28 – Do clinical practice guidelines set the standard of care for VTE prophylaxis?

Heather Hansen.

Response/Recommendation: The development of the current clinical practice guidelines (CPG) which followed the Delphi method, thus removing the potential for bias, may set the “standard of care” in venous thromboembolism (VTE) prophylaxis in orthopaedic surgery, since for the first time, they cover all subspecialties in orthopaedics.

Strength of Recommendation: Moderate.

Rationale: The issue of VTE prophylaxis after orthopaedic procedures has been the subject of discussions in and outside courtrooms. Numerous lawsuits are filed on an annual basis against the medical community, when a patient undergoing a surgical (orthopaedic) procedure develops VTE, fatal or otherwise. The question that attracts attention in the courtroom is whether standard of care related to this issue was followed by the defending physician. The broader questions that we must ask is what is the “standard of care” for VTE prophylaxis after orthopaedic procedures, and if the standard varies depending on the particular condition being operated on, and also who determines the standard of care for a physician? Some might say the treating physician is the one to determine the standard of care. After all he/she is the one who has undergone extensive medical training, conducted medical research and is the one to treat the patient. Others might argue it is the payor/insurance company who decides what care will be reimbursed and hence sets the standard of care. While some argue that CPG determine the standard of care. But medical malpractice lawyers know that in the courtroom, the jury ultimately decides the standard of care.

The jury obviously gets plenty of assistance from experts on both sides of the case who tell them how the doctor violated or upheld the standard of care. The experts may point to the presence of CPG. However, before CPG can be used in the court of law, it must be determined admissible by a judge. There is no set standard on how CPG are used in medical malpractice cases. CPG are the definition of inadmissible hearsay, as the author of the guidelines is not available for cross-examination in most cases. However, many courts rule that CPG fall under the learned treatise exception to the hearsay rule. It is important to note that judges make this determination on a case-by-case basis¹.

Once the CPG have been deemed admissible, either side can use them to support their argument that a provider violated or upheld the standard of care. In the only review this author could find, Hymans et al., did a computerized search of the US Courts from 1980 – 1994. They found 37 uses of CPG by either side. In those cases, they were successfully used in 28 cases, 22 times by the patient’s attorney and only 6 times by the physician’s attorney. There were 9 unsuccessful uses of the CPG, 7 by the patient’s attorney, and 2 by the defense. When used successfully, the CPG were generally from strong, evidence-based sources like the American Medical Association, the American Hospital Association, the American College of Obstetrics and Gynecology or similar authorities².

While there is a strong argument that, in the courtroom, the CPG have more often been used as a sword than a shield, that does not take into consideration what happens before the case gets to the courtroom. Cases are likely rejected by attorneys because there are strong CPG in place that would protect the doctor in court. And doctors’ attorneys may be using the CPG to file dispositive motions that dismiss cases before they get to court.

As you consider the use of VTE CPG in the courtroom, know that once the judge determines their admissibility the jury will determine their weight. Both will likely be based upon the strength of the evidence behind the guideline and the group presenting it. When both are strong, the CPG will be used to prosecute the doctors who have violated those guidelines and thus protect the patient. The reverse is also true in that CPG may provide ample protection to physicians who were aware of them and followed them during the treatment of the patient.

The current CPG on VTE are unique in many ways. They are produced by extremely well-known and recognized experts in the field of VTE from around the world. The delegates were selected using a vigorous process and specialties beyond orthopaedic surgery such as hematology, anesthesia, cardiology, internal medicine, infectious diseases, oncologists, and others were included. The development of the current CPG has followed an established and respected process, namely the Delphi method, that removes the potential for prejudice and bias. The content has been reviewed by numerous experts in the field and has also undergone the vigorous scrutiny imposed by the publishing journal. Finally, these CPG are extremely useful, as for the first time, they cover all subspecialties in orthopaedics.

References:

1.         Moffett P, Moore G. The standard of care: legal history and definitions: the bad and good news. West J Emerg Med. 2011;12(1):109-112.

2.         Hyams AL, Shapiro DW, Brennan TA. Medical practice guidelines in malpractice litigation: an early retrospective. J Health Polit Policy Law. 1996;21(2):289-313. doi:10.1215/03616878-21-2-289