Development of a quality of life measure for left ventricular assist device recipients using a mixed methods approach.

BACKGROUND: Left ventricular assist device (LVAD) recipients report symptom improvement but find adjusting to life with the LVAD challenging. These challenges are unique, and existing patient-reported outcome measures (PROMs) do not reflect their experiences. This study aimed to develop a culturally relevant quality of life PROM for use with LVAD recipients in future research, design evolutions and clinical practice. METHODS: A three-stage mixed-methods approach was used to develop a PROM: stage 1 included group concept mapping (GCM); stage 2 semi-structured qualitative interviews were conducted with 11 LVAD recipients and 10 clinicians, and a questionnaire was developed using a conceptual framework; and stage 3 used exploratory psychometric analysis of the PROM data using Rasch measurement theory. This paper presents stages 2 and 3. RESULTS: The conceptual framework consisted of four key concepts, including general health, life with the LVAD, equipment and clothing and emotional impact. Statements from interviews and GCM were used to create items for the LVAD quality of life (LVAD-QoL). Cognitive interviews tested face validity and participant comprehension. Forty-nine participants were recruited from three UK transplant centres. PROM data were collected and analysed using Rasch analysis. Four items displayed misfit; dependency between item sets was the biggest issue (57/485 pairwise differences). After restructuring and dealing with item misfit, the LVAD-QoL conformed to the Rasch model, supporting the psychometric properties and quality of the LVAD-QoL. CONCLUSIONS: Using a mixed-methods approach ensured the development of a robust and psychometrically sound tool for research, design evolution and clinical practice with LVAD recipients.

Pharmacist management of atrial fibrillation in UK primary care: a cross-sectional study.

Background: Atrial Fibrillation (AF) increases the risk of stroke by a factor of five, leading a significant cost burdens on healthcare system. Pharmacists, especially those based in a primary care environment are well placed to support patients in this therapeutic area. Objectives: To assess primary care pharmacists' actual knowledge on the management of AF symptoms and anticoagulation. Furthermore, to investigate the resources used by pharmacists. Methods: A cross-sectional study using survey was conducted, targeting UK-based registered pharmacists employed within primary care settings. Quantitative data were analysed utilising descriptive univariate and bivariate statistics. Results: 349 pharmacists completed the adapted 19-questions of the pharmacists' knowledge. Out of a maximum of 19 points, the mean score was 14.34 ± 2.2 (75 ± 11.6%). The questionnaire revealed several significant gaps in pharmacists' knowledge. Most of the surveyed pharmacists (62.8%) reported that they used sources of information to support their consultations. Half reported that they used the National Institute for Health and Care Excellence (NICE) guidance (52.4%) and the British National Formulary (BNF) (50.7%). Conclusions: Primary care pharmacists are knowledgeable about AF and its management; however, some gaps exist which may require addressing. Although pharmacists use a variety of information resources, it is the traditional resources that remain the most frequently used.

A Modified Medical Education Research Study Quality Instrument (MMERSQI) developed by Delphi consensus.

BACKGROUND: The Medical Education Research Study Quality Instrument (MERSQI) is widely used to appraise the methodological quality of medical education studies. However, the MERSQI lacks some criteria which could facilitate better quality assessment. The objective of this study is to achieve consensus among experts on: (1) the MERSQI scoring system and the relative importance of each domain (2) modifications of the MERSQI. METHOD: A modified Delphi technique was used to achieve consensus among experts in the field of medical education. The initial item pool contained all items from MERSQI and items added in our previous published work. Each Delphi round comprised a questionnaire and, after the first iteration, an analysis and feedback report. We modified the quality instruments' domains, items and sub-items and re-scored items/domains based on the Delphi panel feedback. RESULTS: A total of 12 experts agreed to participate and were sent the first and second-round questionnaires. First round: 12 returned of which 11 contained analysable responses; second-round: 10 returned analysable responses. We started with seven domains with an initial item pool of 12 items and 38 sub-items. No change in the number of domains or items resulted from the Delphi process; however, the number of sub-items increased from 38 to 43 across the two Delphi rounds. In Delphi-2: eight respondents gave 'study design' the highest weighting while 'setting' was given the lowest weighting by all respondents. There was no change in the domains' average weighting score and ranks between rounds. CONCLUSIONS: The final criteria list and the new domain weighting score of the Modified MERSQI (MMERSQI) was satisfactory to all respondents. We suggest that the MMERSQI, in building on the success of the MERSQI, may help further establish a reference standard of quality measures for many medical education studies.

Living with a left ventricular assist device: Capturing recipients experiences using group concept mapping software.

