Jeremy Howick | University of Leicester (original) (raw)

Papers by Jeremy Howick

Research paper thumbnail of The Effect of Practitioner Empathy on Patient Satisfaction

Annals of internal medicine, Feb 1, 2024

Background: Practitioners who deliver enhanced empa- thy may improve patient satisfaction with ca... more Background: Practitioners who deliver enhanced empa- thy may improve patient satisfaction with care. Patient satisfaction is associated with positive patient outcomes ranging from medication adherence to survival. Purpose: To evaluate the effect of health care practi- tioner empathy on patient satisfaction, using a system- atic review of randomized trials. Data Sources: Ovid MEDLINE, CINAHL, PsycInfo, Cochrane Central Register of Controlled Trials, and Scopus to 23 October 2023. Study Selection: Randomized trials published in any language that evaluated the effect of empathy on improving patient satisfaction as measured on a validated patient satisfaction scale. Data Extraction: Data extraction, risk-of-bias assess- ments, and strength-of-evidence assessments were done by 2 independent reviewers. Disagreements were resolved through consensus. Data Synthesis: Fourteen eligible randomized trials (80 practitioners; 1986 patients) were included in the analysis. Five studies had high risk of bias, and 9 had some concerns about bias. The trials were heterogene- ous in terms of geographic locations (North America,Europe, Asia, and Africa), settings (hospital and pri- mary care), practitioner types (family and hospital physicians, anesthesiologists, nurses, psychologists, and caregivers), and type of randomization (individual patient or clustered by practitioner). Although all trials sug- gested a positive change in patient satisfaction, inad- equate reporting hindered the ability to draw definitive conclusions about the overall effect size. Limitations: Heterogeneity in the way that empathy was delivered and patient satisfaction was measured and incomplete reporting leading to concerns about the certainty of the underpinning evidence. Conclusion: Various empathy interventions have been studied to improve patient satisfaction. Development, testing, and reporting of high-quality studies within well-defined contexts is needed to optimize empathy interventions that increase patient satisfaction. Primary Funding Source: Stoneygate Trust. (PROSPERO: CRD42023412981)

Research paper thumbnail of Randomized Trials and Observational Studies: The Current Philosophical Controversy

This thesis examines philosophical controversies surrounding the evaluation of medical treatments... more This thesis examines philosophical controversies surrounding the evaluation of medical treatments, with a focus on the evidential roles of randomised trials and mechanisms in Evidence-Based Medicine. Current 'best practice' usually involves excluding non-randomised trial evidence from systematic reviews in cases where randomised trials are available for inclusion in the reviews. The first paper challenges this practice and evaluates whether adding of evidence from non-randomised trials might improve the quality and precision of some systematic reviews. The second paper compares the alleged methodological benefits of randomised trials over observational studies for investigating treatment benefits. It suggests that claims about the superiority of well-conducted randomised controlled trials over well-conducted observational studies are justified, especially when results from the two methods are contradictory. The third paper argues that postulating the unpredictability paradox in systematic reviews when no detectable empirical differences can be found requires further justification. The fourth paper examines the problem of absence causation in the context of explaining causal mechanisms and argues that a recent solution (Barros 2013) is incomplete and requires further justification. Solving the problem by describing absences as causes of 'mechanism failure' fails to take into account the effects of absences that lead to vacillating levels of mechanism functionality (i.e. differences in effectiveness or efficiency). The fifth paper criticises literature that has emphasised functioning versus 'broken' or 'non-functioning' mechanisms emphasising that many diseases result from increased or decreased mechanism function, rather than complete loss of function. Mechanistic explanations must account for differences in the effectiveness of performed functions, yet current philosophical mechanistic explanations do not achieve this. The last paper argues that the standard of evidence embodied in the ICE theory of technological function (i.e. testimonial evidence and evidence of mechanisms) is too permissive for evaluating whether the proposed functions of medical technologies have been adequately assessed and correctly ascribed. It argues that high-quality evidence from clinical studies is necessary to justify functional ascriptions to health care technologies.

Research paper thumbnail of An Empathy Imitation Game: Empathy Turing Test for Care- and Chat-bots

Minds and Machines, Feb 4, 2021

Asimo is a robot that helps people with disabilities feed themselves (Honda Motor Company 2007). ... more Asimo is a robot that helps people with disabilities feed themselves (Honda Motor Company 2007). Robear reduces the physical strain of carers' work by lifting and moving heavy patients (Szondy 2015). Pepper organises sing-songs, makes gin and tonics, and can mirror your tone of voice when speaking to you . Carebots have "cousins" called chatbots that simulate human speech but not physical behaviour. They can allegedly provide cognitive behavioural therapy for an array of psychiatric disorders . A chatbot called Woebot uses artificial intelligence (AI) to track moods and offers tips it claims can reduce depression, anxiety, and other psychological problems . A chatbot called Shim successfully promoted mental wellbeing using cognitive behavioural therapy . Carebots and chatbots (henceforth 'artificial carers') are often promoted as a means of coping with the problem posed by a shortage of human carers and a growing elderly population (Pepito and Locsin 2019). Faith in the success of artificial carers assumes that automation-derived efficiency gains in the health and care sectors is likely to mirror those seen in other sectors . Tools and technology have assisted doctors for millennia, and computers have improved doctors' diagnoses for decades ). Yet, one may claim that systems like Asimo, Robear, Woebot do more than help. Artificial carers are getting better and better at doing what humans can do at breakneck speed , which leads some to surmise that they might actually replace (many functions of) human doctors within a few decades . Besides the lack of robust evidence about safety and efficacy, another barrier to this hypothesised future becoming reality, is that it is hard to imagine these artificial carers empathizing, understanding, or offering the same degree of  Jeremy Howick

