Dynamic Electronic Tracking and Escalation to reduce Critical care Transfers (DETECT): the protocol for a stepped wedge mixed method study to explore the clinical effectiveness, clinical utility and cost-effectiveness of an electronic physiological surveillance system for use in children

Abstract Background Active monitoring of hospitalised adults, using handheld electronic physiological surveillance systems, is associated with reduced in-patient mortality in the UK. Potential also exists to improve the recognition and response to deterioration in hospitalised children. However, the clinical effectiveness, the clinical utility, and the cost-effectiveness of this technology to reduce paediatric critical deterioration, have not been evaluated in an NHS environment. Method This is a non-randomised stepped-wedge prospective mixed methods study. Participants will be in-patients under the age of 18 years, at a tertiary children’s hospital. Day-case, neonatal surgery and Paediatric Intensive Care Unit (PICU) patients will be excluded. The intervention is the implementation of Careflow Vitals and Connect (System C) to document vital signs and sepsis screening. The underpinning age-specific Paediatric Early Warning Score (PEWS) risk model calculates PEWS and provides associated clinical decision support. Real-time data of deterioration risk are immediately visible to the entire clinical team to optimise situation awareness, the chronology of the escalation and response are captured with automated reporting of the organisational safety profile. Baseline data will be collected prospectively for 1 year preceding the intervention. Following a 3 month implementation period, 1 year of post-intervention data will be collected. The primary outcome is unplanned transfers to critical care (HDU and/or PICU). The secondary outcomes are critical deterioration events (CDE), the timeliness of critical care transfer, the critical care interventions required, critical care length of stay and outcome. The clinical effectiveness will be measured by prevalence of CDE per 1000 hospital admissions and per 1000 non-PICU bed days. Observation, field notes, e-surveys and focused interviews will be used to establish the clinical utility of the technology to healthcare professionals and the acceptability to in-patient families. The cost-effectiveness will be analysed using Health Related Group costs per day for the critical care and hospital stay for up to 90 days post CDE. Discussion If the technology is effective at reducing CDE in hospitalised children it could be deployed widely, to reduce morbidity and mortality, and associated costs. Trial registration Current Controlled Trials ISRCTN61279068, date of registration 03.06.19, retrospectively registered.

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Lenvatinib and sorafenib for differentiated thyroid cancer after radioactive iodine: a systematic review and economic evaluation

Health Technology Assessment ◽

10.3310/hta24020 ◽

2020 ◽

Vol 24 (2) ◽

pp. 1-180 ◽

Cited By ~ 3

Author(s):

Nigel Fleeman ◽

Rachel Houten ◽

Adrian Bagust ◽

Marty Richardson ◽

Sophie Beale ◽

...

Keyword(s):

