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
This is Cancun Lu, is a master from the Evidence Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, China. Here, I thought the 17th citation in the references of this paper with a mistake. And it should be——Schulz KF, Altman DG, Moher D, et al. CONSORT statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010;2010:c332.
Conflicts of interest
I declare that I have no conflicts of interest.
Expanding the scope – pursuing a fully integrated discourse on health
Thank you for starting a long overdue discussion about the largely “insidious vested interest driven” activity of disease redefinition. Clearly this is causing high risks to the health and well-being of people and communities [1]. However, I think, there is a need to expand the emerging discourse on three front right at the beginning, especially the complex adaptive epistemology of health, a clear elaboration of the limitation of statistics as a means to “prove the truth”, and more fundamentally, the consideration of “biological plausibility”, i.e. the need to focus on integrated network physiology, in considering what are healthy “normal” indicators across the lifespan.
(1) The paper tangentially alludes to the epistemic issues of defining health, illness, dis-ease and disease. Putting it in this way infers as a presupposition that health, illness, dis-ease and disease are distinctively “different things” – essentially a reflection of the reductionist tradition of thought of the past 350 yrs. In the first instance health in all it’s forms is subjective in nature [2], and must be distinguished from the objective features of pathology we use to define disease. As most generalist health professionals know at the end of a consultation patients fall into one of four principle clusters:
• Subjectively healthy with no identifiable pathology
• Subjectively health with well-defined path...
Expanding the scope – pursuing a fully integrated discourse on health
Thank you for starting a long overdue discussion about the largely “insidious vested interest driven” activity of disease redefinition. Clearly this is causing high risks to the health and well-being of people and communities [1]. However, I think, there is a need to expand the emerging discourse on three front right at the beginning, especially the complex adaptive epistemology of health, a clear elaboration of the limitation of statistics as a means to “prove the truth”, and more fundamentally, the consideration of “biological plausibility”, i.e. the need to focus on integrated network physiology, in considering what are healthy “normal” indicators across the lifespan.
(1) The paper tangentially alludes to the epistemic issues of defining health, illness, dis-ease and disease. Putting it in this way infers as a presupposition that health, illness, dis-ease and disease are distinctively “different things” – essentially a reflection of the reductionist tradition of thought of the past 350 yrs. In the first instance health in all it’s forms is subjective in nature [2], and must be distinguished from the objective features of pathology we use to define disease. As most generalist health professionals know at the end of a consultation patients fall into one of four principle clusters:
• Subjectively healthy with no identifiable pathology
• Subjectively health with well-defined pathology
• Subjectively unhealthy/ill/in dis-ease with no identifiable pathology
• Subjectively unhealthy/ill/in dis-ease with identifiable pathology
Patterns typically arise from complex adaptive nonlinear interactions between the elements of a system. Of note, the patterns of health and “unhealth” are emergent outcomes arising as the result of interactions within the hierarchical complex adaptive networks of our external environment (top level) and our biological blueprint (bottom level). Importantly, the higher levels constrain what the lower levels can do [3] – explaining why and how our external contexts positively and negatively influence how we realise/or fail to realise or biologically given health potential [4].
(2) Related to the above is the question about the “nature of evidence”, and by implication if and how the “scientific method” can create evidence for the observable phenomena of the living world. Is there truly any cause-and-effect relationship between one defined intervention to a group of people with their individual dynamic responses to the challenges of their interconnected and interdependent external and internal networks that regulate their health?
Even if there seems to be a statistically significant correlation between a dependent variable and a set of independent variables, it does not prove a causal relationship [5]. As Austin Bradford Hill as far back as 1965 pointed out establishing causation requires a “plurality of reasoning strategies”—strength of association between variables, consistency of results between studies, specificity of variables, temporality, biological gradient, plausibility, coherence, experimental evidence, and analogy [6].
(3) Variables in living system are distributed along a Pareto, rather than a Gaussian distribution [7, 8]. This means that only extreme values at the far end of a parameter’s are likely “truly abnormal”. This impacts the biological plausibility of many disease definitions – the nonlinear distribution of a particular value is not causally related to the occurrence of disease or pre-disease. In addition, as Rothman has shown, a single or even a couple of features may be necessary, but are not sufficient, to define any disease [9].
For example, the diagnosis of hypertension as a BP reading > 120/80 lacks physical and biological plausibility. The circulation of blood is required to ensure adequate oxygen supply to all tissues. Flow = pressure/resistance, i.e. oxygen supply (flow) is dramatically lowered by reducing blood pressure or increasing resistance. Rising blood pressure with increasing age is a – to be expected – compensatory mechanism to maintain adequate oxygen supply in light of the narrowing of blood vessels and rising resistance [10]. As Port has shown rising blood pressure over age – within limits – has no impact on morbidity or mortality [11].