Research paper thumbnail of Tackling statin intolerance with n-of-1 trials (TaSINI) in primary care: protocol for a feasibility randomised trial to increase statin adherence

Research paper thumbnail of Problematic placebos in physical therapy trials

Journal of Evaluation in Clinical Practice, Jun 5, 2016

The function of a placebo control in a randomised trial is to permit blinding and reduce risk of ... more The function of a placebo control in a randomised trial is to permit blinding and reduce risk of bias. Adopting Grűnbaum's definitional scheme of a placebo, all treatments must be viewed as packages consisting of characteristic and incidental features. An adequate placebo for an experimental treatment contains none of the characteristic features, all of the incidental features, and nothing more. For drug treatments, characteristic features can be readily identified, isolated, and separated. By contrast, physical therapy treatments often involve features such as patient-therapist contact and sensory feedback that make this separation difficult both conceptually and practically. It is therefore unsurprising that attempts to construct placebos for physical therapy treatments have in the past led to biased estimates of treatment effects. In this perspective piece, we describe the problem with constructing placebos for physical therapy trials drawing upon Grűnbaum's definition and using paradigmatic examples from existing literature. We conclude by submitting that in the many cases where an adequate placebo cannot be achieved, alternative trial designs, e.g. dose-response or comparative-effectiveness trials, carry a lower risk of bias and should be favoured.

Research paper thumbnail of Did John Stuart Mill influence the design of controlled clinical trials?

Journal of the Royal Society of Medicine, Jun 1, 2019

Research paper thumbnail of Improving Empathy in Healthcare Consultations—a Secondary Analysis of Interventions

Journal of General Internal Medicine, Jul 14, 2020

systematic review of randomised trials suggested that empathic communication improves patient hea... more 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 nonspecific 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.

Research paper thumbnail of A survey of clinical empathy training at UK medical schools

BMC Medical Education, Jan 19, 2023

Background The benefits of enhancing practitioner empathy include better patient outcomes and imp... more Background The benefits of enhancing practitioner empathy include better patient outcomes and improved job satisfaction for practitioners. Evidence suggests empathy can be taught and empathy is listed as an outcome for graduates in the General Medical Council requirements. Despite this, empathy training is not mandatory on medical school curricula and the extent to which medical students are given empathy-specific training is unknown. Aim To conduct a survey of empathy training currently offered to medical students in UK medical schools. Methods An invitation to participate in an online survey was sent to all UK medical schools (n = 40). The survey was developed through a consultancy and pilot process to ensure validity and reliability. Questions explored what empathy-focused training is offered, and asked educators whether or not they believed that current provision of empathy training is sufficient. In parallel, medical school websites were searched to identify what information regarding empathy-focused training is described as being part of the degree course. Descriptive statistics were used to describe empathy training delivery from the results of the online materials survey and closed survey questions. Thematic analysis was used to explore free text comments. Response rate was 70% (28/40), with 28 medical schools included in the analysis. Twenty-six schools reported that their undergraduate curriculum included some form of empathy-focused training with variation in what, when and how this is delivered. Thematic analysis revealed two overarching themes with associated subthemes: (i) empathy-focused training and development (considering where, when and how empathy training should be integrated); (ii) challenges presented by including empathy on the curriculum (considering the system, students and faculty). All schools agreed empathy training should be on the undergraduate curriculum. Conclusion This is the first nationwide survey of empathy-focused training at UK medical schools. While some form of empathy-focused training appears to be provided on the undergraduate curriculum at most UK medical schools, empathy is rarely specifically assessed. Most medical educators do not feel their school does enough to promote empathy and the majority would like to offer more.

Research paper thumbnail of Why might medical student empathy change throughout medical school? a systematic review and thematic synthesis of qualitative studies

BMC Medical Education

Background Several studies suggest that medical student empathy declines throughout medical schoo... more Background Several studies suggest that medical student empathy declines throughout medical school. However, no studies have synthesised the evidence regarding why empathy declines. Objective To conduct a systematic review and thematic synthesis of qualitative studies investigating why student empathy may change throughout medical school. Methods We included any qualitative study that investigated why empathy might change during medical school. We searched the Medline, Scopus, CINAHL, ERIC, and APA PsycInfo databases for relevant studies. All databases were searched from their inception to 18 July 2022. We also searched the reference lists of the included studies and contacted experts to identify additional studies. We used the Joanna Briggs Institute tool to evaluate the risk of bias in the included studies. Overall confidence in our results was assessed using the Confidence in the Evidence from Reviews of Qualitative research (CERQual) approach. We used thematic methods to synthes...

Research paper thumbnail of Clinician views on optimism and empathy in primary care consultations: a qualitative interview study

BJGP Open

BackgroundPractitioner expressions of optimism and empathy may improve treatment engagement, adhe... more BackgroundPractitioner expressions of optimism and empathy may improve treatment engagement, adherence, and patient satisfaction but are not delivered consistently amid the challenges of everyday clinical practice.AimTo explore primary care practitioner (PCP) views about optimistic and empathic communication in consultations; and to identify behavioural, attitudinal, and/or contextual issues likely to encourage or deter PCPs from practising such communication.Design & settingQualitative interview study with 20 PCPs (GPs, practice nurses, and primary care physiotherapists).MethodSemi-structured telephone interviews with 20 PCPs. Data were analysed thematically.ResultsA conceptual mismatch between optimism and patient expectations became apparent; when asked how PCPs communicate about the likely effects of a treatment, answers were focussed around managing patient expectations. When prompted, it became clear PCPs were open to communicating optimistically with patients, but emphasised ...