Thyroid Cancer ◽

Cost Effectiveness ◽

Systematic Reviews ◽

Observational Studies ◽

Differentiated Thyroid Cancer ◽

Radioactive Iodine ◽

Clinical Effectiveness ◽

Economic Evaluations ◽

Base Case ◽

The Cost

Background Thyroid cancer is a rare cancer, accounting for only 1% of all malignancies in England and Wales. Differentiated thyroid cancer (DTC) accounts for ≈94% of all thyroid cancers. Patients with DTC often require treatment with radioactive iodine. Treatment for DTC that is refractory to radioactive iodine [radioactive iodine-refractory DTC (RR-DTC)] is often limited to best supportive care (BSC). Objectives We aimed to assess the clinical effectiveness and cost-effectiveness of lenvatinib (Lenvima®; Eisai Ltd, Hertfordshire, UK) and sorafenib (Nexar®; Bayer HealthCare, Leverkusen, Germany) for the treatment of patients with RR-DTC. Data sources EMBASE, MEDLINE, PubMed, The Cochrane Library and EconLit were searched (date range 1999 to 10 January 2017; searched on 10 January 2017). The bibliographies of retrieved citations were also examined. Review methods We searched for randomised controlled trials (RCTs), systematic reviews, prospective observational studies and economic evaluations of lenvatinib or sorafenib. In the absence of relevant economic evaluations, we constructed a de novo economic model to compare the cost-effectiveness of lenvatinib and sorafenib with that of BSC. Results Two RCTs were identified: SELECT (Study of [E7080] LEnvatinib in 131I-refractory differentiated Cancer of the Thyroid) and DECISION (StuDy of sorafEnib in loCally advanced or metastatIc patientS with radioactive Iodine-refractory thyrOid caNcer). Lenvatinib and sorafenib were both reported to improve median progression-free survival (PFS) compared with placebo: 18.3 months (lenvatinib) vs. 3.6 months (placebo) and 10.8 months (sorafenib) vs. 5.8 months (placebo). Patient crossover was high (≥ 75%) in both trials, confounding estimates of overall survival (OS). Using OS data adjusted for crossover, trial authors reported a statistically significant improvement in OS for patients treated with lenvatinib compared with those given placebo (SELECT) but not for patients treated with sorafenib compared with those given placebo (DECISION). Both lenvatinib and sorafenib increased the incidence of adverse events (AEs), and dose reductions were required (for > 60% of patients). The results from nine prospective observational studies and 13 systematic reviews of lenvatinib or sorafenib were broadly comparable to those from the RCTs. Health-related quality-of-life (HRQoL) data were collected only in DECISION. We considered the feasibility of comparing lenvatinib with sorafenib via an indirect comparison but concluded that this would not be appropriate because of differences in trial and participant characteristics, risk profiles of the participants in the placebo arms and because the proportional hazard assumption was violated for five of the six survival outcomes available from the trials. In the base-case economic analysis, using list prices only, the cost-effectiveness comparison of lenvatinib versus BSC yields an incremental cost-effectiveness ratio (ICER) per quality-adjusted life-year (QALY) gained of £65,872, and the comparison of sorafenib versus BSC yields an ICER of £85,644 per QALY gained. The deterministic sensitivity analyses show that none of the variations lowered the base-case ICERs to < £50,000 per QALY gained. Limitations We consider that it is not possible to compare the clinical effectiveness or cost-effectiveness of lenvatinib and sorafenib. Conclusions Compared with placebo/BSC, treatment with lenvatinib or sorafenib results in an improvement in PFS, objective tumour response rate and possibly OS, but dose modifications were required to treat AEs. Both treatments exhibit estimated ICERs of > £50,000 per QALY gained. Further research should include examination of the effects of lenvatinib, sorafenib and BSC (including HRQoL) for both symptomatic and asymptomatic patients, and the positioning of treatments in the treatment pathway. Study registration This study is registered as PROSPERO CRD42017055516. Funding The National Institute for Health Research Health Technology Assessment programme.

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A systematic review and economic evaluation of adalimumab and dexamethasone for treating non-infectious intermediate uveitis, posterior uveitis or panuveitis in adults

Health Technology Assessment ◽

10.3310/hta21680 ◽

2017 ◽

Vol 21 (68) ◽

pp. 1-170 ◽

Cited By ~ 11

Author(s):

Hazel Squires ◽

Edith Poku ◽

Inigo Bermejo ◽

Katy Cooper ◽

John Stevens ◽

...

Keyword(s):

