The Most Important, and Overlooked, Questions in EBM Research are Qualitative

Mike Tringale, MSM, MSc-EBHC

Quantitative data can’t fix a qualitative problem. I’m sure that some proponents of evidence-based medicine (EBM) will disagree. How could they not? After years of medical education, training, and 366,000 registered clinical trials over the past two decades, ¹ it’s not surprising that modern health care professionals (HCPs) see numbers when they see diseases.

But that’s not what patients see.

Evidence derived from high-quality randomized controlled trials (RCTs) occupies the top tier of the EBM hierarchy, but perhaps it’s time to re-order this from a patient perspective. Quantitative evidence is simply a surrogate or proxy for the penultimate outcome: patient feelings, a uniquely qualitative marker.

Don’t Count on Numbers Alone

No matter how many statistics we use to describe and characterize it, health is a qualitative experience at its core. The asthma patient does not talk about her forced expiratory volume per second – she complains about how hard it is to take a breath, sleep, or exercise. The stroke patient does not talk about continuous electroencephalogram scores – he expresses concerns about his motor skills, mental acuity, and difficulties with activities of daily living. The cancer patient does not talk about the volume of circulating tumor cells – instead, she discusses her pain, energy, appetite, as well as her hopes and fears. And the intensive care nurse does not tell a family that a patient’s heart rate dropped from 60 beats per minute to zero – he sensitively informs them that their loved one has died.

Clinical metrics and epidemiological statistics such as incidence, prevalence, odds ratios, relative risk, and other numerical measures are very important to modern health care. They have helped to advance medicine worldwide by accelerating understanding of diseases and development of treatments and protocols that have doubled the average human lifespan. ² But we can’t rely on quantitative analysis alone to deliver solutions for patients; it only gets us so far.

Eventually, HCPs have to engage patients to deliver care and express concern, compassion, or empathy for their unique perspectives, understandings, wants, needs, values, preferences, and circumstances. Quantitative data plays a supporting role in the HCP-patient consultation but the ultimate purpose is to achieve qualitative outcomes that matter most to individual patients, such as alleviating pain, promoting healing, reducing burdens, achieving independence, or improving quality of life. This is the promise of “patient-centered care.” So, how can EBM get us there?

Patient Values and Preferences is Evidence

From the beginning, the “evidence” in “evidence-based medicine” was intended to include clinical research as well as the full panorama of insights and knowledge affecting decisions related to individual patient care, including the patient’s unique feelings, wants, needs, and circumstances. Broadly described in EBM theory as “patient values and preferences,” it is espoused as an essential component of evidence-based practice and defined as “the unique preferences, concerns and expectations each patient brings to a clinical encounter and which must be integrated into clinical decisions if they are to serve the patient.” ³ But for some, “evidence” has become synonymous with “RCTs.” Even early on, EBM founder David Sackett had to remind practitioners that evidence from the patient in addition to evidence from the best research is what makes EBM unique and patient-centered.⁴

Modern EBM continues to place patient values and preferences on equal theoretical footing with the best research evidence and clinical expertise. But EBM research has little to show for it. RCTs have received overwhelming emphasis in the literature with significantly less systematic consideration for patient values to the point that the role of values has been “almost completely ignored”. ⁵ A simple search on PubMed returns more than 539,000 results for “randomized controlled trial” but only 845 for “patient values” – a ratio of 638-to-1. Furthermore, considerations for patient values are seldom encoded into clinical practice guidelines and there are no established methods for addressing the integration of patient values in guideline development. ^6,7 

Feelings, Not Frequencies

One reason why patient values and preferences are underrepresented in the literature may be that understanding such feelings relies on qualitative research, ⁸ a type of research that does not appear in the EBM hierarchy of evidence. ^9-11Whereas quantitative research analyzes occurrences through frequencies and distributions, qualitative research looks for meaning through feelings and descriptions.¹² The objective, deductive, controllable, precise, and reliable nature of RCTs and observational studies provides a comfort zone for researchers and clinicians, unlike the subjective, inductive, uncertain, and complex nature of qualitative research. But since health is a qualitative experience, patient-centered care is a qualitative construct, and patients are seeking qualitative outcomes, HCPs need to consider qualitative research more.

