It would be helpful if it assessed the standard administration quantitatively and specific frequency utilized in the study ‘s participants , or related studies , At the very least - providing a link to the exact dosing used in this study as a reference point would be beneficial .
Thank you for this measured summary of the recently published HYGIA trial. I am pleased to see you mention the BedMed study ongoing. Readers may be interested to know that there is another study, already in follow-up, which will provide further evidence on whether night-time dosing of blood pressure medications really is better in the prevention of cardiovascular events and mortality.
The University of Dundee's Treatment in Morning vs Evening (TIME, www.timestudy.co.uk) study, funded by the British Heart Foundation, aims to answer the same research question. TIME has recruited 21,104 participants across the UK and should finish in the first half of 2020.
Like so many purported pundits, DuBroff R, de Lorgeril M [1] have attempted to dispute the significance of the role of saturated fat (triglycerides) and LDL-cholesterol in the development of coronary artery disease, while noting the importance of inflammation itself [1,2]. In law, ignorance of the law is not a defense - the same is true for medicine. Not understanding something does not make you an expert [2] and it does not make your argument valid. Appealing to the court of public opinion does not make it so either. Accordingly, we present a brief explanation of why the authors [1,2] – and others – have presented an invalid discussion of the role fat and LDL-cholesterol plays in coronary artery disease.
In the mid-1990s, as one of the reviewers for the American Heart Association, the first author of this letter, Dr Richard M Fleming (RMF) introduced a then controversial theory stating that Coronary Artery Disease (CAD) is the result of an inflammatory process, which builds up within the walls of the arteries impairing their ability to dilate and increase coronary blood flow when needed; thus producing regional blood flow differences resulting in angina [3-6] and ultimately myocardial infarction (MI) and death.
In recent years, people promoting various dietary and lifestyle practices – particularly those promoting LowCarb-Keto diets, have used the obesity epidemic to focus attention on obesity and weight loss. These same individuals have not demonstrated th...
Like so many purported pundits, DuBroff R, de Lorgeril M [1] have attempted to dispute the significance of the role of saturated fat (triglycerides) and LDL-cholesterol in the development of coronary artery disease, while noting the importance of inflammation itself [1,2]. In law, ignorance of the law is not a defense - the same is true for medicine. Not understanding something does not make you an expert [2] and it does not make your argument valid. Appealing to the court of public opinion does not make it so either. Accordingly, we present a brief explanation of why the authors [1,2] – and others – have presented an invalid discussion of the role fat and LDL-cholesterol plays in coronary artery disease.
In the mid-1990s, as one of the reviewers for the American Heart Association, the first author of this letter, Dr Richard M Fleming (RMF) introduced a then controversial theory stating that Coronary Artery Disease (CAD) is the result of an inflammatory process, which builds up within the walls of the arteries impairing their ability to dilate and increase coronary blood flow when needed; thus producing regional blood flow differences resulting in angina [3-6] and ultimately myocardial infarction (MI) and death.
In recent years, people promoting various dietary and lifestyle practices – particularly those promoting LowCarb-Keto diets, have used the obesity epidemic to focus attention on obesity and weight loss. These same individuals have not demonstrated the actual impact their diets have on CAD, anymore than BigPharma has by reporting changes in lipid levels using their drugs. To demonstrate such change in CAD - either by drug or dietary intervention - requires more than the mere showing of changes in weight or serum blood tests as discussed infra. It requires the actual measurement of the changes occurring within the walls of the coronary arteries themselves – not some other artery – where the actual inflammation and resulting change in coronary artery function exists [3,6].
The arguments presented by DuBroff [1] and Ravnskov [2] erroneously use studies measuring lipid and inflammatory surrogate markers - blood tests - to support their position, while others [7] use this same approach to support their dietary recommendations by showing weight loss, and occasionally reductions in cholesterol levels – at least initially in some people. As more studies have been done, it has been shown that these initial reductions in lipid levels either do not occur for everyone or are followed by a subsequent increase. This has forced the purported diet pundits to support the position that LDL-cholesterol and saturated (triglycerides) fat do not clog the (coronary or other) arteries [7].
For the authors [1,2,7] to declare that saturated fat and LDL-cholesterol have nothing to do with the development of inflammatory CAD demonstrates a complete failure to understand the “Inflammation and Heart Disease” Theory [5,8], or a failure to have read it, and therefore cannot be taken seriously.
The specific claims made by Malhotra [7] introduces yet another major misconception into the discussion of CAD. Specifically, the process of “clogging of the coronary arteries.” The narrowing or “clogging” of the coronary artery lumen – where the blood flows - so frequently referred to as CAD, is actually a late process in the development of the inflammatory changes that are CAD [9-15].
CAD begins with an inflammatory process, which first distends the wall of the artery outward away from the lumen – impairing the function of the artery - and only later encroaches upon the coronary lumen itself [3,5,9]. Recognition that the rupture of this inflammatory process may occur following minimal or no coronary lumen narrowing [3-5,9] has resulted in the recent acknowledgement by the Cardiology community that infarction of myocardium may occur with (Type I) or without (TYPE II) coronary lumen obstruction.