Research paper thumbnail of 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

Frontiers in Pain Research

Background: Empathic communication and positive messages are important components of “placebo” ef... more Background: Empathic communication and positive messages are important components of “placebo” effects and can improve patient outcomes, including pain. Communicating empathy and optimism to patients within consultations may also enhance the effects of verum, i.e., non-placebo, treatments. This is particularly relevant for osteoarthritis, which is common, costly and difficult to manage. Digital interventions can be effective tools for changing practitioner behavior. This paper describes the systematic planning, development and optimization of an online intervention—“Empathico”–to help primary healthcare practitioners enhance their communication of clinical empathy and realistic optimism during consultations.Methods: The Person-Based Approach to intervention development was used. This entailed integrating insights from placebo and behavior change theory and evidence, and conducting primary and secondary qualitative research. Systematic literature reviews identified barriers, facilita...

Research paper thumbnail of Why might medical student empathy change throughout medical school? Protocol for a systematic review and thematic synthesis of qualitative studies

BMJ Open

IntroductionSeveral studies suggest that medical student empathy declines throughout medical scho... more IntroductionSeveral studies suggest that medical student empathy declines throughout medical school. However, no studies have systematically investigated why. The objective of our proposed review is to conduct a systematic review and thematic synthesis of qualitative studies investigating the reasons empathy may change throughout medical school.Methods and analysisThis systematic review protocol follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. We have searched MEDLINE, Scopus, CINAHL, ERIC and APA PsycINFO for relevant studies. We will also search reference lists of included studies and contact experts to identify additional studies. We will include any qualitative study investigating the reasons why empathy changes throughout medical school. We will use the Joanna Briggs Institute tool to evaluate the risk of bias in the included studies. We will use thematic analysis to synthesise our results. For all included studies, we will summarise th...

Research paper thumbnail of Cognitive–behavioural therapy for a variety of conditions: an overview of systematic reviews and panoramic meta-analysis

Health Technology Assessment, Feb 1, 2021

Zafra Cooper reports occasional fees for lectures and workshops on cognitive-behaviour therapy (C... more Zafra Cooper reports occasional fees for lectures and workshops on cognitive-behaviour therapy (CBT) for eating disorders, and payment to provide various clinical and research groups with supervision in CBT for eating disorders. Roshan das Nair reports being chairperson of the

Research paper thumbnail of Effectiveness of cognitive–behavioural therapy: a protocol for an overview of systematic reviews and meta-analyses

BMJ Open, Dec 1, 2018

Introduction Cognitive-behavioural therapy (CBT) is a psychological therapy that has been used to... more Introduction Cognitive-behavioural therapy (CBT) is a psychological therapy that has been used to improve patient well-being across multiple mental and physical health problems. Its effectiveness has been examined in thousands of randomised control trials that have been synthesised into hundreds of systematic reviews. The aim of this overview is to map, synthesise and assess the reliability of evidence generated from these systematic reviews of the effectiveness of CBT across all health conditions, patient groups and settings. Methods and analysis We will run our search strategy, to identify systematic reviews of CBT, within the Database of Abstracts of Reviews of Effects, the Cochrane Library of Systematic Reviews, MEDLINE, Embase, PsycInfo, CINAHL, Child Development and Adolescent Studies, and OpenGrey between January 1992 and 25 April 2018. Independent reviewers will sift, perform data extraction in duplicate and assess the quality of the reviews using the Assessing the Methodological Quality of Systematic Reviews (V.2) tool. The outcomes of interest include: health-related quality of life, depression, anxiety, psychosis and physical/physiological outcomes prioritised in the individual reviews. The evidence will be mapped and synthesised where appropriate by health problem, patient subgroups, intervention type, context and outcome. Ethics and dissemination Ethical approval is not required as this is an overview of published systematic reviews. We plan to publish results in peer-reviewed journals and present at international and national academic, clinical and patient conferences. trial registration number CRD42017078690.

Research paper thumbnail of Exploring the causal relationship between empathy and patient satisfaction: A systematic review of randomised trials

BACKGROUNDEmpathic healthcare has been shown to benefit patients and practitioners, including by ... more BACKGROUNDEmpathic healthcare has been shown to benefit patients and practitioners, including by improving patient satisfaction. However, the quality of evidence for the benefits of empathic care is often lacking. ObjectivesThis systematic review aims to assess the relationship between empathy and patient satisfaction.DesignA systematic review and meta-analysis of randomised controlled trials.METHODSEligibility criteriaWe will include randomised trials that investigated the effect of empathy training for practitioners on patient satisfaction. We will exclude non-randomised trials.Information sourcesWe will search MEDLINE, Ovid, Cochrane Central Register of Controlled Trials (CENTRAL), ClinicalTrials.gov and the International Clinical Trials Registry Platform (ICTRP), and OpenGrey, the Grey Literature report all from inception to 31 March 2023. We will also screen the reference lists and conduct cited reference searches for all included studies. In addition, reference chasing of rele...

