Direct measurement of repulsive and attractive pair potentials using pairs of optical traps.

We present a technique for measuring the interactions between pairs of colloidal particles in two optical traps. This method is particularly suitable for measuring strongly attractive potentials, an otherwise challenging task. The interaction energy is calculated from the distribution of inter-particle separations by accounting for the contribution from the optical traps with arbitrary trap profiles. The method is simple to implement and applicable to different types of pair potentials and optical trapping geometries. We apply the method to measure dipolar pair interactions in experiments with paramagnetic colloids in external magnetic fields. We obtain consistent and accurate results in all regimes, from strongly attractive to repulsive potentials. By means of computer simulations, we demonstrate that the proposed method can be successfully applied to systems with complex pair interactions characterized by multiple attractive and repulsive regimes, which are ubiquitous in soft and biological matter.

The International Working Group on New Developments in Pharmacovigilance: Advancing Methods and Communication in Pharmacovigilance.

PURPOSE: In 2019, the International Working Group (IWG), focusing on New Developments in Pharmacovigilance, was established. This group is coordinated by the Drug Safety Research Unit in the United Kingdom, and the mission of the IWG is to progress pharmacovigilance methodologies and promote the safe and effective use of medicines and vaccines, thereby further protecting patients. Novel therapeutics are continuously being developed to alleviate medical conditions, but with advancing technologies, innovative pharmacovigilance methodologies need to be developed to effectively monitor the use and safety of these products. With reduced timelines proposed for premarketing clinical trials and increased application of real-world evidence supporting regulatory approvals, products may be used in real-world clinical practice in shorter timeframes than before. Therefore, the need for effective methods of monitoring medicines and collecting safety data in real-time is of paramount importance to public health. METHODS: The IWG aims to advance existing methodologies used in the detection, monitoring, and analysis of safety data in pharmacovigilance and to communicate best practice proposals to support decision making in health care. The IWG will identify areas requiring review of current processes or methodologic research and will communicate the output of the IWG through peer-reviewed publications, reports, and presentation of findings at relevant conferences and scientific meetings. FINDINGS: The IWG is currently reviewing two areas in pharmacovigilance; case-level causality assessment and the strengths and limitations of data sources. The IWG is advancing these areas by producing two scoping reviews which will be easily accessible to regulatory agencies, industry, academia, and interested persons or organizations. IMPLICATIONS: The scoping reviews comply with the IWGs mission to progress pharmacovigilance methodologies and promote the safe and effective use of medicines and vaccines. The present article shares details of the objectives of the IWG and provides an overview on the status of IWG activities.

Dynamics of a colloidal particle driven by continuous time-delayed feedback.

We perform feedback experiments and simulations in which a colloidal dumbbell particle, acting as a particle on a ring, is followed by a repulsive optical trap controlled by a continuous-time-delayed feedback protocol. The dynamics are described by a persistent random walk similarly to that of an active Brownian particle, with a transition from predominantly diffusive to driven behavior at a critical delay time. We model the dynamics in the short and long delay regimes using stochastic delay differential equations and derive a condition for stable driven motion. We study the stochastic thermodynamic properties of the system, finding that the maximum work done by the trap coincides with a local minimum in the mutual information between the trap and the particle position at the onset of stable driven dynamics.

Safety of Ovaleap® (Follitropin Alfa) in Infertile Women Undergoing Superovulation for Assisted Reproductive Technologies: A Multinational Comparative, Prospective Cohort Study.

