Comparison between the standard and a new alternative format of the Summary-of-Findings tables in Cochrane review users: study protocol for a randomized controlled trial

doi:10.1186/s13063-015-0649-6

Randomized Controlled Trial

. 2015 Apr 16:16:164.

doi: 10.1186/s13063-015-0649-6.

Comparison between the standard and a new alternative format of the Summary-of-Findings tables in Cochrane review users: study protocol for a randomized controlled trial

Alonso Carrasco-Labra^{1

2}, Romina Brignardello-Petersen^{3

4}, Nancy Santesso⁵, Ignacio Neumann⁶, Reem A Mustafa^{7

8}, Lawrence Mbuagbaw⁹, Itziar Etxeandia Ikobaltzeta¹⁰, Catherine De Stio¹¹, Lauren J McCullagh¹², Pablo Alonso-Coello^{13

14}, Joerg J Meerpohl¹⁵, Per Olav Vandvik¹⁶, Jan L Brozek^{17

18}, Elie A Akl^{19

20}, Patrick Bossuyt²¹, Rachel Churchill²², Claire Glenton^{23

24}, Sarah Rosenbaum^{25

26}, Peter Tugwell²⁷, Vivian Welch²⁸, Gordon Guyatt^{29

30}, Holger Schünemann^{31

32}

Affiliations

¹ Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, ON, Canada. alonsocarrascolabra@gmail.com.
² Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Universidad de Chile, Santiago, Chile. alonsocarrascolabra@gmail.com.
³ Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada. rominabp@gmail.com.
⁴ Evidence-Based Dentistry Unit, Faculty of Dentistry, Universidad de Chile, Santiago, Chile. rominabp@gmail.com.
⁵ Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, ON, Canada. santesna@mcmaster.ca.
⁶ Pontificia Universidad Católica de Chile, Santiago, Chile. ignacio.neumann@gmail.com.
⁷ Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, ON, Canada. ramustafa@gmail.com.
⁸ Departments of Medicine/Nephrology and Biomedical & Health Informatics, University of Missouri, Kansas City, MO, USA. ramustafa@gmail.com.
⁹ Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, ON, Canada. mbuagbawl@yahoo.com.
¹⁰ OSTEBA, Basque Office for Health Technology Assessment, Ministry for Health, Basque Government, Donostia-San Sebastián, Spain. itzi.etxe@gmail.com.
¹¹ Department of Medicine, Hofstra North Shore LIJ School of Medicine, Manhasset, NY, USA. cdestio@NSHS.edu.
¹² Department of Medicine, Hofstra North Shore LIJ School of Medicine, Manhasset, NY, USA. lmccullagh@NSHS.edu.
¹³ Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, ON, Canada. palonso@santpau.cat.
¹⁴ Iberoamerican Cochrane Center, Biomedical Research Institute Sant Pau-CIBER of Epidemiology and Public Health (CIBERESP-IIB Sant Pau), Barcelona, Spain. palonso@santpau.cat.
¹⁵ German Cochrane Center, Medical Center - University of Freiburg, Freiburg, Germany. meerpohl@cochrane.de.
¹⁶ Department of Medicine, Innlandet Hospital Trust-division, Gjøvik, Norway. per.vandvik@gmail.com.
¹⁷ Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, ON, Canada. brozekj@mcmaster.ca.
¹⁸ Department of Medicine, McMaster University, Hamilton, ON, Canada. brozekj@mcmaster.ca.
¹⁹ Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, ON, Canada. ea32@aub.edu.lb.
²⁰ American University of Beirut, Beirut, Lebanon. ea32@aub.edu.lb.
²¹ Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Medical Center, University of Amsterdam, Meibergdreef, Amsterdam, The Netherlands. p.m.bossuyt@amc.uva.nl.
²² Center for Academic Mental Health, School of Social and Community Medicine, University of Bristol, Bristol, UK. Rachel.Churchill@ccdan.org.
²³ The Norwegian Branch of the Nordic Cochrane Center, Oslo, Norway. Claire.Glenton@kunnskapssenteret.no.
²⁴ Norwegian Knowledge Center for the Health Services, Oslo, Norway. Claire.Glenton@kunnskapssenteret.no.
²⁵ The Norwegian Branch of the Nordic Cochrane Center, Oslo, Norway. sarah@rosenbaum.no.
²⁶ Norwegian Knowledge Center for the Health Services, Oslo, Norway. sarah@rosenbaum.no.
²⁷ Department of Medicine, Faculty of Medicine, University of Ottawa, K1H 8 M5, Ottawa, ON, Canada. Tugwell.BB@uOttawa.ca.
²⁸ Bruyère Research Institute, University of Ottawa, Ottawa, ON, Canada. Vivian.Welch@uottawa.ca.
²⁹ Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, ON, Canada. guyatt@mcmaster.ca.
³⁰ Department of Medicine, McMaster University, Hamilton, ON, Canada. guyatt@mcmaster.ca.
³¹ Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, ON, Canada. schuneh@mcmaster.ca.
³² Department of Medicine, McMaster University, Hamilton, ON, Canada. schuneh@mcmaster.ca.