Research paper thumbnail of The effect of practitioner empathy on patient satisfaction: A systematic review of randomized trials Authors

Annals of Internal Medicine, 2024

Background: Practitioners who deliver enhanced empa- thy may improve patient satisfaction with ca... more Background: Practitioners who deliver enhanced empa- thy may improve patient satisfaction with care. Patient satisfaction is associated with positive patient outcomes ranging from medication adherence to survival.
Purpose: To evaluate the effect of health care practi- tioner empathy on patient satisfaction, using a system- atic review of randomized trials.

Data Sources: Ovid MEDLINE, CINAHL, PsycInfo, Cochrane Central Register of Controlled Trials, and Scopus to 23 October 2023.
Study Selection: Randomized trials published in any language that evaluated the effect of empathy on improving patient satisfaction as measured on a validated patient satisfaction scale.

Data Extraction: Data extraction, risk-of-bias assess- ments, and strength-of-evidence assessments were done by 2 independent reviewers. Disagreements were resolved through consensus.

Data Synthesis: Fourteen eligible randomized trials (80 practitioners; 1986 patients) were included in the analysis. Five studies had high risk of bias, and 9 had some concerns about bias. The trials were heterogene- ous in terms of geographic locations (North America,Europe, Asia, and Africa), settings (hospital and pri- mary care), practitioner types (family and hospital physicians, anesthesiologists, nurses, psychologists, and caregivers), and type of randomization (individual patient or clustered by practitioner). Although all trials sug- gested a positive change in patient satisfaction, inad- equate reporting hindered the ability to draw definitive conclusions about the overall effect size.

Limitations: Heterogeneity in the way that empathy was delivered and patient satisfaction was measured and incomplete reporting leading to concerns about the certainty of the underpinning evidence.

Conclusion: Various empathy interventions have been studied to improve patient satisfaction. Development, testing, and reporting of high-quality studies within well-defined contexts is needed to optimize empathy interventions that increase patient satisfaction.

Primary Funding Source: Stoneygate Trust. (PROSPERO: CRD42023412981)

Research paper thumbnail of Evidence-based mechanistic reasoning

Journal of the Royal Society of Medicine, Oct 31, 2010

Systematic reviews of high quality randomized trials generally count as the 'best evidence'. 1 Ho... more Systematic reviews of high quality randomized trials generally count as the 'best evidence'. 1 However, well-conducted randomized trials are sometimes unavailable, 2,3 unfeasible, 4 unethical 5 or unnecessary. 6,7 In such cases other forms of evidence must be considered. Many EBM proponents accept mechanistic reasoning ('pathophysiologic rationale') for generalizability, 1,8 hypothesis generation, 9 ruling out implausible hypotheses, 10,11 and for supporting efficacy in the absence of other 'stronger' forms of evidence. Yet because mechanistic reasoning has often led us astray, 12,13 most EBM proponents are justifiably sceptical about using mechanistic reasoning as evidence for efficacy. We suggest that the scepticism about the value of mechanistic reasoning should not extend to high quality mechanistic reasoning. Just as poor quality randomized trials (that are unblinded, 14-16 underpowered or biased, 17 that employ unconcealed allocation, 15,16 or otherwise biased) will not provide high quality evidence for efficacy, so poor quality mechanistic reasoning will be unreliable. In this theoretical exploration we suggest that mechanistic reasoning involving a not incomplete inferential chain and that takes potential complexity into account can and should be used as evidence of efficacy. We support our rules for mechanistic evidence with three examples. Figure 1 The 'black box' in a comparative clinical study ESSAY

Research paper thumbnail of Can understanding mechanisms solve the problem of extrapolating from study to target populations (the problem of ‘external validity’)?

Journal of the Royal Society of Medicine, Mar 1, 2013

Research paper thumbnail of Effects of changing practitioner empathy and patient expectations in healthcare consultations

Cochrane Database of Systematic Reviews, Nov 6, 2015

Effects of changing practitioner empathy and patient expectations in healthcare consultations.

Research paper thumbnail of Positive messages may reduce patient pain: A meta-analysis

European Journal of Integrative Medicine, Apr 1, 2017

Introduction: Current treatments for pain have limited benefits and worrying side effects. Some s... more Introduction: Current treatments for pain have limited benefits and worrying side effects. Some studies suggest that pain is reduced when clinicians deliver positive messages. However, the effects of positive messages are heterogeneous and have not been subject to meta-analysis. We aimed to estimate the efficacy of positive messages for pain reduction. Methods: We included randomized trials of the effects of positive messages in a subset of the studies included in a recent systematic review of context factors for treating pain. Several electronic databases were searched. Reference lists of relevant studies were also searched. Two authors independently undertook study selection, data extraction, risk of bias assessment, and analyses. Our primary outcome measures were differences in patient-or observer-reported pain between groups who were given positive messages and those who were not. Results: Of the 16 randomized trials (1703 patients) that met the inclusion criteria, 12 trials had sufficient data for meta-analysis. The pooled standardized effect size was À0.31 (95% confidence interval [CI] À0.61 to À0.01, p = 0.04, I 2 = 82%). The effect size remained positive but not statistically significant after we excluded studies considered to have a high risk of bias (standard effect size À0.17, 95% CI À0.54 to 0.19, P = 0.36, I 2 = 84%). Conclusion: Care of patients with chronic or acute pain may be enhanced when clinicians deliver positive messages about possible clinical outcomes. However, we have identified several limitations of the present study that suggest caution when interpreting the results. We recommend further high-quality studies to confirm (or falsify) our result.