Clinical Trials ◽

Cost Effectiveness ◽

Current Practice ◽

Clinical Effectiveness ◽

Posterior Uveitis ◽

Sensitivity Analyses ◽

Dexamethasone Implant ◽

Intermediate Uveitis ◽

Sham Procedure ◽

The Cost

BackgroundNon-infectious intermediate uveitis, posterior uveitis and panuveitis are a heterogeneous group of inflammatory eye disorders. Management includes local and systemic corticosteroids, immunosuppressants and biological drugs.ObjectivesTo evaluate the clinical effectiveness and cost-effectiveness of subcutaneous adalimumab (Humira®; AbbVie Ltd, Maidenhead, UK) and a dexamethasone intravitreal implant (Ozurdex®; Allergan Ltd, Marlow, UK) in adults with non-infectious intermediate uveitis, posterior uveitis or panuveitis.Data sourcesElectronic databases and clinical trials registries including MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects and the World Health Organization’s International Clinical Trials Registry Platform were searched to June 2016, with an update search carried out in October 2016.Review methodsReview methods followed published guidelines. A Markov model was developed to assess the cost-effectiveness of dexamethasone and adalimumab, each compared with current practice, from a NHS and Personal Social Services (PSS) perspective over a lifetime horizon, parameterised with published evidence. Costs and benefits were discounted at 3.5%. Substantial sensitivity analyses were undertaken.ResultsOf the 134 full-text articles screened, three studies (four articles) were included in the clinical effectiveness review. Two randomised controlled trials (RCTs) [VISUAL I (active uveitis) and VISUAL II (inactive uveitis)] compared adalimumab with placebo, with limited standard care also provided in both arms. Time to treatment failure (reduced visual acuity, intraocular inflammation, new vascular lesions) was longer in the adalimumab group than in the placebo group, with a hazard ratio of 0.50 [95% confidence interval (CI) 0.36 to 0.70;p < 0.001] in the VISUAL I trial and 0.57 (95% CI 0.39 to 0.84;p = 0.004) in the VISUAL II trial. The adalimumab group showed a significantly greater improvement than the placebo group in the 25-item Visual Function Questionnaire (VFQ-25) composite score in the VISUAL I trial (mean difference 4.20;p = 0.010) but not the VISUAL II trial (mean difference 2.12;p = 0.16). Some systemic adverse effects occurred more frequently with adalimumab than with placebo. One RCT [HURON (active uveitis)] compared a single 0.7-mg dexamethasone implant against a sham procedure, with limited standard care also provided in both arms. Dexamethasone provided significant benefits over the sham procedure at 8 and 26 weeks in the percentage of patients with a vitreous haze score of zero (p < 0.014), the mean best corrected visual acuity improvement (p ≤ 0.002) and the percentage of patients with a ≥ 5-point improvement in VFQ-25 score (p < 0.05). Raised intraocular pressure and cataracts occurred more frequently with dexamethasone than with the sham procedure. The incremental cost-effectiveness ratio (ICER) for one dexamethasone implant in one eye for a combination of patients with unilateral and bilateral uveitis compared with limited current practice, as per the HURON trial, was estimated to be £19,509 per quality-adjusted life-year (QALY) gained. The ICER of adalimumab for patients with mainly bilateral uveitis compared with limited current practice, as per the VISUAL trials, was estimated to be £94,523 and £317,547 per QALY gained in active and inactive uveitis respectively. Sensitivity analyses suggested that the rate of blindness has the biggest impact on the model results. The interventions may be more cost-effective in populations in which there is a greater risk of blindness.LimitationsThe clinical trials did not fully reflect clinical practice. Thirteen additional studies of clinically relevant comparator treatments were identified; however, network meta-analysis was not feasible. The model results are highly uncertain because of the limited evidence base.ConclusionsTwo RCTs of systemic adalimumab and one RCT of a unilateral, single dexamethasone implant showed significant benefits over placebo or a sham procedure. The ICERs for adalimumab were estimated to be above generally accepted thresholds for cost-effectiveness. The cost-effectiveness of dexamethasone was estimated to fall below standard thresholds. However, there is substantial uncertainty around the model assumptions. In future work, primary research should compare dexamethasone and adalimumab with current treatments over the long term and in important subgroups and consider how short-term improvements relate to long-term effects on vision.Study registrationThis study is registered as PROSPERO CRD42016041799.FundingThe National Institute for Health Research Health Technology Assessment programme.

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ASSESSING SEARCHES IN NICE SINGLE TECHNOLOGY APPRAISALS: PRACTICE AND CHECKLIST

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462313000330 ◽

2013 ◽

Vol 29 (3) ◽

pp. 315-322 ◽

Cited By ~ 4

Author(s):

Ruth Wong ◽

Suzy Paisley ◽

Christopher Carroll

Keyword(s):

