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R. Michael Poole

Bio: R. Michael Poole is an academic researcher from Pfizer. The author has contributed to research in topics: Medicine & Fibromyalgia. The author has an hindex of 1, co-authored 1 publications receiving 4002 citations.

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Journal ArticleDOI
01 Nov 2001-Pain
TL;DR: Using a standard outcome across chronic pain studies would greatly enhance the comparability, validity, and clinical applicability of these studies, and the application of these results to future studies may provide a standard definition of clinically important improvement in clinical trials of chronic pain therapies.
Abstract: Pain intensity is frequently measured on an 11-point pain intensity numerical rating scale (PI-NRS), where 0=no pain and 10=worst possible pain. However, it is difficult to interpret the clinical importance of changes from baseline on this scale (such as a 1- or 2-point change). To date, there are no data driven estimates for clinically important differences in pain intensity scales used for chronic pain studies. We have estimated a clinically important difference on this scale by relating it to global assessments of change in multiple studies of chronic pain. Data on 2724 subjects from 10 recently completed placebo-controlled clinical trials of pregabalin in diabetic neuropathy, postherpetic neuralgia, chronic low back pain, fibromyalgia, and osteoarthritis were used. The studies had similar designs and measurement instruments, including the PI-NRS, collected in a daily diary, and the standard seven-point patient global impression of change (PGIC), collected at the endpoint. The changes in the PI-NRS from baseline to the endpoint were compared to the PGIC for each subject. Categories of "much improved" and "very much improved" were used as determinants of a clinically important difference and the relationship to the PI-NRS was explored using graphs, box plots, and sensitivity/specificity analyses. A consistent relationship between the change in PI-NRS and the PGIC was demonstrated regardless of study, disease type, age, sex, study result, or treatment group. On average, a reduction of approximately two points or a reduction of approximately 30% in the PI-NRS represented a clinically important difference. The relationship between percent change and the PGIC was also consistent regardless of baseline pain, while higher baseline scores required larger raw changes to represent a clinically important difference. The application of these results to future studies may provide a standard definition of clinically important improvement in clinical trials of chronic pain therapies. Use of a standard outcome across chronic pain studies would greatly enhance the comparability, validity, and clinical applicability of these studies.

4,568 citations

Journal ArticleDOI
13 Oct 2022
TL;DR: It is suggested that high-dose opioid regimens develop quickly in response to unknown clinical factors, and a dose of 60 mg oral morphine equivalent or more is suggested as a useful "red flag".
Abstract: Background There are concerns about continuing increases in the number of patients prescribed long-term opioids and the prescribing of 'strong' opioids for chronic pain. Little is known about patients who are prescribed these long-term, high-dose drugs. Aim To understand patterns of opioid prescribing that lead to long-term, high-dose use. Design & setting A mixed-method study of the opioid prescription histories of patients using high doses in a North Wales GP practice. Method All patients on high-dose opioids during the census week were identified. Summary graphs of the prescription histories were prepared. Qualitative analysis was conducted individually by four researchers. A workshop was held to arrive at a consensus about common features and to inform further quantitative analysis. Results A quarter of high-dose regimens were initiated outside the practice, either in a different primary care practice or in secondary care. The majority of the remaining patients showed a pattern of dose increases to high levels over a short period (median 3.5 months). None showed a pattern of gradual increases over a longer timescale. Most of the patients remained on high doses continuously once a daily dose of ≥120 mg oral morphine equivalent (OME) was reached. Conclusion These findings suggest that high-dose opioid regimens develop quickly in response to unknown clinical factors. An expected insidious upward drift in dose was not seen. The findings have implications for the prevention of potentially dangerous long-term, high-dose opioid prescribing. A dose of 60 mg OME or more is suggested as a useful 'red flag'.

