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9. Talking in primary care (TIP): protocol for a cluster-randomised controlled trial in UK primary care to assess clinical and cost-effectiveness of communication skills e-learning for practitioners on patients’ musculoskeletal pain and enablement

Author

Bishop, Felicity L, primary, Cross, Nadia, additional, Dewar-Haggart, Rachel, additional, Teasdale, Emma, additional, Herbert, Amy, additional, Robinson, Michelle E, additional, Ridd, Matthew J, additional, Mallen, Christian, additional, Clarson, Lorna, additional, Bostock, Jennifer, additional, Becque, Taeko, additional, Stuart, Beth, additional, Garfield, Kirsty, additional, Morrison, Leanne, additional, Pollet, Sebastien, additional, Vennik, Jane, additional, Atherton, Helen, additional, Howick, Jeremy, additional, Leydon, Geraldine M, additional, Nuttall, Jacqui, additional, Islam, Nazrul, additional, Lee, Paul H, additional, Little, Paul, additional, and Everitt, Hazel A, additional

Published
2024
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14. Philosophical essentials in evidence-based medicine : evaluating the epistemological role of double blinding and placebo controls

Author

Howick, Jeremy

Subjects
616
Abstract

The Evidence-Based Medicine (EBM) movement endorses a hierarchy of evidence that places randomized controlled trials at the top. More specifically, double-blind, placebo- controlled trials are often considered to be the 'best of the best'. This view leads to the paradox that treatments that seem to be most strongly supported by evidence, ranging from tracheotomies to rabies vaccines, have never been tested in randomized trials of any description and are hence supported by (allegedly) sub-optimal evidence. Moreover many of these treatments do not seem supportable by best evidence - how, for example do we keep the surgeons who perform tracheotomies 'blind'. After a brief introduction (chapter 1), and review of the literature (chapter 2), I argue that criticisms of the EBM hierarchy can be launched from the simple basis that best evidence rules out the most plausible rival hypothesis (chapter 3). To examine the relative evidential weight of placebo controlled trials compared to 'active' controlled trials (in which the control treatment is an existing established treatment) requires a good deal of conceptual work. I defend a modified version of Grunbaum's (1981/1986) definition of placebos (chapter 4), then provide constraints on what can count as a 'legitimate' placebo control (chapter 5). Next, I explain why double-blinding does not always rule out additional rival hypotheses. I then argue that the arguments for the superiority of placebo controls are flawed. The 'assay sensitivity' argument is limited in scope and based on a misconception about the nature of placebo controls (chapter 7), while the claim that only placebo controlled trials measure the absolute effect size relies on the questionable assumption that placebo and non-placebo effects add rather than interact (chapter 8). I conclude that the evidence hierarchy endorsed by EBM does not stand on solid foundations.

Published
2008

21. How placebo characteristics can influence estimates of intervention effects in trials

Author

Howick, Jeremy and Hoffmann, Tammy

Subjects
Clinical trials -- Methods, Pharmacological research, Placebos -- Research, Health
Abstract

Researchers now recognize the need to completely describe active interventions within trials. (1,2) However, the importance of clearly describing placebo control interventions is not well reported or understood. Placebo controls [...]

Published
2018
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23. Most healthcare interventions tested in Cochrane Reviews are not effective according to high quality evidence: a systematic review and meta-analysis

Author

Howick, Jeremy, Koletsi, Despina, Ioannidis, John P A, Madigan, Claire, Pandis, Nikolaos, Loef, Martin, Walach, Harald, Sauer, Sebastian, Kleijnen, Jos, Seehra, Jadbinder, Johnson, Tess, Schmidt, Stefan, Howick, Jeremy, Koletsi, Despina, Ioannidis, John P A, Madigan, Claire, Pandis, Nikolaos, Loef, Martin, Walach, Harald, Sauer, Sebastian, Kleijnen, Jos, Seehra, Jadbinder, Johnson, Tess, and Schmidt, Stefan