Cost Effectiveness ◽

Web Site ◽

Search Strategy ◽

Clinical Effectiveness ◽

Evidence Review ◽

The Cost ◽

Reporting Source

Objectives: No guidelines exist in the approach that Evidence Review Groups (ERGs) should take to appraise search methodologies in the manufacturer's submission (MS) in Single Technology Appraisals (STA). As a result, ERGs are left to appraise searches using their own approach. This study investigates the limitations of manufacturers' search methodologies as critiqued by ERGs in published STA reports and to provide a recommended checklist.Methods: Limitations from search critiques in 83 ERG reports published in the NIHR Web site between 2006 and May 2011 were extracted. The limitations were grouped into themes. Comparisons were made between limitations reported in the clinical effectiveness versus cost-effectiveness searches.Results: Twelve themes were identified, six relating to the search strategy, source, limits, filters, translation, reporting, and missing studies. The search strategy theme contained the most limitations. Missing studies were frequently found by the ERG group in the clinical effectiveness searches. The omission of searches by manufacturers for unpublished and ongoing trials was frequently reported by the ERG. By contrast, failure of the manufacturer to report strategies was the most common limitation in the cost-effectiveness searches. Themes with the most frequent limitations in both types of searches are search strategy, reporting and source.Conclusions: It is recommended that a checklist that has reporting, source and search strategy elements be used in the appraisal of manufacturer's searches during the STA process.

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Wide variations in the cost-effectiveness of critical care*

Critical Care Medicine ◽

10.1097/01.ccm.0000242925.93054.2c ◽

2006 ◽

Vol 34 (11) ◽

pp. 2849-2851

Author(s):

Andrew L. Rosenberg ◽

Kevin K. Tremper

Keyword(s):

Critical Care ◽

Cost Effectiveness ◽

The Cost

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Clinical Utility and Cost Effectiveness of Complement 3 and Complement 4 in different Clinical Subspecialties in Hamad Medical Corporation

University of the Future: Re-Imagining Research and Higher Education ◽

10.29117/quarfe.2020.0161 ◽

2020 ◽

Author(s):

Foziyeh Esmaiel Naji ◽

Mohammed Ehlayel ◽

Nader Al-Dewik ◽

Ahmed Malki

Keyword(s):

Cost Effectiveness ◽

Autoimmune Diseases ◽

Complement System ◽

Clinical Utility ◽

Healthcare Providers ◽

Diagnostic Tools ◽

Complement 3 ◽

Hamad Medical Corporation ◽

Complement 4 ◽

The Cost

Background: Complement system is one of ancient innate immune systems in our body fighting against pathogens and foreign bodies. Either one of its three pathways, classical, alternative or lectin activates it. Because of its role and importance in combating against different pathological conditions, it works through defined proteins including regulators and inhibitors. However, over or under stimulation of complement system can lead to various diseases. A number of analytical assays are used to measure complement proteins and its activation states considering complement 3 (C3), complement 4 (C4) as the most common test used. Objectives: Our aims are to study the clinical utility and cost effectiveness of C3 and C4 among different clinical subspecialties in Hamad Medical Corporation (HMC), Doha-Qatar. Design and methods: A retrospective study was conducted using electronic medical records to generate patient’s list from clinical immunology laboratory at HMC. Data on 326 patients were collected from 1st January till 31st March, 2017 and used as pilot study after omitting duplications. The data was studied for its demographical, disease categories, C3 and C4 test results. C3 and C4 test cost were calculated inside HMC and compared to other healthcare providers in country and abroad. Results: A total of 326 patients, 148 males and 178 females (M/F ratio:0.8:1), of age (mean age ±SD) of 36 ± 17.6 years. 289(86%) were >15 years and 47(14%) were 15 or less. Kidney diseases (34%), autoimmune diseases (25%), and allergic diseases (18%) were the top 3 diseases, and constituted 77% of all diseases. 45/336 (13.4%) showed low C3, C4, or both. Mean levels of C3 (±SD) was 120.8 ±36.3 mg/dl, and C4 was27.85±11.9 mg/dl. High C3 and C4 levels were observed in 53 (15.7%) of patients. The cost of performing one test either C3 or C4 in HMC is 22 QR ($6), while other healthcare providers inside the country costed 150-300 QR ($41.2-$82.4). Conclusion: Autoimmune diseases, renal diseases and joist diseases were the most common diseases with low C3 and C4 levels. Although the cost of a single test of C3 or C4 is low, the total annual cost is huge. The treating physician is recommended to exercise judicious clinical wisdom when ordering C3 or C4 tests as diagnostic tools

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Clinical effectiveness and cost-effectiveness of issuing longer versus shorter duration (3-month vs. 28-day) prescriptions in patients with chronic conditions: systematic review and economic modelling

Health Technology Assessment ◽

10.3310/hta21780 ◽

2017 ◽

Vol 21 (78) ◽

pp. 1-128 ◽

Cited By ~ 3

Author(s):

Céline Miani ◽

Adam Martin ◽

Josephine Exley ◽

Brett Doble ◽

Ed Wilson ◽

...

