Exploring the patient experience of remote hypertension management in Scotland during COVID-19: a qualitative study.

OBJECTIVES: The aim of this study was to understand how patients experienced hypertension management, with or without blood pressure (BP) telemonitoring, during the COVID-19 pandemic. DESIGN, METHODS, PARTICIPANTS AND SETTING: This qualitative study conducted between April and November 2022 consisted of 43 semistructured telephone interviews (23 men and 20 women) from 6 primary care practices in one area of Scotland. RESULTS: From the views of 25 participants with experience of using the Connect Me telemonitoring service and 18 participants without such experience, 5 themes were developed. These were: (1) navigating access to services. There were challenges to gaining timely and/or in-person access to services and a reluctance to attend clinical settings because participants were aware of their increased risk of contracting the COVID-19 virus. (2) Adapting National Health Service services. All six practices had adapted care provision in response to potential COVID-19 transmission; however, these adaptations disrupted routine management of in-person primary care hypertension, diabetes and/or asthma checks. (3) Telemonitoring feedback. Telemonitoring reduced the need to attend in-person primary care practices and supported access to remote healthcare monitoring and feedback. (4) Self-management. Many non-telemonitoring participants were motivated to use self-management strategies to track their BP using home monitoring equipment. Also, participants were empowered to self-manage lifestyle and hypertension medication. (5) Experience of having COVID-19. Some participants contracting the COVID-19 virus experienced an immediate increase in their BP while a few experienced ongoing increased BP readings. CONCLUSIONS: The COVID-19 pandemic disrupted routine in-person care for patients with hypertension. Both telemonitoring and some non-telemonitoring patients were motivated to self-manage hypertension, including self-adjusting medication; however, only those with access to telemonitoring had increased access to hypertension monitoring and feedback. BP telemonitoring permitted routine care to continue for participants in this study and may offer a service useful in pandemic proofing hypertension healthcare in the future.

Atrial fibrillation self-management: a mobile telephone app scoping review and content analysis.

Atrial fibrillation (AF) affects over 1.4 million people in the UK, resulting in a five-fold increased stroke risk and a three to four times greater risk of severe, disabling stroke. Atrial fibrillation, a chronic disease, requires monitoring, medication, and lifestyle measures. A self-management approach supported by mobile health (mHealth) may empower AF self-care. To assess the need to develop new mHealth self-management interventions for those with AF this review aimed to identify commercially available AF self-management apps, analyse, and synthesize (i) characteristics, (ii) functions, (iii) privacy/security, (iv) incorporated behaviour change techniques (BCTs), and (v) quality and usability. We searched app stores for 'atrial fibrillation' and 'anticoagulation', and included apps focused on AF self-management in the review. We examined app functions, privacy statements against best practice recommendations, the inclusion of BCTs using the App Behaviour Change Scale, and app quality/usability using the Mobile App Rating Scale. From an initial search of 555 apps, five apps were included in the review. Common functions were educational content, medication trackers, and communication with healthcare professionals. Apps contained limited BCTs, lacked intuitive functions and were difficult to use. Privacy policies were difficult to read. App quality rated from poor to acceptable and no app had been evaluated in a clinical trial. The review reports a lack of commercially available AF self-management apps of sufficient standard for use in healthcare settings. This highlights the need for clinically validated mHealth interventions incorporating evidence-based BCTs to support AF self-management.

Examining the effectiveness of telemonitoring with routinely acquired blood pressure data in primary care: challenges in the statistical analysis.

BACKGROUND: Scale-up BP was a quasi-experimental implementation study, following a successful randomised controlled trial of the roll-out of telemonitoring in primary care across Lothian, Scotland. Our primary objective was to assess the effect of telemonitoring on blood pressure (BP) control using routinely collected data. Telemonitored systolic and diastolic BP were compared with surgery BP measurements from patients not using telemonitoring (comparator patients). The statistical analysis and interpretation of findings was challenging due to the broad range of biases potentially influencing the results, including differences in the frequency of readings, 'white coat effect', end digit preference, and missing data. METHODS: Four different statistical methods were employed in order to minimise the impact of these biases on the comparison between telemonitoring and comparator groups. These methods were "standardisation with stratification", "standardisation with matching", "regression adjustment for propensity score" and "random coefficient modelling". The first three methods standardised the groups so that all participants provided exactly two measurements at baseline and 6-12 months follow-up prior to analysis. The fourth analysis used linear mixed modelling based on all available data. RESULTS: The standardisation with stratification analysis showed a significantly lower systolic BP in telemonitoring patients at 6-12 months follow-up (-4.06, 95% CI -6.30 to -1.82, p < 0.001) for patients with systolic BP below 135 at baseline. For the standardisation with matching and regression adjustment for propensity score analyses, systolic BP was significantly lower overall (- 5.96, 95% CI -8.36 to - 3.55 , p < 0.001) and (- 3.73, 95% CI- 5.34 to - 2.13, p < 0.001) respectively, even after assuming that - 5 of the difference was due to 'white coat effect'. For the random coefficient modelling, the improvement in systolic BP was estimated to be -3.37 (95% CI -5.41 to -1.33 , p < 0.001) after 1 year. CONCLUSIONS: The four analyses provide additional evidence for the effectiveness of telemonitoring in controlling BP in routine primary care. The random coefficient analysis is particularly recommended due to its ability to utilise all available data. However, adjusting for the complex array of biases was difficult. Researchers should appreciate the potential for bias in implementation studies and seek to acquire a detailed understanding of the study context in order to design appropriate analytical approaches.

