International Consensus on Periprosthetic Joint Infection: Description of the Consensus Process

Background Periprosthetic joint infection (PJI), with all its disastrous consequences, continues to pose a challenge to the orthopaedic community. Practicing orthopaedic surgeons have invested great efforts to implement strategies that may minimize surgical site infection (SSI). While new discoveries in orthopaedic research allow us to answer more questions each year on the basis of high-level evidence, there remain numerous topics—including many important ones—for which the evidence is limited, contradictory, or absent. For these clinical issues, it sometimes is helpful to know whether general consensus on diagnosis or treatment exists among individuals who specialize in these areas. Toward that end, we convened a meeting of an international panel of experts during 2 days (July 31 and August 1, 2013) in Philadelphia, PA, USA. The meeting was the penultimate step of a 10-month-long process to generate a set of best practices for management of PJI through engagement of experts in the field. More than 300 experts from various disciplines including orthopaedic surgery, infectious disease, musculoskeletal pathology, microbiology, anesthesiology, dermatology, nuclear medicine, rheumatology, musculoskeletal radiology, veterinary surgery, and pharmacy, as well as numerous scientists with interest in orthopaedic infections attended. Delegates from 52 countries covering all major regions of the globe participated, representing 160 medical institutions and research centers, having memberships in more than 100 medical societies and boards, and sharing a collective experience of many thousands of cases. The panel undertook this consensus effort to help the global medical community improve the efficacy, lower the complication rates, and move toward adoption of standardized measures and techniques for management of PJI. As mentioned, the lack of evidence for many aspects of clinical practice compels the medical community to seek alternatives for development of best practices. A consensus panel is one such alternative, and the process sought to produce a set of procedures and methods using group judgment on a subject matter for which objective information is lacking [2, 3, 6, 11, 15, 17, 20]. When judgments differ, it is important to understand why, and to develop a process to create, if possible, a common view. The word consensus has origins in the Latin word consentire, which means to give assent or approval or to feel together. A dictionary definition of consensus is “a general agreement” and also, very importantly, “group solidarity or concord of opinion or sentiment” [13]. Consensus, therefore, means general agreement about an idea or opinion among most individuals in a group. Majority support for an idea spans from unanimous support (100% agreement) to a simple majority (greater than 50%). Unanimity has been reported as being difficult to achieve, especially in large groups even when, or possibly because, the consensus process is well run. Unanimity is not always a panacea, as sometimes it may occur as a result of “coercion, fear, undue persuasive power or eloquence, inability to comprehend alternatives, or plain impatience with the process of debate” [8, 14, 18]. Even so, the closer to 50/50 a group is vis-à-vis an issue or opinion, the greater the polarization and conflict around that issue. Usually, consensus is understood as the shared opinion of an overwhelming, or super-, majority of the individuals in a group. A supermajority is a majority substantially greater than a simple majority [8, 9, 14, 18]. Although a specific and widely accepted definition of consensus in exact percentage terms does not exist, one rule of thumb is to define consensus as views shared by more than 75% of a group. A more detailed breakdown may establish three levels of consensus as follows [9, 10]: (1) weak consensus = between 3/5 and 2/3 (60%-66%) of a group agree with a given opinion; (2) consensus = between 2/3 and 3/4 (67%-75%) of the individuals of the group agree; and (3) strong consensus = three or more members of a group agree for each dissenting one (≥ 75% individuals in a group agree on an opinion). Unanimous support, when everyone in a group agrees, is the strongest consensus. A consensus process seeks to generate the consent or agreement of all participants around a specific issue, opinion, or recommendation The consensus process involves a series of steps designed to help individuals in a group deliberate ideas or issues and lead them to agree on a resolution that can be supported by as many individuals in the group as possible, even if the specific resolution is not the preferred one of every individual. As noted, many consensus processes attempt to reach a threshold of 75% agreement or greater, that is, a supermajority of 3:1 or better [8-10]. It is important when one refers to a supermajority to take into consideration abstentions and to differentiate between a simple supermajority (based on individuals of a group who are present and have voted) and an absolute supermajority (based on the total number of voters who are qualified or allowed to vote). For example, if a recommendation wins 80% of the vote but only 30% of the eligible voters actually voted, the recommendation is supported by a relative supermajority, but it does not have the support of an absolute supermajority (actually, far from it; that recommendation garnered only 24% of total possible votes). For purposes of our process, we evaluated consensus using both relative and absolute supermajority rules, and more detail on this will follow below, in the Methods section. A robust consensus process has the following characteristics [5, 8-10, 12, 18], which we sought to incorporate in the process used here: Inclusive: The consensus process involved all relevant stakeholders and included as many different views and perspectives as possible. Comprehensive: An effort was made to present all available relevant data (eg, sharing of literature references and studies) for all participants in the process to be thoroughly informed. Participatory: The consensus process actively and repeatedly solicited the input and engagement of all participants. Egalitarian: Individuals were given equal opportunity to voice their views and those views were given equal weight and efforts were made to mitigate the potential effect of differential status of participants (eg, comments were depersonalized). Credible: Broad and representative participation is key to ensure widespread acceptance of recommendations. Invitation to participants in the process was extended without bias other than selecting individuals with relevant expertise. Collaborative: Participants were encouraged to contribute to a common set of recommendations by adding their thoughts to what other members of the group had suggested. The process offered the means (eg, resources, time, technology) to facilitate a sense of working together and in collaboration. Cooperative: Participants were reminded multiple times that the goal was to reach a set of recommendations that had the support of most of the members of the group rather than the views of specific constituencies or their own. Voting through a consensus process is an alternative to other commonly used decision-making