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Perspectives on the application of CONSORT guidelines to randomised controlled trials in nutrition.
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- المؤلفون: Rigutto-Farebrother J;Rigutto-Farebrother J;Rigutto-Farebrother J;Rigutto-Farebrother J; Ahles S; Ahles S; Ahles S; Cade J; Cade J; Murphy KJ; Murphy KJ; Plat J; Plat J; Schwingshackl L; Schwingshackl L; Roche HM; Roche HM; Roche HM; Shyam S; Shyam S; Shyam S; Lachat C; Lachat C; Minihane AM; Minihane AM; Minihane AM; Weaver C; Weaver C
- المصدر:
European journal of nutrition [Eur J Nutr] 2023 Aug; Vol. 62 (5), pp. 2319-2332. Date of Electronic Publication: 2023 Apr 26.- نوع النشر :
Letter- اللغة:
English - المصدر:
- معلومة اضافية
- المصدر: Publisher: Steinkopff Country of Publication: Germany NLM ID: 100888704 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1436-6215 (Electronic) Linking ISSN: 14366207 NLM ISO Abbreviation: Eur J Nutr Subsets: MEDLINE
- بيانات النشر: Original Publication: Darmstadt, Germany : Steinkopff, 1999-
- الموضوع:
- نبذة مختصرة : Purpose: Reporting guidelines facilitate quality and completeness in research reporting. The CONsolidated Standards Of Reporting Trials (CONSORT) statement is widely applied to dietary and nutrition trials but has no extension specific to nutrition. Evidence suggests poor reporting in nutrition research. The Federation of European Nutrition Societies led an initiative to make recommendations for a nutrition extension to the CONSORT statement towards a more robust reporting of the evidence base.
Methods: An international working group was formed of nutrition researchers from 14 institutions in 12 different countries and on five continents. Using meetings over a period of one year, we interrogated the CONSORT statement specifically for its application to report nutrition trials.
Results: We provide a total of 28 new nutrition-specific recommendations or emphasised recommendations for the reporting of the introduction (three), methods (twelve), results (five) and discussion (eight). We also added two additional recommendations that were not allocated under the standard CONSORT headings.
Conclusion: We identify a need to provide guidance in addition to CONSORT to improve the quality and consistency of the reporting and propose key considerations for further development of formal guidelines for the reporting of nutrition trials. Readers are encouraged to engage in this process, provide comments and conduct specific studies to inform further work on the development of reporting guidelines for nutrition trials.
(© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.) - References: Trepanowski JF, Ioannidis JPA (2018) Perspective: limiting dependence on nonrandomized studies and improving randomized trials in human nutrition research: why and how. Adv Nutr. https://doi.org/10.1093/ADVANCES/NMY014. (PMID: 10.1093/ADVANCES/NMY014300322186054237)
Lichtenstein AH, Petersen K, Barger K et al (2021) Perspective: design and conduct of human nutrition randomized controlled trials. Adv Nutr. https://doi.org/10.1093/advances/nmaa109. (PMID: 10.1093/advances/nmaa10933200182)
