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How to Write a Medical Research Paper

Last Updated: February 5, 2024 Approved

This article was co-authored by Chris M. Matsko, MD . Dr. Chris M. Matsko is a retired physician based in Pittsburgh, Pennsylvania. With over 25 years of medical research experience, Dr. Matsko was awarded the Pittsburgh Cornell University Leadership Award for Excellence. He holds a BS in Nutritional Science from Cornell University and an MD from the Temple University School of Medicine in 2007. Dr. Matsko earned a Research Writing Certification from the American Medical Writers Association (AMWA) in 2016 and a Medical Writing & Editing Certification from the University of Chicago in 2017. wikiHow marks an article as reader-approved once it receives enough positive feedback. In this case, 89% of readers who voted found the article helpful, earning it our reader-approved status. This article has been viewed 203,729 times.

Writing a medical research paper is similar to writing other research papers in that you want to use reliable sources, write in a clear and organized style, and offer a strong argument for all conclusions you present. In some cases the research you discuss will be data you have actually collected to answer your research questions. Understanding proper formatting, citations, and style will help you write and informative and respected paper.

Researching Your Paper

• Pick something that really interests you to make the research more fun.
• Choose a topic that has unanswered questions and propose solutions.

• Quantitative studies consist of original research performed by the writer. These research papers will need to include sections like Hypothesis (or Research Question), Previous Findings, Method, Limitations, Results, Discussion, and Application.
• Synthesis papers review the research already published and analyze it. They find weaknesses and strengths in the research, apply it to a specific situation, and then indicate a direction for future research.

• Keep track of your sources. Write down all publication information necessary for citation: author, title of article, title of book or journal, publisher, edition, date published, volume number, issue number, page number, and anything else pertaining to your source. A program like Endnote can help you keep track of your sources.
• Take detailed notes as you read. Paraphrase information in your own words or if you copy directly from the article or book, indicate that these are direct quotes by using quotation marks to prevent plagiarism.
• Be sure to keep all of your notes with the correct source.
• Your professor and librarians can also help you find good resources.

• Keep all of your notes in a physical folder or in a digitized form on the computer.
• Start to form the basic outline of your paper using the notes you have collected.

Writing Your Paper

• Start with bullet points and then add in notes you've taken from references that support your ideas. [1] X Trustworthy Source PubMed Central Journal archive from the U.S. National Institutes of Health Go to source
• A common way to format research papers is to follow the IMRAD format. This dictates the structure of your paper in the following order: I ntroduction, M ethods, R esults, a nd D iscussion. [2] X Research source
• The outline is just the basic structure of your paper. Don't worry if you have to rearrange a few times to get it right.
• Ask others to look over your outline and get feedback on the organization.
• Know the audience you are writing for and adjust your style accordingly. [3] X Research source

• Use a standard font type and size, such as Times New Roman 12 point font.
• Double-space your paper.
• If necessary, create a cover page. Most schools require a cover page of some sort. Include your main title, running title (often a shortened version of your main title), author's name, course name, and semester.

• Break up information into sections and subsections and address one main point per section.
• Include any figures or data tables that support your main ideas.
• For a quantitative study, state the methods used to obtain results.

• Clearly state and summarize the main points of your research paper.
• Discuss how this research contributes to the field and why it is important. [4] X Research source
• Highlight potential applications of the theory if appropriate.
• Propose future directions that build upon the research you have presented. [5] X Research source
• Keep the introduction and discussion short, and spend more time explaining the methods and results.

• State why the problem is important to address.
• Discuss what is currently known and what is lacking in the field.
• State the objective of your paper.
• Keep the introduction short.

• Highlight the purpose of the paper and the main conclusions.
• State why your conclusions are important.
• Be concise in your summary of the paper.
• Show that you have a solid study design and a high-quality data set.
• Abstracts are usually one paragraph and between 250 – 500 words.

• Unless otherwise directed, use the American Medical Association (AMA) style guide to properly format citations.
• Add citations at end of a sentence to indicate that you are using someone else's idea. Use these throughout your research paper as needed. They include the author's last name, year of publication, and page number.
• Compile your reference list and add it to the end of your paper.
• Use a citation program if you have access to one to simplify the process.

• Continually revise your paper to make sure it is structured in a logical way.
• Proofread your paper for spelling and grammatical errors.
• Make sure you are following the proper formatting guidelines provided for the paper.
• Have others read your paper to proofread and check for clarity. Revise as needed.

Expert Q&A

• Ask your professor for help if you are stuck or confused about any part of your research paper. They are familiar with the style and structure of papers and can provide you with more resources. Thanks Helpful 0 Not Helpful 0
• Refer to your professor's specific guidelines. Some instructors modify parts of a research paper to better fit their assignment. Others may request supplementary details, such as a synopsis for your research project . Thanks Helpful 0 Not Helpful 0
• Set aside blocks of time specifically for writing each day. Thanks Helpful 0 Not Helpful 0

• Do not plagiarize. Plagiarism is using someone else's work, words, or ideas and presenting them as your own. It is important to cite all sources in your research paper, both through internal citations and on your reference page. Thanks Helpful 4 Not Helpful 2

You Might Also Like

• ↑ http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3178846/
• ↑ http://owl.excelsior.edu/research-and-citations/outlining/outlining-imrad/
• ↑ http://china.elsevier.com/ElsevierDNN/Portals/7/How%20to%20write%20a%20world-class%20paper.pdf
• ↑ http://intqhc.oxfordjournals.org/content/16/3/191
• ↑ http://www.ruf.rice.edu/~bioslabs/tools/report/reportform.html#form

About This Article

To write a medical research paper, research your topic thoroughly and compile your data. Next, organize your notes and create a strong outline that breaks up the information into sections and subsections, addressing one main point per section. Write the results and discussion sections first to go over your findings, then write the introduction to state your objective and provide background information. Finally, write the abstract, which concisely summarizes the article by highlighting the main points. For tips on formatting and using citations, read on! Did this summary help you? Yes No

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How to Write a Medical Abstract for Publication

Preparing Your Study, Review, or Article for Publication in Medical Journals

The majority of social, behavioral, biological, and clinical journals follow the conventional structured abstract form with the following four major headings (or variations of these headings):

OBJECTIVE   (Purpose; Aim; Goal) : Tells reader the purpose of your research and the questions it intends to answer

METHODS   (Setting; Study Design; Participants) : Explains the methods and process so that other researchers can assess, review, and replicate your study.

RESULTS (Findings; Outcomes) : Summarizes the most important findings of your study

CONCLUSIONS   (Discussion; Implications; Further Recommendations) : Summarizes the interpretation and implications of these results and presents recommendations for further research

Sample Health/Medical Abstract

Structured Abstracts Guidelines *

• Total Word Count: ~200-300 words (depending on the journal)
• Content: The abstract should reflect only the contents of the original paper (no cited work)

*   Always follow the formatting guidelines of the journal to which you are submitting your paper.

Useful Terms and Phrases by Abstract Section

Objective:  state your precise research purpose or question (1-2 sentences).

• Begin with “To”: “We aimed to…” or “The objective of this study was to…” using a verb that accurately captures the action of your study.
• Connect the verb to an object phrase to capture the central elements and purpose of the study, hypothesis , or research problem . Include details about the setting, demographics, and the problem or intervention you are investigating.

METHODS : Explain the tools and steps of your research (1-3 sentences)

• Use the past tense if the study has been conducted; use the present tense if the study is in progress.
• Include details about the study design, sample groups and sizes, variables, procedures, outcome measures, controls, and methods of analysis.

  RESULTS : Summarize the data you obtained (3-6 sentences)

• Use the past tense when describing the actions or outcomes of the research.
• Include results that answer the research question and that were derived from the stated methods; examine data by qualitative or quantitative means.
• State whether the research question or hypothesis was proven or disproven.

CONCLUSIONS : Describe the key findings (2-5 sentences)

• Use the present tense to discuss the findings and implications of the study results.
• Explain the implications of these results for medicine, science, or society.
• Discuss any major limitations of the study and suggest further actions or research that should be undertaken.

Before submitting your abstract to medical journals, be sure to receive proofreading services from Wordvice, including journal manuscript editing and paper proofreading , to enhance your writing impact and fix any remaining errors.

Related Resources

• 40 Useful Words and Phrases for Top-Notch Essays  (Oxford Royale Academy)
• 100+ Strong Verbs That Will Make Your Research Writing Amazing  (Wordvice)
• Essential Academic Writing Words and Phrases  (My English Teacher.eu)
• Academic Vocabulary, Useful Phrases for Academic Writing and Research Paper Writing  (Research Gate)
• How to Compose a Journal Submission Cover Letter  (Wordvice/YouTube)
• How to Write the Best Journal Submission Cover Letter  (Wordvice)

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The International Committee of Medical Journal Editors (ICMJE) offers guidance to authors in its publication Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals (ICMJE Recommendations) , which was formerly the Uniform Requirements for Manuscripts. The recommended style for references is based on the National Information Standards Organization NISO Z39.29-2005 (R2010) Bibliographic References as adapted by the National Library of Medicine for its databases. Details, including fuller citations and explanations, are in Citing Medicine . (Note Appendix F which covers how citations in MEDLINE/PubMed differ from the advice in Citing Medicine.) For datasets (Item 43 below) and software on the Internet (Item 44 below), simplified formats are also shown.

Reference Types

Articles in journals, books and other monographs, other published material, unpublished material, electronic material.

See also #36. Journal article on the Internet and #43. Dataset description article .

1. Standard journal article

Halpern SD, Ubel PA, Caplan AL. Solid-organ transplantation in HIV-infected patients. N Engl J Med. 2002 Jul 25;347(4):284-7.

List the first six authors, followed by et al. If there are more than six authors, list the first six authors, followed by et al. (Note: NLM now lists all authors.):

Rose ME, Huerbin MB, Melick J, Marion DW, Palmer AM, Schiding JK, et al. Regulation of interstitial excitatory amino acid concentrations after cortical contusion injury. Brain Res. 2002;935(1-2):40-6.

Optional: If a journal carries continuous pagination throughout a volume (as many medical journals do), omit the month and issue number.

Halpern SD, Ubel PA, Caplan AL. Solid-organ transplantation in HIV-infected patients. N Engl J Med. 2002;347:284-7.

Optional: Addition of a database's unique identifiers, such as the PubMed PMID, for the citation:

Forooghian F, Yeh S, Faia LJ, Nussenblatt RB. Uveitic foveal atrophy: clinical features and associations. Arch Ophthalmol. 2009 Feb;127(2):179-86. PubMed PMID: 19204236; PubMed Central PMCID: PMC2653214.

Optional: Addition of a clinical trial registration number:

Trachtenberg F, Maserejian NN, Soncini JA, Hayes C, Tavares M. Does fluoride in compomers prevent future caries in children? J Dent Res. 2009 Mar;88(3):276-9. PubMed PMID: 19329464. ClinicalTrials.gov registration number: NCT00065988.

2. Organization as author

Diabetes Prevention Program Research Group. Hypertension, insulin, and proinsulin in participants with impaired glucose tolerance. Hypertension. 2002;40(5):679-86.

3. Both personal authors and organization as author (List all as they appear in the byline.)

Vallancien G, Emberton M, Harving N, van Moorselaar RJ; Alf-One Study Group. Sexual dysfunction in 1,274 European men suffering from lower urinary tract symptoms. J Urol. 2003;169(6):2257-61.

4. No author given

21st century heart solution may have a sting in the tail. BMJ. 2002;325(7357):184.

5. Article not in English

Ellingsen AE, Wilhelmsen I. Sykdomsangst blant medisin- og jusstudenter. Tidsskr Nor Laegeforen. 2002;122(8):785-7. Norwegian.

Optional: Translation of article title (MEDLINE/PubMed practice):

Ellingsen AE, Wilhelmsen I. [Disease anxiety among medical students and law students]. Tidsskr Nor Laegeforen. 2002 Mar 20;122(8):785-7. Norwegian.

6. Volume with supplement

Geraud G, Spierings EL, Keywood C. Tolerability and safety of frovatriptan with short- and long-term use for treatment of migraine and in comparison with sumatriptan. Headache. 2002;42 Suppl 2:S93-9.

7. Issue with supplement

Glauser TA. Integrating clinical trial data into clinical practice. Neurology. 2002;58(12 Suppl 7):S6-12.

8. Volume with part

Abend SM, Kulish N. The psychoanalytic method from an epistemological viewpoint. Int J Psychoanal. 2002;83(Pt 2):491-5.

9. Issue with part

Ahrar K, Madoff DC, Gupta S, Wallace MJ, Price RE, Wright KC. Development of a large animal model for lung tumors. J Vasc Interv Radiol. 2002;13(9 Pt 1):923-8.

10. Issue with no volume

Banit DM, Kaufer H, Hartford JM. Intraoperative frozen section analysis in revision total joint arthroplasty. Clin Orthop. 2002;(401):230-8.

11. No volume or issue

Outreach: bringing HIV-positive individuals into care. HRSA Careaction. 2002 Jun:1-6.

12. Pagination in roman numerals

Chadwick R, Schuklenk U. The politics of ethical consensus finding. Bioethics. 2002;16(2):iii-v.

13. Type of article indicated as needed

Tor M, Turker H. International approaches to the prescription of long-term oxygen therapy [letter]. Eur Respir J. 2002;20(1):242.

Lofwall MR, Strain EC, Brooner RK, Kindbom KA, Bigelow GE. Characteristics of older methadone maintenance (MM) patients [abstract]. Drug Alcohol Depend. 2002;66 Suppl 1:S105.

14. Article containing retraction

Feifel D, Moutier CY, Perry W. Safety and tolerability of a rapidly escalating dose-loading regimen for risperidone. J Clin Psychiatry. 2002;63(2):169. Retraction of: Feifel D, Moutier CY, Perry W. J Clin Psychiatry. 2000;61(12):909-11.