processes such as Robert’s Rules of Order, which are designed to pass resolutions based on a majority vote [16]. This type of decision-making process typically is faster than a consensus process, but its adversarial dynamics often undermine the ability of a group to successfully implement a contentious decision. One major criticism of consensus processes that seeks the input and collaboration of a large number of participants is that it is time-consuming and that the time commitment required of every participant to engage in the process is so substantial that it actually may decrease participation. However, the time invested in creating consensus pays off as implementation of the group’s recommendations tends to be much smoother. The arguments in favor of well-designed and managed consensus processes are that these processes lead to the following benefits [5, 8-10, 12, 18, 19]: (1) better decisions (by including the input of a large number of varied participants, the resulting recommendations will represent more varied and richer views); (2) better implementation (by including views from as many relevant participants as possible and by encouraging as much agreement as possible, the process makes participants more engaged and responsible in implementing the resulting recommendations); and (3) better group relationships (by creating a cooperative, collaborative, inclusive group atmosphere, the process fosters greater group cohesion and interpersonal connections). Methods: The International Consensus Meeting on PJI The consensus process at the International Consensus on Periprosthetic Joint Infection was designed specifically to address as many issues surrounding the management of PJI as possible. The process engaged a large number of individuals from many countries and from various specialties to agree on what is known about PJI (based on available literature) and lead to identification of areas in need of further evidence. The process had three phases: (1) a phase when participants in the process worked remotely and exchanged ideas through a modified Delphi process [1, 7, 12]; (2) a phase when participants worked face-to-face to address and resolve final issues and details and voted on resolutions; and (3) a dissemination and publication phase. The first phase of the process lasted more than 9 months and consisted of identifying the issues and writing position papers or recommendations. This phase was done by conducting a comprehensive review of the available relevant literature. The evidence for current practices, whenever available, then was summarized and presented to the participants. An opportunity was provided to the members to voice their opinion collectively and anonymously. The second phase of the consensus was done in a face-to-face meeting during 2 days in Philadelphia. On the first day of the meeting, delegates of each workgroup convened in individual rooms to discuss their recommendations and disagreements. Once their recommendations were finalized, members of all workgroups convened in a general assembly and shared their recommendations with all the delegates. Importantly, all delegates were likely to have seen the recommendations of other workgroups during the previous months as the recommendations of all workgroups were posted on the social media website that the consensus used for communications, and numerous opinions were exchanged. In the general assembly, further discussions occurred and suggestions were made. The final set of recommendations was loaded onto the electronic audience response system at the end of the first day to be presented the next day for voting by the delegates. The electronic audience response system displays the recommendations on a giant screen one recommendation at a time, pauses for a set amount of time to give the audience a chance to read the recommendation, think about it, and vote by pressing a a “yes”, “no”, or “abstain” button on hand-held units. The following day, all voting delegates were given the opportunity to read the posed questions and recommendations on a large screen and cast their vote. During the day-long meeting, all 207 questions and recommendations were presented and voted on. After the second day of the face-to-face meeting, the final document was assembled and sent to all delegates for their final review during a 2-week period. Numerous communications were exchanged during that period leading to generation of the final document. The third phase will involve dissemination of the produced document to orthopaedic and musculoskeletal infectious disease specialists, and other disciplines. The consensus document and its supplemental material, including this document, are being made available through open access. The consensus document will be posted on the websites of numerous societies, will be published as PubMed cited material, and will be published as an electronic book and a paper book. We also intend to have the document translated into numerous languages. The process by which the PJI consensus was generated is described below (Fig. 1).Fig. 1: A flowchart shows the 14-step consensus processStep 1: Establishing a Steering Committee In September 2012, the idea of conducting an international consensus on the topic of PJI was conceived by two authors of this article (JP, TG). Soon after these discussions, a steering committee consisting of those authors, 17 liaisons, a biostatistician, and a medical editor were assembled. The time line for the entire process was determined and the main objectives were set. At that point, it was intended that the face-to-face meeting of delegates would take place during the annual meeting of the Musculoskeletal Infection Society in August 2013. Step 2: Identification of Issues and the Themes The steering committee then met in person or conducted conference calls on numerous occasions to identify the issues that surround the medical community regarding management of PJI. The issues were organized under the chronologic stages of patient care. Fifteen major areas were identified: (1) mitigation and education on comorbidities, (2) patient preparation, (3) perioperative antibiotics, diagnosis of and treatment and of management of or and of PJI. 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The consensus position papers many during this period. We sought to engage as many workgroup members as possible, as much as possible, to participant in the position paper recommendations. We also that participants their opinions by detailed when possible, references to the literature. of the workgroup also was encouraged to actively their agreement with the to and as a Step of the Step was of the position we were at toward consensus each of the The experts were given 2 the face-to-face meeting to comments or suggestions had regarding the position Step of the the comments and suggestions generated as a result of further input from the members were into the document 2 the meeting in Philadelphia. 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This and global effort in support for a large number of with of all recommendations a supermajority of The of this consensus process represent a step toward a better of the of techniques and adoption of best practices, a more and to the management of and identifying further clinical research to improve patient care.