Telemonitoring at scale for hypertension in primary care: An implementation study.

BACKGROUND: While evidence from randomised controlled trials shows that telemonitoring for hypertension is associated with improved blood pressure (BP) control, healthcare systems have been slow to implement it, partly because of inadequate integration with existing clinical practices and electronic records. Neither is it clear if trial findings will be replicated in routine clinical practice at scale. We aimed to explore the feasibility and impact of implementing an integrated telemonitoring system for hypertension into routine primary care. METHODS AND FINDINGS: This was a quasi-experimental implementation study with embedded qualitative process evaluation set in primary care in Lothian, Scotland. We described the overall uptake of telemonitoring and uptake in a subgroup of representative practices, used routinely acquired data for a records-based controlled before-and-after study, and collected qualitative data from staff and patient interviews and practice observation. The main outcome measures were intervention uptake, change in BP, change in clinician appointment use, and participants' views on features that facilitated or impeded uptake of the intervention. Seventy-five primary care practices enrolled 3,200 patients with established hypertension. In an evaluation subgroup of 8 practices (905 patients of whom 427 [47%] were female and with median age of 64 years [IQR 56-70, range 22-89] and median Scottish Index of Multiple Deprivation 2012 decile of 8 [IQR 6-10]), mean systolic BP fell by 6.55 mm Hg (SD 15.17), and mean diastolic BP by 4.23 mm Hg (SD 8.68). Compared with the previous year, participating patients made 19% fewer face-to-face appointments, compared with 11% fewer in patients with hypertension who were not telemonitoring. Total consultation time for participants fell by 15.4 minutes (SD 68.4), compared with 5.5 minutes (SD 84.4) in non-telemonitored patients. The convenience of remote collection of BP readings and integration of these readings into routine clinical care was crucial to the success of the implementation. Limitations include the fact that practices and patient participants were self-selected, and younger and more affluent than non-participating patients, and the possibility that regression to the mean may have contributed to the reduction in BP. Routinely acquired data are limited in terms of completeness and accuracy. CONCLUSIONS: Telemonitoring for hypertension can be implemented into routine primary care at scale with little impact on clinician workload and results in reductions in BP similar to those in large UK trials. Integrating the telemonitoring readings into routine data handling was crucial to the success of this initiative.

A Mobile Phone Intervention to Improve Obesity-Related Health Behaviors of Adolescents Across Europe: Iterative Co-Design and Feasibility Study.

BACKGROUND: Promotion of physical activity, healthy eating, adequate sleep, and reduced sedentary behavior in adolescents is a major priority globally given the current increase in population health challenges of noncommunicable diseases and risk factors such as obesity. Adolescents are highly engaged with mobile technology, but the challenge is to engage them with mobile health (mHealth) technology. Recent innovations in mobile technology provide opportunities to promote a healthy lifestyle in adolescents. An increasingly utilized approach to facilitate increased engagement with mHealth technology is to involve potential users in the creation of the technology. OBJECTIVE: This study aimed to describe the process of and findings from co-designing and prototyping components of the PEGASO Fit for Future (F4F) mHealth intervention for adolescents from different cultural backgrounds. METHODS: A total of 74 adolescents aged 13 to 16 years from Spain, Italy, and the United Kingdom participated in the co-design of the PEGASO F4F technology. In 3 iterative cycles over 12 months, participants were involved in the co-design, refinement, and feasibility testing of a system consisting of diverse mobile apps with a variety of functions and facilities to encourage healthy weight-promoting behaviors. In the first iteration, participants attended a single workshop session and were presented with mock-ups or early-version prototypes of different apps for user requirements assessment and review. During the second iteration, prototypes of all apps were tested by participants for 1 week at home or school. In the third iteration, further developed prototypes were tested for 2 weeks. Participants' user experience feedback and development ideas were collected through focus groups and completion of questionnaires. RESULTS: For the PEGASO F4F technology to be motivating and engaging, participants suggested that it should (1) allow personalization of the interface, (2) have age-appropriate and easy-to-understand language (of icons, labels, instructions, and notifications), (3) provide easily accessible tutorials on how to use the app or navigate through a game, (4) present a clear purpose and end goal, (5) have an appealing and self-explanatory reward system, (6) offer variation in gamified activities within apps and the serious game, and (7) allow to seek peer support and connect with peers for competitive activities within the technology. CONCLUSIONS: Incorporating adolescents' preferences, the PEGASO F4F technology combines the functions of a self-monitoring, entertainment, advisory, and social support tool. This was the first study demonstrating that it is possible to develop a complex mobile phone-based technological system applying the principles of co-design to mHealth technology with adolescents across 3 countries. The findings from this study informed the development of an mHealth system for healthy weight promotion to be tested in a controlled multinational pilot trial.