Lachat C, Hawwash D, Ocké MC et al (2016) Strengthening the reporting of observational studies in epidemiology—nutritional epidemiology (STROBE-nut): an extension of the STROBE statement. PLoS Med. https://doi.org/10.1371/journal.pmed.1002036. (PMID: 10.1371/journal.pmed.1002036272707494896435)
Zeraatkar D, Bhasin A, Morassut RE et al (2021) Characteristics and quality of systematic reviews and meta-analyses of observational nutritional epidemiology: a cross-sectional study. Am J Clin Nutr. https://doi.org/10.1093/ajcn/nqab002. (PMID: 10.1093/ajcn/nqab002337400398243916)
Liljeberg E, Andersson A, Lövestam E, Nydahl M (2018) Incomplete descriptions of oral nutritional supplement interventions in reports of randomised controlled trials. Clin Nutr. https://doi.org/10.1016/j.clnu.2017.03.024. (PMID: 10.1016/j.clnu.2017.03.02428390844)
te Morenga L, Mallard S, Mann J (2013) Dietary sugars and body weight: Systematic review and meta-analyses of randomised controlled trials and cohort studies. BMJ (Online). https://doi.org/10.1136/bmj.e7492. (PMID: 10.1136/bmj.e7492)
Schulz KF, Altman DC, Moher D (2010) CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. Ital J Public Health. https://doi.org/10.4178/epih/e2014029. (PMID: 10.4178/epih/e2014029)
Moher D, Hopewell S, Schulz KF et al (2010) CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. https://doi.org/10.1136/bmj.c869. (PMID: 10.1136/bmj.c869203325112844943)
Hoffmann TC, Glasziou PP, Boutron I et al (2014) Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ 348:g1687–g1687. https://doi.org/10.1136/bmj.g1687. (PMID: 10.1136/bmj.g168724609605)
Calder PC, Feskens EJM, Kraneveld AD et al (2020) Towards “Improved standards in the science of nutrition” through the establishment of Federation of European Nutrition Societies working groups. Ann Nutr Metab. https://doi.org/10.1159/000506325. (PMID: 10.1159/00050632532074598)
Weaver CM (2014) How sound is the science behind the dietary recommendations for dairy? Am J Clin Nutr. https://doi.org/10.3945/ajcn.113.073007. (PMID: 10.3945/ajcn.113.07300724760975)
Weaver CM, Fukagawa NK, Liska DA et al (2021) Perspective: US documentation and regulation of human nutrition randomized controlled trials. Adv Nutr 12:21–45. https://doi.org/10.1093/advances/nmaa118. (PMID: 10.1093/advances/nmaa11833200185)
Weaver CM, Lichtenstein AH, Kris-Etherton PM (2021) Perspective: guidelines needed for the conduct of human nutrition randomized controlled trials. Adv Nutr 12:21–45. https://doi.org/10.1093/advances/nmaa083. (PMID: 10.1093/advances/nmaa08333200185)
Werner SS, Binder N, Toews I et al (2021) Use of GRADE in evidence syntheses published in high-impact-factor nutrition journals: a methodological survey. J Clin Epidemiol 135:54–69. https://doi.org/10.1016/j.jclinepi.2021.02.010. (PMID: 10.1016/j.jclinepi.2021.02.01033588024)
Schwingshackl L, Knüppel S, Schwedhelm C et al (2016) Perspective: NutriGrade: a scoring system to assess and judge the meta-evidence of randomized controlled trials and cohort studies in nutrition research. Adv Nutr 7:994–1004. https://doi.org/10.3945/an.116.013052. (PMID: 10.3945/an.116.01305228140319)
Schwingshackl L, Schünemann HJ, Meerpohl JJ (2021) Improving the trustworthiness of findings from nutrition evidence syntheses: assessing risk of bias and rating the certainty of evidence. Eur J Nutr. https://doi.org/10.1007/s00394-020-02464-1. (PMID: 10.1007/s00394-020-02464-134075432)
