Background and aims Nalmefene has been approved in Europe for the treatment of alcohol dependence... more Background and aims Nalmefene has been approved in Europe for the treatment of alcohol dependence and subsequently recommended by the UK National Institute for Health and Care Excellence (NICE). This study examines critically the evidence base underpinning both decisions and the issues arising. Methods Published studies of nalmefene were identified through a systematic search, with documents from the European Medicines Agency, the NICE appraisal and public clinical trial registries also examined to identify methodological issues. Results Efficacy data used to support the licensing of nalmefene suffer from risk of bias due to lack of specification of a priori outcome measures and sensitivity analyses, use of post-hoc sample refinement and the use of inappropriate comparators. Despite this evidence for the efficacy of nalmefene in reducing alcohol consumption in those with alcohol dependence is, at best, modest, and of uncertain significance to individual patients. The relevance of existing trial data to routine primary care practice is doubtful. Conclusions Problems with the registration, design, analysis and reporting of clinical trials of nalmefene did not prevent it being licensed and recommended for treating alcohol dependence. This creates dilemmas for primary care clinicians and commissioning organisations where nalmefene has been heavily promoted, and poses wider questions about the effectiveness of the medicines regulation system and how to develop the alcohol treatment evidence base.
Alexander Cohen and colleagues (Feb 2, p 387)1 use American College of Chest Physicians (ACCP) gu... more Alexander Cohen and colleagues (Feb 2, p 387)1 use American College of Chest Physicians (ACCP) guidelines2 to assess thromboprophylaxis regimens in hospitals worldwide. The ACCP guidelines recommend heparin for patients at moderate to high risk of venous ...
Background Raised IOP is the most important risk factor for glaucoma and is the only one that is ... more Background Raised IOP is the most important risk factor for glaucoma and is the only one that is treatable. The instrument used to measure IOP is called a tonometer. The desirable attributes for a tonometer for use in a monitoring programme are accuracy, precision, acceptability to patients and ease of use. GAT, a contact tonometer, is currently the tonometer most widely used by ophthalmologists and is accepted as the current clinical standard. However, GAT has several limitations (see below for further information), and ...
Cho 1997 173 Y The subjects were asked to comment on each technique.'About 50% of subjects p... more Cho 1997 173 Y The subjects were asked to comment on each technique.'About 50% of subjects preferred NCT-2000 over the other tonometers' as air puff is 'weaker'and is non-contact tonometer. The remaining subjects had 'no particular comments on the test used'Y The operator found that NCT-2000 was the 'easiest and fastest'to operate
and BJU International came together to develop a set of guidelines to address common errors of st... more and BJU International came together to develop a set of guidelines to address common errors of statistical analysis, reporting, and interpretation. Authors should 'break any of the guidelines if it makes scientific sense to do so', but would need to provide a clear justification. Adoption of the guidelines will in our view not only increase the quality of published papers in our journals but improve statistical knowledge in our field in general.
Background Pelvic organ prolapse is estimated to affect 41–50% of women aged > 40 years. A mul... more Background Pelvic organ prolapse is estimated to affect 41–50% of women aged > 40 years. A multicentre randomised controlled trial of individualised pelvic floor muscle training found that pelvic floor muscle training was effective in reducing symptoms of prolapse, improved quality of life and showed clear potential to be cost-effective. Provision of pelvic floor muscle training for prolapse has continued to vary across the UK, with limited availability of specialist physiotherapists to deliver it. Objectives This project aimed to study the implementation and outcomes of different models of delivery to increase the service provision of pelvic floor muscle training, and to follow up treatment outcomes for the original trial participants. Design A realist evaluation of pelvic floor muscle training implementation conducted within three full case study sites and two partial case study sites; an observational prospective cohort study comparing patient-reported outcomes pre and post in...
Health technology assessment (Winchester, England), Jun 1, 2012
OBJECTIVES: To determine effective and efficient monitoring criteria for ocular hypertension [rai... more OBJECTIVES: To determine effective and efficient monitoring criteria for ocular hypertension [raised intraocular pressure (IOP)] through (i) identification and validation of glaucoma risk prediction models; and (ii) development of models to determine optimal surveillance pathways. DESIGN: A discrete event simulation economic modelling evaluation. Data from systematic reviews of risk prediction models and agreement between tonometers, secondary analyses of existing datasets (to validate identified risk models and determine optimal ...
Background Obesity increases the risk of type 2 diabetes, heart disease, stroke, mobility problem... more Background Obesity increases the risk of type 2 diabetes, heart disease, stroke, mobility problems and some cancers, and its prevalence is rising. Men engage less than women in existing weight loss interventions. Game of Stones builds on a successful feasibility study and aims to find out if automated text messages with or without endowment incentives are effective and cost-effective for weight loss at 12 months compared to a waiting list comparator arm in men with obesity. Methods A 3-arm, parallel group, assessor-blind superiority randomised controlled trial with process evaluation will recruit 585 adult men with body mass index of 30 kg/m2 or more living in and around three UK centres (Belfast, Bristol, Glasgow), purposively targeting disadvantaged areas. Intervention groups: (i) automated, theory-informed text messages daily for 12 months plus endowment incentives linked to verified weight loss targets at 3, 6 and 12 months; (ii) the same text messages and weight loss assessment...