Fleming and Harrington’s research published in 2008 [16] demonstrated that the relationship between weight loss, and changes in lipids and other blood tests reflecting inflammatory processes [5], are only mildly-to-moderately correlated with actual changes occurring within the coronary arteries themselves. Thus further exposing the erroneous artery “clogging” statement - using the results of blood tests – to declare that saturated fat and cholesterol are not involved in CAD.
To understand the impact LowCarb-Keto diets - or for that matter any diet or drug treatment - has on CAD, one needs to measure what is actually happening to the coronary arteries themselves [17-19]; quantitatively now made possible using FMTVDM [6].
To state that Saturated fat and LDL-cholesterol has nothing to do with CAD and do not result in the “clogging” of coronary arteries or CAD itself, and then to state that CAD is a chronic inflammatory condition - raises serious concerns about the motivation and integrity of their arguments. It also raises serious questions about their actual understanding of the ”Inflammation and Heart Disease” and “Angina” Theories [3,5,20]. Ignorance is not bliss - “we can teach it to you, but we cannot understand it for you.”
We are sadly reminded of these words from Billy Madison:
“Mr. Madison, what you just said is one of the most insanely idiotic things I have ever heard. At no point in your rambling incoherent response were you even close to anything that could be considered a rational thought. Everyone in this room is now dumber for having listened to it. I award you no points and may God have mercy on your soul.”
Acknowledged potential COI: FMTVDM (The Fleming Method for Tissue and Vascular Differentiation and Metabolism) [6] is issued to the first author. The first author authored the “Inflammation and Heart Disease” and “Angina” Theories.
References:
1. DuBroff R, de Lorgeril M. Fat or fiction: the diet-heart hypothesis. BMJ Evidence-Based Medicine 2019 doi:10.1136/bmjebm-2019-111180.
2. Ravnskov U, de Lorgeril M, Diamond DM, et al. LDL-C does not cause cardiovascular disease: a comprehensive review off the current literature. Expert review of clinical pharmacology
3. Fleming RM. Chapter 29. Atherosclerosis: Understanding the relationship between coronary artery disease and stenosis flow reserve. Textbook of Angiology. John C. Chang Editor, Springer-Verlag, New York, NY. 1999. pp. 381-387.
4. Fleming RM. Chapter 30. Cholesterol, Triglycerides and the treatment of hyperlipidemias. Textbook of Angiology. John C. Chang Editor, Springer-Verlag, New York, NY. 1999, pp. 388-396.
5. Fleming RM. Chapter 64. The Pathogenesis of Vascular Disease. Textbook of Angiology. John C. Chang Editor, Springer-Verlag New York, NY. 1999, pp. 787-798.
6. The Fleming Method for Tissue and Vascular Differentiation and Metabolism (FMTVDM) using same state single or sequential quantification comparisons. Patent Number 9566037. Issued 02/14/2017.
7. Malhotra A, Redberg R, Meier P. Saturated fat does not clog the arteries: coronary heart disease is a chronic inflammatory condition, the risk of which can be effectively reduced from healthy lifestyle interventions. British J Sports Med 2017;51:1111-1112.
8. 20/20 Segment on Heart Disease and Inflammation. https://www.youtube.com/watch?v=Hvb_Ced7KyA&t=22s
9. Glagov S, Weisenberg E, Zarins CK, Stankunavicius R, Kolettis GJ. Compensatory enlargement of human atherosclerotic coronary arteries. N Engl J Med 1987;316(22):1371-1375.
10. Fleming RM., Kirkeeide RL, Smalling RW, Gould KL. Patterns in Visual Interpretation of Coronary Arteriograms as Detected by Quantitative Coronary Arteriography. J Am Coll. Cardiol. 1991;18:945- 951.
11. Fleming RM, Harrington GM. Quantitative Coronary Arteriography and its Assessment of Atherosclerosis. Part 1. Examining the Independent Variables. Angiology 1994;45(10):829-833.
12. Fleming RM, Harrington GM. Quantitative Coronary Arteriography and its Assessment of Atherosclerosis. Part 2. Calculating Stenosis Flow Reserve Directly from Percent Diameter Stenosis. Angiology 1994;45(10):835-840.
13. Fleming RM. Shortcomings of coronary angiography. Letter to the Editor. Cleve Clin J Med 2000;67:450.
14. Fleming RM. Coronary Artery Disease is More than Just Coronary Lumen Disease. Amer J Card 2001;88:599-600.
15. Fleming RM, Harrington GM. TAM-A.7 Sestamibi redistribution measurement defines ischemic coronary artery lumen disease. 56th Annual Meeting of the Health Physics Society. (American Conference of Radiological Safety) West Palm Beach, FL, USA, 30 June 2011. http://hpschapters.org/2011AM/program/singlesession.php3?sessid=TAM-A
16. Fleming RM, Harrington GM. What is the Relationship between Myocardial Perfusion Imaging and Coronary Artery Disease Risk Factors and Markers of Inflammation? Angiology 2008;59:16-25.