Background: Ovaleap® (follitropin alfa), a recombinant human follicle stimulating hormone, is a biosimilar medicinal product to Gonal-f® and is used for ovarian stimulation. The main objective of this study was to assess the safety and effectiveness of Ovaleap® compared to Gonal-f® in one treatment cycle in routine clinical practice. Methods: Safety of Ovaleap® Follitropin alfa in Infertile women undergoing superovulation for Assisted reproductive technologies (SOFIA) was a prospective cohort study conducted in six European countries. Eligible patients were infertile women undergoing superovulation for assisted reproductive technology, who were administered Ovaleap® or Gonal-f® for ovarian stimulation and were naïve to follicle stimulating hormone treatment. The recruitment ratio was 1:1. The primary endpoint was incidence proportion of ovarian hyperstimulation syndrome (OHSS) and the secondary endpoint was OHSS severity (Grades I, II, III). The effect of risk factors or potential confounders on the odds ratio for OHSS incidence as well as treatment effect on OHSS incidence was explored using univariate logistic regression. Pregnancy and live birth rates were also assessed. Results: A total of 408 women who were administered Ovaleap® and 409 women who were administered Gonal-f® were eligible for analysis. The incidence proportion of OHSS was 5.1% (95% CI: 3.4, 7.7) in the Ovaleap® cohort and 3.2% (95% CI: 1.9, 5.4) in the Gonal-f® cohort. This difference in OHSS incidence proportion between the two cohorts was not statistically significant neither before (p = 0.159) nor after univariate adjustment for each potential confounder (p > 0.05). The incidence proportion of OHSS severity grades was similar in the two treatment groups (3.4% versus 2.0% for Grade I, 1.2% versus 1.0% for Grade II, and 0.5% versus 0.2% for Grade III, in the Ovaleap® and Gonal-f® cohorts, respectively), without a significant statistical difference (p = 0.865, for each grade). Among patients who had embryo transfer, clinical pregnancy rates were 33% and 31% and live birth rates were 27% and 26%, in the two cohorts, respectively. Conclusions: Findings from the SOFIA study indicate that the incidence proportions of OHSS and OHSS severity, as well as pregnancy and live birth rates, are similar between Ovaleap® and Gonal-f® treatments and corroborate the safety and effectiveness of Ovaleap® as a biosimilar to Gonal-f®.

Evaluation of the incidence of bleeding in patients prescribed rivaroxaban for the treatment and prevention of deep vein thrombosis and pulmonary embolism in UK secondary care: an observational cohort study.

OBJECTIVES: To evaluate the short-term (12 weeks) safety and utilisation of rivaroxaban prescribed to new-user adult patients for the treatment of deep vein thrombosis and pulmonary embolism and for the prevention of recurrent deep vein thrombosis and pulmonary embolism in a secondary care setting in England and Wales. DESIGN: An observational cohort study using the technique of Specialist Cohort Event Monitoring. SETTING: The Rivaroxaban Observational Safety Evaluation study was conducted across 87 participating National Health Service secondary care trusts in England and Wales. PARTICIPANTS: 1532 patients treated with rivaroxaban for the prevention and treatment of deep vein thrombosis/pulmonary embolism from September 2013 to January 2016. INTERVENTIONS: Non-interventional postauthorisation safety study of rivaroxaban. PRIMARY AND SECONDARY OUTCOME MEASURES: (1) Risk of major bleeding in gastrointestinal, intracranial, and urogenital sites and (2) risk of all major and clinically relevant non-major bleeds. RESULTS: Of a total of 4846 patients enrolled in the study from September 2013 to January 2016, 1532 were treated with rivaroxaban for the prevention and treatment of deep vein thrombosis/pulmonary embolism. The median age of the deep vein thrombosis/pulmonary embolism cohort was 63 years, and 54.6% were men. The risk of major bleeding within the gastrointestinal, urogenital and intracranial primary sites was 0.7% (n=11), 0.3% (n=5) and 0.1% (n=1), respectively. The risk of major bleeding in all sites was 1.5% (n=23) at a rate of 8.3 events per 100 patient-years. CONCLUSIONS: In terms of the primary outcome risk of major bleeding in gastrointestinal, intracranial and urogenital sites, the risk estimates in the population using rivaroxaban for deep vein thrombosis/pulmonary embolism were low (<1%) and consistent with the risk estimated from clinical trial data and in routine clinical practice. TRIAL REGISTRATION NUMBERS: ClinicalTrials.gov Registry (NCT01871194); ENCePP Registry (EUPAS3979).