Promoting healthy teenage behaviour across three European countries through the use of a novel smartphone technology platform, PEGASO fit for future: study protocol of a quasi-experimental, controlled, multi-Centre trial.

BACKGROUND: Behaviour change interventions targeting physical activity, diet, sleep and sedentary behaviour of teenagers show promise when delivered through smartphones. However, to date there is no evidence of effectiveness of multicomponent smartphone-based interventions. Utilising a user-centred design approach, we developed a theory-based, multi-dimensional system, PEGASO Fit For Future (PEGASO F4F), which exploits sophisticated game mechanics involving smartphone applications, a smartphone game and activity sensors to motivate teenagers to take an active role in adopting and maintaining a healthy lifestyle. This paper describes the study protocol to assess the feasibility, usability and effectiveness (knowledge/awareness and behavioural change in lifestyle) of the PEGASO system. METHODS: We are conducting a quasi-experimental controlled cluster trial in 4 sites in Spain, Italy, and UK (England, Scotland) over 6 months. We plan to recruit 525, in a 2:1 basis, teenagers aged 13-16 years from secondary schools. The intervention group is provided with the PEGASO system whereas the comparison group continues their usual educational routine. Outcomes include feasibility, acceptance, and usability of the PEGASO system as well as between and within group changes in motivation, self-reported diet, physical activity, sedentary and sleeping behaviour, anthropometric measures and knowledge about a healthy lifestyle. DISCUSSION: PEGASO F4F will provide evidence into the cross-cultural similarities and differences in the feasibility, acceptability and usability of a multi-dimensional smartphone based behaviour change intervention for teenagers. The study will explore facilitating factors, challenges and barriers of engaging teenagers to adapt and maintain a healthy lifestyle when using smartphone technology. Positive results from this ICT based multi component intervention may have significant implications both at clinical level, improving teenagers health and at public health level since it can present an influential tool against the development of chronic disease during adulthood. TRIAL REGISTRATION: https://clinicaltrials.gov Registration number: NCT02930148, registered 4 October 2016.

The 4 'A's test for detecting delirium in acute medical patients: a diagnostic accuracy study.

BACKGROUND: Delirium is a common and serious neuropsychiatric syndrome, usually triggered by illness or drugs. It remains underdetected. One reason for this is a lack of brief, pragmatic assessment tools. The 4 'A's test (Arousal, Attention, Abbreviated Mental Test - 4, Acute change) (4AT) is a screening tool designed for routine use. This project evaluated its usability, diagnostic accuracy and cost. METHODS: Phase 1 - the usability of the 4AT in routine practice was measured with two surveys and two qualitative studies of health-care professionals, and a review of current clinical use of the 4AT as well as its presence in guidelines and reports. Phase 2 - the 4AT's diagnostic accuracy was assessed in newly admitted acute medical patients aged ≥ 70 years. Its performance was compared with that of the Confusion Assessment Method (CAM; a longer screening tool). The performance of individual 4AT test items was related to cognitive status, length of stay, new institutionalisation, mortality at 12 weeks and outcomes. The method used was a prospective, double-blind diagnostic test accuracy study in emergency departments or in acute general medical wards in three UK sites. Each patient underwent a reference standard delirium assessment and was also randomised to receive an assessment with either the 4AT (n = 421) or the CAM (n = 420). A health economics analysis was also conducted. RESULTS: Phase 1 found evidence that delirium awareness is increasing, but also that there is a need for education on delirium in general and on the 4AT in particular. Most users reported that the 4AT was useful, and it was in widespread use both in the UK and beyond. No changes to the 4AT were considered necessary. Phase 2 involved 785 individuals who had data for analysis; their mean age was 81.4 (standard deviation 6.4) years, 45% were male, 99% were white and 9% had a known dementia diagnosis. The 4AT (n = 392) had an area under the receiver operating characteristic curve of 0.90. A positive 4AT score (> 3) had a specificity of 95% [95% confidence interval (CI) 92% to 97%] and a sensitivity of 76% (95% CI 61% to 87%) for reference standard delirium. The CAM (n = 382) had a specificity of 100% (95% CI 98% to 100%) and a sensitivity of 40% (95% CI 26% to 57%) in the subset of participants whom it was possible to assess using this. Patients with positive 4AT scores had longer lengths of stay (median 5 days, interquartile range 2.0-14.0 days) than did those with negative 4AT scores (median 2 days, interquartile range 1.0-6.0 days), and they had a higher 12-week mortality rate (16.1% and 9.2%, respectively). The estimated 12-week costs of an initial inpatient stay for patients with delirium were more than double the costs of an inpatient stay for patients without delirium (e.g. in Scotland, £7559, 95% CI £7362 to £7755, vs. £4215, 95% CI £4175 to £4254). The estimated cost of false-positive cases was £4653, of false-negative cases was £8956, and of a missed diagnosis was £2067. LIMITATIONS: Patients were aged ≥ 70 years and were assessed soon after they were admitted, limiting generalisability. The treatment of patients in accordance with reference standard diagnosis limited the ability to assess comparative cost-effectiveness. CONCLUSIONS: These findings support the use of the 4AT as a rapid delirium assessment instrument. The 4AT has acceptable diagnostic accuracy for acute older patients aged > 70 years. FUTURE WORK: Further research should address the real-world implementation of delirium assessment. The 4AT should be tested in other populations. TRIAL REGISTRATION: Current Controlled Trials ISRCTN53388093. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 40. See the NIHR Journals Library website for further project information. The funder specified that any new delirium assessment tool should be compared against the CAM, but had no other role in the study design or conduct of the study.