Article containing a partial retraction:

Starkman JS, Wolder CE, Gomelsky A, Scarpero HM, Dmochowski RR. Voiding dysfunction after removal of eroded slings. J Urol. 2006 Dec;176(6 Pt 1):2749. Partial retraction of: Starkman JS, Wolter C, Gomelsky A, Scarpero HM, Dmochowski RR. J Urol. 2006 Sep;176(3):1040-4.

15. Article retracted

Feifel D, Moutier CY, Perry W. Safety and tolerability of a rapidly escalating dose-loading regimen for risperidone. J Clin Psychiatry. 2000;61(12):909-11. Retraction in: Feifel D, Moutier CY, Perry W. J Clin Psychiatry. 2002;63(2):169.

Article partially retracted:

Starkman JS, Wolter C, Gomelsky A, Scarpero HM, Dmochowski RR. Voiding dysfunction following removal of eroded synthetic mid urethral slings. J Urol. 2006 Sep;176(3):1040-4. Partial retraction in: Starkman JS, Wolder CE, Gomelsky A, Scarpero HM, Dmochowski RR. J Urol. 2006 Dec;176(6 Pt 1):2749.

16. Article republished with corrections

Mansharamani M, Chilton BS. The reproductive importance of P-type ATPases. Mol Cell Endocrinol. 2002;188(1-2):22-5. Corrected and republished from: Mol Cell Endocrinol. 2001;183(1-2):123-6.

17. Article with published erratum

Malinowski JM, Bolesta S. Rosiglitazone in the treatment of type 2 diabetes mellitus: a critical review. Clin Ther. 2000;22(10):1151-68; discussion 1149-50. Erratum in: Clin Ther. 2001;23(2):309.

18. Article published electronically ahead of the print version

Yu WM, Hawley TS, Hawley RG, Qu CK. Immortalization of yolk sac-derived precursor cells. Blood. 2002 Nov 15;100(10):3828-31. Epub 2002 Jul 5.

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19. Personal author(s)

Murray PR, Rosenthal KS, Kobayashi GS, Pfaller MA. Medical microbiology. 4th ed. St. Louis: Mosby; 2002.

20. Editor(s), compiler(s) as author

Gilstrap LC 3rd, Cunningham FG, VanDorsten JP, editors. Operative obstetrics. 2nd ed. New York: McGraw-Hill; 2002.

21. Author(s) and editor(s)

Breedlove GK, Schorfheide AM. Adolescent pregnancy. 2nd ed. Wieczorek RR, editor. White Plains (NY): March of Dimes Education Services; 2001.

22. Organization(s) as author

American Occupational Therapy Association, Ad Hoc Committee on Occupational Therapy Manpower. Occupational therapy manpower: a plan for progress. Rockville (MD): The Association; 1985 Apr. 84 p.

National Lawyer's Guild AIDs Network (US); National Gay Rights Advocates (US). AIDS practice manual: a legal and educational guide. 2nd ed. San Francisco: The Network; 1988.

23. Chapter in a book

Meltzer PS, Kallioniemi A, Trent JM. Chromosome alterations in human solid tumors. In: Vogelstein B, Kinzler KW, editors. The genetic basis of human cancer. New York: McGraw-Hill; 2002. p. 93-113.

24. Conference proceedings

Harnden P, Joffe JK, Jones WG, editors. Germ cell tumours V. Proceedings of the 5th Germ Cell Tumour Conference; 2001 Sep 13-15; Leeds, UK. New York: Springer; 2002.

25. Conference paper

Christensen S, Oppacher F. An analysis of Koza's computational effort statistic for genetic programming. In: Foster JA, Lutton E, Miller J, Ryan C, Tettamanzi AG, editors. Genetic programming. EuroGP 2002: Proceedings of the 5th European Conference on Genetic Programming; 2002 Apr 3-5; Kinsdale, Ireland. Berlin: Springer; 2002. p. 182-91.

26. Scientific or technical report

Issued by funding/sponsoring agency:

Yen GG (Oklahoma State University, School of Electrical and Computer Engineering, Stillwater, OK). Health monitoring on vibration signatures. Final report. Arlington (VA): Air Force Office of Scientific Research (US), Air Force Research Laboratory; 2002 Feb. Report No.: AFRLSRBLTR020123. Contract No.: F496209810049.

Issued by performing agency:

Russell ML, Goth-Goldstein R, Apte MG, Fisk WJ. Method for measuring the size distribution of airborne Rhinovirus. Berkeley (CA): Lawrence Berkeley National Laboratory, Environmental Energy Technologies Division; 2002 Jan. Report No.: LBNL49574. Contract No.: DEAC0376SF00098. Sponsored by the Department of Energy.

27. Dissertation

Borkowski MM. Infant sleep and feeding: a telephone survey of Hispanic Americans [dissertation]. Mount Pleasant (MI): Central Michigan University; 2002.

Pagedas AC, inventor; Ancel Surgical R&D Inc., assignee. Flexible endoscopic grasping and cutting device and positioning tool assembly. United States patent US 20020103498. 2002 Aug 1.

29. Newspaper article

Tynan T. Medical improvements lower homicide rate: study sees drop in assault rate. The Washington Post. 2002 Aug 12;Sect. A:2 (col. 4).

30. Audiovisual material

Chason KW, Sallustio S. Hospital preparedness for bioterrorism [videocassette]. Secaucus (NJ): Network for Continuing Medical Education; 2002.

31. Legal Material

Public law: Veterans Hearing Loss Compensation Act of 2002, Pub. L. No. 107-9, 115 Stat. 11 (May 24, 2001).

Unenacted bill: Healthy Children Learn Act, S. 1012, 107th Cong., 1st Sess. (2001).

Code of Federal Regulations: Cardiopulmonary Bypass Intracardiac Suction Control, 21 C.F.R. Sect. 870.4430 (2002).

Hearing: Arsenic in Drinking Water: An Update on the Science, Benefits and Cost: Hearing Before the Subcomm. on Environment, Technology and Standards of the House Comm. on Science, 107th Cong., 1st Sess. (Oct. 4, 2001).

Pratt B, Flick P, Vynne C, cartographers. Biodiversity hotspots [map]. Washington: Conservation International; 2000.

33. Dictionary and similar references

Dorland's illustrated medical dictionary. 29th ed. Philadelphia: W.B. Saunders; 2000. Filamin; p. 675.

34. Forthcoming and Preprints

(Note: NLM prefers "Forthcoming" rather than "In press" because not all items will be printed.)

Tian D, Araki H, Stahl E, Bergelson J, Kreitman M. Signature of balancing selection in Arabidopsis. Proc Natl Acad Sci U S A. Forthcoming 2002.

Alvarez R. Near optimal neural network estimator for spectral x-ray photon counting data with pileup. arXiv:1702.01006v1 [Preprint]. 2017 [cited 2017 Feb 9]: [11 p.]. Available from: https://arxiv.org/abs/1702.01006

Bar DZ, Atkatsh K, Tavarez U, Erdos MR, Gruenbaum Y, Collins FS. Biotinylation by antibody recognition- A novel method for proximity labeling. BioRxiv 069187 [Preprint]. 2016 [cited 2017 Jan 12]. Available from: https://www.biorxiv.org/content/10.1101/069187v1

Kording KP, Mensh B. Ten simple rules for structuring papers. BioRxiv [Preprint]. 2016 bioRxiv 088278 [posted 2016 Nov 28; revised 2016 Dec 14; revised 2016 Dec 15; cited 2017 Feb 9]: [12 p.]. Available from: https://www.biorxiv.org/content/10.1101/088278v5 doi: https://doi.org/10.1101/088278

Rupprecht C. Ready for more-than-human? Urban residents’ willingness to coexist with animals and plants. Version: 1. SocArXiv [Preprint]. [posted 2016 Jul 13; revised 2016 Dec 07; cited 2017 Feb 15]: [22 p.]. Available from: https://osf.io/preprints/socarxiv/hbcmz/ .

Anderson SC, Poulsen KB. Anderson's electronic atlas of hematology [CD-ROM]. Philadelphia: Lippincott Williams & Wilkins; 2002.

36. Journal article on the Internet

Abood S. Quality improvement initiative in nursing homes: the ANA acts in an advisory role. Am J Nurs [Internet]. 2002 Jun [cited 2002 Aug 12];102(6):[about 1 p.]. Available from: https://journals.lww.com/ajnonline/Fulltext/2002/06000/Quality_Improvement_Initiative_in_Nursing_Homes.31.aspx Subscription required.

Optional presentation (omits bracketed phrase that qualifies the journal title abbreviation):

Abood S. Quality improvement initiative in nursing homes: the ANA acts in an advisory role. Am J Nurs. 2002 Jun [cited 2002 Aug 12];102(6):[about 1 p.]. Available from: https://journals.lww.com/ajnonline/Fulltext/2002/06000/Quality_Improvement_Initiative_in_Nursing_Homes.31.aspx Subscription required.

Article published on the Internet ahead of the print version: See # 18 .

Optional formats used by NLM in MEDLINE/PubMed:

Article with document number in place of traditional pagination:

Williams JS, Brown SM, Conlin PR. Videos in clinical medicine. Blood-pressure measurement. N Engl J Med. 2009 Jan 29;360(5):e6. PubMed PMID: 19179309.

Article with a Digital Object Identifier (DOI):

Zhang M, Holman CD, Price SD, Sanfilippo FM, Preen DB, Bulsara MK. Comorbidity and repeat admission to hospital for adverse drug reactions in older adults: retrospective cohort study. BMJ. 2009 Jan 7;338:a2752. doi: 10.1136/bmj.a2752. PubMed PMID: 19129307; PubMed Central PMCID: PMC2615549.

Article with unique publisher item identifier (pii) in place of traditional pagination or DOI:

Tegnell A, Dillner J, Andrae B. Introduction of human papillomavirus (HPV) vaccination in Sweden. Euro Surveill. 2009 Feb 12;14(6). pii: 19119. PubMed PMID: 19215721.

37. Monograph on the Internet

Foley KM, Gelband H, editors. Improving palliative care for cancer [Internet]. Washington: National Academy Press; 2001 [cited 2002 Jul 9]. Available from: https://www.nap.edu/catalog/10149/improving-palliative-care-for-cancer .

38. Homepage/Web site

eatright.org [Internet]. Chicago: Academy of Nutrition and Dietetics; c2016 [cited 2016 Dec 27]. Available from: https://www.eatright.org/ .

39. Part of a homepage/Web site

American Medical Association [Internet]. Chicago: The Association; c1995-2016 [cited 2016 Dec 27]. Office of International Medicine; [about 2 screens]. Available from: https://www.ama-assn.org/about/office-international-medicine

40. Database on the Internet

Open database: Who's Certified [Internet]. Evanston (IL): The American Board of Medical Specialists. c2000 -   [cited 2001 Mar 8]. Available from: https://www.abms.org/verify-certification/

Closed database: Jablonski S. Online Multiple Congenital Anomaly/Mental Retardation (MCA/MR) Syndromes [Internet]. Bethesda (MD): National Library of Medicine (US); c1999 [updated 2001 Nov 20; cited 2002 Aug 12]. Available from: //www.nlm.nih.gov/archive//20061212/mesh/jablonski/syndrome_title.html

41. Part of a database on the Internet

MeSH Browser [Internet]. Bethesda (MD): U.S. National Library of Medicine; 2002 -   . Meta-analysis; [cited 2017 Dec 1]; [about 1 p.]. Available from: https://meshb.nlm.nih.gov/record/ui?ui=D017418 MeSH Unique ID: D017418.

Holt M. The Health Care Blog [Internet]. San Francisco: Matthew Holt. 2003 Oct -   [cited 2009 Feb 13]. Available from: http://thehealthcareblog.com/blog/category/matthew-holt/ .

Contribution to a blog:

Mantone J. Head trauma haunts many, researchers say. 2008 Jan 29 [cited 2009 Feb 13]. In: Wall Street Journal. HEALTH BLOG [Internet]. New York: Dow Jones & Company, Inc. c2008 -   . [about 1 screen]. Available from: https://blogs.wsj.com/health/2008/01/29/head-trauma-haunts-many-researchers-say/ .

Campbell A. Diabetes and alcohol: do the two mix? (Part 2). 2008 Jan 28 [cited 2009 Feb 13]. In: Diabetes Self-Management Blog [Internet]. New York: Diabetes Self-Management. [2006 Aug 14] -   . 2 p. Available from: https://www.diabetesselfmanagement.com/blog/Amy_Campbell/Diabetes_and_Alcohol_Do_the_Two_Mix_Part_2

43. Datasets

Dataset description article:

Kraemer MU, Sinka ME, Duda KA, Mylne A, Shearer FM, Brady OJ, Messina JP, Barker CM, Moore CG, Carvalho RG, Coelho GE, Van Bortel W, Hendrickx G, Schaffner F, Wint GR, Elyazar IR, Teng HJ, Hay SI.  The global compendium of Aedes aegypti and Ae. albopictus occurrence. Sci Data. 2015 Jul 7 [cited 2015 Oct 23];2:150035. Available from: http://www.nature.com/articles/sdata201535 doi: 10.1038/sdata.2015.35 eCollection 2015. PubMed PMID: 26175912; PubMed Central PMCID: PMC4493829.

