Teaching materials explaining publication bias. For use with students with no prior knowlede or previous training in critical appraisal skills. It explains both failure to report and selective reporting. The notes beneath each slide give suggestions of how the materials can be used in class. The examples are real example e.g. a trial of activia yoghurt versus yoghurt without live probiotics for irritable bowel syndrome (IBS),
Basic slides will take only 5 minutes in a presentation or the materials can be used in a full one hour interactive workshop. These were put together in 2016 for www.testingtreatments.org which helps explain a fair test of treatment. They are particularly useful for teaching the critical appraisal of systematic reviews.
Publication bias refers to a phenomenon in scientific reporting whereby authors are more likely to submit and journal editors are more likely to publish studies with “positive” results (i.e. results showing a significant finding) than studies with “negative” (i.e. supporting the null hypothesis) or unsupportive results.
Due to such a bias, important—albeit negative—results (e.g., a study showing that a new treatment is ineffective) may never reach the larger scientific community.
An introduction on how to go about a meta-analysis. Primarily designed for people with non statistical background. Heavily borrows from Cochrane Handbook of Systematic Reviews of Interventions.
Nancy Rothman, a nursing professor at Temple University, describes the "Better Decisions Together" project aimed at engaging the chronically homeless and public housing residents in their health care decisions.
This presentation was part of a Shared Decision Making Month webinar -- Shared Decision Making in the Real World: Stories from the Frontline.
Integrated Wellness: Implications for academic libraries and the communities ...Bethany Tschaepe
Presentation of Integrated Wellness: Implications for academic libraries and the communities they serve during ACRL 2015 Conference in Portland, OR. Presenters Leo Lo and Bethany Tschaepe
Publication bias refers to a phenomenon in scientific reporting whereby authors are more likely to submit and journal editors are more likely to publish studies with “positive” results (i.e. results showing a significant finding) than studies with “negative” (i.e. supporting the null hypothesis) or unsupportive results.
Due to such a bias, important—albeit negative—results (e.g., a study showing that a new treatment is ineffective) may never reach the larger scientific community.
An introduction on how to go about a meta-analysis. Primarily designed for people with non statistical background. Heavily borrows from Cochrane Handbook of Systematic Reviews of Interventions.
Nancy Rothman, a nursing professor at Temple University, describes the "Better Decisions Together" project aimed at engaging the chronically homeless and public housing residents in their health care decisions.
This presentation was part of a Shared Decision Making Month webinar -- Shared Decision Making in the Real World: Stories from the Frontline.
Integrated Wellness: Implications for academic libraries and the communities ...Bethany Tschaepe
Presentation of Integrated Wellness: Implications for academic libraries and the communities they serve during ACRL 2015 Conference in Portland, OR. Presenters Leo Lo and Bethany Tschaepe
Antiretroviral therapy for pregnant women living with HIV or hepatitis B: Wha...Health Evidence™
Health Evidence™ hosted a 90 minute webinar examining the effect of antiretroviral therapy for pregnant women living with HIV or hepatitis B. Click here for access to the audio recording for this webinar: https://youtu.be/91moFmIoI3w
Dr. Reed A.C. Siemieniuk, MD, PhD(c), Department of Medicine, University of Toronto, Department of Health Research Methods, Evidence, and Impact, McMaster University led the session and presented findings from their recent systematic review:
Siemieniuk R, Foroutan F, Mirza R, Mah Ming J, Alexander PE, Agarwal A, et al. (2017). Antiretroviral therapy for pregnant women living with HIV or hepatitis B: A systematic review and meta-analysis. BMJ Open, 7(9), e019022.
This review assesses the impact of various antiretroviral/antiviral regimens in pregnant women living with HIV or hepatitis B virus (HBV). Forty-three studies were included in the review. The most common comparison was tenofovir and emtricitabine versus zidovudine and lamivudine. There was no apparent difference between tenofovir-based regimens and alternatives in maternal outcomes, including serious laboratory adverse events and serious clinical adverse events. There was no difference between NRTIs in vertical transmission of HIV or vertical transmission of HBV. We found moderate certainty evidence that tenofovir/emtricitabine increases the risk of stillbirths and early neonatal mortality and the risk of early premature delivery at less than 34 weeks. Tenofovir/emtricitabine is likely to increase stillbirth/early neonatal death and early premature delivery compared with zidovudine/lamivudine, but certainty is low when they are not coprescribed with lopinavir/ritonavir. Other outcomes are likely similar between antiretrovirals.
