Abstract
Understanding clinical information can be challenging for patients, their caregivers, and other lay audiences because of complex scientific concepts, interventions, procedures and/or evaluated outcomes. It is also challenging for health-care providers to effectively communicate such medical research to patients, which is essential for patients’ informed involvement in shared decision-making (SDM). Advanced practice providers (APPs) are on the frontlines of care, often providing detailed and extensive education for patients in and outside of clinical trials. In recent years, scientific researchers, particularly those involved in clinical trial research, have been increasingly using plain language summaries (PLS) to summarize journal publications and conference abstracts in easy-to-read nontechnical language while providing key findings and implications. In this review article, we aim to provide an overview of PLS and show by using published examples, how such communication tools may assist APPs to communicate medical research effectively to patients. This evolving form of scientific communication may be useful to APPs, not only for translating the findings of clinical trials and other health-care research to patients and their caregivers, but also facilitate informed SDM, help them keep up to date on the latest clinical research, and share research perspectives with their care teams.
References
American Academy of Physician Associates. (2024). Competencies for the physician associate profession. https://www.aapa.org/career-central/employer-resources/employing-a-pa/competencies-physician-associate-profession/
Barnes, A., & Patrick, S. (2019). Lay summaries of clinical study results: An overview. Pharmaceutical Medicine, 33(4), 261–268. https://doi.org/10.1007/s40290-019-00285-0
Berkman, N. D., Sheridan, S. L., Donahue, K. E., Halpern, D. J., Viera, A., Crotty, K., Holland, A., Brasure, M., Lohr, K. N., Harden, E., Tant, E., Wallace, I., & Viswanathan, M. (2011). Health literacy interventions and outcomes: An updated systematic review. Evidence Report/Technology Assessment (Full Report), (199), 1–941.
Boutin, M., Dewulf, L., Hoos, A., Geissler, J., Todaro, V., Schneider, R. F., Garzya, V., Garvey, A., Robinson, P., Saffer, T., Krug, S., & Sargeant, I. (2017). Culture and process change as a priority for patient engagement in medicines development. Therapeutic Innovation & Regulatory Science, 51(1), 29–38. https://doi.org/10.1177/2168479016659104
Braun-Inglis, C., Boehmer, L. M., Zitella, L. J., Hoffner, B., Shvetsov, Y. B., Berenberg, J. L., Oyer, R. A., & Benson, A. B., 3rd. (2022). Role of oncology advanced practitioners to enhance clinical research. Journal of the Advanced Practitioner in Oncology, 13(2), 107–119. https://doi.org/10.6004/jadpro.2022.13.2.2
Bredbenner, K., & Simon, S. M. (2019). Video abstracts and plain language summaries are more effective than graphical abstracts and published abstracts. PLoS ONE, 14(11), e0224697. https://doi.org/10.1371/journal.pone.0224697
Bruinooge, S. S., Pickard, T. A., Vogel, W., Hanley, A., Schenkel, C., Garrett-Mayer, E., Tetzlaff, E., Rosenzweig, M., Hylton, H., Westin, S. N., Smith, N., Lynch, C., Kosty, M. P., & Williams, S. F. (2018). Understanding the role of advanced practice providers in oncology in the United States. Journal of Oncology Practice, 14(9), e518–e532. https://doi.org/10.1200/jop.18.00181
Buljan, I., Malički, M., Wager, E., Puljak, L., Hren, D., Kellie, F., West, H., Alfirević, Ž., & Marušić, A. (2018). No difference in knowledge obtained from infographic or plain language summary of a Cochrane systematic review: Three randomized controlled trials. Journal of Clinical Epidemiology, 97, 86–94. https://doi.org/10.1016/j.jclinepi.2017.12.003
Clancy, C. M. (2012). Patient-centered outcomes research and nurse practitioners’ role in shared decision making. Journal of the American Academy of Nurse Practitioners, 24(1), 59–61. https://doi.org/10.1111/j.1745-7599.2011.00692.x
