What I Wish I Knew - Tips for turning your clinical practice into publishable research

Dr. Colvard received her Doctor of Pharmacy degree from Samford University in her hometown of Birmingham, Alabama in 2011. She is proud to have completed a PGY1 pharmacy residency at VA Tennessee Valley Healthcare System in 2012 and PGY2 psychiatric pharmacy residency at the Medical University of South Carolina in 2013.

Dr. Colvard has provided comprehensive medication management services as a Clinical Pharmacist Practitioner in outpatient and inpatient mental health settings and is currently practicing in an outpatient substance use disorder clinic She is passionate about expanding access to medications for opioid use disorder and alcohol use disorder as well as naloxone overdose prevention programs.

Turning your clinical research into publication

Why should we conduct and publish clinical research?

Our fellow CPNP members are doing phenomenal things to improve the lives of patients with mental illness across the country every day. We work as core members of the mental health care team to improve medication outcomes and are continually developing new services. Evaluating our clinical services through research can allows us to find our shortcomings and showcase our accomplishments. It can help us answer questions that are important to fulfilling our mission as psychiatric pharmacists in day to day practice: Are my patients receiving the most safe, effective, and appropriate medication treatment possible? How can I improve it? What impact do my services have on patient care? These type of analysis could be a randomized controlled trial but most often will be designed as retrospective observational studies given limited resource requirement. These will often be exempt as “research” by Institutional Review Board guidelines and classified as quality improvement projects. By publishing our research, we are sharing our findings with peers, other mental health care professionals, and the greater health care community. Publication is key to advancing psychiatric pharmacy practice and expanding our services to reach as many patients as possible. Most importantly, publication can lead to improved patient care.

What makes a research project a publishable project?

If you are interested in publishing, the first step in clinical research is having a clear question in mind. You may begin with a broad question such as “Is there sufficient access to opioid use disorder treatment in my practice area?” but this will need to be narrowed to a more focused and measurable question such as “How many patients with opioid use disorder are discharged from acute psychiatric units with buprenorphine/naloxone or intramuscular naltrexone?”.  While the primary goal is to design a study to improve care for patients at our facilities, we should also consider how those findings could benefit others in the psychiatric community if shared through publication. Ask yourself “Does this question add something new to what we already know?” and “How might it relate to patients outside my facility?”. For example, studies conducted in specific populations, such as veterans, have limitations in external validity, but findings can still be applied to non-veteran practices if they contribute to the current literature. Keep this in mind as you draft your article for publication. Try to minimize terminology specific to your facility or health care system so it more easily translates to as many providers and practices as possible. Consider using the FINER criteria to ensure you are beginning with a strong research question: is the research question feasible, interesting, novel, ethical, and relevant?¹

Once you have established a question and its relevance to current practice, choose the most appropriate study design to achieve your objectives. Retrospective studies are perfect for assessing past interventions and finding direction for future improvements. Non-randomized prospective studies and “pre-post” evaluations are practical methods for residents and clinicians to evaluate new medication practices or pharmacy services. Strong methodology including patient selection, endpoint selection, and data collection procedures is key to success in publishing. For statistics, I would recommend consulting with more experienced mentors or colleagues when it is time for data analysis and interpretation if this is not a strength for you. In fact, it may also be beneficial to consult a statistician associated with your academic medical institution or school of pharmacy in some cases to strengthen your submission for publication. CPNP recommends a few references including PDQ Statistics² and Designing Clinical Research¹ that may come in handy with statistics and for other areas of study design.

After data is collected, analyzed, and summarized, it is time to draft your conclusions. Journal editors and peer reviewers are ensuring the author’s conclusion(s) answer the original study question and accurately portrays the results. What do your findings mean for your patients and clinical practice? What education or research needs do they highlight? When interpreting your results, terminology can play a significant role. For example, is your study design able to establish efficacy? We cannot make conclusions on the efficacy of an intervention without a controlled clinical trial, but don’t underestimate the value of retrospective or observational research. Effectiveness may be a more appropriate term to use when comparing various treatments or strategies to improve the delivery of care in “real-world” clinical practice.

What are some tips for preparing for publication?

Before investing significant time into your manuscript, it’s helpful to choose a few journals of interest. Author guidelines for abstracts, section headings, and word count limit will vary for each journal and submission type. Reviewing author submission guidelines in advance will save you time on the backend. It is also good practice to scan the literature for recently published articles related to your topic to expand your submission options and find the best fit. Talk with peers and mentors for suggestions on journals they have had success with in the past on similar projects or topics. Reach out to the lead editor of journals you are interested in to gauge their interest in your research. This can save you a lot of time in the submission process if they don’t feel your article fits the scope of their journal. It also allows the editor to make suggestions that could increase your chance of acceptance such as changing the type of submission or considering a “sister” journal that may be a better fit. For example, an author submitting research to the Mental Health Clinician may have more success with the “Original Research” or “Innovative Practice” submission type depending on the methodology of their study. Be aware of “predatory journals” which may accept any scientific publication without sufficient peer review for financial profit. Watch out for warning signs such as requests for large publication fees without a clear peer review process, unexpected fees following acceptance, invitations for publication through mass email spamming, and lack of an editorial board or fake editorial board members.

Finally, one of the most important things to remember is to prepare yourself for a possible journal “rejection”. It happens to all of us! It is common for an author to receive multiple rejections before finding the best fit for their publication. The publication process can be long and it is easy for projects to get lost in the shuffle of everyday clinical practice. Stick with it! There are many clinicians out there that can learn and grow from your findings to improve patient care.