The new study by Gartlehner et al. (1) claims that the benefits of homeopathy may have been over-estimated due to high levels of reporting bias. However, as this problem is well-known to affect all areas of medical research, context is everything.
Although the authors state that, “non-publication of trial results and selective outcome reporting …. is not a phenomenon that is limited to homeopathy”, they failed to provide adequate context for their results by making any direct comparison to other areas of clinical research. Homeopathy is arguably out-performing conventional medicine, or, at the very least, has comparable levels of reporting bias. Using representative examples of high-impact studies on reporting bias across all medical fields, when compared with the data presented by Gartlehner et al.(1) it is clear that:
1) half of all registered clinical trials (2) in conventional medicine fail to report their results within 12 months; whereas 62% of all registered homeopathy trials reach publication, and
2) inconsistencies in reporting of primary outcome (3) occur in 43% of conventional medical studies; whilst this happens in only 25% of published homeopathy trials.
The potential impact of unregistered/unpublished results on estimates of treatment effects is well known (4), yet for homeopathy, according to Gartlehner et al.(1), the impact may be minimal, or nothing at all: “the difference in effect sizes between registered and unregistered stud...
The new study by Gartlehner et al. (1) claims that the benefits of homeopathy may have been over-estimated due to high levels of reporting bias. However, as this problem is well-known to affect all areas of medical research, context is everything.
Although the authors state that, “non-publication of trial results and selective outcome reporting …. is not a phenomenon that is limited to homeopathy”, they failed to provide adequate context for their results by making any direct comparison to other areas of clinical research. Homeopathy is arguably out-performing conventional medicine, or, at the very least, has comparable levels of reporting bias. Using representative examples of high-impact studies on reporting bias across all medical fields, when compared with the data presented by Gartlehner et al.(1) it is clear that:
1) half of all registered clinical trials (2) in conventional medicine fail to report their results within 12 months; whereas 62% of all registered homeopathy trials reach publication, and
2) inconsistencies in reporting of primary outcome (3) occur in 43% of conventional medical studies; whilst this happens in only 25% of published homeopathy trials.
The potential impact of unregistered/unpublished results on estimates of treatment effects is well known (4), yet for homeopathy, according to Gartlehner et al.(1), the impact may be minimal, or nothing at all: “the difference in effect sizes between registered and unregistered studies did not reach statistical significance”. Therefore, it is surprising that the authors claim that Dr Mathie’s “landmark meta-analyses”, used as the starting point for their analysis, “might substantially overestimate the true treatment effect of homeopathic remedies and need to be interpreted cautiously”. A thorough examination of their study reveals that their data do not support this claim.
While attempts have been made to use this new study to undermine the evidence base in homeopathy, claiming “poor research practice” (5), such claims are entirely unfounded. Reporting bias occurs in all areas of medical research, so, unsurprisingly, it occurs in homeopathy research too. Contrary to these authors’ claims, the clinical evidence base in homeopathy does not need more “cautious interpretation” than any other scientific evidence.
1. Gartlehner G et al. Assessing the magnitude of reporting bias in trials of homeopathy: a cross-sectional study and meta-analysis. BMJ Evidence-Based Medicine, 2022; eFirst
2. Goldacre B et al. Compliance with requirement to report results on the EU Clinical Trials Register: cohort study and web resource. BMJ, 2018;362:k3218
3. Shah K et al. Outcome reporting bias in Cochrane systematic reviews: a cross-sectional analysis. BMJ Open, 2020;16;10:e032497.
4. Chen T et al. Comparison of clinical trial changes in primary outcome and reported intervention effect size between trial registration and publication. JAMA, 2019; 2(7):e197242
5. https://www.bmj.com/company/newsroom/poor-research-practice-suggests-tru...
Gartlehner et al (1) concluded that the effects of homeopathic clinical trials may be overestimated due to publication bias. Such conclusions are inaccurate based on their own statement and their evaluation of the data they investigated. The authors asserted, “the difference in effect sizes between registered and unregistered studies did not reach statistical significance.” Despite this clear statement of what their data showed, the researchers instead came to a different conclusion that sought to question the integrity of research results with homeopathy.
To their credit, these authors acknowledge that the problem of “non-publication of trial results and selective outcome reporting …. is not a phenomenon that is limited to homeopathy.” And yet, they purposefully chose to not reference any literature that evaluated this problem in publication bias from clinical trails testing conventional medicine. A simple review of the literature would find that conventional medical trials have at least the same rate of publication bias as those reported upon that tested homeopathic medicines (2), to reviews of research that showed a much higher level of publication bias when reporting on conventional medical treatments (3).
The fact is that several media (4)(5) that have reported on this study have come to the mistaken conclusion that the results of homeopathic clinical trials are not to be trusted, and this biased conclusion stems from the Gartlehner articl...
Gartlehner et al (1) concluded that the effects of homeopathic clinical trials may be overestimated due to publication bias. Such conclusions are inaccurate based on their own statement and their evaluation of the data they investigated. The authors asserted, “the difference in effect sizes between registered and unregistered studies did not reach statistical significance.” Despite this clear statement of what their data showed, the researchers instead came to a different conclusion that sought to question the integrity of research results with homeopathy.
To their credit, these authors acknowledge that the problem of “non-publication of trial results and selective outcome reporting …. is not a phenomenon that is limited to homeopathy.” And yet, they purposefully chose to not reference any literature that evaluated this problem in publication bias from clinical trails testing conventional medicine. A simple review of the literature would find that conventional medical trials have at least the same rate of publication bias as those reported upon that tested homeopathic medicines (2), to reviews of research that showed a much higher level of publication bias when reporting on conventional medical treatments (3).
The fact is that several media (4)(5) that have reported on this study have come to the mistaken conclusion that the results of homeopathic clinical trials are not to be trusted, and this biased conclusion stems from the Gartlehner article that made conclusions that didn’t arise from their data.
It seems that these authors themselves are showing evidence of their own reporting bias and of their own avoidance of reporting on evidence that shows that conventional medical research may be as or more guilty of this problem. By maintaining conclusions that are not consistent with their finding that the effect size between registered and non-registered studies did not achieve statistical significance, and then deciding to avoid referencing how common this problem is in conventional medical research, these researchers seem to be showing “bad faith,” in other words, a deliberate intent to mislead.
