Multicentre randomised controlled trial of nasal diamorphine for analgesia in children and teenagers with clinical fractures.

OBJECTIVE: To compare the effectiveness of nasal diamorphine spray with intramuscular morphine for analgesia in children and teenagers with acute pain due to a clinical fracture, and to describe the safety profile of the spray. DESIGN: Multicentre randomised controlled trial. SETTING: Emergency departments in eight UK hospitals. PARTICIPANTS: Patients aged between 3 and 16 years presenting with a clinical fracture of an upper or lower limb. MAIN OUTCOME MEASURES: Patients' reported pain using the Wong Baker face pain scale, ratings of reaction to treatment of the patients and acceptability of treatment by staff and parents, and adverse events. RESULTS: 404 eligible patients completed the trial (204 patients given nasal diamorphine spray and 200 given intramuscular morphine). Onset of pain relief was faster in the spray group than in the intramuscular group, with lower pain scores in the spray group at 5, 10, and 20 minutes after treatment but no difference between the groups after 30 minutes. 80% of patients given the spray showed no obvious discomfort compared with 9% given intramuscular morphine (difference 71%, 95% confidence interval 65% to 78%). Treatment administration was judged acceptable by staff and parents, respectively, for 98% (199 of 203) and 97% (186 of 192) of patients in the spray group compared with 32% (64 of 199) and 72% (142 of 197) in the intramuscular group. No serious adverse events occurred in the spray group, and the frequencies of all adverse events were similar in both groups (spray 24.1% v intramuscular morphine 18.5%; difference 5.6%, -2.3% to 13.6%). CONCLUSION: Nasal diamorphine spray should be the preferred method of pain relief in children and teenagers presenting to emergency departments in acute pain with clinical fractures. The diamorphine spray should be used in place of intramuscular morphine

How to identify when a performance indicator has run its course

The official published version can be found at the link below.Increasing numbers of countries are using indicators to evaluate the quality of clinical care, with some linking payment to achievement. For performance frameworks to remain effective the indicators need to be regularly reviewed. The frameworks cannot cover all clinical areas, and achievement on chosen indicators will eventually reach a ceiling beyond which further improvement is not feasible. However, there has been little work on how to select indictors for replacement. The Department of Health decided in 2008 that it would regularly replace indicators in the national primary care pay for performance scheme, the Quality and Outcomes Framework, making a rigorous approach to removal a priority. We draw on our previous work on pay for performance and our current work advising the National Institute for Health and Clinical Excellence (NICE) on the Quality and Outcomes Framework to suggest what should be considered when planning to remove indicators from a clinical performance framework

Identifying patient and practice characteristics associated with patient-reported experiences of safety problems and harm: a cross-sectional study using a multilevel modelling approach.

This is the author accepted manuscript. The final version is available from BMJ Publishing Group via the DOI in this record.OBJECTIVE: To identify patient and family practice characteristics associated with patient-reported experiences of safety problems and harm. DESIGN: Cross-sectional study combining data from the individual postal administration of the validated Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC) questionnaire to a random sample of patients in family practices (response rate=18.4%) and practice-level data for those practices obtained from NHS Digital. We built linear multilevel multivariate regression models to model the association between patient-level (clinical and sociodemographic) and practice-level (size and case-mix, human resources, indicators of quality and safety of care, and practice safety activation) characteristics, and outcome measures. SETTING: Practices distributed across five regions in the North, Centre and South of England. PARTICIPANTS: 1190 patients registered in 45 practices purposefully sampled (maximal variation in practice size and levels of deprivation). MAIN OUTCOME MEASURES: Self-reported safety problems, harm and overall perception of safety. RESULTS: Higher self-reported levels of safety problems were associated with younger age of patients (beta coefficient 0.15) and lower levels of practice safety activation (0.44). Higher self-reported levels of harm were associated with younger age (0.13) and worse self-reported health status (0.23). Lower self-reported healthcare safety was associated with lower levels of practice safety activation (0.40). The fully adjusted models explained 4.5% of the variance in experiences of safety problems, 8.6% of the variance in harm and 4.4% of the variance in perceptions of patient safety. CONCLUSIONS: Practices' safety activation levels and patients' age and health status are associated with patient-reported safety outcomes in English family practices. The development of interventions aimed at improving patient safety outcomes would benefit from focusing on the identified groups.This research is part-funded by the National Institute for Health Research School for Primary Care Research (NIHR SPCR). The views expressed are those of the authors and not necessarily those of the NIHR, the NHS or the Department of Health

