Prashanth Patel

Background: About 14.9% of people (9.9 million) registered with primary care practices in England and Wales are prescribed medication for hypertension. However, many do not take their medication as prescribed. To address this problem, we need scalable interventions. Objective: To develop a scalable low-cost intervention to support medication adherence in people prescribed medication for hypertension in primary care, and to obtain precise and robust estimates of the effectiveness and cost-effectiveness of the intervention compared with usual care. Design: Systematic reviews and meta-analyses; qualitative meta-synthesis; interviews and focus groups; expert consultations; pre-testing study; randomised feasibility trial; randomised controlled trial of effectiveness and cost-effectiveness; economic modelling. Setting and participants: Primary care practices in England and Wales. Patients prescribed medication for hypertension with poorly controlled blood pressure. Interventions: Very brief intervention delivered by a practice nurse or healthcare assistant followed by a digital intervention (text messaging programme or smartphone app). Main outcome measures: Acceptability, feasibility, fidelity and cost of the interventions. Systolic blood pressure. Biochemical and self-reported measures of medication adherence. Results: Our systematic reviews showed that both app-based and face-to-face interventions in patients with long-term conditions have a positive effect on medication adherence. The meta-synthesis of published qualitative studies showed that: digital interventions to support medication use were perceived as acceptable and useful; a digital intervention would be more effective if it was personalised and tailored; barriers to using digital interventions included lack of interest, lack of confidence and lack of proficiency and experience in using the technology; digital interventions should be simple, easy to navigate and age-appropriate; patients wanted accurate information on their health condition, potential side effects of medication and health consequences of non-adherence; reminder notifications and a self-monitoring feature were perceived as helpful by some patients; some patients suggested that a digital intervention should enable them to communicate with pharmacies, but practitioners were concerned that this would increase their workload. The interview and focus group study identified several barriers to adherence, including forgetting, unpleasant side effects and reluctance to medicate. A digital intervention to support medication adherence was acceptable to patients if it was user-friendly, the content was tailored to the user, and the privacy of user data was protected. Simple reminder messages for taking medication and reordering prescriptions were considered more useful by patients than those providing information on the benefits of medication or the consequences of non-adherence. Patients preferred to receive feedback on their adherence levels in the form of a simple graph, percentage score or statistic. Practitioners thought that it would be feasible to introduce a digital intervention to patients in a very brief face-to-face consultation. In the pre-testing study, participants reported that the interventions we developed were easy to use and that they would recommend them to others. The feasibility trial showed that the combined intervention was acceptable and that a large cost-effectiveness trial was feasible. The main trial showed no difference between arms in systolic blood pressure or medication adherence at 12-month follow-up. The estimate (95% confidence interval) for the difference in means between arms in self-measured systolic blood pressure at 12 months was −0.61 mmHg (−3.05 to 1.82), p = 0.62 [for intervention vs. control (reference group)]. In the base case analysis, the intervention had a mean incremental cost-effectiveness ratio below the usual willingness-to-pay thresholds in the National Health Service in the United Kingdom. The probability of cost-effectiveness was between 77% and 80% at willingness-to-pay thresholds of £15,000, £20,000 and £30,000 per quality-adjusted life-year, but the confidence intervals are wide and cross zero, indicating some chance that the intervention could be less effective and more costly. Limitations: The effectiveness trial was conducted during the COVID-19 pandemic. To reduce the risk of infection, the very brief intervention was delivered by telephone instead of face-to-face, and all study measurements were conducted remotely. This may have led to lower response rates and data quality and lower effectiveness of the intervention. A significant proportion (24%) of participants did not have raised blood pressure at baseline, and self-reported medication adherence was high at baseline, which reduced the possible scope for an intervention effect. Conclusions: The findings on effectiveness do not support the commissioning of the intervention in United Kingdom primary care. The cost-effectiveness findings are more equivocal, showing a high probability of being cost-effective at standard United Kingdom willingness-to-pay thresholds, but with some uncertainty. Future work: Future research should address the challenge of identifying and recruiting people who are poorly adherent and have raised blood pressure and test the intervention in this group. Variants such as face-to-face delivery, adding a follow-up consultation or a purely digital version could also be investigated. Study registration: This study is registered as CRD42017080150; CRD42020164049; ISRCTN12805654; ISRCTN74504989; ISRCTN82013652. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research Programme (NIHR award ref: RP-PG-0615-20013) and is published in full in Programme Grants for Applied Research ; Vol. 14, No. 18. See the NIHR Funding and Awards website for further award information.