Abstract

OBJECTIVE To estimate the proportion of healthcare interventions tested within Cochrane Reviews that are effective according to high-quality evidence. METHODS We selected a random sample of 2,428 (35%) of all Cochrane Reviews published between 1 January 2008 and 5 March 2021. We extracted data about interventions within these reviews that were compared with placebo, or no treatment, and whose outcome quality was rated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. We calculated the proportion of interventions whose benefits were based on high-quality evidence (defined as having high quality GRADE rating for at least one primary outcome, statistically significant positive results, and being judged by review authors as effective. We also calculated the proportion of interventions that suggested harm. RESULTS Of 1,567 eligible interventions, 87 (5.6%) had high-quality evidence supporting their benefits. Harms were measured for 577 (36.8%) interventions. There was statistically significant evidence for harm in 127 (8.1%) of these. Our dependence on the reliability of Cochrane author assessments (including their GRADE assessments) was the main potential limitation of our study. CONCLUSION More than 9 in 10 healthcare interventions studied within recent Cochrane Reviews are not supported by high-quality evidence, and harms are under-reported.

Published
2022

24. Authors' reply

Author

Heneghan, Carl, Thompson, Matthew, Perera-Salazar, Rafael, Gill, Peter, O'Neill, Braden, Nunan, David, Howick, Jeremy, Lasserson, Daniel, and Mahtani, Kamal

Published
2012

26. Clinician views on optimism and empathy in primary care consultations: a qualitative interview study

Author

Hughes, Stephanie, primary, Vennik, Jane Louise, additional, Smith, Kirsten A, additional, Bostock, Jennifer, additional, Howick, Jeremy, additional, Mallen, Christian, additional, Little, Paul, additional, Ratnapalan, Mohana, additional, Lyness, Emily, additional, Leydon, Geraldine M, additional, Dambha-Miller, Hajira, additional, Morrison, Leanne, additional, Everitt, Hazel A, additional, and Bishop, Felicity L, additional

Published
2022
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38. Health and Gender Inequalities of the COVID-19 Pandemic: Adverse Impacts on Women's Health, Wealth and Social Welfare

Author

Guerrina, Roberta, Borisch, Bettina, Callahan, Leigh F., Howick, Jeremy, Reginster, Jean-Yves, and Mobasheri, Ali

Subjects
Global Women's Health, pandemic, Perspective, General Engineering, gender, General Earth and Planetary Sciences, COVID-19, global health, women's health, General Environmental Science
Abstract

In this paper we discuss the nexus of health and gender inequalities associated with the COVID-19 pandemic and highlight its adverse impacts on women's health, welfare and social standing. The COVID-19 pandemic has exposed the link between socio-economic inequalities and health outcomes, especially in the area of rheumatic and musculoskeletal (RMDs) diseases. Women are more adversely affected by RMDs diseases compared to men. Epidemiological research carried out over several decades has demonstrated the presence of clear gender patterns in the manifestation of musculoskeletal diseases, including osteoarthritis (OA), rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), systemic sclerosis (SS) and osteoporosis (OP). The public health measures that have been adopted to curb the spread of Sars-COV-2 are expected to have a particularly detrimental impact on women in the long term precisely because of the nexus between health outcomes and socio-economic structures. Moreover, the prioritization of urgent care will further compound this effect. COVID-19 has created a condition of ontological insecurity that is becoming increasingly manifested through various chronic diseases and associated comorbidities. RMDs and their impact on mobility and the ability of individuals to be independent, happy and mobile is a key public health challenge in the post-COVID-19 reality and a key part of the ongoing pandemic. There is an urgent need to engage with policymakers to publicize and prioritize this problem and develop viable solutions to address it.