Collins, M. (2019). PubMed updates February 2019. National Library of Medicine. https://www.nlm.nih.gov/pubs/techbull/jf19/jf19_february_pubmed_updates.html
Collyar, D., Stevens, M., & O’Leary, C. (2022). How to optimize returns on plain language summaries. Clinical Leader, VertMarkets, Inc. https://www.clinicalleader.com/doc/how-to-optimize-returns-on-plain-language-summaries-0001
DeTora, L. M., Toroser, D., Sykes, A., Vanderlinden, C., Plunkett, F. J., Lane, T., Hanekamp, E., Dormer, L., DiBiasi, F., Bridges, D., Baltzer, L., & Citrome, L. (2022). Good Publication Practice (GPP) guidelines for company-sponsored biomedical research: 2022 update. Annals of Internal Medicine, 175(9), 1298–1304. https://doi.org/10.7326/m22-1460
Dormer, L. (2022). Role of plain language summaries in HEOR publications. Evidence Base powered by Becaris Publishing Limited. https://www.evidencebaseonline.com/role-of-plain-language-summaries-in-heor-publications/
Dormer, L., Schindler, T., Williams, L. A., Lobban, D., Khawaja, S., Hunn, A., Ubilla, D. L., Sargeant, I., & Hamoir, A. M. (2022). A practical ‘how-to’ guide to plain language summaries (PLS) of peer-reviewed scientific publications: Results of a multi-stakeholder initiative utilizing co-creation methodology. Research Involvement and Engagement, 8(1), 23. https://doi.org/10.1186/s40900-022-00358-6
Edgell, C., & Rosenberg, A. (2022). Putting plain language summaries into perspective. Current Medical Research and Opinion, 38(6), 871–874. https://doi.org/10.1080/03007995.2022.2058812
Elwyn, G., Frosch, D., Thomson, R., Joseph-Williams, N., Lloyd, A., Kinnersley, P., Cording, E., Tomson, D., Dodd, C., Rollnick, S., Edwards, A., & Barry, M. (2012). Shared decision making: A model for clinical practice. Journal of General Internal Medicine, 27(10), 1361–1367. https://doi.org/10.1007/s11606-012-2077-6
Elwyn, G., Laitner, S., Coulter, A., Walker, E., Watson, P., & Thomson, R. (2010). Implementing shared decision making in the NHS. BMJ, 341, c5146. https://doi.org/10.1136/bmj.c5146
European Cancer Organization. (2024). European Code of Cancer Practice. https://www.europeancancer.org/2-standard/85-the-code-shared-decision-making
European Medicines Agency. (2023). Clinical Trials Regulation. https://health.ec.europa.eu/medicinal-products/clinical-trials/clinical-trials-regulation-eu-no-5362014_en
European Parliament and the Council. (2014). Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32014R0536
European Union Clinical Trials Expert Group. (2021). Good lay summary practice. https://health.ec.europa.eu/system/files/2021-10/glsp_en_0.pdf
Faiman, B., & Tariman, J. D. (2019). Shared decision making: Improving patient outcomes by understanding the benefits of and barriers to effective communication. Clinical Journal of Oncology Nursing, 23(5), 540–542. https://doi.org/10.1188/19.Cjon.540-542
FitzGibbon, H., King, K., Piano, C., Wilk, C., & Gaskarth, M. (2020). Where are biomedical research plain-language summaries? Health Science Reports, 3(3), e175. https://doi.org/10.1002/hsr2.175
Fox, S., & Rainie, L. (2014). Part 1: How the internet has woven itself into American life. Pew Research Center. https://www.pewresearch.org/internet/2014/02/27/part-1-how-the-internet-has-woven-itself-into-american-life/
Future Medicine. (2024). Plain language summaries. Future Science Group. https://www.futuremedicine.com/plainlanguagesummaries
Gainey, K. M., Smith, J., McCaffery, K. J., Clifford, S., & Muscat, D. M. (2023). What author instructions do health journals provide for writing plain language summaries? A scoping review. The Patient - Patient-Centered Outcomes Research, 16(1), 31–42. https://doi.org/10.1007/s40271-022-00606-7
Hersh, L., Salzman, B., & Snyderman, D. (2015). Health literacy in primary care practice. American Family Physician, 92(2), 118–124. https://www.aafp.org/pubs/afp/issues/2015/0715/p118.pdf
Innes, K., Cotton, S., Campbell, M. K., Elliott, J., & Gillies, K. (2018). Relative importance of informational items in participant information leaflets for trials: A Q-methodology approach. BMJ Open, 8(9), e023303. https://doi.org/10.1136/bmjopen-2018-023303