Dataset deposit record: Citing Medicine format

Kraemer MUG, Sinka ME, Duda KA, Mylne A, Shearer FM, Brady OJ, Messina JP, Barker CM, Moore CG, Carvalho RG, Coelho GE, Van Bortel W, Hendrickx G, Schaffner F, Wint GRW, Elyazar IRF, Teng H, Hay SI. The global compendium of Aedes aegypti and Ae. albopictus occurrence [dataset]. 2015 Jun 30 [cited 2015 Oct 23]. In: Dryad Digital Repository [Internet]. Durham (NC): Dryad. 2008 Jan - . 3 files: 3.406 MB; 1.549 MB; 1.815 MB. Available from: https://datadryad.org/stash/dataset/doi:10.5061/dryad.47v3c Referenced in doi: 10.7554/eLife.08347 

Dataset deposit record: Simplified format

Kraemer MUG, Sinka ME, Duda KA, Mylne A, Shearer FM, Brady OJ, Messina JP, Barker CM, Moore CG, Carvalho RG, Coelho GE, Van Bortel W, Hendrickx G, Schaffner F, Wint GRW, Elyazar IRF, Teng H, Hay SI. The global compendium of Aedes aegypti and Ae. albopictus occurrence [dataset]. 2015 Jun 30 [cited 2015 Oct 23]. Dryad Digital Repository. Available from: https://datadryad.org/stash/dataset/doi:10.5061/dryad.47v3c Referenced in doi: 10.7554/eLife.08347 

Dataset repository: Citing Medicine format

Dryad Digital Repository [Internet]. Durham (NC): Dryad. 2008 Jan - [cited 2014 Oct 3]. Available from: https://datadryad.org/stash/ .

Dataset repository: Simplified format

Dryad Digital Repository. Durham (NC): Dryad. [cited 2014 Oct 3]. Available from: https://datadryad.org/stash/ .

Dataset: Citing Medicine format

RxNorm [dataset on the Internet]. April 4, 2016 Full Monthly Release. Bethesda (MD): U.S. National Library of Medicine; 2016 Apr 4 [cited 2016 Apr 18]. Available from: https://www.nlm.nih.gov/research/umls/rxnorm/docs/rxnormfiles.html

Dataset: Simplified format

RxNorm [dataset]. April 4, 2016 Full Monthly Release. 2016 Apr 4 [cited 2016 Apr 18]. Available from: https://www.nlm.nih.gov/research/umls/rxnorm/docs/rxnormfiles.html

44. Software on the Internet

A full citation for software on the Internet can follow the general guidelines in Item #43 for datasets or in Citing Medicine, Chapter 24 for databases and retrieval systems. Software in other media such as CD-ROM is detailed in Citing Medicine, Chapter 21 .

Software: Simplified format

Publisher is optional and place of publication is not needed. Strive to include an Available from: note with a URL or a doi: xxxxxxx note. Other helpful notes can be added at the end such as a System Requirements note.

Hayes B, Tesar B, Zurow K. OTSoft: Optimality Theory Software. Version 2.3.2 [software]. 2013 Jan 14 [cited 2015 Feb 14]. Available from: https://linguistics.ucla.edu/people/hayes/otsoft/ .

Golda TG, Hough PD, Gay G. APPSPACK (Asynchronous Parallel Pattern Search). Version 5.0.1 [software]. Sandia National Laboratories. 2007 Feb 16 [cited 2016 Apr 4; downloaded 2010 Jan 5]. Available from: https://dakota.sandia.gov/packages/hopspack

Last Reviewed: June 14, 2024

Medical Research: Forms & Consent Templates

Main navigation.

This section contains all of the forms and consent templates that apply to investigators from:     • School of Medicine (SoM)    • Veteran's Affairs (VA) Hospital 

*Please note that when creating a protocol for IRB submission, these investigators need to select the Medical eProtocol Application category.

If you have questions or are having trouble accessing these forms, please contact IRB Education ( email or call 650-724-7141).

The consent/assent form should be in a language that is understandable to someone without a medical or scientific background. Please use the Microsoft Readability Statistics tool as needed when writing your consent form.

See  consent template updates  for recent changes.

Other Forms:

eProtocol Forms:

Health (Nursing, Medicine, Allied Health)

• Find Articles/Databases
• Reference Resources
• Evidence Summaries & Clinical Guidelines
• Drug Information
• Health Data & Statistics
• Patient/Consumer Facing Materials
• Images and Streaming Video
• Grey Literature
• Mobile Apps & "Point of Care" Tools
• Tests & Measures This link opens in a new window
• Citing Sources
• Selecting Databases
• Framing Research Questions
• Crafting a Search
• Narrowing / Filtering a Search
• Expanding a Search
• Cited Reference Searching
• Saving Searches
• Term Glossary
• Critical Appraisal Resources
• What are Literature Reviews?
• Conducting & Reporting Systematic Reviews
• Finding Systematic Reviews
• Tutorials & Tools for Literature Reviews
• Finding Full Text

What are Systematic Reviews? (3 minutes, 24 second YouTube Video)

Systematic Literature Reviews: Steps & Resources

These steps for conducting a systematic literature review are listed below . 

Also see subpages for more information about:

• The different types of literature reviews, including systematic reviews and other evidence synthesis methods
• Tools & Tutorials

Literature Review & Systematic Review Steps

• Develop a Focused Question
• Scope the Literature  (Initial Search)
• Refine & Expand the Search
• Limit the Results
• Download Citations
• Abstract & Analyze
• Create Flow Diagram
• Synthesize & Report Results

1. Develop a Focused   Question 

Consider the PICO Format: Population/Problem, Intervention, Comparison, Outcome

Focus on defining the Population or Problem and Intervention (don't narrow by Comparison or Outcome just yet!)

"What are the effects of the Pilates method for patients with low back pain?"

Tools & Additional Resources:

• PICO Question Help
• Stillwell, Susan B., DNP, RN, CNE; Fineout-Overholt, Ellen, PhD, RN, FNAP, FAAN; Melnyk, Bernadette Mazurek, PhD, RN, CPNP/PMHNP, FNAP, FAAN; Williamson, Kathleen M., PhD, RN Evidence-Based Practice, Step by Step: Asking the Clinical Question, AJN The American Journal of Nursing : March 2010 - Volume 110 - Issue 3 - p 58-61 doi: 10.1097/01.NAJ.0000368959.11129.79

2. Scope the Literature

A "scoping search" investigates the breadth and/or depth of the initial question or may identify a gap in the literature. 

Eligible studies may be located by searching in:

• Background sources (books, point-of-care tools)
• Article databases
• Trial registries
• Grey literature
• Cited references
• Reference lists

When searching, if possible, translate terms to controlled vocabulary of the database. Use text word searching when necessary.

Use Boolean operators to connect search terms:

• Combine separate concepts with AND  (resulting in a narrower search)
• Connecting synonyms with OR  (resulting in an expanded search)

Search:  pilates AND ("low back pain"  OR  backache )

Video Tutorials - Translating PICO Questions into Search Queries

• Translate Your PICO Into a Search in PubMed (YouTube, Carrie Price, 5:11) 
• Translate Your PICO Into a Search in CINAHL (YouTube, Carrie Price, 4:56)

3. Refine & Expand Your Search

Expand your search strategy with synonymous search terms harvested from:

• database thesauri
• reference lists
• relevant studies

Example: 

(pilates OR exercise movement techniques) AND ("low back pain" OR backache* OR sciatica OR lumbago OR spondylosis)

As you develop a final, reproducible strategy for each database, save your strategies in a:

• a personal database account (e.g., MyNCBI for PubMed)
• Log in with your NYU credentials
• Open and "Make a Copy" to create your own tracker for your literature search strategies

4. Limit Your Results

Use database filters to limit your results based on your defined inclusion/exclusion criteria.  In addition to relying on the databases' categorical filters, you may also need to manually screen results.  

• Limit to Article type, e.g.,:  "randomized controlled trial" OR multicenter study
• Limit by publication years, age groups, language, etc.

NOTE: Many databases allow you to filter to "Full Text Only".  This filter is  not recommended . It excludes articles if their full text is not available in that particular database (CINAHL, PubMed, etc), but if the article is relevant, it is important that you are able to read its title and abstract, regardless of 'full text' status. The full text is likely to be accessible through another source (a different database, or Interlibrary Loan).  

• Filters in PubMed
• CINAHL Advanced Searching Tutorial

5. Download Citations

Selected citations and/or entire sets of search results can be downloaded from the database into a citation management tool. If you are conducting a systematic review that will require reporting according to PRISMA standards, a citation manager can help you keep track of the number of articles that came from each database, as well as the number of duplicate records.

In Zotero, you can create a Collection for the combined results set, and sub-collections for the results from each database you search.  You can then use Zotero's 'Duplicate Items" function to find and merge duplicate records.

• Citation Managers - General Guide

6. Abstract and Analyze

• Migrate citations to data collection/extraction tool
• Screen Title/Abstracts for inclusion/exclusion
• Screen and appraise full text for relevance, methods, 
• Resolve disagreements by consensus

Covidence is a web-based tool that enables you to work with a team to screen titles/abstracts and full text for inclusion in your review, as well as extract data from the included studies.

• Covidence Support
• Critical Appraisal Tools
• Data Extraction Tools

7. Create Flow Diagram

The PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) flow diagram is a visual representation of the flow of records through different phases of a systematic review.  It depicts the number of records identified, included and excluded.  It is best used in conjunction with the PRISMA checklist .

Example from: Stotz, S. A., McNealy, K., Begay, R. L., DeSanto, K., Manson, S. M., & Moore, K. R. (2021). Multi-level diabetes prevention and treatment interventions for Native people in the USA and Canada: A scoping review. Current Diabetes Reports, 2 (11), 46. https://doi.org/10.1007/s11892-021-01414-3

• PRISMA Flow Diagram Generator (ShinyApp.io, Haddaway et al. )
• PRISMA Diagram Templates  (Word and PDF)
• Make a copy of the file to fill out the template
• Image can be downloaded as PDF, PNG, JPG, or SVG
• Covidence generates a PRISMA diagram that is automatically updated as records move through the review phases

8. Synthesize & Report Results

There are a number of reporting guideline available to guide the synthesis and reporting of results in systematic literature reviews.

It is common to organize findings in a matrix, also known as a Table of Evidence (ToE).

• Reporting Guidelines for Systematic Reviews
• Download a sample template of a health sciences review matrix  (GoogleSheets)

Steps modified from: 

Cook, D. A., & West, C. P. (2012). Conducting systematic reviews in medical education: a stepwise approach.   Medical Education , 46 (10), 943–952.

• << Previous: Critical Appraisal Resources
• Next: What are Literature Reviews? >>
• Last Updated: Jun 26, 2024 3:00 PM
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This is Degena Bahrey Tadesse from Tigray, Ethiopia. I am new for this web I am assistant professor in Adult Health Nursing Could you share me the sample/templet research proposal for Global Research Nurses Pump-priming Grants 2023: Research Project Award

I have learned lot..Thanks..

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Do you have a task and responsability matrix template for clinical trial managment ? Best

I am very much happy to find myself here as a clinician

Dear Getrude

We have a free 14-module course on research ethics on our training centre; you'll receive a certificate if you complete all the modules and quizzes. You can take it in your own time. Just visit 'Training centre' in the tabs above, then 'short courses'.

Kind regards The Editorial Team

need modules on free online gcp course on research ethics

Estimados: me parece excelente el aporte que han hecho dado que aporta. por un lado a mejorar la transparencia del trabajo como a facilitar el seguimiento y supervisión de los mismos. Muchas gracias por ello

We also have an up to date list of global health events available here: https://globalhealthtrials.tghn.org/community/training-events/

Dear Nazish

Thank you, I am glad you found the seminars and the training courses useful. We list many training events (all relevant to Global Health, and as many of them as possible are either free or subsidised) on the 'community' web pages above. Keep an eye on those for events and activities which you can get involved with. Also, if you post an 'introduction' on the introduction group stating where you are from and your research interests, we can keep you updated of relevant local events.

Thanks so much. These are very helpful seminars. Please let me know any other websites/links that provide free or inexpensive lectures on clinical Research. Appreciate your help.

Hi Nazish, and welcome to the Network. The items here are downloadable templates for you to use; it sounds like you may be seeking lectures and eLearning courses? If so - no problem! You can find free seminars with sound and slides here: https://globalhealthtrainingcentre.tghn.org/webinars/ , and you can find free, certified eLearning courses here: https://globalhealthtrials.tghn.org/elearning . Certificates are awarded for the eLearning courses for those scoring over 80% in the quiz at the end of each course. If you need anything else, do ask! Kind regards The Editorial Team

Hi, I am new to this website and also to the Clinical Research Industry for that matter I only am able to see the PDF of these courses, just wanted to know are these audio lectures and also happen to have audio clips that go with the pdf?

This site is impeccable and very useful for my job!!!!

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How to write a medical research paper for publishing in a high impact journal?

Physician writing and why Physicians are better off involving professional services to help with the process?

Why Perform A Meta – Analysis Evidence Based Research?

Publishing a medical research paper in a high impact journal comes with its perks. Firstly, there’s the fame, the recognition by your peers and also among other scientific communities. Then, there are the material benefits; like grants, funds, and sponsorships for your future projects, and job promotions. Then there is also the increase in responsibility owing to the recognition.

But publishing in a high impact journal is not an easy feat. Only less than 10% of all the works submitted get published. It is understood that to get posted the communication is as important as the science part. High impact journals are the ones that get cited the most and vigorously strive to maintain a high standard for their publishing. Various factors go into consideration for work to be published.

The essential considerations for a researcher writing a manuscript for publishing must be the cover letter, conclusion part of their paper, keywords, literature references, abstract, and visual information. An editor will look at this first, sometimes only this before publishing. And the readers view the title and the abstract before deciding to read. Although written after the rest of the paper, the title and the abstract give the readers the first impression of the article.

In the cover letter;

• Address the importance of the topic
• The significance of your results to the field
• Highlight the innovation your research will bring
• Mention if you are adding on to previous work
• Provide reasons for choosing the particular journal
• Explain why you think readers will like it.