17. Fleming RM, Fleming MR, Chaudhuri TK. Replacing Cardiovascular Risk Factors with True AI and Absolute Quantifiable Measurement (FMTVDM) of Coronary Artery Disease. Inter J Res Studies Med & Health Sci. 2019;4(11):11- 13. ISSN:2456-6373.
18. Fleming RM, Fleming MR, Chaudhuri TK. Are we prescribing the right diets and drugs for CAD, T2D, Cancer and Obesity? Int J Nuclear Med Radioactive Subs 2019;2(2):000115.
19. Fleming RM, Fleming MR, Chaudhuri TK, Harrington GM. Cardiovascular Outcomes of Diet Counseling. Edel J Biomed Res Rev. 2019;1(1):20-29.
20. Fleming RM., Boyd L., Forster M. Angina is Caused by Regional Blood Flow Differences - Proof of a Physiologic (Not Anatomic) Narrowing, Joint Session of the European Society of Cardiology and the American College of Cardiology, Annual American College of Cardiology Scientific Sessions, Anaheim, California, USA, 12 March 2000, 49th (Placed on internet www.prous.com for physician training and CME credit, April 2000.)
We welcome the publication of the Jellinson study (9) which is consistent with the focus on research integrity lead by the BJPsych editorial team (please see our most recent retraction (1) and associated editorial (2)).
The issue of ‘spin’ is a widespread problem across the whole research community and is not unique to psychiatry as recognised by the authors of this study (3, 4, 5). We note that according to the protocol the authors are carrying out and publishing similar studies in the fields of cardiology, otolaryngology (6), orthopaedic surgery, obesity medicine (7), anaesthesiology (8) and emergency medicine.
It is unclear from the article or protocol why this subset of journals was chosen for evaluation. We would be interested to know why the number of journals was limited to 6 and what were the parameters for a journal to be considered ‘influential’. It is also interesting to note that none of the journals chosen exclusively publish psychology research (2 publish psychiatry and psychology research and the remaining 4 journals solely publish psychiatric research). Do the authors infer that the problem is more prevalent in influential psychiatry journals? The authors also acknowledge that identifying spin is subjective, highlighting the difficulties faced by journal editors and reviewers who are also trying to identify instances of spin.
Since December 2017 (the end of data extraction in the study), the BJPsych has proactively t...
We welcome the publication of the Jellinson study (9) which is consistent with the focus on research integrity lead by the BJPsych editorial team (please see our most recent retraction (1) and associated editorial (2)).
The issue of ‘spin’ is a widespread problem across the whole research community and is not unique to psychiatry as recognised by the authors of this study (3, 4, 5). We note that according to the protocol the authors are carrying out and publishing similar studies in the fields of cardiology, otolaryngology (6), orthopaedic surgery, obesity medicine (7), anaesthesiology (8) and emergency medicine.
It is unclear from the article or protocol why this subset of journals was chosen for evaluation. We would be interested to know why the number of journals was limited to 6 and what were the parameters for a journal to be considered ‘influential’. It is also interesting to note that none of the journals chosen exclusively publish psychology research (2 publish psychiatry and psychology research and the remaining 4 journals solely publish psychiatric research). Do the authors infer that the problem is more prevalent in influential psychiatry journals? The authors also acknowledge that identifying spin is subjective, highlighting the difficulties faced by journal editors and reviewers who are also trying to identify instances of spin.
Since December 2017 (the end of data extraction in the study), the BJPsych has proactively taken steps to reduce spin in the reporting of randomised control trials by mandating submission of the appropriate research reporting checklist (CONSORT) which is accessible to editors and reviewers, introducing additional stages for editors to carefully check manuscripts, mandating the prospective registration of clinical trials and increasing the length of abstracts to avoid over-simplification.
Research integrity is a priority for the journal and we welcome partnerships to develop, improve and implement further guidelines surrounding these issues.
1. Guo Z-H, Li Z-J, Ma Y, Sun J, Guo J-H, Li W-X, et al. Brief cognitive–behavioural therapy for patients in the community with schizophrenia: Randomised controlled trial in Beijing, China – RETRACTION. The British Journal of Psychiatry. Cambridge University Press; 2019;215(1):435–: https://doi.org/10.1192/bjp.2019.91
2. Bhui KS, Lee W, Kaufman KR, Lawrie SM. Ensuring research integrity: setting standards for robust and ethical conduct and reporting of research. The British Journal of Psychiatry. Cambridge University Press; 2019;215(1):381–2: https://doi.org/10.1192/bjp.2019.109
3. Lazarus C, Haneef R, Ravaud P, et al. Classification and prevalence of spin in abstracts of non-randomized studies evaluating an intervention. BMC Med Res Methodol 2015;15:85 https://doi.org/10.1186/s12874-015-0079-x
.