PMID: 25873338
PMCID: PMC4416250
DOI: 10.1186/s13063-015-0649-6

Randomized Controlled Trial

Comparison between the standard and a new alternative format of the Summary-of-Findings tables in Cochrane review users: study protocol for a randomized controlled trial

Alonso Carrasco-Labra et al. Trials. 2015.

. 2015 Apr 16:16:164.

doi: 10.1186/s13063-015-0649-6.

Authors

Affiliations

¹ Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, ON, Canada. alonsocarrascolabra@gmail.com.
² Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Universidad de Chile, Santiago, Chile. alonsocarrascolabra@gmail.com.
³ Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada. rominabp@gmail.com.
⁴ Evidence-Based Dentistry Unit, Faculty of Dentistry, Universidad de Chile, Santiago, Chile. rominabp@gmail.com.
⁵ Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, ON, Canada. santesna@mcmaster.ca.
⁶ Pontificia Universidad Católica de Chile, Santiago, Chile. ignacio.neumann@gmail.com.
⁷ Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, ON, Canada. ramustafa@gmail.com.
⁸ Departments of Medicine/Nephrology and Biomedical & Health Informatics, University of Missouri, Kansas City, MO, USA. ramustafa@gmail.com.
⁹ Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, ON, Canada. mbuagbawl@yahoo.com.
¹⁰ OSTEBA, Basque Office for Health Technology Assessment, Ministry for Health, Basque Government, Donostia-San Sebastián, Spain. itzi.etxe@gmail.com.
¹¹ Department of Medicine, Hofstra North Shore LIJ School of Medicine, Manhasset, NY, USA. cdestio@NSHS.edu.
¹² Department of Medicine, Hofstra North Shore LIJ School of Medicine, Manhasset, NY, USA. lmccullagh@NSHS.edu.
¹³ Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, ON, Canada. palonso@santpau.cat.
¹⁴ Iberoamerican Cochrane Center, Biomedical Research Institute Sant Pau-CIBER of Epidemiology and Public Health (CIBERESP-IIB Sant Pau), Barcelona, Spain. palonso@santpau.cat.
¹⁵ German Cochrane Center, Medical Center - University of Freiburg, Freiburg, Germany. meerpohl@cochrane.de.
¹⁶ Department of Medicine, Innlandet Hospital Trust-division, Gjøvik, Norway. per.vandvik@gmail.com.
¹⁷ Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, ON, Canada. brozekj@mcmaster.ca.
¹⁸ Department of Medicine, McMaster University, Hamilton, ON, Canada. brozekj@mcmaster.ca.
¹⁹ Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, ON, Canada. ea32@aub.edu.lb.
²⁰ American University of Beirut, Beirut, Lebanon. ea32@aub.edu.lb.
²¹ Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Medical Center, University of Amsterdam, Meibergdreef, Amsterdam, The Netherlands. p.m.bossuyt@amc.uva.nl.
²² Center for Academic Mental Health, School of Social and Community Medicine, University of Bristol, Bristol, UK. Rachel.Churchill@ccdan.org.
²³ The Norwegian Branch of the Nordic Cochrane Center, Oslo, Norway. Claire.Glenton@kunnskapssenteret.no.
²⁴ Norwegian Knowledge Center for the Health Services, Oslo, Norway. Claire.Glenton@kunnskapssenteret.no.
²⁵ The Norwegian Branch of the Nordic Cochrane Center, Oslo, Norway. sarah@rosenbaum.no.
²⁶ Norwegian Knowledge Center for the Health Services, Oslo, Norway. sarah@rosenbaum.no.
²⁷ Department of Medicine, Faculty of Medicine, University of Ottawa, K1H 8 M5, Ottawa, ON, Canada. Tugwell.BB@uOttawa.ca.
²⁸ Bruyère Research Institute, University of Ottawa, Ottawa, ON, Canada. Vivian.Welch@uottawa.ca.
²⁹ Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, ON, Canada. guyatt@mcmaster.ca.
³⁰ Department of Medicine, McMaster University, Hamilton, ON, Canada. guyatt@mcmaster.ca.
³¹ Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, ON, Canada. schuneh@mcmaster.ca.
³² Department of Medicine, McMaster University, Hamilton, ON, Canada. schuneh@mcmaster.ca.