Incidence of major and clinically relevant non-major bleeding in patients prescribed rivaroxaban for stroke prevention in non-valvular atrial fibrillation in secondary care: Results from the Rivaroxaban Observational Safety Evaluation (ROSE) study.

INTRODUCTION: Although the direct oral anticoagulant rivaroxaban is recommended for stroke prevention in patients with non-valvular atrial fibrillation based on Phase III clinical trials, there is still a need for additional safety data from everyday clinical practice. The ROSE study was initiated to collect further information on the safety and utilisation of rivaroxaban in a broader range of patient groups in routine clinical practice. METHODS AND RESULTS: The ROSE study was conducted in hospitals in England and Wales. Consenting adults with non-valvular atrial fibrillation newly started on rivaroxaban were eligible and followed up for 12 weeks. Data was derived through secondary use of medical records. The primary outcome was major bleeding within gastrointestinal, urogenital and intracranial sites. A total of 4846 patients were enrolled in the study September 2013 to January 2016, 965 of which were treated with rivaroxaban for non-valvular atrial fibrillation. The median age in the rivaroxaban non-valvular atrial fibrillation cohort was 76 years, 53.6% were male. The median HAS-BLED score was 2 and the median CHA2DS2-VASc score was 4. The risk of major bleeding within each of the primary sites of gastrointestinal, urogenital and intracranial during the 12 week observation period was low (0.2%; n = 2). The risk of major bleeding in all sites was 1.0% (n = 10) at a rate of 5.5 events per 100 patient years. CONCLUSION: In terms of the primary outcome risk of major bleeding within gastrointestinal, urogenital and intracranial sites during the 12 week observation period, the risk estimates in the non-valvular atrial fibrillation rivaroxaban user population were low (<1%), and consistent with risk estimated from clinical trial data and in routine clinical practice.

Observational assessment of safety in seroquel (OASIS): a specialist cohort event monitoring (SCEM) study in England.

BACKGROUND: This study was designed to monitor the short-term (up to 12 weeks) use and safety of quetiapine (Seroquel) extended release (XL) and quetiapine immediate release (IR) prescribed to patients with a clinical diagnosis of schizophrenia, and/or manic episodes associated with bipolar disorder by psychiatrists under normal conditions of use. METHODS: A Specialist Cohort Event Monitoring (SCEM) study was conducted in England February 2010-April 2013. This observational cohort study recruited patients prescribed quetiapine XL within the secondary care setting by psychiatrists. A reference cohort of quetiapine IR users was also recruited. Baseline and 12 week observational data were collected from psychiatrists who abstracted information from medical records onto bespoke questionnaires. Data were collected on demographics, indication, past medical history, prescribing information and events of interest. Summary descriptive statistics were calculated. RESULTS: The final cohort consisted of 869 eligible patients; 646 XL users and 223 IR users. The majority of XL and IR users were female (56.2% and 55.6%, respectively), with a median age of 40 (interquartile range [IQR]: 29, 49) and 39 (IQR: 28, 50) years, respectively. The most frequent indication for treatment was Manic episodes associated with Bipolar Affective disorder (53.4% XL and 49.8% IR). Median index dose was 200 mg/day (IQR: 100, 300) for XL users and 50 mg/day (IQR: 50, 100) for IR users, while median final maintenance dose was 400mg/day (IQR: 250, 600) and 300 mg/day (IQR: 100, 400), respectively. The most frequently reported event of interest in both cohorts was sedation (n = 151, 23.9% XL cohort and n = 49, 23.0% IR cohort). CONCLUSION: Utilisation of quetiapine XL appeared to be in line with prescribing guidelines in terms of dose, and commonly reported events of interest were in concordance with the known safety profile. Overall, this SCEM study provided important information on the safety and utilisation of quetiapine XL in the secondary care setting in England.

