Elements of Research Methods in Surgery

By Aparajeya Shanker

Introduction

Over the last few years, research in surgery has gained interest around the world. Indeed, the requirements for surgeons to conduct research, mostly in the form of surgical audits, has become an essential part of some surgeons’ professional duties. This article is a short introduction to the elements of Research Methods in Surgery and is directed towards medical students and junior doctors interested in conducting a research project, and is meant to serve as a very brief introduction to the available research methods in surgery. This article is presented in conjunction with a lecture titled “Elements of Research Methods in Surgery”, which can be found here. The lecture was delivered to medical students from across the world and was conducted with the invaluable co-operation of the Global Consortium of Medical Education and Research (GCMER)-Bulgaria. Their website is linked here.

Why Surgical Research?

Surgical Research is conducted for achieving two primary aims, the first being the foundation of good medical practice: that of improving outcomes for patients, and the second reason is to expand the training of current and future surgeons. Current evidence based practice of medicine is central to improving patient outcomes and reducing mortality and morbidity, and this aim of evidence based medicine expands into surgery.

Research in general is a good way of introducing medical students into the more advanced areas of practice. Research serves as a foundation upon which medical students can transition into medical practice, and contribute the understanding of medicine and surgery. I have always believed that no contribution to medical research is too small, because modern research is less about sudden impactful discoveries, but about understanding increasingly complex interconnected relationships between data points. Research is also a good extracurricular activity because it builds bridges across countries, and across systems of medicine. It is essential for medical students and junior doctors to engage with research because it is a productive outlet and is directly related to their understanding of medicine and surgery.

What are the aims of Research in Surgery?

The aims of research in surgery can be summarized by its attempt to answer the following basic questions. Please note, this list of questions is very limited, because surgical research is vast.

  1. How do we improve outcomes for our patients?
  2. When should we operate and when shouldn’t we operate?
  3. Which procedure is the best for my patient?

It will be prudent to note that surgical research aims to understand two things, the best procedure and the best patient for said procedure. This is a fundamental issue in surgery, knowing the patient well enough so that we can choose for the best procedure for the patient. Surgical research is heavily dependent on interventions (which also happens to be a major challenge for research), and interventions of any kind do not exist in a vacuum, but are performed on patients. It is, therefore, crucial to understand patients so that the best procedure can be chosen for them.

What types of Research Methods are there in Surgery?

There are many research methods that are used in Surgical Research. The following is a short list and is by no means exhaustive:

  1. Case Reports
  2. Retrospective Observational Studies
  3. Case Series
  4. Prospective Cohort Studies
  5. Surgical Audits
  6. Randomized Control Trials

From the above list, there are a select few that are “easier” than others. The term “easier” is only used within a certain context, research in general is a long, time-consuming and sometimes frustrating process. With an increase in the complexity of the research project, the need for specialized team members such as experienced researchers, statisticians, methodologists and other colleagues will also increase. For those interested in research and for those who have just begun their journey in medical research, it is prudent to remember that small, steady steps which begin with simpler or more feasible projects often lead to more fruitful outcomes.

The Escalator of Complexity

As a result of my experiences with research (which involve humble contributions to various areas of medicine and surgery), I designed a conceptual design framework that I call “The Escalator of Complexity”. It is inspired by the “Ladder of Reconstruction” used in Plastic Surgery to determine the best reconstructive method for a patient. I am immensely pleased with frameworks because they provide a scaffolding upon which we can build a research project. Other important research frameworks are included in this article.

Defining the Escalator of Complexity

The escalator of complexity is a conceptual design framework which determines the kind of surgical research project that you can undertake based on the interplay between different factors. The factors that determine the type of research project one can undertake are listed below:

  1. Infrastructure
  2. Patient Availability
  3. Your own knowledge
  4. Support from senior staff or mentors
  5. Availability of data

The conceptual frameworks of the Escalator of Complexity is not entirely unique, I am sure that other frameworks exist which can help you determine the best study or research method you can use, but in my experience, those frameworks are based on many assumptions that do not factor in what a medical student or a beginner in research can do.

Start from the bottom and go up.