BACKGROUND: Left ventricular assist device (LVAD) implantation significantly impacts on a recipient's symptoms and quality of life. Capturing their experiences and post implant journey is an important part of clinical practice, research and device design evolution. Patient reported outcome measures (PROMs) are a useful tool for capturing that experience. However, patient reported outcome measures need to reflect recipients' experiences. Discussions with a patient partner group found that none of the frequently used cardiology PROMs captured their unique experiences. AIMS: To capture the experiences and important issues for LVAD recipients. Develop a conceptual map of domains and items that should be reflected in patient reported outcomes. METHODS: Group concept mapping (GCM) web-based software was used to remotely capture and structure recipients' experiences across a wide geographical area. GCM is a semi-quantitative mixed method consisting of 3 stages: item generation, item sorting and rating (importance, relevance and frequency). Patient partners were involved in all aspects of the study design and development. RESULTS: 18 LVAD recipients consented to take part. 101 statements were generated and multi-dimensional scaling, and hierarchical cluster analysis identified 9 clusters. Cluster themes included: Activities, Partner/family support, Travel, Mental wellbeing, Equipment and clothing, Physical and cognitive limitations, LVAD Restrictions, LVAD Challenges and positive impact of the LVAD (LVAD Positives). LVAD Positives were scored highest across all the rating variables, e.g., frequency (2.85), relevance (2.44) and importance (2.21). Other domains rated high for importance included physical and cognitive limitations (2.19), LVAD restrictions (2.11), Partner/family support (2.02), and Equipment and clothing (2.01). CONCLUSION: Online GCM software facilitated the inclusion of geographically dispersed recipients and provided useful insights into the experiences of LVAD recipients. The conceptual framework identifies important domains and items that should be prioritised and included in patient reported outcomes in future research, LVAD design evolution, and clinical practice.

Evaluating the role and integration of general practice pharmacists in England: a cross-sectional study.

Background Since 2015, NHS England has facilitated the recruitment of pharmacists in general practice (GP) to reduce workload of general practitioners. The role of pharmacists is therefore expected to become more clinical and patient oriented. However, little is known about the current roles performed and the integration of GP pharmacists. Objective To assess the role performed by GP pharmacists and their integration into practice exploring facilitators and barriers to integration. Setting A cross-sectional survey of GP pharmacists in England. Method This study used both online and paper-based questionnaires for a period of six months. Survey items included demographics, roles performed, integration including available support and practice environment. Quantitative data were analysed using descriptive statistics and 95% confidence intervals. Open comments were analysed thematically to identify pharmacists' perceptions of barriers and facilitators to their integration into practice. Main outcome measure Current role and integration of pharmacists into GP. Results 195 participants completed the questionnaire. Three quarters of pharmacists (76%) had only been in GP since 2015. Most pharmacists (81%) were independent prescribers (PIPs). The most reported pharmacists' roles were medicine reconciliation (95%), telephone support for patients (95%) and face-to-face medication review (91%). 82% (95% CI: 76% to 86.8%) were satisfied with their overall integration into practice. Half of pharmacists (45%) were working in a shared office or at a hot desk and 9% had no designated workspace. PIPs had more access to a convenient workplace (p = 0.016) compared to non-IPs. Conclusion Practice pharmacists are fulfilling a wide range of clinical and non-clinical roles in England. Findings highlight relatively a satisfactory level of pharmacists' integration into practice and shed the light on their integration issues. These findings could be significant for the development of future roles of pharmacists in GP.

Mobile Apps to Improve Medication Adherence in Cardiovascular Disease: Systematic Review and Meta-analysis.