PMID: 25873338
PMCID: PMC4416250
DOI: 10.1186/s13063-015-0649-6

Abstract

Background: Systematic reviews represent one of the most important tools for knowledge translation but users often struggle with understanding and interpreting their results. GRADE Summary-of-Findings tables have been developed to display results of systematic reviews in a concise and transparent manner. The current format of the Summary-of-Findings tables for presenting risks and quality of evidence improves understanding and assists users with finding key information from the systematic review. However, it has been suggested that additional methods to present risks and display results in the Summary-of-Findings tables are needed.

Methods/design: We will conduct a non-inferiority parallel-armed randomized controlled trial to determine whether an alternative format to present risks and display Summary-of-Findings tables is not inferior compared to the current standard format. We will measure participant understanding, accessibility of the information, satisfaction, and preference for both formats. We will invite systematic review users to participate (that is clinicians, guideline developers, and researchers). The data collection process will be undertaken using the online 'Survey Monkey' system. For the primary outcome understanding, non-inferiority of the alternative format (Table A) to the current standard format (Table C) of Summary-of-Findings tables will be claimed if the upper limit of a 1-sided 95% confidence interval (for the difference of proportion of participants answering correctly a given question) excluded a difference in favor of the current format of more than 10%.

Discussion: This study represents an effort to provide systematic reviewers with additional options to display review results using Summary-of-Findings tables. In this way, review authors will have a variety of methods to present risks and more flexibility to choose the most appropriate table features to display (that is optional columns, risks expressions, complementary methods to display continuous outcomes, and so on).

Trials registration: NCT02022631 (21 December 2013).

PubMed Disclaimer

Figures

**Figure 1**
Study design and flow-chart.

**Figure 2**
Alternative Summary-of-Findings (SoF) table format (Table A).

**Figure 3**
Current Summary-of-Findings (SoF) table format (Table C).

See this image and copyright information in PMC

Cited by

Interactive Visual Displays for Interpreting the Results of Clinical Trials: Formative Evaluation With Case Vignettes.
Bian J, Weir C, Unni P, Borbolla D, Reese T, Wan YJ, Del Fiol G. Bian J, et al. J Med Internet Res. 2018 Jun 25;20(6):e10507. doi: 10.2196/10507. J Med Internet Res. 2018. PMID: 29941416 Free PMC article.
Deworming drugs for soil-transmitted intestinal worms in children: effects on nutritional indicators, haemoglobin, and school performance.
Taylor-Robinson DC, Maayan N, Soares-Weiser K, Donegan S, Garner P. Taylor-Robinson DC, et al. Cochrane Database Syst Rev. 2015 Jul 23;2015(7):CD000371. doi: 10.1002/14651858.CD000371.pub6. Cochrane Database Syst Rev. 2015. Update in: Cochrane Database Syst Rev. 2019 Sep 11;9:CD000371. doi: 10.1002/14651858.CD000371.pub7. PMID: 26202783 Free PMC article. Updated.
Knowledge mobilization activities to support decision-making by youth, parents, and adults using a systematic and living map of evidence and recommendations on COVID-19: protocol for three randomized controlled trials and qualitative user-experience studies.
Charide R, Stallwood L, Munan M, Sayfi S, Hartling L, Butcher NJ, Offringa M, Elliott S, Richards DP, Mathew JL, Akl EA, Kredo T, Mbuagbaw L, Motillal A, Baba A, Prebeg M, Relihan J, Scott SD, Suvada J, Falavigna M, Klugar M, Lotfi T, Stevens A, Pottie K, Schünemann HJ. Charide R, et al. Trials. 2023 Jan 14;24(1):27. doi: 10.1186/s13063-023-07067-9. Trials. 2023. PMID: 36641457 Free PMC article.
School-based interventions for preventing HIV, sexually transmitted infections, and pregnancy in adolescents.
Mason-Jones AJ, Sinclair D, Mathews C, Kagee A, Hillman A, Lombard C. Mason-Jones AJ, et al. Cochrane Database Syst Rev. 2016 Nov 8;11(11):CD006417. doi: 10.1002/14651858.CD006417.pub3. Cochrane Database Syst Rev. 2016. PMID: 27824221 Free PMC article.
High quality (certainty) evidence changes less often than low-quality evidence, but the magnitude of effect size does not systematically differ between studies with low versus high-quality evidence.
Djulbegovic B, Ahmed MM, Hozo I, Koletsi D, Hemkens L, Price A, Riera R, Nadanovsky P, Dos Santos APP, Melo D, Pathak R, Pacheco RL, Fontes LE, Miranda E, Nunan D. Djulbegovic B, et al. J Eval Clin Pract. 2022 Jun;28(3):353-362. doi: 10.1111/jep.13657. Epub 2022 Jan 28. J Eval Clin Pract. 2022. PMID: 35089627 Free PMC article.

