ReviewEvidence-Based and Personalized Medicine. It’s [AND] not [OR]
Section snippets
The Pyramid of Evidence Versus the Best Available Evidence
The EBM movement introduced doctors to the pyramid of evidence which ranked the value of evidence from highest to lowest (Fig 2). In present day surgical practice this ranking may be used in the levels of evidence for clinical practice guidelines [3], but it is a subject of debate and change. Although helpful in categorizing types of studies, it has become clear that it is too simplistic to rank evidence by methodologic sophistication. There are times when accurate observation is most or all
Case Reports
Humans have evolved as a successful species by observation and experimentation with the world around us. Having discovered which berries are nourishing and which are poisonous, how to hunt and kill an animal, how to catch a fish, how to make a controlled fire and to cook with it, man’s instinct is to stick with what he knows works. In medicine we love case reports as can readily be gathered from the tally of published items in The Annals of Thoracic Surgery volume 100 (Fig 3).
A case report is
Case Series
These are observational studies that report on a subject group without a comparison population. In surgery they are typically a single surgeon or an institutional report summarizing a sequence of operations of a particular type. Case series remain one of the most common forms of evidence in journals of clinical surgery (Fig 3). They are low cost and easy to conduct. They may be helpful in refining new techniques or in defining treatment protocols. The limitations are that there was an unknown
Registries
For a recently introduced or evolving treatment there is commonly a call to set up a registry. People offering the treatment are invited to join and pool their data. Sometimes contributing data to the registry is a requirement to have access to a device or equipment. The virtue is that a large number of patients can be included.
Prospective Cohort Studies
A cohort study is one in which a group of subjects, selected to represent the population of interest, is studied over time. A cohort study may be either retrospective or prospective. Retrospective cohort studies concern a certain exposure in the past (eg, an operation) and then study the occurrence of an outcome (eg, death or complications) until the present time. Prospective cohort studies start in present time and include future patients with a certain exposure and then wait for prespecified
Matching Studies
A comparison group is derived from existing data. Patients who did not have the treatment but might have are selected from a data set to match as many factors as are available with patients who did have the treatment. There may be more than one patient matched. They may be matched as a group. A standard method at present is to derive a propensity score based on available predictors of the risk of an adverse outcome. It only works if patients were suitable for both courses of action. If there is
Randomized Controlled Trials
There are several essential features of the typical two-arm randomized trial. Its design can be simplified to the acronym PICO (P for participants, patients, problem, or population; I for the intervention under test; C for the control group or comparator; and O for the outcome(s) to be reported).
The reporting of randomized trials has been standardized in the CONSORT statement (Consolidated Standards of Reporting Trials) which if adhered to greatly assists in reviewing the study and later
Systematic Reviews
Before making guidelines for treatment, or embarking on a new trial to resolve a question with respect to treatment, it is best practice to systematically review all the evidence available. This is clearly preferable to nonsystematic selective citing by guidelines committees; hence, the need to a priori clearly document search terms and strategies as hinted at in the title of this article. By individually assessing studies for their sample size, patient and treatment characteristics, quality,
Clinical Practice Guidelines
Ideally, we want to combine all available evidence when we attempt to provide guidance for optimal patient treatment. Although a systematic review of all relevant RCTs may provide cause–effect relationships, it is often not generalizable to all patients in clinical practice. However, observational studies may be more generalizable, but they only provide associations between patient and treatment characteristics and outcome. They are subject to reporting bias because we tend to prefer to publish
References (46)
- et al.
Surgical management of aneurysms of the ascending aorta. Including those assocated with aortic valvular incompetence
Surg Clin North Am
(1966) - et al.
Ten traps for the unwary in surgical series: a case study in mesothelioma reports
J Thorac Cardiovasc Surg
(2007) - et al.
Long-term results of lung metastasectomy: prognostic analyses based on 5206 cases
J Thorac Cardiovasc Surg
(1997) - et al.