International Committee of Medical Journal Editors. (2024). Overlapping publications. International Committee of Medical Journal Editors. https://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/overlapping-publications.html#four
King, K., Yelling, S., Stones, S., & Dheepa, C. (2022). The role of plain-language summaries in communicating clinical trial data. Medical Affairs Professional Society. https://medicalaffairs.org/plain-language-summaries-clinical-trial/
Kwame, A., & Petrucka, P. M. (2021). A literature-based study of patient-centered care and communication in nurse-patient interactions: Barriers, facilitators, and the way forward. BMC Nursing, 20(1), 158. https://doi.org/10.1186/s12912-021-00684-2
Langewitz, W. A., Eich, P., Kiss, A., & Wössmer, B. (1998). Improving communication skills–a randomized controlled behaviorally oriented intervention study for residents in internal medicine. Psychosomatic Medicine, 60(3), 268–276. https://doi.org/10.1097/00006842-199805000-00009
Logullo, P., de Beyer, J. A., Kirtley, S., Schlüssel, M. M., & Collins, G. S. (2023). Open access journal publication in health and medical research and open science: Benefits, challenges and limitations. BMJ Evidence-Based Medicine. https://doi.org/10.1136/bmjebm-2022-112126
Martínez Silvagnoli, L., Shepherd, C., Pritchett, J., & Gardner, J. (2022). Optimizing readability and format of plain language summaries for medical research articles: Cross-sectional survey study. Journal of Medical Internet Research, 24(1), e22122. https://doi.org/10.2196/22122
McCabe, C. (2004). Nurse-patient communication: An exploration of patients’ experiences. Journal of Clinical Nursing, 13(1), 41–49. https://doi.org/10.1111/j.1365-2702.2004.00817.x
Mielke, C., Kuballa, S., Schulze, M., & Haux, R. (2020). A metric for evaluating a transformation of subscription-based journals into Open-Access journals. Journal of Medical Systems, 44(11), 196. https://doi.org/10.1007/s10916-020-01651-1
Muscat, D. M., Shepherd, H. L., Nutbeam, D., Trevena, L., & McCaffery, K. J. (2021a). Health literacy and shared decision-making: Exploring the relationship to enable meaningful patient engagement in healthcare. Journal of General Internal Medicine, 36(2), 521–524. https://doi.org/10.1007/s11606-020-05912-0
Muscat, D. M., Smith, J., Mac, O., Cadet, T., Giguere, A., Housten, A. J., Langford, A. T., Smith, S. K., Durand, M. A., & McCaffery, K. (2021b). Addressing health literacy in patient decision aids: An update from the International Patient Decision Aid Standards. Medical Decision Making, 41(7), 848–869. https://doi.org/10.1177/0272989x211011101
National Institutes of Health. (2024). Plain language at NIH. National Institutes of Health. https://www.nih.gov/institutes-nih/nih-office-director/office-communications-public-liaison/clear-communication/plain-language
National Institutes of Health. (2021). Health literacy. National Institutes of Health. https://www.nih.gov/institutes-nih/nih-office-director/office-communications-public-liaison/clear-communication/health-literacy
National Organization for Nurse Practitioner Faculties. (2022). NONPF’s NP role core competencies. https://www.nonpf.org/page/NP_Role_Core_Competencies
Patient Focused Medicines Development. (2022). Plain language summaries (PLS) of peer-reviewed publications and conference presentations: Practical ‘How-To’ Guide for multi-stakeholder co-creation. https://pemsuite.org/how-to-guides/
Penlington, M., Goulet, P., & Metcalfe, B. (2022). Improving knowledge and trust in vaccines: A survey-based assessment of the potential of the European Union Clinical Trial Regulation No 536/2014 plain language summary to increase health literacy. Vaccine, 40(6), 924–933. https://doi.org/10.1016/j.vaccine.2021.12.045
Pfizer, Inc. (2024). Abstract plain language summaries. https://www.pfizer.com/news/media-resources/press-kits/oncology-media-kit/apls
Rosenberg, A., Baróniková, S., Feighery, L., Gattrell, W., Olsen, R. E., Watson, A., Koder, T., & Winchester, C. (2021). Open Pharma recommendations for plain language summaries of peer-reviewed medical journal publications. Current Medical Research and Opinion, 37(11), 2015–2016. https://doi.org/10.1080/03007995.2021.1971185