Background: One of the main indications for parathyroidectomy surgery in primary hyperparathyroidism (PHPT) is osteoporosis. NICE guideline recommends 2-3 yearly Dual-energy X-ray absorptiometry (DEXA) assessments to evaluate bone mineral density (BMD) in asymptomatic PHPT. Objective: We undertook an audit to evaluate bone health practice in PHPT patients in line with NICE guidelines. Methodology: Retrospective case notes and electronic records’ review was undertaken to identify PHPT patients in University Hospitals of Leicester. Results: n=121 (106F:15M) patients with PHPT & Osteoporosis (T-score < -2.5) or osteopenia (T-score <- 1.0 to -2.5) were identified between 1987 and 2022; 88% were females. Mean age: 61 years at diagnosis, Mean Adjusted calcium 2.76 mmol/l (2.12-2.51), Mean Parathormone 21.22 pmol/l (2-8.5). 104/121 (86%) had DEXA at diagnosis: 37% Osteopenia and 63% had Osteoporosis; 20/121 (16%) had fragility fractures. 57 (47%) were treated surgically achieving cure rate in 51 patients (90%); Adjusted calcium 2.78 mmol/l normalised to 2.39 mmol/l post-surgically. Of those, only 23 (40%), had at least one DEXA performed after parathyroidectomy. Mean T-scores improved from -2.74 to -2.17 from osteoporosis to osteopenia range post-surgically indicating BMD improvement. Of the 64/121 non-surgically-treated patients 7 (11%) had at least one DEXA repeated within 3 years. 30/64 (47%) of non-surgical patients received medical treatment for osteoporosis. Interestingly 24/57 (42%) of surgically excised parathyroid adenomas were localised the right inferior location. Discussion: Although immediate improvement in T-scores were noted post-surgically, assessment of BMD and Osteoporosis treatment remained suboptimal. We intend to address this with a quality improvement project undertaken prospectively as a result of this audit. Conclusion: 1. Long term bone health assessment and treatment remains vital irrespective of PHPT surgery as it takes time to improve BMD even after surgery. 2. Patient education, prevention/treatment of osteoporosis, strict specialist monitoring such as DEXA evaluations is recommended.

Background: Healthcare workers (HCWs) and ethnic minority groups are at increased risk of COVID-19 infection and adverse outcomes. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination is now available for frontline UK HCWs; however, demographic/occupational associations with vaccine uptake in this cohort are unknown. We sought to establish these associations in a large UK hospital workforce. Methods and findings: We conducted cross-sectional surveillance examining vaccine uptake amongst all staff at University Hospitals of Leicester NHS Trust. We examined proportions of vaccinated staff stratified by demographic factors, occupation, and previous COVID-19 test results (serology/PCR) and used logistic regression to identify predictors of vaccination status after adjustment for confounders. We included 19,044 HCWs; 12,278 (64.5%) had received SARS-CoV-2 vaccination. Compared to White HCWs (70.9% vaccinated), a significantly smaller proportion of ethnic minority HCWs were vaccinated (South Asian, 58.5%; Black, 36.8%; p < 0.001 for both). After adjustment for age, sex, ethnicity, deprivation, occupation, SARS-CoV-2 serology/PCR results, and COVID-19-related work absences, factors found to be negatively associated with vaccine uptake were younger age, female sex, increased deprivation, pregnancy, and belonging to any non-White ethnic group (Black: adjusted odds ratio [aOR] 0.30, 95% CI 0.26–0.34, p < 0.001; South Asian: aOR 0.67, 95% CI 0.62–0.72, p < 0.001). Those who had previously had confirmed COVID-19 (by PCR) were less likely to be vaccinated than those who had tested negative. Limitations include data being from a single centre, lack of data on staff vaccinated outside the hospital system, and that staff may have taken up vaccination following data extraction. Conclusions: Ethnic minority HCWs and those from more deprived areas as well as younger staff and female staff are less likely to take up SARS-CoV-2 vaccination. These findings have major implications for the delivery of SARS-CoV-2 vaccination programmes, in HCWs and the wider population, and should inform the national vaccination programme to prevent the disparities of the pandemic from widening.

[This corrects the article DOI: 10.2196/11289.].