Biostatistics primer: what a clinician ought to know–prognostic and predictive factors
J Thorac Oncol
(2013) - et al.
Long-term clinical outcomes after percutaneous coronary intervention versus coronary artery bypass grafting for ostial/midshaft lesions in unprotected left main coronary artery from the DELTA registry: a multicenter registry evaluating percutaneous coronary intervention versus coronary artery bypass grafting for left main treatment
JACC Cardiovasc Interv
(2014) - et al.
Randomised, prospective, single-blind comparison of laparoscopic versus small-incision cholecystectomy
Lancet
(1996) - et al.
A prospective controlled trial of St. Jude versus Starr Edwards aortic and mitral valve prostheses
Ann Thorac Surg
(2003) - et al.
The role of surgical cytoreduction in the treatment of malignant pleural mesothelioma: meeting summary of the International Mesothelioma Interest Group Congress, September 11-14, 2012, Boston, Mass
J Thorac Cardiovasc Surg
(2013) The Rise and Fall of Modern Medicine
(1999)- et al.
Evidence based medicine: what it is and what it isn't
BMJ
(1996)
Guidelines on the management of valvular heart disease (version 2012)
Eur Heart J
When are randomised trials unnecessary? Picking signal from noise
BMJ
Evidence-Based Medicine: How to Practice and Teach EBM
Extrapleural pneumonectomy plus rib resection for malignant pleural mesothelioma: a case report
J Cardiothorac Surg
An exception that proves the rule: recurrence free survival five years after extrapleural pneumonectomy for malignant pleural mesothelioma
J Cardiothorac Surg
A technique for complete replacement of the ascending aorta
Thorax
Valvulotomy for mitral stenosis; report of six successful cases
Br Med M
Cardiotomy and valvulotomy for mitral stenosis. Experimental observations and clinical notes concerning an operative case with recovery
Boston Med Surg J
The surgical treatment of mitral stenosis
Br Med J
Present status of surgical procedures in chronic valvular disease of the heart; final report of all surgical cases
Arch Surg
The surgery of mitral stenosis 1898-1948: why did it take 50 years to establish mitral valvotomy?
Ann R Coll Surg Engl
The surgical treatment of mitral stenosis (mitral commissurotomy)
Dis Chest
The surgical treatment of mitral stenosis; valvuloplasty
N Engl J Med
Cited by (13)
Has anything changed in Evidence-Based Medicine?
2023, InjuryCitation Excerpt :How to separate quality from quantity? To answer these questions, the EBM movement introduced the concept of “pyramid of evidence” (aka “EBM hierarchy”), which is behind the basis of the levels of evidence for research and clinical practice, and which is getting fine-tuned periodically [21]. In this system, evidence methodologies residing on the top of the pyramid are considered superior: At its summit are the meta-analyses and systematic reviews, followed by randomized controlled trials (RCTs), cohorts, case-control studies, case series and case reports, and at the very bottom expert opinion.
Validity of chemotherapy information derived from routinely collected healthcare data: A national cohort study of colon cancer patients
2021, Cancer EpidemiologyCitation Excerpt :RCTs, however, include highly selected patient populations under rigorously controlled conditions, generally under-representing older patients, and those who are frail or comorbid. Population-based studies, using data such as electronic healthcare records, are needed to assess outcomes in diverse non-selected populations under realistic clinical conditions, and can be used to complement RCT findings [4–8]. All English National Health Service (NHS) chemotherapy providers are mandated to collect data for all patients in routine care via the Systemic Anti-Cancer Therapy (SACT) dataset [9].
Clinical research in critical care. Difficulties and perspectives
2018, Medicina IntensivaThoracotomy: Gain With Less Pain?
2019, Seminars in Thoracic and Cardiovascular SurgeryAortic Valve Embryology, Mechanobiology, and Second Messenger Pathways: Implications for Clinical Practice
2024, Journal of Cardiovascular Development and Disease