(1) Gartlehner G, Emprechtinger R, Hackl M, et al. Assessing the magnitude of reporting bias in trials of
homeopathy: a cross-sectional study and meta-analysis BMJ Evidence-Based Medicine. Epub ahead of print: 15 March 2022. doi:10.1136/bmjebm-2021-111846.
(2) Kicinski M, Springate DA, Kontopantelis E. Publication bias in meta-analyses from the Cochrane Database of Systematic Reviews. Stat Med. 2015 Sep 10;34(20):2781-93. doi: 10.1002/sim.6525. Epub 2015 May 18. PMID: 25988604. https://pubmed.ncbi.nlm.nih.gov/25988604/
(3) Decullier E, Lhéritier V, Chapuis F. Fate of biomedical research protocols and publication bias in France: retrospective cohort study. BMJ. 2005;331(7507):19. doi:10.1136/bmj.38488.385995.8F https://www.ncbi.nlm.nih.gov/pmc/articles/PMC558532/
The article by Gartlehner et al. [1] is interesting because it allows the homeopathic community to elaborate on potential publication bias in clinical trials of homeopathy. There are, however, several questionable elements: in the article, and in the announcement made on the BMJ web, it is concluded that there was a high proportion of trials not preregistered, but at the same time Gartlehner acknowledges in the press that over time there has been a substantial improvement in the preregistration of trials [2]; it is mentioned that homeopaths must improve, but at the same time it is implied that "homeopathy cannot work".
On the second point, it is worth mentioning that in the article Gartlehner et al cite two trials, one by Grimes [3] and the other by Grams [4]. These essays are based on a biased selection of literature and have elementary errors. For example, Grimes says that Jacques Benveniste's famous study was published in "1987" and that Madaleine Ennis' work was negative when in fact it was positive [5]. Grimes bases his conclusions on theoretical claims (a simple calculation of Avogadro's constant) and not on experimental studies that at the time were available (e.g. [6]). Grams, on the other hand, only cites some old articles from 1992 and 1993 without mentioning more recent studies (e.g. [7]).
References:
1. Gartlehner G, Emprechtinger E, Hackl M, Gartlehner J, Nonninger J, et al. (2022). Assessing the magnitude...
The article by Gartlehner et al. [1] is interesting because it allows the homeopathic community to elaborate on potential publication bias in clinical trials of homeopathy. There are, however, several questionable elements: in the article, and in the announcement made on the BMJ web, it is concluded that there was a high proportion of trials not preregistered, but at the same time Gartlehner acknowledges in the press that over time there has been a substantial improvement in the preregistration of trials [2]; it is mentioned that homeopaths must improve, but at the same time it is implied that "homeopathy cannot work".
On the second point, it is worth mentioning that in the article Gartlehner et al cite two trials, one by Grimes [3] and the other by Grams [4]. These essays are based on a biased selection of literature and have elementary errors. For example, Grimes says that Jacques Benveniste's famous study was published in "1987" and that Madaleine Ennis' work was negative when in fact it was positive [5]. Grimes bases his conclusions on theoretical claims (a simple calculation of Avogadro's constant) and not on experimental studies that at the time were available (e.g. [6]). Grams, on the other hand, only cites some old articles from 1992 and 1993 without mentioning more recent studies (e.g. [7]).
References:
1. Gartlehner G, Emprechtinger E, Hackl M, Gartlehner J, Nonninger J, et al. (2022). Assessing the magnitude of reporting bias in trials of homeopathy: a cross-sectional study and meta-analysis. BMJ Evidence-Based Medicine; 27(1): 1-20.
2. Doheny K. (2022). Homeopathy: do ‘cherry-picked?’ studies exaggerate benefits? WebMD. Available in: https://www.webmd.com/balance/news/20220401/homeopathy-benefits-may-be-e...
3. Grimes R. (2012). Proposed mechanisms for homeopathy are physically impossible. Focus on Alternative and Complementary Therapies; 17(3): 149-155.
4. Grams N. (2019). Homeopathy – where is the science? A current inventory on a pre-scientific artifact. EMBO Reports; 20(3): 1-50.
5. Belon P, Cumps J, Ennis M, Mannaioni P, Sainte J, et al. (1999). Inhibition of human basophil degranulation by successive histamine dilutions: results of a European multicentre trial. Inflammation Research; 48 (S1): 17–18.
6. Demangeat L. (2009). NMR water proton relaxation in unheated and heated ultrahigh aqueous dilutions of histamine: evidence for an air-dependent supramolecular organization of water. Journal of Molecular Liquids; 144(1): 32-39.
7. Laudy S & Belon P. (2009). Inhibition of basophil activation by histamine: a sensitive and reproducible model for the study of the biological activity of high dilutions. Homeopathy; 98(4): 186-197.
Conflict of Interest: None. I am not a homeopath, but I have researched the subject of homeopathy from a social and historical point of view.
To our great sadness on Wednesday, April 13th 2022, Ingeborg Griffioen, author of “Innovating in healthcare: perspective from a dual role” passed away, at the age of 50. She departed with acceptance of the inevitable and in connection to those she loved and who loved her.
Ingeborg was founder and owner of Panton design studio, specialized in healthcare. In 2016 she started a PhD research on the use of service design to support shared decision making. Less than one year later, her husband was diagnosed with pancreatic cancer. Ingeborg incorporated their experiences with his care trajectory in her research, which led to the development of MetroMapping, a method to support shared decision making (www.metromapping.org/en). During this development process, Ingeborg herself was diagnosed with breast cancer.
It was one of Ingeborg’s dreams that MetroMapping be further developed and implemented at a large scale. Even during her chemotherapy she contributed to the 4D PICTURE project proposal, which focuses on adapting, evaluating and implementing MetroMapping in hospitals throughout Europe. Early 2022, we received the news that Ingeborg’s dream will come true, as 4D PICTURE was selected for funding by Horizon Europe. Ingeborg wrote a beautiful testimonial for 4D PICTURE:
“As a designer I have worked for 25 years in healthcare settings and as a researcher I studied treatment decision-making. I know the importance of...
To our great sadness on Wednesday, April 13th 2022, Ingeborg Griffioen, author of “Innovating in healthcare: perspective from a dual role” passed away, at the age of 50. She departed with acceptance of the inevitable and in connection to those she loved and who loved her.
Ingeborg was founder and owner of Panton design studio, specialized in healthcare. In 2016 she started a PhD research on the use of service design to support shared decision making. Less than one year later, her husband was diagnosed with pancreatic cancer. Ingeborg incorporated their experiences with his care trajectory in her research, which led to the development of MetroMapping, a method to support shared decision making (www.metromapping.org/en). During this development process, Ingeborg herself was diagnosed with breast cancer.
