scholarly journals Carer administration of as-needed subcutaneous medication for breakthrough symptoms in people dying at home: the CARiAD feasibility RCT

2020 ◽  
Vol 24 (25) ◽  
pp. 1-150 ◽  
Author(s):  
Marlise Poolman ◽  
Jessica Roberts ◽  
Stella Wright ◽  
Annie Hendry ◽  
Nia Goulden ◽  
...  
Keyword(s):  
Health Care ◽  
Health Technology Assessment ◽  
Usual Care ◽  
Outcome Measures ◽  
Technology Assessment ◽  
Health Care Professionals ◽  
Retention Rate ◽  
Health Technology ◽  
Dying At Home ◽  
At Home

Background Most people who are dying want to be cared for at home, but only half of them achieve this. The likelihood of a home death often depends on the availability of able and willing lay carers. When people who are dying are unable to take oral medication, injectable medication is used. When top-up medication is required, a health-care professional travels to the dying person’s home, which may delay symptom relief. The administration of subcutaneous medication by lay carers, although not widespread UK practice, has proven to be key in achieving better symptom control for those dying at home in other countries. Objectives To determine if carer administration of as-needed subcutaneous medication for common breakthrough symptoms in people dying at home is feasible and acceptable in the UK, and if it would be feasible to test this intervention in a future definitive randomised controlled trial. Design We conducted a two-arm, parallel-group, individually randomised, open pilot trial of the intervention versus usual care, with a 1 : 1 allocation ratio, using convergent mixed methods. Setting Home-based care without 24/7 paid care provision, in three UK sites. Participants Participants were dyads of adult patients and carers: patients in the last weeks of their life who wished to die at home and lay carers who were willing to be trained to give subcutaneous medication. Strict risk assessment criteria needed to be met before approach, including known history of substance abuse or carer ability to be trained to competency. Intervention Intervention-group carers received training by local nurses using a manualised training package. Main outcome measures Quantitative data were collected at baseline and 6–8 weeks post bereavement and via carer diaries. Interviews with carers and health-care professionals explored attitudes to, experiences of and preferences for giving subcutaneous medication and experience of trial processes. The main outcomes of interest were feasibility, acceptability, recruitment rates, attrition and selection of the most appropriate outcome measures. Results In total, 40 out of 101 eligible dyads were recruited (39.6%), which met the feasibility criterion of recruiting > 30% of eligible dyads. The expected recruitment target (≈50 dyads) was not reached, as fewer than expected participants were identified. Although the overall retention rate was 55% (22/40), this was substantially unbalanced [30% (6/20) usual care and 80% (16/20) intervention]. The feasibility criterion of > 40% retention was, therefore, considered not met. A total of 12 carers (intervention, n = 10; usual care, n = 2) and 20 health-care professionals were interviewed. The intervention was considered acceptable, feasible and safe in the small study population. The context of the feasibility study was not ideal, as district nurses were seriously overstretched and unfamiliar with research methods. A disparity in readiness to consider the intervention was demonstrated between carers and health-care professionals. Findings showed that there were methodological and ethics issues pertaining to researching last days of life care. Conclusion The success of a future definitive trial is uncertain because of equivocal results in the progression criteria, particularly poor recruitment overall and a low retention rate in the usual-care group. Future work regarding the intervention should include understanding the context of UK areas where this has been adopted, ascertaining wider public views and exploring health-care professional views on burden and risk in the NHS context. There should be consideration of the need for national policy and of the most appropriate quantitative outcome measures to use. This will help to ascertain if there are unanswered questions to be studied in a trial. Trial registration Current Controlled Trials ISRCTN11211024. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 25. See the NIHR Journals Library website for further project information.

HEALTH TECHNOLOGY ASSESSMENT IN THE NETHERLANDS

2000 ◽  
Vol 16 (2) ◽  
pp. 485-519 ◽  
Author(s):  
Michael Bos
Keyword(s):  
Health Care ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Private Insurance ◽  
National Level ◽  
Health Technology ◽  
Care Quality ◽  
High Tech ◽  
Fee For Service ◽  
Equal Distribution