Keep the cover letter precise and concise, as this will help the editor note the key points.

Almost all research papers follow a similar general format. The final draft of the document opens with the abstract of the whole paper, followed by the introduction, the literature review, the methodology, research results, discussions, conclusion, reference, and the appendices.

The general rules for medical writing include all the regulatory, academic writing guidelines like sticking to the same tense, providing proper citations depending on the chosen or given style, limiting the use of jargons depending on the target audience. The critical components to get the paper published are the style and the structure.

It is better to start writing the main body of the research at first. This includes the literature review , methodology, results, and discussions. The literature review provides an overview of the existing knowledge and related investigations. The methodology chapter contains all the processes followed in the study and the justifications for choosing the specific method. It provides the reader with knowledge of the research design and approach. The chapter must provide thorough information on the means for another investigator to apply elsewhere.

The research results and discussions chapters go into details of the achievement or the lack thereof, of the research. It explains the thesis proved or disproved. These chapters form the crux of the study. The conclusion reiterates the salient features of the investigation while explaining the significance of it to the field of study.

The benefit of writing introduction and conclusion after the completion of the main body of the paper is that it will be easier to cite from the research. The introduction is written with the reader in mind, for it introduces the study. The chapter provides the context and the background of the research and also hints at the style and structure of the paper. The introduction contains the thesis statement in the middle or at the end.

The abstract is the summary of the paper that doesn’t exceed a page. The references, bibliography, and appendices are provided appropriate to the chosen style.

If you follow high impact journals regularly, you may note that certain authors get published more often than others. This isn’t because the editors favour them, instead the quality of their writing. The paper must explain why what you have done matters than what you have done. After everything is said and done, publishing is still up to the editor and referees and if you think you were rejected unfairly, do write them about it.

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150+ Medical research paper topics for students

Published 26 Jun 2024

Med Research Topics: What Makes a Good One?

Several essential attributes characterize an excellent medical research topic. First and foremost, it should address a significant and relevant issue within the medical field. The topic must have practical implications, contributing to advancing medical knowledge and improving patient care. For example, researching a new treatment for a prevalent disease or understanding the underlying mechanisms of a standard physical and mental health condition can provide valuable insights that can be applied in clinical practice.

Furthermore, a robust medical research topic should be specific and well-defined, allowing for a focused investigation. Vague or overly broad issues can make formulating a straightforward research question and designing a robust study challenging. Interested researchers can delve deeper into the subject matter by narrowing the scope and producing more detailed and meaningful findings. For instance, instead of broadly studying "cancer and treatment options," a more defined topic like "the efficacy of a specific immunotherapy in treating melanoma" would yield more actionable results.

Another critical aspect of an excellent medical research topic is feasibility. Researchers need to consider the availability of resources, such as funding, equipment, and expertise, as well as ethical considerations. The topic should be practical to study within the given constraints and timeframe. The feasibility of interesting topics also encompasses recruiting sufficient participants if human subjects are involved, ensuring that the study can be conducted effectively and ethically.

Lastly, a compelling medical research topic should be innovative and contribute new knowledge. It should challenge existing paradigms, explore uncharted areas, or offer new perspectives on established concepts. Innovation drives progress in medicine, leading to breakthroughs that can revolutionize patient care and improve patient outcomes. By choosing a topic that pushes the boundaries of current knowledge, healthcare researchers can make a lasting impact on the medical community and beyond.

How to Pick a Good Medical Research Paper Topic

Selecting a good medical research paper topic involves carefully considering several key factors. Firstly, choosing a topic that addresses a significant and current issue in the medical field is essential. One such issue is healthcare access, which is crucial in addressing inequities and barriers leading to health disparities and injustices. This ensures that the research will be relevant and contribute valuable knowledge to ongoing discussions and advancements in oral health elsewhere. Reviewing recent literature on medical research topics and identifying gaps in existing research can help pinpoint areas that need further exploration.

Next, the chosen topic should be specific and focused. A narrow scope allows for a more in-depth investigation and produces more detailed and actionable findings. For example, instead of a broad topic like "diabetes management," focusing on "the impact of a specific diet on blood sugar levels in Type 2 diabetes patients" can yield more precise and practical insights.

Feasibility is another crucial aspect to consider. Ensure that the necessary resources, including time, funding, and access to data or study participants, are available to complete the research effectively. Ethical considerations should be addressed, mainly when human subjects are involved. This involves obtaining the appropriate approvals and ensuring the study design protects participants' rights and well-being.

Lastly, the topic should be innovative and advance medical knowledge or practice. Aim to explore new perspectives, challenge existing assumptions, or investigate novel treatments or interventions. By selecting a topic that pushes the boundaries of understanding herbal medicine, researchers can significantly impact trends in the field and contribute to meaningful advancements in medicine.

150 medical research topics for college students

• Impact of lifestyle changes on hypertension management
• Genetic predispositions to heart disease
• Advances in minimally invasive heart surgery
• Role of diet in preventing cardiovascular diseases
• Efficacy of new anticoagulants in stroke prevention
• Long-term effects of statins on heart health
• Emerging treatments for congestive heart failure
• Non-invasive techniques for detecting coronary artery disease
• Impact of mental health on cardiac health
• Role of inflammation in atherosclerosis development
• Immunotherapy for advanced melanoma
• Genetic markers for early cancer detection
• Impact of diet and lifestyle on cancer prognosis
• New targeted therapies for breast cancer
• Role of microRNA in cancer progression
• Advances in radiotherapy for brain tumors
• Psychological support for cancer patients
• Personalized medicine in oncology
• Impact of environmental toxins on cancer incidence
• Survivorship and quality of life post-cancer treatment
• New treatments for Alzheimer's disease
• Role of genetics in multiple sclerosis
• Advances in the understanding of Parkinson's disease
• Impact of sleep disorders on neurological health
• Efficacy of new migraine treatments
• Neuroplasticity in stroke recovery
• Role of gut microbiome in neurodegenerative diseases
• Emerging therapies for epilepsy
• Impact of chronic stress on brain health
• Non-pharmacological interventions for ADHD
• Vaccination and childhood disease prevention
• Impact of screen time on child development
• Pediatric obesity and associated health risks
• Advances in neonatal care
• Genetic disorders in children and early interventions
• Efficacy of behavioral therapies for autism
• Role of nutrition in childhood growth and development
• Preventing and treating pediatric asthma
• Long-term outcomes of premature birth
• Pediatric mental health and early intervention

Endocrinology

• New treatments for Type 1 diabetes
• Impact of thyroid disorders on overall health
• Advances in understanding insulin resistance
• Role of hormones in metabolic syndrome
• Long-term effects of hormone replacement therapy
• Efficacy of new medications for osteoporosis
• Relationship between stress and endocrine disorders
• Impact of endocrine disruptors on health
• Role of diet and exercise in managing diabetes
• Advances in adrenal gland disorder treatments

Infectious Diseases

• Impact of antibiotic resistance on public health
• New vaccines for emerging infectious diseases
• Role of climate change in disease spread
• Advances in HIV treatment and prevention
• Efficacy of antiviral therapies for hepatitis C
• Impact of global travel on infectious disease transmission
• Role of the microbiome in infection prevention
• Emerging zoonotic diseases
• Efficacy of new tuberculosis treatments
• Strategies for preventing hospital-acquired infections
• Advances in the treatment of depression
• Impact of social media on mental health
• Role of genetics in psychiatric disorders
• Efficacy of cognitive-behavioral therapy for anxiety
• Long-term effects of antipsychotic medications
• Role of Lifestyle changes in managing bipolar disorder
• Impact of trauma on mental health
• Emerging treatments for PTSD
• Role of neurobiology in addiction
• Efficacy of mindfulness-based therapies
• Insomnia effect on patients with mental health conditions

Public Health

• Impact of public health policies on smoking rates
• Role of community programs in obesity prevention
• Strategies for reducing health disparities
• Impact of urbanization on public health
• Efficacy of health education programs
• Role of public health in disaster preparedness
• Advances in global health initiatives
• Impact of socioeconomic status on health outcomes
• Role of vaccination in public health
• Efficacy of public health interventions for substance abuse
• Impact of public health regulations on social behavior and health outcomes amid COVID-19

Dermatology

• Advances in the treatment of psoriasis
• Role of diet in managing acne
• Efficacy of new therapies for eczema
• Impact of environmental factors on skin health
• Role of genetics in skin disorders
• Advances in melanoma detection
• Impact of skincare products on skin health
• Role of microbiome in skin diseases
• Efficacy of laser treatments for skin conditions
• Strategies for preventing skin cancer

Gastroenterology

• Impact of diet on gut health
• Advances in the treatment of inflammatory bowel disease
• Role of probiotics in digestive health
• Efficacy of new therapies for irritable bowel syndrome
• Effect of gut microbiome on overall health
• Role of genetics in gastrointestinal disorders
• Advances in colorectal cancer screening
• Efficacy of dietary interventions for celiac disease
• Impact of chronic stress on digestive health
• Strategies for managing liver diseases
• Impact of electronic health records on gastroenterology research

Pulmonology

• Advances in asthma management
• Role of genetics in lung diseases
• Impact of air pollution on respiratory health
• Efficacy of new treatments for COPD
• Role of Lifestyle changes in managing Sleep Apnea
• Advances in lung cancer treatment
• Effect of Smoking Cessation Programs
• Efficacy of pulmonary rehabilitation
• Role of diet in respiratory health
• Strategies for managing chronic bronchitis
• Advances in kidney transplant techniques
• Role of diet in managing kidney disease
• Impact of hypertension on kidney health
• Efficacy of new treatments for chronic kidney disease
• Role of genetics in nephrological disorders
• Advances in dialysis technology
• Impact of diabetes on kidney health
• Efficacy of lifestyle interventions for kidney stones
• Role of hydration in preventing kidney diseases
• Strategies for early detection of kidney disorders

Orthopedics

• Advances in joint replacement surgery
• Role of physical therapy in managing osteoarthritis
• Efficacy of new treatments for osteoporosis
• Impact of sports on musculoskeletal health
• Role of genetics in orthopedic disorders
• Advances in minimally invasive orthopedic surgery
• Efficacy of regenerative therapies for bone injuries
• Role of nutrition in bone health
• Strategies for preventing sports injuries
• Impact of aging on musculoskeletal health

Ophthalmology

• Advances in cataract surgery techniques
• Role of genetics in eye diseases
• Impact of screen time on vision health
• Efficacy of new treatments for glaucoma
• Role of diet in maintaining eye health
• Advances in retinal disease management
• Efficacy of laser eye surgery
• Strategies for preventing macular degeneration
• Role of lifestyle changes in managing dry eye syndrome
• Impact of environmental factors on eye health

Rheumatology

• Advances in the treatment of rheumatoid arthritis
• Role of genetics in autoimmune disorders
• Efficacy of new therapies for lupus
• Impact of diet on inflammatory conditions
• Role of physical activity in managing arthritis
• Advances in understanding fibromyalgia
• Efficacy of biologic drugs in rheumatology
• Impact of chronic inflammation on overall health
• Strategies for managing gout
• Role of complementary therapies in rheumatic diseases

Selecting a Medical Research Paper Topic

Choosing a good medical research paper topic is a critical first step in the research process, influencing the direction and impact of the study. A well-chosen topic should address a significant and current issue within the medical field, ensuring relevance and the potential to contribute valuable insights to ongoing medical discussions and advancements. By focusing research projects on areas of primary care that need further exploration, researchers can make meaningful contributions to the body of medical knowledge.

A specific and well-defined topic allows for a focused investigation, leading to detailed and actionable findings for future medical students and others. Narrowing the scope helps researchers delve deeper into the subject matter, enhancing the quality and precision of the research. This approach benefits the study and ensures that the results are practical and applicable in real-world medical scenarios. Additionally, the feasibility of the topic, considering available resources and ethical considerations, is crucial for completing the research.

Innovative research topics that push the boundaries of current understanding are essential for driving progress in medicine. Researchers can significantly impact the field by exploring new perspectives, challenging existing assumptions, and investigating novel treatments or interventions for chronic diseases. Such groundbreaking research has the potential to revolutionize patient care and improve health outcomes on a broader scale.

If you're embarking on your medical research journey, start by identifying a topic that not only fascinates you but also meets the criteria of significance, specificity, feasibility, and innovation. Dive into current literature, consult with experts, and consider the practical implications of your research. By choosing a compelling topic, you'll set the stage for a successful and impactful study that can contribute to advancing medical science and improving patient care. Don't hesitate to seek guidance and support from your peers and mentors throughout this process, as collaboration and feedback are invaluable in refining your research focus.

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Written by David Kidwell

David is one of those experienced content creators from the United Kingdom who has a high interest in social issues, culture, and entrepreneurship. He always says that reading, blogging, and staying aware of what happens in the world is what makes a person responsible. He likes to learn and share what he knows by making things inspiring and creative enough even for those students who dislike reading.

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• J Minim Access Surg
• v.15(3); Jul-Sep 2019

How to write an article: An introduction to basic scientific medical writing

Anil sharma.

Department of Minimal Access, Metabolic and Bariatric Surgery, Institute of Minimal Access, Metabolic and Bariatric Surgery, Max Healthcare Institute Ltd., Saket, New Delhi, India

An original scientific article published in a peer-reviewed professional journal of repute provides great personal satisfaction, adds stature and endows professional respectability to contributing authors. Various types of surgical publications that exist nowadays are case report, cohort study, case–control study, randomised controlled trial narrative review, systematic review, Cochrane review, meta-analysis, editorials and leading articles. A study/research protocol is a standardised document, common to all research projects that typically comprise study objectives, study design, selection of participants, study intervention, study evaluations, safety assessments, statistics and participant rights committees. Once the study protocol is completed and reviewed, it is submitted to the local Institutional Review Board/Institutional Ethics Committee for approval. An outline of the levels of evidence and grades of recommendation is available from the Centre for evidence-based medicine at the University of Oxford. A standardised, structured template exists for scientific presentations in the field of medicine which is also followed in medical writing and publications Introduction Methods Results And Discussion (IMRAD). Instructions to authors would normally include reference to International Committee of Medical Journal Editors and Committee on Publication Ethics guidelines for good and ethical publication practice. It is strongly advised to follow the recommended guidelines appropriate for the published study.

