The Opportunity to Contribute to Improved Patient Care
The primary benefit of large-scale RCTs is their ability to definitively answer patient-important questions with the promise to improve patient care. In general, most health-care practitioners will not change their practice after reading and appraising a study of lower quality; however, they may be more apt to change their practice following the completion of a high-quality RCT that is applicable to their patient population5. Many who participate in these large trials feel an intrinsic responsibility to collaborate with the intent of identifying and disseminating the best evidence for their patients. Thus, there exists a promise of contributing to the greater good.
The Opportunity to Become Informed with Regard to Personal Clinical Decision-Making
Although multicenter RCTs demonstrate a high level of external validity, the findings may not always apply to all patient groups. Readers may find it challenging to determine if the results are applicable to the patients seen in their practice. Through involvement in a multicenter RCT, clinical site investigators are able to ensure that the data derived from the trial is relevant to their local patient population. This eliminates the extrapolation in appraising the applicability of the study findings.
The Opportunity to Develop Collaborations
Investigators may reap many personal benefits through participation in a multicenter RCT. Through collaboration, investigators create new partnerships and strengthen existing peer relationships. With recent advances in technology, communication and data transfer between clinical sites have never been easier, allowing international investigators to connect instantly6. Collaboration may also lead to mental stimulation through the learning of new research methods and through participation in academic discussions.
The Opportunity to Learn New Techniques and Remain Current
Large RCTs may also provide orthopaedic surgeons with the opportunity to learn new surgical techniques and to remain current in their surgical practice. Protocols for large multicenter RCTs standardize key aspects of preoperative, operative, and postoperative care so that patient care is similar across treatment arms and across clinical sites. To ensure that care among patients is standardized, investigators typically receive training on novel techniques or devices, and may also receive additional training on standard-of-care procedures. Training may be done by industry representatives or by experts in the field.
Participating surgeons may also have access to novel devices and innovative ideas before they become available on the market or come into common use. For example, the large multicenter Fluid Lavage of Open Wounds (FLOW) study, which evaluates different treatment options for open fracture wounds, includes the novel approach of washing open fracture wounds with soap. All participating clinical sites are provided with soap and lavage devices (if necessary) to use on trial participants7.
The Opportunity to Lead Substudies
Participation in a large-scale RCT can also enable an investigator to have the opportunity to lead substudies on the topic area. With the data already collected, partnerships already formed, and a familiarity with the existing literature in the topic area, the investigators have many resources at their disposal to conduct secondary analyses for publication. Through such analyses, an investigator can develop expertise in the area under investigation and have the opportunity to present substudy results at academic meetings as well as to publish. The Study to Prospectively Evaluate Reamed Intramedullary Nails in Patients with Tibial Fractures (SPRINT) provided many opportunities for investigators to conduct and complete substudies that addressed methodological issues as well as important clinical questions8-18.
The Opportunity to Contribute in Peer-Reviewed Publications
One of the personal incentives to participating in a research study of any nature is the opportunity to contribute to the literature base. In an era of “publish or perish”19, authorship is a significant factor in career advancement and academic promotion20. However, depending on the type of research and study design, there are great differences in the time and energy investment involved in completing a research initiative and preparing the corresponding manuscript for publication. For example, depending on its scope, a case series may take a short few months to complete. In contrast, from the time of inception until the time of publication, large-scale multicenter RCTs may take more than ten years to complete. Ultimately, for those who believe they are judged and valued on the basis of their publication record, the time investment required to develop and carry out a large-scale RCT raises potential barriers to involvement.
Authorship becomes a complex issue when the number of investigators contributing to a larger study becomes higher. Most journals limit the number of named authors in a research publication to fewer than ten. To accommodate larger studies, a group authorship model is often employed. In the group authorship model, the authorship byline lists the study investigators and then every individual who had a role in the trial is listed in the appendix on the resulting publication. Typically, investigators’ names along with their contribution(s) to the trial are listed. For example, the SPRINT study utilized group authorship. The study byline read “The SPRINT Investigators” and differentiated all investigators according to their contribution to the study, which included steering committee membership, writing committee membership, adjudication committee membership, data monitoring committee membership, and site investigators21.