It was one of Ingeborg’s dreams that MetroMapping be further developed and implemented at a large scale. Even during her chemotherapy she contributed to the 4D PICTURE project proposal, which focuses on adapting, evaluating and implementing MetroMapping in hospitals throughout Europe. Early 2022, we received the news that Ingeborg’s dream will come true, as 4D PICTURE was selected for funding by Horizon Europe. Ingeborg wrote a beautiful testimonial for 4D PICTURE:
“As a designer I have worked for 25 years in healthcare settings and as a researcher I studied treatment decision-making. I know the importance of thinking carefully about treatments goals and weighing benefits and risks. I thought I knew my way around in healthcare…
Then, in 2016, my husband was diagnosed with pancreatic cancer, and in early 2021, I turned out to have Triple Negative breast cancer. Twice I experienced a burdensome trajectory. Twice, there were clinicians intended to involve us in decision-making processes. However, twice, I often felt overwhelmed and unable to navigate the many treatment steps and decisions. Information was confusing and roles of caregivers were often unclear.
The problem turned out to be the unresponsive healthcare system, a system in which people and their needs get lost.
My experiences, as patient, as partner, as designer and researcher, inspired me to lay the foundation for the MetroMapping method. A first step to redesign entire care paths, together with patients, families, and clinicians.
My dream is to improve healthcare systems all around Europe, with patients at the heart of all care. This requires thinking big. I am so happy to be involved in a dedicated team of researchers, designers, clinicians and patient advocates. A team that knows how to use Big Data and that has drafted a solid plan, targeting at a web-based, user-friendly, open-source method and manual of MetroMapping, that includes support for decision making, and is freely accessible for all European hospitals and (future) patients. I'm in!”
In her last three months of life, which she called her “bonus time”, she set up a Foundation to support work on MetroMapping. Throughout her disease process she shared her ideas, experiences, and dreams in her blog (https://allthewaywithingebee.blog/), using striking metaphors and imagery.
Ingeborg initiated and inspired. She taught us so much and will continue to inspire all: designers, clinicians, quality of care staff, patients, and all others dedicated to improving the care trajectories and experiences of patients and their caregivers.
In loving memory,
Anne Stiggelbout, Marleen Kunneman, Arwen Pieterse. Medical Decision Making, Leiden University Medical Center
Dirk Snelders, Marijke Melles, Ena Voûte. Faculty of Industrial Design Engineering, Delft University of Technology
Judith Rietjens, Ida Korfage. Department of Public Health, Erasmus MC, University Medical Center Rotterdam
Jasper Brands, Mario de Zeeuw. Panton Design Studio, Deventer
Dr. Terry Campbell, a lecturer at the university's School of Nursing
This is a response to the article that was published on August 31, 2019, which can be seen above. The article was quite fascinating to read since it focuses on hypertension and how the therapy would effect medication usage in insured individuals; however, the study that was offered was based on a review of the healthcare system in China's population. After reading this study, I have come to the conclusion that it is essential to supply patients with information that is pertinent to their conditions and to take into account the patients' values in the process of making clinical decisions. Doing so can boost patient participation and contribute to the development of patient-centered, individualized care. The researcher provided individual counseling and found that the rate of willingness to pay completely out of pocket for antihypertensive drugs dropped significantly after evidence- based individualised counselling; however, it is uncertain whether that evidence- based, individualised counselling regarding hypertension and its treatment would actually impact medication use in insured patients with mild hypertension.
The findings of this research are restricted in a few important ways. To begin, it may be affected by reporting bias, which is a typical worry in data that is self-reported. This bias may occur when people lie about what they did. Prescription refills, patients'...
Dr. Terry Campbell, a lecturer at the university's School of Nursing
This is a response to the article that was published on August 31, 2019, which can be seen above. The article was quite fascinating to read since it focuses on hypertension and how the therapy would effect medication usage in insured individuals; however, the study that was offered was based on a review of the healthcare system in China's population. After reading this study, I have come to the conclusion that it is essential to supply patients with information that is pertinent to their conditions and to take into account the patients' values in the process of making clinical decisions. Doing so can boost patient participation and contribute to the development of patient-centered, individualized care. The researcher provided individual counseling and found that the rate of willingness to pay completely out of pocket for antihypertensive drugs dropped significantly after evidence- based individualised counselling; however, it is uncertain whether that evidence- based, individualised counselling regarding hypertension and its treatment would actually impact medication use in insured patients with mild hypertension.
The findings of this research are restricted in a few important ways. To begin, it may be affected by reporting bias, which is a typical worry in data that is self-reported. This bias may occur when people lie about what they did. Prescription refills, patients' scales, and self-reporting are only few of the measures that are regularly used to assess a patient's level of adherence to their medical regimen. Because the antihypertensive prescription could be refilled at any hospital, primary care centers, or even pharmacies in the city where the study was conducted. This was due to the fact that the network among the hospitals, centers, and pharmacies had not yet been established, which meant that we were unable to check all of the refills that were obtained from various locations for a single patient. As a consequence of this, the prescription history kept only at the community health centers where this research was carried out was available and would underestimate the real refills. The patients' scales was not used in this research was due to the fact that they had not been adequately validated for the purpose of researching patients' adherence to antihypertensive medication in Chinese communities. In addition, it is yet unknown whether or not patients' drug-taking behaviors will alter if the EBI counselling had been provided by the attentive doctors; for this reason, more study is still required.
My name is Student Nurse Montel Stuart. from the University of the Bahamas. I have read your article and found the area of research to be very interesting and encourage to you to further your research on the effect of counselling on uninsured patients.
Regards,
Montel Stuart
This refreshing article does much to help move forward from the self-imposed strictures of the EBM orthodoxy. I hope EBM+ grows as an idea as, currently, EBM feels, sometimes, quasi-religious in the fervour to reject “the wrong sort” of evidence. It leaves clinicians in fields like addiction - where RCTs are very difficult to do unless so simple in their structure that the results are clinically difficult to use or, worse, irrelevant - stuck. Meta-analyses of clinically irrelevant studies are still clinically irrelevant. Data is hard to come by that is not EBM-perfect, so why bother doing the clinical research? Hopefully this suggestion will improve that disconnect.
