participants. New in CONSORT 2010 are sub-items or full items to clarify trial design, any changes to the methods or outcome measures after the trial began, encouragement to present both relative and absolute effect sizes, and registration, funding, and protocol information. Important changes in CONSORT 2010, compared with the previous version, are summarised in panel 1 in the accompanying Comment, which also discusses why mention of how the success of masking might have been evaluated is no longer required. Ken Schulz, Doug Altman, and David Moher have successfully led the CONSORT Group to this latest reincarnation of the guidelines. It is now down to authors and editors to ensure that CONSORT 2010 is diligently implemented. ■ The Lancet
Improving quality of care in the NHS
Getty Images
UK hospital standards are in the spotlight after previous high-profile inquiries uncovering shocking cases of the neglect of patients and poor hygiene standards at MidStaffordshire, Basildon and Thurrock, and Tameside National Health Service (NHS) trusts. Scrutiny intensified after a BBC radio programme last week drew attention to an apparently disproportionate number of deaths in 25 NHS hospital trusts in England. The documentary highlighted work by Sir Brian Jarman, emeritus professor at Imperial College School of Medicine. Jarman, who was previously a member of the inquiry into the deaths of children receiving heart surgery at Bristol Royal Infirmary, used the hospital standardised mortality ratio and the number of mortality alerts for particular procedures to estimate that 4600 more patients died than would be normally expected in 2007–08 in the 25 trusts. Although a death rate that is higher than expected does not necessarily indicate that clinical standards are unsatisfactory, it does suggest that tighter scrutiny of patients’ care is needed. 1136
Fortunately, some measures that might address the issues are already in place. From April 1, 2010, all NHS trusts in England must register with the Care Quality Commission (CQC), the independent regulator of all health and adult social care in England, to legally treat patients. Trusts will be visited by inspectors at least once every 2 years under a new system to scrutinise standards, and the CQC will fine, prosecute, or close down trusts failing to meet benchmarks. These measures are a vast improvement on the previous CQC regulatory system, which relied on hospitals completing self-assessments on standards and in which only about a fifth of all hospitals were inspected per year. For some trusts, registration under the new system is conditional on improvements being made in areas such as infection control and use of unregistered nursing agencies. Such improvements to independent oversight are welcome, but continuous monitoring and enforceable penalties are essential to bring all trusts up to the level to which the NHS aspires and the public expects. ■ The Lancet www.thelancet.com Vol 375 April 3, 2010