Reagan-Shaw S, Nihal M, Ahmad N (2008) Dose translation from animal to human studies revisited. FASEB J. https://doi.org/10.1096/fj.07-9574lsf. (PMID: 10.1096/fj.07-9574lsf17942826)
Whaley P, Piggott T, Morgan RL et al (2022) Biological plausibility in environmental health systematic reviews: a GRADE concept paper. Environ Int 162:107109. https://doi.org/10.1016/j.envint.2022.107109. (PMID: 10.1016/j.envint.2022.10710935305498)
Gylling H, Plat J, Turley S et al (2014) Plant sterols and plant stanols in the management of dyslipidaemia and prevention of cardiovascular disease. Atherosclerosis 232:346–360. https://doi.org/10.1016/j.atherosclerosis.2013.11.043. (PMID: 10.1016/j.atherosclerosis.2013.11.04324468148)
Umhau JC, Zhou W, Carson RE et al (2009) Imaging incorporation of circulating docosahexaenoic acid into the human brain using positron emission tomography. J Lipid Res 50:1259–1268. https://doi.org/10.1194/jlr.M800530-JLR200. (PMID: 10.1194/jlr.M800530-JLR20019112173)
Saleh RNM, Minihane AM (2022) Fish, n-3 fatty acids, cognition and dementia risk: not just a fishy tale. Proc Nutr Soc 81:27. https://doi.org/10.1017/S0029665121003700. (PMID: 10.1017/S002966512100370034632980)
Moher D, Schulz KF, Simera I, Altman DG (2010) Guidance for developers of health research reporting guidelines. PLoS Med. https://doi.org/10.1371/journal.pmed.1000217. (PMID: 10.1371/journal.pmed.100021721829330)
Boutron I, Altman DG, Moher D et al (2017) CONSORT Statement for randomized trials of nonpharmacologic treatments: a 2017 update and a CONSORT extension for nonpharmacologic trial abstracts. Ann Intern Med 167:40–47. https://doi.org/10.7326/M17-0046. (PMID: 10.7326/M17-004628630973)
Juszczak E, Altman DG, Hopewell S, Schulz K (2019) Reporting of multi-arm parallel-group randomized trials. JAMA 321:1610. https://doi.org/10.1001/jama.2019.3087. (PMID: 10.1001/jama.2019.308731012939)
Campbell MK, Piaggio G, Elbourne DR et al (2012) Consort 2010 statement: extension to cluster randomised trials. BMJ 345:e5661. https://doi.org/10.1136/bmj.e5661. (PMID: 10.1136/bmj.e566122951546)
Dwan K, Li T, Altman DG, Elbourne D (2019) CONSORT 2010 statement: extension to randomised crossover trials. BMJ. https://doi.org/10.1136/bmj.l4378. (PMID: 10.1136/bmj.l437831366597)
Dimairo M, Pallmann P, Wason J et al (2020) The adaptive designs CONSORT extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design. Trials 21:528. https://doi.org/10.1186/s13063-020-04334-x. (PMID: 10.1186/s13063-020-04334-x32546273)
Pandis N, Chung B, Scherer RW et al (2017) CONSORT 2010 statement: extension checklist for reporting within person randomised trials. BMJ 357:j2835. https://doi.org/10.1136/bmj.j2835. (PMID: 10.1136/bmj.j283528667088)
Piaggio G, Elbourne DR, Pocock SJ et al (2012) Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement. JAMA 308:2594–2604. https://doi.org/10.1001/jama.2012.87802. (PMID: 10.1001/jama.2012.8780223268518)
Eldridge SM, Chan CL, Campbell MJ et al (2016) CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ 355:i5239. https://doi.org/10.1136/bmj.i5239. (PMID: 10.1136/bmj.i5239277772235076380)
Hemming K, Taljaard M, McKenzie JE et al (2018) Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration. BMJ. https://doi.org/10.1136/bmj.k1614. (PMID: 10.1136/bmj.k1614304134176225589)
