A demonstration of using formal consensus methods within guideline development; a case study

BMC Medical Research Methodology - 2021
Patrice Carter1, Katriona O’Donoghue2, Katharina Dworzynski2, Laura E. O’Shea2, Victoria Louise Roberts1, Tim Reeves2, Anastasios Bastounis1, M. A. Mugglestone1, Joe Fawke3, Stephen Pilling2
1Centre for Outcomes Research and Effectiveness, Research Department of Clinical, Educational & Health Psychology, University College London, 1-19 Torrington Place, London, WC1E 7HB, UK
2National Guideline Alliance, Royal College of Obstetricians and Gynaecologists, 10-18 Union Street, London, SE1 1SZ, UK
3Leicester Neonatal Service, University Hospitals Leicester Infirmary Square, Leicester, LE1 5WW, UK

Tóm tắt

Abstract Background Recommendations within guidelines are developed by synthesising the best available evidence; when limited evidence is identified recommendations are generally based on informal consensus. However, there are potential biases in group decision making, and formal consensus methods may help reduce these. Methods We conducted a case study using formal consensus, to develop one set of recommendations within the Neonatal Parenteral Nutrition guideline being produced for the National Institute for Health and Care Excellence. Statements were generated through identification of published guidelines on several topics relating to neonatal parenteral nutrition. Ten high quality guidelines were included, and 28 statements were generated; these statements were rated by the committee via two rounds of voting. The statements which resulted in agreement were then used to develop the recommendations. Results The approach was systematic and provided transparency. Additionally, a number of lessons were learnt; including the value of selecting the appropriate topic, giving adequate time to the process, and ensuring methodologies are understood by the committee for their value and relevance. Conclusion Formal consensus is a valuable option for use within guideline development when specific criteria are met. The approach provides transparent methodology, ensuring clarity on how recommendations are developed.

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Tài liệu tham khảo

National Institute for Health Care and Excellence. Developing NICE guidelines: the manual. 2014 [cited 2019 3rd January]; Available from: https://www.nice.org.uk/Media/Default/About/what-we-do/our-programmes/developing-NICE-guidelines-the-manual.pdf.

Goncalo JA, Duguid MM. Hidden consequences of the group-serving bias: causal attributions and the quality of group decision making. Organ Behav Hum Decis Process. 2008;107(2):219–33. https://doi.org/10.1016/j.obhdp.2008.02.011.

Lipman T. Power and influence in clinical effectiveness and evidence-based medicine. Fam Pract. 2000;17(6):557–63. https://doi.org/10.1093/fampra/17.6.557.

Vinokur A, Burnstein E, Sechrest L, Wortman PM. Group decision making by experts: field study of panels evaluating medical technologies. J Pers Soc Psychol. 1985;49(1):70–84. https://doi.org/10.1037/0022-3514.49.1.70.

Larson JR Jr, et al. Diagnosing groups: the pooling, management, and impact of shared and unshared case information in team-based medical decision making. J Pers Soc Psychol. 1998;75(1):93–108. https://doi.org/10.1037/0022-3514.75.1.93.

Galinsky AD, Kray LJ. From thinking about what might have been to sharing what we know: the effects of counterfactual mind-sets on information sharing in groups. J Exp Soc Psychol. 2004;40(5):606–18. https://doi.org/10.1016/j.jesp.2003.11.005.

Jones J, Hunter D. Consensus methods for medical and health services research. BMJ. 1995;311(7001):376–80. https://doi.org/10.1136/bmj.311.7001.376.

McMillan SS, King M, Tully MP. How to use the nominal group and Delphi techniques. Int J Clin Pharm. 2016;38(3):655–62. https://doi.org/10.1007/s11096-016-0257-x.

National Institute for Health and Care Excellence (NICE). Early and locally advanced breast cancer: diagnosis and managment [NG 101]. 2018 [cited 2020 October]; Available from: https://www.nice.org.uk/guidance/ng101.

National Comprehensive Cancer Network. Development and Update of the NCCN Guidelines. 2021 [cited 2021 March]; Available from: https://www.nccn.org/professionals/development.aspx.

