After 9 years as Editor of Research in Gerontological Nursing (RGN), I feel it is the right time for me to retire, and I am pleased to welcome my successor. More on this later. But first, I am pleased to report that in this issue, RGN is publishing our first study protocol (Richards et al., 2020). The study is a double-blind, placebo-controlled, randomized trial entitled “Nighttime Agitation and Restless Legs Syndrome in People with Alzheimer's Disease,” with Kathy Richards, PhD, RN, FAAN, FAASM, as the principal investigator. A study protocol describes how a study will be conducted. It includes a description of the background, rationale, aims, design, methodology, analytical plan, and organization of a clinical research project. I would like to share a few reasons why our Editorial Board decided that publishing a limited number of study protocols is a good idea and would have a positive effect on the quality of science in the field of gerontology.
The most often cited reason for publishing study protocols is because it creates an early record of the planned study. For example, the restless legs study was registered at ClinicalTrials.gov on March 6, 2017, before data collection began (ClinicalTrials.gov Identifier: NCT03082755). This early transparency helps prevent a systematic bias in which the published hypotheses, methods, or results differ from the planned study. Differences between the planned and reported outcomes are an example of selective reporting and can certainly provide a misleading and erroneous picture about an intervention's efficacy.
Publishing a funded major study protocol can help others, including the readers of RGN, improve their methodologies and grant writing. Winning proposals include a logical and convincing chain of ideas that provide insight into a study team's thinking. I have always encouraged early investigators to take advantage of top-notch scientific development opportunities, such as those offered by the National Institutes of Health and the Hartford Centers for Geriatric Excellence. These programs provide a lot of great information about preparing competitive grant applications, but even more important, they help young scientists know “where the bar is” that must be reached to be competitive in earning major research funding. Publishing funded major research protocols gives you easy access to “winning” ideas, innovations, and methodologies. It can also help novice grant writers learn ways to provide conceptual and methodological detail in a concise format.
The grant-writing process, I have found, is like completing a challenging 10,000-piece puzzle. It is a tough road, and a complex one. For those professors who successfully obtain research grants, one reward is found in the promotion and tenure process. But the creativity, scholarship, and tenacity involved in writing a successful grant application can also be publicly acknowledged through publication of study protocols.
The protocol published in this issue underscores the work involved in grant-seeking. As commonly seen, this particular effort involves scientists across multiple disciplines—in this case experts who are affiliated with university and health care organizations across the United States as well as in China. And finding the right people with the needed expertise involves not just searching the literature or repositories of funded research, such as Research Portfolio Online Reporting Tools (RePORT) (access https://report.nih.gov). It also involves networking, attending conferences, and developing collaborative working relationships with these expert colleagues over time. And finally, there is the hard work of revising and polishing the grant application: If I ever counted on two hands the number of drafts I typically did before submitting my final applications, I'd run out of fingers. Any experienced researcher can say the same.
Publishing a study protocol may yield reader feedback that helps strengthen the conceptualization and methods. Identifying and correcting problems early in the research process can improve one's study. Writing the protocol paper may also help investigators independently recognize a gap or way to improve the study.
Replication of research by scientists who are independent from the initial study can add legitimacy and confidence to findings from a single study and is an important part of the research process. However, duplicating research that has been verified through multiple existing studies without the intention of extending previous research is often not very useful and may be a waste of resources. Publication of study protocols may prevent some unnecessary duplication.
RGN welcomes the submission of manuscripts of study protocols of major funded prospective clinical research studies that have Institutional Review Board approval and have not completed participant recruitment at the time of submission. Study protocols for small pilot or feasibility studies are not considered. Preference will be given to submissions describing clinical trials, long-term studies, and those likely to make a new and significant contribution to the field. The SPIRIT (i.e., Standard Protocol Items: Recommendations for Interventional Trials) guidelines define standard protocol items for clinical trials and include a 33-item checklist (access https://www.spirit-statement.org). These guidelines were developed in response to the variability and gaps in protocol content. RGN supports the SPIRIT guidelines, but due to space restrictions, does not require that all 33 recommended items be included in each manuscript. Additional content in the SPIRIT guidelines may be submitted at the discretion of the authors for online only publication. Further information on submitting manuscripts of study protocols can be found in our Information for Authors (access https://www.healio.com/nursing/journals/rgn/submit-an-article).
The Editorial Board believes that giving readers an early look at study protocols is another example of our commitment to provide the scientific community with a cutting-edge journal in the field of gerontology that is topically relevant, useful, and methodologically sophisticated. We welcome feedback from our readers on this change to RGN, as well as any other suggestions for improving the journal and the quality of our science.
It has been a privilege to serve as editor of RGN and to work with the stellar team at SLACK Incorporated, whose support for the journal and the growth of the journal has been unwavering. During my term as Editor, the journal has grown in readership, impact factor, and quality of scientific papers published. This could not have been accomplished without time and effort from a dedicated community of scientists in the field of gerontology. I am so grateful to the members of the Editorial Board and our excellent reviewers for their commitment to the journal and the countless hours of their time given to grow the journal and gerontological science. Prominent and beginning scholars have published groundbreaking state of the science papers, research, and theoretical papers in RGN. I am pleased to pass the reigns as Editor to a highly capable colleague and scientist, Heather M. Young, PhD, RN, FAAN, FGSA. RGN serves an important role in advancing science that directly applies to the health and care of older adults. I look forward to witnessing the next chapter in the growth of RGN.
Christine R. Kovach, PhD, RN, FAAN, FGSA
- Richards, K., Morrison, J., Wang, Y. Y., Rangel, A., Loera, A., Hanlon, A., Lozano, A., Kovach, C., Gooneratne, N., Fry, L. & Allen, R. (2020). Nighttime agitation and restless legs syndrome in persons with Alzheimer's disease: Study protocol for a double-blind, placebo-controlled, randomized trial (NightRest). Research in Gerontological Nursing, 13(6), 280–288 doi:10.3928/19404921-20200918-01 [CrossRef]