The clinical evidence we produce which impacts the care we deliver to patients must have the highest standards. Unlike biomedical evidence, the evidence behind our treatments, risk factors and diagnostic tests should be relevant to the patients and clinicians who practice at the coal-face and real-world of General Practice and our hospitals.
We may have had 250,000 'peer-reviewed' articles relating to COVID-19 (whatever credibility that affords), but allowing biomedical assumptions to creep into guidelines and direct patient care, is taking a step backwards in evidence-based practice. COVID saw a multitude of 'experts' give their opinion freely in the media and on social media platforms, based on biomedical ‘evidence’, on opinion, through the platforming of academic-status and on dubious case-studies. This was self-evidently un-scientific, and arguably has set science back. Yet this article seems to advance the notion that this evidence should impact patient care.
So much has to be done to enable EBM to flourish- yet this article will likely set EBM back. The evidence underpinning our treatments should be quantifiable in absolute terms, and the uncertainties and conflicts of interests (COIs) acknowledged. The evidence behind our risk factors characterised in absolute terms, within the context of confounders and biases from observational studies. Our diagnostic tests should be understood within the context of odds and post-test probability. O...
The clinical evidence we produce which impacts the care we deliver to patients must have the highest standards. Unlike biomedical evidence, the evidence behind our treatments, risk factors and diagnostic tests should be relevant to the patients and clinicians who practice at the coal-face and real-world of General Practice and our hospitals.
We may have had 250,000 'peer-reviewed' articles relating to COVID-19 (whatever credibility that affords), but allowing biomedical assumptions to creep into guidelines and direct patient care, is taking a step backwards in evidence-based practice. COVID saw a multitude of 'experts' give their opinion freely in the media and on social media platforms, based on biomedical ‘evidence’, on opinion, through the platforming of academic-status and on dubious case-studies. This was self-evidently un-scientific, and arguably has set science back. Yet this article seems to advance the notion that this evidence should impact patient care.
So much has to be done to enable EBM to flourish- yet this article will likely set EBM back. The evidence underpinning our treatments should be quantifiable in absolute terms, and the uncertainties and conflicts of interests (COIs) acknowledged. The evidence behind our risk factors characterised in absolute terms, within the context of confounders and biases from observational studies. Our diagnostic tests should be understood within the context of odds and post-test probability. Our guidelines currently inhibit the practice of EBM, without such information.
By providing credibility to case studies, mechanistic evidence and expert opinion as a reliable predictor of exposure to outcome, I fear a Trojan horse of 'science-experts' driving un-evidenced practices into clinical medicine will happen- at huge risk to patient care, shared decision-making, conflicts of interest and healthcare costs.
Not a good day for EBM.
Airborne transmission and inhalation, of SARS-CoV-2 is recognized by international public health agencies (Addleman et al. 2021) from both short- and long-range aerosol transmission (Tang et al. 2021).
When comparing filtering face piece (FFP) respirators, with a surgical (medical) masks, for protection against an inhalable (ISO 7708) airborne virus such as SARS-CoV-2, “EQUIPOISE” a central tenet for conducting a randomised control trial (RCT), does not exist. The futility of using a RCT is analogous to carrying out a study in a construction site for hard hats or seat belts in a passenger vehicle. FFP respirators used in Canada are selected and used in accordance with CAN/CSA-Z94.4-18 (Selection, use, and care of respirators). Specifications are provided in CSA Z94.4.1:21 (Performance of filtering respirators).
At least two international studies using RCT have been initiated since the start of the COVID-19 pandemic.
a) United Kingdom: The impact of different grades of respiratory protective equipment on sickness absence due to respiratory infections including SARS-CoV-2 for healthcare workers (The funding committee did not recommend funding).
b) Canada, multi-centre: where nurses are randomized to either use of a medical mask or to a fit-tested N95 respirator when providing care for patients with febrile respiratory illness.
The findings from a poorly designed RCT may also be used as improper and biased rationale to downgrade respirator (masks...
Airborne transmission and inhalation, of SARS-CoV-2 is recognized by international public health agencies (Addleman et al. 2021) from both short- and long-range aerosol transmission (Tang et al. 2021).
When comparing filtering face piece (FFP) respirators, with a surgical (medical) masks, for protection against an inhalable (ISO 7708) airborne virus such as SARS-CoV-2, “EQUIPOISE” a central tenet for conducting a randomised control trial (RCT), does not exist. The futility of using a RCT is analogous to carrying out a study in a construction site for hard hats or seat belts in a passenger vehicle. FFP respirators used in Canada are selected and used in accordance with CAN/CSA-Z94.4-18 (Selection, use, and care of respirators). Specifications are provided in CSA Z94.4.1:21 (Performance of filtering respirators).
At least two international studies using RCT have been initiated since the start of the COVID-19 pandemic.
a) United Kingdom: The impact of different grades of respiratory protective equipment on sickness absence due to respiratory infections including SARS-CoV-2 for healthcare workers (The funding committee did not recommend funding).
b) Canada, multi-centre: where nurses are randomized to either use of a medical mask or to a fit-tested N95 respirator when providing care for patients with febrile respiratory illness.
The findings from a poorly designed RCT may also be used as improper and biased rationale to downgrade respirator (masks) to surgical masks (Greenhalgh et al. 2022).
A subject should be enrolled in an RCT only if there is true uncertainty (equipoise) about which of the trial arms is likely to benefit the participants (Fries & Krishan 2004), otherwise the study may be unethical. Other study methodology should not be discounted and EBM+ provides a way forward.
An “observational” cohort study from Switzerland, covering 2919 HCWs spread over 7 health care networks, demonstrated 21% of infections occurred for HCWs using respirator masks compared with 35% for those using surgical/mixed masks (Dorr et al. 2022). Infections may have been greatly reduced if there was a solid respiratory protection program in place, which is not clear from the information provided.
An observational study by Ferris et al. 2021, demonstrated how important it is for HCWs caring for patients with COVID-19, whether aerosol generating procedures (AGPs) were undertaken or not to use respirators and not surgical masks.
A cross-sectional prospective study from Finland clearly demonstrated that respirators are superior (Oksanen et al. 2021). A systematic review where eight studies (9164 participants) were included after screening 153 articles followed by a meta-analysis (Collins et al. 2021).
Healthcare workers (at risk) need respiratory protection in accordance with international standards; plus, good ventilation, and administrative controls, to limit their risk of exposure to infected co-workers and patients. Reduced infection lowers the risk of work overload, moral injury and household and community transmission.
