I would like to congratulate Dr. Abbott and her team in generating this piece of important and interesting article, which applied the methods of meta-science to the early systematic review articles and the infodemics related to COVID-19.
Indeed, the COVID-19 pandemic came quick and ferocious, starting early 2020 and lasted till recently and with new possible variants emerging, it still presents the medical community and indeed the scientific circles with challenging question. Thankfully to the selfless work of researchers, patients and frontline medical staffs, we now have some valuable means to deal with this Pandemic.
The research community was presented with a rather challenging task of designing and conducting researches to answer important questions relating to the new infectious diseases at the time of early 2020. The “new” corona virus was ravaging parts of our world without checks. So studies were conducted at pace, which unfortunately resulted in much duplicated and poor methodological studies conducted. But on the other hand, the sheer volume of studies itself may be useful as it generated evidence to inform us of what does and what does not work in terms combating the COVID-19. For example, dexamethasone (RECOVERY trial) was found to be essential for severe COVID-19 patients and the use of Hydroxychloroquine is ineffective for COVID-19.
Having said this, I must state that I am not in support of the generation of poor quality clinical studi...
I would like to congratulate Dr. Abbott and her team in generating this piece of important and interesting article, which applied the methods of meta-science to the early systematic review articles and the infodemics related to COVID-19.
Indeed, the COVID-19 pandemic came quick and ferocious, starting early 2020 and lasted till recently and with new possible variants emerging, it still presents the medical community and indeed the scientific circles with challenging question. Thankfully to the selfless work of researchers, patients and frontline medical staffs, we now have some valuable means to deal with this Pandemic.
The research community was presented with a rather challenging task of designing and conducting researches to answer important questions relating to the new infectious diseases at the time of early 2020. The “new” corona virus was ravaging parts of our world without checks. So studies were conducted at pace, which unfortunately resulted in much duplicated and poor methodological studies conducted. But on the other hand, the sheer volume of studies itself may be useful as it generated evidence to inform us of what does and what does not work in terms combating the COVID-19. For example, dexamethasone (RECOVERY trial) was found to be essential for severe COVID-19 patients and the use of Hydroxychloroquine is ineffective for COVID-19.
Having said this, I must state that I am not in support of the generation of poor quality clinical studies, but what I am saying is that different clinical / public health circumstances may call for different overall research strategies, sometimes we need quick answers to important clinical questions, then unfortunately, quality is often sacrificed/overlooked for the sake of the generation of "rapid" evidence, and the early phase of the COVID-19 pandemic may fall into this category. A relative lake of research capacity and resources may also contributed to this unfortunate phenomenon as we just do not have the means to generate massive amount of high quality researches in a short period of time.
It is my view that medical research can perhaps be broadly divided into four categories:
1). Very Important and urgent: such as the COVID-19 or any past or future public health emergencies
2). Important but not urgent: hypertension, diabetes etc.
3). Not as important but urgent: diagnosis or care of rare genetic diseases etc.
4). Least important and not urgent: patient flow, drug compliance issues etc.
I would concur with Dr. Abbott and her team and both the authors and the editors of the scientific community share the "duty" of ensuring and also improve the quality of systematic reviews. As an educator, we are equally responsible for providing future clinicians and scholars with the knowledge and skills to conduct high quality studies. Furthermore, meta-researches are as important to provide us with a scoping view of the evidences of review articles and to remind us of the need of research vigilance. Lastly it is perhaps also the responsibility of the policy makers and governments to ensure the persistent and appropriate resources are channeled into the research community, especially in times of future public health emergencies.
Dear Editor,
This response is in relation to the titled article above published in June 2019. Firstly, I would like to commend the outstanding work of research done. While reading the article, I understood the correlation between the nursing field, evidence-based research, and ways in which patients benefit from current health practices. Furthermore, the research conducted a wide range of research benefits in other nursing career paths globally. It showed experts views on teaching evidenced based prospectus, evidence-based deliberations, and stakeholders’ engagement which can impact patients involved. I agree with the study conducted and how research is essential for future advancements as well as improvements in care to patients. Unfortunately, there aren’t as much published research work in The Bahamas on evidence-based practices from an expert view. Through further research this thesis can become widespread to obtain more views on this pressing matter.