The Dutch healthcare system is not a single overall plan, but has evolved from a constantly changing mix of institutions, regulations, and responsibilities. The resulting system provides high-quality care with reasonable efficiency and equal distribution over the population. Every Dutch citizen is entitled to health care. Health insurance is provided by a mix of compulsory national insurance and public and private insurance schemes. Hospitals generally have a private legal basis but are heavily regulated. Supraregional planning of high-tech medical services is also regulated. Hospitals function under fixed, prospective budgets with regulation of capital investments. Independent general practitioners serve a gatekeeper role for specialist and hospital services and are paid by capitation or fee for service. Specialists are paid by fee for service. All physicians' fees are controlled by the Ministry of Economic Affairs. Coverage of benefits is an important method of controlling the cost of services. There is increasing concern about health care quality. Health technology assessment (HTA) has become increasingly visible during the last 15 years. A special national fund for HTA, set up in 1988, has led to many formal and informal changes. HTA has evolved from a research activity into policy research for improving health care on the national level. In 1993 the government stated formally that enhancing effectiveness in health care was one of its prime targets and that HTA would be a prime tool for this purpose. The most important current issue is coordination of HTA activities, which is now undertaken by a new platform representing the important actors in health care and HTA.

HEALTH TECHNOLOGY ASSESSMENT AND CLINICAL DECISION MAKING:

1999 ◽  
Vol 15 (3) ◽  
pp. 585-592 ◽  
Author(s):  
Alicia Granados
Keyword(s):  
Health Care ◽  
Decision Making ◽  
Health Technology Assessment ◽  
Case Studies ◽  
Technology Assessment ◽  
Clinical Decision Making ◽  
Clinical Decision ◽  
Health Technology ◽  
Evidence Based ◽  
Systematic Process

This paper examines the rationality of the concepts underlying evidence—based medicineand health technology assessment (HTA), which are part of a new current aimed at promoting the use of the results of scientific studies for decision making in health care. It describes the different approaches and purposes of this worldwide movement, in relation to clinical decision making, through a summarized set of specific HTA case studies from Catalonia, Spain. The examples illustrate how the systematic process of HTA can help in several types of uncertainties related to clinical decision making.

scholarly journals Health technology assessment in the United Kingdom

2009 ◽  
Vol 25 (S1) ◽  
pp. 178-181 ◽  
Author(s):  
Michael Drummond ◽  
David Banta
Keyword(s):  
Health Care ◽  
United Kingdom ◽  
Cost Effectiveness ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Clinical Excellence ◽  
Present Situation ◽  
Health Technology ◽  
The United Kingdom ◽  
Short Run

Objectives: The aim of this study was to describe generally the development and present situation with health technology assessment (HTA) in the United Kingdom.Methods: The methods used are a review of important materials that have described the development process and present situation, supplemented by some personal experiences.Results: The United Kingdom has been characterized historically as a country with a strong interest in evidence in health care, both clinical trials for efficacy and cost-effectiveness analyses. However, this evidence was not well-linked to the needs of the National Health Services (NHS) before formation of the NHS R&D Programme in 1991, The R&D Programme brought substantial resources into HTA and related activities, with the central aim of improving health care in Britain and increasing value for money. However, policy makers as well as staff of the R&D Programme were dissatisfied with the use of the HTA results in clinical and administrative practice. Therefore, the National Institute of Clinical Excellence (NICE) was formed in 1999. NICE issues guidance intended to influence practical decision making in health care at the national and local levels, based on efficacy information and, in some cases, economic analyses. NICE is now also seeking ways to maximize impacts on practice.Conclusions: The UK experience shows that information on clinical and cost-effectiveness may not be enough to change practice, at least in the short-run. Still, one may conclude that the United Kingdom now has one of the few most important and influential HTA programs in the world.

scholarly journals History of health technology assessment in Belgium

2009 ◽  
Vol 25 (S1) ◽  
pp. 82-87 ◽  
Author(s):  
Irina Cleemput ◽  
Philippe Van Wilder
Keyword(s):  
Health Care ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Good Clinical Practice ◽  
Health Technology ◽  
Services Research ◽  
Drug Reimbursement ◽  
History Of ◽  
The Impact ◽  
Further Development

Objectives: This paper gives an overview of health technology assessment (HTA) in Belgium.Methods: The information included in the overview is based on legal documents and publicly available year reports of the Belgian Health Care Knowledge Centre (KCE).Results: Belgium has a relatively young history in HTA. The principle of evidence-based medicine (EBM) was introduced in the drug reimbursement procedure in 2001, with the establishment of the Drug Reimbursement Committee (DRC). The DRC assesses the efficacy, safety, convenience, applicability, and effectiveness of a drug relative to existing treatment alternatives. For some drugs, relative cost-effectiveness is also evaluated. The activities of the DRC can, therefore, be considered to be the first official HTA activities in Belgium. Later, in 2003, KCE was established. Its mission was to perform policy preparing research in the healthcare and health insurance sector and to give advice to policy makers about how they can obtain an efficient allocation of limited healthcare resources that optimizes the quality and accessibility of health care. This broad mission has been operationalized by activities in three domains of research: HTA, health services research, and good clinical practice. KCE is independent from the policy maker. Its HTAs contain policy recommendations that may inform policy decisions but are not binding.Conclusions: Although the Belgian history of HTA is relatively short, its foundations are strong and the impact of HTA increasing. Nevertheless KCE has many challenges for the future, including continued quality assurance, further development of international collaboration, and further development of methodological guidance for HTA.

