The Necessity for Clinical Reasoning in the Era of Evidence-Based Medicine

doi:10.1016/j.mayocp.2013.07.012

Mayo Clinic Proceedings

Volume 88, Issue 10, October 2013, Pages 1108-1114

https://doi.org/10.1016/j.mayocp.2013.07.012 Get rights and content

Abstract

Clinical decisions are increasingly driven by evidence-based recommendations of guideline groups, which aim to be based on the highest quality knowledge—randomized clinical trials (RCTs) and meta-analyses. Although RCTs provide the best assessment of the overall value of a therapy, high-quality evidence from RCTs is often incomplete, contradictory, or absent even in areas that have been most exhaustively studied. Moreover, the likelihood of the success or failure of a therapy is not identical in all the individuals treated in any trial because therapy is not the only determinant of outcome. Therefore, the overall results of a trial cannot be assumed to apply to any particular individual, not even someone who corresponds to all the entry criteria for the trial. In addition, the potential for bias due to financial conflicts remains in many guideline groups. Guidelines are key sources of knowledge. Nevertheless, limitations in the extent, quality, generalizability, and transferability of evidence mean that we clinicians must still reason through the best choices for an individual because even in the absence of full and secure knowledge, clinical decisions must still be made. Clinical reasoning is the pragmatic, tried-and-true process of expert clinical problem solving that does value mechanistic reasoning and clinical experience as well as RCTs and observational studies. Clinicians must continue to value clinical reasoning if our aim is the best clinical care for all the individuals we treat.

Section snippets

No Evidence, Incomplete Evidence, or Conflicting Evidence

We contend that limitations in the evidence are a major limitation of EBM. For many clinical problems, there is simply no RCT evidence to apply. Consider antibiotic prophylaxis for endocarditis. The most recent guidelines⁵ differ dramatically from those that preceded them.⁶ However, the evidence, or what there is of it, did not change. Time and many of the evaluators did. For many other issues, multiple RCTs have been performed, but the outcomes and the conclusions may conflict,⁷ with the

What is Clinical Reasoning?

If the highest-quality evidence is incomplete, as it so often is and as guideline writers themselves admit,⁴ how can the gap to best care be bridged? We argue that clinical reasoning is the best tool the physician can use to do so. Of course, our reasoning is imperfect, but, as Croskerry³¹ has recently highlighted, not all forms of decision making are equally fragile. There is the intuitive mode of problem solving, the rapid, generally subconscious approach, driven by experience—an approach

Conclusion

Clinical reasoning remains integral to clinical care because the evidence from RCTs remains incomplete and the generalizability and transferability of the results of RCTs remain challenging. Few physicians, if any, have the time or the expertise to review all the relevant knowledge, and therefore, the guideline process remains essential to sort out and evaluate what is known. However, the evaluation of evidence is only one step in the process of care. To be sure, guidelines frequently state, at