Keyword(s):

Systematic Review ◽

Primary Care ◽

Cost Effectiveness ◽

Health Outcomes ◽

Chronic Conditions ◽

Clinical Effectiveness ◽

Cost Study ◽

Clinical Scenarios ◽

Retrospective Cohort Studies ◽

The Cost

BackgroundTo reduce expenditure on, and wastage of, drugs, some commissioners have encouraged general practitioners to issue shorter prescriptions, typically 28 days in length; however, the evidence base for this recommendation is uncertain.ObjectiveTo evaluate the evidence of the clinical effectiveness and cost-effectiveness of shorter versus longer prescriptions for people with stable chronic conditions treated in primary care.Design/data sourcesThe design of the study comprised three elements. First, a systematic review comparing 28-day prescriptions with longer prescriptions in patients with chronic conditions treated in primary care, evaluating any relevant clinical outcomes, adherence to treatment, costs and cost-effectiveness. Databases searched included MEDLINE (PubMed), EMBASE, Cumulative Index to Nursing and Allied Health Literature, Web of Science and Cochrane Central Register of Controlled Trials. Searches were from database inception to October 2015 (updated search to June 2016 in PubMed). Second, a cost analysis of medication wastage associated with < 60-day and ≥ 60-day prescriptions for five patient cohorts over an 11-year period from the Clinical Practice Research Datalink. Third, a decision model adapting three existing models to predict costs and effects of differing adherence levels associated with 28-day versus 3-month prescriptions in three clinical scenarios.Review methodsIn the systematic review, from 15,257 unique citations, 54 full-text papers were reviewed and 16 studies were included, five of which were abstracts and one of which was an extended conference abstract. None was a randomised controlled trial: 11 were retrospective cohort studies, three were cross-sectional surveys and two were cost studies. No information on health outcomes was available.ResultsAn exploratory meta-analysis based on six retrospective cohort studies suggested that lower adherence was associated with 28-day prescriptions (standardised mean difference –0.45, 95% confidence interval –0.65 to –0.26). The cost analysis showed that a statistically significant increase in medication waste was associated with longer prescription lengths. However, when accounting for dispensing fees and prescriber time, longer prescriptions were found to be cost saving compared with shorter prescriptions. Prescriber time was the largest component of the calculated cost savings to the NHS. The decision modelling suggested that, in all three clinical scenarios, longer prescription lengths were associated with lower costs and higher quality-adjusted life-years.LimitationsThe available evidence was found to be at a moderate to serious risk of bias. All of the studies were conducted in the USA, which was a cause for concern in terms of generalisability to the UK. No evidence of the direct impact of prescription length on health outcomes was found. The cost study could investigate prescriptions issued only; it could not assess patient adherence to those prescriptions. Additionally, the cost study was based on products issued only and did not account for underlying patient diagnoses. A lack of good-quality evidence affected our decision modelling strategy.ConclusionsAlthough the quality of the evidence was poor, this study found that longer prescriptions may be less costly overall, and may be associated with better adherence than 28-day prescriptions in patients with chronic conditions being treated in primary care.Future workThere is a need to more reliably evaluate the impact of differing prescription lengths on adherence, on patient health outcomes and on total costs to the NHS. The priority should be to identify patients with particular conditions or characteristics who should receive shorter or longer prescriptions. To determine the need for any further research, an expected value of perfect information analysis should be performed.Study registrationThis study is registered as PROSPERO CRD42015027042.FundingThe National Institute for Health Research Health Technology Assessment programme.

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The effectiveness and cost effectiveness of a hospital avoidance program in a residential aged care facility: a prospective cohort study and modelled decision analysis

10.21203/rs.3.rs-18188/v4 ◽

2020 ◽

Author(s):

Hannah Carter ◽

Xing J. Lee ◽

Trudy Dwyer ◽

Barbara O’Neill ◽

Dee Jeffrey ◽

...

