Overwhelming evidence shows the quality of reporting of randomised controlled trials RCTs is not optimal.
Without transparent reporting, readers cannot judge the reliability and validity of trial findings nor extract information for systematic reviews. Recent methodological analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects.
Such systematic error is seriously damaging to RCTs, which are considered the gold standard for evaluating interventions because of their ability to minimise or avoid bias. It was first published in and updated in The statement consists of a checklist and flow diagram that authors can use for reporting an RCT. The statement facilitates critical appraisal and interpretation of RCTs. This update improves the wording and clarity of the previous checklist and incorporates recommendations related to topics that have only recently received recognition, such as selective outcome reporting bias.
This explanatory and elaboration document—intended to enhance the use, understanding, and dissemination of the CONSORT statement—has also been extensively revised.
It presents the meaning and rationale for each new and updated checklist item providing examples of good reporting and, where possible, references to relevant empirical studies.
Several examples of flow diagrams are included. Well designed and properly executed randomised controlled trials RCTs provide the most reliable evidence on the efficacy of healthcare interventions, but trials with inadequate methods are associated with bias, especially exaggerated treatment effects.
Critical appraisal of the quality of clinical trials is possible only if the design, conduct, and analysis of RCTs are thoroughly and accurately described in the report. Far from being transparent, the reporting of RCTs is often incomplete, 6 7 8 9 compounding problems arising from poor methodology.
Many reviews have documented deficiencies in reports of clinical trials. Reporting is not only often incomplete but also sometimes inaccurate. Proper randomisation reduces selection bias at trial entry and is the crucial component of high quality RCTs. The method used to assign interventions to trial participants is a Best Paper Ghostwriting Sites Gb aspect of clinical trial design.
Random assignment is the preferred method; it has been successfully used regularly in trials for more than 50 years. Without randomisation, treatment comparisons may be prejudiced, whether consciously or not, by selection of participants of a particular kind to receive a particular treatment. Second, random assignment permits the use of probability theory to express the likelihood that any difference in outcome between intervention groups merely reflects chance.
Successful randomisation in practice depends on two interrelated aspects—adequate generation of an unpredictable allocation sequence and concealment of Best Paper Ghostwriting Sites Gb sequence until assignment occurs. Unfortunately, despite that central role, reporting of the methods used for allocation of participants to interventions is also generally inadequate. It is aimed at primary reports of RCTs with two group, parallel designs.
Most of CONSORT is also relevant to a wider class of trial designs, such as non-inferiority, equivalence, factorial, cluster, and crossover trials. Extensions to the CONSORT checklist for reporting trials with some of these designs have been published, 39 40 41 as have those for reporting certain types of data harms 42 click, types of interventions non-pharmacological treatments 43herbal interventions 44and abstracts.
Trial reports need be clear, complete, and transparent. Many items not explicitly mentioned in CONSORT should also be included in a report, such as information about approval by an ethics committee, obtaining informed consent from participants, and, where relevant, existence of a data safety and monitoring committee.
In addition, any other aspects of a trial that are mentioned should be properly reported, such as information pertinent to cost effectiveness analysis.
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It discussed the rationale and scientific background for each item and provided published examples of good reporting. The rationale for revising that article is similar to that for revising the statement, described above. We briefly describe below the main additions and deletions to this version of the explanation and elaboration article. We have also updated some existing explanations, including adding more recent references to methodological evidence, and used some better examples.
Where possible, we describe the findings of relevant empirical studies. Many excellent books on clinical trials offer fuller discussion of methodological issues. Explanation— The ability to identify a report of a randomised trial in an electronic database depends to a large extent on how it was indexed.
Indexers may not classify a report as a randomised trial if the authors do not explicitly report this information.
Explanation— Clear, transparent, and sufficiently detailed abstracts are important because readers often base their assessment of a trial on such information. Some readers use an abstract as a screening tool to decide whether to read the full article. However, as not all trials are freely available and some health professionals do not have access to the full trial reports, healthcare decisions are sometimes made on the basis of abstracts of randomised trials.
A journal abstract should contain sufficient information about a trial to serve as an accurate record of its conduct and findings, providing optimal information about the trial within the space constraints and format of a journal.
A properly constructed and written abstract helps individuals to assess quickly the relevance of the findings and aids the retrieval of relevant reports from electronic databases. Studies comparing the go here of information reported in a journal abstract with that reported in the text of the full publication have found claims that are inconsistent with, or missing from, the body of the full article.
They provide readers with information about the trial under a series of headings pertaining to the design, conduct, analysis, and interpretation. It is not our intention to suggest changes to these formats, but to recommend what information should be reported.
Items to include when reporting a randomised trial in a journal abstract.
At the time the current trial was designed midsadjuvant chemotherapy had not become standard clinical practice … The clinical rationale for neo-adjuvant chemotherapy is three-fold: Explanation— Typically, the introduction consists of free flowing text, in which authors explain the scientific background and rationale for their trial, and its general outline.