4. Patel SV, Van Koughnett JA, Howe B, et al. Spin is common in studies assessing robotic colorectal surgery: an assessment of reporting and interpretation of study results. Dis Colon Rectum 2015;58:878–84. https://doi.org/10.1097/DCR.0000000000000425
5. Mathieu S, Giraudeau B, Soubrier M, et al. Misleading abstract conclusions in randomized controlled trials in rheumatology: comparison of the abstract conclusions and the results section. Joint Bone Spine 2012;79:262–7. https://doi.org/10.1016/j.jbspin.2011.05.008
6. Cooper, C. M., Gray, H. M., Ross, A. E., Hamilton, T. A., Bea Downs, J. , Wayant, C. and Vassar, M. (2019), Evaluation of spin in the abstracts of otolaryngology randomized controlled trials. The Laryngoscope. doi:10.1002/lary.27750
7. Austin, J, Smith, C, Natarajan, K, Som, M, Wayant, C, Vassar, M. Evaluation of spin within abstracts in obesity randomized clinical trials: A cross‐sectional review. Clin Obes. 2019; 9:e12292. https://doi.org/10.1111/cob.12292
8. Presence of ‘spin’ in the abstracts and titles of anaesthesiology randomised controlled trials Kinder, N.C. et al. British Journal of Anaesthesia, Volume 122, Issue 1, e13 - e14 https://doi.org/10.1016/j.bja.2018.10.023
9. Jellinson, S., Roberts, W., Bowers, A., et al. Evaluation of spin in abstracts of papers in psychiatry and psychology journals. BMJ Evidence-Based Medicine. Published Online First: 05 August 2019. doi: 10.1136/bmjebm-2019-111176
Psychiatry is, to an extent, a looking glass world, in which the evidence base can be shrunk, expanded, or, the same as Alice, made to descend down a deep, deep hole.
Joanna Moncrieff for anti- psychotics (1), and Irving Kirsch for anti- depressants, have been suspicious that the drugs concerned may often be not much better than placebo- or that the complexity of the drugs makes comparison with placebo problematic. (Moncrieff cites the impossibility of true double blinding because side effects are, unfortunately, so evident for patients and clinicians alike).
The problem is money. Big Pharma tends to be avaricious, and how soon greed may make one disregard that silly obstacle known as truth!
Spin can be the case even if there appears to be statistical significance. A large sample size- as in meta-analysis- will conclude a tiny difference, of no medical worth, is statistically significant. 'Overpowering' is spin too.
Big Pharma, roaming around its own psychopharmacological 'wonderland', is ensuring, in the most bizarre and baffling ways possible, that everything is 'curiouser and curiouser'.
References:
(1) The Bitterest Pills. The Troubling Story of Anti-Psychotics. Joanna Moncrieff. Palgrave Macmillan. 2013.
We thank Dr. Bhui and Mrs. Shuttleworth for commenting on our paper and giving us the opportunity to clarify some aspects of our methods. In their response, they invite us to elaborate on our rationale for journal selection and if we infer that spin is more prevalent in psychiatry journals versus psychology journals. Here, we attempt to clarify our methodology and conclusion regarding our article over spin.
The journals in our study were selected due to their ranking on Google Scholar Metrics under the subcategory “Psychiatry” at the time of the search [1]. It should be noted that as this search was conducted on May 21 2018, the rankings found today may differ from what we found. We selected the highest 10 ranking journals on Google Scholar, according to their h-5 index. However, not all journals primarily published RCTs in humans and were therefore excluded from our study, leaving us with a total of 6 journals.
The aim of our paper was not to compare the prevalence of spin between trials published in psychiatry and those published in psychology journals. Rather, our study examined the rates of spin in RCTs published in high-ranking journals, as indexed by a popular journal ranking platform.
We commend the editors of British Journal of Psychiatry on taking steps to confront spin, such as mandatory use of the CONSORT checklist. For example, CONSORT item 22 requires that interpretations presented in discussion sections of clinical t...
We thank Dr. Bhui and Mrs. Shuttleworth for commenting on our paper and giving us the opportunity to clarify some aspects of our methods. In their response, they invite us to elaborate on our rationale for journal selection and if we infer that spin is more prevalent in psychiatry journals versus psychology journals. Here, we attempt to clarify our methodology and conclusion regarding our article over spin.
The journals in our study were selected due to their ranking on Google Scholar Metrics under the subcategory “Psychiatry” at the time of the search [1]. It should be noted that as this search was conducted on May 21 2018, the rankings found today may differ from what we found. We selected the highest 10 ranking journals on Google Scholar, according to their h-5 index. However, not all journals primarily published RCTs in humans and were therefore excluded from our study, leaving us with a total of 6 journals.
The aim of our paper was not to compare the prevalence of spin between trials published in psychiatry and those published in psychology journals. Rather, our study examined the rates of spin in RCTs published in high-ranking journals, as indexed by a popular journal ranking platform.
We commend the editors of British Journal of Psychiatry on taking steps to confront spin, such as mandatory use of the CONSORT checklist. For example, CONSORT item 22 requires that interpretations presented in discussion sections of clinical trials be congruent with the trial’s results. Beyond reporting guideline adherence, additional steps may also be necessary. We hope that other journals follow suite, as spin is a problem within all disciplines.