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
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.
Title: “Claims about the main claim”
Author: Suhail A, Doi, Polychronis, Kostoulas, Paul, Glasziou
In response to the published article "Likelihood ratio interpretation of the relative risk"
Rapid response :
September 16, 2022
The problem in evidence-based medicine arises when we port relative risks derived from one study to settings with different baseline risks. For example, a baseline risk of 0.2 and treated risk of 0.4 for an event in a trial gives a RR of 2 (0.4/0.2) and the complementary cRR of 0.75 (0.6/0.8). Thus the ratio of LRs (RR/cRR) is 2/0.75 = 2.67. If applied to a baseline risk of 0.5 the predicted risk under treatment with the RR “interpretation” is 1.0 but with the ratio of LRs “interpretation” is 0.73. Here, the interpretation of the risk ratio as a likelihood ratio, using Bayes’ theorem, clearly gives different results, and solves the problem of impossible risks as clearly depicted in the manuscript and the example.
If, in our effort to highlight the need of this correct interpretation, we have used strong wording that annoyed the commentator we feel the need to express regret. We hope that the commentator could also feel similarly for his scientifically unbecoming choice of wording that culminated with “Doi’s Conjecture”.
Conflict of Interest
None declared
I am writing to request further clarification on the paper “Likelihood ratio interpretation of the relative risk”. The “key messages” section of this paper states that the study adds the following to the literature:
⇒ It is demonstrated that the conventional interpretation of the relative risk is in conflict with Bayes’ theorem.
⇒ The interpretation of the relative risk as a likelihood ratio connecting prior (unconditional) intervention risk to outcome conditional intervention risk is required to avoid conflict with Bayes’ Theorem
I will refer to the first bullet point as “Doi’s Conjecture”. Doi’s Conjecture is also stated in the second section of the main text, where it is claimed that “the usual interpretation (33% increase in the +ve outcome under treatment) contravenes Bayes Theorem”.
No attempt is made within the text to prove Doi’s Conjecture. But perhaps more worryingly, no attempt is made to define the term “interpretation”, a term which is not defined in standard probability theory. The meaning of Doi’s Conjecture is therefore at best ambiguous. Moreover, the manuscript relies substantially on claims about how effect measures are “perceived”, another term which is defined neither in probability theory not in the manuscript.
The relative risk is defined as the risk of the outcome under treatment, divided by the risk of the outcome under the control condition; that is, as a ratio of two probabilities. Thi...
I am writing to request further clarification on the paper “Likelihood ratio interpretation of the relative risk”. The “key messages” section of this paper states that the study adds the following to the literature:
⇒ It is demonstrated that the conventional interpretation of the relative risk is in conflict with Bayes’ theorem.
⇒ The interpretation of the relative risk as a likelihood ratio connecting prior (unconditional) intervention risk to outcome conditional intervention risk is required to avoid conflict with Bayes’ Theorem
I will refer to the first bullet point as “Doi’s Conjecture”. Doi’s Conjecture is also stated in the second section of the main text, where it is claimed that “the usual interpretation (33% increase in the +ve outcome under treatment) contravenes Bayes Theorem”.
No attempt is made within the text to prove Doi’s Conjecture. But perhaps more worryingly, no attempt is made to define the term “interpretation”, a term which is not defined in standard probability theory. The meaning of Doi’s Conjecture is therefore at best ambiguous. Moreover, the manuscript relies substantially on claims about how effect measures are “perceived”, another term which is defined neither in probability theory not in the manuscript.
The relative risk is defined as the risk of the outcome under treatment, divided by the risk of the outcome under the control condition; that is, as a ratio of two probabilities. This manuscript appears to claim that “interpreting” the relative risk in the manner that it is defined, is inconsistent with Bayes’ Theorem, a fundamental result in probability theory. If this is true, probability theory is in deep conceptual trouble.
There are multiple correct (and mathematically equivalent) ways to represent effects within a study, to predict risk under treatment and to determine the posterior probability. This manuscript provides no coherent reason for one valid approach to take precedence over another valid approach.
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
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.
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.
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
I would like to congratulate Dr. Abbott and her team in generating this piece of important and interesting article, which applied the methods of meta-science to the early systematic review articles and the infodemics related to COVID-19.