Lyuba Lytvyn, MSc, PhD(c), Department of Health Research Methods, Evidence, and Impact, McMaster University also briefly presented the findings from their linked systematic review on values and preferences of pregnant women with HIV:
Lytvyn L, Siemieniuk R, Dilmitis S, Ion A, Chang Y, Bala M, et al. (2017). Values and preferences of women living with HIV who are pregnant, postpartum or considering pregnancy on choice of antiretroviral therapy during pregnancy. BMJ Open, 7(9), e019023.
Phillip Keen, (NAPWA) discusses the background, goals and objectives of NAPWA's billboard and web campaign encouraging people with HIV to get up to date about treatments. This presentation was given at the AFAO/NAPWA Gay Men's HIV Health Promotion Conference in May 2012.
From the event "Specimen Science: Ethics and Policy Implications," held at Harvard Law School on November 16, 2015.
This event is a collaboration between The Center for Child Health and Policy at Case Western Reserve University and University Hospitals Rainbow Babies & Children’s Hospital; the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School; the Multi-Regional Clinical Trials Center of Harvard and Brigham and Women's Hospital; and Harvard Catalyst | The Harvard Clinical and Translational Science Center. It is supported by funding from the National Human Genome Research Institute and the Oswald DeN. Cammann Fund at Harvard University.
For more information, visit our website at http://petrieflom.law.harvard.edu/events/details/specimen-science-ethics-and-policy
Simon Finfer is a leading critical care clinical researcher. Hear his candid talk on the reality of research and publication and why it's relevant to you!
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Carrie Shaw (Embodied Labs): The Intersection of VR Storytelling and Healthcare Training to Improve Caregiver Readiness in the Aging Healthcare Service Workforce
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http://AugmentedWorldExpo.com
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The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
Antiretroviral therapy for pregnant women living with HIV or hepatitis B: Wha...Health Evidence™
Health Evidence™ hosted a 90 minute webinar examining the effect of antiretroviral therapy for pregnant women living with HIV or hepatitis B. Click here for access to the audio recording for this webinar: https://youtu.be/91moFmIoI3w
Dr. Reed A.C. Siemieniuk, MD, PhD(c), Department of Medicine, University of Toronto, Department of Health Research Methods, Evidence, and Impact, McMaster University led the session and presented findings from their recent systematic review:
Siemieniuk R, Foroutan F, Mirza R, Mah Ming J, Alexander PE, Agarwal A, et al. (2017). Antiretroviral therapy for pregnant women living with HIV or hepatitis B: A systematic review and meta-analysis. BMJ Open, 7(9), e019022.
This review assesses the impact of various antiretroviral/antiviral regimens in pregnant women living with HIV or hepatitis B virus (HBV). Forty-three studies were included in the review. The most common comparison was tenofovir and emtricitabine versus zidovudine and lamivudine. There was no apparent difference between tenofovir-based regimens and alternatives in maternal outcomes, including serious laboratory adverse events and serious clinical adverse events. There was no difference between NRTIs in vertical transmission of HIV or vertical transmission of HBV. We found moderate certainty evidence that tenofovir/emtricitabine increases the risk of stillbirths and early neonatal mortality and the risk of early premature delivery at less than 34 weeks. Tenofovir/emtricitabine is likely to increase stillbirth/early neonatal death and early premature delivery compared with zidovudine/lamivudine, but certainty is low when they are not coprescribed with lopinavir/ritonavir. Other outcomes are likely similar between antiretrovirals.
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Lytvyn L, Siemieniuk R, Dilmitis S, Ion A, Chang Y, Bala M, et al. (2017). Values and preferences of women living with HIV who are pregnant, postpartum or considering pregnancy on choice of antiretroviral therapy during pregnancy. BMJ Open, 7(9), e019023.
Phillip Keen, (NAPWA) discusses the background, goals and objectives of NAPWA's billboard and web campaign encouraging people with HIV to get up to date about treatments. This presentation was given at the AFAO/NAPWA Gay Men's HIV Health Promotion Conference in May 2012.