Under the model of group authorship, investigators who are listed among a larger group (fifty to 200 names) may perceive that their efforts have not been sufficiently rewarded and they may feel that participating in a smaller-scale study as the primary or the senior author may reflect more positively on their curriculum vitae and may be valued more highly by the academic promotion committee within their center. Moreover, academic promotion committees may not value the time spent focused as an investigator on a multicenter trial compared directly with a similar effort on a smaller, single-center study of lesser quality.
In an effort to assess the relative importance of a variety of academic activities and publication types in the consideration of academic promotion, we electronically surveyed the academic promotions committee chairpersons of sixty-five academic medical centers in the United States and Canada. The survey asked about the relative importance of seven factors (including publications, research grants, teaching, and reference letters) in evaluating a candidate for promotion (Table I). Each item was graded on a scale from one (extremely unimportant) to seven (extremely important). The respondents were also asked to rank these activities according to order of importance. To gain an understanding of how promotion committee chairpersons viewed various types of primary literature, the chairpersons were asked their opinion of the importance of nine types of publications that varied in quality and the amount of work effort that needed to be expended, from a case report to being on the steering committee of a large-scale RCT. To represent these publications, the chairpersons were asked to score nine hypothetical authorship bylines on a 100-point visual analog scale (VAS; with a score of 1 indicating least important and a score of 100 indicating greatest importance) for importance as it related to promotion. By estimating the number of hours that it would take to complete each of the different types of papers, we determined the academic relative value (ARV) of each (VAS divided by the number of hours to complete each different paper type).
Of the sixty-five academic promotions committee chairpersons surveyed, the forty-six respondents valued authorship in peer-reviewed publications to be of the greatest importance (6.4 of 7 points) when considering a candidate for promotion, and they valued authorship in books and chapters to be of the lowest importance (4.2 of 7 points) (Table I). All but one respondent considered the author’s position in the byline to be important. When asked to grade the positions, the position as last author (which is conventionally reserved for the senior researcher), was considered to be the most important (6.6 of 7 points). Being a lead author on a publication or chairperson of a writing committee in a multicenter trial were seen as being equivalent (both 5.3 of 7 points) by those surveyed (Table II). This is surprising, as many more hours are invested in leading a multicenter trial (typical of a chairperson of a writing committee) than are invested in any other study design.
Surprisingly, when grading nine fictitious bylines for their relative value on a 100-point VAS, being the first author of a small multicenter RCT (five authors) ranked just above being the first author for a consortium multicenter RCT (86 versus 83 points). In addition, the chairpersons who were surveyed placed the highest academic relative value on case reports (8.9), retrospective case-control studies (5.9), and prospective cohort studies (1.6) as opposed to the multicenter RCTs (0.2) (Table III). On the basis of this paradigm, surgeons are given forty-four-fold relative credit for writing a case report than for being the lead author on a small multicenter trial. This translates to participation in RCTs being severely undervalued as compared with authorship of case reports, case-control studies, or prospective cohort studies.
This survey demonstrated that academic promotion committee chairpersons may not sufficiently recognize and value participation in large multicenter RCTs. Instead, they place higher value on studies that fall lower on the hierarchy of evidence, which is likely based on authorship accreditation (i.e., being the first or last author). Ultimately, the culture of academic promotion needs to progress to ensure that participation in large RCTs is appropriately recognized during academic review.
There are many benefits to participating in large RCTs both at the societal level and at the personal level. However, the value of RCTs must continue to be promoted among the orthopaedic surgery community, and the leaders of large RCT consortiums and collaborations need to continue to find innovative ways of engaging their peers. Leaders in the field and academic surgeons need to continue to advocate that participation in multicenter RCTs receive the appropriate consideration during academic review. In light of the abundance of important clinical questions, the orthopaedic surgery community ultimately needs to feel encouraged and supported in conducting high-quality studies and, in turn, needs to be proactive in engaging in multicenter RCTs. Undoubtedly, through the increase in the completion of high-quality multicenter RCTs, patient care will be improved.