INTRODUCTION

The impact of the published article in a scientific journal of repute is powerful and protracted for as Kenneth Rothman states, ‘The written word reaches the widest audience and constitutes the archival message’. Authorship in a scientific journal implies that the authors have critically analysed and presented a scientific work of merit. ‘Reading maketh a full man, conference a ready man and writing an exact man’, (Francis Bacon). With scientific publishing, surgeons make their contributions to the profession for wide dissemination within their community and in the process create intellectual property that will be preserved down the ages. ‘The universal object of men of letters is reputation’, said John Adams.

A majority of practicing surgeons would not write and would remain engaged in busy surgical practices, bread winning and increasing administrative responsibilities. However, an increasing segment of surgeons in training and academic surgeons now feel the need to write and publish. The reasons for writing and publishing are both egoistic and altruistic.[ 1 ] Egoistic motives are the desire to progress academically and professionally, improve status and develop professional contacts. Altruistic motives are dissemination of knowledge and a moral obligation to publish a significant novel observation in the larger interest of better patient care. In several institutions, for academic appointments and promotions, the pressures to publish are sometimes inordinate. In many teaching institutions, to progress academically to whatever academic title one aspires, one's published output must constantly grow in number and quality. However, good-quality writing and publishing are not just in the domain of academic institutions. Several astute clinicians with clarity of vision from non-academic institutions have made significant contributions to surgical literature. It is imperative that contributions to surgical literature are derived from surgeons (academic and non-academic) at various locations (different continents, regions and nationalities) and workplaces (urban, semi-urban and rural). Such literature would be more relevant to the real world as opposed to surgical practice in highly sophisticated ivory towers. In the final analysis, an original scientific article published in a peer-reviewed professional journal of repute provides great personal satisfaction adds stature and endows professional respectability to contributing authors.

MANUSCRIPT TYPES

‘You don’t write because you want to say something; you write because you have something to say’, (Scot Fitzgerald). The essence of fine surgical writing is to write what you as a surgeon would want to read. Enumerated below is a list of various types of surgical publications that exist nowadays arranged in the order of increasing complexity.

• Letter/communication to the Editor

Case report

Cohort study (non-randomised, observational study), case–control study (non-randomised, observational study).

• Randomised controlled trial (RCT)

Narrative review

Systematic review and cochrane review, meta-analysis.

• Editorials and leading articles.

Letter/communication to the editor

This would be with reference to an article that has previously been published. The letter should be polite, constructive and should provide comments that offer a novel perspective of the published article. The comments should add, detract or critically review the contents of the published article in a fair and reasonable manner. The objective is to closely focus on and examine critical issues that may not have been appropriately addressed.

Many esteemed surgical writers, even journal editors, began a literary career with a time-honoured case report.[ 2 ] The humble case report would probably be the first step that an aspiring surgeon takes in surgical writing. Unfortunately, pressure of space and editorial policies directed at enhancing the impact factor of individual journals have reduced the opportunities for publication of case reports.[ 3 ]

The cohort study, case–control study and RCT constitute ‘original articles’ in surgical publications. The narrative review, systematic review and meta-analysis are ‘review articles’.

A cohort study is when patients are followed forward and assessed from time of exposure until time of consequences of exposure (target outcome). An example is ‘initial experience with single incision laparoscopic cholecystectomy.’

A case–control study is when patients are selected once they have the target outcome or not and researchers look backward to try to determine the factors of exposure. An example is ‘bile duct injury with single incision laparoscopic cholecystectomy.’

Randomised controlled trial

An RCT is performed when investigators want to assess treatment effects, usually considered to be beneficial. An example is ‘an RCT comparing recurrence rates between laparoscopic hernioplasty and Shouldice repair for groin hernias’.

A cohort study is feasible when randomisation of exposure is not possible. A case–control study overcomes temporal delays and may only require small sample size. However, both these studies are susceptible to bias and therefore have limited validity. The advantage of an RCT is that it provides the highest level of evidence. It is therefore useful to disprove efficacy which is important in the present era of technology-driven surgery. There is immense pressure from the manufacturers to use devices and procedures, many of which may not measure up to the scientific scrutiny of a well-conducted RCT. The design and execution of an RCT in surgery, however, is fraught with several difficulties and challenges. The nature of treatment by surgical intervention may lead to ethical issues that make design of the study difficult. Moreover, surgical skills and competence may vary from one hospital and surgeon to another making comparison odious. In most surgical studies, blinding of procedure from assessor is very difficult, and therefore, bias is inevitable.

A narrative review is usually written by invitation to an expert. The expert objectively reviews the subject in a concise and impartial manner. He/she addresses new developments and summarises recent literature. A narrative review leaves an imprint of the approach and thought process of the expert on the subject.

A systematic review involves more rigorous compilation of evidence. A systematic review is designed to present complete and unbiased evidence on the subject that presently exists in the literature. Strict adherence to follow and complete all components of a clearly defined protocol is mandatory.

A meta-analysis is a type of systematic review that uses statistical methods to combine and summarise the results of clinical trials. A meta-analysis must always include a formal examination of heterogeneity as an indicator of similar or divergent results.

Editorials and leading articles

These are usually written by invitation on a specific research area. The opinion and judgement of the editor do not only be based on review of literature but also carry the imprimatur of his/her personal beliefs and experience.

EVIDENCE-BASED MEDICINE

We live in an era of evidence-based medicine where increasingly an evidence-based approach to surgical practice would dictate the refining of systems and processes of patient care. Evidence-based practice is the, explicit and judicious use of the current best evidence in making decisions about the care of individual patients’.[ 4 ] An outline of the levels of evidence and grades of recommendation is available from the Centre for evidence-based medicine at the University of Oxford[ 5 , 6 ] Table 1 describes the levels of evidence for therapeutic studies.[ 7 ]

Levels of evidence for therapeutic studies

CONSTRUCTING THE MANUSCRIPT

‘If you can’t explain it simply, you don’t understand it well enough’, (Albert Einstein).

At the outset, formulation of the study/research protocol is required. The study/research protocol is a standardised document, common to all research projects that should be available in teaching institutions. The protocol template typically comprises the following.

• Study objectives
• Study design
• Selection of participants
• Study intervention
• Study evaluations
• Safety assessments
• Participant rights
• Committees.

Once the study protocol is completed and reviewed, it is submitted to the local Institutional Review Board (IRB)/Institutional Ethics Committee (IEC) for approval. Written consent is obtained and the study is registered at the Clinical Trial Registry of India at www.ctri.in .

‘If you don’t know where you are going, you will end up someplace else’, (Yogi Berra).

A standardised, structured template exists for scientific presentations in the field of medicine, and this is also followed in Medical writing and publications Introduction Methods Results And Discussion (IMRAD).

• Introduction: Why did we start?
• Methods: What did we do?
• Results: What did we find?
• Discussion: Hence, what does it mean?

Enumerated below are the constituent segments and contents therein in an original article of a scientific medical manuscript.

Introduction (two paragraphs)

The Introduction commences with a brief lesson on the subject as described in literature. Current knowledge, insights and recent developments on the subject are briefly stated. A lacuna or gap in knowledge or incomplete information on some aspect of the subject forms the basis and reason to perform the present research/study. The last line in the Introduction section normally reads ‘The aim of this study was…’, ‘We report… or ‘We reviewed…’.

Methods (seven paragraphs)

The Methods section narrates the story of what the authors did. The narration is arranged in a logical framework of time. A logical sequence for presentation is ethical approval, patient selection, surgical intervention, outcome assessments and statistical methods employed.

Results (six paragraphs)

The Results Section is an overall description of the major findings of the study. The Results section presents measurements and data on all stated end-points (primary and secondary) of the study. Data presentation should be clear and concise.

Discussion (seven paragraphs)

The Discussion section summarises the article and presents a perspective of the message in the article. The first paragraph provides a summary of the main aim, methods and results of the study. The last paragraph provides a tentative answer to the research question posed in the study and also a suggestion for future research in a related area of the study. The limitations of the present study are discussed (e.g. nature of study, numbers of patients and limited follow-up). The strengths of the present study, if any, may be enumerated. Similar studies in the literature are discussed and how the present study fits in is analysed. The implications of the present study are discussed in terms of future research, change in patient management policies and suggested amendments to clinical practice.

The title should be descriptive yet concise while conveying the essential features of the contents of the article. The title should contain words that will make the article accessible to workers in the field. Clarity, brevity and above all human interest are the hallmarks of a good title.

Titles and abstracts are freely available to browse across a wide array of databases on the Internet. An attractive title and a concise abstract serve to attract the attention of readers. The abstract serves as a stand-alone summary that describes the major contents and message of the article. The abstract is structured (IMRAD) with a strict word limit. It serves as a quick reference and shortcut for busy researchers.

Keywords are short phrases that capture the main topics of the article. These follow the abstract in the article. Keywords assist in cross-indexing and literature search.

Most journal editors subscribe to guidance from the International Committee of Medical Journal Editors (ICMJE)[ 8 ] also known as the Vancouver group. Contributors who meet all four of the below-mentioned criteria qualify for authorship.

• Substantial contributions to the conception or design of the work or the acquisition, analysis or interpretation of data for the work
• Drafting the work or revising it critically for important intellectual content
• Final approval of the version to be published
• Agreement to be accountable for all aspects of the work.

Acknowledgements

Those whose contributions do not justify authorship may be acknowledged and their contributions should be specified (e.g., ‘served as scientific advisors’, ‘critically reviewed the study proposal’, ‘collected data’, ‘provided and cared for study patients’ and ‘participated in writing or technical editing of the manuscript’).[ 8 ]

Conflict of interest

The ICMJE states that ‘a conflict of interest exists when professional judgement concerning a primary interest (such as patient's welfare or the validity of research) may be influenced by a secondary interest (such as financial gain)’. Public trust in the scientific process and the credibility of published articles depend in part on how transparently conflicts of interest are handled during the planning, implementation, writing, peer review, editing and publication of scientific work. Financial relationships (such as employment, consultancies, stock ownership or options, honoraria, patents and paid expert testimony) are the most easily identifiable conflicts of interest and the most likely to undermine the credibility of the journal, the authors, and science itself.[ 8 ]

A reference to articles serves to guide readers to a connected body of literature. Conference abstracts should not be used as references. They can be cited in the text, in parentheses, but not as page footnotes. References to papers accepted but not yet published should be designated as ‘in press’ or ‘forthcoming’. Information from manuscripts submitted but not accepted should be cited in the text as ‘unpublished observations’ with written permission from the source. Avoid citing a ‘personal communication’ unless it provides essential information not available from a public source, in which case the name of the person and date of communication should be cited in parentheses in the text.[ 8 ]

INSTRUCTIONS TO AUTHORS

It is mandatory to read and follow ‘Instructions to Authors’ provided by the journal where the manuscript is being sent for evaluation. Journals require electronic submission of manuscripts through specially designed editorial software (e.g. edition manager, manuscript central). The instructions provide detailed submission guidelines to Authors for submission of manuscripts. Instructions would normally include reference to ICMJE what an editor expects…pg 1124[ 9 ] and Committee on Publication Ethics (COPE) Guidelines[ 10 ] for good and ethical publication practice.

REPORTING GUIDELINES

It is strongly advised to follow recommended guidelines appropriate for the published study. These guidelines set international standards for reporting different types of research studies. A good checklist is provided for preparing the publication. The guidelines standardise trial design, facilitate accurate reporting and correct interpretation of results [ Table 2 ].[ 11 ]

Reporting guidelines for main study types

ROLE OF BIOSTATISTICIAN

The biostatistician provides invaluable input, advice and suggestions in construction of the manuscript. He/she should be consulted right from the concept and planning stage. He/she assists in protocol development with study design and study evaluations. He/she plans data management by confirming assessment of data on primary and secondary end-points of the study. He/she supervises data collection, archival and analysis. He/she implements and monitors the study on a periodic basis to its conclusion. Finally, the biostatistician assists with reporting results during writing of the manuscript.

DATA MANAGEMENT

Data management is the strategy used for collecting, organising and analysing data. The ultimate aim of conducting a study is to generate data to provide answers to the research question. The quality of data generated plays an important role in the outcome of the study. It follows that if primary data collection and entry are not considerate and meticulous, subsequent data analysis for outcome measures would not be satisfactory. Data need to be ultimately stored in electronic data capturing systems for ease of data management and analysis.

Several data analysis software systems are available that provide statistical results when data are fed into then in a predetermined format (Analyse-it, SPSS, WINKS SDA, Stata, Vitalnet).

WRITING STYLE

An effective writing style is easy to read and simple to understand. The connoisseur writer filters out unnecessary details and distills the essence of his/her communication in the manuscript. A short manuscript presented clear and lucidly is the most effective. Simple sentences in straightforward language convey the most information. A short sentence is easier to read and comprehend than a long rambling one, short, simple and familiar words are more reader-friendly than longer complicated phrases (replace ‘illustrate’ with ‘show’, ‘fundamental’ with ‘basic’ and ‘remainder’ with ‘rest’). A spell check and grammar check are mandatory after completing the manuscript.