From the event "Specimen Science: Ethics and Policy Implications," held at Harvard Law School on November 16, 2015.
This event is a collaboration between The Center for Child Health and Policy at Case Western Reserve University and University Hospitals Rainbow Babies & Children’s Hospital; the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School; the Multi-Regional Clinical Trials Center of Harvard and Brigham and Women's Hospital; and Harvard Catalyst | The Harvard Clinical and Translational Science Center. It is supported by funding from the National Human Genome Research Institute and the Oswald DeN. Cammann Fund at Harvard University.
For more information, visit our website at http://petrieflom.law.harvard.edu/events/details/specimen-science-ethics-and-policy
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http://AugmentedWorldExpo.com
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Amanda burls ppt teaching materials for publication bias
1. Publication bias – teaching
materials
• The attached slides can be used to teach people
about publication bias
• There are notes beneath the slides with
suggestions of how they might be used
• Prepared by Professor Amanda Burls and available
from http://openaccess.city.ac.uk/id/eprint/13488Amanda.Burls.1@city.ac.uk
• Publication bias by Dr Amanda Burls is licensed
under a Creative Commons Attribution 4.0 International
License.
3. You are seeing a patient and she
asks…
“Should I buy Activia™
to help with my
tummy pain and
improve my
constipation?”
You have 1 minute to discuss with your
neighbour what you would tell her?
1:000:590:580:570:560:550:540:530:520:510:500:490:480:470:460:450:440:430:420:410:400:390:380:370:360:350:340:330:320:310:300:290:280:270:260:250:240:230:220:210:200:190:180:170:160:150:140:130:120:110:100:090:080:070:060:050:040:030:020:01End
4. Which of the following is closest to
your answer?
1. 2. 3. 4. 5. 6. 7.
3%
21%
0%
39%
18%
5%
13%
1. Try it - it can help some people
2. You need to ask a doctor a
question like that
3. Yes, but any live yoghurt will do
4. No, there’s no evidence it helps
5. I don’t know
6. I don’t know, but it can’t do any
harm
7. I don’t know, but I’ll look up the
evidence and tell you next week
5. What is the evidence?
• What sort of study design would be best for
answering this question?
6. Randomised Control Trial (RCT) of live
yoghurt for Inflammatory Bowel Syndrome
(IBS)
• P: Adults with IBS
• I: Activia (2 pots per day)
• C: Identical yoghurt with no live
bacteria (2 pots per day)
• O: Adequate symptom relief
• T: 12 weeks
• Funded by Danone
• Undertaken by independent
researchers at the University of
Birmingham
7. RCT comparing live yoghurt with
ordinary yoghurt IBS
• The trial ended in 2005
• What do you think the
results showed?
8. Results for primary outcome
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10. One participant in trial finally
wrote to the investigator when
these results had not been
published five years later.
This was the reply…
11. Sent: 19 January 2010 15:45
To: Dr Amanda Burls
Subject: RE: Yoghurt trial
Dear Amanda,
The trial is not yet in press - this is in part due to the
much longer than anticipated further analysis of the
data at the funders request. In summary this was a
negative trial - although both groups demonstrated
benefit, those in the active product group did not show
greater benefit and at times the difference actually
favoured the control product….
13. The trial was finally published
eight years later (after pressure to
do so)...
14. However, publication bias is
• Not only about not publishing
• Can also be about reporting outcomes that were
positive but not mentioning those that were not
(even when they were the primary outcome)
• Putting more positive results in the Abstract of the
paper
• Distorting the Conclusions
16. Let’s compare our implications
for practice with those of the
authors
17. A biased conclusion - great for
Danone!
• Activia was worse than the control yoghurt
• But, let’s recommend fermented dairy products
anyway!
• To back up such a recommendation randomized
control trials are needed showing that fermented
dairy products help patients with IBS compared to
not having them.
• Otherwise we can’t exclude bias or regression to
the mean (that people get better anyway, without
treatment!)
21. Funnel plots…
• …are scatter plots of treatment effect
estimated from individual studies (x axis)
against a measure of each study’s
sample size (y axis).