The EBM Verdict by O'Sullivan on the CREDENCE trial of canagliflozin and renal outcomes (1) concluded that "Sodium-glucose cotransporter-2 (SGLT2) inhibitors appear effective to reduce cardiovascular events and deterioration of renal disease in patients with type 2 diabetes and renal impairment." O'Sullivan stated that the study was well-conducted based on conventional assessments of validity (blinding, randomization method, choice of outcomes). However, an important overlooked source of potential bias was not mentioned. The CREDENCE study was sponsored by the pharmaceutical company (Janssen). The analyses of the data was conducted by Janssen, and important conflicts of interest were reported by authors of the paper. A Cochrane review of the relationship of industry sponsorship and research results (2) found significantly more favorable efficacy results in studies by the manufacturing company than sponsorship by other sources, and that the industry bias could not be explained by other "risk of bias" assessments. This important source of bias warrants caution in the interpretation of the results in the absence of independent (non-industry sponsored) data.
1. Perkovic V. et. al. Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy. CREDENCE Trial Investigators. N Engl J Med 2019;380:2295–2306.
2. Lundh A, Lexchin J, Mintzes B, Schroll JB, Bero L. Industry sponsorship and research outcome. Cochrane Database of Systema...
The EBM Verdict by O'Sullivan on the CREDENCE trial of canagliflozin and renal outcomes (1) concluded that "Sodium-glucose cotransporter-2 (SGLT2) inhibitors appear effective to reduce cardiovascular events and deterioration of renal disease in patients with type 2 diabetes and renal impairment." O'Sullivan stated that the study was well-conducted based on conventional assessments of validity (blinding, randomization method, choice of outcomes). However, an important overlooked source of potential bias was not mentioned. The CREDENCE study was sponsored by the pharmaceutical company (Janssen). The analyses of the data was conducted by Janssen, and important conflicts of interest were reported by authors of the paper. A Cochrane review of the relationship of industry sponsorship and research results (2) found significantly more favorable efficacy results in studies by the manufacturing company than sponsorship by other sources, and that the industry bias could not be explained by other "risk of bias" assessments. This important source of bias warrants caution in the interpretation of the results in the absence of independent (non-industry sponsored) data.
1. Perkovic V. et. al. Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy. CREDENCE Trial Investigators. N Engl J Med 2019;380:2295–2306.
2. Lundh A, Lexchin J, Mintzes B, Schroll JB, Bero L. Industry sponsorship and research outcome. Cochrane Database of Systematic Reviews 2017, Issue 2. Art. No.: MR000033. DOI: 10.1002/14651858.MR00
I commend the authors for their well balanced and informative review on recent evidence on reduced fetal movement (RFM). Over the years I sadly saw the practice in the NHS being driven by fear and emotions rather than evidence, certainly, some units now offer mothers induction of labour even after a single episode of RFM! Junior doctors are prompted to act on RFM at induction day, and hospitals are adopting the official Care Bundle from the NHS promoting action (http://www.geh.nhs.uk/latest-news/saving-babies-lives-campaign/) yet, where is the evidence that any of this is beneficial?! certainly efforts like the AFFIRM study need wider dissemination and adoption by policymakers. The question remains, what can we offer to worried couples presenting with RFM daily? Still waiting for the game-changer.
I read this rapid review with interest and agree this topic has reached a point at which a full systematic review could be useful. I have a few suggestions to the authors and/or future reviewers in this area, as there are several nuances in the studies presented that have not been acknowledged.
Future reviews need to consider what primary outcome the study was powered for, and what the comparator is. For example, Bonner et al. looked at physical activity and diet changes as well as smoking in a combined measure and found no statistical difference between absolute risk and heart age when presented in the same format, but the smoking result is isolated and reported as “clinically significant” in the review. In contrast, Lopez-Gonzalez et al. compared an interactive online format for heart age to usual care which generally involves a verbal description of absolute risk by the doctor, so it is difficult to determine whether heart age or a more engaging presentation format produced the results.
Psychological outcomes should also be considered. Modest gains in behaviour change may not be outweighed by reduced accuracy of risk perception, negative affect or reduced credibility of the assessment as per Bonner et al. While these age-based formats appear to elicit a stronger emotional response, this may not be sufficient to produce greater behaviour change or even intentions without additional support (e.g. Soureti et al. and Witteman et al.). It is unclear from the r...
I read this rapid review with interest and agree this topic has reached a point at which a full systematic review could be useful. I have a few suggestions to the authors and/or future reviewers in this area, as there are several nuances in the studies presented that have not been acknowledged.
Future reviews need to consider what primary outcome the study was powered for, and what the comparator is. For example, Bonner et al. looked at physical activity and diet changes as well as smoking in a combined measure and found no statistical difference between absolute risk and heart age when presented in the same format, but the smoking result is isolated and reported as “clinically significant” in the review. In contrast, Lopez-Gonzalez et al. compared an interactive online format for heart age to usual care which generally involves a verbal description of absolute risk by the doctor, so it is difficult to determine whether heart age or a more engaging presentation format produced the results.