Kwakkenbos L, Imran M, McCall SJ et al (2021) CONSORT extension for the reporting of randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE): checklist with explanation and elaboration. BMJ 373:n857. https://doi.org/10.1136/bmj.n857. (PMID: 10.1136/bmj.n857339269048082311)
Eysenbach G (2011) CONSORT-EHEALTH: improving and standardizing evaluation reports of web-based and mobile health interventions. J Med Internet Res 13:e126–e126. https://doi.org/10.2196/jmir.1923. (PMID: 10.2196/jmir.1923222098293278112)
Bose R (2010) CONSORT extensions for development effectiveness: guidelines for the reporting of randomised control trials of social and economic policy interventions in developing countries. J Dev Effect 2:173–186. https://doi.org/10.1080/19439341003624441. (PMID: 10.1080/19439341003624441)
Lo CW, Paris PW, Clemens TL et al (1985) Vitamin D absorption in healthy subjects and in patients with intestinal malabsorption syndromes. Am J Clin Nutr 42:644–649. https://doi.org/10.1093/ajcn/42.4.644. (PMID: 10.1093/ajcn/42.4.6444050723)
Tangpricha V, Koutkia P, Rieke SM et al (2003) Fortification of orange juice with vitamin D: a novel approach for enhancing vitamin D nutritional health. Am J Clin Nutr 77:1478–1483. https://doi.org/10.1093/ajcn/77.6.1478. (PMID: 10.1093/ajcn/77.6.147812791627)
Juraschek SP, Woodward M, Sacks FM et al (2017) Time course of change in blood pressure from sodium reduction and the DASH diet. Hypertension 70:923–929. https://doi.org/10.1161/HYPERTENSIONAHA.117.10017. (PMID: 10.1161/HYPERTENSIONAHA.117.1001728993451)
Yates AA, Dwyer JT, Erdman JW et al (2021) Perspective: framework for developing recommended intakes of bioactive dietary substances. Adv Nutr 12:1087–1099. https://doi.org/10.1093/advances/nmab044. (PMID: 10.1093/advances/nmab044339624618321833)
Weaver CM, Martin BR, Jackson GS et al (2009) Antiresorptive effects of phytoestrogen supplements compared with estradiol or risedronate in postmenopausal women using (41)Ca methodology. J Clin Endocrinol Metab 94:3798–3805. https://doi.org/10.1210/jc.2009-0332. (PMID: 10.1210/jc.2009-0332195841892758721)
Blumberg J, Heaney RP, Huncharek M et al (2010) Evidence-based criteria in the nutritional context. Nutr Rev 68:478–484. https://doi.org/10.1111/j.1753-4887.2010.00307.x. (PMID: 10.1111/j.1753-4887.2010.00307.x20646225)
Prentice RL, Pettinger MB, Jackson RD et al (2013) Health risks and benefits from calcium and vitamin D supplementation: Women’s Health Initiative clinical trial and cohort study. Osteoporos Int 24:567–580. https://doi.org/10.1007/s00198-012-2224-2. (PMID: 10.1007/s00198-012-2224-223208074)
Jackman LA, Millane SS, Martin BR et al (1997) Calcium retention in relation to calcium intake and postmenarcheal age in adolescent females. Am J Clin Nutr 66:327–333. https://doi.org/10.1093/ajcn/66.2.327. (PMID: 10.1093/ajcn/66.2.3279250111)
Braun M, Martin BR, Kern M et al (2006) Calcium retention in adolescent boys on a range of controlled calcium intakes. Am J Clin Nutr 84:414–418. https://doi.org/10.1093/ajcn/84.1.414. (PMID: 10.1093/ajcn/84.1.41416895892)
Agriculture and Agri-Food Canada (2013) Best practices for food-based clinical trials: guidance for planning, conducting and reporting on human studies to support health claims. Minister of Agriculture and Agri-Food Canada, Ottawa.