The Canada, Quebec’s court decision, ensures that all health-care professionals are provided an N95 respirator immediately when a resident or patient is suspected to be infected with COVID-19 (Hedges et al 2021, Justice Philippe Bouvier – court decision 2021).
“Thousands of lives were likely lost as a result of what was incorrectly claimed to be an evidence-based approach dismissing or downgrading mechanistic evidence, overvaluing the findings from poorly designed or irrelevant RCTs, and advocating for inaction where RCT evidence was lacking” (Greenhalgh 2022, p.1).
All relevant disciplines must be engaged (e.g., engineers, occupational hygienists, aerosol scientists, social and behavioural scientists, epidemiologists) in the research so that “up to date” and mechanistic evidence (Greenhalgh et al. 2022a, table 2) is incorporated in important policy decision making.
EBM+ provides a framework moving forward at this critical time.
References
Addleman S, Leung V, Asadi, L, Sharkawy, A, McDonald J 2021, “Mitigating airborne transmission of SARS-CoV-2”. Canadian Medical Association Journal (CMAJ), CMAJ July 05, 2021 193 (26) E1010-E1011; DOI: Retrieved 9 August 2022: https://doi.org/10.1503/cmaj.210830
Canadian Aerosol Transmission Coalition (CATC), January 4 2021, “There is still time to address aerosol transmission of COVID-19”, correspondence with Canadian and Provincial, Public Health Agency of Canada (PHAC), premiers and ministers. Retrieved 9 August 2022: https://www.aerosoltransmissioncoalition.ca/_files/ugd/cdecb4_0c05d1fea9...
Canadian CSA Group CAN/CSA-Z94.4-18 Selection, use, and care of respirators. Retrieved 9 August 2022: https://www.csagroup.org/store/product/CAN%25100CSA-Z94.4-18/
Canadian CSA Group CSA Z94.4.1, Performance of filtering respirators. Retrieved 9 August 2022: https://www.csagroup.org/store/product/2429470/
Collins AP, Service BS, Gupta S, Mubarak, N, Zeini, IM, Osbahr DC, Romeo AA 2021, N95 respirator and surgical mask effectiveness against respiratory viral illnesses in the healthcare setting: A systematic review and meta-analysis. J Am Coll Emerg Physicians Open .2021 Oct 28;2(5):e12582. doi: 10.1002/emp2.12582. eCollection 2021 Oct. Retrieved 9 August 2022: https://pubmed.ncbi.nlm.nih.gov/34746923/
Dörr, T Sabine, Haller TS, Müller MF, Friedel A, Vuichard D, Kahlert CR, Kohler P 2022, Risk of SARS-CoV-2 Acquisition in Health Care Workers According to Cumulative Patient Exposure and Preferred Mask Type, JAMA Network Open, Infectious Diseases, Open. 2022;5(8). August 15 2022.
Ferris M, Ferris R, Workman C, O’Connor E, Enoch DA, Goldesgeyme E, Quinnell N, et al. 2021, “ Efficacy of FFP3 respirators for prevention of SARS-CoV-2 infection in healthcare workers”, Epidemiology and Global Health | Microbiology and Infectious Disease, eLife 2021;10:e71131. DOI: Retrieved 9 August 2022: https://doi.org/10.7554/eLife.71131
Fries JF, Krishnan E 2004, Equipoise, design bias, and randomized controlled trials: the elusive ethics of new drug development, Arthritis Res Ther. 2004;6(3):R250-5. doi: 10.1186/ar1170. Epub 2004 Mar 18. Retrieved 9 August 2022. https://pubmed.ncbi.nlm.nih.gov/15142271/
Greenhalgh T, Kane B, Reicher S 2022, “Downgrade your mask before entering”—a dangerous NHS policy at a critical public health juncture”. BMJ 2022;378:o1929. Retrieved 9 August 2022: https://www.bmj.com/content/378/bmj.o1929
Greenhalgh T, Fisman D, Cane DJ, et al. 2022a. “Adapt or die: how the pandemic made the shift from EBM to EBM+ more urgent” BMJ Evidence-Based Medicine Published Online First: 19 July 2022. doi: 10.1136/bmjebm-2022-111952. Retrieved 9 August 2022: https://ebm.bmj.com/content/early/2022/07/19/bmjebm-2022-111952
Hedges K, 2021, Correspondence with the Government of Canada, Responsible Conduct of Research, Tri-council Federal Office Panel on the responsible conduct of research, The Secretariat on Responsible Conduct of Research (SRCR) on behalf of Workplace Health Without Borders WHWB (International). Retrieved 9 August 2022: https://healthcareworkersaustralia.com/wp-content/uploads/2020/08/REBTri...
ISO 7708:1995, Air quality — Particle size fraction definitions for health-related sampling. Retrieved 9 August 2022: https://www.iso.org/standard/14534.html
Justice Philippe Bouvier (Quebec court decision) (2021):
(Paragraph 16 of Décision 735965 (N95) of the TRIBUNAL ADMINISTRATIF DU TRAVAIL
(Division de la santé et de la sécurité du travail) of March 23, 2021).([16] Par ailleurs, le Tribunal
retient que l’un des modes de transmission du virus duSRAS-CoV-2 est la voie aérienne ou par
inhalation. Dans cette perspective, les masquesmédicaux, qu’ils soient qualifiés de chirurgical ou
de procédure, ne représentent pas une protection efficace pour les travailleurs affectés aux
zones chaudes et tièdes. Le Tribunaljuge également que les Employeurs ne se sont pas acquittés
de leurs obligations en matière de santé et sécurité du travail dans la détermination des zones à
risque et de la création des équipes dédiées).
McMaster University (Canada), Office of Academic Integrity 2021, follow up correspondence to Hedges K, 2021. Retrieved 9 August 2022: https://www.aerosoltransmissioncoalition.ca/_files/ugd/cdecb4_f3401b5e36...
National Institute for Health and Care Research (Funding and Awards), “WIPPET: The impact of different grades of respiratory protective equipment on sickness absence due to respiratory infections including SARS-CoV-2 in healthcare workers”. Retrieved 9 August 2022: https://fundingawards.nihr.ac.uk/award/NIHR135521
Njoo H 2021, Deputy Chief Public Health Officer, Interim Vice-President, Infectious Disease Prevention and Control Branch, Public Health Agency of Canada (PHAC), March 2021, response to correspondence (CATC of January 4, 2021). Retrieved 9 August 2022: https://www.aerosoltransmissioncoalition.ca/_files/ugd/cdecb4_08749cfd02...