Published
2021

39. Harnessing Placebo Effects in Primary Care: Using the Person-Based Approach to Develop an Online Intervention to Enhance Practitioners' Communication of Clinical Empathy and Realistic Optimism During Consultations

Author

Smith, Kirsten A., primary, Vennik, Jane, additional, Morrison, Leanne, additional, Hughes, Stephanie, additional, Steele, Mary, additional, Tiwari, Riya, additional, Bostock, Jennifer, additional, Howick, Jeremy, additional, Mallen, Christian, additional, Little, Paul, additional, Ratnapalan, Mohana, additional, Lyness, Emily, additional, Misurya, Pranati, additional, Leydon, Geraldine M., additional, Dambha-Miller, Hajira, additional, Everitt, Hazel A., additional, and Bishop, Felicity L., additional

Published
2021
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40. “Consensus on Placebo and Nocebo Effects Connects Science with Practice:” Reply to “Questioning the Consensus on Placebo and Nocebo Effects”

Author

Evers, Andrea W.M., Colloca, Luana, Blease, Charlotte, Gaab, Jens, Jensen, Karin B., Atlas, Lauren Y., Beedie, Chris J., Benedetti, Fabrizio, Bingel, Ulrike, Büchel, Christian, Bussemaker, Jet, Colagiuri, Ben, Crum, Alia J., Finniss, Damien G., Geers, Andrew L., Howick, Jeremy, Klinger, Regine, Meeuwis, Stefanie Helena, Meissner, Karin, Napadow, Vitaly, Petrie, Keith J., Rief, Winfried, Smeets, Ionica, Wager, Tor D., Wanigasekera, Vishvarani, Vase, Lene, Kelley, John M., Kirsch, Irving, Evers, Andrea W.M., Colloca, Luana, Blease, Charlotte, Gaab, Jens, Jensen, Karin B., Atlas, Lauren Y., Beedie, Chris J., Benedetti, Fabrizio, Bingel, Ulrike, Büchel, Christian, Bussemaker, Jet, Colagiuri, Ben, Crum, Alia J., Finniss, Damien G., Geers, Andrew L., Howick, Jeremy, Klinger, Regine, Meeuwis, Stefanie Helena, Meissner, Karin, Napadow, Vitaly, Petrie, Keith J., Rief, Winfried, Smeets, Ionica, Wager, Tor D., Wanigasekera, Vishvarani, Vase, Lene, Kelley, John M., and Kirsch, Irving

Published
2021
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42. Exploring patient views of empathic optimistic communication for osteoarthritis in primary care: a qualitative interview study using vignettes

Author

Lyness, Emily, primary, Vennik, Jane Louise, additional, Bishop, Felicity L, additional, Misurya, Pranati, additional, Howick, Jeremy, additional, Smith, Kirsten A, additional, Ratnapalan, Mohana, additional, Hughes, Stephanie, additional, Dambha-Miller, Hajira, additional, Bostock, Jennifer, additional, Morrison, Leanne, additional, Mallen, Christian D, additional, Yardley, Lucy, additional, Leydon, Geraldine, additional, Little, Paul, additional, and Everitt, Hazel, additional

Published
2021
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44. Improving empathy in healthcare consultations – a secondary analysis of interventions

Author

Smith, Kirsten, Bishop, Felicity, Dambha-Miller, Hajira, Ratnapalan, Mohana, Lyness, Emily, Vennik, Jane, Hughes, Stephanie, Bostock, Jennifer, Morrison, Leanne, Mallen, Christian, Yardley, Lucy, Everitt, Hazel, Little, Paul, and Howick, Jeremy

