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There is no evidence that NRT used for smoking cessation in pregnancy has either positive or negative impacts on birth outcomes Coleman et al. Nicolaides et al.
It is believed that this device reduces direct pressure on the cervix and prolongs pregnancy Arabin et al. This randomized trial compared spontaneous preterm births among women with pessaries with those who underwent expectant management and found that the pessary had no significant effect on the rate of preterm delivery This is a reversal of off-pump coronary-artery bypass.
As the usage of glucocorticoid injections increased to treat various ailments, so did the cost. This is a reversal of administering epidural glucocorticoid injections in patients who have lumbar central spinal stenosis and moderate-to-severe leg pain and disability. Traditionally, surgeons performed surgery on the arrested heart, on-pump CABG, which allowed for increased surgical precision Shroyer et al.
However, surgeons grew concerned that the cross clamping of the aorta, necessary for the on-pump CABG procedure, may be harmful to patients and increase mortality and risk of stroke or other systemic embolic events in these patients. The off-pump method, operating on a beating heart, was developed to decrease the perioperative risks Grover, The costs between the two treatments was similar as well.
This is a reversal of off-pump coronary-artery bypass grafting.
In contrast, we observed better long-term survival in the group of patients undergoing on-pump CABG with the use of cardiopulmonary bypass and cardioplegic arrest. Based on the current evidence, on-pump CABG should continue to be the standard surgical treatment. However, off-pump CABG may be acceptable when there are contraindications for cannulation of the aorta and cardiopulmonary bypass. Further randomised clinical trials should address the optimal treatment in such patients.
Katz et al. Given the frequency and cost of arthroscopic partial meniscectomy and lack of concrete evidence on the clinical benefit of the procedure, the METEOR trial was designed to assess the efficacy of arthroscopic partial meniscectomy surgery as compared with a physical-therapy for increasing physical function of patients with a meniscal tear and moderate osteoarthritis Katz et al.
METEOR found that there was not a significant decrease in the WOMAC score—a measure of physical function in which a higher score means worse physical function—between the patients undergoing surgery and those receiving initial physical therapy. The authors conclude that the finding of the METEOR trial advocates for an initial nonoperative strategy for treatment. Given the current widespread use of arthroscopic meniscal surgeries, more research is urgently needed to support evidence-based practice in meniscal surgery in order to reduce the numbers of ineffective interventions and support potentially beneficial surgery.
This list represents practices from all disciplines of medical care. These practices add to a previously reported list of medical reversals published during years — Prasad et al. Efforts to identify low-value practices are numerous. In the US Choosing Wisely initiative began by asking members of each medical specialty to provide a list of the top five diagnostic tests or treatments that are expensive and have evidence showing a lack of benefit Schpero, : similar initiatives have been implemented in other countries de Vries et al.
Some have performed systematic searches of the scientific databases using key words de Vries et al. Others have used a multiplatform attempt, consisting of searching the peer-reviewed literature, insurance and health organization databases, and opportunistic samplings of knowledgeable experts in the field Elshaug et al.
Each of these ways to identify medical reversals or low-value practices has advantages and disadvantages, but identifying these practices can be challenging because of their heterogeneity, the lack of established methods to identify these practices, the difficulty in applying them to the correct population or subpopulation, and the obstacle of prioritizing which practices are more or less low-value Elshaug et al.
Prior work by Schwartz and colleagues approximated the financial costs of 26 low-value services that are more commonly used in the older adult population Schwartz et al. These results are especially notable considering the authors only used the 26 most commonly used low-value services. In contrast, the ubiquity of medical reversals has been previously reported upon in the NEJM, where practices were identified as medical reversals over a decade Prasad et al.
Here, we hope to add to the prior efforts of others in providing a larger and more comprehensive list practices in total for clinicians and researchers to guide practice as they care for patients more effectively and more economically.
We found reversals in a variety of medical sub-fields and types of devices, procedures, or practices. These reversals had been practiced and tested in high-income as well as low- to middle-income countries, although the highest percentage of reversals was in high-income countries, likely because most randomized trials are performed in this setting.