Rationale and design of a European epidemiological post-authorization safety study (PASS) program: rivaroxaban use in routine clinical practice.

BACKGROUND: Rivaroxaban is a highly selective factor Xa inhibitor approved for use in Europe for multiple indications. STUDY DESIGN AND METHODS: The European rivaroxaban epidemiological post-authorization safety study (PASS) program consists of seven complementary observational studies. For four of the studies, data are obtained from health-care databases in the UK, the Netherlands, Germany, and Sweden. These database studies describe patterns of rivaroxaban use and patient characteristics over time, and investigate safety and effectiveness outcomes in new users of rivaroxaban using a cohort analysis and nested case-control analysis. To put these results in context, safety outcomes are also analyzed in new users of standard of care. In addition, a modified prescription event monitoring study conducted in the early post-launch phase in primary care, and two specialist cohort event monitoring studies that investigated rivaroxaban use in the secondary care hospital setting, systematically collected drug utilization and safety data via questionnaires completed by health-care professionals in the UK. DISCUSSION: The European rivaroxaban epidemiological PASS is a comprehensive program of complementary studies generating evidence from patients treated in routine clinical practice that will expand our understanding of the risk-benefit profile of rivaroxaban.

Lopinavir-Ritonavir in the Treatment of COVID-19: A Dynamic Systematic Benefit-Risk Assessment.

INTRODUCTION AND OBJECTIVE: COVID-19 is an ongoing, global public health crisis for which safe and effective treatments need to be identified. The benefit-risk balance for the use of lopinavir-ritonavir in COVID-19 needs to be monitored on an ongoing basis, therefore a systematic benefit-risk assessment was designed and conducted. A key objective of this study was to provide a platform for a dynamic systematic benefit-risk evaluation; although initially this evaluation is likely to contain limited information, it is required because of the urgent unmet public need. Importantly, it allows additional data to be incorporated as they become available, and re-evaluation of the benefit-risk profile. METHODS: A systematic benefit-risk assessment was conducted using the Benefit-Risk Action Team (BRAT) framework. The exposure of interest was lopinavir-ritonavir treatment in severe COVID-19 compared to standard of care, placebo or other treatments. A literature search was conducted in PubMed and Embase to identify peer-reviewed papers reporting clinical outcomes. Two clinicians constructed a value tree and ranked key benefits and risks in order of considered clinical importance. RESULTS: We screened 143 papers from PubMed and 264 papers from Embase for lopinavir-ritonavir; seven papers were included in the final benefit-risk assessment. In comparison to standard of care, data for several key benefits and risks were identified for lopinavir-ritonavir. Time to clinical improvement was not significantly different for lopinavir-ritonavir in comparison to standard of care (hazard ratio 1.31, 95% confidence interval 0.95-1.80). From one study, there were fewer cases of acute respiratory distress syndrome with lopinavir-ritonavir compared with standard of care (13% vs 27%). There also appeared to be fewer serious adverse events with lopinavir-ritonavir (20%) vs standard of care (32%). Limited data were available for comparison of lopinavir-ritonavir to other treatments. CONCLUSIONS: Based on currently available data, there was no clear benefit for the use of lopinavir-ritonavir compared to standard of care in severe COVID-19. Risk data suggested a possible decrease in serious adverse events. There was a reduction in acute respiratory distress syndrome with lopinavir-ritonavir in one study. Overall, the benefit-risk profile for lopinavir-ritonavir in severe COVID-19 cannot be considered positive until further efficacy and effectiveness data become available.

Remdesivir in Treatment of COVID-19: A Systematic Benefit-Risk Assessment.