A second example relates to statin drugs – their benefit on improved cardiac mortality results from blocking the inflammation mediated by the Rho/ ROCK enzyme pathways in endothelial plaques [12, 13], not the drug’s side effect, the – easily measurable (and marketable) – lowering of cholesterol [14]. Most notable, and unsurprisingly, the benefit of statins is independent of the initial cholesterol level, and equal across the varied racially normal distribution ranges [15, 16].
References
1. Moynihan R, Brodersen J, Heath I, Johansson M, Kuehlein T, Minué-Lorenzo S, et al. Reforming disease definitions: a new primary care led, people-centred approach. BMJ Evidence-Based Medicine. 2019:bmjebm-2018-111148.
2. Sturmberg JP. The personal nature of health. J Eval Clin Pract. 2009;15(4):766-9.
3. Ellis GFR. Top-down causation and emergence: some comments on mechanisms. Interface Focus. 2012;2(1):126-40.
4. Sturmberg JP, Picard M, Aron DC, Bennett JM, Bircher J, deHaven MJ, et al. Health and Disease—Emergent States Resulting From Adaptive Social and Biological Network Interactions. Frontiers in Medicine. 2019;6:59.
5. Sturmberg JP. Evidence‐based medicine—Not a panacea for the problems of a complex adaptive world. J Eval Clin Pract. 2019;26:early view.
6. Hill AB. The Environment and Disease: Association or Causation? Proc R Soc Med. 1965;58(5):295-300.
7. West GB. The origin of universal scaling laws in biology. Physica A: Statistical Mechanics and its Applications. 1999;263(1–4):104-13.
8. West BJ. Homeostasis and Gauss Statistics: barriers to understanding natural variability. J Eval Clin Pract. 2010;16(3):403–8.
9. Rothman KJ. Causes. Am J Epidemiol. 1976;104(6):587-92.
10. Sturmberg J. Hype and Tension in Hypertension. Debating the Latest Hypertension Guidelines. European Journal for Person Centered Healthcare. 2018;6(1):128-37.
11. Port S, Demer L, Jennrich R, Walter D, Garfinkel A. Systolic blood pressure and mortality. Lancet. 2000;355(3):175-80.
12. Hansson GK, Hermansson A. The immune system in atherosclerosis. Nature Immunology. 2011;12(3):204-12.
13. Wei C-Y, Huang K-C, Chou Y-H, Hsieh P-F, Lin K-H, Lin W-W. The Role of Rho-Associated Kinase in Differential Regulation by Statins of Interleukin-1β- and Lipopolysaccharide-Mediated Nuclear Factor κB Activation and Inducible Nitric-Oxide Synthase Gene Expression in Vascular Smooth Muscle Cells. Mol Pharmacol. 2006;69(3):960-7.
14. Bennett JM, Reeves G, Billman G, Sturmberg JP. Inflammation, nature’s way to efficiently respond to all types of challenges: Implications for understanding and managing “the epidemic” of chronic diseases Frontiers in Medicine. 2018(5):316.
15. Kromhout D. On the waves of the Seven Countries Study; a public health perspective on cholesterol. Eur Heart J. 1999;20(11):796-802.
16. Sturmberg JP, Miles A. The Complex Nature of Knowledge. In: Sturmberg JP, Martin CM, editors. Handbook of Systems and Complexity in Health. New York: Springer 2013. p. 39-62.
I find this discussion unbalanced. Yes, bias is pervasive, and - unfortunately - primary care organizations are not exempt. Like, "the public" can be mislead - about chlorinated water and measles vaccination. But most importantly, put simply, expanding disease definitions usually means more patients to treat, and more cost to account for - this can be a negative incentive in health systems. I have witnessed on several occasions - including WHO BP treatment panels - a strong, explicit bias by primary care organizations to resist the evidence of benefit to treatment at lower levels of BP because it would increase patient loads. Historically the call to "not over-treat" goes back to the '60's, when many argued that "high BP was just like a fever - a symptom not a cause", and every step of progress has been to adopt lower targets. In my view, like it or not, pills are a new era in public health - much like vaccination. And, yes, wide use of safe, effective pills is being resisted for many of the same reasons. But progress cannot be denied, BP goals have declined from "never treat" to SBP of 120, with 80-90% decline in CVD - esp stroke. The US may have the bias toward more treatment (some doctors get patient for more visits . . ) but stroke rates are much lower than in Europe, and many dozens of US health systems have achieved the goal of 80% of treated patients with BP < 140, with excellent results. It shoul...
