Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
BMC Medical Research Methodology
Published in: BMC Medical Research Methodology 1/2019

Open Access 01-12-2019 | Research article

Hierarchies of evidence applied to lifestyle Medicine (HEALM): introduction of a strength-of-evidence approach based on a methodological systematic review

Authors: D. L. Katz, M. C. Karlsen, M. Chung, M. M. Shams-White, L. W. Green, J. Fielding, A. Saito, W. Willett

Published in: BMC Medical Research Methodology | Issue 1/2019

Login to get access

Abstract

Background

Current methods for assessing strength of evidence prioritize the contributions of randomized controlled trials (RCTs). The objective of this study was to characterize strength of evidence (SOE) tools in recent use, identify their application to lifestyle interventions for improved longevity, vitality, or successful aging, and to assess implications of the findings.

Methods

The search strategy was created in PubMed and modified as needed for four additional databases: Embase, AnthropologyPlus, PsycINFO, and Ageline, supplemented by manual searching. Systematic reviews and meta-analyses of intervention trials or observational studies relevant to lifestyle intervention were included if they used a specified SOE tool. Data was collected for each SOE tool. Conditions necessary for assigning the highest SOE grading and treatment of prospective cohort studies within each SOE rating framework were summarized. The expert panel convened to discuss the implications of findings for assessing evidence in the domain of lifestyle medicine.