INTRODUCTION: There is a need to identify effective, safe treatments for COVID-19 (coronavirus disease) rapidly, given the current, ongoing pandemic. A systematic benefit-risk assessment was designed and conducted to examine the benefit-risk profile of remdesivir in COVID-19 patients compared with standard of care, placebo or other treatments. A key objective of this study was to provide a platform for a dynamic systematic benefit-risk evaluation, which starts with inevitably limited information (to meet the urgent unmet public health need worldwide), then update the benefit-risk evaluation as more data become available. METHODS: The Benefit-Risk Action Team (BRAT) framework was used to assess the overall benefit-risk of the use of remdesivir as a treatment for COVID-19 compared with standard of care, placebo or other treatments. We searched PubMed, Google Scholar and government agency websites to identify literature reporting clinical outcomes in patients taking remdesivir for COVID-19. A value tree was constructed and key benefits and risks were ranked by two clinicians in order of considered importance. RESULTS: Using the BRAT method, several key benefits and risks for use of remdesivir in COVID-19 compared with placebo have been identified. In one trial, the benefit of time to clinical improvement was not statistically significant (21 vs 23 days, HR 1.23, 95% CI 0.87-1.75), although the study was underpowered. In another trial, a shorter time to recovery in patients treated with remdesivir was observed (11 vs 15 days), with non-significant reduced mortality risk (8% vs 12%). Risk data were only available from one trial. This trial reported fewer serious adverse events in patients taking remdesivir (18%) compared with the placebo group (26%); however, more patients in the remdesivir group discontinued treatment as a result of an adverse event compared with those patients receiving placebo (12% vs 5%). CONCLUSIONS: Preliminary clinical trial results suggest that there may be a favourable benefit-risk profile for remdesivir compared with placebo in severe COVID-19 infection and further data on benefits would strengthen this evaluation. There is limited safety data for remdesivir, which should be obtained in further studies. The current framework summarises the key anticipated benefits and risks for which further data are needed. Ongoing clinical trial data can be incorporated into the framework when available to provide an updated benefit-risk assessment.

Systematic benefit-risk assessment for buprenorphine implant: a semiquantitative method to support risk management.

BACKGROUND: Prior to approval in the European Union, a systematic benefit-risk assessment was required to compare buprenorphine implant to sublingual buprenorphine as part of the license application to the European Medicines Agency. OBJECTIVE: The Benefit-Risk Action Team framework was used to describe the overall benefit-risk of buprenorphine implant in comparison to sublingual buprenorphine. STUDY SELECTION/METHODS: A value tree of key benefits and risks related to the implant formulation of buprenorphine was constructed. Risk differences (RD) or reporting ORs (ROR) and corresponding 95% CIs were calculated for each outcome, along with the number needed to treat and number needed to harm. Swing weighting was assigned to outcomes and the weighted net clinical benefit (wNCB) was calculated. FINDINGS: Key benefits assessed: reduced risk of illicit opioid use (RD=0.09, 95% CI 0.01 to 0.17), reduced risk of misuse and diversion (ROR=0.13, 95% CI 0.02 to 0.94), improved compliance and convenience (RD=0.20) and quality of life measures (RD=0.03). Key risks assessed: clinically significant implant breakage (RD=0.01, 95% CI 0.00 to 0.01), migration/missing implant (RD=0.01, 95% CI 0.00 to 0.02), infection at insertion/removal site (RD=0.08, 95% CI 0.03 to 0.12) and implant-related allergic reaction (RD=0.07, 95% CI 0.03 to 0.11). The wNCB for buprenorphine implant was 4.96, which suggests a favourable benefit-risk profile. CONCLUSIONS: The benefit-risk profile of buprenorphine implant is considered favourable in comparison to sublingual buprenorphine, based on this semiquantitative analysis using available data. Further data from real-world use on benefits and risks should be used for ongoing monitoring of the benefit-risk profile of buprenorphine implants in the postmarketing setting.