BACKGROUND: Adherence rates of preventative medication for cardiovascular disease (CVD) have been reported as 57%, and approximately 9% of all CVD events in Europe are attributable to poor medication adherence. Mobile health technologies, particularly mobile apps, have the potential to improve medication adherence and clinical outcomes. OBJECTIVE: The objective of this study is to assess the effects of mobile health care apps on medication adherence and health-related outcomes in patients with CVD. This study also evaluates apps' functionality and usability and the involvement of health care professionals in their use. METHODS: Electronic databases (MEDLINE [Ovid], PubMed Central, Cochrane Library, CINAHL Plus, PsycINFO [Ovid], Embase [Ovid], and Google Scholar) were searched for randomized controlled trials (RCTs) to investigate app-based interventions aimed at improving medication adherence in patients with CVD. RCTs published in English from inception to January 2020 were reviewed. The Cochrane risk of bias tool was used to assess the included studies. Meta-analysis was performed for clinical outcomes and medication adherence, with meta-regression analysis used to evaluate the impact of app intervention duration on medication adherence. RESULTS: This study included 16 RCTs published within the last 6 years. In total, 12 RCTs reported medication adherence as the primary outcome, which is the most commonly self-reported adherence. The duration of the interventions ranged from 1 to 12 months, and sample sizes ranged from 24 to 412. Medication adherence rates showed statistically significant improvements in 9 RCTs when compared with the control, and meta-analysis of the 6 RCTs reporting continuous data showed a significant overall effect in favor of the app intervention (mean difference 0.90, 95% CI 0.03-1.78) with a high statistical heterogeneity (I2=93.32%). Moreover, 9 RCTs assessed clinical outcomes and reported an improvement in systolic blood pressure, diastolic blood pressure, total cholesterol, and low-density lipoprotein cholesterol levels in the intervention arm. Meta-analysis of these clinical outcomes from 6 RCTs favored app interventions, but none were significant. In the 7 trials evaluating app usability, all were found to be acceptable. There was a great variation in the app characteristics. A total of 10 RCTs involved health care professionals, mainly physicians and nurses, in the app-based interventions. The apps had mixed functionality: 2 used education, 7 delivered reminders, and 7 provided reminders in combination with educational support. CONCLUSIONS: Apps tended to increase medication adherence, but interventions varied widely in design, content, and delivery. Apps have an acceptable degree of usability; yet the app characteristics conferring usability and effectiveness are ill-defined. Future large-scale studies should focus on identifying the essential active components of successful apps. TRIAL REGISTRATION: PROSPERO International Prospective Register of Systematic Reviews CRD42019121385; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=121385.

Prevalence of non-adherence to antihypertensive medication in Asia: a systematic review and meta-analysis.

Background Hypertension and its associated complications are one of the leading causes of morbidity and mortality in Asia. Racial disparities in terms of treatment outcomes among hypertension patients have been reported in literature with Asian patients resulting in poorer treatment outcomes. Non-adherence to antihypertensive therapy is frequently associated with poor treatment outcomes. Aim of the review The aim of this review was to estimate the prevalence of non-adherence to antihypertensive medications among patients with hypertension residing in Asia. Method PubMed, Google Scholar, MEDLINE, Embase, Scopus, CINHAL and Cochrane library were searched for studies published between 2000 and 2019 involving hypertensive patients. Studies investigating the prevalence of medication non-adherence in Asian countries, rated either good or fair on National Institute of Health quality assessment tool and published in English language were included in our review. Data were extracted by one author and checked by another using a structured and pilot-tested data extraction sheet. A random-effects meta-analysis was performed using STATA version 14.3®. Results Sixty-Six studies from 22 Asian countries including 2,532,582 hypertensive patients were included. Mean (± SD) age of participants was 58(± 6) years. Overall, the estimated prevalence of non-adherence to antihypertensive medication in Asia was 48% (95% CI: 41-54, P = 0.001). The rate of non-adherence was higher among females 49% (95% CI: 41-56, P = 0.001) compared to males 47% (95% CI: 40-53, P = 0.001). As per the region, the highest prevalence of non-adherence was found in South Asia 48% (95% 44-51, P = 0.877) followed by East Asia 45% (31-59, P = 0.001) and the Middle East 41 (95% 30-52, P = 0.001). Similarly, higher rate of non-adherence was observed in low and lower middle-income countries i.e. 50% (95% CI: 47-54, P = 0.220) as compare to upper-middle and high-income countries i.e. 37% (95% CI: 25-49, P = 0.001) and 44% (95% CI: 29-59, P = 0.001) respectively. Conclusion The prevalence of non-adherence to antihypertensive medication is high in Asia. This may partly explain poor treatment outcomes and incidence of higher mortality rate in Asia frequently reported in the literature. There is a need to implement appropriate policies and clinical practices to improve medication adherence.

Effectiveness of technology-enhanced simulation in teaching digital rectal examination: a systematic review narrative synthesis.

Background: Digital rectal examination (DRE) is a challenging examination to learn. Objective: To synthesise evidence regarding the effectiveness of technology-enhanced simulation (TES) for acquiring DRE skills. Study selection: EMBASE, Medline, CINAHL, Cochrane, Web of Knowledge (Science and Social Science), Scopus and IEEE Xplore were searched; the last search was performed on 3 April 2019. Included were original research studies evaluating TES to teach DRE. Data were abstracted on methodological quality, participants, instructional design and outcomes; a descriptive synthesis was performed. Quality was assessed using a modified Medical Education Research Study Quality Instrument. The study design domain was modified by scoring the papers based on (1) evaluation of risk of bias for randomised controlled trials, (2) description of participants and (3) assessment of robustness and degree of simulation fidelity of the assessments used to evaluate learning. Findings: 863 articles were screened; 12 were eligible, enrolling 1507 prequalified medical/clinical students and 20 qualified doctors. For skill acquisition, role player was statistically significantly superior to a static manikin (2 studies). For knowledge acquisition, manikin use was significantly superior to role player (1 study); 2 studies showed no difference. For confidence, manikin use was significantly superior to no manikin (4 studies). For comfort, manikin use was significantly superior to no manikin (2 studies). For anxiety, role player was significantly superior to manikin (1 study).Median overall quality score (QS) was 48% (27-62). Highest median QS was 73% (33-80) for data analysis; lowest median QS was 20% (7-40) for the validity of instrument. Six papers scored over 50% of the maximum score for overall quality. Conclusions: TES training is associated with improved DRE skills and should be used more widely.

