Intermittently Scanned Continuous Glucose Monitoring for Type 1 Diabetes.

BACKGROUND: In persons with type 1 diabetes and high glycated hemoglobin levels, the benefits of intermittently scanned continuous glucose monitoring with optional alarms for high and low blood glucose levels are uncertain. METHODS: In a parallel-group, multicenter, randomized, controlled trial involving participants with type 1 diabetes and glycated hemoglobin levels between 7.5% and 11.0%, we investigated the efficacy of intermittently scanned continuous glucose monitoring as compared with participant monitoring of blood glucose levels with fingerstick testing. The primary outcome was the glycated hemoglobin level at 24 weeks, analyzed according to the intention-to-treat principle. Key secondary outcomes included sensor data, participant-reported outcome measures, and safety. RESULTS: A total of 156 participants were randomly assigned, in a 1:1 ratio, to undergo intermittently scanned continuous glucose monitoring (the intervention group, 78 participants) or to monitor their own blood glucose levels with fingerstick testing (the usual-care group, 78 participants). At baseline, the mean (±SD) age of the participants was 44±15 years, and the mean duration of diabetes was 21±13 years; 44% of the participants were women. The mean baseline glycated hemoglobin level was 8.7±0.9% in the intervention group and 8.5±0.8% in the usual-care group; these levels decreased to 7.9±0.8% and 8.3±0.9%, respectively, at 24 weeks (adjusted mean between-group difference, -0.5 percentage points; 95% confidence interval [CI], -0.7 to -0.3; P<0.001). The time per day that the glucose level was in the target range was 9.0 percentage points (95% CI, 4.7 to 13.3) higher or 130 minutes (95% CI, 68 to 192) longer in the intervention group than in the usual-care group, and the time spent in a hypoglycemic state (blood glucose level, <70 mg per deciliter [<3.9 mmol per liter]) was 3.0 percentage points (95% CI, 1.4 to 4.5) lower or 43 minutes (95% CI, 20 to 65) shorter in the intervention group. Two participants in the usual-care group had an episode of severe hypoglycemia, and 1 participant in the intervention group had a skin reaction to the sensor. CONCLUSIONS: Among participants with type 1 diabetes and high glycated hemoglobin levels, the use of intermittently scanned continuous glucose monitoring with optional alarms for high and low blood glucose levels resulted in significantly lower glycated hemoglobin levels than levels monitored by fingerstick testing. (Funded by Diabetes UK and others; FLASH-UK ClinicalTrials.gov number, NCT03815006.).

The impact of statin discontinuation and restarting rates on the optimal time to initiate statins and on the number of cardiovascular events prevented.

INTRODUCTION: A patient is eligible for statins in England if they have a 10-year risk of cardiovascular disease >10%. We hypothesize that if statin discontinuation rates are high it may be better to delay statin initiation until patients are at a higher risk, to maximize the benefit of the drug. METHODS: A four-state health state transition model was used to assess the optimal time to initiate statins after a risk assessment, in order to prevent the highest number of cardiovascular events, for a given risk profile (age, gender, risk) and adherence rate. A Clinical Practice Research Datalink dataset linked to Hospital Episodes Statistics and Office for National Statistics was used to inform the transition probabilities in this model, taking into account observed statin discontinuation and re-continuation patterns. RESULTS: Our results suggest, if statins are initiated in a cohort of 50-year old men with a 10% 10-year risk, we prevent 4.78 events per 100 individuals. If we wait 10 years to prescribe, at which point 10-year risk scores are at 20%, we prevent 5.45 events per 100 individuals. If the observed discontinuation rate was reduced by a sixth, third or half in the same cohort, we would prevent 7.29, 9.01 or 10.22 events per 100 individuals. CONCLUSIONS: In certain scenarios, extra cardiovascular disease events could be prevented by delaying statin initiation beyond a risk of 10% until reaching a age (59 for men, 63 for women), based on statin discontinuation rates in England. The optimal time to initiate statins was driven by age, not by cardiovascular risk.

Econometric estimation of WHO-CHOICE country-specific costs for inpatient and outpatient health service delivery.