Results and conclusions

A total of 15 unique tools were identified. Ten were tools developed and used by governmental agencies or other equivalent professional bodies and were applicable in a variety of settings. Of these 10, four require consistent results from RCTs of high quality to award the highest rating of evidence. Most SOE tools include prospective cohort studies only to note their secondary contribution to overall SOE as compared to RCTs. We developed a new construct, Hierarchies of Evidence Applied to Lifestyle Medicine (HEALM), to illustrate the feasibility of a tool based on the specific contributions of diverse research methods to understanding lifetime effects of health behaviors. Assessment of evidence relevant to lifestyle medicine requires a potential adaptation of SOE approaches when outcomes and/or exposures obviate exclusive or preferential reliance on RCTs. This systematic review was registered with the International Prospective Register of Systematic Reviews, PROSPERO [CRD42018082148].
Appendix
Available only for authorised users
Literature
1.
Ioannidis JP, Trepanowski JF. Disclosures in nutrition research: why it is different. JAMA. 2018;319(6):547–8.PubMedCrossRef
2.
Laville M, Segrestin B, Alligier M, Ruano-Rodríguez C, Serra-Majem L, Hiesmayr M, et al. Evidence-based practice within nutrition: what are the barriers for improving the evidence and how can they be dealt with? Trials. 2017;18(1):425.PubMedPubMedCentralCrossRef
3.
Jørgensen T, Jacobsen RK, Toft U, Aadahl M, Glümer C, Pisinger C. Effect of screening and lifestyle counselling on incidence of ischaemic heart disease in general population: Inter99 randomised trial. BMJ. 2014;348:g3617.PubMedPubMedCentralCrossRef
4.
Katz DLFE, Medicine FMDL. Maxcy-Rosenau-last public health and preventive Medicine. 16th Ed. In: Production: January; 2019.
5.
Atkins D, Best D, Briss PA, Eccles M, Falck-Ytter Y, Flottorp S, et al. Grading quality of evidence and strength of recommendations. BMJ (Clinical research ed). 2004;328(7454):1490.CrossRef
6.
Owens DK, Lohr KN, Atkins D, Treadwell JR, Reston JT, Bass EB, et al. AHRQ series paper 5: grading the strength of a body of evidence when comparing medical interventions—Agency for Healthcare Research and Quality and the effective health-care program. J Clin Epidemiol. 2010;63(5):513–23.PubMedCrossRef
7.
Guyatt GH, Oxman AD, Schünemann HJ, Tugwell P, Knottnerus A. GRADE guidelines: a new series of articles in the journal of clinical epidemiology. J Clin Epidemiol. 2011;64(4):380–2.PubMedCrossRef
8.
Guyatt GH, Oxman AD, Kunz R, Vist GE, Falck-Ytter Y, Schünemann HJ. Rating quality of evidence and strength of recommendations: what is “quality of evidence” and why is it important to clinicians? BMJ: British medical journal. 2008;336(7651):995.PubMedCrossRef
9.
Guyatt GH, Oxman AD, Kunz R, Falck-Ytter Y, Vist GE, Liberati A, et al. Rating quality of evidence and strength of recommendations: going from evidence to recommendations. BMJ: British Medical Journal. 2008;336(7652):1049.PubMedCrossRef
10.
Kushner RF, Sorensen KW. Lifestyle medicine: the future of chronic disease management. Curr Opin Endocrinol Diabetes Obes. 2013;20(5):389–95.PubMedCrossRef
11.
Ioannidis JP. We need more randomized trials in nutrition—preferably large, long-term, and with negative results. Oxford University Press. 2016.
12.
Rosen L, Manor O, Engelhard D, Zucker D. In defense of the randomized controlled trial for health promotion research. Am J Public Health. 2006;96(7):1181–6.PubMedPubMedCentralCrossRef
13.
14.
Barnard ND, Willett WC, Ding EL. The misuse of meta-analysis in nutrition research. JAMA. 2017;318(15):1435–6.PubMedCrossRef
15.
Mokdad AH, Ballestros K, Echko M, Glenn S, Olsen HE, Mullany E, et al. The state of US health, 1990-2016: burden of diseases, injuries, and risk factors among US states. JAMA. 2018;319(14):1444–72.PubMedPubMedCentralCrossRef
16.
Horwitz RI, Hayes-Conroy A, Caricchio R, Singer BH. From evidence based Medicine to Medicine based evidence. Am J Med. 2017.
17.
Hannan EL. Randomized clinical trials and observational studies. guidelines for assessing respective strengths and limitations JACC Cardiovasc Interv. 2008;1(3):211–7.PubMedCrossRef
18.
Feinstein AR, Horwitz RI. Problems in the “evidence” of “evidence-based medicine”. Am J Med. 1997;103(6):529–35.PubMedCrossRef
19.
Frieden TR. Evidence for health decision making - beyond randomized, controlled trials. N Engl J Med. 2017;377(5):465–75.PubMedCrossRef
20.
Guerin E. Disentangling vitality, well-being, and quality of life: a conceptual examination emphasizing their similarities and differences with special application in the physical activity domain. J Phys Act Health. 2012;9(6):896–908.PubMedCrossRef
21.
Fries J, Green L, Levine S. Health promotion and the compression of morbidity. Lancet. 1989;333(8636):481–3.CrossRef
22.
Charlton BM, Rich-Edwards JW, Colditz GA, Missmer SA, Rosner BA, Hankinson SE, et al. Oral contraceptive use and mortality after 36 years of follow-up in the Nurses' health study: prospective cohort study. BMJ. 2014;349:g6356.PubMedPubMedCentralCrossRef