Subclinical thyroid dysfunction symptoms in older adults: cross-sectional study in UK primary care.

BACKGROUND: Subclinical thyroid dysfunction - abnormal serum thyrotrophin (thyroid-stimulating hormone; TSH) concentrations with normal free thyroxine (FT4) is common in older people. It remains unclear whether individuals with subclinical serum status experience an increased symptom profile. AIM: To compare the prevalence of those symptoms typically associated with overt thyroid dysfunction in older individuals with a subclinical and euthyroid serum profile. DESIGN AND SETTING: Cross-sectional study, nested within the Birmingham Elderly Thyroid Study (BETS); from 19 UK general practices. METHOD: Adults living in a community setting (aged ≥65 years), without overt thyroid dysfunction or associated treatment, self-reported the presence or absence of 18 symptoms (while serum result naïve). Serum concentrations of TSH and FT4 were measured to establish thyroid status. RESULTS: A total of 2870 individuals were screened: 2703 (94%) were categorised as euthyroid (normal), 29 (1%) subclinically hyperthyroid, and 138 (5%) subclinically hypothyroid. Symptoms were common in all groups. No significant differences in the prevalence of individual symptoms were observed between the euthyroid and subclinically hypothyroid groups nor in comparison with the subclinically hyperthyroid group. Multivariate logistic regression analysis failed to reveal an association between individual or multiple symptoms and subclinical status. CONCLUSION: Findings suggest that subclinical thyroid dysfunction does not confer a symptom burden in older individuals and support adherence to guidelines in the non-treatment of subclinical thyroid dysfunction. GPs may use the findings to reassure older people presenting with symptoms that subclinical thyroid dysfunction is an unlikely explanation. The presence of persistently abnormal TSH concentrations may be linked to long-term risks of cardiovascular disease, especially atrial fibrillation, but whether this should prompt treatment and whether such treatment alters vascular outcomes is unknown.

Impact of the pharmacist-led intervention on the control of medical cardiovascular risk factors for the primary prevention of cardiovascular disease in general practice: A systematic review and meta-analysis of randomised controlled trials.

AIMS: To conduct a systematic review and meta-analysis of the effectiveness of general practice-based pharmacist interventions in reducing the medical risk factors for the primary prevention of cardiovascular events. METHODS: A systemic search was undertaken in 8 databases: PubMed, MEDLINE, EMBAS, PsycINFO, Cochrane Library, CINAHL Plus, SCOPUS and Science Citation Index, with no start date up to 27 March 2019. Randomised controlled trials assessing the effectiveness of pharmacist-led interventions delivered in the general practice in reducing the medical risk factors of cardiovascular events were included in the review. The risk of bias in the studies was assessed using the Cochrane risk of bias tool. RESULTS: A total of 1604 studies were identified, with 21 randomised controlled trials (8933 patients) meeting the inclusion criteria. Fourteen studies were conducted in patients with diabetes, 7 in hypertension, 2 involving dyslipidaemia, and 2 with hypertension and diabetes together. The most frequently used interventions were medication review and medication management. The quality of the included studies was variable. Patients receiving pharmacist-led interventions were associated with a statistically significant reduction in their systolic blood pressure (-9.33 mmHg [95% Confidence Interval (CI) -13.36 to -5.30]), haemoglobin A1C (-0.76% [95% CI -1.15 to -0.37]) and low-density lipoprotein-cholesterol (-15.19 mg/dL [95% CI -24.05 to -6.33]). Moreover, practice-based pharmacists' interventions were also reported to have a positive impact on patient adherence to medications. CONCLUSION: The findings of this review suggest that pharmacist-led interventions in general practice can significantly reduce the medical risk factors of cardiovascular disease events. These findings support the involvement of pharmacists as healthcare providers in managing patients with hypertension, diabetes and dyslipidaemia.

A cluster randomised, double-blind pilot and feasibility trial of an active behavioural physiotherapy intervention for acute whiplash-associated disorder (WAD)II.