A randomised controlled trial to test the effectiveness of decision training on assessors' ability to determine optimal fitness-to-drive recommendations for older or disabled drivers.

BACKGROUND: Driving licensing jurisdictions require detailed assessments of fitness-to-drive from occupational therapy driver assessors (OTDAs). We developed decision training based on the recommendations of expert OTDAs, to enhance novices' capacity to make optimal fitness-to-drive decisions. The aim of this research was to determine effectiveness of training on novice occupational therapists' ability to make fitness-to-drive decisions. METHODS: A double blind, parallel, randomised controlled trial was conducted to test the effectiveness of decision training on novices' fitness-to-drive recommendations. Both groups made recommendations on a series of 64 case scenarios with the intervention group receiving training after reviewing two thirds of the cases; the control group, at this same point, just received a message of encouragement to continue. Participants were occupational therapy students on UK and Australian pre-registration programmes who individually took part online, following the website instructions. The main outcome of training was the reduction in mean difference between novice and expert recommendations on the cases. RESULTS: Two hundred eighty-nine novices were randomised into intervention; 166 completed the trial (70 in intervention; 96 in control). No statistical differences in scores were found pre-training. Post training, the control group showed no significant change in recommendations compared to the experts (t(96) = -.69; p = .5), whereas the intervention group exhibited a significant change (t(69) = 6.89; p < 0.001). For the intervention group, the mean difference compared with the experts' recommendations reduced with 95% CI from -.13 to .09. Effect size calculated at the post-training demonstrated a moderate effect (d = .69, r = .32). CONCLUSIONS: Novices who received the decision training were able to change their recommendations whereas those who did not receive training did not. Those receiving training became more able to identify drivers who were not fit-to-drive, as measured against experts' decisions on the same cases. This research demonstrated that novice occupational therapists can be trained to make decisions more aligned to those of expert OTDAs. The decision training and cases have been launched as a free training resource at www.fitnesstodrive.com . This can be used by novice driver assessors to increase their skill to identify drivers who are, and are not fit-to-drive, potentially increasing international workforce capacity in this growing field of practice.

Enhanced referral prioritisation for acute adult dietetic services: A randomised control trial to test a web-based decision training tool.

BACKGROUND & AIMS: Dietitians in acute adult services need to prioritise dietetic referrals in order to manage their daily workload and ensure effective treatment of patients. Newly qualified dietitians do not usually receive specific training on prioritisation and could be helped with an evidence-based, effective, decision-training tool that is based on the practice of experienced dietitians. We developed an internationally available web-based decision-training tool designed to improve novice dietitians' ability to make dietetic prioritisation decisions. The training tool comprised of a pre-training task, a post-training task and training materials. The aim of this study was to test the effectiveness of the training tool on novices' ability for dietetic prioritisation. METHODS: Pre-registration dietitians and recent graduates (one-year) from across the UK were invited to participate in this randomised controlled trial (RCT). Each participant made prioritisation decisions on a set of dietetic referral scenarios: 53 scenarios at pre-training and 27 at post-training. After pre-training the intervention group was presented with the training materials, whereas the control group was told to carry on with the post-training task. Participants did not know which group they had been randomly allocated to. We calculated i) level of agreement between decisions made by each novice and experts' consensus using Pearson correlation, intra-class correlation (ICC(2,1)); ii) intra-rater consistency using ICC(1,1) and iii) intra-group consistency using ICC (2,1). We compared group means at pre-training and post-training; estimated effect size using the degree of change from pre- to post-training, and 2-factor mixed ANOVA to assess overall effect of the training across the groups and time-points. RESULTS: 151 participants (69 in control and 82 in intervention) completed the trial. The groups did not differ in demographic characteristics. Both Pearson and ICC(2,1) correlations increased with training intervention; a moderate effect of training was found for both metrics, d = 0.69 (r = 0.32) for the former and d = 0.54 (r = 0.26) for the latter. Intra-rater consistency improved with training but with a small effect size, d = 0.32 (r = 0.16). The intra-group consistency also improved with training: ICC = 0.48 pre-training to 0.61 post-training. CONCLUSIONS: The training tool was found to be effective in improving the novice dietitian's ability to prioritise referrals in the acute adult setting. The training tool is freely available at www.dietitianreferral.org for use by all student or early career dietitians internationally.

