Introduction

Research is becoming an increasingly integral part of clinical practice.  More than ever, patients and payers are interested in outcomes of medical treatment.  This information will shape our clinical practices and also be utilized in determining reimbursement policies.  Orthopaedic surgeons are changing also in that the majority of residents currently do fellowships in which they have exposure to research activities.  Many enthusiastic young surgeons begin practice eager about research activities.  However, the busy aspects of a clinical practice and balancing work and family life often take precedence, and these interests unfortunately wane as time goes on.  Young practitioners and surgeons should be encouraged to set goals and be supported in these efforts. There are several different ways to ensure a productive and meaningful research program.

Determining Your Long Term Goals – Picking a Topic

Selecting a suitable subject of research is the first and most important aspect of any meaningful research program.  The most successful and notable researchers are those who have selected a very specific topic and have studied that subject extensively.  They utilize large data bases to answer a number of different research questions, and one study leads to another as new questions arise.  These individuals or groups become recognized as experts in their given field.  Groups of studies focused on a single topic also enable grant preparation by demonstrating both commitment and capability to perform a sustained program of research.  Multiple retrospective small studies on various topics may also be a contribution to the literature, however if the long term goal is to obtain grant funding, the research must focus on one single area.

Select a topic which is of importance to peers and colleagues and make sure that it is indeed a burning question.  Spending a lot of time researching something that most people don’t care about is going to be a waste of time and will make manuscript publication extremely challenging.  Make sure that your topic is of clinical relevance and that your research will have an impact on clinical practice.  Ask yourself the following before you begin “What question am I trying to answer”, “Is anyone interested in this?”  and “Will my research change clinical practice?”

Consider what your institution and/or department does well.  Find out whether there are other individuals in your community or in your university who are researching similar topics.  These individuals can be very helpful in evaluating your research plan and making good suggestions. This is also a good way to network and to identify potential research collaborators.  It is much easier to do research as a strong team than as an individual.  Spend some time working hard to identify this team.

Study Design

Study design is critical.  It is helpful to begin with a prepared study proposal (the hypothesis, materials and methods, and data evaluation).  The proposal should be detailed. It is important at the planning stage to look back at clinic and/or surgery schedules, hospital billing records and/or registries to get a realistic estimation of how many patients will be candidates for the project. Once a draft proposal is completed, this can be shared with experienced colleagues in order to get advice.  The more help you get at the beginning, the more problems you will be able to foresee and work out before you invest a lot of time.  Do a thorough literature search and read the complete paper, not just the abstracts. This avoids wasting time and resources on redundancy and insures the research builds upon what already exists, follows established models and answers new meaningful questions.

The written proposal should also include details on how you will collect the information.  At the outset, this often seems easy, however this can be one of the most challenging aspects of a study.  In a busy clinic, collecting research information from patients is time consuming and you will likely need assistance or online forms that are accessible to patients.  Older patients may have difficulty accessing and completing online forms.

The proposal should contain a budget.  In order to formulate the budget think in detail again, about how patient information will be collected, who will help collect and enter data, and how much this is going to cost. List all the materials and personnel needed.  Evaluate research resources in your institution.  In an academic practice, this may be fairly easy, however, in a different setting you may have to be more creative.

Every study needs to be approved by an institutional review board.  In a university setting, this will be easier, as there is an office assigned to this task.  Most of the forms can be accessed online.  In a community setting, most hospitals are affiliated with an independent entity which oversees study approval.

Patient Enrollment

One of the most challenging aspects of any clinical research project is patient enrollment.  A plan should be in place in order to identify eligible patients.  Speak with your staff and nurses about your study so that they are aware that you are recruiting for a study.  It is often helpful to post notes in your clinic as reminders of the study.  Having these reminders on the wall will keep the project in the front of your mind as patients come through the office.  Recruiting patients is always more difficult than anticipated.  Actual numbers of cases and patients who meet your inclusion criteria are invariably fewer than expected.  Anticipate a certain dropout rate.

Ideally patient information should be collected prospectively; however, resources do not always allow this.  Entering hand written data into computer spreadsheets takes a lot of time.  Additional personnel may be necessary if this is the way data is collected.  This individual should also be responsible for reviewing the data sheets and making sure that information is entered correctly.  Maintaining patient privacy is also important.  Patients should be de-identified, with only principal investigators able to access private information.  Maintaining and organizing systems for managing information is important.  As time goes on and further data points are obtained, this same meticulous methodology should be applied.