Whiplash-associated disorder (WAD) causes substantial social and economic burden, with ≥70% patients classified as WADII (neck complaint and musculoskeletal sign(s)). Effective management in the acute stage is required to prevent development of chronicity; an issue for 60% of patients. An Active Behavioural Physiotherapy Intervention (ABPI) was developed to address both physical and psychological components of WAD. The ABPI is a novel complex intervention designed through a rigorous sequential multiphase project to prevent transition of acute WAD to chronicity. An external pilot and feasibility cluster randomised double-blind (assessor, participants) parallel two-arm clinical trial was conducted in the UK private sector. The trial compared ABPI versus standard physiotherapy to evaluate trial procedures and feasibility of the ABPI for managing acute WADII in preparation for a future definitive trial. Six private physiotherapy clinics were recruited and cluster randomised using a computer-generated randomisation sequence. Twenty-eight (20 ABPI, 8 standard physiotherapy) participants [median age 38.00 (IQR = 21.50) years] were recruited. Data were analysed descriptively with a priori establishment of success criteria. Ninety-five percent of participants in the ABPI arm fully recovered (Neck Disability Index ≤4, compared to 17% in the standard physiotherapy arm); required fewer treatment sessions; and demonstrated greater improvement in all outcome measures (pain intensity, Cervical Range of Motion, Pressure Pain Threshold, EuroQol-5 Dimensions) except for the Impact of Events Scale and Fear Avoidance Beliefs Questionnaire. The findings support the potential value of the ABPI, and that an adequately powered definitive trial to evaluate effectiveness (clinical, cost) is feasible with minor modifications to procedures.

Stability of thyroid function in older adults: the Birmingham Elderly Thyroid Study.

BACKGROUND: Thyroid function tests (TFTs) are among the most requested tests internationally. However, testing practice is inconsistent, and potentially suboptimal and overly costly. The natural history of thyroid function remains poorly understood. AIM: To establish the stability of thyroid function over time, and identify predictors of development of overt thyroid dysfunction. DESIGN AND SETTING: Longitudinal follow-up in 19 general practices in the UK. METHOD: A total of 2936 participants from the Birmingham Elderly Thyroid Study (BETS 1) with a baseline TFT result indicating euthyroid or subclinical state were re-tested after approximately 5 years. Change in thyroid-stimulating hormone (TSH), free thyroxine (FT4), and thyroid status between baseline and follow-up was determined. Predictors of progression to overt dysfunction were modelled. RESULTS: Participants contributed 12 919 person-years; 17 cases of overt thyroid dysfunction were identified, 13 having been classified at baseline as euthyroid and four as having subclinical thyroid dysfunction. Individuals with subclinical results at baseline were 10- and 16-fold more likely to develop overt hypothyroidism and hyperthyroidism, respectively, compared with euthyroid individuals. TSH and FT4 demonstrated significant stability over time, with 61% of participants having a repeat TSH concentration within 0.5 mIU/L of their original result. Predictors of overt hypothyroidism included new treatment with amiodarone (odds ratio [OR] 92.1), a new diagnosis of atrial fibrillation (OR 7.4), or renal disease (OR 4.8). CONCLUSION: High stability of thyroid function demonstrated over the 5-year interval period should discourage repeat testing, especially when a euthyroid result is in the recent clinical record. Reduced repeat TFTs in older individuals is possible without conferring risk, and could result in significant cost savings.

Outcome of fixed volume intracameral sodium hyaluronate 1.4% injection for early postoperative hypotony after Baerveldt glaucoma implant.

IMPORTANCE: Using an ophthalmic viscoelastic device to manage early postoperative hypotony after Baerveldt glaucoma implant (BGI). BACKGROUND: To determine the outcome of intracameral sodium hyaluronate injection for early postoperative hypotony treatment after BGI. DESIGN: A retrospective study. PARTICIPANTS: One-hundred-and-thirty-eight patients (176 eyes) had BGI from January 2012 to November 2015. Those who had hypotony within 3 months postoperatively were studied. METHODS: Hypotonous eyes were injected with 0.1 mL sodium hyaluronate 1.4% intracameral on the slit-lamp. The patients were followed up weekly and the injection repeated up to 3 times if hypotony persisted. The tube was tied surgically as a last resort. MAIN OUTCOME MEASURES: The intraocular pressure and best-corrected visual acuity at week 1, 2, 3, 4, 6 and month 4 were assessed. RESULTS: Thirty (17.0%) out of 176 eyes developed early postoperative hypotony. The median intraocular pressure and median best-corrected visual acuity when hypotony first presented were 3 mmHg and 0.8 logMAR. Two eyes were excluded as they had more than 0.1 mL injection. Eight (29%) of the 28 hypotonous eyes resolved after one injection, seven (25%) required two and 10 (36%) needed three injections. Three (11%) eyes had surgical tube tie. The median intraocular pressures were 5, 7, 8, 10, 11 and 13 mmHg at week 1, 2, 3, 4, 6 and month 4 post-injection. The median best-corrected visual acuity were 0.60, 0.50, 0.50, 0.45, 0.40 and 0.40 logMAR for the same period. CONCLUSIONS AND RELEVANCE: Standardised intracameral 0.1 mL sodium hyaluronate 1.4% is an effective and safe way to manage early postoperative hypotony after BGI.