Utilisation and Safety of Deferasirox: Results from an Observational Cohort Study in England.

INTRODUCTION: Deferasirox (EXJADE®, Novartis, UK) is an oral iron-chelating agent primarily used to reduce chronic iron overload in patients receiving blood transfusions for various chronic anaemias and some non-transfusion dependant anaemias. OBJECTIVE: The aim of this study was to examine the utilisation and safety of deferasirox used in general practice in England. METHOD: A single exposure observational cohort study design was used. Patients were identified from dispensed prescriptions for deferasirox between September 2006 and September 2014. Outcome data were collected via postal questionnaires sent to prescribers ≥ 6 months after first dispensed prescription for an individual patient. Summary descriptive statistics were calculated. RESULTS: The evaluable cohort consisted of 122 patients, of which 41.8% were aged 2-17 years. Frequent reasons for prescribing were sickle cell anaemia (27/103 where specified, 26.2%) and beta thalassaemia (26, 25.2%). The majority of patients (43/51, 84.3%) were prescribed the licensed doses of 10 or 20 mg/kg/day at start. Prior measurements of serum creatinine were only reported for a small proportion this study (18/122, 14.8%). In total, 91 incident events were reported, including two of raised serum creatinine. CONCLUSION: These results show that deferasirox is largely being prescribed for its licensed indications in general practice in England and events reported were consistent with the known safety profile.

Using Social Judgment Theory method to examine how experienced occupational therapy driver assessors use information to make fitness-to-drive recommendations.

INTRODUCTION: As people with a range of disabilities strive to increase their community mobility, occupational therapy driver assessors are increasingly required to make complex recommendations regarding fitness-to-drive. However, very little is known about how therapists use information to make decisions. The aim of this study was to model how experienced occupational therapy driver assessors weight and combine information when making fitness-to-drive recommendations and establish their level of decision agreement. METHOD: Using Social Judgment Theory method, this study examined how 45 experienced occupational therapy driver assessors from the UK, Australia and New Zealand made fitness-to-drive recommendations for a series of 64 case scenarios. Participants completed the task on a dedicated website, and data were analysed using discriminant function analysis and an intraclass correlation coefficient. RESULTS: Accounting for 87% of the variance, the cues central to the fitness-to-drive recommendations made by assessors are the client's physical skills, cognitive and perceptual skills, road law craft skills, vehicle handling skills and the number of driving instructor interventions. Agreement (consensus) between fitness-to-drive recommendations was very high: intraclass correlation coefficient = .97, 95% confidence interval .96-.98). CONCLUSION: Findings can be used by both experienced and novice driver assessors to reflect on and strengthen the fitness-to-drive recommendations made to clients.

Identifying and enhancing risk thresholds in the detection of elder financial abuse: a signal detection analysis of professionals' decision making.