Data Analysis

A preliminary analysis should be performed after a complete data set is obtained on a small number of patients.  For example, if you seek to enroll one hundred patients in a study, perform a preliminary analysis in the first 15 to 20 patients when your data set is complete.  This enables identification of problems in the early phase of the study so changes can be made to more efficiently utilize resources and obtain proper information going forward.  It is surprising what problems can be averted with an early preliminary analysis.

At the time of data analysis, statisticians and other qualified collaborators help maintain the integrity of the research.  Unless the principal investigator is a qualified statistician, seeking assistance from someone who can analyze a large amount of data is very important.  This person should understand what the hypothesis is and exactly what questions are being answered.  Other collaborators such as pathologist, radiologist, or other related practitioners can also be strong team members in offering important information in assistance with data interpretation and manuscript preparation.  It is ideal to involve these individuals from the outset so that they also feel invested in the research.

Remember to be respectful of other’s time, and consider their perspective in performing your research.  For example, if you are working with graduate students or PhD candidates, remember that at this phase of their lives, they often stay up late, sleep later and come to work later than surgeons.  Likewise most physicians in other fields of medicine do not keep the hours of an orthopaedic surgeon.  Therefore, schedule team research meetings at times when they are normally at work and utilize their time in their most productive hours.  Asking a graduate student to show up for a 6:30am meeting will not bode well in the long term.  It is better to meet at a more reasonable time as all individuals will be happier and more productive.

Submission of Abstracts for Presentation

When submitting an abstract for presentation at a meeting, present your study in clear, concise language.  Emphasize your most important message.  Too much detail or information will dilute the primary message and make the abstract difficult to understand and read.  The introduction should be short, as the purpose of the introduction is not to educate reviewers on your topic.  The introduction should focus on your hypothesis and the key research question.  For example, when submitting an abstract to a shoulder meeting, the reviewer is likely a shoulder specialist.  Therefore, don’t begin the abstract with “rotator cuff disease is a bad problem.”  Assume the reviewer knows that and get right to the point.  Keep in mind, that reviewers of the abstracts are often reading forty to sixty and maybe even one hundred abstracts that are submitted to a given meeting.  With this in mind, it is very important to be clear, concise and straight forward.  Any allowable figures should also be clear and simple, not complicated by extraneous data.  All of those other details can be included in the manuscript.

Manuscript Preparation

A good medical, scientific writing course can be extremely helpful to a surgeon planning to make research part of their career.  Writing is a learned skill.  Scientific writing is in fact an art perfected with experience.  A scientific writing course extraordinarily helps develop skills critical in writing successful grants and manuscripts.  Have others review your manuscript before submission and make sure you read the instructions for authors to avoid redundant work.

Manuscripts are much shorter today than in the past.  While manuscripts twenty years ago were a treatise on a given topic, many popular journals put strict limits on the length of submissions.  The introduction should be three paragraphs.  The introduction should not be a review of all of the previous literature.  The purpose of the introduction is to establish the relevance of the present study.  Materials and methods should be clear and concise.  Many journals offer an opportunity to add supplementary material.  Consider submitting some of the lengthy details as a supplement so the manuscript doesn’t become unduly difficult to read. Your figures should be illustrative and clear.  The figure legends are just as important as the figures themselves.  The discussion section should be approximately three typed pages.  Again, this is not an opportunity to provide a review of all the existing literature.  The purpose of the discussion is to place the new data into the context of what is already known.  One common mistake is to over step the bounds of the data and make conclusions that are unsubstantiated.  Make sure that the conclusions do not overstep the bounds of your data.

Manuscript preparation can begin even before the data is completely analyzed.  For example, the introduction and the materials and methods can be written while data is being analyzed. Procrastination is a barrier to ultimate completion of the manuscript.  Everyone suffers from this problem, and finding ways to balance time makes the process easier.  Presenting studies at a meeting is not enough.  Studies are not generally accepted as a contribution to the scientific literature until they are published, preferably in the peer reviewed literature.

Conclusion

Research can be incredibly gratifying.  Young Orthopaedic Surgeons should be encouraged to participate in research.  Building collaborations with other individuals and specialists is a smart and supportive way to build a program.  Spend time to plan a meaningful project, organize data collection, and assemble a strong team of collaborators.  Anticipate problems such as patient enrollment, limited resources and data organization.  Plan manuscript preparation and set goals early in terms of obtaining publication.  Lastly, remember to have fun with this.  This is a learning activity and contributions to the scientific literature help not only your own patients but also the patients of other surgeons.

Leesa M. Galatz, M.D.

Professor of Orthopedic Surgery

Washington University Orthopedics

Barnes-Jewish Hospital

St Louis, MO

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