Rosenberg, A., Baróniková, S., Gattrell, W., Ghildyal, N., Koder, T., Koskenkorva, T., Liew, A., Narayan, R., Osório, J., Philippon, V., Shane, M., Skobe, C., & Wager, K. (2022). Assessing PubMed metatag usage for plain language summary discoverability. American Medical Association. https://peerreviewcongress.org/abstract/assessing-pubmed-metatag-usage-for-plain-language-summary-discoverability/
Rugo, H. S., Im, S. A., Joy, A. A., Shparyk, Y., Walshe, J. M., Sleckman, B., Loi, S., Theall, K. P., Kim, S., Huang, X., Bananis, E., Mahtani, R., Finn, R. S., & Diéras, V. (2022). Effect of palbociclib plus endocrine therapy on time to chemotherapy across subgroups of patients with hormone receptor–positive/human epidermal growth factor receptor 2–negative advanced breast cancer: Post hoc analyses from PALOMA-2 and PALOMA-3. Breast, 66, 324–331. https://doi.org/10.1016/j.breast.2022.11.005
Rugo, H. S., Im, S. A., Joy, A. A., Shparyk, Y., Walshe, J. M., Sleckman, B., Loi, S., Theall, K. P., Kim, S., Huang, X., Bananis, E., Mahtani, R., Finn, R. S., & Diéras, V. (2024a). The effects of adding palbociclib to endocrine therapy to treat advanced breast cancer: A plain language summary of a study using the PALOMA-2 and PALOMA-3 trial results. Future Oncology, 20(1), 5–16. https://doi.org/10.2217/fon-2023-0407
Rugo, H. S., Liu, X., Li, B., McRoy, L., Chen, C., Layman, R. M., & Brufsky, A. (2023). Real-world effectiveness of palbociclib plus aromatase inhibitors in African American patients with metastatic breast cancer. The Oncologist, 28(10), 866–874. https://doi.org/10.1093/oncolo/oyad209
Rugo, H. S., Liu, X., Li, B., McRoy, L., Chen, C., Layman, R. M., Tomlin-Harris, T., & Brufsky, A. (2024b). Prolonging the lives of African-Americans with metastatic breast cancer by adding palbociclib to an aromatase inhibitor in routine clinical practice: A plain language summary of a real-world database study. Future Oncology. https://doi.org/10.2217/fon-2023-1079
Sage Publications. (2024). Plain language summaries of publications (PLS-P). Sage Publications. https://us.sagepub.com/en-us/nam/plain-language-summaries-of-publications-pls-p
Schuler, K., Passador, L., Campbell, D., Patel, R., LaRue, L., Schwarzkopf, M., LoPresti, B., & Wolf Gianares, B. (2023). Making data engaging and comprehensible – what is the impact of enhanced publication content (EPC)? Current Medical Research and Opinion, 39, S26. https://www.tandfonline.com/doi/abs/10.1080/03007995.2023.2194075
Shiely, F., & Daly, A. (2023). Trial lay summaries were not fit for purpose. Journal of Clinical Epidemiology, 156, 105–112. https://doi.org/10.1016/j.jclinepi.2023.02.023
Smith, R. (2021). Improving and spreading plain language summaries of peer-reviewed medical journal publications. Current Medical Research and Opinion, 37(11), 2017–2018. https://doi.org/10.1080/03007995.2021.1974824
Stacey, D., Légaré, F., Lyddiatt, A., Giguere, A. M., Yoganathan, M., Saarimaki, A., Pardo, J. P., Rader, T., & Tugwell, P. (2016). Translating evidence to facilitate shared decision making: Development and usability of a consult decision aid prototype. The Patient - Patient-Centered Outcomes Research, 9(6), 571–582. https://doi.org/10.1007/s40271-016-0177-9
Stacey, D., Lewis, K. B., Smith, M., Carley, M., Volk, R., Douglas, E. E., Pacheco-Brousseau, L., Finderup, J., Gunderson, J., Barry, M. J., Bennett, C. L., Bravo, P., Steffensen, K., Gogovor, A., Graham, I. D., Kelly, S. E., Légaré, F., Sondergaard, H., Thomson, R., Trenaman, L., & Trevena, L. (2024). Decision aids for people facing health treatment or screening decisions. Cochrane Database of Systematic Reviews, 1(1), CD001431. https://doi.org/10.1002/14651858.CD001431.pub6
Stein, D., Cannity, K., Weiner, R., Hichenberg, S., Leon-Nastasi, A., Banerjee, S., & Parker, P. (2022). General and unique communication skills challenges for advanced practice providers: A mixed-methods study. Journal of the Advanced Practitioner in Oncology, 13(1), 32–43. https://doi.org/10.6004/jadpro.2022.13.1.3