New information is provided in a new paragraph. The main point appears at the start and should be clear, succinct and easy to find. The author consciously needs to avoid elitism/triumphalism in the article (the first report, the only study, the largest cohort). Exclamation and quotation marks are avoided in a formal medical manuscript. Proper punctuation marks such as full stops and commas are mandatory.

Text verbatim (copy and paste) from a previously published article or book must be marked as reference source. The author needs to follow the reference style required for submission to the journal. The Vancouver system[ 12 ] is the most commonly used. Abbreviations (INR – international normalised ratio, PT – prothrombin time) and acronyms (IMV – inferior mesenteric vein) should always be defined the first time they are used in the text. Abbreviations are useful to avoid unnecessary and frequent use of long phrases in the text. However, their use should be restricted in the text and never used in the title and abstract. In figures, abbreviations need to be explained in the legend and for tables in the footnote.

Tables and figures must be sufficiently clear, well labelled and interpretable without having to refer to the text. These should be placed in the text as near as possible to the place where they are referred to. Tables should not be used when data can be summarised in text (e.g. population sizes, sex ratios) or where data are better represented in graphs and figures. The legend carries descriptive information on the tables and figures to make them understandable as stand-alone segments. Table legends are placed above the body of the table, and figure legends are placed below the figures. Footnotes in a table explain abbreviations and P values.

PUBLICATION ETHICS

The COPE was founded in 1997 as a voluntary body to attempt to define best practice in the ethics of scientific publishing. The COPE guidelines on good publication practice are useful for authors, editors, editorial board members, readers, owners of journals and publishers. They address study design and ethical approval, data analysis, authorship, conflicts of interest, peer-review process, redundant publication, plagiarism, duties of editors, media relations, advertising and how to deal with misconduct.

• Study design and ethical approval: Good research should be well justified, well planned appropriately designed and ethically approved. To conduct research to a lower standard may constitute misconduct
• Data analysis: Data should be appropriately analysed, but inappropriate analysis does not necessarily amount to misconduct. Fabrication and falsification of data do constitute misconduct
• Authorship: There is no universally agreed definition of authorship although attempts have been made. As a minimum, authors should take responsibility for a particular section of the study

They may be personal, commercial, political, academic or financial. ‘Financial’ interests may include employment, research funding, stock or share ownership, payment for lectures or travel, consultancies and company support for staff

• Peer review: Peer reviewers are external experts chosen by editors to provide written opinions, with the aim of improving the study. Working methods vary from journal to journal, but some use open procedure in which the name of the reviewer is disclosed, together with the full or ‘edited’ report
• Redundant publication: Redundant publication occurs when two or more papers, without full cross-references, share the same hypothesis, data, discussion points, or conclusions
• Plagiarism: Plagiarism ranges from the unreferenced use of others published and unpublished ideas, including research grant applications to submission under ‘new’ authorship of a complete paper, something in a different language. It may occur at any stage of planning, research writing or publication: It applies to print and electronic versions
• Duties of editors: Editors are stewards of journals. They usually take over their journal from the previous editor(s) and always want to hand over the journal in good shape. Most editors provide direction for the journal and build a strong management team. They must consider and balance the interests of many constituents, including readers, authors, staff, owners, editorial board members, advertisers and the media
• Media relations: Medical research findings are of increasing interest to the print and broadcast media. Journalists may attend scientific meetings at which preliminary research findings are presented, leading to their premature publication in the mass media
• Advertising: Many scientific journals and meetings derive significant income from advertising. Reprints may also be lucrative.

Financial support and sponsorship

Conflicts of interest.

There are no conflicts of interest.

• Open access
• Published: 14 June 2024

Associations between deep venous thrombosis and thyroid diseases: a two-sample bidirectional Mendelian randomization study

• Lifeng Zhang 1   na1 ,
• Kaibei Li 2   na1 ,
• Qifan Yang 1 ,
• Yao Lin 1 ,
• Caijuan Geng 1 ,
• Wei Huang 1 &
• Wei Zeng 1  

European Journal of Medical Research volume  29 , Article number:  327 ( 2024 ) Cite this article

316 Accesses

Metrics details

Some previous observational studies have linked deep venous thrombosis (DVT) to thyroid diseases; however, the findings were contradictory. This study aimed to investigate whether some common thyroid diseases can cause DVT using a two-sample Mendelian randomization (MR) approach.

This two-sample MR study used single nucleotide polymorphisms (SNPs) identified by the FinnGen genome-wide association studies (GWAS) to be highly associated with some common thyroid diseases, including autoimmune hyperthyroidism (962 cases and 172,976 controls), subacute thyroiditis (418 cases and 187,684 controls), hypothyroidism (26,342 cases and 59,827 controls), and malignant neoplasm of the thyroid gland (989 cases and 217,803 controls. These SNPs were used as instruments. Outcome datasets for the GWAS on DVT (6,767 cases and 330,392 controls) were selected from the UK Biobank data, which was obtained from the Integrative Epidemiology Unit (IEU) open GWAS project. The inverse variance weighted (IVW), MR-Egger and weighted median methods were used to estimate the causal association between DVT and thyroid diseases. The Cochran’s Q test was used to quantify the heterogeneity of the instrumental variables (IVs). MR Pleiotropy RESidual Sum and Outlier test (MR-PRESSO) was used to detect horizontal pleiotropy. When the causal relationship was significant, bidirectional MR analysis was performed to determine any reverse causal relationships between exposures and outcomes.

This MR study illustrated that autoimmune hyperthyroidism slightly increased the risk of DVT according to the IVW [odds ratio (OR) = 1.0009; p  = 0.024] and weighted median methods [OR = 1.001; p  = 0.028]. According to Cochran’s Q test, there was no evidence of heterogeneity in IVs. Additionally, MR-PRESSO did not detect horizontal pleiotropy ( p  = 0.972). However, no association was observed between other thyroid diseases and DVT using the IVW, weighted median, and MR-Egger regression methods.

Conclusions

This study revealed that autoimmune hyperthyroidism may cause DVT; however, more evidence and larger sample sizes are required to draw more precise conclusions.

Introduction

Deep venous thrombosis (DVT) is a common type of disease that occurs in 1–2 individuals per 1000 each year [ 1 ]. In the post-COVID-19 era, DVT showed a higher incidence rate [ 2 ]. Among hospitalized patients, the incidence rate of this disease was as high as 2.7% [ 3 ], increasing the risk of adverse events during hospitalization. According to the Registro Informatizado Enfermedad Tromboembolica (RIETE) registry, which included data from ~ 100,000 patients from 26 countries, the 30-day mortality rate was 2.6% for distal DVT and 3.3% for proximal DVT [ 4 ]. Other studies have shown that the one-year mortality rate of DVT is 19.6% [ 5 ]. DVT and pulmonary embolism (PE), collectively referred to as venous thromboembolism (VTE), constitute a major global burden of disease [ 6 ].

Thyroid diseases are common in the real world. Previous studies have focused on the relationship between DVT and thyroid diseases, including thyroid dysfunction and thyroid cancer. Some case reports [ 7 , 8 , 9 ] have demonstrated that hyperthyroidism is often associated with DVT and indicates a worse prognosis [ 10 ]. The relationship between thyroid tumors and venous thrombosis has troubled researchers for many years. In 1989, the first case of papillary thyroid carcinoma presenting with axillary vein thrombosis as the initial symptom was reported [ 11 ]. In 1995, researchers began to notice the relationship between thyroid tumors and hypercoagulability [ 12 ], laying the foundation for subsequent extensive research. However, the aforementioned observational studies had limitations, such as small sample sizes, selection bias, reverse causality, and confounding factors, which may have led to unreliable conclusions [ 13 ].

Previous studies have explored the relationship of thyroid disease and DVT and revealed that high levels of thyroid hormones may increase the risk of DVT. Hyperthyroidism promotes a procoagulant and hypofibrinolytic state by affecting the von Willebrand factor, factors VIII, IV, and X, fibrinogen, and plasminogen activator inhibitor-1 [ 14 , 15 ]. At the molecular level, researchers believe that thyroid hormones affect coagulation levels through an important nuclear thyroid hormone receptor (TR), TRβ [ 16 ], and participate in pathological coagulation through endothelial dysfunction. Thyroid hormones may have non-genetic effects on the behavior of endothelial cells [ 17 , 18 ]. In a study regarding tumor thrombosis, Lou [ 19 ] found that 303 circular RNAs were differentially expressed in DVT using microarray. Kyoto Encyclopedia of Genes and Genomes (KEGG) analysis revealed that the most significantly enriched pathways included thyroid hormone-signaling pathway and endocytosis, and also increased level of proteoglycans in cancer. This indicated that tumor cells and thyroid hormones might interact to promote thrombosis. Based on these studies, we speculated that thyroid diseases, including thyroid dysfunction and thyroid tumors, may cause DVT.

Mendelian randomization (MR) research is a causal inference technique that can be used to assess the causal relationship and reverse causation between specific exposure and outcome factors. If certain assumptions [ 20 ] are fulfilled, genetic variants can be employed as instrumental variables (IVs) to establish causal relationships. Bidirectional MR analysis can clarify the presence of reverse causal relationships [ 21 ], making the conclusions more comprehensive. Accordingly, we aimed to apply a two-sample MR strategy to investigate whether DVT is related to four thyroid diseases, including autoimmune hyperthyroidism, subacute thyroiditis, hypothyroidism, and thyroid cancer.

Study design

MR relies on single nucleotide polymorphisms (SNPs) as IVs. The IVs should fulfill the following three criteria [ 22 ]: (1) IVs should be strongly associated with exposure. (2) Genetic variants must be independent of unmeasured confounding factors that may affect the exposure–outcome association. (3) IVs are presumed to affect the outcome only through their associations with exposure (Fig.  1 ). IVs that met the above requirements were used to estimate the relationship between exposure and outcome. Our study protocol conformed to the STROBE-MR Statement [ 23 ], and all methods were performed in accordance with the relevant guidelines and regulations.

The relationship between instrumental variables, exposure, outcome, and confounding factors

Data sources and instruments

Datasets (Table  1 ) in this study were obtained from a publicly available database (the IEU open genome-wide association studies (GWAS) project [ 24 ] ( https://gwas.mrcieu.ac.uk )). There was no overlap in samples between the data sources of outcome and exposures. Using de-identified summary-level data, privacy information such as overall age and gender were hidden. Ethical approval was obtained for all original work. This study complied with the terms of use of the database.

MR analysis was performed using the R package “TwoSampleMR”. SNPs associated with each thyroid disease at the genome-wide significance threshold of p  < 5.0 × 10 –8 were selected as potential IVs. To ensure independence between the genetic variants used as IVs, the linkage disequilibrium (LD) threshold for grouping was set to r 2  < 0.001 with a window size of 10,000 kb. The SNP with the lowest p -value at each locus was retained for analyses.

Statistical analysis

Multiple MR methods were used to infer causal relationships between thyroid diseases and DVT, including the inverse variance weighted (IVW), weighted median, and MR-Egger tests, after harmonizing the SNPs across the GWASs of exposures and outcomes. The main analysis was conducted using the IVW method. Heterogeneity and pleiotropy were also performed in each MR analysis. Meanwhile, the MR-PRESSO Global test [ 25 ] was utilized to detect horizontal pleiotropy. The effect trend of SNP was observed through a scatter plot, and the forest plot was used to observe the overall effects. When a significant causal relationship was confirmed by two-sample MR analysis, bidirectional MR analysis was performed to assess reverse causal relationships by swapping exposure and outcome factors. Parameters were set the same as before. All abovementioned statistical analyses were performed using the package TwoSampleMR (version 0.5.7) in the R program (version 4.2.1).

After harmonizing the SNPs across the GWASs for exposures and outcomes, the IVW (OR = 1.0009, p  = 0.024, Table  2 ) and weighted median analyses (OR = 1.001, p  = 0.028) revealed significant causal effects between autoimmune hyperthyroidism and DVT risk. Similar results were observed using the weighted median approach Cochran’s Q test, MR-Egger intercept, and MR-PRESSO tests suggested that the results were not influenced by pleiotropy and heterogeneity (Table  2 ). However, the leave-one-out analysis revealed a significant difference after removing some SNPs (rs179247, rs6679677, rs72891915, and rs942495, p  < 0.05, Figure S2a), indicating that MR results were dependent on these SNPs (Figure S2, Table S1). No significant effects were observed in other thyroid diseases (Table  2 ). The estimated scatter plot of the association between thyroid diseases and DVT is presented in Fig.  2 , indicating a positive causal relationship between autoimmune hyperthyroidism and DVT (Fig.  2 a). The forest plots of single SNPs affecting the risk of DVT are displayed in Figure S1.

The estimated scatter plot of the association between thyroid diseases and DVT. MR-analyses are derived using IVW, MR-Egger, weighted median and mode. By fitting different models, the scatter plot showed the relationship between SNP and exposure factors, predicting the association between SNP and outcomes

Bidirectional MR analysis was performed to further determine the relationship between autoimmune hyperthyroidism and DVT. The reverse causal relationship was not observed (Table S2), which indicated that autoimmune hyperthyroidism can cause DVT from a mechanism perspective.

This study used MR to assess whether thyroid diseases affect the incidence of DVT. The results showed that autoimmune hyperthyroidism can increase the risk of DVT occurrence, but a reverse causal relationship was not observed between them using bidirectional MR analysis. However, other thyroid diseases, such as subacute thyroiditis, hypothyroidism, and thyroid cancer, did not show a similar effect.