Delirium is the sudden onset of confusion that can happen when someone is unwell. It is common in older people who go into hospital, and it is upsetting for both the patients and their families. Delirium is important to diagnose, because people with delirium do less well than those without, and it is often treatable. The ideal way to diagnose delirium is with a full assessment by a specialist, but this is expensive and time-consuming. We therefore developed a short test called the 4 'A's Test (4AT). The four 'A's stand for Arousal, Attention, Abbreviated Mental Test ­ 4, and Acute change. First, we interviewed hospital staff about delirium and the 4AT. We found that the 4AT was already widely used and that people found it easy to use. We then tested how the 4AT performed in practice. A total of 785 recently admitted patients aged ≥ 70 years participated, of whom around one in eight had delirium. A researcher carried out the full standard delirium assessment on each patient and then a different researcher carried out the 4AT. A normal 4AT score reliably ruled out delirium. An abnormal score was also reasonably effective in detecting delirium, but staff still needed to follow up such patients with a full assessment. People with higher 4AT scores stayed in hospital longer and were more likely to die, and their treatment was more expensive. We conclude that the 4AT is a useful test to rule out delirium or to see if more detailed testing is required. It could help treat patients correctly and quickly. This would save money and improve outcomes.

Delirium detection in older acute medical inpatients: a multicentre prospective comparative diagnostic test accuracy study of the 4AT and the confusion assessment method.

BACKGROUND: Delirium affects > 15% of hospitalised patients but is grossly underdetected, contributing to poor care. The 4 'A's Test (4AT, www.the4AT.com ) is a short delirium assessment tool designed for routine use without special training. The primary objective was to assess the accuracy of the 4AT for delirium detection. The secondary objective was to compare the 4AT with another commonly used delirium assessment tool, the Confusion Assessment Method (CAM). METHODS: This was a prospective diagnostic test accuracy study set in emergency departments or acute medical wards involving acute medical patients aged ≥ 70. All those without acutely life-threatening illness or coma were eligible. Patients underwent (1) reference standard delirium assessment based on DSM-IV criteria and (2) were randomised to either the index test (4AT, scores 0-12; prespecified score of > 3 considered positive) or the comparator (CAM; scored positive or negative), in a random order, using computer-generated pseudo-random numbers, stratified by study site, with block allocation. Reference standard and 4AT or CAM assessments were performed by pairs of independent raters blinded to the results of the other assessment. RESULTS: Eight hundred forty-three individuals were randomised: 21 withdrew, 3 lost contact, 32 indeterminate diagnosis, 2 missing outcome, and 785 were included in the analysis. Mean age was 81.4 (SD 6.4) years. 12.1% (95/785) had delirium by reference standard assessment, 14.3% (56/392) by 4AT, and 4.7% (18/384) by CAM. The 4AT had an area under the receiver operating characteristic curve of 0.90 (95% CI 0.84-0.96). The 4AT had a sensitivity of 76% (95% CI 61-87%) and a specificity of 94% (95% CI 92-97%). The CAM had a sensitivity of 40% (95% CI 26-57%) and a specificity of 100% (95% CI 98-100%). CONCLUSIONS: The 4AT is a short, pragmatic tool which can help improving detection rates of delirium in routine clinical care. TRIAL REGISTRATION: International standard randomised controlled trial number (ISRCTN) 53388093 . Date applied 30/05/2014; date assigned 02/06/2014.

