Veterinary communication skills and training in the United Kingdom and the United States of America

Veterinary communication is a core clinical skill and is believed to have a positive impact on client satisfaction, trust and adherence to patient management recommendations. Veterinary communication skills training has therefore been incorporated into veterinary undergraduate and postgraduate education. This thesis focuses on the topic of veterinary communication and comprises two studies. The aim of the first study was to gain a current understanding of the state, adequacy, and relevance of veterinary communication skills and training in the United Kingdom (UK) and United States of America (USA). This was done by conducting a survey of a sample of veterinary surgeons in each country about communication skills and training in the context of a veterinary consultation. A quantitative and qualitative analysis of the data from the survey was undertaken. Key findings were that 98 percent of respondents (1,708/1,748) believed communication skills to be equal in importance to, or more important than, clinical knowledge, whereas only 40 percent (705/1,759) were interested in further communication skills training. Barriers to participation in communication CPD appear to include lack of time and/or employer support, and a belief among some practitioners that communication training could no longer benefit them or was inadequately matched to real-world communication challenges. The aim of the second study was to assess several factors that may impact on communication dynamics during a consultation. Fifty-five video-recorded veterinary consultations in the UK and USA were analysed as follows: 1. The complexity of the consultations was assessed using a tool previously validated for recording information via direct observation of consultations. Elements recorded included details on the patient(s) and reasons for the visit, problems investigated, body systems involved, tests performed, diagnoses, and outcomes. Categorical data statistics were recorded as whole numbers and percentages and Chi-Square calculations were done to measure differences between UK and USA data. Continuous data statistics were recorded as median, range, and interquartile ratio (IQR) and Mann-Whitney U tests were performed to measure UK versus USA differences. (Continuous data for the remaining elements in the study were analysed in the same manner.) Key findings were that consultations were complex, involving multiple problems, body systems, tests, diagnoses, and outcomes. 2. Consultations were analysed for alignment with two consultation models, the Calgary-Cambridge Model for Veterinary Consultations (GCCVM) and the Patient-centred Clinical Method, by coding elements of each consultation model in the consultation transcripts. The frequency and proportion of model elements demonstrated in each consultation were assessed, as was the alignment of the consultations to each model, defined by the percent of possible model elements demonstrated in each consultation. There was 86.67% alignment with the GCCVM and 62.50% alignment with the Patient-centred Clinical Method. Veterinary surgeons in the study spent more time gathering information and explaining than empathising or soliciting client input. 3. Consultations were also analysed for dominance of medical versus lifeworld dialogue using the Mishler Discourse Analysis, and medical dialogue dominated over lifeworld dialogue (65.62% to 34.48%). 4. Client/relationship centredness was evaluated using a novel application of a tool in veterinary communication research, the Verona Patient-centred Communication Evaluation Scale (VR-COPE). Results suggested a relatively high degree of client/relationship centredness (a median score of 76/100), though with somewhat lower scores for elements related to client emotions and the veterinary surgeon responding to them. 5. Client satisfaction was evaluated using the previously validated Client Satisfaction Quotient (CSQ). There was a high degree of satisfaction expressed by clients (median score of 94/114), though average scores were slightly lower for topics related to cost and expression of interest in the client’s opinion. Limitations of the research included the low response rate of US veterinary surgeons to the survey, the small, convenience-based sample used in the consultation study, the reliance on the researcher for maintaining quality and validity, and the scoring of client/relationship-centredness with a tool that heretofore had not been used in veterinary medicine and was not subjected to extensive inter-rater variability testing. The findings in this thesis support the contention that communication skills are important for veterinary practitioners. The work also highlights the need for making communication training a priority in undergraduate veterinary education and an accessible and relevant component of postgraduate CPD. The findings also suggest a need to equip veterinary students and practitioners for communication during consultations that are relatively complex with highly iterative flow between topics, as well as for addressing emotions and inviting input of clients. Elements of the GCCVM and other models may help provide a framework for training in these competencies

Veterinary communication skills and training in the United Kingdom and the United States of America