It may also be appropriate to include here the objectives of the trial see item 2b. The rationale may be explanatory for example, to assess the possible influence of a drug on renal function or pragmatic for example, to guide practice by comparing the benefits and harms of two treatments. Authors should report any evidence of the benefits and harms of active interventions included in a trial and should suggest a plausible explanation for how the interventions might work, if this is not obvious.
The Declaration of Helsinki states that biomedical research involving people should be based on a thorough knowledge of the scientific literature. Some clinical trials have been shown to have been unnecessary because the question they addressed had been or could have been answered by a systematic review of the existing literature. Ideally, it should include a reference to a systematic review of previous similar trials or a note of the absence of such trials.
Explanation— Objectives are the questions that the trial was designed to answer. They often relate to the efficacy of a particular therapeutic or preventive intervention. Hypotheses are pre-specified questions being tested to help meet the objectives. Hypotheses are more specific than objectives and are amenable to explicit statistical evaluation.
In practice, objectives and hypotheses are not always easily differentiated. Most reports of RCTs provide adequate information about trial objectives and hypotheses. Many specific aspects of the broader trial design, including details of randomisation and blinding, are addressed elsewhere in the CONSORT checklist.
Here we seek information on the article source of trial, such as parallel group or factorial, and read more conceptual framework, such as superiority or non-inferiority, and other Best Paper Ghostwriting Sites Gb issues not addressed elsewhere in the checklist.
In fact, little more than half of published trials have such a design. Also, most trials are set to identify the superiority of a new intervention, if it exists, but others are designed to assess non-inferiority or equivalence. It is desirable also to include these details in the abstract see item 1b. If a less common design is employed, authors are encouraged to explain their choice, especially as such designs may imply the need for a larger sample size or more complex analysis and interpretation.
Although most trials use equal randomisation such as 1: For drug trials, specifying the phase of the trial I-IV may also be relevant. The protocol was immediately amended in accordance with that recommendation, Best Paper Ghostwriting Sites Gb participants were subsequently randomly assigned in 2: Explanation— A few trials may start without any fixed plan that is, are entirely exploratorybut Best Paper Ghostwriting Sites Gb most will have a protocol that specifies in great detail how the trial will be conducted.
There may be deviations from the original protocol, as it is impossible to predict every possible change in circumstances during the course of a trial.
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Some trials will therefore have important changes to the methods after trial commencement. Changes could be due to external information becoming available from other studies, or internal financial difficulties, or could be due to a disappointing recruitment rate.
In some trials, an independent data monitoring committee will have as part of its remit the possibility of recommending protocol changes based on seeing unblinded data.
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Such changes might affect the study methods such as changes to treatment regimens, eligibility criteria, randomisation ratio, or duration of follow-up or trial conduct such as dropping a centre with poor data quality. There are, however, important ethical, statistical, and practical Best Paper Ghostwriting Sites Gb in considering such a design. Whether the modifications are explicitly part of the trial design or in response to changing circumstances, it is essential that they are fully reported to help the reader interpret the results.
Changes from protocols are not currently well reported. A review of comparisons with protocols showed that about half of journal articles describing RCTs had an unexplained discrepancy in the primary outcomes. Exclusion criteria were pregnancy and lactation or participation in another supplementary feeding programme.
Explanation— A comprehensive description of the eligibility criteria used to select the trial participants is needed to help readers interpret the study.
Because they are applied before randomisation, eligibility criteria do not affect the internal validity of a trial, but they are central to its external validity. Typical and widely accepted selection criteria relate to the nature and stage of the disease being studied, the exclusion of persons thought to be particularly vulnerable to harm from the study intervention, and to issues required to ensure that the study satisfies legal and ethical norms.
Informed consent by study participants, for example, is typically required in intervention studies. The common distinction between inclusion and exclusion criteria is unnecessary; the same criterion can be phrased to include or exclude participants. Despite their importance, eligibility criteria are often not reported adequately. Explanation— Along with the eligibility criteria for participants see item 4a and the description of the interventions see item 5information on the settings and locations is crucial to judge the applicability and generalisability of a trial.
Were participants recruited from primary, secondary, or tertiary health care or from the community? Healthcare institutions vary greatly in their organisation, experience, and resources and the baseline risk for the condition under investigation. Best Paper Ghostwriting Sites Gb should report the number and type of settings and describe the care providers involved.
They should report the locations in which the study was carried out, including the country, city if applicable, and immediate environment for example, community, office practice, hospital clinic, or inpatient unit. This description should provide enough information so that readers can judge whether the results of the trial could be relevant to their own setting. Study drug administration required a heart rate of 50 bpm or more and a systolic blood pressure of mm Hg or greater; these haemodynamics were checked before each administration.
If, at any time during the first 6 h after surgery, heart rate was 80 bpm or more and systolic blood pressure was mm Hg or higher, patients received their first postoperative dose extended-release metoprolol mg or matched placebo orally.
Best Paper Ghostwriting Sites Gb the study drug was not given during the first 6 h, patients received their first postoperative dose at 6 h after surgery. Patients whose heart rate was consistently bpm and systolic blood pressure exceeded mm Hg delayed taking the study drug for 12 h. The splint was a rigid rest orthosis recommended for use only at night.
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