See all "Cited by" articles

References

1. Sauerland S, Seiler CM. Role of systematic reviews and meta-analysis in evidence-based medicine. World J Surg. 2005;29(5):582–7. doi: 10.1007/s00268-005-7917-7. - DOI - PubMed
1. Moat KA, Lavis JN, Wilson MG, Rottingen JA, Barnighausen T. Twelve myths about systematic reviews for health system policymaking rebutted. J Health Serv Res Policy. 2013;18(1):44–50. doi: 10.1258/jhsrp.2012.011175. - DOI - PubMed
1. Mazur DJ, Hickam DH. Patients’ interpretations of probability terms. J Gen Intern Med. 1991;6(3):237–40. doi: 10.1007/BF02598968. - DOI - PubMed
1. Mazur DJ, Merz JF. How age, outcome severity, and scale influence general medicine clinic patients’ interpretations of verbal probability terms. J Gen Intern Med. 1994;9(5):268–71. doi: 10.1007/BF02599654. - DOI - PubMed
1. Lipkus IM. Numeric, verbal, and visual formats of conveying health risks: suggested best practices and future recommendations. Med Decis Making. 2007;27(5):696–713. doi: 10.1177/0272989X07307271. - DOI - PubMed

Publication types

Actions
Actions
Actions
Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions

Associated data

Actions
- Search in PubMed
- Search in ClinicalTrials.gov

LinkOut - more resources

Full Text Sources
Other Literature Sources
- scite Smart Citations
Medical
- ClinicalTrials.gov

[1] Sauerland S, Seiler CM. Role of systematic reviews and meta-analysis in evidence-based medicine. World J Surg. 2005;29(5):582–7. doi: 10.1007/s00268-005-7917-7. - DOI - PubMed

[2] Sauerland S, Seiler CM. Role of systematic reviews and meta-analysis in evidence-based medicine. World J Surg. 2005;29(5):582–7. doi: 10.1007/s00268-005-7917-7. - DOI - PubMed

[3] Moat KA, Lavis JN, Wilson MG, Rottingen JA, Barnighausen T. Twelve myths about systematic reviews for health system policymaking rebutted. J Health Serv Res Policy. 2013;18(1):44–50. doi: 10.1258/jhsrp.2012.011175. - DOI - PubMed

[4] Moat KA, Lavis JN, Wilson MG, Rottingen JA, Barnighausen T. Twelve myths about systematic reviews for health system policymaking rebutted. J Health Serv Res Policy. 2013;18(1):44–50. doi: 10.1258/jhsrp.2012.011175. - DOI - PubMed

[5] Mazur DJ, Hickam DH. Patients’ interpretations of probability terms. J Gen Intern Med. 1991;6(3):237–40. doi: 10.1007/BF02598968. - DOI - PubMed

[6] Mazur DJ, Hickam DH. Patients’ interpretations of probability terms. J Gen Intern Med. 1991;6(3):237–40. doi: 10.1007/BF02598968. - DOI - PubMed

[7] Mazur DJ, Merz JF. How age, outcome severity, and scale influence general medicine clinic patients’ interpretations of verbal probability terms. J Gen Intern Med. 1994;9(5):268–71. doi: 10.1007/BF02599654. - DOI - PubMed

[8] Mazur DJ, Merz JF. How age, outcome severity, and scale influence general medicine clinic patients’ interpretations of verbal probability terms. J Gen Intern Med. 1994;9(5):268–71. doi: 10.1007/BF02599654. - DOI - PubMed

[9] Lipkus IM. Numeric, verbal, and visual formats of conveying health risks: suggested best practices and future recommendations. Med Decis Making. 2007;27(5):696–713. doi: 10.1177/0272989X07307271. - DOI - PubMed

[10] Lipkus IM. Numeric, verbal, and visual formats of conveying health risks: suggested best practices and future recommendations. Med Decis Making. 2007;27(5):696–713. doi: 10.1177/0272989X07307271. - DOI - PubMed

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

Comparison between the standard and a new alternative format of the Summary-of-Findings tables in Cochrane review users: study protocol for a randomized controlled trial

Affiliations

Comparison between the standard and a new alternative format of the Summary-of-Findings tables in Cochrane review users: study protocol for a randomized controlled trial

Authors

Affiliations

Abstract

Figures

Similar articles

Cited by

References

Publication types

MeSH terms

Associated data

LinkOut - more resources

Full Text Sources

Other Literature Sources

Medical