The Green Journal (Obstetrics & Gynecology) special issue on case reports recently* featured an editorial by Dr. Nancy Chescheir, Editor-in-Chief, discussing the importance of publishing case reports in academic journals. Many journals have opted to no longer include case reports, or to only publish them in special issues or on a very limited basis, demonstrating their decreasing value in published literature and medical evidence. Case reports are one of the last strongholds of individualized care in published journals, though slowly increasing attention by the medical community on patient-centered care might be the antidote.
What’s a case report? It is a write-up of one patient’s diagnosis, treatment, outcomes, and lessons learned by the care providers.
What is a randomized controlled trial? These are studies with (often) large populations, where one treatment modality is tested against another intervention.
Writes Dr. Chescheir:
“Case reports are the Rodney Dangerfield of medical publishing – they get ‘no respect.’ Those who advocate eliminating the publication of case reports raise concerns that they contribute nothing to health care in the age of evidence-based medicine.”
In Dr. Chescheir she discusses her beliefs as to why case reports are diminishing in respect from the journal community: the need for journals to include articles that discuss efficacy and safety in diagnosis and treatment, the business perspective of journals that publish articles that are rarely cited and create a negative “impact factor” thus decreasing the journal’s revenue, and the upward trend in numbers of journals that have stopped publishing case reports and others following suit. Even the Green Journal only publishes them in modified special issues, and many other journals publish them only online or not at all. Despite these supposed solid rationales from diminishing publication, Chescheir continues in defense of writing and distributing case reports:
“…there are myriad examples of case reports being the first vehicle of description of previously unrecognized disorders… case reports also can draw attention to unusual complications of exposures… rare diseases, unusual treatment complications, and novel diagnostic and therapeutic interventions can be communicated well in the form of a case report and can stimulate hypothesis generating research.”
What this statement indicates is that case reports allow a space for providers to find unique approaches and outcomes, perhaps innovative and not within the standard approach or the most often use evidence-base. If medicine, or more specifically if health care (meaning the care of people), is reduced to an algorithm of outcomes determined by randomized controlled trials, this leads to a cascade of providers and treatments and patients being integrated into a closed loop: the work of innovators and questioners and ponderers is never published or discussed, new ideas will have to work even harder to surface and be considered in the world of the gold standard of RCTs, the rare findings and successes that could eventually be changemakers in healthcare will become even more rare, novel interventions will be limited to spread by word-of-mouth, and publications will become rote within their own structure. Healthcare will become rote, about what research shows “works for most,” completely forgetting the individual and how the conclusion “works for most” was actually reached, typically through the RCT.
The randomized controlled trial amasses people and treats them as a collective. It tries to “control” for factors of their lives that might otherwise actually contribute to their individualization, and individualized care needs. While perhaps ‘control’ in RCTs can be considered a mere statistical term, it mirrors as a double entendre, especially in the care of women where control over their health is culturally foundational in patriarchal medicine. In women’s health research, amassing the complexities of even one woman’s care with others, and controlling their individual factors as noncontributory to their outcomes, really creates a conundrum for determining results. No one woman’s situation is like the other, so who came up with the idea that one outcome based on as few factors as possible would help most people?
While I applaud Chescheir’s editorial, describing her rationale of why case reports should continue, in the next breath she discusses how much the Green Journal has already ramped down their publication of these individualized studies, and asks for specific attention to this special issue on case reports, since it happens so infrequently. The trend to no longer publish case reports is part of a broader system of hierarchical evidence which not only eliminates individual variation, but completely ignores physiologic occurrences to largely normal processes in the human body, such as birth.