Supplemental material, MSJ768722_Appendix_1 for Factors affecting continuation of clean intermitt... more Supplemental material, MSJ768722_Appendix_1 for Factors affecting continuation of clean intermittent catheterisation in people with multiple sclerosis: Results of the COSMOS mixed-methods study by Doreen McClurg, Carol Bugge, Andrew Elders, Tasneem Irshad, Suzanne Hagen, Katherine N Moore, Brian Buckley and Mandy Fader in Multiple Sclerosis Journal
muscle training in women with pelvic organ prolapse: a multicentre randomised controlled trial. L... more muscle training in women with pelvic organ prolapse: a multicentre randomised controlled trial. Lancet 2014;383(9919):796-806. 4 This is the final draft, after peer-review, of a manuscript published in The Lancet. The definitive version, detailed above, is available online at www.thelancet.com 5 6 Title page 7 Brief title: RCT of pelvic floor muscle training for prolapse Author name Preferred
Objective: Smoking during pregnancy causes risks to mother and infant health. We investigated the... more Objective: Smoking during pregnancy causes risks to mother and infant health. We investigated the feasibility and likely success of SKIP-IT, a narrative and picture-based smoking cessation intervention delivered via text messages. Methods: A feasibility and pilot trial. We aimed to recruit 70 pregnant women who smoked, randomised to usual care alone, or usual care and the SKIP-IT intervention, between 12 weeks of pregnancy and 6 weeks post due-date. Outcomes assessed were recruitment, retention, acceptability of, and engagement with the intervention, smoking behaviour, intentions, perceived risk, and self-efficacy. Results: Of 312 women initially approached by smoking cessation services only 54 (17%) agreed to be contacted by the research team. Twenty were then either ineligible or uncontactable and 28 (82%) participated. Most women reported texts to be entertaining and helpful. The proportion of women not smoking at follow-up was lower in the intervention group, but numbers were too small to draw conclusions about effectiveness. Conclusion: The intervention was acceptable, but difficulty in making initial and follow-up contacts meant our methods were unfeasible for a larger trial. Practice implications: Digital Storytelling interventions could help women quit smoking, but further research is required to identify alternative methods for studies with pregnant women who smoke.
Background and aims Nalmefene has been approved in Europe for the treatment of alcohol dependence... more Background and aims Nalmefene has been approved in Europe for the treatment of alcohol dependence and subsequently recommended by the UK National Institute for Health and Care Excellence (NICE). This study examines critically the evidence base underpinning both decisions and the issues arising. Methods Published studies of nalmefene were identified through a systematic search, with documents from the European Medicines Agency, the NICE appraisal and public clinical trial registries also examined to identify methodological issues. Results Efficacy data used to support the licensing of nalmefene suffer from risk of bias due to lack of specification of a priori outcome measures and sensitivity analyses, use of post-hoc sample refinement and the use of inappropriate comparators. Despite this evidence for the efficacy of nalmefene in reducing alcohol consumption in those with alcohol dependence is, at best, modest, and of uncertain significance to individual patients. The relevance of existing trial data to routine primary care practice is doubtful. Conclusions Problems with the registration, design, analysis and reporting of clinical trials of nalmefene did not prevent it being licensed and recommended for treating alcohol dependence. This creates dilemmas for primary care clinicians and commissioning organisations where nalmefene has been heavily promoted, and poses wider questions about the effectiveness of the medicines regulation system and how to develop the alcohol treatment evidence base.
Alexander Cohen and colleagues (Feb 2, p 387)1 use American College of Chest Physicians (ACCP) gu... more Alexander Cohen and colleagues (Feb 2, p 387)1 use American College of Chest Physicians (ACCP) guidelines2 to assess thromboprophylaxis regimens in hospitals worldwide. The ACCP guidelines recommend heparin for patients at moderate to high risk of venous ...
Background Raised IOP is the most important risk factor for glaucoma and is the only one that is ... more Background Raised IOP is the most important risk factor for glaucoma and is the only one that is treatable. The instrument used to measure IOP is called a tonometer. The desirable attributes for a tonometer for use in a monitoring programme are accuracy, precision, acceptability to patients and ease of use. GAT, a contact tonometer, is currently the tonometer most widely used by ophthalmologists and is accepted as the current clinical standard. However, GAT has several limitations (see below for further information), and ...