Qualitative research is increasingly useful for health care practice and policy to help understand HCP and patient behaviors and interactions between them. ¹³ Qualitative inquiries can explore questions that quantitative analysis cannot, such as “why?” or “how?” resulting in meaningful explanations, insights, new theories, or additional research questions. It can also help provide missing links between statistics from RCTs and complex feelings that drive real-world patient behaviors. But understanding what each patient thinks, feels, values, or prefers is challenging. Not only are patient values and preferences heterogeneous, but they can be vague, difficult to express or predict, subject to change, and dependent on a host of confounding factors.¹⁴

That’s why the Postgraduate Certificate in Qualitative Health Research Methods, as well as the modules Qualitative Research Methods, Introduction to Synthesizing Qualitative Research, and Advanced Qualitative Research Methods, are brilliant – and essential – choices for health professionals. These provide critical grounding for clinicians, researchers, and policymakers to understand how qualitative methodologies and methods can help you make better sense of the issues underlying the quantitative data you’ve gathered.

But more importantly, it matters to patients. A recent systematic review identified what patients say they value in health care including feelings of uniqueness, autonomy, compassion, professionalism, responsiveness, partnership, and empowerment. ⁸ What’s not on this list? Math skills.

1. Mikulic M. Total number of registered clinical studies worldwide since 2000 (as of february 2021). www.statista.com Web site. https://www.statista.com/statistics/732997/number-of-registered-clinical-studies-worldwide/#:~:text=The%20number%20of%20registered%20clinical,just%202%2C119%20registered%20in%202000. Accessed May 1, 2021.

2. Roster M, Ortiz-Ospina E, Ritchie H. Life expectancy. www.ourworldindata.org Web site. https://ourworldindata.org/life-expectancy#:~:text=The%20United%20Nations%20estimate%20a,any%20country%20back%20in%201950.

3. Straus SE, Pattani R, Veroniki AA. Evidence-based medicine : How to practice and teach EBM. Fifth ed. Edinburgh: Elsevier; 2019.

4. Sackett DL, Rosenberg WMC, Gray JAM, Haynes RB, Richardson WS. Evidence based medicine: What it is and what it isn't. BMJ. 1996;312(7023):71. doi: 10.1136/bmj.312.7023.71.

5. Kelly MP, Heath I, Howick J, Greenhalgh T. The importance of values in evidence-based medicine. BMC Med Ethics. 2015;16(1):69-3. doi: 10.1186/s12910-015-0063-3 [doi].

6. van DW, Pieterse AH, Koelewijn-van Loon M,S., et al. How can clinical practice guidelines be adapted to facilitate shared decision making? A qualitative key-informant study. BMJ Qual Saf. 2013;22(10):855. doi: 10.1136/bmjqs-2012-001502.

7. Zhang Y, Coello PA, Brożek J, et al. Using patient values and preferences to inform the importance of health outcomes in practice guideline development following the GRADE approach. Health and quality of life outcomes. 2017;15(1):52. doi: 10.1186/s12955-017-0621-0.

8. Bastemeijer CM, Voogt L, van Ewijk J,P., Hazelzet JA. What do patient values and preferences mean? A taxonomy based on a systematic review of qualitative papers. Patient Educ Couns. 2017;100(5):871-881. doi: 10.1016/j.pec.2016.12.019.

9. Petrisor B, Bhandari M. The hierarchy of evidence: Levels and grades of recommendation. Indian J Orthop. 2007;41(1):11-15. doi: 10.4103/0019-5413.30519 [doi].

10. Porta M, Greenland S, Burón A. A dictionary of epidemiology. Sixth ed. Oxford, England: Oxford University Press; 2014.

11. University of Oxford, Centre for Evidence-Based Medicine. EBM levels of evidence. www.cebm.ox.ac.uk Web site. https://www.cebm.ox.ac.uk/resources/levels-of-evidence/oxford-centre-for-evidence-based-medicine-levels-of-evidence-march-2009. Accessed September, 2020.

12. Al-Busaidi Z. Qualitative research and its uses in health care. Sultan Qaboos University medical journal. 2008;8(1):11-19. https://pubmed.ncbi.nlm.nih.gov/21654952 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3087733/.

13. Mays N, Pope C. Qualitative research: Rigour and qualitative research. BMJ. 1995;311(6997):109-112. http://www.bmj.com/content/311/6997/109.abstract. doi: 10.1136/bmj.311.6997.109.

14. Lee YK, Low WY, Ng CJ. Exploring patient values in medical decision making: A qualitative study. PLoS One. 2013;8(11):e80051. doi: 10.1371/journal.pone.0080051 [doi].