Much published health sciences literature is misleading and biased
Efforts to correct this include use of reporting guidelines- criteria for doing science and reporting the results properly
Also discussion of conflicts of interest - how to report them.
Re-analysis of the Cochrane Library data and heterogeneity challengesEvangelos Kontopantelis
Heterogeneity issues and a re-analysis of the Cochrane Library data. Presented in the 35th Annual Conference of the International Society for Clinical Biostatistics (ISCB35) in Vienna
Experimental Epidemiology
1st Clinical trial
Basic steps in RCT
Randomization & its method
Manipulation/ Intervention
Types of RCT
Phases in Clinical trial
Hierarchy of epidemiological study
Re-analysis of the Cochrane Library data and heterogeneity challengesEvangelos Kontopantelis
Heterogeneity issues and a re-analysis of the Cochrane Library data. Presented in the 35th Annual Conference of the International Society for Clinical Biostatistics (ISCB35) in Vienna
Experimental Epidemiology
1st Clinical trial
Basic steps in RCT
Randomization & its method
Manipulation/ Intervention
Types of RCT
Phases in Clinical trial
Hierarchy of epidemiological study
the role of Cochrane collaboration and specifically the menstrual disorder & subfertility group is illustrated . simple explanation how to use cochrane reviews is done.
Clinical Questions types .
A Hierarchy of Preprocessed Evidence.
EBM definition and value.
Knowledge and Skills Necessary for Optimal Evidence-Based Practice.
Basic computer and internet knowledge for electronic searching of the literature
the role of Cochrane collaboration and specifically the menstrual disorder & subfertility group is illustrated . simple explanation how to use cochrane reviews is done.
Clinical Questions types .
A Hierarchy of Preprocessed Evidence.
EBM definition and value.
Knowledge and Skills Necessary for Optimal Evidence-Based Practice.
Basic computer and internet knowledge for electronic searching of the literature
EBM is the practice of integrating individual clinical expertise with the best available clinical evidence from systematic research to maximize the quality and quantity of life for individual patients.
SLC CME- Evidence based medicine 07/27/2007cddirks
Saint Luke's Care, a quality improvement organization within Saint Luke's Health System, presents a CME presentation by Dr. Brent Beasley on Evidence Based Medical Care.
What is research, Types of research, Requisites of good research, Concept in epidemiology, Epidemiologic studies , Literature search, Protocol designing, Ethical issues, Dissertation writing , Research paper writing , Reviewing a research paper
Evidence based decision making in periodonticsHardi Gandhi
INTRODUCTION TO EVIDENCE BASED DENTISTRY
EVIDENCE BASED PERIODONTOLOGY
NEED, PRINCIPLES, GOALS AND ADVANTAGES OF EBDM
SKILLS NEEDED FOR EBDM
ASSESING THE EVIDENCE
INCORPORATING INTO THE PRACTICE
Why bother with evidence-based practice?PaulGlasziou
An introduction to evidence-based medicine (EBM) with short section in history and why EBM? Then a brief overview of the 4 steps of EBM.
These slides have been used for starting a 1-day workshops in EBM
Editorial Integrity Conflict of Interest COPE London March 09John Hoey
Editor's perspective on maintaining the integrity and scientific validity of publication. Threats to integrity, financial conflicts of interest, relationships between editor and journal owners (companies, professional societies)
Presented March 09, COPE, London, UK
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
Acute scrotum is a general term referring to an emergency condition affecting the contents or the wall of the scrotum.
There are a number of conditions that present acutely, predominantly with pain and/or swelling
A careful and detailed history and examination, and in some cases, investigations allow differentiation between these diagnoses. A prompt diagnosis is essential as the patient may require urgent surgical intervention
Testicular torsion refers to twisting of the spermatic cord, causing ischaemia of the testicle.
Testicular torsion results from inadequate fixation of the testis to the tunica vaginalis producing ischemia from reduced arterial inflow and venous outflow obstruction.