Indeed, the COVID-19 pandemic came quick and ferocious, starting early 2020 and lasted till recently and with new possible variants emerging, it still presents the medical community and indeed the scientific circles with challenging question. Thankfully to the selfless work of researchers, patients and frontline medical staffs, we now have some valuable means to deal with this Pandemic.
The research community was presented with a rather challenging task of designing and conducting researches to answer important questions relating to the new infectious diseases at the time of early 2020. The “new” corona virus was ravaging parts of our world without checks. So studies were conducted at pace, which unfortunately resulted in much duplicated and poor methodological studies conducted. But on the other hand, the sheer volume of studies itself may be useful as it generated evidence to inform us of what does and what does not work in terms combating the COVID-19. For example, dexamethasone (RECOVERY trial) was found to be essential for severe COVID-19 patients and the use of Hydroxychloroquine is ineffective for COVID-19.
Show MoreHaving said this, I must state that I am not in support of the generation of poor quality clinical studi...
Dear Editor,
This response is in relation to the titled article above published in June 2019. Firstly, I would like to commend the outstanding work of research done. While reading the article, I understood the correlation between the nursing field, evidence-based research, and ways in which patients benefit from current health practices. Furthermore, the research conducted a wide range of research benefits in other nursing career paths globally. It showed experts views on teaching evidenced based prospectus, evidence-based deliberations, and stakeholders’ engagement which can impact patients involved. I agree with the study conducted and how research is essential for future advancements as well as improvements in care to patients. Unfortunately, there aren’t as much published research work in The Bahamas on evidence-based practices from an expert view. Through further research this thesis can become widespread to obtain more views on this pressing matter.
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
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.
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'...
Title: “Claims about the main claim”
Author: Suhail A, Doi, Polychronis, Kostoulas, Paul, Glasziou
In response to the published article "Likelihood ratio interpretation of the relative risk"
Rapid response :
September 16, 2022
The problem in evidence-based medicine arises when we port relative risks derived from one study to settings with different baseline risks. For example, a baseline risk of 0.2 and treated risk of 0.4 for an event in a trial gives a RR of 2 (0.4/0.2) and the complementary cRR of 0.75 (0.6/0.8). Thus the ratio of LRs (RR/cRR) is 2/0.75 = 2.67. If applied to a baseline risk of 0.5 the predicted risk under treatment with the RR “interpretation” is 1.0 but with the ratio of LRs “interpretation” is 0.73. Here, the interpretation of the risk ratio as a likelihood ratio, using Bayes’ theorem, clearly gives different results, and solves the problem of impossible risks as clearly depicted in the manuscript and the example.
If, in our effort to highlight the need of this correct interpretation, we have used strong wording that annoyed the commentator we feel the need to express regret. We hope that the commentator could also feel similarly for his scientifically unbecoming choice of wording that culminated with “Doi’s Conjecture”.
Conflict of Interest
None declared
Dear Prof. Franco,
I am writing to request further clarification on the paper “Likelihood ratio interpretation of the relative risk”. The “key messages” section of this paper states that the study adds the following to the literature:
⇒ It is demonstrated that the conventional interpretation of the relative risk is in conflict with Bayes’ theorem.
⇒ The interpretation of the relative risk as a likelihood ratio connecting prior (unconditional) intervention risk to outcome conditional intervention risk is required to avoid conflict with Bayes’ Theorem
I will refer to the first bullet point as “Doi’s Conjecture”. Doi’s Conjecture is also stated in the second section of the main text, where it is claimed that “the usual interpretation (33% increase in the +ve outcome under treatment) contravenes Bayes Theorem”.
No attempt is made within the text to prove Doi’s Conjecture. But perhaps more worryingly, no attempt is made to define the term “interpretation”, a term which is not defined in standard probability theory. The meaning of Doi’s Conjecture is therefore at best ambiguous. Moreover, the manuscript relies substantially on claims about how effect measures are “perceived”, another term which is defined neither in probability theory not in the manuscript.
The relative risk is defined as the risk of the outcome under treatment, divided by the risk of the outcome under the control condition; that is, as a ratio of two probabilities. Thi...
Show MoreAirborne 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...
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...
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.
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...
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