Some Useful Frameworks

As discussed earlier, these are the best frameworks to get you started:

  1. FINER
  2. CARE – guidelines
  3. PICO

FINER is a framework for generating hypotheses. It stands for Feasible, Interesting, Novel, Ethical, Relevant. Whenever you wish to form a hypothesis, it is important to look at the framework and determine whether a study is feasible. To determine whether a study is feasible use the Escalator of Complexity to get your answer.

CARE Guidelines are an attempt at setting a gold standard for writing case reports. The associated CARE Writer, an app which runs in your browser, is essential to give you the building blocks for writing a good case report.

PICO stands for Population, Intervention, Comparator, Outcome. It is the best framework for writing a good literature review. An example of using PICO is to ask yourself “What is the patient population I want to study, and what intervention should they have had, and what intervention should I compare it to?”, the outcome part is based on three principles. Is an intervention better, equal to or worse than another intervention? An adjunct to that is to ask whether an intervention is better than no intervention at all.

Resources to help you with your journey in Surgical Research

I have compiled a list of resources which should help you with surgical research.

The presentation “Elements of Research Methods in Surgery”

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Where do I start with research?

You can watch my talk titled “Candles in the Dark- An introductory guide to medical research for students”

You can also read the presentation from the talk below:

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Frameworks explained further

CARE Guidelines – Linked here
FINER Protocol – https://scientific-publishing.webshop.elsevier.com/research-process/finer-research-framework/
PICO Explained- Linked here

Further reading

Blencowe, N.S., Brown, J.M., Cook, J.A., Metcalfe, C., Morton, D.G., Nicholl, J., Sharples, L.D., Treweek, S., Blazeby, J.M., 2015. Interventions in randomised controlled trials in surgery: issues to consider during trial design. Trials 16, 392. https://doi.org/10.1186/s13063-015-0918-4

Clinical Research Methods for Surgeons, n.d.

Dijkgraaf, M.G.W., Haukoos, J., Itani, K.M.F., 2022. Practical Guide to Design Choice of Randomized Clinical Trials in Surgery. JAMA Surgery 157, 1154–1155. https://doi.org/10.1001/jamasurg.2022.4889

Hüttner, F.J., Doerr-Harim, C., Probst, P., Tenckhoff, S., Knebel, P., Diener, M.K., 2014. Study Methods in Evidence-Based Surgery: Methodological Impediments and Suggested Approaches for the Creation and Transfer of Knowledge in Surgery. ESR 53, 86–94. https://doi.org/10.1159/000366201

Kishore, K., Mahajan, R., 2020. Understanding Superiority, Noninferiority, and Equivalence for Clinical Trials. Indian Dermatol Online J 11, 890–894. https://doi.org/10.4103/idoj.IDOJ_130_20

Meshikhes, A.-W.N., 2015. Evidence-based surgery: The obstacles and solutions. International Journal of Surgery 18, 159–162. https://doi.org/10.1016/j.ijsu.2015.04.071

Penson, D.F., Wei, J., 2006. Clinical research methods for surgeons. Humana Press, Totowa, N.J.

Robinson, N.B., Fremes, S., Hameed, I., Rahouma, M., Weidenmann, V., Demetres, M., Morsi, M., Soletti, G., Di Franco, A., Zenati, M.A., Raja, S.G., Moher, D., Bakaeen, F., Chikwe, J., Bhatt, D.L., Kurlansky, P., Girardi, L.N., Gaudino, M., 2021. Characteristics of Randomized Clinical Trials in Surgery From 2008 to 2020: A Systematic Review. JAMA Network Open 4, e2114494. https://doi.org/10.1001/jamanetworkopen.2021.14494

Slim, K., 2005. Limits of Evidence-based Surgery. World journal of surgery 29, 606–9. https://doi.org/10.1007/s00268-005-7922-x

Williams, P.J., Murphy, P., Van Koughnett, J.A.M., Ott, M.C., Dubois, L., Allen, L., Vogt, K.N., 2018. Statistical Techniques in General Surgery Literature: What Do We Need to Know? Journal of the American College of Surgeons 227, 450-454e1. https://doi.org/10.1016/j.jamcollsurg.2018.07.656

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