Cho 1997 173 Y The subjects were asked to comment on each technique.'About 50% of subjects p... more Cho 1997 173 Y The subjects were asked to comment on each technique.'About 50% of subjects preferred NCT-2000 over the other tonometers' as air puff is 'weaker'and is non-contact tonometer. The remaining subjects had 'no particular comments on the test used'Y The operator found that NCT-2000 was the 'easiest and fastest'to operate
and BJU International came together to develop a set of guidelines to address common errors of st... more and BJU International came together to develop a set of guidelines to address common errors of statistical analysis, reporting, and interpretation. Authors should 'break any of the guidelines if it makes scientific sense to do so', but would need to provide a clear justification. Adoption of the guidelines will in our view not only increase the quality of published papers in our journals but improve statistical knowledge in our field in general.
Background Pelvic organ prolapse is estimated to affect 41–50% of women aged > 40 years. A mul... more Background Pelvic organ prolapse is estimated to affect 41–50% of women aged > 40 years. A multicentre randomised controlled trial of individualised pelvic floor muscle training found that pelvic floor muscle training was effective in reducing symptoms of prolapse, improved quality of life and showed clear potential to be cost-effective. Provision of pelvic floor muscle training for prolapse has continued to vary across the UK, with limited availability of specialist physiotherapists to deliver it. Objectives This project aimed to study the implementation and outcomes of different models of delivery to increase the service provision of pelvic floor muscle training, and to follow up treatment outcomes for the original trial participants. Design A realist evaluation of pelvic floor muscle training implementation conducted within three full case study sites and two partial case study sites; an observational prospective cohort study comparing patient-reported outcomes pre and post in...
Health technology assessment (Winchester, England), Jun 1, 2012
OBJECTIVES: To determine effective and efficient monitoring criteria for ocular hypertension [rai... more OBJECTIVES: To determine effective and efficient monitoring criteria for ocular hypertension [raised intraocular pressure (IOP)] through (i) identification and validation of glaucoma risk prediction models; and (ii) development of models to determine optimal surveillance pathways. DESIGN: A discrete event simulation economic modelling evaluation. Data from systematic reviews of risk prediction models and agreement between tonometers, secondary analyses of existing datasets (to validate identified risk models and determine optimal ...
Background Obesity increases the risk of type 2 diabetes, heart disease, stroke, mobility problem... more Background Obesity increases the risk of type 2 diabetes, heart disease, stroke, mobility problems and some cancers, and its prevalence is rising. Men engage less than women in existing weight loss interventions. Game of Stones builds on a successful feasibility study and aims to find out if automated text messages with or without endowment incentives are effective and cost-effective for weight loss at 12 months compared to a waiting list comparator arm in men with obesity. Methods A 3-arm, parallel group, assessor-blind superiority randomised controlled trial with process evaluation will recruit 585 adult men with body mass index of 30 kg/m2 or more living in and around three UK centres (Belfast, Bristol, Glasgow), purposively targeting disadvantaged areas. Intervention groups: (i) automated, theory-informed text messages daily for 12 months plus endowment incentives linked to verified weight loss targets at 3, 6 and 12 months; (ii) the same text messages and weight loss assessment...
Supplemental material, MSJ768722_Appendix_1 for Factors affecting continuation of clean intermitt... more Supplemental material, MSJ768722_Appendix_1 for Factors affecting continuation of clean intermittent catheterisation in people with multiple sclerosis: Results of the COSMOS mixed-methods study by Doreen McClurg, Carol Bugge, Andrew Elders, Tasneem Irshad, Suzanne Hagen, Katherine N Moore, Brian Buckley and Mandy Fader in Multiple Sclerosis Journal
muscle training in women with pelvic organ prolapse: a multicentre randomised controlled trial. L... more muscle training in women with pelvic organ prolapse: a multicentre randomised controlled trial. Lancet 2014;383(9919):796-806. 4 This is the final draft, after peer-review, of a manuscript published in The Lancet. The definitive version, detailed above, is available online at www.thelancet.com 5 6 Title page 7 Brief title: RCT of pelvic floor muscle training for prolapse Author name Preferred
Objective: Smoking during pregnancy causes risks to mother and infant health. We investigated the... more Objective: Smoking during pregnancy causes risks to mother and infant health. We investigated the feasibility and likely success of SKIP-IT, a narrative and picture-based smoking cessation intervention delivered via text messages. Methods: A feasibility and pilot trial. We aimed to recruit 70 pregnant women who smoked, randomised to usual care alone, or usual care and the SKIP-IT intervention, between 12 weeks of pregnancy and 6 weeks post due-date. Outcomes assessed were recruitment, retention, acceptability of, and engagement with the intervention, smoking behaviour, intentions, perceived risk, and self-efficacy. Results: Of 312 women initially approached by smoking cessation services only 54 (17%) agreed to be contacted by the research team. Twenty were then either ineligible or uncontactable and 28 (82%) participated. Most women reported texts to be entertaining and helpful. The proportion of women not smoking at follow-up was lower in the intervention group, but numbers were too small to draw conclusions about effectiveness. Conclusion: The intervention was acceptable, but difficulty in making initial and follow-up contacts meant our methods were unfeasible for a larger trial. Practice implications: Digital Storytelling interventions could help women quit smoking, but further research is required to identify alternative methods for studies with pregnant women who smoke.
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