Measurement of blood pressure for the diagnosis and management of hypertension in different ethnic groups: one size fits all.

BACKGROUND: Hypertension is a major risk factor for cardiovascular disease and prevalence varies by ethnic group. The diagnosis and management of blood pressure are informed by guidelines largely based on data from white populations. This study addressed whether accuracy of blood pressure measurement in terms of diagnosis of hypertension varies by ethnicity by comparing two measurement modalities (clinic blood pressure and home monitoring) with a reference standard of ambulatory BP monitoring in three ethnic groups. METHODS: Cross-sectional population study (June 2010 - December 2012) with patients (40-75 years) of white British, South Asian and African Caribbean background with and without a previous diagnosis of hypertension recruited from 28 primary care practices. The study compared the test performance of clinic BP (using various protocols) and home-monitoring (1 week) with a reference standard of mean daytime ambulatory measurements using a threshold of 140/90 mmHg for clinic and 135/85 mmHg for out of office measurement. RESULTS: A total of 551 participants had complete data of whom 246 were white British, 147 South Asian and 158 African Caribbean. No consistent difference in accuracy of methods of blood pressure measurement was observed between ethnic groups with or without a prior diagnosis of hypertension: for people without hypertension, clinic measurement using three different methodologies had high specificity (75-97%) but variable sensitivity (33-65%) whereas home monitoring had sensitivity of 68-88% and specificity of 64-80%. For people with hypertension, detection of a raised blood pressure using clinic measurements had sensitivities of 34-69% with specificity of 73-92% and home monitoring had sensitivity (81-88%) and specificity (55-65%). CONCLUSIONS: For people without hypertension, ABPM remains the choice for diagnosing hypertension compared to the other modes of BP measurement regardless of ethnicity. Differences in accuracy of home monitoring and clinic monitoring (higher sensitivity of the former; higher specificity of the latter) were also not affected by ethnicity.

Development of an active behavioural physiotherapy intervention (ABPI) for acute whiplash-associated disorder (WAD) II management: a modified Delphi study.

OBJECTIVE: To develop an active behavioural physiotherapy intervention (ABPI) for managing acute whiplash-associated disorder (WAD) II using a modified Delphi method to develop consensus for the basic features of the ABPI. DESIGN: Modified Delphi study. Our systematic review and meta-analysis evaluating conservative management for acute WADII found that a combined ABPI may be a useful intervention to prevent patients progressing to chronicity. No previous research has considered a combined behavioural approach and active physiotherapy in the management of acute WADII patients. The ABPI was therefore developed using a rigorous consensus method using international research and local clinical whiplash experts. Descriptive statistics were used to assess consensus in each round. SETTING: Online international survey. PARTICIPANTS: A purposive sample of 97 potential participants (aiming to recruit n=30) consisting of international research whiplash experts, UK private physiotherapists and UK postgraduate musculoskeletal physiotherapy students were invited to participate via electronic mail with an attached participant information sheet and consent form. RESULTS: 36 individuals signed and returned the consent form. In round 1, 32/36 participants (response rate=89%, mean age±SD=36.03±13.22 years) across 8 countries (Australia, Finland, Greece, India, Netherlands, Norway, Sweden and UK) contributed to round 1 questionnaire. Response rates were 78% and 75% for rounds 2 and 3, respectively. Following round 3, 12 underlying principles (eg, return to normal function as soon as possible, pain management, encouragement of self-management, reduce fear avoidance and anxiety) achieved consensus. The treatment components reaching consensus included behavioural (eg, education, reassurance, self-management) and physiotherapy components (eg, exercises for stability and mobility). No passive intervention achieved consensus. CONCLUSIONS: Experts suggested and agreed the underlying principles and treatment components of the ABPI for the management of acute WADII. The ABPI was underpinned by social cognitive theory focusing on self-efficacy enhancement prior to conducting a phase II trial.

Acute Whiplash Injury Study (AWIS): a protocol for a cluster randomised pilot and feasibility trial of an Active Behavioural Physiotherapy Intervention in an insurance private setting.