Research paper thumbnail of The Effect of Practitioner Empathy on Patient Satisfaction

Annals of internal medicine, Feb 1, 2024

Background: Practitioners who deliver enhanced empa- thy may improve patient satisfaction with ca... more Background: Practitioners who deliver enhanced empa- thy may improve patient satisfaction with care. Patient satisfaction is associated with positive patient outcomes ranging from medication adherence to survival. Purpose: To evaluate the effect of health care practi- tioner empathy on patient satisfaction, using a system- atic review of randomized trials. Data Sources: Ovid MEDLINE, CINAHL, PsycInfo, Cochrane Central Register of Controlled Trials, and Scopus to 23 October 2023. Study Selection: Randomized trials published in any language that evaluated the effect of empathy on improving patient satisfaction as measured on a validated patient satisfaction scale. Data Extraction: Data extraction, risk-of-bias assess- ments, and strength-of-evidence assessments were done by 2 independent reviewers. Disagreements were resolved through consensus. Data Synthesis: Fourteen eligible randomized trials (80 practitioners; 1986 patients) were included in the analysis. Five studies had high risk of bias, and 9 had some concerns about bias. The trials were heterogene- ous in terms of geographic locations (North America,Europe, Asia, and Africa), settings (hospital and pri- mary care), practitioner types (family and hospital physicians, anesthesiologists, nurses, psychologists, and caregivers), and type of randomization (individual patient or clustered by practitioner). Although all trials sug- gested a positive change in patient satisfaction, inad- equate reporting hindered the ability to draw definitive conclusions about the overall effect size. Limitations: Heterogeneity in the way that empathy was delivered and patient satisfaction was measured and incomplete reporting leading to concerns about the certainty of the underpinning evidence. Conclusion: Various empathy interventions have been studied to improve patient satisfaction. Development, testing, and reporting of high-quality studies within well-defined contexts is needed to optimize empathy interventions that increase patient satisfaction. Primary Funding Source: Stoneygate Trust. (PROSPERO: CRD42023412981)

Research paper thumbnail of Randomized Trials and Observational Studies: The Current Philosophical Controversy

This thesis examines philosophical controversies surrounding the evaluation of medical treatments... more This thesis examines philosophical controversies surrounding the evaluation of medical treatments, with a focus on the evidential roles of randomised trials and mechanisms in Evidence-Based Medicine. Current 'best practice' usually involves excluding non-randomised trial evidence from systematic reviews in cases where randomised trials are available for inclusion in the reviews. The first paper challenges this practice and evaluates whether adding of evidence from non-randomised trials might improve the quality and precision of some systematic reviews. The second paper compares the alleged methodological benefits of randomised trials over observational studies for investigating treatment benefits. It suggests that claims about the superiority of well-conducted randomised controlled trials over well-conducted observational studies are justified, especially when results from the two methods are contradictory. The third paper argues that postulating the unpredictability paradox in systematic reviews when no detectable empirical differences can be found requires further justification. The fourth paper examines the problem of absence causation in the context of explaining causal mechanisms and argues that a recent solution (Barros 2013) is incomplete and requires further justification. Solving the problem by describing absences as causes of 'mechanism failure' fails to take into account the effects of absences that lead to vacillating levels of mechanism functionality (i.e. differences in effectiveness or efficiency). The fifth paper criticises literature that has emphasised functioning versus 'broken' or 'non-functioning' mechanisms emphasising that many diseases result from increased or decreased mechanism function, rather than complete loss of function. Mechanistic explanations must account for differences in the effectiveness of performed functions, yet current philosophical mechanistic explanations do not achieve this. The last paper argues that the standard of evidence embodied in the ICE theory of technological function (i.e. testimonial evidence and evidence of mechanisms) is too permissive for evaluating whether the proposed functions of medical technologies have been adequately assessed and correctly ascribed. It argues that high-quality evidence from clinical studies is necessary to justify functional ascriptions to health care technologies.

Research paper thumbnail of An Empathy Imitation Game: Empathy Turing Test for Care- and Chat-bots

Minds and Machines, Feb 4, 2021

Asimo is a robot that helps people with disabilities feed themselves (Honda Motor Company 2007). ... more Asimo is a robot that helps people with disabilities feed themselves (Honda Motor Company 2007). Robear reduces the physical strain of carers' work by lifting and moving heavy patients (Szondy 2015). Pepper organises sing-songs, makes gin and tonics, and can mirror your tone of voice when speaking to you . Carebots have "cousins" called chatbots that simulate human speech but not physical behaviour. They can allegedly provide cognitive behavioural therapy for an array of psychiatric disorders . A chatbot called Woebot uses artificial intelligence (AI) to track moods and offers tips it claims can reduce depression, anxiety, and other psychological problems . A chatbot called Shim successfully promoted mental wellbeing using cognitive behavioural therapy . Carebots and chatbots (henceforth 'artificial carers') are often promoted as a means of coping with the problem posed by a shortage of human carers and a growing elderly population (Pepito and Locsin 2019). Faith in the success of artificial carers assumes that automation-derived efficiency gains in the health and care sectors is likely to mirror those seen in other sectors . Tools and technology have assisted doctors for millennia, and computers have improved doctors' diagnoses for decades ). Yet, one may claim that systems like Asimo, Robear, Woebot do more than help. Artificial carers are getting better and better at doing what humans can do at breakneck speed , which leads some to surmise that they might actually replace (many functions of) human doctors within a few decades . Besides the lack of robust evidence about safety and efficacy, another barrier to this hypothesised future becoming reality, is that it is hard to imagine these artificial carers empathizing, understanding, or offering the same degree of  Jeremy Howick