Veterinary communication is a core clinical skill and is believed to have a positive impact on client satisfaction, trust and adherence to patient management recommendations. Veterinary communication skills training has therefore been incorporated into veterinary undergraduate and postgraduate education. This thesis focuses on the topic of veterinary communication and comprises two studies. The aim of the first study was to gain a current understanding of the state, adequacy, and relevance of veterinary communication skills and training in the United Kingdom (UK) and United States of America (USA). This was done by conducting a survey of a sample of veterinary surgeons in each country about communication skills and training in the context of a veterinary consultation. A quantitative and qualitative analysis of the data from the survey was undertaken. Key findings were that 98 percent of respondents (1,708/1,748) believed communication skills to be equal in importance to, or more important than, clinical knowledge, whereas only 40 percent (705/1,759) were interested in further communication skills training. Barriers to participation in communication CPD appear to include lack of time and/or employer support, and a belief among some practitioners that communication training could no longer benefit them or was inadequately matched to real-world communication challenges. The aim of the second study was to assess several factors that may impact on communication dynamics during a consultation. Fifty-five video-recorded veterinary consultations in the UK and USA were analysed as follows: 1. The complexity of the consultations was assessed using a tool previously validated for recording information via direct observation of consultations. Elements recorded included details on the patient(s) and reasons for the visit, problems investigated, body systems involved, tests performed, diagnoses, and outcomes. Categorical data statistics were recorded as whole numbers and percentages and Chi-Square calculations were done to measure differences between UK and USA data. Continuous data statistics were recorded as median, range, and interquartile ratio (IQR) and Mann-Whitney U tests were performed to measure UK versus USA differences. (Continuous data for the remaining elements in the study were analysed in the same manner.) Key findings were that consultations were complex, involving multiple problems, body systems, tests, diagnoses, and outcomes. 2. Consultations were analysed for alignment with two consultation models, the Calgary-Cambridge Model for Veterinary Consultations (GCCVM) and the Patient-centred Clinical Method, by coding elements of each consultation model in the consultation transcripts. The frequency and proportion of model elements demonstrated in each consultation were assessed, as was the alignment of the consultations to each model, defined by the percent of possible model elements demonstrated in each consultation. There was 86.67% alignment with the GCCVM and 62.50% alignment with the Patient-centred Clinical Method. Veterinary surgeons in the study spent more time gathering information and explaining than empathising or soliciting client input. 3. Consultations were also analysed for dominance of medical versus lifeworld dialogue using the Mishler Discourse Analysis, and medical dialogue dominated over lifeworld dialogue (65.62% to 34.48%). 4. Client/relationship centredness was evaluated using a novel application of a tool in veterinary communication research, the Verona Patient-centred Communication Evaluation Scale (VR-COPE). Results suggested a relatively high degree of client/relationship centredness (a median score of 76/100), though with somewhat lower scores for elements related to client emotions and the veterinary surgeon responding to them. 5. Client satisfaction was evaluated using the previously validated Client Satisfaction Quotient (CSQ). There was a high degree of satisfaction expressed by clients (median score of 94/114), though average scores were slightly lower for topics related to cost and expression of interest in the client’s opinion. Limitations of the research included the low response rate of US veterinary surgeons to the survey, the small, convenience-based sample used in the consultation study, the reliance on the researcher for maintaining quality and validity, and the scoring of client/relationship-centredness with a tool that heretofore had not been used in veterinary medicine and was not subjected to extensive inter-rater variability testing. The findings in this thesis support the contention that communication skills are important for veterinary practitioners. The work also highlights the need for making communication training a priority in undergraduate veterinary education and an accessible and relevant component of postgraduate CPD. The findings also suggest a need to equip veterinary students and practitioners for communication during consultations that are relatively complex with highly iterative flow between topics, as well as for addressing emotions and inviting input of clients. Elements of the GCCVM and other models may help provide a framework for training in these competencies

Design and rationale for a randomized, double-blind, placebo-controlled Phase 2/3 trial of oral arimoclomol in inclusion body myositis