scholarly journals Restricted fluid bolus versus current practice in children with septic shock: the FiSh feasibility study and pilot RCT

2018 ◽  
Vol 22 (51) ◽  
pp. 1-106 ◽  
Author(s):  
David Inwald ◽  
Ruth R Canter ◽  
Kerry Woolfall ◽  
Caitlin B O’Hara ◽  
Paul R Mouncey ◽  
...  
Keyword(s):  
Septic Shock ◽  
Health Technology Assessment ◽  
Outcome Measures ◽  
Technology Assessment ◽  
Current Practice ◽  
Health Technology ◽  
Fluid Bolus ◽  
Site Staff ◽  
Pilot Rct ◽  
The Uk

Background There has been no randomised controlled trial (RCT) of fluid bolus therapy in paediatric sepsis in the developed world despite evidence that excess fluid may be associated with harm. Objectives To determine the feasibility of the Fluids in Shock (FiSh) trial – a RCT comparing restricted fluid bolus (10 ml/kg) with current practice (20 ml/kg) in children with septic shock in the UK. Design (1) Qualitative feasibility study exploring parents’ views about the pilot RCT. (2) Pilot RCT over a 9-month period, including integrated parental and staff perspectives study. Setting (1) Recruitment took place across four NHS hospitals in England and on social media. (2) Recruitment took place across 13 NHS hospitals in England. Participants (1) Parents of children admitted to a UK hospital with presumed septic shock in the previous 3 years. (2) Children presenting to an emergency department with clinical suspicion of infection and shock after 20 ml/kg of fluid. Exclusion criteria were receipt of > 20 ml/kg of fluid, conditions requiring fluid restriction and the patient not for full active treatment (i.e. palliative care plan in place). Site staff and parents of children in the pilot were recruited to the perspectives study. Interventions (1) None. (2) Children were randomly allocated (1 : 1) to 10- or 20-ml/kg fluid boluses every 15 minutes for 4 hours if in shock. Main outcome measures (1) Acceptability of FiSh trial, proposed consent model and potential outcome measures. (2) Outcomes were based on progression criteria, including recruitment and retention rates, protocol adherence and separation between the groups, and collection and distribution of potential outcome measures. Results (1) Twenty-one parents were interviewed. All would have consented for the pilot study. (2) Seventy-five children were randomised, 40 to the 10-ml/kg fluid bolus group and 35 to the 20-ml/kg fluid bolus group. Two children were withdrawn. Although the anticipated recruitment rate was achieved, there was variability across the sites. Fifty-nine per cent of children in the 10-ml/kg fluid bolus group and 74% in the 20-ml/kg fluid bolus group required only a single trial bolus before shock resolved. The volume of fluid (in ml/kg) was 35% lower in the first hour and 44% lower over the 4-hour period in the 10-ml/kg fluid bolus group. Fluid boluses were delivered per protocol (volume and timing) for 79% of participants in the 10-ml/kg fluid bolus group and for 55% in the 20-ml/kg fluid bolus group, mainly as a result of delivery not being completed within 15 minutes. There were no deaths. Length of hospital stay, paediatric intensive care unit (PICU) transfers, and days alive and PICU free did not differ significantly between the groups. Two adverse events were reported in each group. A questionnaire was completed by 45 parents, 20 families and seven staff were interviewed and 20 staff participated in focus groups. Although a minority of site staff lacked equipoise in favour of more restricted boluses, all supported the trial. Conclusions Even though a successful feasibility and pilot RCT were conducted, participants were not as unwell as expected. A larger trial is not feasible in its current design in the UK. Future work Further observational work is required to determine the epidemiology of severe childhood infection in the UK in the postvaccine era. Trial registration Current Controlled Trials ISRCTN15244462. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 51. See the NIHR Journals Library website for further project information.

scholarly journals Combining mirtazapine with SSRIs or SNRIs for treatment-resistant depression: the MIR RCT

2018 ◽  
Vol 22 (63) ◽  
pp. 1-136 ◽  
Author(s):  
David Kessler ◽  
Alison Burns ◽  
Debbie Tallon ◽  
Glyn Lewis ◽  
Stephanie MacNeill ◽  
...  
Keyword(s):  
Primary Care ◽  
Health Technology Assessment ◽  
Usual Care ◽  
Reuptake Inhibitor ◽  
Technology Assessment ◽  
Primary Outcome ◽  
Health Technology ◽  
Treatment Resistant Depression ◽  
Treatment Resistant ◽  
Resistant Depression