Exercise Training to Target Gait Unsteadiness in People with Diabetes

Balance impairment and an associated high fall rate in people with diabetes is common, and a huge burden to quality of life and healthcare systems. Causes of impaired balance are commonly attributed to both sensory and motor deficits, which includes impaired muscle strength and function. This study investigated the effects of resistance exercise training on balance control during walking over level ground and on stairs. Ten DM people (age: 62 years, BMI: 29kg/m2, VPT: 9V) and 6 DM people with DPN (age: 59 years, BMI: 27kg/m2, VPT: 31V) performed a 16-week intervention of weekly resistance exercise training to increase ankle and knee extensor muscle strength. Six DM controls did not take part in the intervention (age: 50 years, BMI: 26kg/m2, VPT: 12V). Balance during gait was quantified before and after the intervention, by separation between the body centre-of-mass and centre-of-pressure under the feet during both level and stair walking. Knee and ankle extensor muscle strength was assessed using a dynamometer. The exercise intervention increased strength of ankle plantar flexors (22%) and knee extensors (30%). Despite the increases in lower limb muscle strength produced by the intervention, no improvements in balance were seen post training. However, gait speed did increase by 8%, which previous research has shown to be associated with quality of life. Controls showed no training effects in any variables. Although this exercise intervention had a positive effect on gait by increasing walking speed, there was no effect on the control of balance. Previous research has identified that medio-lateral (side-to-side) balance is impaired in people with DPN. The muscles exercised in the present study mainly control the major sagittal plane (forwards-backwards) movements that occur during gait. Interventions targeting the lateral stabilising muscles of the hip and trunk, may show greater potential efficacy in redressing the balance impairment of this population

Measuring patient safety in primary care: The development and validation of the “Patient Reported Experiences and Outcomes of Safety in Primary Care” (PREOS-PC)

This is the author accepted manuscript. The final version is available from Annals of Family Medicine via the DOI in this recordPURPOSE We set out to develop and validate a patient-reported instrument for measuring experiences and outcomes related to patient safety in primary care. METHOD The instrument was developed in a multistage process supported by an international expert panel and informed by a systematic review of instruments, a meta-synthesis of qualitative studies, 4 patient focus groups, 18 cognitive interviews, and a pilot study. The trial version of Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC) covered 5 domains and 11 scales: practice activation (1 scale); patient activation (1 scale); experiences of patient safety events (1 scale); harm (6 scales); and general perceptions of patient safety (2 scales). The questionnaire was posted to 6,736 patients in 45 practices across England. We used “gold standard” psychometric methods to evaluate its acceptability, reliability, structural and construct validity, and ability to discriminate among practices. RESULTS 1,244 completed questionnaires (18.5%) were returned. Median itemspecific response rate was 91.3% (interquartile range 28.0%). No major ceiling or floor effects were observed. All 6 multi-item scales showed high internal consistency (Cronbach’s α 0.75-0.96). Factor analysis, correlation between scales, and known group analyses generally supported structural and construct validity. The scales demonstrated a heterogeneous ability to discriminate between practices. The final version of PREOS-PC consisted of 5 domains, 8 scales, and 58 items. CONCLUSIONS PREOS-PC is a new multi-dimensional patient safety instrument for primary care developed with experts and patients. Initial testing shows its potential for use in primary care, and future developments will further address its use in actual clinical practice.UK National Institute for Health Research School for Primary Care Research (NIHR SPCR

Withdrawing performance indicators: retrospective analysis of general practice performance under UK Quality and Outcomes Framework.

This is a freely-available open access publication. Please cite the published version which is available via the DOI link in this record.OBJECTIVES: To investigate the effect of withdrawing incentives on recorded quality of care, in the context of the UK Quality and Outcomes Framework pay for performance scheme. DESIGN: Retrospective longitudinal study. SETTING: Data for 644 general practices, from 2004/05 to 2011/12, extracted from the Clinical Practice Research Datalink. PARTICIPANTS: All patients registered with any of the practices over the study period-13,772,992 in total. INTERVENTION: Removal of financial incentives for aspects of care for patients with asthma, coronary heart disease, diabetes, stroke, and psychosis. MAIN OUTCOME MEASURES: Performance on eight clinical quality indicators withdrawn from a national incentive scheme: influenza immunisation (asthma) and lithium treatment monitoring (psychosis), removed in April 2006; blood pressure monitoring (coronary heart disease, diabetes, stroke), cholesterol concentration monitoring (coronary heart disease, diabetes), and blood glucose monitoring (diabetes), removed in April 2011. Multilevel mixed effects multiple linear regression models were used to quantify the effect of incentive withdrawal. RESULTS: Mean levels of performance were generally stable after the removal of the incentives, in both the short and long term. For the two indicators removed in April 2006, levels in 2011/12 were very close to 2005/06 levels, although a small but statistically significant drop was estimated for influenza immunisation. For five of the six indicators withdrawn from April 2011, no significant effect on performance was seen following removal and differences between predicted and observed scores were small. Performance on related outcome indicators retained in the scheme (such as blood pressure control) was generally unaffected. CONCLUSIONS: Following the removal of incentives, levels of performance across a range of clinical activities generally remained stable. This indicates that health benefits from incentive schemes can potentially be increased by periodically replacing existing indicators with new indicators relating to alternative aspects of care. However, all aspects of care investigated remained indirectly or partly incentivised in other indicators, and further work is needed to assess the generalisability of the findings when incentives are fully withdrawn.National Institute for Health Research (NIHR