Oksanen, LM, Sanmark, E, Oksanen, E, SA, Antilla, VJ, Paterno, JJ, Lappalainen, M, Lehtonen, L, Geneid, A 2021, “Sources of healthcare workers’ COVID-19 infections and related safety guidelines”. International Journal of Occupational Medicine and Environmental Health (IJOMEH 2021; 34 (2)). Retrieved 9 August 2022: http://ijomeh.eu/Sources-of-healthcare-workers-COVID-19-infections-and-r...
Tang JW, Bahnfleth WP, Bluyssen PM, et al. (2021), Dismantling myths on the airborne transmission of severe acute respiratory syndrome coronavirus (SARS-CoV-2). J Hosp Infect. 2021;110:89–96. Retrieved 9 August 2022: https://www.journalofhospitalinfection.com/article/S0195-6701(21)00007-4/fulltext
Workplace Health Without Borders (WHWB) International, April 2020, correspondence with the Government of Canada, Minister of Health and Chief Public Health Officer Public Health Agency of Canada. Retrieved 9 August 2022: https://www.ioha.net/wp-content/uploads/2020/04/WHWB-to-Canada-Minister-...
World Health Organization WHO (2021)Coronavirus disease (COVID-19): How is it transmitted? [news release]. Geneva: World Health Organization; modified 2021 Apr. 30. Available: https://www.who.int/news-room/q-a-detail/coronavirus-disease-covid-19-ho...
US National Library of Medicine ClinicalTrials.gov, Medical Masks vs N95 Respirators for COVID-19 - ClinicalTrials.gov Identifier: NCT04296643, Retrieved 9 August 2022: https://clinicaltrials.gov/ct2/show/NCT04296643 see also: https://www.smartpatients.com/trials/NCT04296643
In their article McPherson and Speed claim that NICE’s independence seems to have diminished over time, and that it has been significantly undermined during the COVID-19 pandemic. They attempt to explain how various soft political factors may operate and how they undermine NICE’s scientific integrity.
The authors begin by suggesting that NICE’s re-establishment as a non-departmental public body (NDPB) in 2013 was prompted by the need to “increase the deniability of rationing claims or for other political purposes”.
Rather surprisingly, the authors then go on to claim that:
“This revision to the relationship can be regarded as a move towards a more explicit form of meta-governance, whereby government mechanisms are enacted through a range of quasi-autonomous bureaucratic devices.”
and further that:
“decisions about access to healthcare, for example, can be made remotely from ministers and political motive obscured by claims of the need for availability to be determined by science, not politics."
These statements are baffling because the legal position is clear. As a statutory corporation NICE is more, rather than less, independent as an arms length body (ALB) and as a body subject to administrative law and the administrative court, NICE is positively required as a matter of law to reach its decisions independently. If it did not do so its decision would be subject to being overturned by the courts. Furthermore, the regulations...
In their article McPherson and Speed claim that NICE’s independence seems to have diminished over time, and that it has been significantly undermined during the COVID-19 pandemic. They attempt to explain how various soft political factors may operate and how they undermine NICE’s scientific integrity.
The authors begin by suggesting that NICE’s re-establishment as a non-departmental public body (NDPB) in 2013 was prompted by the need to “increase the deniability of rationing claims or for other political purposes”.
Rather surprisingly, the authors then go on to claim that:
“This revision to the relationship can be regarded as a move towards a more explicit form of meta-governance, whereby government mechanisms are enacted through a range of quasi-autonomous bureaucratic devices.”
and further that:
“decisions about access to healthcare, for example, can be made remotely from ministers and political motive obscured by claims of the need for availability to be determined by science, not politics."
These statements are baffling because the legal position is clear. As a statutory corporation NICE is more, rather than less, independent as an arms length body (ALB) and as a body subject to administrative law and the administrative court, NICE is positively required as a matter of law to reach its decisions independently. If it did not do so its decision would be subject to being overturned by the courts. Furthermore, the regulations governing NICE specifically prevent the Secretary of State from directing NICE as to the content of its recommendations and any such purported direction would be a legal nullity. NICE’s reestablishment as an NDPB rather than a special health authority increased its independence because now any change to its powers or governance can only be made by Parliament, whereas as a special health authority such changes could be made by ministers alone.
We would like to comment on the two main key messages of the article.
The first is the assertion that the NICE processes for developing rapid guidelines for COVID-19 reveals that “the explicit removal of some or all scientific checks and balances in an emergency situation suggests that the central reliance of NICE on claims to scientific legitimacy is not in fact central at all. Rather, it is the first feature to be removed in the interests of expediency as though scientific processes were unnecessary bureaucracy.”
The authors suggest that political drivers could now, without any new legal agreement, prior discussion in parliament or amendment to the Framework Agreement, directly influence the scope and content of rapid guidelines. This suggestion makes very little sense since, other than topic selection there is no way in which a “political” driver could impact on any of NICE’s work.
In relation to the rapid guidelines, we remained independent from government. The guidelines were developed at the request of NHS England and NHS Improvement in response to the COVID-19 pandemic, a level 4 national emergency. Normally a topic selection oversight group at NICE considers topics for guideline development, taking into account a range of factors such as:
1. Whether there is existing NICE-accredited guidance on which to base a quality standard that encompasses the whole of the topic
2. The priority given to the topic by commissioners and professional organisations, and organisations for people using services, their families and carers
3. The health and care burden, and the potential to improve outcomes and quality of life
NICE then discusses topics identified in this way with NHS England, the Department of Health and Social Care, and Public Health England, and a prioritised list is agreed by these 3 bodies.
On 17 March 2021, we moved our priorities for the first wave of the pandemic to publish only those guidelines that were therapeutically critical and/or addressed COVID-19 diagnostic or therapeutic interventions. We worked with NHS England and NHS Improvement to identify topics to support managing symptoms of COVID-19, managing conditions that increased risk, or providing services during the pandemic. We developed interim process and methods that retained the core elements of scoping, evidence search and retrieval, working with experts, consultation, equality impact assessment and quality assurance. Inevitably, because of the urgency with which the guidance was required by the system, the process was rapid.