Psychological outcomes should also be considered. Modest gains in behaviour change may not be outweighed by reduced accuracy of risk perception, negative affect or reduced credibility of the assessment as per Bonner et al. While these age-based formats appear to elicit a stronger emotional response, this may not be sufficient to produce greater behaviour change or even intentions without additional support (e.g. Soureti et al. and Witteman et al.). It is unclear from the review whether any behavioural effects can be attributed to age formats directly or whether the interventions included additional behaviour change techniques such as action plans or referrals to lifestyle programs.
In addition, these age-based models have generally not been validated as predictive models for long-term health outcomes, which is not clear from the discussion of validity in this review. For example, heart age assessment tools are often based on converting the absolute risk from validated CVD risk models but this is not the same thing as being validated in itself.
Finally, the variability between the age produced by different models is important to consider, as discussed in other review papers on vascular/heart age. The same person may receive a younger or older age result depending on the underlying model, which is likely to affect the behavioural outcome.
I agree with the authors that additional high quality trials are needed to better understand this issue, as the growing use of age-based risk tools appears to be outpacing the limited evidence for their efficacy.
Muscat et al1 report on their evidence-based information or ‘literature searching’ service supporting clinicians to answer their clinical questions. They found that treatment-related enquiries were one of the most common categories of clinical questions from a group of General Practitioners (GPs) from five practices in NSW and QLD, Australia. Medications are included in the classification systems used by the group. In particular the taxonomy of generic clinical questions includes at least seven codes specifically incorporating drug-related issues such as timing (code 2.1.1.3), indications (code 2.1.2.1* and 2.1.2.2), safety (code 2.1.3.3), adverse drug reactions (codes 2.1.3.1 and 2.1.3.2) and drug interactions (code 2.1.4.1).
Medicines Information (MI) services also support clinicians in providing effective patient care and optimising therapeutic strategies in a timely manner. The National Prescribing Service funded Therapeutic Advice and Information Service (TAIS) operated in Australia from 2000 to 20102. It was a telephone-based service provided by a consortium of hospital-based medicines information services and handled over 6 000 enquiries annually from community based healthcare professionals across Australia. One third of enquiries were from GPs. Requests for advice regarding medication safety issues such as adverse drug reactions, drug interactions, dosing or administration and pregnancy or lactation were among the most common, supporting the findings of Musc...
Muscat et al1 report on their evidence-based information or ‘literature searching’ service supporting clinicians to answer their clinical questions. They found that treatment-related enquiries were one of the most common categories of clinical questions from a group of General Practitioners (GPs) from five practices in NSW and QLD, Australia. Medications are included in the classification systems used by the group. In particular the taxonomy of generic clinical questions includes at least seven codes specifically incorporating drug-related issues such as timing (code 2.1.1.3), indications (code 2.1.2.1* and 2.1.2.2), safety (code 2.1.3.3), adverse drug reactions (codes 2.1.3.1 and 2.1.3.2) and drug interactions (code 2.1.4.1).
Medicines Information (MI) services also support clinicians in providing effective patient care and optimising therapeutic strategies in a timely manner. The National Prescribing Service funded Therapeutic Advice and Information Service (TAIS) operated in Australia from 2000 to 20102. It was a telephone-based service provided by a consortium of hospital-based medicines information services and handled over 6 000 enquiries annually from community based healthcare professionals across Australia. One third of enquiries were from GPs. Requests for advice regarding medication safety issues such as adverse drug reactions, drug interactions, dosing or administration and pregnancy or lactation were among the most common, supporting the findings of Muscat et al1. However, there were issues of sustainability and funding for TAIS was terminated.
A range of other MI services exist in Australia, many of which are located within pharmacy or clinical pharmacology units at major tertiary hospitals. Funding and available resources dictate the scope of practice and many GPs would not have access to this expertise. Medicines Information services are not unique to Australia, they are available in many other countries, including New Zealand, the United Kingdom (UK Medicines Information), Norway (RELIS) and India. Each service is unique in its scope of practice and resource allocation.
A total of 42% of the questions coded in the taxonomy used in the study by Muscat et al involved ‘drug’ use1. Whilst the authors conclude that current guideline formats may not meet knowledge demands of GPs and that their work may lead to revised or additional guidelines, the ability of guidelines to provide the specific drug-related advice necessary to answer the complex clinical dilemmas that face GPs is questioned. This complexity means that guidelines will never be able to encompass all the possibilities in every case. Even with access to specific resources, the challenge often lies in the time and expertise required to locate, analyse and use the information for clinical decision-making within the context of a busy practice. An MI service with specialist MI pharmacists can provide the expertise in a timely manner.
By identifying common question types, Muscat et al provides data to inform the ‘push’ for more relevant and timely evidence for use in the clinical encounter. MI services can also meet GPs' specific information needs by providing medicines information and therapeutic advice. They are examples of a resource that should be targeted and supported.