Recently, several studies have suggested that thyroid-related diseases may be associated with the occurrence of DVT in the lower extremities, which provided etiological clues leading to the occurrence of DVT in our subsequent research. In 2006, a review mentioned the association between thyroid dysfunction and coagulation disorders [ 26 ], indicating a hypercoagulable state in patients with hyperthyroidism. In 2011, a review further suggested a clear association between hypothyroidism and bleeding tendency, while hyperthyroidism appeared to increase the risk of thrombotic events, particularly cerebral venous thrombosis [ 27 ]. A retrospective cohort study [ 28 ] supported this conclusion, but this study only observed a higher proportion of concurrent thyroid dysfunction in patients with cerebral venous thrombosis. The relationship between thyroid function and venous thromboembolism remains controversial. Krieg VJ et al. [ 29 ] found that hypothyroidism has a higher incidence rate in patients with chronic thromboembolic pulmonary hypertension and may be associated with more severe disease, which seemed to be different from previous views that hyperthyroidism may be associated with venous thrombosis. Alsaidan [ 30 ] also revealed that the risk of developing venous thrombosis was almost increased onefold for cases with a mild-to-moderate elevation of thyroid stimulating hormone and Free thyroxine 4(FT4). In contrast, it increased twofold for cases with a severe elevation of thyroid stimulating hormone and FT4. Raised thyroid hormones may increase the synthesis or secretion of coagulation factors or may decrease fibrinolysis, which may lead to the occurrence of coagulation abnormality.

Other thyroid diseases are also reported to be associated with DVT. In a large prospective cohort study [ 31 ], the incidence of venous thromboembolism was observed to increase in patients with thyroid cancer over the age of 60. However, other retrospective studies did not find any difference compared with the general population [ 32 ]. In the post-COVID-19 era, subacute thyroiditis has received considerable attention from researchers. New evidence suggests that COVID-19 may be associated with subacute thyroiditis [ 33 , 34 ]. Mondal et al. [ 35 ] found that out of 670 COVID-19 patients, 11 presented with post-COVID-19 subacute thyroiditis. Among them, painless subacute thyroiditis appeared earlier and exhibited symptoms of hyperthyroidism. Another case report also indicated the same result, that is, subacute thyroiditis occurred after COVID-19 infection, accompanied by thyroid function changes [ 36 ]. This led us to hypothesize that subacute thyroiditis may cause DVT through alterations in thyroid function.

This study confirmed a significant causal relationship between autoimmune hyperthyroidism and DVT ( p  = 0.02). The data were tested for heterogeneity and gene pleiotropy using MR-Egger, Cochran’s Q, and MR-PRESSO tests. There was no evidence that the results were influenced by pleiotropy or heterogeneity. In the leave-one-out analysis, four of the five selected SNPs showed significant effects of autoimmune hyperthyroidism on DVT, suggesting an impact of these SNPs on DVT outcome. Previous studies have focused on the relationship between hyperthyroidism and its secondary arrhythmias and arterial thromboembolism [ 37 , 38 ]. This study emphasized the risk of DVT in patients with hyperthyroidism, which has certain clinical implications. Prophylactic anticoagulant therapy was observed to help prevent DVT in patients with hyperthyroidism. Unfortunately, the results of this study did not reveal any evidence that suggests a relationship between other thyroid diseases and DVT occurrence. This may be due to the limited database, as this study only included the GWAS data from a subset of European populations. Large-scale multiracial studies are needed in the future.

There are some limitations to this study. First, it was limited to participants of European descent. Consequently, further investigation is required to confirm these findings in other ethnicities. Second, this study did not reveal the relationship between complications of hyperthyroidism and DVT. Additionally, this study selected IVs from the database using statistical methods rather than selecting them from the real population. This may result in weaker effects of the screened IVs and reduce the clinical significance of MR analysis. Moreover, the definitions of some diseases in this study were not clear in the original database, and some of the diseases were self-reported, which may reduce the accuracy of diagnosis. Further research is still needed to clarify the causal relationship between DVT and thyroid diseases based on prospective cohort and randomized controlled trials (RCTs).

This study analyzed large-scale genetic data and provided evidence of a causal relationship between autoimmune hyperthyroidism and the risk of DVT, Compared with the other thyroid diseases investigated. Prospective RCTs or MR studies with larger sample sizes are still needed to draw more precise conclusions.

Availability of data and materials

The IEU open gwas project, https://gwas.mrcieu.ac.uk/

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Lifeng Zhang and Kaibei Li have contributed equally to this work and share the first authorship.

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Department of Vascular Surgery, Hospital of Chengdu University of Traditional Chinese Medicine, No. 39, Shierqiao Road, Jinniu District, Chengdu, 610072, Sichuan, People’s Republic of China

Lifeng Zhang, Qifan Yang, Yao Lin, Caijuan Geng, Wei Huang & Wei Zeng

Disinfection Supply Center, Hospital of Chengdu University of Traditional Chinese Medicine, No. 39, Shierqiao Road, Jin Niu District, Chengdu, 610072, Sichuan, People’s Republic of China

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Conception and design: LFZ and WZ. Analysis and interpretation: LFZ, KBL and WZ. Data collection: LFZ, QFY, YL, CJG and WH. Writing the article: LFZ, KBL. Critical revision of the article: LFZ, GFY and WZ. Final approval of the article: LFZ, KBL, YL, CJG, WH, QFY and WZ. Statistical analysis: YL, QFY.

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Zhang, L., Li, K., Yang, Q. et al. Associations between deep venous thrombosis and thyroid diseases: a two-sample bidirectional Mendelian randomization study. Eur J Med Res 29 , 327 (2024). https://doi.org/10.1186/s40001-024-01933-1

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Published on 27.6.2024 in Vol 26 (2024)

A Symptom-Checker for Adult Patients Visiting an Interdisciplinary Emergency Care Center and the Safety of Patient Self-Triage: Real-Life Prospective Evaluation

Authors of this article:

Original Paper

• Andreas Meer 1 , MSc, MD   ; 
• Philipp Rahm 2 , MD   ; 
• Markus Schwendinger 2 , MD   ; 
• Michael Vock 3 , PhD   ; 
• Bettina Grunder 1 , MD   ; 
• Jacopo Demurtas 1 , MD, PhD   ; 
• Jonas Rutishauser 4 , MD  

1 In4medicine Inc, Bern, Switzerland

2 Cantonal Hospital Baden, Baden, Switzerland

3 Institute of Mathematical Statistics and Actuarial Science, University of Bern, Bern, Switzerland

4 Clinical Trial Unit, Cantonal Hospital Baden and Medical Faculty, University of Basel, Baden, Switzerland

Corresponding Author:

Andreas Meer, MSc, MD

In4medicine Inc

Monbijoustrasse 23

Switzerland

Phone: 41 313701330

Email: [email protected]

Background: Symptom-checkers have become important tools for self-triage, assisting patients to determine the urgency of medical care. To be safe and effective, these tools must be validated, particularly to avoid potentially hazardous undertriage without leading to inefficient overtriage. Only limited safety data from studies including small sample sizes have been available so far.

Objective: The objective of our study was to prospectively investigate the safety of patients’ self-triage in a large patient sample. We used SMASS (Swiss Medical Assessment System; in4medicine, Inc) pathfinder, a symptom-checker based on a computerized transparent neural network.

Methods: We recruited 2543 patients into this single-center, prospective clinical trial conducted at the cantonal hospital of Baden, Switzerland. Patients with an Emergency Severity Index of 1-2 were treated by the team of the emergency department, while those with an index of 3-5 were seen at the walk-in clinic by general physicians. We compared the triage recommendation obtained by the patients’ self-triage with the assessment of clinical urgency made by 3 successive interdisciplinary panels of physicians (panels A, B, and C). Using the Clopper-Pearson CI, we assumed that to confirm the symptom-checkers’ safety, the upper confidence bound for the probability of a potentially hazardous undertriage should lie below 1%. A potentially hazardous undertriage was defined as a triage in which either all (consensus criterion) or the majority (majority criterion) of the experts of the last panel (panel C) rated the triage of the symptom-checker to be “rather likely” or “likely” life-threatening or harmful.

Results: Of the 2543 patients, 1227 (48.25%) were female and 1316 (51.75%) male. None of the patients reached the prespecified consensus criterion for a potentially hazardous undertriage. This resulted in an upper 95% confidence bound of 0.1184%. Further, 4 cases met the majority criterion. This resulted in an upper 95% confidence bound for the probability of a potentially hazardous undertriage of 0.3616%. The 2-sided 95% Clopper-Pearson CI for the probability of overtriage (n=450 cases,17.69%) was 16.23% to 19.24%, which is considerably lower than the figures reported in the literature.

Conclusions: The symptom-checker proved to be a safe triage tool, avoiding potentially hazardous undertriage in a real-life clinical setting of emergency consultations at a walk-in clinic or emergency department without causing undesirable overtriage. Our data suggest the symptom-checker may be safely used in clinical routine.

Trial Registration: ClinicalTrials.gov NCT04055298; https://clinicaltrials.gov/study/NCT04055298

Introduction

In potentially critical situations, clinical warning signs and symptoms may be considered too late by patients due to a lack of professional triage [ 1 ]. In this context, various initiatives have been launched to improve outpatient emergency care and the population’s access to a low-threshold initial medical assessment [ 2 ]. Symptom-checkers, which enable medical self-triage, have recently been introduced for this purpose. Such tools could assist the increasing number of persons without ready access to a primary care physician, for example, migrants or young persons who had been previously healthy. If implemented in settings outside the hospital, that is, at home or work, tools for efficient and safe self-triage could help avoid unnecessary emergency hospital visits, thus contributing to reducing overcrowding and costs.

To fulfill the regulatory requirements [ 3 ] and to be used as a part of standard care, the appropriateness and safety of these instruments must be evaluated in concrete clinical settings with real patients [ 4 - 6 ].

Appropriate care results from adequate triage and treatment, while inappropriate care may lead to unsuitable or even dangerous health care delivery. The concept of appropriateness hence includes a widespread range of quality aspects, of which safety is only one. The difficulty of assessing appropriateness in health care and of gaining agreement between clinicians on acceptable and safe care is highlighted by different authors [ 7 , 8 ]. When assessing the appropriateness of medical triage, the question “Was the decision right” suggests that there is merely one single correct triage decision. This question does not appropriately reflect the complex interaction of clinical, social, and environmental factors in medical decision-making. Rather, physicians should consider a range of appropriate triage decisions to guide their actions. Safety is an essential quality attribute of a medical service. In contrast to the idea of appropriateness, the concept of safety focuses on the risk of a specific conduct. When asking about the safety of a symptom-checker, a risk-based approach should be taken, and safety should encompass possible risks to a patient’s health and life [ 3 ].

An evaluation of 23 symptom-checkers using 45 patient vignettes concluded that most symptom-checkers were deficient in both appropriate triage and correct diagnosis [ 9 ]. However, the study did not comment on the safety of the tested devices. A review paper including 14 studies found inconsistent evidence regarding the triage and diagnostic appropriateness of symptom-checkers for common health problems. The average appropriateness of triage ranged from 27% to 92%. This paper did not specifically evaluate the safety of symptom-checkers [ 5 ]. Another review paper cited only 6 studies that analyzed the safety of symptom-checkers [ 10 ]. These studies were mostly short-term and included samples that were too small and heterogeneous to make reliable statements about safety.

Given the present shortage of data on self-triage, we aimed to investigate the safety of a newly developed symptom-checker (SMASS; Swiss Medical Assessment System) in a concrete clinical setting with patients seeking emergency care.

Study Design

Before the inclusion of the first patient, this study was registered (ClinicalTrials.gov identifier: NCT04055298).

This study was performed between November 25, 2019, and May 1, 2020, at the walk-in clinic and interdisciplinary emergency department (WIC/ED) of the cantonal hospital of Baden, Switzerland. The WIC/ED is open 24 hours a day, 365 days a year and treats about 55,000 patients annually. Patients are routinely triaged by a nurse using the Emergency Severity Index (ESI) [ 11 ]. ESI 1-2 patients are treated in the ED, while ESI 3-5 patients are treated in the WIC.

The symptom-checker used in this study (SMASS in the pathfinder version, release 4.1.12) was developed by in4medicine, Inc. The first author (author AM) is the chief executive officer and founder of this company. To minimize bias, a majority of independent researchers were involved in this study, including establishing the protocol and all practical aspects of the trial. No employee of in4medicine took part in the actual conduct of the trial. Data analysis and statistical calculations were performed by an independent biostatistician. This study was independently monitored by the clinical trial unit of the Medical Faculty of the University of Bern.

The SMASS pathfinder symptom-checker is a medical device class I under the Medical Device Directive and medical device class IIb under the Medical Device Regulation. The Conformité Européenne declaration of conformity to the Swiss Agency for Therapeutic Products (Swissmedic) was made on June 4, 2018. The symptom-checker is a web-based software that aims to support health professionals and laypersons in the structured documentation and assessment of health problems and to advise users about possible medical assessment steps and treatment measures. It is based on a computerized neural network that incorporates extensive data from scientific studies, guidelines, and expertise from various professional boards of specialists in the field of prehospital medical triage. The symptom-checker provides digitalized questionnaires of 125 frequent reasons for consultations (eg, fever, cough, and abdominal pain) and their associated red flags. Based on the triage result, a report including patient gender, age group, symptoms, medical history, and recommendations as to the appropriate time-to-treat and point-of-care is provided. Depending on the presence of red flags, the symptom-checker assigns the clinical condition of the patient to a triage level ( Tables 1 and 2 ). If 5 or more assessment questions are answered as “unclear,” the user is notified that the software cannot provide targeted triage advice and that the patient should seek immediate consultation with a physician concerning his or her medical complaints.

a Not applicable.

a CPR: cardiopulmonary resuscitation.

b For example, family doctor, family doctor substitute, family doctor emergency service, or suitable specialist.