Challenges and barriers to optimising sedation in intensive care: a qualitative study in eight Scottish intensive care units.

OBJECTIVES: Various strategies to promote light sedation are highly recommended in recent guidelines, as deep sedation is associated with suboptimum patient outcomes. Yet, the challenges met by clinicians in delivering high-quality analgosedation is rarely addressed. As part of the evaluation of a cluster-randomised quality improvement trial in eight Scottish intensive care units (ICUs), we aimed to understand the challenges to optimising sedation in the Scottish ICU settings prior to the trial. This article reports on the findings. DESIGN: A qualitative exploratory design: We conducted focus groups (FG) with clinicians during the preintervention period. Setting and participants: Eight Scottish ICUs. Nurses, physiotherapists and doctors working in each ICU volunteered to participate. FG were recorded and verbatim transcribed and inserted in NVivo V.10 for analysis. Qualitative thematic analysis was undertaken to develop emergent themes from the patterns identified in relation to sedation practice. Ethical approval was secured by Scotland A Research ethics committee. RESULTS: Three themes emerged from the inductive analysis: (a) a recent shift in sedation practice, (b) uncertainty in decision-making and (c) system-level factors including the ICU environment, organisational factors and educational gaps. Clinicians were challenged daily to manage agitated or difficult-to-sedate patients in the era of a progressive mantra of 'just sedate less' imposed by the pain-agitation-delirium guidelines. CONCLUSIONS: The current implementation of guidelines does not support behaviour change strategies to allow a patient-focused approach to sedation management, which obstructs optimum sedation-analgesia management. Recognition of the various challenges when mandating less sedation needs to be considered and novel sedation-analgesia strategies should allow a system-level approach to improve sedation-analgesia quality. DESIST REGISTRATION NUMBER: NCT01634451.

Implementing telemonitoring in primary care: learning from a large qualitative dataset gathered during a series of studies.

BACKGROUND: Telemonitoring for long term conditions such as hypertension and diabetes has not been widely adopted despite evidence of efficacy in trials and policy support. The Telescot programme comprised a series of seven trials and observational studies of telemonitoring for long term conditions in primary care, all with an explanatory qualitative component which had been analysed and published separately. There were changes to the models of care within and between studies and combining datasets would provide a longitudinal view of the evolution of primary care based telemonitoring services that was not available in the individual studies, as well as allowing comparison across the different conditions monitored. We aimed to explore what drove changes to the way telemonitoring was implemented, compare experience of telemonitoring across the range of long term conditions, and identify what issues, in the experience of the participants, need to be considered in implementing new telemonitoring systems. METHOD: Synthesis and thematic reanalysis of transcribed qualitative interview and focus group data from the Telescot programme adopting an interpretive description approach. All transcribed and coded text was re-read and data relating to the experience of the telemonitoring services, perceptions of future use and strategies for implementation were recoded into one consistent system. This was analysed thematically. RESULTS: The combined dataset contained transcribed qualitative interview and focus group data from 181 patients and 109 professionals. Four major themes were identified, using data, empowering patients, adjusting the model of care and system design. CONCLUSION: Telemonitoring was valued by patients who found it empowering and convenient. This, combined with initial professional concern that increased surveillance may create dependency led to the development of a more patient led service. However, despite a number of initial concerns being addressed as the service evolved, primary care professionals identified a number of barriers to widespread routine adoption of telemonitoring, many of which could be addressed by improved system design.

Prospective external validation of the Predicting Out-of-OFfice Blood Pressure (PROOF-BP) strategy for triaging ambulatory monitoring in the diagnosis and management of hypertension: observational cohort study.

OBJECTIVE: To prospectively validate the Predicting Out-of-OFfice Blood Pressure (PROOF-BP) algorithm to triage patients with suspected high blood pressure for ambulatory blood pressure monitoring (ABPM) in routine clinical practice. DESIGN: Prospective observational cohort study. SETTING: 10 primary care practices and one hospital in the UK. PARTICIPANTS: 887 consecutive patients aged 18 years or more referred for ABPM in routine clinical practice. All underwent ABPM and had the PROOF-BP applied. MAIN OUTCOME MEASURES: The main outcome was the proportion of participants whose hypertensive status was correctly classified using the triaging strategy compared with the reference standard of daytime ABPM. Secondary outcomes were the sensitivity, specificity, and area under the receiver operator characteristic curve (AUROC) for detecting hypertension. RESULTS: The mean age of participants was 52.8 (16.2) years. The triaging strategy correctly classified hypertensive status in 801 of the 887 participants (90%, 95% confidence interval 88% to 92%) and had a sensitivity of 97% (95% confidence interval 96% to 98%) and specificity of 76% (95% confidence interval 71% to 81%) for hypertension. The AUROC was 0.86 (95% confidence interval 0.84 to 0.89). Use of triaging, rather than uniform referral for ABPM in routine practice, would have resulted in 435 patients (49%, 46% to 52%) being referred for ABPM and the remainder managed on the basis of their clinic measurements. Of these, 69 (8%, 6% to 10%) would have received treatment deemed unnecessary had they received ABPM. CONCLUSIONS: In a population of patients referred for ABPM, this new triaging approach accurately classified hypertensive status for most, with half the utilisation of ABPM compared with usual care. This triaging strategy can therefore be recommended for diagnosis or management of hypertension in patients where ABPM is being considered, particularly in settings with limited resources.