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Hysteroscopic morcellation vs. curettage for removal of retained products of conception: a multicenter randomized controlled trial
2023, Fertility and Sterility
To study the comparison between hysteroscopic morcellation (HM) of retained products of conception (RPOC) with ultrasound (US)-guided electric vacuum aspiration in terms of intrauterine adhesion (IUA) formation, efficacy, and complications.
A randomized controlled, nonblinded trial.
Three teaching hospitals and one university hospital from April 2015 to June 2022.
A total of 133 women with RPOC on US, ranging from 1–4 cm, were randomized to receive either HM or electric vacuum aspiration.
Hysteroscopic morcellation was performed with the TruClear System (Medtronic, Minneapolis, MN, USA). Electric vacuum aspiration was performed using an 8- or 10-mm flexible plastic Karman cannula under US guidance. Women allocated to vacuum aspiration underwent the procedure as soon as possible.
In the HM group, an office diagnostic hysteroscopy was planned a minimum of 6 weeks after the end of pregnancy, followed by retained product of conception removal at least 8 weeks after the end of the pregnancy. Postoperatively, an office second-look hysteroscopy was scheduled to assess the primary outcome of IUAs.
Postoperative IUAs were seen in 14.3% (9/63) of patients in the HM group and 20.6% (13/64) of patients in the vacuum aspiration group (−6% [−19.1% to 7.1%]). Significantly more RPOC were removed completely by HM compared with vacuum aspiration (95.2% vs. 82.5% (−14% [−24.9% to −3.1%]), and additional operative hysteroscopy was less frequently necessary in the HM group (12.5%) compared with the vacuum aspiration group (31.3%) (−20.1% [−34.3% to −6%]). The median operating time was shorter for vacuum aspiration compared with HM (5.80 minutes vs. 7.15 minutes). No differences were observed between HM and vacuum aspiration for the occurrence of intraoperative or postoperative complications (5.5% vs. 5.0% and 2.7% vs. 1.3%, respectively).
In our randomized controlled trial, no significant differences were found in the occurrence of IUAs and complications. However, the RPOC were more often completely removed by HM than vacuum aspiration, and the HM group required fewer additional hysteroscopic treatments.
NTR4923 (https://trialsearch.who.int/Trial2.aspx?TrialID=NTR4923). Date of registration: November 23, 2014, date of initial participant enrollment: January 1, 2015
Morcelación histeroscópica vs legrado para la escisión de productos de la concepción retenidos: un ensayo controlado aleatorizado multicéntrico
Estudiar la comparación entre morcelación histeroscópica (HM) de productos de la concepción retenidos (RPOC) y aspiración por vacío guiada por ecografía en cuanto a formación de adherencias intrauterinas (IUA), eficacia y complicaciones.
Un ensayo controlado aleatorizado, no ciego.
Tres hospitales de formación y un hospital universitario entre abril de 2015 y junio de 2022.
Un total de 133 mujeres con RPOC diagnosticado por ecografía, de entre 1 y 4 cm, fueron aleatorizadas para recibir o HM o aspiración por vacío.
La morcelación histeroscópica se realizó mediante el sistema TruClear (Medtronic, Minneapolis, MN, USA). La aspiración se realizó utilizando una cánula Karman flexible de 8 ó 10 mm, guiada por ecografía. Las mujeres asignadas a aspiración fueron intervenidas tan pronto como fue posible.
En el grupo de HM, se programó una histeroscopia diagnóstica ambulatoria al menos 6 semanas después del fin del embarazo, seguida de una escisión del producto retenido al menos 8 semanas tras el fin del embarazo. En el postoperatorio, se realizó otra histeroscopia ambulatoria para evaluar el principal resultado, las IUA.
Se observaron IUA en el 14,3% (9/63) de las pacientes en el grupo HM y en el 20,6% (13/64) en el grupo de aspiración (-6% [-19,1% a 7,1%]). Se eliminaron significativamente más RPOC de forma completa mediante HM que mediante aspiración (95,2% vs 82,5%, -14% [-24,0% a -3,1%]), y la necesidad de otra histeroscopia operatoria fue menos frecuente en el grupo HM (12,5%) que en el grupo de aspiración (31,3%, -20,1% [-34,3% a -6%]). La mediana del tiempo operatorio fue menor en el grupo de aspiración comparado con el grupo HM (5,80 minutos vs 7,15 minutos). No se observaron diferencias entre HM y aspiración en cuanto a complicaciones intra o postoperatorias (5,5% vs 5,0% y 2,7% vs 1,3%, respectivamente).
En nuestro ensayo controlado aleatorizado no se observaron diferencias significativas en la ocurrencia de IUA u otras complicaciones. Sin embargo, la HM resultó en una eliminación completa de los RPOC más frecuentemente que la aspiración y el grupo HM requirió menos histeroscopias adicionales.
Operative hysteroscopy versus ultrasound-guided electric vacuum aspiration for removal of retained products of conception: A prospective cohort study
2023, European Journal of Obstetrics and Gynecology and Reproductive Biology: X
To compare intrauterine adhesion (IUA) formation after hysteroscopic removal (HR) of retained products of conception (RPOC) with IUA formation after ultrasound-guided electric vacuum aspiration (EVA) and externally validate the outcomes of an RCT.
This prospective cohort study was conducted from April 2015 until June 2022 in 2 Dutch teaching hospitals and one Belgian university hospital. Women opting for EVA underwent the procedure as soon as possible. In the HR group, the therapeutic hysteroscopy was performed at least eight weeks after the end of pregnancy. Postoperatively, an office second-look hysteroscopy was offered to all patients. Women were included if they had been diagnosed with RPOC ranging from 1 to 4 cm on ultrasound and did not want to participate in the RCT. EVA was performed using a Karman cannula. Operative hysteroscopy consisted either of hysteroscopic morcellation with the TruClear™ System or the Intrauterine BIGATTI Shaver or cold loop resection with a bipolar resectoscope.
Of 178 included women, 124 were treated with HR and 28 with EVA. Outcomes of HR and EVA did not differ significantly in terms of complications (5.6 % vs 3.6 %; p = 1.00). Second-look hysteroscopy showed IUAs in 14 of 91 women (15.4 %) after HR and in 1 of 16 (6.3 %) after EVA (p = .461). Completeness of removal was significantly higher (90.1 %) after HR than after EVA (68.8 %) (p = .035). Additional operative hysteroscopy was required in 14.3 % of the HR group versus 37.5 % in the EVA group (p = .036).
In our cohort study, no significant differences in IUAs or complications were found. RPOC removal with HR was more often complete than removal with EVA, and additional therapeutic hysteroscopy was less frequently required after HR. These findings need to be correlated with those of RCTs.