Research paper thumbnail of Tackling statin intolerance with n-of-1 trials (TaSINI) in primary care: protocol for a feasibility randomised trial to increase statin adherence

Research paper thumbnail of Problematic placebos in physical therapy trials

Journal of Evaluation in Clinical Practice, Jun 5, 2016

The function of a placebo control in a randomised trial is to permit blinding and reduce risk of ... more The function of a placebo control in a randomised trial is to permit blinding and reduce risk of bias. Adopting Grűnbaum's definitional scheme of a placebo, all treatments must be viewed as packages consisting of characteristic and incidental features. An adequate placebo for an experimental treatment contains none of the characteristic features, all of the incidental features, and nothing more. For drug treatments, characteristic features can be readily identified, isolated, and separated. By contrast, physical therapy treatments often involve features such as patient-therapist contact and sensory feedback that make this separation difficult both conceptually and practically. It is therefore unsurprising that attempts to construct placebos for physical therapy treatments have in the past led to biased estimates of treatment effects. In this perspective piece, we describe the problem with constructing placebos for physical therapy trials drawing upon Grűnbaum's definition and using paradigmatic examples from existing literature. We conclude by submitting that in the many cases where an adequate placebo cannot be achieved, alternative trial designs, e.g. dose-response or comparative-effectiveness trials, carry a lower risk of bias and should be favoured.

Research paper thumbnail of Did John Stuart Mill influence the design of controlled clinical trials?

Journal of the Royal Society of Medicine, Jun 1, 2019

Research paper thumbnail of Improving Empathy in Healthcare Consultations—a Secondary Analysis of Interventions

Journal of General Internal Medicine, Jul 14, 2020

systematic review of randomised trials suggested that empathic communication improves patient hea... more 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 nonspecific 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.

Research paper thumbnail of A survey of clinical empathy training at UK medical schools

BMC Medical Education, Jan 19, 2023

Background The benefits of enhancing practitioner empathy include better patient outcomes and imp... more Background The benefits of enhancing practitioner empathy include better patient outcomes and improved job satisfaction for practitioners. Evidence suggests empathy can be taught and empathy is listed as an outcome for graduates in the General Medical Council requirements. Despite this, empathy training is not mandatory on medical school curricula and the extent to which medical students are given empathy-specific training is unknown. Aim To conduct a survey of empathy training currently offered to medical students in UK medical schools. Methods An invitation to participate in an online survey was sent to all UK medical schools (n = 40). The survey was developed through a consultancy and pilot process to ensure validity and reliability. Questions explored what empathy-focused training is offered, and asked educators whether or not they believed that current provision of empathy training is sufficient. In parallel, medical school websites were searched to identify what information regarding empathy-focused training is described as being part of the degree course. Descriptive statistics were used to describe empathy training delivery from the results of the online materials survey and closed survey questions. Thematic analysis was used to explore free text comments. Response rate was 70% (28/40), with 28 medical schools included in the analysis. Twenty-six schools reported that their undergraduate curriculum included some form of empathy-focused training with variation in what, when and how this is delivered. Thematic analysis revealed two overarching themes with associated subthemes: (i) empathy-focused training and development (considering where, when and how empathy training should be integrated); (ii) challenges presented by including empathy on the curriculum (considering the system, students and faculty). All schools agreed empathy training should be on the undergraduate curriculum. Conclusion This is the first nationwide survey of empathy-focused training at UK medical schools. While some form of empathy-focused training appears to be provided on the undergraduate curriculum at most UK medical schools, empathy is rarely specifically assessed. Most medical educators do not feel their school does enough to promote empathy and the majority would like to offer more.

Research paper thumbnail of Why might medical student empathy change throughout medical school? a systematic review and thematic synthesis of qualitative studies

BMC Medical Education

Background Several studies suggest that medical student empathy declines throughout medical schoo... more Background Several studies suggest that medical student empathy declines throughout medical school. However, no studies have synthesised the evidence regarding why empathy declines. Objective To conduct a systematic review and thematic synthesis of qualitative studies investigating why student empathy may change throughout medical school. Methods We included any qualitative study that investigated why empathy might change during medical school. We searched the Medline, Scopus, CINAHL, ERIC, and APA PsycInfo databases for relevant studies. All databases were searched from their inception to 18 July 2022. We also searched the reference lists of the included studies and contacted experts to identify additional studies. We used the Joanna Briggs Institute tool to evaluate the risk of bias in the included studies. Overall confidence in our results was assessed using the Confidence in the Evidence from Reviews of Qualitative research (CERQual) approach. We used thematic methods to synthes...

Research paper thumbnail of Clinician views on optimism and empathy in primary care consultations: a qualitative interview study

BJGP Open

BackgroundPractitioner expressions of optimism and empathy may improve treatment engagement, adhe... more BackgroundPractitioner expressions of optimism and empathy may improve treatment engagement, adherence, and patient satisfaction but are not delivered consistently amid the challenges of everyday clinical practice.AimTo explore primary care practitioner (PCP) views about optimistic and empathic communication in consultations; and to identify behavioural, attitudinal, and/or contextual issues likely to encourage or deter PCPs from practising such communication.Design & settingQualitative interview study with 20 PCPs (GPs, practice nurses, and primary care physiotherapists).MethodSemi-structured telephone interviews with 20 PCPs. Data were analysed thematically.ResultsA conceptual mismatch between optimism and patient expectations became apparent; when asked how PCPs communicate about the likely effects of a treatment, answers were focussed around managing patient expectations. When prompted, it became clear PCPs were open to communicating optimistically with patients, but emphasised ...