BACKGROUND: Policy makers require information on costs related to inpatient and outpatient health services to inform resource allocation decisions. METHODS: Country data sets were gathered in 2008-2010 through literature reviews, website searches and a public call for cost data. Multivariate regression analysis was used to explore the determinants of variability in unit costs using data from 30 countries. Two models were designed, with the inpatient and outpatient models drawing upon 3407 and 9028 observations respectively. Cost estimates are produced at country and regional level, with 95% confidence intervals. RESULTS: Inpatient costs across 30 countries are significantly associated with the type of hospital, ownership, as well as bed occupancy rate, average length of stay, and total number of inpatient admissions. Changes in outpatient costs are significantly associated with location, facility ownership and the level of care, as well as to the number of outpatient visits and visits per provider per day. CONCLUSIONS: These updated WHO-CHOICE service delivery unit costs are statistically robust and may be used by analysts as inputs for economic analysis. The models can predict country-specific unit costs at different capacity levels and in different settings.

Identifying patient-level health and social care costs for older adults discharged from acute medical units in England.

BACKGROUND: acute medical units allow for those who need admission to be correctly identified, and for those who could be managed in ambulatory settings to be discharged. However, re-admission rates for older people following discharge from acute medical units are high and may be associated with substantial health and social care costs. OBJECTIVE: identifying patient-level health and social care costs for older people discharged from acute medical units in England. DESIGN: a prospective cohort study of health and social care resource use. SETTING: an acute medical unit in Nottingham, England. PARTICIPANTS: four hundred and fifty-six people aged over 70 who were discharged from an acute medical unit within 72 h of admission. METHODS: hospitalisation and social care data were collected for 3 months post-recruitment. In Nottingham, further approvals were gained to obtain data from general practices, ambulance services, intermediate care and mental healthcare. Resource use was combined with national unit costs. RESULTS: costs from all sectors were available for 250 participants. The mean (95% CI, median, range) total cost was £1926 (1579-2383, 659, 0-23,612). Contribution was: secondary care (76.1%), primary care (10.9%), ambulance service (0.7%), intermediate care (0.2%), mental healthcare (2.1%) and social care (10.0%). The costliest 10% of participants accounted for 50% of the cost. CONCLUSIONS: this study highlights the costs accrued by older people discharged from acute medical units (AMUs): they are mainly (76%) in secondary care and half of all costs were incurred by a minority of participants (10%).

Community pharmacists workforce readiness to deliver vaccination services: A cross-sectional study from Jordan.

This study assesses Jordanian community pharmacists' readiness and willingness to deliver vaccination services in their practice sites. Between February and April 2021, a self-administered online questionnaire was distributed via social media, WhatsApp messages, and personal communication. The questionnaire targeted practicing community pharmacies. Descriptive and inferential data analysis was carried out. A total of 403 community pharmacists participated in the study. Almost 146 (36%) community pharmacists reported vaccinating patients in their practice sites. However, readiness assessment revealed that only 54 (13.4%) pharmacists received the required training and qualifications. Moreover, 33 (8.2%) study participants worked in adequately equipped and designed community pharmacies. Overall, surveyed participants held positive attitudes toward their involvement in vaccination services: 260 (64.5%) pharmacists were willing to vaccinate patients, and 227 (65.0%) out of unready, unqualified, participants were willing to get needed training and qualifications. According to study participants, regulatory and professional bodies (Ministry of Health, Jordan Pharmacists Association) are influential in supporting pharmacist-vaccinators. Among the investigated factors, organizational structure and employment status were significantly associated with pharmacists' readiness to deliver vaccination. This study revealed that further work is needed to increase pharmacists' and pharmacies' readiness to deliver vaccination services and that regulators should follow a more active approach in highlighting the importance of training and the impact of training in patients' safety and satisfaction.

'New Medicine Service': supporting adherence in people starting a new medication for a long-term condition: 26-week follow-up of a pragmatic randomised controlled trial.