All patients aged ≥18 years attending the WIC/ED between 8 AM and 5 PM were eligible. Exclusion criteria included aged <18 years; ESI 1 patients requiring immediate, life-saving intervention; inability to use a tablet PC; inability to communicate in German, French, Italian, or English; inability or unwillingness to give written informed consent and follow the procedures of this study; known or suspected noncompliance; known drug or alcohol abuse; the presence of symptoms or complaints not encompassed by the symptom-checker database (eg, long-lasting hiccups, hair loss).

After instruction by the study’s staff and providing written informed consent, the participants independently assessed their health status and complaints as instructed by the symptom-checker on a tablet PC. They were subsequently evaluated and treated by routine medical staff.

In primary care, medical triage decisions usually have to be based solely on the patient’s symptoms. We have chosen experts independent of the treatment (panels A, B, and C) as evaluators to ensure that the triage decision is based purely on the symptoms of this study’s patients. Including treating physicians as comparators in this study could have influenced the triage decision by additional information (physical examination and diagnostic test results).

Our evaluation of the symptom-checker focused on safety, as this is an essential quality attribute of a medical device [ 3 ]. To reflect the highly individual nature of medical decision-making, which usually results in low interrater reliability [ 12 - 14 ], an independent team of experienced physicians engaged in a stepwise evaluation procedure in which each case that was classified as undertriaged by panel A experts was assessed by several experts.

A research assistant and 3 external interdisciplinary panels of board-certified physicians were involved in the evaluation process (panel A, 5 experts; panel B, 2 experts; panel C, 5 experts). Except for one of the 12 panelists (author BG), they were not affiliated with in4medicine, Inc. None of them took part in the conduct of this study. For every patient, the symptom-checker issued a report summarizing the clinical information. Patients and panelists were unaware of the triage-level recommendations (time-to-treat and point-of-care) made by the symptom-checker. All reports were first assessed by members of panel A, who adjudicated an appropriate range of triage levels to every case. The research assistant then compared the adjudication of the panel A experts with the recommendation issued by the symptom-checker. If the comparison showed that the recommendation of the symptom-checker was below the appropriate range of triage levels determined by the rater of panel A, hence was undertriaged, the case was assigned to panel B. In 80 instances, panelists erroneously examined the same cases twice and concluded on diverse triage recommendations. In these cases, the first of the 2 recommendations was used for the analysis.

The evaluation procedure was repeated by panel B. Each of the 2 panelists evaluated all diverging cases. If the case was undertriaged according to 3 experts (1 expert from panel A and 2 experts from panel B), the case was subsequently analyzed by panel C.

Each member of panel C individually assessed the clinical safety of the triage decision based on the complete structured reports generated by the symptom-checker as well as the WIC/ED’s redacted discharge reports. Each of the 5 panelists decided individually on potentially hazardous undertriage. In a modified Delphi process, the panelists first individually adjudicated potentially hazardous undertriage on a 4-point Likert scale. Possible ratings were “unlikely,” “rather unlikely,” “rather likely,” and “likely” that the patient was exposed to a risk to life or health. If the panelists subsequently reached a consensus that the triage of the symptom-checker was “rather likely” or “likely” exposing a patient to a risk to life or health, the case was considered a potentially hazardous undertriage (consensus criterion). As a complement to the original analysis plan, a modified criterion for potentially hazardous undertriage was evaluated, defined as a majority of panel C members judging a risk to life or health as “rather likely” or “likely” (majority criterion).

The primary analysis consisted of the calculation of the 95% upper Clopper-Pearson confidence bound for the probability of undertriage resulting in a risk to life or health (potentially hazardous undertriage). To confirm the safety of the symptom-checker, this upper confidence bound should lie below 1%. For the sample size calculation, we assumed that a 20% probability of failure to meet this criterion is acceptable for a true probability of potentially hazardous undertriage of no more than 0.5%. This is equivalent to requiring a 1-sided test at level 5% to show that the probability of potentially hazardous undertriage is below 1% with a power of 80%, assuming that the true probability is 0.5%. This resulted in a minimal sample size of 2185 patients. Accounting for an estimated rate of 2% “unclear” responses, at least 2230 patients were planned to be included. Secondary analyses included central 95% Clopper-Pearson CIs for the further probabilities, based on corresponding empirical proportions. The software R (version 4.2.0; R Foundation for Statistical Computing) was used for the statistical evaluations.

Ethical Considerations

This study was approved by the competent ethics committee (Ethikkommission Nordwest- und Zentralschweiz EKNZ, project ID 01784) and was conducted per the most recent version of the Declaration of Helsinki, complying with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use—good clinical practice and International Organization for Standardization European Norm 14155 (clinical investigation of medical devices for human subjects—good clinical practice) as well as with applying national legal and regulatory requirements. All patients gave written informed consent to participate in this study. They did not receive any financial or other compensation. Patients were anonymized upon data collection. Discharge notes studied by panel C were redacted.

Generative artificial intelligence was not used in any portion of this paper’s writing.

The baseline characteristics of the participants are shown in Table 3 and the recommendations obtained by the symptom-checker in Table 4 . Figure 1 shows the flow of analyses by panels A-C.

In 210 (8.26%) of the 2543 cases, the recommendation issued by the symptom-checker was below the range of appropriate triage levels defined by the panel A experts and therefore undertriaged. Further, 50 (1.96%) of these 210 patients were equally undertriaged according to panel B. However, for none of these 50 patients did panel C reach a consensus that the undertriage was potentially hazardous. This resulted in an upper 95% confidence bound for the probability of a potentially hazardous undertriage of 0.1184%. If the criterion for potentially hazardous undertriage was defined as a majority of panel C members considering life-threatening or harmful self-triage “rather likely” or “likely,” 4 of the 50 cases fulfilled this criterion. This resulted in an upper 95% confidence bound for the probability of a potentially hazardous undertriage of 0.3616%.

Table 5 shows the adjudication of potentially hazardous undertriage for all 50 cases evaluated by the experts of panel C.

The central (2-sided) 95% Clopper-Pearson CI for the probability of undertriage according to panel A is 7.22% to 9.40%. The central (2-sided) 95% Clopper-Pearson CI for the probability of overtriage according to panel A (450 cases, 17.69%) is 16.23% to 19.24%.

For the 50 out of 2543 cases that were undertriaged according to the judgments of panels A and B, the central (2-sided) 95% Clopper-Pearson CI for the corresponding probability is 1.539% to 2.688%.

The central (2-sided) 95% Clopper-Pearson CI for the probability of a potentially hazardous undertriage for the consensus criterion (0 out of 2543 cases) is 0% to 0.1458% and 0.0431% to 0.4045%, according to the majority criterion (4 out of 2543 cases).

Principal Findings

Our study corroborates the safety of the SMASS pathfinder symptom-checker for medical self-assessment of acute complaints in a real-life clinical setting. A stepwise evaluation of 2543 consecutive patients by 3 independent expert panels yielded no cases of potentially hazardous undertriage when the consensus criterion was applied and 4 cases when the majority criterion was applied.

In a systematic literature search, we found insufficient evidence from comparatively small studies for the safe use of symptom-checkers in clinical routine (Demurtas et al, unpublished data, 2021). Further, 1 study with 825 patients showing “exactly matched” triage in 52.6% has been published in abstract form only [ 15 ]. Another study yielded correct triage in only 50%-74% of cases [ 16 ]. A third study, from Germany, evaluated the safety of urgency advice provided to 378 patients at an interdisciplinary ED by a symptom-checker [ 17 ], showing undertriage in 34 (8.9%) and overtriage in 216 (57.1%) cases. A potentially hazardous situation was identified in 20 (5.3%) cases. This figure appears considerably higher than our finding, although an interrater variability was not taken into account in the German study. Another study aimed to analyze the performance of a clinical decision support system that allowed patients to self-triage in the ED of a university hospital. The authors concluded that the self-triage device was safe, as the assessments by the system and the physicians were congruent concerning the classification as an emergency. However, in contrast to our study, the risk to life or health was not assessed [ 18 ].

In the absence of a broad study base, we cannot compare our results with previous, similarly designed studies for symptom-checkers. In contrast, medical telephone triage has been extensively evaluated during the last 25 years [ 19 - 24 ] and has gained broad clinical support, despite ambivalent conclusions regarding safety.

In a systematic review analyzing 13 observational studies and 10 studies that simulated high-risk patients, safe triage was found to be 46% to 97% [ 25 ]. Another systematic review involving computer-assisted telephone triage in urgent care [ 26 ] pointed out 4 studies that indicated potential undertriage errors [ 27 - 30 ]. Notably, hospitalization rates of patients who were advised to seek nonurgent care ranged from 9.2% to 48%. Potentially life-threatening situations emerged in 0.84% of cases according to 1 study [ 29 ].

We have previously investigated the safety of computer-assisted telephone triage in 208 patients with non–life threatening conditions consulting the ED at a university hospital [ 31 ]. We found poor agreement between the assessments by the call center, the emergency physician, and the general practitioners who later cared for the patients. In 1 case, a risk to health or life was found.

The Cochrane Collaboration in their 2004 systematic review on telephone triage concluded that insufficient data existed regarding safety [ 32 ]. In light of the available information, the results of our study compare favorably to the published data on telephone triage.

Our study has several strengths and weaknesses. We included a large number of patients in a real-world clinical setting. In addition, this study’s design enabled us to eliminate the low interrater reliability of medical triage decisions by having 3 independent expert panels. This allows robust conclusions about the safety of the evaluated symptom-checker.

For reasons of feasibility, we performed our study in a hospital setting, where patients were triaged to the WIC or ED according to ESI criteria. Thus, a wide variety of cases could be assessed. On the other hand, the symptom-checker was not used in a setting outside the hospital, limiting generalizability. However, presenting symptoms largely overlap with those encountered in primary care, and a potential selection bias toward more severe cases would support the conclusion on the device’s safety if it were used in primary care.

A potential limitation of our study is its single-center design. However, the Cantonal Hospital Baden serves a mixed urban and rural population of approximately 300,000 people and offers all medical services except cardiac surgery and neurosurgery. We therefore believe that the patient sample in our study is fairly representative of the general population.

The total number of patients frequenting the WIC and ED during the time of recruitment was 22,676; thus, only approximately 11% of them participated in this study, potentially resulting in selection bias. Due to limited resources, inclusions were possible only during the daytime, leaving approximately 7550 potential participants. Further, 1.5% (340/22,676) were ESI 1 patients, who were not eligible for this study. It could be speculated that patients visiting an ED at night time might be more seriously ill than those during the daytime. This potential bias would make our cohort more comparable to a setting in primary care.

In our study, we have focused on the safety of the symptom-checker. A possible limitation may have resulted from the fact that each case was initially assessed by a single member of panel A. This could have precluded passing a potentially hazardous case to panel B. While maximum patient safety may theoretically be desirable, it should be weighed against the disadvantages of overtriage, notably inefficiency, unnecessary referrals, and a higher risk of overmedicalization, all of which increase costs. In our study, the overtriage rate after assessment by panel A was 17.69% (450 cases). This figure is comparable to published rates of overtriage by teleconsultation and teletriage, which range from 12% to 57% [ 33 - 37 ]. In a further round of data analysis, we will also have the overtriaged cases assessed by panel B to include the low interrater reliability in the analysis. As with undertriaged cases, this is likely to reduce the overtriaged cases.

From the end of February, the COVID-19 pandemic required special hygiene measures for the tablet computers used, making patient recruitment more difficult as the first wave of the pandemic peaked in March 2020. The pandemic is also likely to have affected the case mix, which may have shifted slightly toward COVID-19–positive patients.

The urgency grading used in the 2D matrix for the triage levels ( Table 1 ) was defined at the discretion of this study’s team, implicating a certain degree of subjectiveness. While the range of appropriate triage levels was defined based on this order, the experts did not always explicitly mark all of the intermediate triage levels as appropriate.

Conclusions

The SMASS pathfinder symptom-checker proved to be a safe triage tool, avoiding undertriage in a real-life clinical setting of emergency consultations at a walk-in clinic and ED. Although for practical reasons the symptom-checker was not evaluated outside the hospital environment, our data do not suggest that its safety may have been compromised if used for self-triage by patients in a domestic setting.

Acknowledgments

We thank this study’s nurses of the clinical trial unit, Simone Fontana, Stefanie Leuenberger, and Franziska Rutz, PhD, for their excellent work as well as Elena Righi, PhD, and Lee Smith, PhD, for proofreading this paper. This study was funded by the Health Innovation Hub of the Cantonal Hospital Baden, Switzerland. The symptom-checker was provided by in4medicine, Inc, at no charge.

Data Availability

The raw data of our study is available from in4medicine, Inc [ 38 ].

Authors' Contributions

AM, JR, MS, and MV were responsible for the concept and design. PR, MS, and BG acquired the data, which were analyzed and interpreted by MV, AM, JD, and JR. The first draft was written by AM and then critically revised in conjunction with JR, JD, and MV. Data analysis was done by MV, with oversight by AM and JR.

Conflicts of Interest

AM is the founder and chief executive officer of in4medicine, Inc. BG is a part-time employee of in4medicine, Inc, and JD received a scientific grant from in4medicine, Inc. MV received an honorarium from in4medicine, Inc. The other authors report no conflicts of interest.

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Abbreviations

Edited by A Mavragani; submitted 07.03.24; peer-reviewed by C Lowe, R Payne; comments to author 30.03.24; revised version received 15.04.24; accepted 29.05.24; published 27.06.24.

©Andreas Meer, Philipp Rahm, Markus Schwendinger, Michael Vock, Bettina Grunder, Jacopo Demurtas, Jonas Rutishauser. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 27.06.2024.

This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in the Journal of Medical Internet Research (ISSN 1438-8871), is properly cited. The complete bibliographic information, a link to the original publication on https://www.jmir.org/, as well as this copyright and license information must be included.