Subjects
education
Abstract

A recent systematic review of randomised trials suggested that empathic communication improves patient health outcomes. However, the methods for training healthcare practitioners (medical professionals; HCPs) in empathy and the empathic behaviours demonstrated within the trials were heterogeneous, making the evidence difficult to implement in routine clinical practice. In this secondary analysis of seven trials in the review, we aimed to identify (1) the methods used to train HCPs, (2) the empathy behaviours they were trained to perform and (3) behaviour change techniques (BCTs) used to encourage the adoption of those behaviours. This detailed understanding of interventions is necessary to inform implementation in clinical practice. We conducted a content analysis of intervention descriptions, using an inductive approach to identify training methods and empathy behaviours and a deductive approach to describe the BCTs used. The most commonly used methods to train HCPs to enhance empathy were face-to-face training (n = 5), role-playing (n = 3) and videos (self or model; n = 3). Duration of training was varied, with both long and short training having high effect sizes. The most frequently targeted empathy behaviours were providing explanations of treatment (n = 5), providing non-specific empathic responses (e.g. expressing understanding) and displaying a friendly manner and using non-verbal behaviours (e.g. nodding, leaning forward, n = 4). The BCT most used to encourage HCPs to adopt empathy behaviours was “Instruction on how to perform behaviour” (e.g. a video demonstration, n = 5), followed by “Credible source” (e.g. delivered by a psychologist, n = 4) and “Behavioural practice” (n = 3 e.g. role-playing). We compared the effect sizes of studies but could not extrapolate meaningful conclusions due to high levels of variation in training methods, empathy skills and BCTs. Moreover, the methods used to train HCPs were often poorly described which limits study replication and clinical implementation. This analysis of empathy training can inform future research, intervention reporting standards and clinical practice.

Published
2020

45. European Headache Federation recommendations for placebo and nocebo terminology

Author

Mitsikostas, Dimos D, Blease, Charlotte, Carlino, Elisa, Colloca, Luana, Geers, Andrew L, Howick, Jeremy, Evers, Andrea WM, Flaten, Magne A, Kelley, John M, Kirsch, Irving, Mitsikostas, Dimos D, Blease, Charlotte, Carlino, Elisa, Colloca, Luana, Geers, Andrew L, Howick, Jeremy, Evers, Andrea WM, Flaten, Magne A, Kelley, John M, and Kirsch, Irving

Published
2020
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46. The quality of evidence for medical interventions does not improve or worsen: a metaepidemiological study of Cochrane reviews

Author

Howick, Jeremy, Koletsi, Despina, Pandis, Nikolaos, Fleming, Padhraig S, Loef, Martin, Walach, Harald, Schmidt, Stefan, Ioannidis, John P A, Howick, Jeremy, Koletsi, Despina, Pandis, Nikolaos, Fleming, Padhraig S, Loef, Martin, Walach, Harald, Schmidt, Stefan, and Ioannidis, John P A

Abstract

OBJECTIVES The objective of the study was to determine the change in quality of evidence in updates of Cochrane reviews that were initially published between January 1, 2013 and June 30, 2014. We used the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system to document evidence quality. STUDY DESIGN AND SETTING We searched the Cochrane Database of Systematic Reviews on March 20, 2020 to identify which of the reviews from the initial (2013/14) sample had been updated. Using the same methods to determine the quality of evidence in the previous analysis, we assessed the quality of evidence for the first-listed primary outcomes in the updated reviews. RESULTS Of the 608 reviews in the original sample, 154 had been updated with and 151 contained available data for both original and updated systematic reviews (24.8%). The updated reviews included: 15 (9.9%) with high-quality evidence, 56 (37.1%) with moderate-quality evidence, 47 (31.1%) with low-quality evidence, and 33 (21.9%) with very low-quality evidence. No change in the GRADE quality of evidence was found for most (103, 68.2%) of the updated reviews. The quality of evidence rating was downgraded in 28 reviews (58.3%) and upgraded in 20 (41.7%), although only six reviews were promoted to high quality. CONCLUSION Updated systematic reviews continued to suggest that only a minority of outcomes for health care interventions are supported by high-quality evidence. The quality of the evidence did not consistently improve or worsen in updated reviews.

Published
2020

47. Cognitive–behavioural therapy for a variety of conditions: an overview of systematic reviews and panoramic meta-analysis

Author

Fordham, Beth, primary, Sugavanam, Thavapriya, additional, Edwards, Katherine, additional, Hemming, Karla, additional, Howick, Jeremy, additional, Copsey, Bethan, additional, Lee, Hopin, additional, Kaidesoja, Milla, additional, Kirtley, Shona, additional, Hopewell, Sally, additional, das Nair, Roshan, additional, Howard, Robert, additional, Stallard, Paul, additional, Hamer-Hunt, Julia, additional, Cooper, Zafra, additional, and Lamb, Sarah E, additional

Published
2021
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