I find this discussion unbalanced. Yes, bias is pervasive, and - unfortunately - primary care organizations are not exempt. Like, "the public" can be mislead - about chlorinated water and measles vaccination. But most importantly, put simply, expanding disease definitions usually means more patients to treat, and more cost to account for - this can be a negative incentive in health systems. I have witnessed on several occasions - including WHO BP treatment panels - a strong, explicit bias by primary care organizations to resist the evidence of benefit to treatment at lower levels of BP because it would increase patient loads. Historically the call to "not over-treat" goes back to the '60's, when many argued that "high BP was just like a fever - a symptom not a cause", and every step of progress has been to adopt lower targets. In my view, like it or not, pills are a new era in public health - much like vaccination. And, yes, wide use of safe, effective pills is being resisted for many of the same reasons. But progress cannot be denied, BP goals have declined from "never treat" to SBP of 120, with 80-90% decline in CVD - esp stroke. The US may have the bias toward more treatment (some doctors get patient for more visits . . ) but stroke rates are much lower than in Europe, and many dozens of US health systems have achieved the goal of 80% of treated patients with BP < 140, with excellent results. It should be noted that goal implies a mean treated BP of ~ 120 (since the SD = 20 for SBP). We recently showed that meeting SPRINT-based guidelines would reduce CVD deaths by > 100k per year in the US.
Let us not be professional "anti-vaxers" . . SPRINT showed highly significant reduction in all cause, CVD, and modest improvement in cognitive function. There was no excess of permanent harm. Statins likewise have made enormous contribution to reduction in CVD, and are unfortunately resisted by some Nordic countries (eg, Norway) with continued high rates of CHD, While few patients with CKD develop CRF, many die of CVD, and thus CKD is a major risk factor, and like diabetes should usually prompt the use of a statin.
For CVD we can now rely on evidence, Overwhelmingly trials and the historical trajectory of disease rates support broad treatment of risk - with medication if necessary.
Dear 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...
This is Cancun Lu, is a master from the Evidence Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, China. Here, I thought the 17th citation in the references of this paper with a mistake. And it should be——Schulz KF, Altman DG, Moher D, et al. CONSORT statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010;2010:c332.
Conflicts of interest
I declare that I have no conflicts of interest.
Expanding the scope – pursuing a fully integrated discourse on health
Thank you for starting a long overdue discussion about the largely “insidious vested interest driven” activity of disease redefinition. Clearly this is causing high risks to the health and well-being of people and communities [1]. However, I think, there is a need to expand the emerging discourse on three front right at the beginning, especially the complex adaptive epistemology of health, a clear elaboration of the limitation of statistics as a means to “prove the truth”, and more fundamentally, the consideration of “biological plausibility”, i.e. the need to focus on integrated network physiology, in considering what are healthy “normal” indicators across the lifespan.
(1) The paper tangentially alludes to the epistemic issues of defining health, illness, dis-ease and disease. Putting it in this way infers as a presupposition that health, illness, dis-ease and disease are distinctively “different things” – essentially a reflection of the reductionist tradition of thought of the past 350 yrs. In the first instance health in all it’s forms is subjective in nature [2], and must be distinguished from the objective features of pathology we use to define disease. As most generalist health professionals know at the end of a consultation patients fall into one of four principle clusters:
Show More• Subjectively healthy with no identifiable pathology
• Subjectively health with well-defined path...
I find this discussion unbalanced. Yes, bias is pervasive, and - unfortunately - primary care organizations are not exempt. Like, "the public" can be mislead - about chlorinated water and measles vaccination. But most importantly, put simply, expanding disease definitions usually means more patients to treat, and more cost to account for - this can be a negative incentive in health systems. I have witnessed on several occasions - including WHO BP treatment panels - a strong, explicit bias by primary care organizations to resist the evidence of benefit to treatment at lower levels of BP because it would increase patient loads. Historically the call to "not over-treat" goes back to the '60's, when many argued that "high BP was just like a fever - a symptom not a cause", and every step of progress has been to adopt lower targets. In my view, like it or not, pills are a new era in public health - much like vaccination. And, yes, wide use of safe, effective pills is being resisted for many of the same reasons. But progress cannot be denied, BP goals have declined from "never treat" to SBP of 120, with 80-90% decline in CVD - esp stroke. The US may have the bias toward more treatment (some doctors get patient for more visits . . ) but stroke rates are much lower than in Europe, and many dozens of US health systems have achieved the goal of 80% of treated patients with BP < 140, with excellent results. It shoul...
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