Effect of financial incentives on incentivised and non-incentivised clinical activities: longitudinal analysis of data from the UK Quality and Outcomes Framework

This is the final version. Available on open access from BMJ Publishing Group via the DOI in this recordData sharing: Technical appendix and statistical code available from the corresponding author ([email protected]). The dataset was derived from the General Practice Research Database and is not available from the authors, but it can be derived on application to GPRD.OBJECTIVE: To investigate whether the incentive scheme for UK general practitioners led them to neglect activities not included in the scheme. DESIGN: Longitudinal analysis of achievement rates for 42 activities (23 included in incentive scheme, 19 not included) selected from 428 identified indicators of quality of care. SETTING: 148 general practices in England (653 500 patients). MAIN OUTCOME MEASURES: Achievement rates projected from trends in the pre-incentive period (2000-1 to 2002-3) and actual rates in the first three years of the scheme (2004-5 to 2006-7). RESULTS: Achievement rates improved for most indicators in the pre-incentive period. There were significant increases in the rate of improvement in the first year of the incentive scheme (2004-5) for 22 of the 23 incentivised indicators. Achievement for these indicators reached a plateau after 2004-5, but quality of care in 2006-7 remained higher than that predicted by pre-incentive trends for 14 incentivised indicators. There was no overall effect on the rate of improvement for non-incentivised indicators in the first year of the scheme, but by 2006-7 achievement rates were significantly below those predicted by pre-incentive trends. CONCLUSIONS: There were substantial improvements in quality for all indicators between 2001 and 2007. Improvements associated with financial incentives seem to have been achieved at the expense of small detrimental effects on aspects of care that were not incentivised.There was no direct funding for this study, but the National Primary Care Research and Development Centre receives core funding from the UK Department of Health

Artificial intelligence for automated detection of diabetic foot ulcers: A real-world proof-of-concept clinical evaluation

Objective: Conduct a multicenter proof-of-concept clinical evaluation to assess the accuracy of an artificial intelligence system on a smartphone for automated detection of diabetic foot ulcers. Methods: The evaluation was undertaken with patients with diabetes (n = 81) from September 2020 to January 2021. A total of 203 foot photographs were collected using a smartphone, analysed using the artificial intelligence system, and compared against expert clinician judgement, with 162 images showing at least one ulcer, and 41 showing no ulcer. Sensitivity and specificity of the system against clinician decisions was determined and inter- and intra-rater reliability analysed. Results: Predictions/decisions made by the system showed excellent sensitivity (0.9157) and high specificity (0.8857). Merging of intersecting predictions improved specificity to 0.9243. High levels of inter- and intra-rater reliability for clinician agreement on the ability of the artificial intelligence system to detect diabetic foot ulcers was also demonstrated (Kα > 0.8000 for all studies, between and within raters). Conclusions: We demonstrate highly accurate automated diabetic foot ulcer detection using an artificial intelligence system with a low-end smartphone. This is the first key stage in the creation of a fully automated diabetic foot ulcer detection and monitoring system, with these findings underpinning medical device development

Whole home exercise intervention for depression in older care home residents (the OPERA study) : a process evaluation

Background: The ‘Older People’s Exercise intervention in Residential and nursing Accommodation’ (OPERA) cluster randomised trial evaluated the impact of training for care home staff together with twice-weekly, physiotherapist-led exercise classes on depressive symptoms in care home residents, but found no effect. We report a process evaluation exploring potential explanations for the lack of effect. Methods: The OPERA trial included over 1,000 residents in 78 care homes in the UK. We used a mixed methods approach including quantitative data collected from all homes. In eight case study homes, we carried out repeated periods of observation and interviews with residents, care staff and managers. At the end of the intervention, we held focus groups with OPERA research staff. We reported our first findings before the trial outcome was known. Results: Homes showed large variations in activity at baseline and throughout the trial. Overall attendance rate at the group exercise sessions was low (50%). We considered two issues that might explain the negative outcome: whether the intervention changed the culture of the homes, and whether the residents engaged with the intervention. We found low levels of staff training, few home champions for the intervention and a culture that prioritised protecting residents from harm over encouraging activity. The trial team delivered 3,191 exercise groups but only 36% of participants attended at least 1 group per week and depressed residents attended significantly fewer groups than those who were not depressed. Residents were very frail and therefore most groups only included seated exercises. Conclusions: The intervention did not change the culture of the homes and, in the case study homes, activity levels did not change outside the exercise groups. Residents did not engage in the exercise groups at a sufficient level, and this was particularly true for those with depressive symptoms at baseline. The physical and mental frailty of care home residents may make it impossible to deliver a sufficiently intense exercise intervention to impact on depressive symptoms