1 citations

Journal ArticleDOI
10 Oct 2022
TL;DR: Themes emerging from this study suggest that GPs lack appropriate control of opioid prescribing and there is a need to develop methods to help patients and GPs to work together to manage chronic pain safely.
Abstract: Background Prescribing of opioid medication has increased over the past 20 years. Most occurs in primary care for chronic pain. There is little evidence that these drugs are effective for this indication. There are concerns about the continuing prescribing of opioids, particularly in the long term and at high doses. Aim To explore GPs’ experiences of prescribing opioids, problems encountered, and factors militating against good prescribing practice. Design & setting Qualitative interviews with GPs who prescribe opioids in primary care in North East Wales. Method Semi-structured interviews with 20 GPs were transcribed and subjected to thematic analysis utilising the framework approach. Results Participating GPs identified a range of problems associated with prescribed opioids. They were concerned about limited effectiveness of the drugs and what they perceived as addiction resulting from their use. They identified healthcare system factors that were obstacles to good prescribing practice such as lack of continuity of care, poor access to secondary care pain management support, and, most importantly, constant time pressure. They reported adverse effects on relationships with patients. Unrealistic expectations that pain could be eliminated resulted in pressure to prescribe stronger drugs and increased doses. It led to difficulties in establishing and maintaining trust and in persuading patients to agree to, and to carry out, dose reductions. Conclusion Themes emerging from this study suggest that GPs lack appropriate control of opioid prescribing. There is a need to develop methods to help patients and GPs to work together to manage chronic pain safely.
Journal ArticleDOI
TL;DR: In this article , the authors explored changes in medical students' knowledge/attitude towards social determinants of health (SDOH) during and after psychiatry placements at HMP-Berwyn prison.
Abstract: Aims/Background Social determinants of health (SDOH) are social factors that have a causal role in ill health and have an adverse effect on health outcomes. SDOH are part of the UK medical student curriculum but mainly discusses epidemiologically. There are few educational approaches that aim to incorporate an understanding of SDOH into the experiential and competency-based elements of undergraduate medical education. Prisoners are a population who experience high levels of stigma, social adversity and health disadvantage. Clinical attachments in prison may teach students about the impact of SDOH in a vivid and memorable way. Aims: We aim to explore changes in medical students' knowledge/attitude towards SDOH during and after psychiatry placements at HMP-Berwyn prison. Methods All year four medical students on psychiatry placement in North East Wales during 2021–2022 participated. In each of the six placement cohorts, one student did their psychiatry placement in prison. All the other students visited for one day. All students participated in two seminars focused on their prison experience and SDOH in psychiatry. Baseline and mid-placement bespoke questionnaires were completed, and all students participated in end-of-placement individual interviews. Results 29 students participated. Student assessment of the importance of SDOH did not show a significant change between baseline and mid-placement. However, student attitudes to experience in prison became more positive at end-of-placement. Comparing baseline to mid-placement questionnaires showed a 14% increase in students' rating of prison placements as educationally beneficial. 14% of students mentioned improved confidence in dealing with challenging patients, and 28% commented on the benefits of exposure to incarcerated patients. Interestingly, only 3% of students considered hospital placement more beneficial than prison placement. Prison placement was considered an exceptional experience than other settings by 17%. Conclusion There are no previous UK empirical studies on medical student placements in prison. Overseas studies identify reduced anxiety over dealing with demanding patients. Our findings so far lack statistical power but show positive satisfaction and knowledge trends amongst participants. Prison placement appears to be acceptable and educationally valuable. It offers opportunities for experiential teaching about SDOH. In addition, it may improve student understanding of a marginalised and stigmatised population. Implication for practice, policy and research On completion, this study may provide evidence on one method of improving attitudes toward marginalised people and understanding SDOH in the medical profession. This research was funded by Betsi Cadwaladr University Health Board and sponsored by Bangor University.

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Journal ArticleDOI
01 Dec 2003-Pain
TL;DR: In this article, the authors provide recommendations for the core outcome domains that should be considered by investigators conducting clinical trials of the efficacy and effectiveness of treatments for chronic pain, and develop a core set of outcome domains would facilitate comparison and pooling of d
Abstract: Objective. To provide recommendations for the core outcome domains that should be considered by investigators conducting clinical trials of the efficacy and effectiveness of treatments for chronic pain. Development of a core set of outcome domains would facilitate comparison and pooling of d

3,476 citations

Journal ArticleDOI
TL;DR: A consensus meeting was convened by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) to provide recommendations for interpreting clinical importance of treatment outcomes in clinical trials of the efficacy and effectiveness of chronic pain treatments as discussed by the authors.

2,581 citations

Journal ArticleDOI
TL;DR: All three pain-rating scales are valid, reliable and appropriate for use in clinical practice, although the Visual Analogue Scale has more practical difficulties than the Verbal Rating Scale or the Numerical Rating Scale.
Abstract: Aims and objectives. This review aims to explore the research available relating to three commonly used pain rating scales, the Visual Analogue Scale, the Verbal Rating Scale and the Numerical Rating Scale. The review provides information needed to understand the main properties of the scales. Background. Data generated from pain-rating scales can be easily misunderstood. This review can help clinicians to understand the main features of these tools and thus use them effectively. Method. A MedLine review via PubMed was carried out with no restriction of age of papers retrieved. Papers were examined for methodological soundness before being included. The search terms initially included pain rating scales, pain measurement, Visual Analogue Scale, VAS, Verbal Rating Scale, VRS, Numerical/numeric Rating Scale, NRS. The reference lists of retrieved articles were used to generate more papers and search terms. Only English Language papers were examined. Conclusions. All three pain-rating scales are valid, reliable and appropriate for use in clinical practice, although the Visual Analogue Scale has more practical difficulties than the Verbal Rating Scale or the Numerical Rating Scale. For general purposes the Numerical Rating Scale has good sensitivity and generates data that can be statistically analysed for audit purposes. Patients who seek a sensitive pain-rating scale would probably choose this one. For simplicity patients prefer the Verbal Rating Scale, but it lacks sensitivity and the data it produces can be misunderstood. Relevance to clinical practice. In order to use pain-rating scales well clinicians need to appreciate the potential for error within the tools, and the potential they have to provide the required information. Interpretation of the data from a pain-rating scale is not as straightforward as it might first appear.

2,337 citations