INTRODUCTION: Whiplash-associated disorder (WAD) causes substantial social and economic burden internationally. Up to 60% of patients with WAD progress to chronicity. Research therefore needs to focus on effective management in the acute stage to prevent the development of chronicity. Approximately 93% of patients are classified as WADII (neck complaint and musculoskeletal sign(s)), and in the UK, most are managed in the private sector. In our recent systematic review, a combination of active and behavioural physiotherapy was identified as potentially effective in the acute stage. An Active Behavioural Physiotherapy Intervention (ABPI) was developed through combining empirical (modified Delphi study) and theoretical (social cognitive theory focusing on self-efficacy) evidence. This pilot and feasibility trial has been designed to inform the design of an adequately powered definitive randomised controlled trial. METHODS AND ANALYSIS: Two parallel phases. (1) An external pilot and feasibility cluster randomised double-blind (assessor and participants), parallel two-arm (ABPI vs standard physiotherapy) clinical trial to evaluate procedures and feasibility. Six UK private physiotherapy clinics will be recruited and cluster randomised by a computer-generated randomisation sequence. Sixty participants (30 each arm) will be assessed at recruitment (baseline) and at 3 months postbaseline. The planned primary outcome measure is the neck disability index. (2) An embedded exploratory qualitative study using semistructured indepth interviews (n=3-4 physiotherapists) and a focus group (n=6-8 patients) and entailing the recruitment of purposive samples will explore perceptions of the ABPI. Quantitative data will be analysed descriptively. Qualitative data will be coded and analysed deductively (identify themes) and inductively (identify additional themes). ETHICS AND DISSEMINATION: This trial is approved by the University of Birmingham Ethics Committee (ERN_15-0542). TRIAL REGISTRATION NUMBER: ISRCTN84528320.

Ethnicity and differences between clinic and ambulatory blood pressure measurements.

BACKGROUND: This study investigated the relationship of ethnicity to the differences between blood pressure (BP) measured in a clinic setting and by ambulatory blood pressure monitoring (ABPM) in individuals with a previous diagnosis of hypertension (HT) and without a previous diagnosis of hypertension (NHT). METHODS: A cross-sectional comparison of BP measurement was performed in 770 participants (white British (WB, 39%), South Asian (SA, 31%), and African Caribbean (AC, 30%)) in 28 primary care clinics in West Midlands, United Kingdom. Mean differences between daytime ABPM, standardized clinic (mean of 3 occasions), casual clinic (first reading on first occasion), and last routine BP taken at the general practitioner practice were compared in HT and NHT individuals. RESULTS: Daytime systolic and diastolic ABPM readings were similar to standardized clinic BP (systolic: 128 (SE 0.9) vs. 125 (SE 0.9) mm Hg (NHT) and 132 (SE 0.7) vs. 131 (SE 0.7) mm Hg (HT)) and were not associated with ethnicity to a clinically important extent. When BP was taken less carefully, differences emerged: casual clinic readings were higher than ABPM, particularly in the HT group where the systolic differences approached clinical relevance (131 (SE 1.2) vs. 129 (SE 1.0) mm Hg (NHT) and 139 (SE 0.9) vs. 133 (SE 0.7) mm Hg (HT)) and were larger in SA and AC hypertensive individuals (136 (SE 1.5) vs. 133 (SE 1.2) mm Hg (WB), 141 (SE 1.7) vs. 133 (SE 1.4) mm Hg (SA), and 142 (SE 1.6) vs. 134 (SE 1.3) mm Hg (AC); mean differences: 3 (0-7), P = 0.03 and 4 (1-7), P = 0.01, respectively). Differences were also observed for the last practice reading in SA and ACs. CONCLUSIONS: BP differences between ethnic groups where BP is carefully measured on multiple occasions are small and unlikely to alter clinical management. When BP is measured casually on a single occasion or in routine care, differences appear that could approach clinical relevance.

Effect of self-monitoring and medication self-titration on systolic blood pressure in hypertensive patients at high risk of cardiovascular disease: the TASMIN-SR randomized clinical trial.