Protocol for validation of the 4AT, a rapid screening tool for delirium: a multicentre prospective diagnostic test accuracy study.

INTRODUCTION: Delirium is a severe neuropsychiatric syndrome of rapid onset, commonly precipitated by acute illness. It is common in older people in the emergency department (ED) and acute hospital, but greatly under-recognised in these and other settings. Delirium and other forms of cognitive impairment, particularly dementia, commonly coexist. There is a need for a rapid delirium screening tool that can be administered by a range of professional-level healthcare staff to patients with sensory or functional impairments in a busy clinical environment, which also incorporates general cognitive assessment. We developed the 4 'A's Test (4AT) for this purpose. This study's primary objective is to validate the 4AT against a reference standard. Secondary objectives include (1) comparing the 4AT with another widely used test (the Confusion Assessment Method (CAM)); (2) determining if the 4AT is sensitive to general cognitive impairment; (3) assessing if 4AT scores predict outcomes, including (4) a health economic analysis. METHODS AND ANALYSIS: 900 patients aged 70 or over in EDs or acute general medical wards will be recruited in three sites (Edinburgh, Bradford and Sheffield) over 18 months. Each patient will undergo a reference standard delirium assessment and will be randomised to assessment with either the 4AT or the CAM. At 12 weeks, outcomes (length of stay, institutionalisation and mortality) and resource utilisation will be collected by a questionnaire and via the electronic patient record. ETHICS AND DISSEMINATION: Ethical approval was granted in Scotland and England. The study involves administering tests commonly used in clinical practice. The main ethical issues are the essential recruitment of people without capacity. Dissemination is planned via publication in high impact journals, presentation at conferences, social media and the website www.the4AT.com. TRIAL REGISTRATION NUMBER: ISRCTN53388093; Pre-results.

Are self-reported telemonitored blood pressure readings affected by end-digit preference: a prospective cohort study in Scotland.

OBJECTIVE: Simple forms of blood pressure (BP) telemonitoring require patients to text readings to central servers creating an opportunity for both entry error and manipulation. We wished to determine if there was an apparent preference for particular end digits and entries which were just below target BPs which might suggest evidence of data manipulation. DESIGN: Prospective cohort study SETTING: 37 socioeconomically diverse primary care practices from South East Scotland. PARTICIPANTS: Patients were recruited with hypertension to a telemonitoring service in which patients submitted home BP readings by manually transcribing the measurements into text messages for transmission ('patient-texted system'). These readings were compared with those from primary care patients with uncontrolled hypertension using a system in which readings were automatically transmitted, eliminating the possibility of manipulation of values ('automatic-transmission system'). METHODS: A generalised estimating equations method was used to compare BP readings between the patient-texted and automatic-transmission systems, while taking into account clustering of readings within patients. RESULTS: A total of 44 150 BP readings were analysed on 1068 patients using the patient-texted system compared with 20 705 readings on 199 patients using the automatic-transmission system. Compared with the automatic-transmission data, the patient-texted data showed a significantly higher proportion of occurrences of both systolic and diastolic BP having a zero end digit (OR 2.1, 95% CI 1.7 to 2.6) although incidence was <2% of readings. Similarly, there was a preference for systolic 134 and diastolic 84 (the threshold for alerts was 135/85) (134 systolic BP OR 1.5, 95% CI 1.3 to 1.8; 84 diastolic BP OR 1.5, 95% CI 1.3 to 1.9). CONCLUSION: End-digit preference for zero numbers and specific-value preference for readings just below the alert threshold exist among patients in self-reporting their BP using telemonitoring. However, the proportion of readings affected is small and unlikely to be clinically important. TRIAL REGISTRATION NUMBER: ISRCTN72614272; Post-results.

The Comparative Effectiveness of Treatments for Ureteropelvic Junction Obstruction.