World Health Organization. WHO Handbook for Guideline Development, 2nd Edition. 2014 [cited 2021 March]; Available from: https://www.who.int/publications/i/item/9789241548960.

The Pharmaceutical Benefits Advisor Committee. Guidelines for preparing submission to the Pharmaceutical Benefits Advisory Committee (PBAC). 2016 [cited 2021 19 March ]; Available from: https://pbac.pbs.gov.au/home.html.

Baxter, P., . Jack, S.,, Qualitative case study methodology: study design and implementation for novice researchers. Qual Rep, 2008. 13: p. 544–559.

Murphy MK, Black NA, Lamping DL, McKee CM, Sanderson CF, Askham J, et al. Consensus develpment methods, and their use in clinical guideline development. Health Technol Assess. 1998;2(3).

Nair R, Aggarwal R, Khanna D. Methods of formal consensus in classification/diagnostic criteria and guideline development. Semin Arthritis Rheum. 2011;41(2):95–105. https://doi.org/10.1016/j.semarthrit.2010.12.001.

National Institute for Health and Care Excellence. Neonatal parenteral nutrition. 2020 [cited 2020 26th February]; Available from: https://www.nice.org.uk/guidance/NG154.

Brouwers MC, Kho ME, Browman GP, Burgers JS, Cluzeau F, Feder G, Fervers B, Graham ID, Grimshaw J, Hanna SE, Littlejohns P, Makarski J, Zitzelsberger L. CMAJ. 2010;182(18):E839–E842. https://doi.org/10.1503/cmaj.090449.

Ben X-M. Nutritional management of newborn infants: practical guidelines. World J Gastroenterol. 2008;14(40):6133–9. https://doi.org/10.3748/wjg.14.6133.

Boullata JI, et al. A.S.P.E.N. Clin Guidelines. 2014;38(3):334–77.

Medicine, B.A.o.P. The Provision of Parenteral Nutrition within Neonatal Services - A Framework for Practice. 2016 [cited 2019 25th July]; Available from: https://www.bapm.org/resources/provision-parenteral-nutrition-within-neonatal-services-framework-practice-2016 .

Cai W. CSPEN guidelines for nutrition support in neonates. Asia Pac J Clin Nutr. 2013;22(4):655–63.

Fusch C, et al. Neonatology/Paediatrics - Guidelines on Parenteral Nutrition, Chapter 13. German Med Sci. 2009;7:Doc15.

Ireland, H.S.E.a.R.C.o.P.o. Guideline on the Use of Parenteral Nutrition in Neonatal and Paediatric Units. 2017 [cited 2019 4th October]; Available from: https://www.hse.ie/eng/services/publications/clinical-strategy-and-programmes/guideline-on-the-use-of-parenteral-nutrition-in-neonatal-and-paediatric-units.pdf.

Radbone L, Birch J, Sun B. Clinical Guideline: Parenteral Feeding of Infants on the Neonatal Unit. NHS East of England Perinatal Network. 2015. https://www.nnuh.nhs.uk/publication/tpn-parenteral-feeding-of-infants-on-the-neonatal-unit-regional-network/.

Puntis JWL, Hojsak I, Ksiazyk J, Braegger C, Bronsky J, Cai W, et al. ESPGHAN/ESPEN/ESPR/CSPEN guidelines on pediatric parenteral nutrition: Organisational aspects. Clin Nutr. 2018;37(6):2392–400. https://doi.org/10.1016/j.clnu.2018.06.953.

Mihatsch W, Fewtrell M, Goulet O, Molgaard C, Picaud JC, Senterre T, et al. ESPGHAN/ESPEN/ESPR/CSPEN guidelines on pediatric parenteral nutrition: calcium, phosphorus and magnesium. Clin Nutr. 2018;37(6):2360–5. https://doi.org/10.1016/j.clnu.2018.06.950.

David, O. Guideline. Women and Babies: Newborn parenteral nutition. 2018 [cited 2019 4th October]; Available from: https://www.slhd.nsw.gov.au/RPA/neonatal%5Ccontent/pdf/guidelines/Newborn_parenteral_nutrition_2018.pdf.