Stewart, M. A. (1995). Effective physician-patient communication and health outcomes: A review. Canadian Medical Association Journal, 152(9), 1423–1433. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1337906/pdf/cmaj00069-0061.pdf
Tariman, J. D., & Szubski, K. L. (2015). The evolving role of the nurse during the cancer treatment decision-making process: A literature review. Clinical Journal of Oncology Nursing, 19(5), 548–556. https://doi.org/10.1188/15.Cjon.548-556
Taylor & Francis. (2024). How to write and publish a plain language summary. Taylor & Francis, an Informa Group Company. https://authorservices.taylorandfrancis.com/publishing-your-research/writing-your-paper/how-to-write-a-plain-language-summary/
Taylor & Francis Group. (2023). Plain language summaries of publications (PLSPs): Author guidelines for development, submission & publication. https://files.taylorandfrancis.com/plsp%20guidelines%20for%20authors.pdf
Taylor & Francis News. (2023). New plain language summaries of publications unlock the latest medical research for patients, healthcare professionals and policymakers. Taylor & Francis, Informa UK Limited, an Informa Group Company. https://newsroom.taylorandfrancisgroup.com/plain-language-summaries-of-publications/
Tennant, J. P., Waldner, F., Jacques, D. C., Masuzzo, P., Collister, L. B., & Hartgerink, C. H. (2016). The academic, economic and societal impacts of open access: An evidence-based review. F1000Research, 5, 632. https://doi.org/10.12688/f1000research.8460.3
The Cochrane Collaboration. (2022). Updated template and guidance for writing plain language summaries in Cochrane Reviews now available. The Cochrane Collaboration. https://community.cochrane.org/news/updated-template-and-guidance-writing-plain-language-summaries-cochrane-reviews-now-available
United States House of Representatives. (2010). Patient Protection and Affordable Care Act. https://www.healthcare.gov/glossary/patient-protection-and-affordable-care-act/
US Agency for Healthcare Research and Quality. (2023). The SHARE Approach. https://www.ahrq.gov/health-literacy/professional-training/shared-decision/index.html
US Food & Drug Administration. (2017). Draft FDA guidance on provision of plain language summaries. https://www.regulations.gov/document/FDA-2017-D-5478-0001
Warde, F., Papadakos, J., Papadakos, T., Rodin, D., Salhia, M., & Giuliani, M. (2018). Plain language communication as a priority competency for medical professionals in a globalized world. Canadian Medical Education Journal, 9(2), e52–e59. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6044302/pdf/CMEJ-9-e052.pdf
Wilcox, C. S., Franceschi, L., & Simmons, A. (2020). Layperson/plain language summaries: Can sponsors, CROs, and sites deliver in 2020? Innovations in Clinical Neuroscience, 17(7–9), 41–44. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7839658/pdf/icns_17_7-9_41.pdf
Yadav, S., Todd, A., Patel, K., Tabriz, A. A., Nguyen, O., Turner, K., & Hong, Y. R. (2022). Public knowledge and information sources for clinical trials among adults in the USA: Evidence from a Health Information National Trends Survey in 2020. Clinical Medicine, 22(5), 416–422. https://doi.org/10.7861/clinmed.2022-0107
Yeh, C., Zhou, M., Bapodra, N., Rivero, M., Dominguez, E., Moran, M., Hershman, D., Fojo, A., & Bates, S. (2022a). A novel analysis of data from the PALOMA-3 trial confirms the efficacy of palbociclib and provides an option for efficacy assessments that could accelerate drug approvals. Journal of Clinical Oncology, 40, 1069. https://doi.org/10.1200/JCO.2022.40.16_suppl.1069
Yeh, C., Zhou, M., Bapodra, N., Rivero, M., Dominguez, E., Moran, M., Hershman, D., Fojo, A., & Bates, S. (2022b). Tumor growth rate as an early indicator of survival in women with advanced breast cancer who were treated with palbociclib. Pfizer, Inc. https://www.pfizeroncologycongresshub.com/files/Pfizer_ASCO_Digital_updated-version-with-presentation-and-pls-links-1.pdf