Kirkpatrick SI, Baranowski T, Subar AF et al (2019) Best practices for conducting and interpreting studies to validate self-report dietary assessment methods. J Acad Nutr Diet 119:1801–1816. https://doi.org/10.1016/j.jand.2019.06.010. (PMID: 10.1016/j.jand.2019.06.01031521583)
Yu E, Hu FB (2018) Dairy products, dairy fatty acids, and the prevention of cardiometabolic disease: a review of recent evidence. Curr Atheroscler Rep 20:24. https://doi.org/10.1007/s11883-018-0724-z. (PMID: 10.1007/s11883-018-0724-z29564646)
Astrup A, Magkos F, Bier DM et al (2020) Saturated fats and health: a reassessment and proposal for food-based recommendations: JACC state-of-the-art review. J Am Coll Cardiol 76:844–857. https://doi.org/10.1016/j.jacc.2020.05.077. (PMID: 10.1016/j.jacc.2020.05.07732562735)
Li Y, Hruby A, Bernstein AM et al (2015) Saturated fats compared with unsaturated fats and sources of carbohydrates in relation to risk of coronary heart disease: a prospective cohort study. J Am Coll Cardiol 66:1538–1548. https://doi.org/10.1016/j.jacc.2015.07.055. (PMID: 10.1016/j.jacc.2015.07.05526429077)
Schwingshackl L, Heseker H, Kiesswetter E, Koletzko B (2022) Dietary fat and fatty foods in the prevention of non-communicable diseases: a review of the evidence. Trends Food Sci Technol 128:173–184. https://doi.org/10.1016/j.tifs.2022.08.002. (PMID: 10.1016/j.tifs.2022.08.002)
Hooshmand S, Chai SC, Saadat RL et al (2011) Comparative effects of dried plum and dried apple on bone in postmenopausal women. Br J Nutr 106:923–930. https://doi.org/10.1017/S000711451100119X. (PMID: 10.1017/S000711451100119X21736808)
Weaver CM, Hodges JK (2021) Designing, conducting, and documenting human nutrition plant-derived intervention trials. Front Nutr. https://doi.org/10.3389/fnut.2021.782703. (PMID: 10.3389/fnut.2021.78270335004813)
Grant SP, Mayo-Wilson E, Melendez-Torres GJ, Montgomery P (2013) Reporting quality of social and psychological intervention trials: a systematic review of reporting guidelines and trial publications. PLoS ONE 8:e65442. https://doi.org/10.1371/journal.pone.0065442. (PMID: 10.1371/journal.pone.006544223734256)
Sterne JAC, Savović J, Page MJ et al (2019) RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ. https://doi.org/10.1136/bmj.l4898. (PMID: 10.1136/bmj.l489831533922)
Leroy JL, Frongillo EA, Kase BE et al (2022) Strengthening causal inference from randomised controlled trials of complex interventions. BMJ Glob Health 7:e008597. https://doi.org/10.1136/bmjgh-2022-008597. (PMID: 10.1136/bmjgh-2022-00859735688484)
Petersen KS, Kris-Etherton PM, Mccabe GP et al (2021) Perspective: planning and conducting statistical analyses for human nutrition randomized controlled trials: ensuring data quality and integrity. Adv Nutr 12:1610–1624. https://doi.org/10.1093/advances/nmab045. (PMID: 10.1093/advances/nmab04533957665)
Maki KC, Miller JW, Mccabe GP et al (2021) Perspective: laboratory considerations and clinical data management for human nutrition randomized controlled trials: guidance for ensuring quality and integrity. Adv Nutr 12:46–58. https://doi.org/10.1093/advances/nmaa088. (PMID: 10.1093/advances/nmaa08833200184)
Bennett DA, Landry D, Little J, Minelli C (2017) Systematic review of statistical approaches to quantify, or correct for, measurement error in a continuous exposure in nutritional epidemiology. BMC Med Res Methodol 17:146. https://doi.org/10.1186/s12874-017-0421-6. (PMID: 10.1186/s12874-017-0421-628927376)
Tomova GD, Arnold KF, Gilthorpe MS, Tennant PWG (2022) Adjustment for energy intake in nutritional research: a causal inference perspective. Am J Clin Nutr 115:189–198. https://doi.org/10.1093/ajcn/nqab266. (PMID: 10.1093/ajcn/nqab26634313676)
Sacks FM, Svetkey LP, Vollmer WM et al (2001) Effects on blood pressure of reduced dietary sodium and the Dietary Approaches to Stop Hypertension (DASH) diet. N Engl J Med 344:3–10. https://doi.org/10.1056/NEJM200101043440101. (PMID: 10.1056/NEJM20010104344010111136953)
Jongstra R, Hossain MM, Galetti V et al (2022) The effect of zinc-biofortified rice on zinc status of Bangladeshi preschool children: a randomized, double-masked, household-based, controlled trial. Am J Clin Nutr 115:724–737. https://doi.org/10.1093/ajcn/nqab379. (PMID: 10.1093/ajcn/nqab37934792094)
de Benoist B, Darnton-Hill I, Davidsson L et al (2007) Conclusions of the joint WHO/UNICEF/IAEA/IZiNCG interagency meeting on zinc status indicators. Food Nutr Bull 28:S480–S484. https://doi.org/10.1177/15648265070283S306. (PMID: 10.1177/15648265070283S30617988008)
World Health Organization (2007) Assessment of iodine deficiency disorders and monitoring their elimination: a guide for programme managers, 3rd edn. World Health Organization, Geneva.