  Ethical publication statement We confirm that we have read the Journal’s position on issues involved in ethical publication and affirm that this report is consistent with those guidelines.   Disclosure of conflicts of interest P.M.M. has received consulting fees and funding support from Orphazyme A/S, paid to his academic institution (University College London), for the oversight and conduct of this study. R.J.B. has received funding from the FDA Office Orphan Products Development grant for his role in this study. M.P.M. has no relevant conflicts of interest to declare. C.S. and T.B. are employees of Orphazyme A/S. M.G.H. receives research funding from the Medical Research Council UK and has previously acted a consultant for Novartis and for Orphazyme A/S. M.M.D. is a consultant for Orphazyme and received funding support, paid to his academic institution (University of Kansas Medical Center, Research Institute), from Orphazyme A/S for the oversight and conduct of this study. Design and rationale for a randomized, double-blind, placebo-controlled Phase 2/3 trial of oral arimoclomol in inclusion body myositis Abstract Introduction/Aims: Inclusion body myositis (IBM) is the most common progressive, debilitating muscle disease in people over the age of 50 years, for whom there is no effective treatment. Here, we present the design and rationale for one of the largest clinical studies conducted in IBM to date, to evaluate the efficacy, safety, and tolerability of arimoclomol, a novel, oral amplifier of the cellular heat shock response. Methods: This is a randomized, double-blind, placebo-controlled, parallel group trial conducted at 11 centers in the US and one center in the UK. Eligible patients had a diagnosis of IBM fulfilling European Neuromuscular Centre 2011 criteria, with onset of weakness at > 45 years of age. Enrolled participants were randomized 1:1 to receive either oral arimoclomol citrate 1,200 mg/day or matching placebo for up to 20 months. The primary endpoint is the change from baseline to Month 20 in the IBM functional rating scale (IBMFRS) total score. The secondary efficacy endpoints include evaluations of participants’ functional abilities, strength, and physical health-related quality of life (HRQoL). A sub-study will characterize muscle changes using MRI in a subset of participants. Discussion: This study will generate important clinical data on a novel therapeutic strategy for patients with IBM, a population with no current treatment options

Machine Learning Prediction of Cancer Cell Sensitivity to Drugs Based on Genomic and Chemical Properties

Predicting the response of a specific cancer to a therapy is a major goal in modern oncology that should ultimately lead to a personalised treatment. High-throughput screenings of potentially active compounds against a panel of genomically heterogeneous cancer cell lines have unveiled multiple relationships between genomic alterations and drug responses. Various computational approaches have been proposed to predict sensitivity based on genomic features, while others have used the chemical properties of the drugs to ascertain their effect. In an effort to integrate these complementary approaches, we developed machine learning models to predict the response of cancer cell lines to drug treatment, quantified through IC50 values, based on both the genomic features of the cell lines and the chemical properties of the considered drugs. Models predicted IC50 values in a 8-fold cross-validation and an independent blind test with coefficient of determination R2 of 0.72 and 0.64 respectively. Furthermore, models were able to predict with comparable accuracy (R2 of 0.61) IC50s of cell lines from a tissue not used in the training stage. Our in silico models can be used to optimise the experimental design of drug-cell screenings by estimating a large proportion of missing IC50 values rather than experimentally measuring them. The implications of our results go beyond virtual drug screening design: potentially thousands of drugs could be probed in silico to systematically test their potential efficacy as anti-tumour agents based on their structure, thus providing a computational framework to identify new drug repositioning opportunities as well as ultimately be useful for personalized medicine by linking the genomic traits of patients to drug sensitivity

A checklist for clinical trials in rare disease: Obstacles and anticipatory actions-lessons learned from the FOR-DMD trial

