By: AMFS Orthopedic Surgeon
Wikipedia defines a “clinical protocol” as a document with the aim of guiding decisions and criteria regarding diagnosis, management, and treatment of specific areas of healthcare. The definition further states that “such documents have been in use for thousands of years, during the entire history of medicine”. Previous approaches were often based on tradition or authority, but modern medical guidelines are based on an examination of current evidence within the paradigm of Evidence Based Medicine. They usually include summarized consensus statements, but also address ‘practical issues’. Unlike ‘clinical pathways’ and ‘clinical protocols’, Evidence Based guidelines do not stipulate a process or schedule to be followed and are not intended to obstruct individualized treatment.
Physicians rightly fear the perception that today’s health insurers, including new healthcare initiatives, will establish rigid arbitrary clinical pathways and algorithms that will intentionally and rigidly box in the provider’s ability treat the individual patient.
Physicians have already experienced rejection of care/procedure authorization from insurers, work compensation adjustors, etc. in their daily medical practices. The AMA “guides” control treatment planning and care of work injured parties, one of the reasons fewer physicians are willing to take these patients on. But, if one carefully scrutinizes the definition above, and the process defined below, perhaps an ‘Evidence Based guideline’ should not intimidate.
If there were responsible Guidelines based on real, verifiable medical evidence, most physicians, patients also, would likely welcome their use. In theory, one might also hope that such guideline based care would improve treatment results, lessen patient morbidity, engender patient ‘trust’ and also protect the physician from legal action.
So, how does a guideline come into being? What is the methodology behind it?
Step #1: The Clinical Question that deserves investigation needs be identified. Trained participants who have experience in the issues involved, submit specific questions on the chosen topic (e.g. Spinal stenosis, Cervical herniated disc, Carpal Tunnel, etc., whatever topic will be subjected to scrutiny); the questions are ranked for clarity and pertinence, to serve as the focus of the guideline. It is common to have 5-10 specific questions in a topic that need an answer. The guideline will intend to answer only these questions, nothing more.
Step #2: Multidisciplinary ‘work groups’, are identified from the trained volunteer participants. A ‘work group’ is then assigned several questions to investigate, and attempt to answer. Clearly the more participants are available, more likely the better the results.
Step#3: Comprehensively searching the medical literature involves determining search ‘terms’ and parameters. This takes a Medical/research Librarian to identify all potential literature. Work groups then review the abstracts for relevance to the questions (as they have the ‘medical experience filter’). In general this will identify a number of useful articles, relevant to the question to be answered. The number of articles examined by each group can vary from very few, and can exceed a hundred, depending on their relevance.
Step#4: Analysis; Each member then is charged with reading and analyzing the full text/articles, and so develops his own evidentiary table summarizing study conclusions and weaknesses, and identifying levels of evidence (see below). As multiple reviewers also review and assign their own interpretation of the levels of evidence, internal bias is lessened. When the findings are collated and further discussed in multiple conference phone calls, or in person, a consensus can be established as to whether the question can be answered and with what ‘strength’ of evidence.
Step#5: Only then can an Evidence Based Recommendation be offered, and only on the specific question that this ‘subgroup’ has been assigned.
Step#6: Since there were probably several groups with their focused assignment, it is now when the full list of specific questions are re-joined (some with answers, and some unanswerable). The full ‘draft guideline’ is now submitted to the whole committee for feedback and integration from the individual subgroups.
Step#7: Submission for Board Approval follows; Comment and suggestions are considered, but only when substantiated by preponderance of appropriate level evidence.
It is important to clearly understand the “language’ used in the final published report:
To ‘RECOMMEND’ a treatment one needs the highest quality data and strong Level I evidence, defined as high quality randomized and ‘blinded’ reviewed studies and usually multiple studies that come to the same conclusion.
If the guideline states ‘SUGGESTED’, it is a recommendation of Moderate Strength, not authoritative, not Level 1 evidence, but rather a lesser Level II or III, studies that have less stringent controls on their research and conclusions including most retrospective analysis.
The term ‘CONSIDERED’ is used when the Level of evidence is IV or V, studies that are reports of ‘case series’, or opinion of an ‘expert’. (Recognizing that these studies or opinions do have value to the treating physician, but there needs to be greater evaluation and scrutiny placed before the treatment can be suggested or recommended based on reproducible evidence.
Ultimately, it is not just the Guideline, but also the Recommendations from that guideline that have the value to patients and practitioners. This is where the ‘rubber meets the road’, the place where physicians fear governmental and payor/insurance intrusion into the clinical practice of Medicine.
Evidence Based Research should lead to an evidence based practice of medicine, should not intimidate the practitioner and should have benefits to physician and patient alike.
We must nevertheless guard against misuse of this information by administrative agencies that do not appreciate the intent of these voluntary multiple General and Specialty society and committee efforts to improve quality care.
These guidelines all respect the individual physician-patient specific needs and these guides cannot ‘control’ care, only inform and act a resource by accessing valid research and medical information. The physician patient relationship remains intact.