Kehoe SH, Chheda PS, Sahariah SA et al (2009) Reporting of participant compliance in randomized controlled trials of nutrition supplements during pregnancy. Matern Child Nutr 5:97–103. https://doi.org/10.1111/j.1740-8709.2008.00178.x. (PMID: 10.1111/j.1740-8709.2008.00178.x19292744)
Wu B, White K, Maw MTT et al (2022) Adherence to diet and meal timing in a randomized controlled feeding study of time-restricted feeding. Nutrients 14:2283. https://doi.org/10.3390/nu14112283. (PMID: 10.3390/nu1411228335684083)
Downer MK, Gea A, Stampfer M et al (2016) Predictors of short- and long-term adherence with a Mediterranean-type diet intervention: the PREDIMED randomized trial. Int J Behav Nutr Phys Act 13:67. https://doi.org/10.1186/s12966-016-0394-6. (PMID: 10.1186/s12966-016-0394-627297426)
de Souza RJ, Eisen RB, Perera S et al (2016) Best (but oft-forgotten) practices: sensitivity analyses in randomized controlled trials. Am J Clin Nutr 103:5–17. https://doi.org/10.3945/ajcn.115.121848. (PMID: 10.3945/ajcn.115.12184826675766)
Rowe S, Alexander N, Clydesdale F et al (2009) Funding food science and nutrition research: financial conflicts and scientific integrity. Nutr Rev. https://doi.org/10.1111/j.1753-4887.2009.00188.x. (PMID: 10.1111/j.1753-4887.2009.00188.x19386030)
Chartres N, Fabbri A, Bero LA (2016) Association of industry sponsorship with outcomes of nutrition studies. JAMA Intern Med 176:1769. https://doi.org/10.1001/jamainternmed.2016.6721. (PMID: 10.1001/jamainternmed.2016.672127802480)
Fabbri A, Lai A, Grundy Q, Bero LA (2018) The influence of industry sponsorship on the research agenda: a scoping review. Am J Public Health 108:e9–e16. https://doi.org/10.2105/AJPH.2018.304677. (PMID: 10.2105/AJPH.2018.30467730252531)
Schlussel M, Moraes Silva F (2019) Securing Transparency And Reproducibility in studies of NUTritional interventions (STAR-NUT): A research programme to consolidate reporting standards for randomised controlled trials and systematic reviews of nutritional interventions. https://osf.io/b38z9/ . Accessed 1 Nov 2022.
Hopewell S, Boutron I, Chan A-W et al (2022) An update to SPIRIT and CONSORT reporting guidelines to enhance transparency in randomized trials. Nat Med 28:1740–1743. https://doi.org/10.1038/s41591-022-01989-8. (PMID: 10.1038/s41591-022-01989-836109642)
Ruel MT, Alderman H (2013) Nutrition-sensitive interventions and programmes: how can they help to accelerate progress in improving maternal and child nutrition? The Lancet 382:536–551. https://doi.org/10.1016/S0140-6736(13)60843-0. (PMID: 10.1016/S0140-6736(13)60843-0) - Contributed Indexing: Keywords: CONSORT; Dietary interventions; Expert opinion; Guidelines; Nutrition trials; Reporting
- الموضوع: Date Created: 20230426 Date Completed: 20230727 Latest Revision: 20230727
- الموضوع: 20231215
- الرقم المعرف: 10.1007/s00394-023-03137-5
- الرقم المعرف: 37099211
- المصدر:
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