The prevalence of testicular torsion in adult patients hospitalized with acute scrotal pain is approximately 25 to 50 percent
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
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New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
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16. Randomization in the Canadian National Breast Screening Study: a review for evidence of subversion . Bailar JC, MacMahon B. CMAJ 1997;156:193-9 Harms? Can science be trusted? Ethical responsibility to study subjects Today - still unclear if mammography is beneficial - harms to women, costs to society
17. Schulz et al - Quality of RCTS Cochrane Pregancy and childbirth data base 33 meta-analyses - 250 trials Quality of randomization and risk estimates Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias: dimensions of methogological quality associated with estimates of treatment effects in controlled trials. JAMA 1995;273(5):408-12 (currently cited 1777 times in )
18.
19. Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias: dimensions of methogological quality associated with estimates of treatment effects in controlled trials. JAMA 1995;273(5):408-12 Quality of 250 trials Concealment % of trials
20. Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias: dimensions of methogological quality associated with estimates of treatment effects in controlled trials. JAMA 1995;273(5):408-12 Quality of 250 trials % Exaggeration of Risk Ratio % of trials
21. Study design - RCT R Rx A Placebo Outcome Primary Outcome -Specified in Protocol? or fishing expedition?
22. Selective publication - Outcome bias publishing the more interesting (usually positive) result Was there an hypothesis? A plan for analysis and reporting of data? In an RCT, this is the primary outcome
23. Selective publication - Outcome bias (publishing the more interesting result) 48 trials 1402 outcomes 31% - 59% incompletely reported (40% not reported at all) Chan, A.-W. et al. CMAJ 2004;171:735-740
24. Selective publication - Outcome bias (publishing the more interesting result) Interpretation: Intensive multitherapy for patients with poorly controlled type 2 diabetes is successful in helping patients meet most of the goals set by a national diabetes association. However, 6 months after intensive therapy stopped and patients returned to usual care the benefits had vanished, However, 6 months after intensive therapy stopped and patients returned to usual care the benefits had vanished.
25.
26. Reporting Bias Kay Dickinson, Reporting and other biases in studies of Neurontin for migraine, psychiatric/bipolar disorders, nociceptive pain, and neuropathic pain . August, 2008 http://dida.library.ucsf.edu/pdf/oxx18r10
30. P Wessely, C Baumgartner, D Klinger, J Kreczi, N … - Cephalalgia, 1987 Neurontin for migraine headaches study Bias Example Publication Final negative primary results not published, only positive preliminary results Selective outcome reporting Outcome reported was not primary or secondary outcome Selective statistical analyses 2 nonrandomized patients assigned to neurotin were include with those randomized Spin Emphasis on “positive” outcomes
31. 16 Citations P Wessely , C Baumgartner, D Klinger, J Kreczi, N … - Cephalalgia, 1987 Who cares? General Principles of Migraine Management: The Changing Role of Prevention E Loder, D Biondi - Headache: The Journal of Head and Face Pain, 2005 - Blackwell Synergy Preventive treatment of migraine - SD Silberstein - Trends in Pharmacolog ical Sciences, 2006 - Elsevier M igraine prevention DW Dodick, SD Silberstein - British Medical Journal, 2007 - pn.bmj.com Neuromodulator s for Migraine Prev ention R Kaniecki - Headache: The Journal of Head and Face Pain, 2008 - Blackwell Synergy Practice parameter: Evidence-based guidelines for migraine headache (an evidence-based review) Stephen D. Silberstein , MD, FACP, for the US Headache Consortium Neurology 2000;55:754-762
35. “ Ghost authorship exists when someone has made substantial contributions to writing a manuscript and this role is not mentioned in the manuscript itself. WAME considers ghost authorship dishonest and unacceptable ” www.wame.org/resources/policies
36.
37. Ghost Writing - the case of Dr. Reckless vs. Pfizer “ I don’t think we should be too hasty with this request,” • “ I agree with your answer. Although I would love to publish SOMETHING about 945- 224, Donna McVey made it very clear that we should take care not to publish anything that damages neurontin’s marketing success.” “ ..We would need to have ‘editorial’ control, but would certainly involve Dr. Reckless in the process, asking for his expert comment.” “ I think that we can limit the potential downsides of the 224 study by delaying the publication for as long as possible and also from where it is published. More importantly it will be more important to how WE write up the study. We are using a medical agency to put the paper together which we will show to Dr. Reckless. We are not allowing him to write it up himself.”