*duplicated in table
References
1. Muscat DM, Patel P, Reid S, et al. Content analysis of clinical questions from Australian general practice which are prioritised for answering: identifying common question types and perceived knowledge gaps. BMJ Evidence-Based Medicine Published Online First: 24 June 2019. doi: 10.1136/bmjebm-2019-111210
2. McGuire, T & Patounas, M. Goodbye TAIS and thanks for all the information! Aust Presc 2010;33:147-9
It would be helpful if it assessed the standard administration quantitatively and specific frequency utilized in the study ‘s participants , or related studies , At the very least - providing a link to the exact dosing used in this study as a reference point would be beneficial .
Thank you for this measured summary of the recently published HYGIA trial. I am pleased to see you mention the BedMed study ongoing. Readers may be interested to know that there is another study, already in follow-up, which will provide further evidence on whether night-time dosing of blood pressure medications really is better in the prevention of cardiovascular events and mortality.
The University of Dundee's Treatment in Morning vs Evening (TIME, www.timestudy.co.uk) study, funded by the British Heart Foundation, aims to answer the same research question. TIME has recruited 21,104 participants across the UK and should finish in the first half of 2020.
Like so many purported pundits, DuBroff R, de Lorgeril M [1] have attempted to dispute the significance of the role of saturated fat (triglycerides) and LDL-cholesterol in the development of coronary artery disease, while noting the importance of inflammation itself [1,2]. In law, ignorance of the law is not a defense - the same is true for medicine. Not understanding something does not make you an expert [2] and it does not make your argument valid. Appealing to the court of public opinion does not make it so either. Accordingly, we present a brief explanation of why the authors [1,2] – and others – have presented an invalid discussion of the role fat and LDL-cholesterol plays in coronary artery disease.
In the mid-1990s, as one of the reviewers for the American Heart Association, the first author of this letter, Dr Richard M Fleming (RMF) introduced a then controversial theory stating that Coronary Artery Disease (CAD) is the result of an inflammatory process, which builds up within the walls of the arteries impairing their ability to dilate and increase coronary blood flow when needed; thus producing regional blood flow differences resulting in angina [3-6] and ultimately myocardial infarction (MI) and death.
In recent years, people promoting various dietary and lifestyle practices – particularly those promoting LowCarb-Keto diets, have used the obesity epidemic to focus attention on obesity and weight loss. These same individuals have not demonstrated th...
Show MoreDear Editor,
We welcome the publication of the Jellinson study (9) which is consistent with the focus on research integrity lead by the BJPsych editorial team (please see our most recent retraction (1) and associated editorial (2)).
The issue of ‘spin’ is a widespread problem across the whole research community and is not unique to psychiatry as recognised by the authors of this study (3, 4, 5). We note that according to the protocol the authors are carrying out and publishing similar studies in the fields of cardiology, otolaryngology (6), orthopaedic surgery, obesity medicine (7), anaesthesiology (8) and emergency medicine.
It is unclear from the article or protocol why this subset of journals was chosen for evaluation. We would be interested to know why the number of journals was limited to 6 and what were the parameters for a journal to be considered ‘influential’. It is also interesting to note that none of the journals chosen exclusively publish psychology research (2 publish psychiatry and psychology research and the remaining 4 journals solely publish psychiatric research). Do the authors infer that the problem is more prevalent in influential psychiatry journals? The authors also acknowledge that identifying spin is subjective, highlighting the difficulties faced by journal editors and reviewers who are also trying to identify instances of spin.
Since December 2017 (the end of data extraction in the study), the BJPsych has proactively t...
Show MorePsychiatry is, to an extent, a looking glass world, in which the evidence base can be shrunk, expanded, or, the same as Alice, made to descend down a deep, deep hole.
Joanna Moncrieff for anti- psychotics (1), and Irving Kirsch for anti- depressants, have been suspicious that the drugs concerned may often be not much better than placebo- or that the complexity of the drugs makes comparison with placebo problematic. (Moncrieff cites the impossibility of true double blinding because side effects are, unfortunately, so evident for patients and clinicians alike).
The problem is money. Big Pharma tends to be avaricious, and how soon greed may make one disregard that silly obstacle known as truth!
Spin can be the case even if there appears to be statistical significance. A large sample size- as in meta-analysis- will conclude a tiny difference, of no medical worth, is statistically significant. 'Overpowering' is spin too.
Big Pharma, roaming around its own psychopharmacological 'wonderland', is ensuring, in the most bizarre and baffling ways possible, that everything is 'curiouser and curiouser'.
References:
(1) The Bitterest Pills. The Troubling Story of Anti-Psychotics. Joanna Moncrieff. Palgrave Macmillan. 2013.
Dear Editors,
We thank Dr. Bhui and Mrs. Shuttleworth for commenting on our paper and giving us the opportunity to clarify some aspects of our methods. In their response, they invite us to elaborate on our rationale for journal selection and if we infer that spin is more prevalent in psychiatry journals versus psychology journals. Here, we attempt to clarify our methodology and conclusion regarding our article over spin.