BACKGROUND: Financial abuse of elders is an under acknowledged problem and professionals' judgements contribute to both the prevalence of abuse and the ability to prevent and intervene. In the absence of a definitive "gold standard" for the judgement, it is desirable to try and bring novice professionals' judgemental risk thresholds to the level of competent professionals as quickly and effectively as possible. This study aimed to test if a training intervention was able to bring novices' risk thresholds for financial abuse in line with expert opinion. METHODS: A signal detection analysis, within a randomised controlled trial of an educational intervention, was undertaken to examine the effect on the ability of novices to efficiently detect financial abuse. Novices (n = 154) and experts (n = 33) judged "certainty of risk" across 43 scenarios; whether a scenario constituted a case of financial abuse or not was a function of expert opinion. Novices (n = 154) were randomised to receive either an on-line educational intervention to improve financial abuse detection (n = 78) or a control group (no on-line educational intervention, n = 76). Both groups examined 28 scenarios of abuse (11 "signal" scenarios of risk and 17 "noise" scenarios of no risk). After the intervention group had received the on-line training, both groups then examined 15 further scenarios (5 "signal" and 10 "noise" scenarios). RESULTS: Experts were more certain than the novices, pre (Mean 70.61 vs. 58.04) and post intervention (Mean 70.84 vs. 63.04); and more consistent. The intervention group (mean 64.64) were more certain of abuse post-intervention than the control group (mean 61.41, p = 0.02). Signal detection analysis of sensitivity (A´) and bias (C) revealed that this was due to the intervention shifting the novices' tendency towards saying "at risk" (C post intervention -.34) and away from their pre intervention levels of bias (C-.12). Receiver operating curves revealed more efficient judgments in the intervention group. CONCLUSION: An educational intervention can improve judgements of financial abuse amongst novice professionals.

Educating novice practitioners to detect elder financial abuse: a randomised controlled trial.

BACKGROUND: Health and social care professionals are well positioned to identify and intervene in cases of elder financial abuse. An evidence-based educational intervention was developed to advance practitioners' decision-making in this domain. The objective was to test the effectiveness of a decision-training educational intervention on novices' ability to detect elder financial abuse. The research was funded by an E.S.R.C. grant reference RES-189-25-0334. METHODS: A parallel-group, randomised controlled trial was conducted using a judgement analysis approach. Each participant used the World Wide Web to judge case sets at pre-test and post-test. The intervention group was provided with training after pre-test testing, whereas the control group were purely given instructions to continue with the task. 154 pre-registration health and social care practitioners were randomly allocated to intervention (n78) or control (n76). The intervention comprised of written and graphical descriptions of an expert consensus standard explaining how case information should be used to identify elder financial abuse. Participants' ratings of certainty of abuse occurring (detection) were correlated with the experts' ratings of the same cases at both stages of testing. RESULTS: At pre-test, no differences were found between control and intervention on rating capacity. Comparison of mean scores for the control and intervention group at pre-test compared to immediate post-test, showed a statistically significant result. The intervention was shown to have had a positive moderate effect; at immediate post-test, the intervention group's ratings had become more similar to those of the experts, whereas the control's capacity did not improve. The results of this study indicate that the decision-training intervention had a positive effect on detection ability. CONCLUSIONS: This freely available, web-based decision-training aid is an effective evidence-based educational resource. Health and social care professionals can use the resource to enhance their ability to detect elder financial abuse. It has been embedded in a web resource at http://www.elderfinancialabuse.co.uk.

Factors influencing decision-making by social care and health sector professionals in cases of elder financial abuse.

This study aimed to identify the factors that have the greatest influence on UK social care and health sector professionals' certainty that an older person is being financially abused, their likelihood of intervention, and the type of action most likely to be taken. A factorial survey approach, applying a fractional factorial design, was used. Health and social care professionals (n = 152) viewed a single sample of 50 elder financial abuse case vignettes; the vignettes contained seven pieces of information (factors). Following multiple regression analysis, incremental F tests were used to compare the impact of each factor on judgements. Factors that had a significant influence on judgements of certainty that financial abuse was occurring included the older person's mental capacity and the nature of the financial problem suspected. Mental capacity accounted for more than twice the variance in likelihood of action than the type of financial problem. Participants from social care were more likely to act and chose more actions compared to health sector participants. The results are discussed in relation to a bystander intervention model. The impact of the older person's mental capacity on decision-making suggests the need for training to ensure action is also taken in cases where older people have full mental capacity and are being abused. Training also needs to highlight the more subtle types of financial abuse, the types that appear not to lead to certainty or action.