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Background: Poor adherence to cardiovascular medications is associated with worse clinical outcomes. Evidence for effective education interventions that address medication adherence for the primary prevention of cardiovascular disease is lacking. The Ready to Reduce Risk (3R) study aims to investigate whether a complex intervention, involving group education plus telephone and text messaging follow-up support, can improve medication adherence and reduce cardiovascular risk. Objective: This protocol paper details the design and rationale for the development of the 3R intervention and the study methods used. Methods: This is an open and pragmatic randomized controlled trial with 12 months of follow-up. We recruited participants from primary care and randomly assigned them at a 1:1 frequency, stratified by sex and age, to either a control group (usual care from a general practitioner) or an intervention group involving 2 facilitated group education sessions with telephone and text messaging follow-up support, with a theoretical underpinning and using recognized behavioral change techniques. The primary outcome was medication adherence to statins. The primary measure was an objective, novel, urine-based biochemical measure of medication adherence. We also used the 8-item Morisky Medication Adherence Scale to assess medication adherence. Secondary outcomes were changes in total cholesterol, blood pressure, high-density lipoprotein, total cholesterol to high-density lipoprotein ratio, body mass index, waist to hip ratio, waist circumference, smoking behavior, physical activity, fruit and vegetable intake, patient activation level, quality of life, health status, health and medication beliefs, and overall cardiovascular disease risk score. We also considered process outcomes relating to acceptability and feasibility of the 3R intervention. Results: We recruited 212 participants between May 2015 and March 2017. The 12-month follow-up data collection clinics were completed in April 2018, and data analysis will commence once all study data have been collected and verified. Conclusions: This study will identify a potentially clinically useful and effective educational intervention for the primary prevention of cardiovascular disease. Medication adherence to statins is being assessed using a novel urine assay as an objective measure, in conjunction with other validated measures. Trial Registration: International Standard Randomized Controlled Trial Number ISRCTN16863160; http://www.isrctn.com/ISRCTN16863160 (Archived by WebCite at http://www.webcitation.org/734PqfdQw) International Registered Report Identifier (IRRID): DERR1-10.2196/11289

Background: Conventional treatment for chronic hypoparathyroidism (CHP) is Vitamin-D analogues and calcium supplementation, not replacement of lacking hormone, as done in other hormone-deficiency states. Objectives: Retrospective evaluation of CHP management in line with European Society of Endocrinology Guideline was undertaken, to assess adequacy of calcium-homeostasis and morbidity. Methodology: Retrospective case-note and electronic-record review of 93 consecutive CHP cases (Post-surgical-56, Genetic-15, Autoimmune-6, Unknown-16), minimum 12 months follow-up between 1989 and 2017, was undertaken; audit No 9217. Results: n=93 (67-females, 26-males), mean age 53 years (17-94yrs), mean duration of follow-up 13.5 years (1.2-29 years). 94%(87/93) treated with Vitamin-D analogues (86% alfacalcidiol, 8% calcitriol) with or without calcium-salts and 6%(6/93) calcium salts only. At follow-up, target range achieved: serum adjusted calcium 58% (54/93) (2.10 – 2.40 mmol/L); 24-hr urinary calcium 63% (17/27 performed) (2.5–7.5 mmol/L); serum phosphate 81% (75/93) (0.8–1.5 mmol/L); magnesium 92% (54/59 performed) (0.7–1 mmol/L) and vitamin-D 54% (43/79 performed) (>50 nmol/L). Regular monitoring was not undertaken in 71% (66/93) for 24-hr urinary calcium, 37% (34/93) for magnesium and 15% (14/93) for vitamin-D. 365 hypocalcaemia episodes (Ca < 2.0 mmol/L) in 62%(58/93); 56 hypercalcaemia episodes (Ca >2.60 mmol/L) in 18% (17/93) patients; 37% (34/93) required hospital admissions related to calcium-dysregulation resulting in 253 total inpatient days over 8 years (2010–2017). There was progression to CKD3 17% (16/93) and CKD4 2% (2/93); Renal stones 3; Nephrocalcinosis 1; Cataracts 4; unrelated death 5. Discussion: 1. Conventional CHP management resulted in suboptimal calcium homeostasis in half of patients; 1/3^rd required hospital admissions for calcium regulation. 2. Suboptimal monitoring of 24-hr urine-calcium and magnesium was noted. 3. Regular biochemical monitoring and dose adjustments may improve outcomes. 4. Evidence seems to be growing for recombinant human parathyroid hormone (1-84) for challenging cases.