The study was registered in de Dutch Trial Register (NTR4923). Date of registration 23-11-2014. Date of first enrollment 01-01-2015. https://trialsearch.who.int/Trial2.aspx?TrialID=NTR4923
To treat with curative intent or modify disease?
2023, Blood
Two sides of the same coin? A comparison of research and practice orientation for teachers and doctors
2023, Social Sciences and Humanities Open
Teacher training and medical degrees prepare students for evidence-based practice. This study examines how the learning opportunities of both programmes qualify students for this. Until now, a large-scale perspective on the university courses of student teachers and medical students in Germany has been lacking. The present study aims to fill this gap by comparing learning opportunities in teacher training and medical degrees. Three research questions are addressed: (1) Are the learning opportunities oriented to research and practice? (2) How are the learning opportunities designed didactically? (3) Which didactic designs are related to research orientation and practice orientation? NEPS-data from student teachers (N = 6322) and medical students (N = 1063) were used for the analyses. On this basis, implications for the design of teacher training learning opportunities are discussed.
Therapeutic drug monitoring (TDM) as intervention: A cross-sectional analysis of characteristics of 173 registered clinical trials
2022, Contemporary Clinical Trials Communications
Citation Excerpt :
Insufficient blinding is not surprising, because in most cases it is not easy to use blinding in implementing TDM. Concededly, randomized controlled trials (RCTs) is the ideal method to test safety and effectiveness of interventions and obtaining convincing experimental findings [11]. Moreover, the trial design with insufficient randomization and no masking may lead to a deviation between the intervention effect and the expected results of clinical trials.
To examine fundamental characteristics of clinical trials with therapeutic drug monitoring (TDM) as intervention on world major clinical trials registry platform.
Cross-sectional analysis of clinical trials with TDM as intervention that were registered on WHO International Clinical Trials Registry Platform (ICTRP) or ClinicalTrials.gov. Relevant trial entries registered before and on March 2nd, 2022 were downloaded, deduplicated, and reviewed. Recruit country, monetary source, start years, study design, medical conditions, involved drugs, outcome measure, and subject information were extracted and analyzed.
Overall, 173 clinical trials were included in this study. Majority of the trials were conducted in several economically prosperous countries. The earliest initiated trials dates back to 2002. Most of the trials were funded by hospitals (36.4%). A higher proportion of trials were conducted within one country (86.1%), as phase Ⅳ (34.1%) interventional study (82.7%), randomized (52.6%), parallel assignment (53.8%) and open label (67.0%). The most concerned medical condition were infectious or parasitic disease and neoplasms, with the most monitored drugs were immunosuppressants and β-lactam antibacterials. Most of the trials enroll no more than 50 subjects (30.6%), with both gender (95.4%), and adults (67.0%).
The trials were mainly conducted in several economically prosperous countries. The number of registered trials had gradually increased during the past years. Novel biological drugs have increasingly become the research hotspot. We expect that with abundant financial support, more high-quality large-scale, multicenter randomized clinical trials (RCTs) are designed and implemented to promote the development of TDM in the future.
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Atherosclerotic cardiovascular disease (ASCVD) is epidemic throughout the world and is etiologic for such acute cardiovascular events as myocardial infarction, ischemic stroke, unstable angina, and death. ASCVD also impacts risk for dementia, chronic kidney disease peripheral arterial disease and mobility, impaired sexual response, and a host of other visceral impairments that adversely impact the quality and rate of progression of aging. The relationship between low-density lipoprotein cholesterol (LDL-C) and risk for ASCVD is one of the most highly established and investigated issues in the entirety of modern medicine. Elevated LDL-C is a necessary condition for atherogenesis induction. Basic scientific investigation, prospective longitudinal cohorts, and randomized clinical trials have all validated this association. Yet despite the enormous number of clinical trials which support the need for reducing the burden of atherogenic lipoprotein in blood, the percentage of high and very high-risk patients who achieve risk stratified LDL-C target reductions is low and has remained low for the last thirty years. Atherosclerosis is a preventable disease. As clinicians, the time has come for us to take primordial and primary prevention more serously. Despite a plethora of therapeutic approaches, the large majority of patients at risk for ASCVD are poorly or inadequately treated, leaving them vulnerable to disease progression, acute cardiovascular events, and poor aging due to loss of function in multiple visceral organs. Herein we discuss the need to greatly intensify efforts to reduce risk, decrease disease burden, and provide more comprehensive and earlier risk assessment to optimally prevent ASCVD and its complications. Evidence is presented to support that treatment should aim for far lower goals in cholesterol management, should take into account many more factors than commonly employed today and should begin significantly earlier in life.

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Special articleThe Necessity for Clinical Reasoning in the Era of Evidence-Based Medicine

Abstract

Section snippets

No Evidence, Incomplete Evidence, or Conflicting Evidence

What is Clinical Reasoning?

Conclusion

J Clin Epidemiol

J Clin Lipidol

Atherosclerosis

Can J Cardiol

Lancet

Lancet

Lancet

Evidence based medicine: what it is and what it isn’t

BMJ

Preliminary report: effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infarction

N Engl J Med

The Philosophy of Evidence-Based Medicine

Scientific evidence underlying the ACC/AHA clinical practice guidelines

JAMA

Circulation

Prevention of bacterial endocarditis: recommendations by the American Heart Association

JAMA

Contradicted and initially stronger effects in highly cited clinical research

JAMA

Narrative review: statin-related myopathy

Ann Intern Med

Special article
The Necessity for Clinical Reasoning in the Era of Evidence-Based Medicine