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Bruno's Marketplace offers gourmet food products from Northern California, including Bruno's Wax Peppers, Sierra Nevada Chileno Peppers, Waterloo BBQ Sauce, Bruno's. CONSORT 2. 01. 0 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials. Title and abstract. Item 1a. Identification as a randomised trial in the title. Example—“Smoking reduction with oral nicotine inhalers: double blind, randomised clinical trial of efficacy and safety.”6. 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. To help ensure that a study is appropriately indexed and easily identified, authors should use the word “randomised” in the title to indicate that the participants were randomly assigned to their comparison groups. Item 1b. Structured summary of trial design, methods, results, and conclusions. For specific guidance see CONSORT for abstracts. 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. The abstract should accurately reflect what is included in the full journal article and should not include information that does not appear in the body of the paper. Studies comparing the accuracy 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. Conversely, omitting important harms from the abstract could seriously mislead someone’s interpretation of the trial findings. A recent extension to the CONSORT statement provides a list of essential items that authors should include when reporting the main results of a randomised trial in a journal (or conference) abstract (see table 2. They provide readers with information about the trial under a series of headings pertaining to the design, conduct, analysis, and interpretation. Some studies have found that structured abstracts are of higher quality than the more traditional descriptive abstracts. We recognise that many journals have developed their own structure and word limit for reporting abstracts. It is not our intention to suggest changes to these formats, but to recommend what information should be reported. Table 2 Items to include when reporting a randomised trial in a journal abstract Introduction. Item 2a. Scientific background and explanation of rationale. Example—“Surgery is the treatment of choice for patients with disease stage I and II non- small cell lung cancer (NSCLC) . At the time the current trial was designed (mid- 1. 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. That is, it is unethical to expose humans unnecessarily to the risks of research. 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. Thus, the need for a new trial should be justified in the introduction. Ideally, it should include a reference to a systematic review of previous similar trials or a note of the absence of such trials. Item 2b. Specific objectives or hypotheses. Example—“In the current study we tested the hypothesis that a policy of active management of nulliparous labour would: 1. 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. Methods. Item 3a. Description of trial design (such as parallel, factorial) including allocation ratio. Example—“This was a multicenter, stratified (6 to 1. 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 type of trial, such as parallel group or factorial, and the conceptual framework, such as superiority or non- inferiority, and other related issues not addressed elsewhere in the checklist. The CONSORT statement focuses mainly on trials with participants individually randomised to one of two “parallel” groups. In fact, little more than half of published trials have such a design. The main alternative designs are multi- arm parallel, crossover, cluster,4. 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 important that researchers clearly describe these aspects of their trial, including the unit of randomisation (such as patient, GP practice, lesion). 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: 1 for two groups), it is helpful to provide the allocation ratio explicitly. For drug trials, specifying the phase of the trial (I- IV) may also be relevant. Item 3b. Important changes to methods after trial commencement (such as eligibility criteria), with reasons. Example—“Patients were randomly assigned to one of six parallel groups, initially in 1: 1: 1: 1: 1: 1 ratio, to receive either one of five otamixaban . During the trial, this committee recommended that the group receiving the lowest dose of otamixaban (0. The protocol was immediately amended in accordance with that recommendation, and participants were subsequently randomly assigned in 2: 2: 2: 2: 1 ratio to the remaining otamixaban and control groups, respectively.”8. Explanation—A few trials may start without any fixed plan (that is, are entirely exploratory), but the 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. 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. Such protocol changes should be made without breaking the blinding on the accumulating data on participants’ outcomes. 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. 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). Some trials are set up with a formal “adaptive” design. There is no universally accepted definition of these designs, but a working definition might be “a multistage study design that uses accumulating data to decide how to modify aspects of the study without undermining the validity and integrity of the trial.”8. The modifications are usually to the sample sizes and the number of treatment arms and can lead to decisions being made more quickly and with more efficient use of resources. There are, however, important ethical, statistical, and practical issues 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. Frequent unexplained discrepancies have also been observed for details of randomisation, blinding,9. Item 4a. Eligibility criteria for participants. Example—“Eligible participants were all adults aged 1. HIV who met the eligibility criteria for antiretroviral therapy according to the Malawian national HIV treatment guidelines (WHO clinical stage III or IV or any WHO stage with a CD4 count < 2. BMI < 1. 8. 5. Exclusion criteria were pregnancy and lactation or participation in another supplementary feeding programme.”9. Explanation—A comprehensive description of the eligibility criteria used to select the trial participants is needed to help readers interpret the study.
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