38. So what? http://dida.library.ucsf.edu/pdf/oxx18r10 In total, I find that there were 43 million off-label prescriptions of Neurontin as a result of the ... promotional activities related to the off-label uses ... that would not have occurred absent the challenged conduct. ” Meredith Rosenthal
39. what can be done? Education in research Skepticism ++ *Conflict of interest *Use Reporting guidelines
sequence generation = i.e. ‘assign every other subject to placebo’ table of random numbers etc. Allocation concealment = did those assigning know the assignment destination (placebo, active group)? Implementation = specifically how was it done?
Quality
33 meta-analyses in cochrane pregnancy and childbirth database - 250 trials. assessed for quality of reporting randomization and assignemnt - effect of RR Objective.-To determine if inadequate approaches to randomized controlled trial design and execution are associated with evidence of bias in estimating treatment effects. Design.-An observational study in which we assessed the methodological quality of 250 controlled trials from 33 meta-analyses and then analyzed, using multiple logistic regression models, the associations between those assessments and estimated treatment effects. Data Sources.-Meta-analyses from the Cochrane Pregnancy and Childbirth Database. Main Outcome Measures.-The associations between estimates of treatment effects and inadequate allocation concealment, exclusions after randomization, and lack of double-blinding. Results.-Compared with trials in which authors reported adequately concealed treatment allocation, trials in which concealment was either inadequate or unclear (did not report or incompletely reported a concealment approach) yielded larger estimates of treatment effects (P<.001). Odds ratios were exaggerated by 41% for inadequately concealed trials and by 30% for unclearly concealed trials (adjusted for other aspects of quality). Trials in which participants had been excluded after randomization did not yield larger estimates of effects, but that lack of association may be due to incomplete reporting. Trials that were not double-blind also yielded larger estimates of effects (P=.01), with odds ratios being exaggerated by 17%. Conclusions.-This study provides empirical evidence that inadequate methodological approaches in controlled trials, particularly those representing poor allocation concealment, are associated with bias. Readers of trial reports should be wary of these pitfalls, and investigators must improve their design, execution, and reporting of trials
33 meta-analyses in cochrane pregnancy and childbirth database - 250 trials. assessed for quality of reporting randomization and assignemnt - effect of RR Objective.-To determine if inadequate approaches to randomized controlled trial design and execution are associated with evidence of bias in estimating treatment effects. Design.-An observational study in which we assessed the methodological quality of 250 controlled trials from 33 meta-analyses and then analyzed, using multiple logistic regression models, the associations between those assessments and estimated treatment effects. Data Sources.-Meta-analyses from the Cochrane Pregnancy and Childbirth Database. Main Outcome Measures.-The associations between estimates of treatment effects and inadequate allocation concealment, exclusions after randomization, and lack of double-blinding. Results.-Compared with trials in which authors reported adequately concealed treatment allocation, trials in which concealment was either inadequate or unclear (did not report or incompletely reported a concealment approach) yielded larger estimates of treatment effects (P<.001). Odds ratios were exaggerated by 41% for inadequately concealed trials and by 30% for unclearly concealed trials (adjusted for other aspects of quality). Trials in which participants had been excluded after randomization did not yield larger estimates of effects, but that lack of association may be due to incomplete reporting. Trials that were not double-blind also yielded larger estimates of effects (P=.01), with odds ratios being exaggerated by 17%. Conclusions.-This study provides empirical evidence that inadequate methodological approaches in controlled trials, particularly those representing poor allocation concealment, are associated with bias. Readers of trial reports should be wary of these pitfalls, and investigators must improve their design, execution, and reporting of trials
Chan et al looked at studies funded by the Canadian Institutes of Health Research during the late 1990’s and then tried to find published versions of these studies. They compared the funded protocol with the published papers. Despite careful literature searches and contacts with the funded researchers they were unable to find publications for 40% of the funded trials. (unreported). Of the reported trials between 31% (for efficacy outcomes) and 59% (for harm outcomes) were incompletely reported.
Reporting bias ought to concern editors. It means that published reports - whether published in peer reviewed journals, abstracts to meetings or in other grey literature (web sites, non-indexed literature, and so on) is biased, meaning that the estimates of results are not only wrong, they are biased from the truth. As editors we ought to be concerned. Our job is to spot this type of bias and ask authors to correct it before publication, or reject the paper. We are doing a bad job of this. Even journals with large editorial staffs have accepted papers for publication that contained only part of the evidence or evidence that was biased.