OBJECTIVE: To examine the effectiveness of the 3 primary treatments for ureteropelvic junction obstruction (ie, open pyeloplasty, minimally invasive pyeloplasty, and endopyelotomy) as assessed by failure rates. MATERIALS AND METHODS: Using MarketScan data, we identified adults (ages 18-64 years) who underwent treatment for ureteropelvic junction obstruction between 2002 and 2010. Our primary outcome was failure (ie, need for a secondary procedure). We fit a Cox proportional hazards model to examine the effects of different patient, regional, and provider characteristics on treatment failure. We then implemented a survival analysis framework to examine the failure-free probability for each treatment. RESULTS: We identified 1125 minimally invasive pyeloplasties, 775 open pyeloplasties, and 1315 endopyelotomies with failure rates of 7%, 9%, and 15%, respectively. Compared with endopyelotomy, minimally invasive pyeloplasty was associated with a lower risk of treatment failure (adjusted hazards ratio [aHR] 0.52; 95% confidence interval [CI], 0.39-0.69). Minimally invasive and open pyeloplasties had similar failure rates. Compared with open pyeloplasty, endopyelotomy was associated with a higher risk of treatment failure (aHR 1.78; 95% CI, 1.33-2.37). The average length of stay was 2.7 days for minimally invasive pyeloplasty and 4.2 days for open pyeloplasty (P <.001). CONCLUSION: Endopyelotomy has the highest failure rate, yet it remains a common treatment for ureteropelvic junction obstruction. Future research should examine to what extent patients and physicians are driving the use of endopyelotomy.

Predicting Out-of-Office Blood Pressure in the Clinic for the Diagnosis of Hypertension in Primary Care: An Economic Evaluation.

Clinical guidelines in the United States and United Kingdom recommend that individuals with suspected hypertension should have ambulatory blood pressure (BP) monitoring to confirm the diagnosis. This approach reduces misdiagnosis because of white coat hypertension but will not identify people with masked hypertension who may benefit from treatment. The Predicting Out-of-Office Blood Pressure (PROOF-BP) algorithm predicts masked and white coat hypertension based on patient characteristics and clinic BP, improving the accuracy of diagnosis while limiting subsequent ambulatory BP monitoring. This study assessed the cost-effectiveness of using this tool in diagnosing hypertension in primary care. A Markov cost-utility cohort model was developed to compare diagnostic strategies: the PROOF-BP approach, including those with clinic BP ≥130/80 mm Hg who receive ambulatory BP monitoring as guided by the algorithm, compared with current standard diagnostic strategies including those with clinic BP ≥140/90 mm Hg combined with further monitoring (ambulatory BP monitoring as reference, clinic, and home monitoring also assessed). The model adopted a lifetime horizon with a 3-month time cycle, taking a UK Health Service/Personal Social Services perspective. The PROOF-BP algorithm was cost-effective in screening all patients with clinic BP ≥130/80 mm Hg compared with current strategies that only screen those with clinic BP ≥140/90 mm Hg, provided healthcare providers were willing to pay up to £20 000 ($26 000)/quality-adjusted life year gained. Deterministic and probabilistic sensitivity analyses supported the base-case findings. The PROOF-BP algorithm seems to be cost-effective compared with the conventional BP diagnostic options in primary care. Its use in clinical practice is likely to lead to reduced cardiovascular disease, death, and disability.

Learning lessons from the analysis of patient complaints relating to staff attitudes, behaviour and communication, using the concept of emotional labour.

AIMS AND OBJECTIVES: This article explores the content of letters of complaint by patients and carers about the behaviour, attitudes and communication of healthcare staff. BACKGROUND: The most common focus of patient complaints in the UK and other high-income countries is staff attitudes, behaviour and communication. There is a move to learn lessons from patient complaints, which can be used to improve patient care and experience. METHODS: Fifty letters of complaint made by patients and carers relating to the behaviour, attitudes and communication of healthcare staff were analysed. RESULTS: Poor attitudes, behaviours and communication have significant negative impact on the emotional well-being of patients and carers. Many patients and carers have heightened sensitivities due to both health-related stresses and also other factors. The healthcare role is expected to include compassion and kindness. The concept of emotional labour is useful in explaining the skills and effort required of staff in this often invisible and undervalued aspect of health care. CONCLUSIONS: Given the increasing focus on patient experience, it is important that the importance of good staff attitudes, behaviours and communication is understood and that the emotional labour associated with this is recognised. RELEVANCE TO CLINICAL PRACTICE: An understanding of emotional intelligence can protect staff from burnout and other negative outcomes which those in a caring role can experience.

Transition to parenthood in the neonatal care unit: a qualitative study and conceptual model designed to illuminate parent and professional views of the impact of webcam technology.