IMPORTANCE: Self-monitoring of blood pressure with self-titration of antihypertensives (self-management) results in lower blood pressure in patients with hypertension, but there are no data about patients in high-risk groups. OBJECTIVE: To determine the effect of self-monitoring with self-titration of antihypertensive medication compared with usual care on systolic blood pressure among patients with cardiovascular disease, diabetes, or chronic kidney disease. DESIGN, SETTING, AND PATIENTS: A primary care, unblinded, randomized clinical trial involving 552 patients who were aged at least 35 years with a history of stroke, coronary heart disease, diabetes, or chronic kidney disease and with baseline blood pressure of at least 130/80 mm Hg being treated at 59 UK primary care practices was conducted between March 2011 and January 2013. INTERVENTIONS: Self-monitoring of blood pressure combined with an individualized self-titration algorithm. During the study period, the office visit blood pressure measurement target was 130/80 mm Hg and the home measurement target was 120/75 mm Hg. Control patients received usual care consisting of seeing their health care clinician for routine blood pressure measurement and adjustment of medication if necessary. MAIN OUTCOMES AND MEASURES: The primary outcome was the difference in systolic blood pressure between intervention and control groups at the 12-month office visit. RESULTS: Primary outcome data were available from 450 patients (81%). The mean baseline blood pressure was 143.1/80.5 mm Hg in the intervention group and 143.6/79.5 mm Hg in the control group. After 12 months, the mean blood pressure had decreased to 128.2/73.8 mm Hg in the intervention group and to 137.8/76.3 mm Hg in the control group, a difference of 9.2 mm Hg (95% CI, 5.7-12.7) in systolic and 3.4 mm Hg (95% CI, 1.8-5.0) in diastolic blood pressure following correction for baseline blood pressure. Multiple imputation for missing values gave similar results: the mean baseline was 143.5/80.2 mm Hg in the intervention group vs 144.2/79.9 mm Hg in the control group, and at 12 months, the mean was 128.6/73.6 mm Hg in the intervention group vs 138.2/76.4 mm Hg in the control group, with a difference of 8.8 mm Hg (95% CI, 4.9-12.7) for systolic and 3.1 mm Hg (95% CI, 0.7-5.5) for diastolic blood pressure between groups. These results were comparable in all subgroups, without excessive adverse events. CONCLUSIONS AND RELEVANCE: Among patients with hypertension at high risk of cardiovascular disease, self-monitoring with self-titration of antihypertensive medication compared with usual care resulted in lower systolic blood pressure at 12 months. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN87171227.

The role of social deprivation in severe neovascular age-related macular degeneration.

BACKGROUND/AIMS: Advances in therapy have improved outcomes for patients with neovascular age-related macular degeneration (nAMD). Prompt access to treatment is a priority and may be used as a key performance indicator. In this study, we investigate how social deprivation may impact on access to services, treatment and visual impairment registration. METHODS: Patients were identified retrospectively through the Certificate of Visual Impairment system for the University Hospitals Birmingham Medical Retina service. The Index of Multiple Deprivation (IMD) 2007 score was calculated for each patient. The impact of deprivation, age, gender and ethnicity on key stages in the care pathway was assessed. RESULTS: 120 patients were identified. Patients with greater social deprivation were under-represented, had worse visual acuity at first presentation (correlation of the better-seeing eye with IMD 0.225 (p=0.013)) and had sight-impairment registration earlier (correlation -0.246; p=0.007). Deprivation did not affect time to first appointment, and was not associated with a higher rate of non-attendance. CONCLUSIONS: The late presentation and under-representation of patients with greater social deprivation is a serious concern. Our study strongly suggests that this vulnerable group is encountering barriers in accessing treatment in nAMD, and that these occur prior to entry into the Hospital Eye Service.

Targets and self-management for the control of blood pressure in stroke and at risk groups (TASMIN-SR): protocol for a randomised controlled trial.

BACKGROUND: Self-monitoring of hypertension with self-titration of antihypertensives (self-management) results in lower systolic blood pressure for at least one year. However, few people in high risk groups have been evaluated to date and previous work suggests a smaller effect size in these groups. This trial therefore aims to assess the added value of self-management in high risk groups over and above usual care. METHODS/DESIGN: The targets and self-management for the control of blood pressure in stroke and at risk groups (TASMIN-SR) trial will be a pragmatic primary care based, unblinded, randomised controlled trial of self-management of blood pressure (BP) compared to usual care. Eligible patients will have a history of stroke, coronary heart disease, diabetes or chronic kidney disease and will be recruited from primary care. Participants will be individually randomised to either usual care or self-management. The primary outcome of the trial will be difference in office SBP between intervention and control groups at 12 months adjusted for baseline SBP and covariates. 540 patients will be sufficient to detect a difference in SBP between self-management and usual care of 5 mmHg with 90% power. Secondary outcomes will include self-efficacy, lifestyle behaviours, health-related quality of life and adverse events. An economic analysis will consider both within trial costs and a model extrapolating the results thereafter. A qualitative analysis will gain insights into patients' views, experiences and decision making processes. DISCUSSION: The results of the trial will be directly applicable to primary care in the UK. If successful, self-management of blood pressure in people with stroke and other high risk conditions would be applicable to many hundreds of thousands of individuals in the UK and beyond. TRIAL REGISTRATION: ISRCTN87171227.