Research paper thumbnail of 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

Frontiers in Pain Research

Background: Empathic communication and positive messages are important components of “placebo” ef... more Background: Empathic communication and positive messages are important components of “placebo” effects and can improve patient outcomes, including pain. Communicating empathy and optimism to patients within consultations may also enhance the effects of verum, i.e., non-placebo, treatments. This is particularly relevant for osteoarthritis, which is common, costly and difficult to manage. Digital interventions can be effective tools for changing practitioner behavior. This paper describes the systematic planning, development and optimization of an online intervention—“Empathico”–to help primary healthcare practitioners enhance their communication of clinical empathy and realistic optimism during consultations.Methods: The Person-Based Approach to intervention development was used. This entailed integrating insights from placebo and behavior change theory and evidence, and conducting primary and secondary qualitative research. Systematic literature reviews identified barriers, facilita...

Research paper thumbnail of Why might medical student empathy change throughout medical school? Protocol for a systematic review and thematic synthesis of qualitative studies

BMJ Open

IntroductionSeveral studies suggest that medical student empathy declines throughout medical scho... more IntroductionSeveral studies suggest that medical student empathy declines throughout medical school. However, no studies have systematically investigated why. The objective of our proposed review is to conduct a systematic review and thematic synthesis of qualitative studies investigating the reasons empathy may change throughout medical school.Methods and analysisThis systematic review protocol follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. We have searched MEDLINE, Scopus, CINAHL, ERIC and APA PsycINFO for relevant studies. We will also search reference lists of included studies and contact experts to identify additional studies. We will include any qualitative study investigating the reasons why empathy changes throughout medical school. We will use the Joanna Briggs Institute tool to evaluate the risk of bias in the included studies. We will use thematic analysis to synthesise our results. For all included studies, we will summarise th...

Research paper thumbnail of Cognitive–behavioural therapy for a variety of conditions: an overview of systematic reviews and panoramic meta-analysis

Health Technology Assessment, Feb 1, 2021

Zafra Cooper reports occasional fees for lectures and workshops on cognitive-behaviour therapy (C... more Zafra Cooper reports occasional fees for lectures and workshops on cognitive-behaviour therapy (CBT) for eating disorders, and payment to provide various clinical and research groups with supervision in CBT for eating disorders. Roshan das Nair reports being chairperson of the

Research paper thumbnail of Effectiveness of cognitive–behavioural therapy: a protocol for an overview of systematic reviews and meta-analyses

BMJ Open, Dec 1, 2018

Introduction Cognitive-behavioural therapy (CBT) is a psychological therapy that has been used to... more Introduction Cognitive-behavioural therapy (CBT) is a psychological therapy that has been used to improve patient well-being across multiple mental and physical health problems. Its effectiveness has been examined in thousands of randomised control trials that have been synthesised into hundreds of systematic reviews. The aim of this overview is to map, synthesise and assess the reliability of evidence generated from these systematic reviews of the effectiveness of CBT across all health conditions, patient groups and settings. Methods and analysis We will run our search strategy, to identify systematic reviews of CBT, within the Database of Abstracts of Reviews of Effects, the Cochrane Library of Systematic Reviews, MEDLINE, Embase, PsycInfo, CINAHL, Child Development and Adolescent Studies, and OpenGrey between January 1992 and 25 April 2018. Independent reviewers will sift, perform data extraction in duplicate and assess the quality of the reviews using the Assessing the Methodological Quality of Systematic Reviews (V.2) tool. The outcomes of interest include: health-related quality of life, depression, anxiety, psychosis and physical/physiological outcomes prioritised in the individual reviews. The evidence will be mapped and synthesised where appropriate by health problem, patient subgroups, intervention type, context and outcome. Ethics and dissemination Ethical approval is not required as this is an overview of published systematic reviews. We plan to publish results in peer-reviewed journals and present at international and national academic, clinical and patient conferences. trial registration number CRD42017078690.

Research paper thumbnail of Exploring the causal relationship between empathy and patient satisfaction: A systematic review of randomised trials

BACKGROUNDEmpathic healthcare has been shown to benefit patients and practitioners, including by ... more BACKGROUNDEmpathic healthcare has been shown to benefit patients and practitioners, including by improving patient satisfaction. However, the quality of evidence for the benefits of empathic care is often lacking. ObjectivesThis systematic review aims to assess the relationship between empathy and patient satisfaction.DesignA systematic review and meta-analysis of randomised controlled trials.METHODSEligibility criteriaWe will include randomised trials that investigated the effect of empathy training for practitioners on patient satisfaction. We will exclude non-randomised trials.Information sourcesWe will search MEDLINE, Ovid, Cochrane Central Register of Controlled Trials (CENTRAL), ClinicalTrials.gov and the International Clinical Trials Registry Platform (ICTRP), and OpenGrey, the Grey Literature report all from inception to 31 March 2023. We will also screen the reference lists and conduct cited reference searches for all included studies. In addition, reference chasing of rele...