23.
Elliot AJ, Mooney CJ, Infurna FJ, Chapman BP. Associations of lifetime trauma and chronic stress with C-reactive protein in adults ages 50 years and older: examining the moderating role of perceived control. Psychosom Med. 2017;79(6):622–30.PubMedCrossRef
24.
Reinikainen J, Laatikainen T, Karvanen J, Tolonen H. Lifetime cumulative risk factors predict cardiovascular disease mortality in a 50-year follow-up study in Finland. Int J Epidemiol. 2015;44(1):108–16.PubMedCrossRef
25.
Ioannidis JP. Some main problems eroding the credibility and relevance of randomized trials. Bull NYU Hosp Jt Dis. 2008;66(2):135–9.PubMed
26.
Seidelmann SB, Claggett B, Cheng S, Henglin M, Shah A, Steffen LM, et al. Dietary carbohydrate intake and mortality: a prospective cohort study and meta-analysis. Lancet Public Health. 2018;3(9):e419–e28.PubMedPubMedCentralCrossRef
27.
Crichton GE, Howe PR, Buckley JD, Coates AM, Murphy KJ, Bryan J. Long-term dietary intervention trials: critical issues and challenges. Trials. 2012;13:111.PubMedPubMedCentralCrossRef
28.
The alpha-tocopherol, beta-carotene lung cancer prevention study: design, methods, participant characteristics, and compliance. The ATBC Cancer Prevention Study Group. Ann Epidemiol. 1994;4(1):1–10.
29.
Nakamura R. Animal models and basic science—bench to bedside: session introduction. ILAR J. 2011;52(Suppl_1):493.
30.
Sanson-Fisher RW, Bonevski B, Green LW, D'Este C. Limitations of the randomized controlled trial in evaluating population-based health interventions. Am J Prev Med. 2007;33(2):155–61.PubMedCrossRef
31.
Moher D, Liberati A, Tetzlaff J, Altman DG. Group P. preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Ann Intern Med. 2009;151(4):264–9, W64.PubMedCrossRef
32.
33.
David Katz, Jonathan Fielding, Lawrence Green, Ralph Horwitz, John Ioannidis, Walter Willett, Mei Chung, Micaela Karlsen, Marissa Shams-White, Ayumi Saito, Deena Wang. Hierarchies of evidence applied to lifestyle Medicine (HEaLM): a methodological systematic review of evidence grading tools to inform development of the best method to assess strength of evidence for lifestyle medicine interventions and related clinical outcomes, including longevity and healthy aging. PROSPERO 2018 CRD42018082148 available from: https://​www.​crd.​york.​ac.​uk/​prospero/​display_​record.​php?​RecordID=​82148.
34.
35.
Atkins D, Best D, Briss PA, Eccles M, Falck-Ytter Y, Flottorp S, et al. Grading quality of evidence and strength of recommendations. BMJ. 2004;328(7454):1490.PubMedCrossRef
36.
Food, Administration D. Guidance for industry and FDA: interim evidence-based ranking system for scientific data. July 10, 2003.
37.
Sallis JF, Prochaska JJ, Taylor WC. A review of correlates of physical activity of children and adolescents. Med Sci Sports Exerc. 2000;32(5):963–75.PubMedCrossRef
38.
Bully P, Sanchez A, Zabaleta-del-Olmo E, Pombo H, Grandes G. Evidence from interventions based on theoretical models for lifestyle modification (physical activity, diet, alcohol and tobacco use) in primary care settings: a systematic review. Prev Med. 2015;76 Suppl:S76–93.PubMedCrossRef
39.
van Poppel MN, Koes BW, Smid T, Bouter LM. A systematic review of controlled clinical trials on the prevention of back pain in industry. Occup Environ Med. 1997;54(12):841–7.PubMedPubMedCentralCrossRef
40.
Slavin RE. Best evidence synthesis: an intelligent alternative to meta-analysis. J Clin Epidemiol. 1995;48(1):9–18.PubMedCrossRef
41.
Mansi S, Milosavljevic S, Baxter GD, Tumilty S, Hendrick P. A systematic review of studies using pedometers as an intervention for musculoskeletal diseases. BMC Musculoskelet Disord. 2014;15(1):231.PubMedPubMedCentralCrossRef
42.
Geraedts H, Zijlstra A, Bulstra SK, Stevens M, Zijlstra W. Effects of remote feedback in home-based physical activity interventions for older adults: a systematic review. Patient Educ Couns. 2013;91(1):14–24.PubMedCrossRef
43.
Singh A, Uijtdewilligen L, Twisk JW, Van Mechelen W, Chinapaw MJ. Physical activity and performance at school: a systematic review of the literature including a methodological quality assessment. Arch Pediatr Adolesc Med. 2012;166(1):49–55.PubMedCrossRef
44.
Peurala SH, Karttunen AH, Sjögren T, Paltamaa J, Heinonen A. Evidence for the effectiveness of walking training on walking and self-care after stroke: a systematic review and meta-analysis of randomized controlled trials. J Rehabil Med. 2014;46(5):387–99.PubMedCrossRef
45.
Stuck AE, Walthert JM, Nikolaus T, Bula CJ, Hohmann C, Beck JC. Risk factors for functional status decline in community-living elderly people: a systematic literature review. Soc Sci Med. 1999;48(4):445–69.PubMedCrossRef
46.
van der Vorst A, Zijlstra GR, De Witte N, Duppen D, Stuck AE, Kempen GI, et al. Limitations in activities of daily living in community-dwelling people aged 75 and over: a systematic literature review of risk and protective factors. PLoS One. 2016;11(10):e0165127.PubMedPubMedCentralCrossRef
47.
