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Julian Bowen Consort Dining Table, Honey, Height: 77, Width: 92, Depth: 92cm

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Consolidated Standards of Reporting Trials ( CONSORT) encompasses various initiatives developed by the CONSORT Group to alleviate the problems arising from inadequate reporting of randomized controlled trials. It is part of the larger EQUATOR Network initiative to enhance the transparency and accuracy of reporting in research. Keech A, Gebski VJ, Pike R. Interpreting and reporting clinical trials. A guide to the CONSORT Statement and the principles of randomised controlled trials. 2007: Australasian Medical Publishing: NSW, Australia.

CONSORT 2010 Statement: updated guidelines for reporting CONSORT 2010 Statement: updated guidelines for reporting

Clinicians, patients, and policy makers rely on published results from clinical trials to help make evidence-informed decisions. To critically evaluate and use trial results, readers require complete and transparent information regarding what was planned, done, and found. Specific and harmonized guidance as to what outcome-specific information should be reported in publications of clinical trials is needed to reduce deficient reporting practices that obscure issues with outcome selection, assessment, and analysis. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008;337:a1655. Abraham C, Michie S. A taxonomy of behavior change techniques used in interventions. Health Psychol. 2007;27:379–87. Welch V, Jull J, Petkovic J, et al. Protocol for the development of a CONSORT-equity guideline to improve reporting of health equity in randomized trials. Implement Sci. 2015;10(1):146. Within person randomised trials present some particular challenges. One problem is the potential for a “carry across effect,” whereby, for example, an intervention applied to one eye or in an area of the mouth can affects the other eye, systemically, 14 or other areas of the mouth, locally. 15 16 Success or failure of the first replacement hip in a patient requiring bilateral hip replacement can affect the success or failure of the second hip operation. 17 A related problem is the possibility of participants dropping out of the trial if the two interventions are not applied concurrently.Taichman DB, Sahni P, Pinborg A, et al. Data sharing statements for clinical trials: a requirement of the International Committee of Medical Journal Editors. JAMA. 2017;317(24):2491–2.

Consolidated Standards of Reporting Trials - Wikipedia

If treatments are given sequentially will baseline information be recorded at the time of randomisation or at the time of treatment administration?

References

Open Science Collaboration. Estimating the reproducibility of psychological science. Science. 2015;349(6251):aac4716. The main CONSORT Statement is based on the "standard" two-group parallel design. Extensions of the CONSORT Statement have been developed to give additional guidance for randomized trials with specific designs (e.g., cluster randomized trials, [3] noninferiority and equivalence trials, [4] pragmatic trials, [5]), data (e.g., harms, [6] abstracts [7]), and various types of intervention (e.g., herbals, [8] non-pharmacologic treatments, [9] acupuncture [10]). A number of guidelines have been designed to complement CONSORT, including TIDieR (encouraging adequate descriptions of interventions) [11] and TIDieR-Placebo (encouraging adequate descriptions of placebo or sham controls). [12] This list is by no means exhaustive, and work is ongoing. Storage & organisation Furniture Textiles Kitchenware & tableware Kitchens Lighting Decoration Rugs, mats & flooring Beds & mattresses Baby & children Smart home Bathroom products Laundry & cleaning Plants & plant pots Home electronics Home improvement Outdoor living Food & beverages Christmas Shop Shop by room Information about settings and locations of intervention delivery and data collection are essential for understanding trial context. Important details might include the geographic location, day and time of trial activities, space required, and features of the inner setting (e.g. implementing organisation) and outer setting (e.g. external context and environment) that might influence implementation [ 68]. Authors should refer to the mechanism of action when deciding what information about setting and location to report. Methods: interventions Item 5: the interventions for each group with sufficient details to allow replication, including how and when they were actually administered Mayo-Wilson E, Fusco N, Li T, et al. Multiple outcomes and analyses in clinical trials create challenges for interpretation and research synthesis. J Clin Epidemiol. 2017;86:39–50.

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CONSORT Abstracts: Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman DG, Schulz KF, the CONSORT Group. CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaboration. PLoS Med. 2008; 5(1):e20. PMID: 18215107 Shamseer L, Hopewell S, Altman DG, Moher D, Schulz KF. Update on the endorsement of CONSORT by high impact factor journals: a survey of journal ‘instructions to authors’ in 2014. Trials. 2016;17(1):301. McCord J. Cures that harm: unanticipated outcomes of crime prevention programs. Ann Am Acad Polit Soc Sci. 2003;587:16–30.Department of Medicine, Women's College Research Institute, University of Toronto, Toronto, Ontario, Canada. This guideline was published simultaneously in 9 journals. You can read the guideline in any of these journals using the links below. Gagnier JJ, Boon H, Rochon P, Moher D, Barnes J, Bombardier C. Reporting randomized, controlled trials of herbal interventions: an elaborated CONSORT statement. Ann Intern Med. 2006;144:364–7. In addition to the eligibility criteria that apply to individuals, social and psychological intervention trials often have eligibility criteria for the settings where participants will be recruited and interventions delivered, as well as intervention providers [ 44]. Authors should describe these criteria to help readers compare the trial context with other contexts in which interventions might be used [ 48, 66, 67]. Item 4b: settings and locations of intervention delivery and where the data were collected A recent study identified 43 split mouth designs in a sample of 413 RCTs (10%) published in eight oral health journals with high impact factors from 1992 to 2012. 20 Another study found that 67 of 276 (24%) RCTs published between 1989 and 2011 in implant dentistry journals used the split mouth design. 21

The CONSORT statement - PMC - National Center for The CONSORT statement - PMC - National Center for

Centre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.

Footnotes

Cuijpers P, Cristea IA. How to prove that your therapy is effective, even when it is not: a guideline. Epidemiol Psychiatr Sci. 2016;25(5):428–35. Ioannidis JP, Munafo MR, Fusar-Poli P, Nosek BA, David SP. Publication and other reporting biases in cognitive sciences: detection, prevalence, and prevention. Trends Cogn Sci. 2014;18(5):235–41. The Methods section should include a detailed report of how the trial was conducted including the type of design followed and the description of the protocol followed. The type of trial conducted needs to be noted clearly i.e., whether it consisted of a parallel group design or a factorial design.[ 3] The most common trial design followed is a randomized parallel group design, and in fact the CONSORT statement focuses mainly on such a trial design.[ 6] It is essential that all the eligibility criteria utilized in the trial protocol are clearly defined since this will enable the reader to interpret the study results adequately. Furthermore, the setting and location (county, city, hospital, and clinic) of the trial needs to be reported, since such information impacts on the study's validity.[ 3] CONSORT for orthodontic trials: Pandis N, Fleming PS, Hopewell S, Altman DG. The CONSORT Statement: Application within and adaptations for orthodontic trials. Am J Orthod Dentofacial Orthop. 2015;147(6):663-679. PMID: 26038070 Department of Chronic Disease Epidemiology, School of Public Health, Yale University, New Haven, Connecticut.

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