The journals in our study were selected due to their ranking on Google Scholar Metrics under the subcategory “Psychiatry” at the time of the search [1]. It should be noted that as this search was conducted on May 21 2018, the rankings found today may differ from what we found. We selected the highest 10 ranking journals on Google Scholar, according to their h-5 index. However, not all journals primarily published RCTs in humans and were therefore excluded from our study, leaving us with a total of 6 journals.
The aim of our paper was not to compare the prevalence of spin between trials published in psychiatry and those published in psychology journals. Rather, our study examined the rates of spin in RCTs published in high-ranking journals, as indexed by a popular journal ranking platform.
We commend the editors of British Journal of Psychiatry on taking steps to confront spin, such as mandatory use of the CONSORT checklist. For example, CONSORT item 22 requires that interpretations presented in discussion sections of clinical t...
Show MoreThe EBM Verdict by O'Sullivan on the CREDENCE trial of canagliflozin and renal outcomes (1) concluded that "Sodium-glucose cotransporter-2 (SGLT2) inhibitors appear effective to reduce cardiovascular events and deterioration of renal disease in patients with type 2 diabetes and renal impairment." O'Sullivan stated that the study was well-conducted based on conventional assessments of validity (blinding, randomization method, choice of outcomes). However, an important overlooked source of potential bias was not mentioned. The CREDENCE study was sponsored by the pharmaceutical company (Janssen). The analyses of the data was conducted by Janssen, and important conflicts of interest were reported by authors of the paper. A Cochrane review of the relationship of industry sponsorship and research results (2) found significantly more favorable efficacy results in studies by the manufacturing company than sponsorship by other sources, and that the industry bias could not be explained by other "risk of bias" assessments. This important source of bias warrants caution in the interpretation of the results in the absence of independent (non-industry sponsored) data.
1. Perkovic V. et. al. Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy. CREDENCE Trial Investigators. N Engl J Med 2019;380:2295–2306.
Show More2. Lundh A, Lexchin J, Mintzes B, Schroll JB, Bero L. Industry sponsorship and research outcome. Cochrane Database of Systema...
I commend the authors for their well balanced and informative review on recent evidence on reduced fetal movement (RFM). Over the years I sadly saw the practice in the NHS being driven by fear and emotions rather than evidence, certainly, some units now offer mothers induction of labour even after a single episode of RFM! Junior doctors are prompted to act on RFM at induction day, and hospitals are adopting the official Care Bundle from the NHS promoting action (http://www.geh.nhs.uk/latest-news/saving-babies-lives-campaign/) yet, where is the evidence that any of this is beneficial?! certainly efforts like the AFFIRM study need wider dissemination and adoption by policymakers. The question remains, what can we offer to worried couples presenting with RFM daily? Still waiting for the game-changer.
I read this rapid review with interest and agree this topic has reached a point at which a full systematic review could be useful. I have a few suggestions to the authors and/or future reviewers in this area, as there are several nuances in the studies presented that have not been acknowledged.
Future reviews need to consider what primary outcome the study was powered for, and what the comparator is. For example, Bonner et al. looked at physical activity and diet changes as well as smoking in a combined measure and found no statistical difference between absolute risk and heart age when presented in the same format, but the smoking result is isolated and reported as “clinically significant” in the review. In contrast, Lopez-Gonzalez et al. compared an interactive online format for heart age to usual care which generally involves a verbal description of absolute risk by the doctor, so it is difficult to determine whether heart age or a more engaging presentation format produced the results.
Psychological outcomes should also be considered. Modest gains in behaviour change may not be outweighed by reduced accuracy of risk perception, negative affect or reduced credibility of the assessment as per Bonner et al. While these age-based formats appear to elicit a stronger emotional response, this may not be sufficient to produce greater behaviour change or even intentions without additional support (e.g. Soureti et al. and Witteman et al.). It is unclear from the r...
Show MoreMuscat et al1 report on their evidence-based information or ‘literature searching’ service supporting clinicians to answer their clinical questions. They found that treatment-related enquiries were one of the most common categories of clinical questions from a group of General Practitioners (GPs) from five practices in NSW and QLD, Australia. Medications are included in the classification systems used by the group. In particular the taxonomy of generic clinical questions includes at least seven codes specifically incorporating drug-related issues such as timing (code 2.1.1.3), indications (code 2.1.2.1* and 2.1.2.2), safety (code 2.1.3.3), adverse drug reactions (codes 2.1.3.1 and 2.1.3.2) and drug interactions (code 2.1.4.1).
Show MoreMedicines Information (MI) services also support clinicians in providing effective patient care and optimising therapeutic strategies in a timely manner. The National Prescribing Service funded Therapeutic Advice and Information Service (TAIS) operated in Australia from 2000 to 20102. It was a telephone-based service provided by a consortium of hospital-based medicines information services and handled over 6 000 enquiries annually from community based healthcare professionals across Australia. One third of enquiries were from GPs. Requests for advice regarding medication safety issues such as adverse drug reactions, drug interactions, dosing or administration and pregnancy or lactation were among the most common, supporting the findings of Musc...
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