OBJECTIVE: To examine the effectiveness and cost-effectiveness of the community pharmacy New Medicine Service (NMS) at 26 weeks. METHODS: Pragmatic patient-level parallel randomised controlled trial in 46 English community pharmacies. 504 participants aged ≥14, identified in the pharmacy when presenting a prescription for a new medicine for predefined long-term conditions, randomised to receive NMS (n=251) or normal practice (n=253) (NMS intervention: 2 consultations 1 and 2 weeks after prescription presentation). Adherence assessed through patient self-report at 26-week follow-up. Intention-to-treat analysis employed. National Health Service (NHS) costs calculated. Disease-specific Markov models estimating impact of non-adherence combined with clinical trial data to calculate costs per extra quality-adjusted life-year (QALY; NHS England perspective). RESULTS: Unadjusted analysis: of 327 patients still taking the initial medicine, 97/170 (57.1%) and 103/157 (65.6%) (p=0.113) patients were adherent in normal practice and NMS arms, respectively. Adjusted intention-to-treat analysis: adherence OR 1.50 (95% CI 0.93 to 2.44, p=0.095), in favour of NMS. There was a non-significant reduction in 26-week NHS costs for NMS: -£104 (95% CI -£37 to £257, p=0.168) per patient. NMS generated a mean of 0.04 (95% CI -0.01 to 0.13) more QALYs per patient, with mean reduction in lifetime cost of -£113.9 (-1159.4, 683.7). The incremental cost-effectiveness ratio was -£2758/QALY (2.5% and 97.5%: -38 739.5, 34 024.2. NMS has an 89% probability of cost-effectiveness at a willingness to pay of £20 000 per QALY. CONCLUSIONS: At 26-week follow-up, NMS was unable to demonstrate a statistically significant increase in adherence or reduction in NHS costs, which may be attributable to patient attrition from the study. Long-term economic evaluation suggested NMS may deliver better patient outcomes and reduced overall healthcare costs than normal practice, but uncertainty around this finding is high. TRIAL REGISTRATION NUMBER: NCT01635361, ISRCTN23560818, ISRCTN23560818, UKCRN12494.

Cost Effectiveness of Support for People Starting a New Medication for a Long-Term Condition Through Community Pharmacies: An Economic Evaluation of the New Medicine Service (NMS) Compared with Normal Practice.

BACKGROUND: The English community pharmacy New Medicine Service (NMS) significantly increases patient adherence to medicines, compared with normal practice. We examined the cost effectiveness of NMS compared with normal practice by combining adherence improvement and intervention costs with the effect of increased adherence on patient outcomes and healthcare costs. METHODS: We developed Markov models for diseases targeted by the NMS (hypertension, type 2 diabetes mellitus, chronic obstructive pulmonary disease, asthma and antiplatelet regimens) to assess the impact of patients' non-adherence. Clinical event probability, treatment pathway, resource use and costs were extracted from literature and costing tariffs. Incremental costs and outcomes associated with each disease were incorporated additively into a composite probabilistic model and combined with adherence rates and intervention costs from the trial. Costs per extra quality-adjusted life-year (QALY) were calculated from the perspective of NHS England, using a lifetime horizon. RESULTS: NMS generated a mean of 0.05 (95% CI 0.00-0.13) more QALYs per patient, at a mean reduced cost of -£144 (95% CI -769 to 73). The NMS dominates normal practice with a probability of 0.78 [incremental cost-effectiveness ratio (ICER) -£3166 per QALY]. NMS has a 96.7% probability of cost effectiveness compared with normal practice at a willingness to pay of £20,000 per QALY. Sensitivity analysis demonstrated that targeting each disease with NMS has a probability over 0.90 of cost effectiveness compared with normal practice at a willingness to pay of £20,000 per QALY. CONCLUSIONS: Our study suggests that the NMS increased patient medicine adherence compared with normal practice, which translated into increased health gain at reduced overall cost. TRIAL REGISTRATION: ClinicalTrials.gov Trial reference number NCT01635361 ( http://clinicaltrials.gov/ct2/show/NCT01635361 ). Current Controlled trials: Trial reference number ISRCTN 23560818 ( http://www.controlled-trials.com/ISRCTN23560818/ ; DOI 10.1186/ISRCTN23560818 ). UK Clinical Research Network (UKCRN) study 12494 ( http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=12494 ). FUNDING: Department of Health Policy Research Programme.

Economic evaluation of a community-based diagnostic pathway to stratify adults for non-alcoholic fatty liver disease: a Markov model informed by a feasibility study.