Research paper thumbnail of The effect of practitioner empathy on patient satisfaction: A systematic review of randomized trials Authors

Annals of Internal Medicine, 2024

Background: Practitioners who deliver enhanced empa- thy may improve patient satisfaction with ca... more Background: Practitioners who deliver enhanced empa- thy may improve patient satisfaction with care. Patient satisfaction is associated with positive patient outcomes ranging from medication adherence to survival.
Purpose: To evaluate the effect of health care practi- tioner empathy on patient satisfaction, using a system- atic review of randomized trials.

Data Sources: Ovid MEDLINE, CINAHL, PsycInfo, Cochrane Central Register of Controlled Trials, and Scopus to 23 October 2023.
Study Selection: Randomized trials published in any language that evaluated the effect of empathy on improving patient satisfaction as measured on a validated patient satisfaction scale.

Data Extraction: Data extraction, risk-of-bias assess- ments, and strength-of-evidence assessments were done by 2 independent reviewers. Disagreements were resolved through consensus.

Data Synthesis: Fourteen eligible randomized trials (80 practitioners; 1986 patients) were included in the analysis. Five studies had high risk of bias, and 9 had some concerns about bias. The trials were heterogene- ous in terms of geographic locations (North America,Europe, Asia, and Africa), settings (hospital and pri- mary care), practitioner types (family and hospital physicians, anesthesiologists, nurses, psychologists, and caregivers), and type of randomization (individual patient or clustered by practitioner). Although all trials sug- gested a positive change in patient satisfaction, inad- equate reporting hindered the ability to draw definitive conclusions about the overall effect size.

Limitations: Heterogeneity in the way that empathy was delivered and patient satisfaction was measured and incomplete reporting leading to concerns about the certainty of the underpinning evidence.

Conclusion: Various empathy interventions have been studied to improve patient satisfaction. Development, testing, and reporting of high-quality studies within well-defined contexts is needed to optimize empathy interventions that increase patient satisfaction.

Primary Funding Source: Stoneygate Trust. (PROSPERO: CRD42023412981)

Research paper thumbnail of Evidence-based mechanistic reasoning

Journal of the Royal Society of Medicine, Oct 31, 2010

Systematic reviews of high quality randomized trials generally count as the 'best evidence'. 1 Ho... more Systematic reviews of high quality randomized trials generally count as the 'best evidence'. 1 However, well-conducted randomized trials are sometimes unavailable, 2,3 unfeasible, 4 unethical 5 or unnecessary. 6,7 In such cases other forms of evidence must be considered. Many EBM proponents accept mechanistic reasoning ('pathophysiologic rationale') for generalizability, 1,8 hypothesis generation, 9 ruling out implausible hypotheses, 10,11 and for supporting efficacy in the absence of other 'stronger' forms of evidence. Yet because mechanistic reasoning has often led us astray, 12,13 most EBM proponents are justifiably sceptical about using mechanistic reasoning as evidence for efficacy. We suggest that the scepticism about the value of mechanistic reasoning should not extend to high quality mechanistic reasoning. Just as poor quality randomized trials (that are unblinded, 14-16 underpowered or biased, 17 that employ unconcealed allocation, 15,16 or otherwise biased) will not provide high quality evidence for efficacy, so poor quality mechanistic reasoning will be unreliable. In this theoretical exploration we suggest that mechanistic reasoning involving a not incomplete inferential chain and that takes potential complexity into account can and should be used as evidence of efficacy. We support our rules for mechanistic evidence with three examples. Figure 1 The 'black box' in a comparative clinical study ESSAY

Research paper thumbnail of Can understanding mechanisms solve the problem of extrapolating from study to target populations (the problem of ‘external validity’)?

Journal of the Royal Society of Medicine, Mar 1, 2013

Research paper thumbnail of Effects of changing practitioner empathy and patient expectations in healthcare consultations

Cochrane Database of Systematic Reviews, Nov 6, 2015

Effects of changing practitioner empathy and patient expectations in healthcare consultations.

Research paper thumbnail of Positive messages may reduce patient pain: A meta-analysis

European Journal of Integrative Medicine, Apr 1, 2017

Introduction: Current treatments for pain have limited benefits and worrying side effects. Some s... more Introduction: Current treatments for pain have limited benefits and worrying side effects. Some studies suggest that pain is reduced when clinicians deliver positive messages. However, the effects of positive messages are heterogeneous and have not been subject to meta-analysis. We aimed to estimate the efficacy of positive messages for pain reduction. Methods: We included randomized trials of the effects of positive messages in a subset of the studies included in a recent systematic review of context factors for treating pain. Several electronic databases were searched. Reference lists of relevant studies were also searched. Two authors independently undertook study selection, data extraction, risk of bias assessment, and analyses. Our primary outcome measures were differences in patient-or observer-reported pain between groups who were given positive messages and those who were not. Results: Of the 16 randomized trials (1703 patients) that met the inclusion criteria, 12 trials had sufficient data for meta-analysis. The pooled standardized effect size was À0.31 (95% confidence interval [CI] À0.61 to À0.01, p = 0.04, I 2 = 82%). The effect size remained positive but not statistically significant after we excluded studies considered to have a high risk of bias (standard effect size À0.17, 95% CI À0.54 to 0.19, P = 0.36, I 2 = 84%). Conclusion: Care of patients with chronic or acute pain may be enhanced when clinicians deliver positive messages about possible clinical outcomes. However, we have identified several limitations of the present study that suggest caution when interpreting the results. We recommend further high-quality studies to confirm (or falsify) our result.