Briss PA, Zaza S, Pappaioanou M, Fielding J, Wright-De Aguero L, Truman BI, et al. Developing an evidence-based guide to community preventive services--methods. The task force on community preventive services. Am J Prev Med. 2000;18(1 Suppl):35–43.PubMedCrossRef
48.
Moyer V, Bibbins-Domingo K. The US preventive services task force: what is it and what does it do? N C Med J. 2015;76(4):238–42.PubMed
49.
Scientific Report of the 2015 Dietary Guidelines Advisory Committee. 2015.
50.
Handu D, Moloney L, Wolfram T, Ziegler P, Acosta A, Steiber A. Academy of nutrition and dietetics methodology for conducting systematic reviews for the evidence analysis library. J Acad Nutr Diet. 2016;116(2):311–8.PubMedCrossRef
51.
Berkman ND, Lohr KN, Ansari MT, Balk EM, Kane R, McDonagh M, et al. Grading the strength of a body of evidence when assessing health care interventions: an EPC update. J Clin Epidemiol. 2015;68(11):1312–24.PubMedCrossRef
52.
53.
Oxford Center for Evidence-Based Medicine Levels of Evidence. Accessed online May Afhwcno-l-o-e.
54.
55.
Katz DL, Meller S. Can we say what diet is best for health? Annu Rev Public Health. 2014;35:83–103.PubMedCrossRef
56.
Blake P, Durao S, Naude CE, Bero L. An analysis of methods used to synthesize evidence and grade recommendations in food-based dietary guidelines. Nutr Rev. 2018;76(4):290–300.PubMedPubMedCentralCrossRef
57.
National Academies of Sciences E, Medicine. Guiding principles for developing dietary reference intakes based on chronic disease: National Academies Press; 2017.
58.
Global, regional, and national age-sex-specific mortality for 282 causes of death in 195 countries and territories, 1980–2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018;392(10159):1736–1788.
59.
Belbasis L, Köhler C, Stefanis N, Stubbs B, van Os J, Vieta E, et al. Risk factors and peripheral biomarkers for schizophrenia spectrum disorders: an umbrella review of meta-analyses. Acta Psychiatr Scand. 2018;137(2):88–97.PubMedCrossRef
60.
Manson JE, Chlebowski RT, Stefanick ML, Aragaki AK, Rossouw JE, Prentice RL, et al. Menopausal hormone therapy and health outcomes during the intervention and extended poststopping phases of the Women’s Health Initiative randomized trials. JAMA. 2013;310(13):1353–68.PubMedCrossRef
61.
Anglemyer A, Horvath HT, Bero L. Healthcare outcomes assessed with observational study designs compared with those assessed in randomized trials. Cochrane Database Syst Rev. (2014, 4):MR000034.
62.
Estruch R, Ros E, Salas-Salvado J, Covas MI, Corella D, Aros F, et al. Primary prevention of cardiovascular disease with a Mediterranean diet supplemented with extra-virgin olive oil or nuts. N Engl J Med. 2018;378(25):e34.PubMedCrossRef
63.
Goldberg RB, Bray GA, Marcovina SM, Mather KJ, Orchard TJ, Perreault L, et al. Non-traditional biomarkers and incident diabetes in the diabetes prevention program: comparative effects of lifestyle and metformin interventions. Diabetologia. 2018.
64.
Sarrel PM, Njike VY, Vinante V, Katz DL. The mortality toll of estrogen avoidance: an analysis of excess deaths among hysterectomized women aged 50 to 59 years. Am J Public Health. 2013;103(9):1583–8.PubMedPubMedCentralCrossRef
65.
Prentice RL, Langer R, Stefanick ML, Howard BV, Pettinger M, Anderson G, et al. Combined postmenopausal hormone therapy and cardiovascular disease: toward resolving the discrepancy between observational studies and the Women's Health Initiative clinical trial. Am J Epidemiol. 2005;162(5):404–14.PubMedCrossRef
66.
Hodis HN, Sarrel PM. Menopausal hormone therapy and breast cancer: what is the evidence from randomized trials? Climacteric : the journal of the International Menopause Society. 2018;21(6):521–8.CrossRef
67.
Silverman SL. From randomized controlled trials to observational studies. Am J Med. 2009;122(2):114–20.PubMedCrossRef
Metadata
Title
Hierarchies of evidence applied to lifestyle Medicine (HEALM): introduction of a strength-of-evidence approach based on a methodological systematic review
Authors
D. L. Katz
M. C. Karlsen
M. Chung
M. M. Shams-White
L. W. Green
J. Fielding
A. Saito
W. Willett
Publication date
01-12-2019
Publisher
BioMed Central
Published in
BMC Medical Research Methodology / Issue 1/2019
Electronic ISSN: 1471-2288
DOI
https://doi.org/10.1186/s12874-019-0811-z

Other articles of this Issue 1/2019

BMC Medical Research Methodology 1/2019 Go to the issue

Technical advance

A comparison of the polytomous Rasch analysis output of RUMM2030 and R (ltm/eRm/TAM/lordif)

Research article

The current use of feasibility studies in the assessment of feasibility for stepped-wedge cluster randomised trials: a systematic review

Research article

Illustration of different modelling assumptions for estimation of loss in expectation of life due to cancer

Research article

Cross-cultural adaptation of the Pain Medication Questionnaire for use in Brazil

Debate

Scoping implementation science for the beginner: locating yourself on the “subway line” of translational research

Research article

Assessment of the abstract reporting of systematic reviews of dose-response meta-analysis: a literature survey