OBJECTIVES: To assess the long-term cost-effectiveness of a risk stratification pathway, compared with standard care, for detecting non-alcoholic fatty liver disease (NAFLD) in primary care. SETTING: Primary care general practices in England. PARTICIPANTS: Adults who have been identified in primary care to have a risk factor for developing NAFLD, that is, type 2 diabetes without a history of excessive alcohol use. INTERVENTION: A community-based pathway, which uses transient elastography and hepatologists to stratify patients at risk of NAFLD, has been implemented and demonstrated to be feasible (NCT02037867). Earlier identification could mean earlier treatments, referral to specialist and enrolment into surveillance programmes. DESIGN: The impact of earlier detection and treatment with the risk stratification pathway on progression to later stages of liver disease was examined using decision modelling with Markov chains to estimate lifetime health and economic effects of the two comparators. DATA SOURCES: Data from a prospective cross-sectional feasibility study indicating risk stratification pathway and standard care diagnostic accuracies were combined with a Markov model that comprised the following states: no/mild liver disease, significant liver disease, compensated cirrhosis, decompensated cirrhosis, hepatocellular carcinoma, liver transplant and death. The model data were chosen from up-to-date UK sources, published literature and an expert panel. OUTCOME MEASURE: An incremental cost-effectiveness ratio (ICER) indicating cost per quality-adjusted life year (QALY) of the risk stratification pathway compared with standard care was estimated. RESULTS: The risk stratification pathway was more effective than standard care and costs £2138 per QALY gained. The ICER was most sensitive to estimates of the rate of fibrosis progression and the effect of treatment on reducing this, and ranged from -£1895 to £7032/QALY. The risk stratification pathway demonstrated an 85% probability of cost-effectiveness at the UK willingness-to-pay threshold of £20 000/QALY. CONCLUSIONS: Implementation of a community-based risk stratification pathway is likely to be cost-effective. TRIAL REGISTRATION NUMBER: NCT02037867, ClinicalTrials.gov.

Supporting adherence for people starting a new medication for a long-term condition through community pharmacies: a pragmatic randomised controlled trial of the New Medicine Service.

OBJECTIVE: To examine the effectiveness of the New Medicine Service (NMS), a national community pharmacy service to support medicines-taking in people starting a new medicine for a long-term condition, compared with normal practice. METHODS: Pragmatic patient-level parallel randomised controlled trial, in 46 community pharmacies in England. Patients 1:1 block randomisation stratified by drug/disease group within each pharmacy. 504 participants (NMS: 251) aged 14 years and over, identified in the pharmacy on presentation of a prescription for asthma/chronic obstructive pulmonary disease, hypertension, type 2 diabetes or an anticoagulant/antiplatelet agent. NMS intervention: One consultation 7-14 days after presentation of prescription followed by another 14-21 days thereafter to identify problems with treatment and provide support if needed. Controls received normal practice. Adherence, defined as missing no doses without the advice of a medical professional in the previous 7 days, was assessed through patient self-report at 10 weeks. Intention-to-treat analysis was employed, with outcome adjusted for recruiting pharmacy, NMS disease category, age, sex and medication count. Cost to the National Health Service (NHS) was collected. RESULTS: At 10 weeks, 53 patients had withdrawn and 443 (85%) patients were contacted successfully by telephone. In the unadjusted analysis of 378 patients still taking the initial medicine, 61% (95% CI 54% to 67%) and 71% (95% CI 64% to 77%) patients were adherent in the normal practice and NMS arms, respectively (p=0.04 for difference). In the adjusted intention-to-treat analysis, the OR for increased adherence was 1.67 (95% CI 1.06 to 2.62; p=0.027) in favour of the NMS arm. There was a general trend to reduced NHS costs, albeit, statistically non-significant, for the NMS intervention: saving £21 (95% CI -£59 to £100, p=0.128) per patient. CONCLUSIONS: The NMS significantly increased the proportion of patients adhering to their new medicine by about 10%, compared with normal practice. TRIAL REGISTRATION NUMBERS: ClinicalTrials.gov trial reference number NCT01635361 (http://clinicaltrials.gov/ct2/show/NCT01635361). Current Controlled trials: trial reference number ISRCTN 23560818 (http://www.controlled-trials.com/ISRCTN23560818/; DOI 10.1186/ISRCTN23560818). UK Clinical Research Network (UKCRN) study 12494 (http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=12494).