BACKGROUND: Complications during pregnancy, childbirth and/or the postnatal period may result in the admission of a baby to a neonatal unit (NNU). While the survival and long-term prospects of high-risk infants are enhanced by admission, the enforced separation of the parent and child may have psychological consequences for both. There is a need to develop and evaluate interventions to help parents 'feel closer' to their infants in circumstances where they are physically separated from them. In this paper we present findings from an in-depth, theoretically-driven, evaluation of a technological innovation designed to address this need. The study sought to explore parent and professional views of the impact of the technology, which transmits real-time images of the baby via a webcam from the NNU to the mother's bedside in the post-natal care environment. METHODS: A qualitative approach was adopted, guided by a critical realist perspective. Participants were recruited purposively from a NNU located in East-central Scotland. Thirty-three parents and 18 professionals were recruited. Data were collected during individual, paired and small group interviews and were analysed thematically. Following the initial analysis process, abductive inference was used to consider contextual factors and mechanisms of action appearing to account for reported outcomes. RESULTS: Views on the technology were overwhelmingly positive. It was perceived as a much needed and important advancement in care delivery. Benefits centred on: enhanced feelings of closeness and responsiveness; emotional wellbeing; physical recovery; and the involvement of family/friends. These benefits appeared to function as important mechanisms in supporting the early bonding process and wider transition to parenthood. However, for a small number of the parents, use of the technology had not enhanced their experience and it is important, as with any intervention, that professionals monitor the parents' response and act accordingly. CONCLUSIONS: With a current global increase in premature births, the technology appears to offer an important solution to periods of enforced parent-infant separation in the early post-natal period. The current study is one of a few world-wide to have sought to evaluate this form of technology in the neonatal care environment.

Home monitoring of breathing rate in people with chronic obstructive pulmonary disease: observational study of feasibility, acceptability, and change after exacerbation.

Telehealth programs to promote early identification and timely self-management of acute exacerbations of chronic obstructive pulmonary diseases (AECOPDs) have yielded disappointing results, in part, because parameters monitored (symptoms, pulse oximetry, and spirometry) are weak predictors of exacerbations. PURPOSE: Breathing rate (BR) rises during AECOPD and may be a promising predictor. Devices suitable for home use to measure BR have recently become available, but their accuracy, acceptability, and ability to detect changes in people with COPD is not known. PATIENTS AND METHODS: We compared five BR monitors, which used different monitoring technologies, with a gold standard (Oxycon Mobile®; CareFusion®, a subsidiary of Becton Dickinson, San Diego, CA, USA). The monitors were validated in 21 stable COPD patients during a 57-min "activities of daily living protocol" in a laboratory setting. The two best performing monitors were then tested in a 14-day trial in a home setting in 23 stable COPD patients to determine patient acceptability and reliability of signal. Acceptability was explored in qualitative interviews. The better performing monitor was then given to 18 patients recruited during an AECOPD who wore the monitor to observe BR during the recovery phase of an AECOPD. RESULTS: While two monitors demonstrated acceptable accuracy compared with the gold standard, some participants found them intrusive particularly when ill with an exacerbation, limiting their potential utility in acute situations. A reduction in resting BR during the recovery from an AECOPD was observed in some, but not in all participants and there was considerable day-to-day individual variation. CONCLUSION: Resting BR shows some promise in identifying exacerbations; however, further prospective study to assess this is required.

Cohort profile: the Scottish Research register SHARE. A register of people interested in research participation linked to NHS data sets.

PURPOSE: Recruitment to trials is often difficult. Many trials fail to meet recruitment targets resulting in underpowered studies which waste resources and the time of those who participated. While there is evidence that many people are willing to take part in research, particularly if it involves a condition from which they suffer, researchers are unable to easily contact such people often relying on busy clinicians to identify them. Many clinicians perceive themselves as too busy to take part in research activities. The Scottish Health Research Register SHARE adopts an approach which asks the public to consent to their data held in National Health Service databases to be used to determine their suitability for research projects. Additionally, participants can consent for spare blood, left after routine venepuncture to be automatically identified in the laboratory and stored for future research studies. PARTICIPANTS: Anyone over the age of 16 years in Scotland can participate. Participants are approached through a range of methods including directly at outpatient clinics and general practitioners practices, leaflets with hospital letters and personal email from employers. FINDINGS TO DATE: SHARE has recruited around 130 000 people. SHARE has demonstrated that it can quickly and efficiently recruit to studies, over 20 until now. In addition, it can be used to administer questionnaire studies by email and recruit to patient and public involvement groups. FUTURE PLANS: SHARE continues to steadily recruit with the ambition of eventually achieving 1 000 000 people in Scotland. We are steadily increasing the number of data sets we use for identifying participants. We are adding a mobile app which will facilitate dissemination about research and allow the collection of physiological and activity data if desired. We anticipate that SHARE will soon become the main source of health research recruitment in Scotland.