Background: Trials in rare diseases have many challenges, among which are the need to set up multiple sites in different countries to achieve recruitment targets and the divergent landscape of clinical trial regulations in those countries. Over the past years, there have been initiatives to facilitate the process of international study set-up, but the fruits of these deliberations require time to be operationally in place. FOR-DMD (Finding the Optimum Steroid Regimen for Duchenne Muscular Dystrophy) is an academic-led clinical trial which aims to find the optimum steroid regimen for Duchenne muscular dystrophy, funded by the National Institutes of Health (NIH) for 5 years (July 2010 to June 2015), anticipating that all sites (40 across the USA, Canada, the UK, Germany and Italy) would be open to recruitment from July 2011. However, study start-up was significantly delayed and recruitment did not start until January 2013. Method: The FOR-DMD study is used as an example to identify systematic problems in the set-up of international, multi-centre clinical trials. The full timeline of the FOR-DMD study, from funding approval to site activation, was collated and reviewed. Systematic issues were identified and grouped into (1) study set-up, e.g. drug procurement; (2) country set-up, e.g. competent authority applications; and (3) site set-up, e.g. contracts, to identify the main causes of delay and suggest areas where anticipatory action could overcome these obstacles in future studies. Results: Time from the first contact to site activation across countries ranged from 6 to 24 months. Reasons of delay were universal (sponsor agreement, drug procurement, budgetary constraints), country specific (complexity and diversity of regulatory processes, indemnity requirements) and site specific (contracting and approvals). The main identified obstacles included (1) issues related to drug supply, (2) NIH requirements regarding contracting with non-US sites, (3) differing regulatory requirements in the five participating countries, (4) lack of national harmonisation with contracting and the requirement to negotiate terms and contract individually with each site and (5) diversity of languages needed for study materials. Additionally, as with many academic-led studies, the FOR-DMD study did not have access to the infrastructure and expertise that a contracted research organisation could provide, organisations often employed in pharmaceutical-sponsored studies. This delay impacted recruitment, challenged the clinical relevance of the study outcomes and potentially delayed the delivery of the best treatment to patients. Conclusion: Based on the FOR-DMD experience, and as an interim solution, we have devised a checklist of steps to not only anticipate and minimise delays in academic international trial initiation but also identify obstacles that will require a concerted effort on the part of many stakeholders to mitigate

A randomized trial of memantine as treatment for spasticity in multiple sclerosis

Abstract We report the results of a single center randomized, double-blind, placebo-controlled, parallel group trial of memantine in adults with multiple sclerosis and spasticity conducted over 12 weeks. Eligible MS patients had to have an Ashworth spasticity rating of 2 or higher in at least one lower extremity muscle group. Subjects were randomized to receive either placebo or memantine 10 mg twice a day. The primary outcome measure for efficacy was the change in Ashworth Spasticity Scale Score. Although well tolerated, memantine treatment did not demonstrate efficacy in treatment of spasticity in this 12-week small exploratory study

A randomized trial of memantine as treatment for spasticity in multiple sclerosis

Abstract We report the results of a single center randomized, double-blind, placebo-controlled, parallel group trial of memantine in adults with multiple sclerosis and spasticity conducted over 12 weeks. Eligible MS patients had to have an Ashworth spasticity rating of 2 or higher in at least one lower extremity muscle group. Subjects were randomized to receive either placebo or memantine 10 mg twice a day. The primary outcome measure for efficacy was the change in Ashworth Spasticity Scale Score. Although well tolerated, memantine treatment did not demonstrate efficacy in treatment of spasticity in this 12-week small exploratory study

Leg strength in peripheral arterial disease: associations with disease severity and lower-extremity performance

AbstractObjectiveThe purpose of this study was to determine relationships between lower-extremity arterial obstruction, leg strength, and lower-extremity functioning.DesignThe study design was cross-sectional. A total of 514 outpatients (269 with ankle-brachial index [ABI] <0.90), aged 55 and older, were identified from three Chicago-area hospitals. Individuals with history of lower-extremity revascularization were excluded.Main outcome measuresStrength in each leg, 6-minute walk, 4-meter walking velocity, accelerometer-measured physical activity, and a summary performance score were measured. The summary performance score is a composite measure of lower-extremity functioning, ranging from 0 to 12 (12 = best). The leg with the lower ABI was defined as the “index” leg, and the leg with higher ABI was defined as the “contralateral” leg.ResultsIndex leg ABI levels were associated linearly and significantly with strength for hip extension (P < .001), hip flexion (P < .001), knee extension (P = .066), and knee flexion (P = .003), adjusting for known and potential confounders. In adjusted analyses, the index ABI was also associated linearly and significantly with strength in the contralateral leg. Adjusting for confounders, including ABI, knee extension strength, was associated independently with functional measures.ConclusionAmong patients without prior leg revascularization, strength in each leg is highly correlated with the lower-leg ABI. Leg strength is associated independently with functional performance. Further study is needed to determine whether lower-extremity resistance training improves functioning in patients with peripheral arterial disease