• The precision of the estimates of the
treatment effect increases as sample size
increases.
• Effect estimates from small studies
scatter more widely at the bottom of the
graph, with the spread narrowing among
larger studies.
• In the absence of bias the plot should
resemble a symmetrical inverted funnel.
Size of study
Treatment effect
28. Sources of asymmetry
• Publication bias
• Poor methodological quality of smaller studies
• True heterogeneity i.e. size of effect differs
according to study size
• for example, due to differences in the intensity of
interventions or differences in underlying risk between
studies of different sizes
• Chance
Editor's Notes
Please feel free to use these materials in any way you want, re-mixing or just as they are. I have included examples of where I use them together with TurningPoint clickers for large groups with sample results of votes, but the same can be achieved by a show of hands if a safe learning environment is created.
Engage the students by getting them to chat about the TV adverts they have seen for friendly bacteria and/or get them to say if they take Actimel or other probiotic “health” drinks.
This can be friend or colleague rather than patient if your audience is not a clinical audience. The timer counts down 1 minute/
This particular group voted after about four other examples showing them why they need to look for research evidence before giving advice to patients. When used at the beginning of a presentation most people vote for 6.
The best primary study to address this question would be a randomized control trial and the best study design for looking for an answer would be an up-to-date high quality systematic review of randomized controlled trials. Students can be engaged by asking them if they think that there would be trials of such a question (most vote “no”).
PICO stands for Population, Intervention, Comparator and Outcome
The photo is of the intervention used in an RCT of Activia (not named in trial) funded by Danone
This picture is also useful for discussion blinding and placebo effects.
I don’t usually included the text that is grayed out above, I just say this at some point when going through the story.
(I was a participant in the trial!)
PICO stands for population, intervention, comparator and outcome
The photo is of the intervention used in an RCT of Activia (not named in trial) funded by Danone
This picture is also useful for discussion blinding and placebo effects.
I don’t usually included the text that is grayed out above, I just say this at some point when going through the story.
(I was a participant in the trial!)
What do these results mean. Get participants to discuss in pairs. Get them to think both about the findings and to write a brief lay summary including implications for practice. Two minute timer. You can collect the summaries to talk about later.
An even better way of doing this is to hand out cards with the result but half of them have the results reversed for active and control product. As shown on next slide. This enables you to explore the effect of prior beliefs and direction of effect with class in relation to what they wrote.
Faked slide with control and active product results reversed.
An even better way of doing this is to hand out cards with the result but half of them have the results reversed for active and control product. As shown on next slide. This enables you to explore the effect of prior beliefs and direction of effect with class in relation to what they wrote.
I searched for the results of this trial every six months from 2006 onwards but could not find the results. Finally, I wrote to the principal investigator and this is the email she sent back!
These slides I would tend to use on a subsequent teaching session – I wouldn’t introduce funnel plots to new learners until they had some confidence in critical appraisal, but I have included them in case you find them useful.
I use these slides with a large bag of green and yellow counters where I get the students to estimate the proportion of counters that are green drawing different size samples. You can draw on a flipchart the estimate each time based on number of counters drawn out (and replaced)
You end up creating a funnel plot around the true proportion. So that students can understand that the variation at the bottom is just due to chance and that the bigger the sample the less variation there is due to chance and that because it is due to chance it is equally as likely to underestimate as overestimate the true result and therefore the plot will be symmetrical.
You can toggle backwards and forwards between this slide and the previous slide using up and down arrows to talk about how treatment effectiveness is distorted
substantial benefit may be seen only in patients at high risk for the outcome that is affected by the intervention, and these high risk patients are usually more likely to be included in early, small studies (Davey Smith 1994, Glasziou 1995). In addition, small trials are generally conducted before larger trials are established, and in the intervening years standard treatment may have improved. Furthermore, some interventions may have been implemented less thoroughly in larger trials and, therefore, may have resulted in smaller estimates of the treatment effect (Stuck 1998). It has also been argued that funnel plot asymmetry may be an artefact (Irwig 1998), but simulation studies have shown that this will occur infrequently if the overall treatment effect is very large and the outcome of interest is rare (Sterne, unpublished). Finally, it is clearly possible that an asymmetrical funnel plot arises merely by the play of chance.