Vanek VW, et al. A.S.P.E.N. Position Paper. 2012;27(4):440–91.

Vanek VW, Ayers P, Kraft M, Bouche JM, Do VT, Durham CW, et al. A call to action for optimizing the electronic health record in the parenteral nutrition workflow. Am J Health Syst Pharm. 2018;75(18):1400–20. https://doi.org/10.2146/ajhp180276.

Service, W.A.W.a.N.H. Parenteral Nutrition. 2016 [cited 2019 4th October]; Available from: https://www.kemh.health.wa.gov.au/~/media/Files/Hospitals/WNHS/For%20health%20professionals/Clinical%20guidelines/NEO/WNHS.NEO.ParenteralNutition.pdf.

Jochum F, Moltu SJ, Senterre T, Nomayo A, Goulet O, Iacobelli S, et al. ESPGHAN/ESPEN/ESPR/CSPEN guidelines on pediatric parenteral nutrition: fluid and electrolytes. Clin Nutr. 2018;37(6):2344–53. https://doi.org/10.1016/j.clnu.2018.06.948.

Domellöf M, Szitanyi P, Simchowitz V, Franz A, Mimouni F, Braegger C, et al. ESPGHAN/ESPEN/ESPR/CSPEN guidelines on pediatric parenteral nutrition: Iron and trace minerals. Clin Nutr. 2018;37(6):2354–9. https://doi.org/10.1016/j.clnu.2018.06.949.

Bronsky J, Campoy C, Braegger C, Braegger C, Bronsky J, Cai W, et al. ESPGHAN/ESPEN/ESPR/CSPEN guidelines on pediatric parenteral nutrition: vitamins. Clin Nutr. 2018;37(6):2366–78. https://doi.org/10.1016/j.clnu.2018.06.951.

Hartman C, Shamir R, Simchowitz V, Lohner S, Cai W, Decsi T, et al. ESPGHAN/ESPEN/ESPR/CSPEN guidelines on pediatric parenteral nutrition: complications. Clin Nutr. 2018;37(6):2418–29. https://doi.org/10.1016/j.clnu.2018.06.956.

Lapillonne A, Fidler Mis N, Goulet O, van den Akker CHP, Wu J, Koletzko B, et al. ESPGHAN/ESPEN/ESPR/CSPEN guidelines on pediatric parenteral nutrition: lipids. Clin Nutr. 2018;37(6):2324–36. https://doi.org/10.1016/j.clnu.2018.06.946.

Campbell SM, Cantrill JA. Consensus methods in prescribing research. J Clin Pharm Ther. 2001;26(1):5–14. https://doi.org/10.1046/j.1365-2710.2001.00331.x.

Roberts VK. Participants expectations and experiences of using the nominal group technique (NGT) in a NICE healthcare guideline: a pilot study. In: Clinical, Education & Health Psychology: UCL; 2019.

Eccles M, Clapp Z, Grimshaw J, Adams PC, Higgins B, Purves I, et al. Developing valid guidelines: methodological and procedural issues from the north of England evidence based guideline development project. Quality in Health Care. 1996;5(1):44–50. https://doi.org/10.1136/qshc.5.1.44.

Trickey H, Harvey I, Wilcock G, Sharp D. Formal consensus and consultation: a qualitative method for development of a guideline for dementia. Quality in Health Care. 1998;7(4):192–9. https://doi.org/10.1136/qshc.7.4.192.

Rycroft-Malone J. Formal consensus: the development of a national clinical guideline. Quality in Health Care. 2001;10(4):238–44. https://doi.org/10.1136/qhc.0100238.

Hutchings A, Raine R, Sanderson C, Black N. A comparison of formal consensus methods used for developing clinical guidelines. J Health Serv Res Policy. 2006;11(4):218–24. https://doi.org/10.1258/135581906778476553. PMID: 17018195.

Raine R, Sanderson C, Hutchings A, Carter S, Larkin K, Black N. An experimental study of determinants of group judgments in clinical guideline development. Lancet. 2004;364(9432):429–37. https://doi.org/10.1016/S0140-6736(04)16766-4.

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