Economic Evaluation of a General Hospital Unit for Older People with Delirium and Dementia (TEAM Randomised Controlled Trial).

BACKGROUND: One in three hospital acute medical admissions is of an older person with cognitive impairment. Their outcomes are poor and the quality of their care in hospital has been criticised. A specialist unit to care for older people with delirium and dementia (the Medical and Mental Health Unit, MMHU) was developed and then tested in a randomised controlled trial where it delivered significantly higher quality of, and satisfaction with, care, but no significant benefits in terms of health status outcomes at three months. OBJECTIVE: To examine the cost-effectiveness of the MMHU for older people with delirium and dementia in general hospitals, compared with standard care. METHODS: Six hundred participants aged over 65 admitted for acute medical care, identified on admission as cognitively impaired, were randomised to the MMHU or to standard care on acute geriatric or general medical wards. Cost per quality adjusted life year (QALY) gained, at 3-month follow-up, was assessed in trial-based economic evaluation (599/600 participants, intervention: 309). Multiple imputation and complete-case sample analyses were employed to deal with missing QALY data (55%). RESULTS: The total adjusted health and social care costs, including direct costs of the intervention, at 3 months was £7714 and £7862 for MMHU and standard care groups, respectively (difference -£149 (95% confidence interval [CI]: -298, 4)). The difference in QALYs gained was 0.001 (95% CI: -0.006, 0.008). The probability that the intervention was dominant was 58%, and the probability that it was cost-saving with QALY loss was 39%. At £20,000/QALY threshold, the probability of cost-effectiveness was 94%, falling to 59% when cost-saving QALY loss cases were excluded. CONCLUSIONS: The MMHU was strongly cost-effective using usual criteria, although considerably less so when the less acceptable situation with QALY loss and cost savings were excluded. Nevertheless, this model of care is worthy of further evaluation. TRIAL REGISTRATION: ClinicalTrials.gov NCT01136148.

Cost-Effectiveness of a Specialist Geriatric Medical Intervention for Frail Older People Discharged from Acute Medical Units: Economic Evaluation in a Two-Centre Randomised Controlled Trial (AMIGOS).

BACKGROUND: Poor outcomes and high resource-use are observed for frail older people discharged from acute medical units. A specialist geriatric medical intervention, to facilitate Comprehensive Geriatric Assessment, was developed to reduce the incidence of adverse outcomes and associated high resource-use in this group in the post-discharge period. OBJECTIVE: To examine the costs and cost-effectiveness of a specialist geriatric medical intervention for frail older people in the 90 days following discharge from an acute medical unit, compared with standard care. METHODS: Economic evaluation was conducted alongside a two-centre randomised controlled trial (AMIGOS). 433 patients (aged 70 or over) at risk of future health problems, discharged from acute medical units within 72 hours of attending hospital, were recruited in two general hospitals in Nottingham and Leicester, UK. Participants were randomised to the intervention, comprising geriatrician assessment in acute units and further specialist management, or to control where patients received no additional intervention over and above standard care. Primary outcome was incremental cost per quality adjusted life year (QALY) gained. RESULTS: We undertook cost-effectiveness analysis for 417 patients (intervention: 205). The difference in mean adjusted QALYs gained between groups at 3 months was -0.001 (95% confidence interval [CI]: -0.009, 0.007). Total adjusted secondary and social care costs, including direct costs of the intervention, at 3 months were £4412 (€5624, $6878) and £4110 (€5239, $6408) for the intervention and standard care groups, the incremental cost was £302 (95% CI: 193, 410) [€385, $471]. The intervention was dominated by standard care with probability of 62%, and with 0% probability of cost-effectiveness (at £20,000/QALY threshold). CONCLUSIONS: The specialist geriatric medical intervention for frail older people discharged from acute medical unit was not cost-effective. Further research on designing effective and cost-effective specialist service for frail older people discharged from acute medical units is needed. TRIAL REGISTRATION: ISRCTN registry ISRCTN21800480 http://www.isrctn.com/ISRCTN21800480.