Background Depression is usually managed in primary care and antidepressants are often the first-line treatment, but only half of those treated respond to a single antidepressant. Objectives To investigate whether or not combining mirtazapine with serotonin–noradrenaline reuptake inhibitor (SNRI) or selective serotonin reuptake inhibitor (SSRI) antidepressants results in better patient outcomes and more efficient NHS care than SNRI or SSRI therapy alone in treatment-resistant depression (TRD). Design The MIR trial was a two-parallel-group, multicentre, pragmatic, placebo-controlled randomised trial with allocation at the level of the individual. Setting Participants were recruited from primary care in Bristol, Exeter, Hull/York and Manchester/Keele. Participants Eligible participants were aged ≥ 18 years; were taking a SSRI or a SNRI antidepressant for at least 6 weeks at an adequate dose; scored ≥ 14 points on the Beck Depression Inventory-II (BDI-II); were adherent to medication; and met the International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, criteria for depression. Interventions Participants were randomised using a computer-generated code to either oral mirtazapine or a matched placebo, starting at a dose of 15 mg daily for 2 weeks and increasing to 30 mg daily for up to 12 months, in addition to their usual antidepressant. Participants, their general practitioners (GPs) and the research team were blind to the allocation. Main outcome measures The primary outcome was depression symptoms at 12 weeks post randomisation compared with baseline, measured as a continuous variable using the BDI-II. Secondary outcomes (at 12, 24 and 52 weeks) included response, remission of depression, change in anxiety symptoms, adverse events (AEs), quality of life, adherence to medication, health and social care use and cost-effectiveness. Outcomes were analysed on an intention-to-treat basis. A qualitative study explored patients’ views and experiences of managing depression and GPs’ views on prescribing a second antidepressant. Results There were 480 patients randomised to the trial (mirtazapine and usual care, n = 241; placebo and usual care, n = 239), of whom 431 patients (89.8%) were followed up at 12 weeks. BDI-II scores at 12 weeks were lower in the mirtazapine group than the placebo group after adjustment for baseline BDI-II score and minimisation and stratification variables [difference –1.83 points, 95% confidence interval (CI) –3.92 to 0.27 points; p = 0.087]. This was smaller than the minimum clinically important difference and the CI included the null. The difference became smaller at subsequent time points (24 weeks: –0.85 points, 95% CI –3.12 to 1.43 points; 12 months: 0.17 points, 95% CI –2.13 to 2.46 points). More participants in the mirtazapine group withdrew from the trial medication, citing mild AEs (46 vs. 9 participants). Conclusions This study did not find convincing evidence of a clinically important benefit for mirtazapine in addition to a SSRI or a SNRI antidepressant over placebo in primary care patients with TRD. There was no evidence that the addition of mirtazapine was a cost-effective use of NHS resources. GPs and patients were concerned about adding an additional antidepressant. Limitations Voluntary unblinding for participants after the primary outcome at 12 weeks made interpretation of longer-term outcomes more difficult. Future work Treatment-resistant depression remains an area of important, unmet need, with limited evidence of effective treatments. Promising interventions include augmentation with atypical antipsychotics and treatment using transcranial magnetic stimulation. Trial registration Current Controlled Trials ISRCTN06653773; EudraCT number 2012-000090-23. Funding This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 63. See the NIHR Journals Library website for further project information.

scholarly journals History of health technology assessment: Spain

2009 ◽  
Vol 25 (S1) ◽  
pp. 163-173 ◽  
Author(s):  
Laura Sampietro-Colom ◽  
Jose Asua ◽  
Eduardo Briones ◽  
Jordi Gol ◽  
Keyword(s):  
Health Care ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Policy Decision ◽  
Health Technology ◽  
Policy Coordination ◽  
Public Healthcare ◽  
Regional Government ◽  
Health Care Environment ◽  
Health Technologies