Keyword(s):

Cohort Study ◽

Cost Effectiveness ◽

Length Of Stay ◽

Hospital Admissions ◽

Care Facility ◽

Aged Care ◽

Residential Aged Care ◽

Aged Care Facility ◽

Residential Aged Care Facility ◽

The Cost

Abstract Background: Residential aged care facility residents experience high rates of hospital admissions which are stressful, costly and often preventable. The EDDIE program is a hospital avoidance initiative designed to enable nursing and care staff to detect, refer and quickly respond to early signals of a deteriorating resident. The program was implemented in a 96-bed residential aged care facility in regional Australia. Methods: A prospective pre-post cohort study design was used to collect data on costs of program delivery, hospital admission rates and length of stay for the 12 months prior to, and following, the intervention. A Markov decision model was developed to synthesize study data with published literature in order to estimate the cost-effectiveness of the program. Quality adjusted life years (QALYs) were adopted as the measure of effectiveness. Results: The EDDIE program was associated with a 19% reduction in annual hospital admissions and a 31% reduction in the average length of stay. The cost-effectiveness analysis found the program to be both more effective and less costly than usual care, with 0.06 QALYs gained and $249,000 health system costs saved in a modelled cohort of 96 residents. A probabilistic sensitivity analysis estimated that there was an 86% probability that the program was cost-effective after taking the uncertainty of the model inputs into account. Conclusions: This study provides promising evidence for the effectiveness and cost-effectiveness of a nurse led, early intervention program in preventing unnecessary hospital admissions within a residential aged care facility. Further research in multi-site randomised studies is needed to confirm the generalisability of these results.

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The cost-effectiveness of prehospital critical care for out-of-hospital cardiac arrest

Resuscitation ◽

10.1016/j.resuscitation.2019.06.021 ◽

2019 ◽

Vol 142 ◽

pp. e4-e5

Author(s):

Johannes von Vopelius-Feldt ◽

Richard Morris ◽

Jane Powell ◽

Jonathan Benger

Keyword(s):

Cardiac Arrest ◽

Critical Care ◽

Cost Effectiveness ◽

The Cost ◽

Hospital Cardiac Arrest

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The Critical Care Medicine Research: A Systematic Review

University of the Future: Re-Imagining Research and Higher Education ◽

10.29117/quarfe.2020.0205 ◽

2020 ◽

Author(s):

Kawthar Hasan Jasim

Keyword(s):

Systematic Review ◽

Critical Care ◽

Cost Effectiveness ◽

Impact Factor ◽

Journal Impact Factor ◽

Journal Citation Report ◽

Critical Care Medicine ◽

Medicine Research ◽

The Cost ◽

Journal Impact

Objectives: The cost-effectiveness terminology is a common term used in the critical care medicine research. A systematic review analysis was conducted to study the patterns of the use and misuse of the cost-effectiveness terminology in the critical care medicine literature between 1998 and 2018. Methods: A search in the inCite journal citation report was done to identify all the critical care medicine journals. An independednt search done to identify all the articles between 1980 to 2018 that claimed in their abstracts/article to perform a cost-effectiveness analysis (CEA). Eligible articles were included and analyzed using x2-test. The articles were categorized into four different levels based on the appropriateness of CEA terminology use. The analysis performed to assess the association between the appropriateness of CEA terminology and the journal impact factor (IF), author background, and the publication year (5-year time points). Results: Out of 7,835 articles in targeted subject category, 76 met the inclusion criteria, but 50 of them were analyzed. Of these 50 articles, 32 (64.0%) met the appropriate criterion of CEA terminology use. 71.4% of articles published in journals with IF: 3.0 - 21.4 were appropriately using CEA term compared to 54.5% studies that are published in journals with IF: 0.4 - 2.8. Of these articles, which are appropriately use CEA terminology, 56.2% of the articles have at least one author with health economics expertise. Conclusion and recommendation: The preliminary data suggest that there is an association between the level of appropriateness and journal impact factor and the author health-economic background authorship. However, we did not demonstrate changes in the level of appropriateness with time. Decision-makers, authors, and editors should pay better attention in seeking ways to monitor the appropriate use of “cost-effectiveness” terminology. More future studies should be done in this context.

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