It is not an erosion of scientific or political independence to take into account a range of different views, including those of NHS England, especially in a national emergency. If we had used our normal process and methods for example by including a 4-week consultation period, we would have missed the optimum time identified by clinicians and commissioners for the guidance to be most useful to those managing pandemic. We achieved an optimal balance of speed and engagement for consultation, with a significant volume of comments received from a wide range of organisations.
Because COVID-19 is a new disease, evidence and practice are developing rapidly and we have implemented a process to keep the guidelines up to date as new evidence emerges. The guidelines have been very well received by clinicians and commissioners and our rapid response widely praised.
The second key message of the article is that “NICE cannot be truly led by science, in part because of its relationship to the state, however obscure that relationship has been made.”
NICE is not, and never has been, a ‘scientific authority’. Indeed, and as the authors acknowledge, in 2005, NICE published a guide setting out the social and scientific value judgements that informed our approach to developing guidance. The Social Value Judgements document helped our advisory committees resolve uncertainty in the available evidence. It informed their judgements when developing guidance, by giving them a set of principles. The Social Value Judgements were originally designed to support decision-making in guidance on new technologies. NICE’s remit has grown significantly since then. We now produce a wide range of guidance for different audiences, including local government and social care providers, which draws on a wider range of evidence. The original Social Value Judgements document remains relevant to our work, and much of what it contains is included in our methods and process manuals. In 2019 we replaced our Social Value Judgement document with a statement of our principles. This focuses on the key principles that are universal to all our guidance and standards and explains the morals, ethics and values that underpin our recommendations.
We were always clear that we would create recommendations for the system based on the evidence, but also taking into account a range of different morals, ethics and values from patients, clinicians, commissioners and other users of our guidance. Our independent advisory groups are expected to use our principles, along with our methods and process guides and the NICE charter, to inform their decisions.
One of the principles is the use of independent advisory committees to develop recommendations. This is to ensure that our recommendations are unbiased and objective and relevant for the wide range of people affected by our guidance.
We have a rigorous approach to managing conflicts of interest, with a policy that is world-leading in its standards. Committees include people from the NHS, commissioners and providers of social care, local authorities, academia, relevant industries, organisations that represent people who use services and carers, and the general public.
We also require committees to take into account stakeholder comments submitted during open consultation, and I would argue that this is a more robust, reliable and transparent method of ensuring quality and relevance than any process of traditional peer review – in fact quite the opposite of ‘light touch’. We publish both the comments we review and the responses to those comments.
In summary, NICE is an independent body that balances science, expertise and social and moral values to produce guidance informed by the best available evidence. We had to adapt and respond to an unprecedented set of circumstances in developing and maintaining guidance on COVID-19. Perhaps the authors might more usefully have addressed the question as to what else we should have done in response to a pandemic? We would argue that retaining our existing processes and topics without regard to the urgency of the situation would have been a manifestly worse position.
The new study by Gartlehner et al. (1) claims that the benefits of homeopathy may have been over-estimated due to high levels of reporting bias. However, as this problem is well-known to affect all areas of medical research, context is everything.
Although the authors state that, “non-publication of trial results and selective outcome reporting …. is not a phenomenon that is limited to homeopathy”, they failed to provide adequate context for their results by making any direct comparison to other areas of clinical research. Homeopathy is arguably out-performing conventional medicine, or, at the very least, has comparable levels of reporting bias. Using representative examples of high-impact studies on reporting bias across all medical fields, when compared with the data presented by Gartlehner et al.(1) it is clear that:
1) half of all registered clinical trials (2) in conventional medicine fail to report their results within 12 months; whereas 62% of all registered homeopathy trials reach publication, and
2) inconsistencies in reporting of primary outcome (3) occur in 43% of conventional medical studies; whilst this happens in only 25% of published homeopathy trials.
The potential impact of unregistered/unpublished results on estimates of treatment effects is well known (4), yet for homeopathy, according to Gartlehner et al.(1), the impact may be minimal, or nothing at all: “the difference in effect sizes between registered and unregistered stud...
Show MoreGartlehner et al (1) concluded that the effects of homeopathic clinical trials may be overestimated due to publication bias. Such conclusions are inaccurate based on their own statement and their evaluation of the data they investigated. The authors asserted, “the difference in effect sizes between registered and unregistered studies did not reach statistical significance.” Despite this clear statement of what their data showed, the researchers instead came to a different conclusion that sought to question the integrity of research results with homeopathy.
To their credit, these authors acknowledge that the problem of “non-publication of trial results and selective outcome reporting …. is not a phenomenon that is limited to homeopathy.” And yet, they purposefully chose to not reference any literature that evaluated this problem in publication bias from clinical trails testing conventional medicine. A simple review of the literature would find that conventional medical trials have at least the same rate of publication bias as those reported upon that tested homeopathic medicines (2), to reviews of research that showed a much higher level of publication bias when reporting on conventional medical treatments (3).
The fact is that several media (4)(5) that have reported on this study have come to the mistaken conclusion that the results of homeopathic clinical trials are not to be trusted, and this biased conclusion stems from the Gartlehner articl...
Show MoreThe article by Gartlehner et al. [1] is interesting because it allows the homeopathic community to elaborate on potential publication bias in clinical trials of homeopathy. There are, however, several questionable elements: in the article, and in the announcement made on the BMJ web, it is concluded that there was a high proportion of trials not preregistered, but at the same time Gartlehner acknowledges in the press that over time there has been a substantial improvement in the preregistration of trials [2]; it is mentioned that homeopaths must improve, but at the same time it is implied that "homeopathy cannot work".
On the second point, it is worth mentioning that in the article Gartlehner et al cite two trials, one by Grimes [3] and the other by Grams [4]. These essays are based on a biased selection of literature and have elementary errors. For example, Grimes says that Jacques Benveniste's famous study was published in "1987" and that Madaleine Ennis' work was negative when in fact it was positive [5]. Grimes bases his conclusions on theoretical claims (a simple calculation of Avogadro's constant) and not on experimental studies that at the time were available (e.g. [6]). Grams, on the other hand, only cites some old articles from 1992 and 1993 without mentioning more recent studies (e.g. [7]).
References:
Show More1. Gartlehner G, Emprechtinger E, Hackl M, Gartlehner J, Nonninger J, et al. (2022). Assessing the magnitude...
To our great sadness on Wednesday, April 13th 2022, Ingeborg Griffioen, author of “Innovating in healthcare: perspective from a dual role” passed away, at the age of 50. She departed with acceptance of the inevitable and in connection to those she loved and who loved her.