For example, bevacizumab Avastin was approved in by the Food and Drug Administration FDA in the US for metastatic breast cancer under the accelerated approval program, but was later shown to not improve overall survival Vitry et al. Reversals were not just limited to practices performed by physician or health care providers only. Wearable technology has become especially popular among people who are interested in tracking their physical activity in an effort to lose weight.
A study on the use of wearable technology, however, found that weight loss was significantly less among the group that had access to wearable technology, compared to the group that did not Jakicic et al.
With increasing availability of healthcare interventions that are readily accessible to everyone without a prescription, there needs to be greater discussion on whether these work between patients and physicians, as well as discussion on the regulation of these interventions. Finally, reversals highlight the importance of independent, governmental and non-conflicted funding of clinical research.
The majority of reversal studies we found were funded by such sources Strengths and limitations There are several strengths and limitations to this paper.
First, we looked at just three journals each of which has a high impact factor. Second, documented evidence of the use of a newer practice was sometimes easier to find because it had come about during a time when there was more internet use. Conversely, documented evidence of an older practice was sometimes easier to find because there had been more historical commentary about its use.
Because of this, newer or more recent practices may be more or less likely to be categorized as established than older or less recent practices. Third, others may categorize results differently, depending on background expertise of the investigators. To help overcome this limitation, physicians in the clinical setting from a range of backgrounds were invited to review and comment on practices identified as reversals. Our dataset is presented in full in Supplementary file 2.
It is inevitable that others may feel differently and choose to reclassify some of our examples. We hope our work may serve to enhance and expand upon other efforts to identify and disincentivize low-value practices. Fifth, we did not evaluate the quality of the meta-analysis used to confirm or refute the medical reversal. However, we tried to find the most recent review that was published in either Cochrane or medical journal for that specialty to confirm or refute the reversal.
Finally, our definition of established may be broad in that we did not limit established practices to only those that were being used widespread, in part because once a practice has been adopted, even intermittently, it is difficult to get patients and patients to abandon this practice.
We did, however, maintain that proof of establishment needed to codified into guidelines or be one for which we could prove use outside of a clinical trial or clinical protocol.
Additionally, multiple physicians reviewed each practice to confirm that these practices were indeed reversals. Our primary research objective was to compile a comprehensive review of medical reversals for the benefit of both medical professionals and lay persons. This type of work is fundamentally descriptive and does not seek to test a binary hypothesis. Nevertheless, there are a number of concepts and lessons that may be realized from the results. The breadth of reversals across the various fields of medicine emphasize the importance of conducting randomized trials for both novel and established practices.
While it may impractical, if not impossible, to test every medical practice in a randomized setting, there are many testable practices that are adopted based on nonrandomized data or bio plausibility.
There is a danger in expediting treatments into practice without data proving their efficacy. Once an ineffective practice is established, it is difficult to convince practitioners to abandon its use; eliminating a reversal from standard practice occurs slowly and with resistance Prasad et al. By aiming to test novel treatments before they are widespread, we can reduce the number of reversals in practice and prevent harms to patients and to the reputation of the medical field.
Conclusions We have identified medical reversals spanning different types of medical disciplines, types of interventions, and populations. The de-adoption of these and other low-value medical practices will lead to cost savings and improvements in medical care.
Methods Aim of study We sought to compile a list of medical reversals that appeared in three leading general medical journals during a 15 year period.
Search strategy We used methods similar to our prior survey of 10 years of publications in one high-impact journal Prasad et al. This study was conducted from March 1, through November 11, Article inclusion We identified all randomized trials of a clinical practice, or, in other words, any investigation that assessed screening, diagnostic testing, medication s , procedure s , surgery, medical device, treatment algorithms, or any change in health care provision systems. We excluded randomized controlled trials RCTs that did not concern a medical practice e.
We then excluded trials of novel practices, defined as practices only used in the confines of clinical trials. Established practices were included and defined as those used regularly outside of research trials. This could include off-label use or use outside of the US.
Next, we excluded trials that reached positive or inconclusive results. An article was considered positive if the trial met its primary endpoint and negative if it failed to meet the primary outcome or if the study measured a hard endpoint quality of life, mortality, etc.
For non-inferiority or equivalence studies, meeting the pre-specified margin would be considered positive. For studies comparing two established interventions, the more expensive intervention needed to show benefit to be considered positive.