Henci Goer and Amy Romano present a detailed critique of the RCT in “Optimal Care in Childbirth: The Case for a Physiologic Approach.” One of their conclusions, pointing specifically toward the recognition of the RCT’s inherent incapacity to research physiologic approaches versus interventions:
“Moreover, the structure of RCTs limits them to posing the question, ‘Is intervention X better than standard management (control group) or, in some trials, intervention Y?’ which shuts out the possibility that physiologic care or intervention Z might be better than either. RCTs are also predicated on the assumption that context can be eliminated, but factors such as environment and care provider philosophy and judgment powerfully affect outcomes.” p. 13
There is the consideration that the RCT is part of the broader medicinal construct to remove the personal from the patient, and to reduce them to a disease or a construct. She is “the IUFD in room 14.” She is “the VBAC in room 5.” She is the “pre-eclamptic frustrating everyone with her confusion while on magnesium.” Language like this, set within a medical culture that removes names and personal information from educational structures and academic practicum, such as journals, encourages providers to forget the individual, the person. Rather, she is Monica with the fetal demise and family in need of more support. She is Yadira with the traumatic first birth through c-section who researched everything online and created a birth plan. She is Tamika with her first pregnancy and birth and complicated outcome, confused as to what is going on and where her baby is and why she cannot hold her. To name names and list specifics requires personalization of a patient to an individual. Monica. Yadira. Tamika. And on the micro level that requires an emotional recognition of the patient as a person. On the macro level it recognizes that healthcare is hard, it isn’t an algorithm, and people are involved.
In stark contrast to the trend referenced by Chescheir, some providers and organizations are doing a 180, realizing that we have forgotten the “care” in “healthcare,” and are advertising more of a “patient-centered approach.” Commendably, the American Diabetes Association recently published new guidelines that do just that: backpedal on the RCT “one-size-fits-all” philosophy for Type 2 DM, and recognizing the complexities of medications and people’s lives and fitting within a proscribed goal. The most important statement from the recommendations**: “Individualization of treatment is the cornerstone of success.” A wonderful excerpt from the statement within the section on “Patient-Centered Approach”:
“Evidence-based advice depends on the existence of primary source evidence. This emerges only from clinical trial results in highly selected patients, using limited strategies. It does not address the range of choices available, or the order of use of additional therapies. Even if such evidence were available, the data would show median responses and not address the vital question of who responded to which therapy and why (24). Patient-centered care is defined as an approach to “providing care that is respectful of and responsive to individual patient preferences, needs, and values and ensuring that patient values guide all clinical decisions” (25). This should be the organizing principle underlying health care for individuals with any chronic disease, but given our uncertainties in terms of choice or sequence of therapy, it is particularly appropriate in type 2 diabetes. Ultimately, it is patients who make the final decisions regarding their lifestyle choices and, to some degree, the pharmaceutical interventions they use; their implementation occurs in the context of the patients’ real lives and relies on the consumption of resources (both public and private).
Patient involvement in the medical decision making constitutes one of the core principles of evidence-based medicine, which mandates the synthesis of best available evidence from the literature with the clinician’s expertise and patient’s own inclinations (26). During the clinical encounter, the patient’s preferred level of involvement should be gauged and therapeutic choices explored, potentially with the utilization of decision aids (21). In a shared decision-making approach, clinician and patient act as partners, mutually exchanging information and deliberating on options, in order to reach a consensus on the therapeutic course of action (27). There is good evidence supporting the effectiveness of this approach (28). Importantly, engaging patients in health care decisions may enhance adherence to therapy…”
This thought process should not only apply to chronic conditions, to problems that require complex therapy, to issues which require adherence to treatment. Each person, each complication, each strategy may very well be different. Each person is a case report unto themselves, and providers reading case reports might well remember that when it comes to considering their approaches with each of their patients.
Concludes Chescheir regarding the special issue of the Green Journal Case Reports:
“We encourage you to enjoy the case reports and let them stimulate your thinking about the care you provide your patients. If you are an investigator, consider using them to generate ideas for interesting future research… All of us should respect what case reports have to offer our practice while at the same time respecting their limits.”
Which is to say, I hope, that women’s health providers continue to consider the holistic picture of a patient’s needs, from their individual “case” of presentation, to the evidence of best practices, to the personal factors affecting her life and its intersection with her health and care. Even when we abscond the names given to people by those who’ve known them the longest, and reduce people to diseases or problems, case reports continue to provide an individuality, a moment of recognition that one person’s experience and treatment and outcome, might be unique. The macro in healthcare cannot overtake the micro, because the micro is a person, is an individual, is her own amassing of needs and abilities and plans. Let us stimulate our thinking about the care we provide each patient, every time.
*Case Reports Deserve Respect – Nancy C. Chescheir, MD
Obstetrics & Gynecology, Volume 122, Number 2, Part 2, August 2013
**Management of Hyperglycemia in Type 2 Diabetes: A Patient-Centered Approach. Position Statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Inzucchi, S.E. et al. Diabetes Care. June 2012, 35(6), 1364-1379).