Ingeborg was founder and owner of Panton design studio, specialized in healthcare. In 2016 she started a PhD research on the use of service design to support shared decision making. Less than one year later, her husband was diagnosed with pancreatic cancer. Ingeborg incorporated their experiences with his care trajectory in her research, which led to the development of MetroMapping, a method to support shared decision making (www.metromapping.org/en). During this development process, Ingeborg herself was diagnosed with breast cancer.
It was one of Ingeborg’s dreams that MetroMapping be further developed and implemented at a large scale. Even during her chemotherapy she contributed to the 4D PICTURE project proposal, which focuses on adapting, evaluating and implementing MetroMapping in hospitals throughout Europe. Early 2022, we received the news that Ingeborg’s dream will come true, as 4D PICTURE was selected for funding by Horizon Europe. Ingeborg wrote a beautiful testimonial for 4D PICTURE:
“As a designer I have worked for 25 years in healthcare settings and as a researcher I studied treatment decision-making. I know the importance of...
Show MoreDr. Terry Campbell, a lecturer at the university's School of Nursing
This is a response to the article that was published on August 31, 2019, which can be seen above. The article was quite fascinating to read since it focuses on hypertension and how the therapy would effect medication usage in insured individuals; however, the study that was offered was based on a review of the healthcare system in China's population. After reading this study, I have come to the conclusion that it is essential to supply patients with information that is pertinent to their conditions and to take into account the patients' values in the process of making clinical decisions. Doing so can boost patient participation and contribute to the development of patient-centered, individualized care. The researcher provided individual counseling and found that the rate of willingness to pay completely out of pocket for antihypertensive drugs dropped significantly after evidence- based individualised counselling; however, it is uncertain whether that evidence- based, individualised counselling regarding hypertension and its treatment would actually impact medication use in insured patients with mild hypertension.
Show MoreThe findings of this research are restricted in a few important ways. To begin, it may be affected by reporting bias, which is a typical worry in data that is self-reported. This bias may occur when people lie about what they did. Prescription refills, patients'...
Dear Editor:
My name is Student Nurse Montel Stuart. from the University of the Bahamas. I have read your article and found the area of research to be very interesting and encourage to you to further your research on the effect of counselling on uninsured patients.
Regards,
Montel Stuart
This refreshing article does much to help move forward from the self-imposed strictures of the EBM orthodoxy. I hope EBM+ grows as an idea as, currently, EBM feels, sometimes, quasi-religious in the fervour to reject “the wrong sort” of evidence. It leaves clinicians in fields like addiction - where RCTs are very difficult to do unless so simple in their structure that the results are clinically difficult to use or, worse, irrelevant - stuck. Meta-analyses of clinically irrelevant studies are still clinically irrelevant. Data is hard to come by that is not EBM-perfect, so why bother doing the clinical research? Hopefully this suggestion will improve that disconnect.
The clinical evidence we produce which impacts the care we deliver to patients must have the highest standards. Unlike biomedical evidence, the evidence behind our treatments, risk factors and diagnostic tests should be relevant to the patients and clinicians who practice at the coal-face and real-world of General Practice and our hospitals.
Show MoreWe may have had 250,000 'peer-reviewed' articles relating to COVID-19 (whatever credibility that affords), but allowing biomedical assumptions to creep into guidelines and direct patient care, is taking a step backwards in evidence-based practice. COVID saw a multitude of 'experts' give their opinion freely in the media and on social media platforms, based on biomedical ‘evidence’, on opinion, through the platforming of academic-status and on dubious case-studies. This was self-evidently un-scientific, and arguably has set science back. Yet this article seems to advance the notion that this evidence should impact patient care.
So much has to be done to enable EBM to flourish- yet this article will likely set EBM back. The evidence underpinning our treatments should be quantifiable in absolute terms, and the uncertainties and conflicts of interests (COIs) acknowledged. The evidence behind our risk factors characterised in absolute terms, within the context of confounders and biases from observational studies. Our diagnostic tests should be understood within the context of odds and post-test probability. O...
Airborne transmission and inhalation, of SARS-CoV-2 is recognized by international public health agencies (Addleman et al. 2021) from both short- and long-range aerosol transmission (Tang et al. 2021).
Show MoreWhen comparing filtering face piece (FFP) respirators, with a surgical (medical) masks, for protection against an inhalable (ISO 7708) airborne virus such as SARS-CoV-2, “EQUIPOISE” a central tenet for conducting a randomised control trial (RCT), does not exist. The futility of using a RCT is analogous to carrying out a study in a construction site for hard hats or seat belts in a passenger vehicle. FFP respirators used in Canada are selected and used in accordance with CAN/CSA-Z94.4-18 (Selection, use, and care of respirators). Specifications are provided in CSA Z94.4.1:21 (Performance of filtering respirators).
At least two international studies using RCT have been initiated since the start of the COVID-19 pandemic.
a) United Kingdom: The impact of different grades of respiratory protective equipment on sickness absence due to respiratory infections including SARS-CoV-2 for healthcare workers (The funding committee did not recommend funding).
b) Canada, multi-centre: where nurses are randomized to either use of a medical mask or to a fit-tested N95 respirator when providing care for patients with febrile respiratory illness.
The findings from a poorly designed RCT may also be used as improper and biased rationale to downgrade respirator (masks...
In their article McPherson and Speed claim that NICE’s independence seems to have diminished over time, and that it has been significantly undermined during the COVID-19 pandemic. They attempt to explain how various soft political factors may operate and how they undermine NICE’s scientific integrity.
The authors begin by suggesting that NICE’s re-establishment as a non-departmental public body (NDPB) in 2013 was prompted by the need to “increase the deniability of rationing claims or for other political purposes”.
Rather surprisingly, the authors then go on to claim that:
“This revision to the relationship can be regarded as a move towards a more explicit form of meta-governance, whereby government mechanisms are enacted through a range of quasi-autonomous bureaucratic devices.”
and further that:
“decisions about access to healthcare, for example, can be made remotely from ministers and political motive obscured by claims of the need for availability to be determined by science, not politics."
These statements are baffling because the legal position is clear. As a statutory corporation NICE is more, rather than less, independent as an arms length body (ALB) and as a body subject to administrative law and the administrative court, NICE is positively required as a matter of law to reach its decisions independently. If it did not do so its decision would be subject to being overturned by the courts. Furthermore, the regulations...
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