These meanings reflect current popular usage and I’ll use them here. Dickison makes these distinctions.
Most of what I used to see when editing a medical journal was probably incompetence or carelessness or both. I suspect that most journal editors have the same experience. The high-traffic journals get more manuscripts, so they can more easily just discard a lot. Smaller journals can’t. At least that was my experience. When I arrived at the Journal in 1996, CMAJ was publishing about 200 research articles a year. When I left we were publishing but 50. This allowed us to increase the rejection rate to about 90%, decrease our workload as editors, devote more time to articles and hopefully correct some of the incomeptence (and be aware of the very rare malfeasance), preform our function as editors more in line with the Helsinki guidelines, (and increase our impact factor). Fortunately, at the same time as we were doing this, online journals exploded in number, so papers we rejected had a pretty good chance of geting published elsewhere. Or so we hoped. Non-publication of negative results is self-evident. Selective publication of results usually involves non-publication results describing outcomes of the primary objectives in a RCT or substitution of secondary objectives and portraying them as primary. (Need to verify the protocol for RCTs.) Same situation for observational studies. Was there a primary hypothesis? What was it? Is it reported as the main result? Reported at all? Multiple publication of the same results increases citations, confuses and devalues meta-analyses and systematic reviews. Language bias referes to publishig negative results in literature that is more difficult to access and may be missed. (non-English, the grey literature - web pages, letters to editor, abstracts to meetings). Time lag bias - delay publication (a sister of non-publication). Undeclared conflicts of interest. Result in less careful scrutiny by editors, peer reviewers and readers. Should serve as a warnig sign to be attentive. Ghost writing - slide following Dickinsen lists several reporting biases and carefully documents them. We don’t have time to cover them all here. Most are familar to you all. The bias is almost always in favour of the positive outcome. There is a growing literature documeting the effect size of these biases. The effect sizes are substantial. Dickinson has a nice bibliography for those interested in a particular bias.
Approved by US FDA 1994 RX partial seizures By 2003, one of Pfizer’s best selling drugs for minor seizures. Off-label uses account for 90% of sales migraine, bipolar disorders, OCD, depression, insommnia, etc.. Adverse effects - dizziness, mood swings etc.. hepatotoxcity, depression, suicide, Court cases - for illegally marketing a drug based on no evidence of efficacy
Dickinson’s analysis of another paper that was used by Pfizer to promote off-label uses of Neurontin. Clearly this is a seriously flawed RCT, as published by an editor, I hope not one in this room.
Does it matter. Well yes. This misleadingly reported study is still being cited, the drug is still being recommended for prevention of migraine and worse, has found it’s way into guidelines that are Evidence Based, whatever that means in this context.
Group 2 are highly recommended based on RCT evidence.
“ Ghost authorship exists when someone has made substantial contributions to writing a manuscript and this role is not mentioned in the manuscript itself. WAME considers ghost authorship dishonest and unacceptable (emphasis mine) . Ghost authors generally work on behalf of companies, or agents acting for those companies, with a commercial interest in the topic, and this compounds the problem.” ( http://www.wame.org/resources/policies accessed August 1, 2008)
Dr. Reckless study Neuroptin for neruopathic pain UK Investigator multicentre study at 59 sites in 6 countries 1998-99 Results showed no benefit.April 2002 - Results not written up - Dr. Reckless complains to Pfizer:
Study 945-224 was a multicenter, placebo controlled trial, conducted at 59 sites in the UK, France, Germany, Italy, Spain, and 2 in South Africa, comparing three doses of Neurontin® for treatment of neuropathic pain. Statements in the informed consent document that those enrolling would benefit others by their participation were carefully made: “ Information gained in this study may eventually benefit other persons with painful diabetic neuropathy.” (RR 720-04130 p.259) The studied period was May 1998 to September 1999. No statistically significant differences were observed between any of the three Neurontin dosage groups and the placebo group for the primary endpoint (mean pain score). Several secondary outcomes were statistically significant, depending on the dosage group. On 18 April 2000, Dr. Reckless, a UK investigator in the 945-224 study, complained to the Clinical Trials Monitor for Parke-Davis about failure to publish the study.