Objectives: The aim of this study was to describe the characteristics of the introduction and diffusion of health technology assessment (HTA) in Spain.Methods: A survey to summarize the evolution of HTA was sent to representatives of different HTA initiatives in Spain.Results: HTA was introduced in the late 1980s. The main factors were the trend to an increase in healthcare expenditure, concerns regarding efficiency in providing health care, as well as in the level of rationality introducing high technology. Spain has direct (i.e., regulation) and indirect (i.e., payment systems, evidence-based programs, HTA) mechanisms to control health technologies. A recent high priority regulation has established the need of HTA to decide the introduction of a new health technology in the lists of public healthcare coverage, although similar regulations existed in the past and were scarcely implemented. HTA initiatives started at the regional government level. Its introduction followed a progressive pattern among regions. In the beginning, resources were scarce and expertise limited, with work done at intramural level. With time, expertise increase, and promotion of commissioned work was implemented. HTA knowledge transfer in the healthcare system has been carried out through courses, publications, and commissioned research. Currently, there are seven HTA units/agencies, which coordinate their work.Conclusions: HTA in Spain is in its maturity. Facing the unavoidable change of health care environment over time, HTA is also evolving and, currently, there is a trend to broaden the areas of influence of HTA by devolving capacity to hospitals and applying principles to very early phases of health technology development, under the umbrella of regional HTA units/agencies. However, there are two main challenges ahead. One is to have a real impact at the highest level of healthcare policy coordination among Spanish regions, which is done at the Central Ministry of Health. The other is to avoid the influence of political waves in the level of recognition of HTA at the policy decision-making level and to have an adequate and stable funding of HTA initiatives.

scholarly journals Special Section: Assessing Information Technologies for Health: Health Technology Assessment

2006 ◽  
Vol 15 (01) ◽  
pp. 16-19
Author(s):  
E. Ammenwerth ◽  
Keyword(s):  
Health Care ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Informatics ◽  
Information Technologies ◽  
Special Section ◽  
Health Technology ◽  
Unintended Effects ◽  
Excellent Research ◽  
Study Designs

SummaryTo summarize current excellent research in the field of health technology assessment.Synopsis of the articles selected for the IMIA Yearbook 2006.Five excellent articles representing the research in four different nations were selected for the IMIA Yearbook 2006 from three international peer reviewed journals.The best paper selection for the Yearbook section ‘Assessing Information Technologies for Health’ presents papers evaluating the benefit and side-effects of information technology in various settings. They clearly indicate that benefit of IT in health care can be achieved when the systems are appropriately designed, implemented and operated. Besides the presented quantitative studies, also qualitative study designs are of value to find unintended effects of IT, or to better explain found effects. IT evaluation supports a reflective practice on how health informatics influences health care, enabling the emergence of an evidence-based health informatics.

OP04 Lessons Learnt When Implementing A Health Technology Assessment Institution In Costa Rica

2017 ◽  
Vol 33 (S1) ◽  
pp. 3-4
Author(s):  
Iñaki Gutiérrez-Ibarluzea ◽  
James Cercone ◽  
Daniel Bronstein ◽  
Luis Tacsan ◽  
Pablo Morales ◽  
...  
Keyword(s):  
Health Care ◽  
Costa Rica ◽  
Social Security ◽  
Health Technology Assessment ◽  
Health System ◽  
Technology Assessment ◽  
Access To Health Care ◽  
Health Technology ◽  
Right To Health ◽  
Independent Evidence

INTRODUCTION:Faced with increasing financial challenges to the single-payer social security system and constitutional challenges supporting all citizen's right to health, Costa Rica has endeavored to introduce Health Technology Assessment (HTA) to ensure sustainability and promote the timely introduction of technology innovations in the health system. The Ministry of Health initiated a process to establish an independent, external institution providing leadership in the process of HTA.METHODS:Based on a survey developed by REDETSA/PAHO (HTA Network of the Americas/Pan American Health Organization), an inclusive method of stakeholders participation was used to analyze the strengths, weaknesses, opportunities and threats regarding the implementation of an HTA entity. This was combined with qualitative research methods, market access situation analysis and the review of coverage and provision processes to define the elements for the new HTA institution. The “in-depth” interviews extended to manufacturers, ministry representatives, services providers, purchasers, patients and citizens representatives, judiciary court, professional colleges, academia and non-governmental organizations (NGOs). Analysis of the professional competencies required for the HTA institution was carried out based on best practice analysis of international HTA institutions.RESULTS:The implementation of an HTA unit in Costa Rica was identified by all the actors as crucial to ensuring the health system's sustainability. Costa Rica's health system is based on all citizens right to health and all inputs required delivering health services, judicialization and access to health care have become a big issue. Two main issues were identified as essential to implement an HTA institution: the establishment of a clear framework to provide legal and financial support and the need to have sufficient independence from the Ministry and the Social Security, including maximum transparency and methodological robustness.CONCLUSIONS:The business model for the new HTA institution should consider the participation of all the interested actors. The HTA institution should bridge the gap between technology regulation and health technology management and aim to improve both processes. It should also provide third party independent evidence to inform the constitutional court around health care claims.

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