scholarly journals Bridging health technology assessment and healthcare quality improvement using international consortium of health outcomes measurement standard sets

Author(s):  
Rachel R. J. Kalf ◽  
Marloes Zuidgeest ◽  
Diana M. J. Delnoij ◽  
Marcel L. Bouvy ◽  
Wim G. Goettsch

Abstract Objective Although health technology assessment (HTA) and healthcare quality improvement are distinct processes, a greater level of alignment in outcome measures used may increase the quality and efficiency of data collection. This study evaluates the agreement in outcome measures used in oncology for healthcare quality improvement and HTAs, and how these align to the International Consortium for Health Outcomes Measurement (ICHOM) standard sets. Methods We conducted a cross-sectional comparative analysis of ICHOM sets focusing on oncological indications and publicly available measures for healthcare quality and HTA reports published by the National Health Care Institute from the Netherlands and the National Institute for Health and Care Excellence from the United Kingdom. Results All ICHOM sets and HTAs used overall survival, whereas quality improvement used different survival estimates. Different progression estimates for cancer were used in HTAs, ICHOM sets, and quality improvement. Data on health-related quality of life (HRQoL) was recommended in all ICHOM sets and all HTAs, but selectively for quality improvement. In HTAs, generic HRQoL questionnaires were preferred, whereas, in quality improvement and ICHOM sets, disease-specific questionnaires were recommended. Unfavorable outcomes were included in all HTAs and all ICHOM sets, but not always for quality improvement. Conclusions Although HTA and quality improvement use outcome measures from the same domains, a greater level of alignment seems possible. ICHOM may provide input on standardized outcome measures to support this alignment. However, residual discrepancies will remain due to the different objectives of HTA and quality improvement.

2019 ◽  
Vol 35 (S1) ◽  
pp. 37-37
Author(s):  
Wafa Allouche ◽  
Sami El Gouddi ◽  
Emna Allouche ◽  
Ali Mrabet

IntroductionProviding high-quality and affordable care is a big challenge facing policy makers, especially in low and middle income countries (LMIC). The purpose of this presentation is to illustrate how health technology assessment (HTA) benefits the improvement of the healthcare quality, and to highlight the fact that HTA domains match to the dimensions of health quality: safety, effectiveness, efficiency and patient-centeredness.MethodsThis presentation will be based on explaining the ability of HTA to improve the quality of healthcare. Some countries, mainly LMIC where resources are limited, do not have formal HTA whose goal is to inform the development of safe, effective and patient centered health policies. The theoretical concepts of HTA demonstrate a strong connection between HTA and healthcare quality improvement. By way of illustration an example of successful experiences will be given.ResultsThe presentation items are: - The definition of health technology - Introduction to health technology assessment as a multidisciplinary process that summarizes information about the medical, social, economic and ethical issues related to the use of a health technology. - Why is health technology assessment used, the identification of the HTA report domains including Safety, Clinical Effectiveness, Ethical analysis, Social aspects, Legal aspects and the importance of patient experience in HTA. - The identification of the six dimensions of healthcare quality and the determination of the connection between HTA and healthcare quality improvement. - A presentation of the international Decision Support Initiative (iDSI) experience in some LMIC.ConclusionsHTA has many meeting points with healthcare quality dimensions. HTA is likely to become an increasingly important influence in health decisions.


2018 ◽  
Vol 22 (51) ◽  
pp. 1-106 ◽  
Author(s):  
David Inwald ◽  
Ruth R Canter ◽  
Kerry Woolfall ◽  
Caitlin B O’Hara ◽  
Paul R Mouncey ◽  
...  

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.


Author(s):  
Anastasia K. Kadda

The aim of this study is to describe the social role of technology in healthcare quality improvement. Methodologically, the study was based on a review of the relevant literature, Greek and foreign, as well as Internet sources related to the social role of technology in healthcare quality improvement. The main conclusions drawn were the following: a) The development of new technologies in the field of health and their involvement within the social context is today a fast accelerating process; b) The presentday expansion of health-oriented technology is of vital importance because of current trends in the field of healthcare and of the social evolution on healthcare services; c) Information technology is capable of profoundly contributing to the improvement of the quality of health, and thus to the wellbeing of the citizens in a society; d) By the use of health technology, more efficient and productive financial management is achieved with numerous benefits for the economy; e) Electronic health can improve the quality of healthcare thereby facilitating the work of health professionals; f) Greek society is being increasingly influenced by both international and domestic scientific and technological advances in health technology despite the existence of significant legal barriers; g) Current trends in the European Union as far as health technology is concerned are intimately connected with expanding citizen participation in the electronic revolution and their increasing access to the Information Society.


2020 ◽  
Vol 24 (25) ◽  
pp. 1-150 ◽  
Author(s):  
Marlise Poolman ◽  
Jessica Roberts ◽  
Stella Wright ◽  
Annie Hendry ◽  
Nia Goulden ◽  
...  

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.


2020 ◽  
Vol 36 (4) ◽  
pp. 297-303
Author(s):  
Annette Bauer ◽  
Raphael Wittenberg ◽  
Amanda Ly ◽  
Anders Gustavsson ◽  
Christin Bexelius ◽  
...  

ObjectivesDue to the nature of Alzheimer's disease (AD), health technology assessment (HTA) agencies might face considerable challenges in choosing appropriate outcomes and outcome measures for drugs that treat the condition. This study sought to understand which outcomes informed previous HTAs, to explore possible reasons for prioritizations, and derive potential implications for future assessments of AD drugs.MethodWe conducted a literature review of studies that analyzed decisions made in HTAs (across disease areas) in three European countries: England, Germany, and The Netherlands. We then conducted case studies of technology assessments conducted for AD drugs in these countries.ResultsOverall, outcomes measured using clinical scales dominated decisions or recommendations about whether to fund AD drugs, or price negotiations. HTA processes did not always allow the inclusion of outcomes relevant to people with AD, their carers, and families. Processes did not include early discussion and agreement on what would constitute appropriate outcome measures and cut-off points for effects.ConclusionsWe conclude that in order to ensure that future AD drugs are valued appropriately and timely, early agreement with various stakeholders about outcomes, outcome measures, and cut-offs is important.


Author(s):  
Esther Jacobs ◽  
Sunya-Lee Antoine ◽  
Barbara Prediger ◽  
Edmund Neugebauer ◽  
Michaela Eikermann

Background: Defining relevant outcome measures for clinical trials on medical devices (MD) is complex, as there is a large variety of potentially relevant outcomes. The chosen outcomes vary widely across clinical trials making the assessment in evidence syntheses very challenging. The objective is to provide an overview on the current common procedures of health technology assessment (HTA) institutions in defining outcome measures in MD trials.Methods: In 2012–14, the Web pages of 126 institutions involved in HTA were searched for methodological manuals written in English or German that describe methods for the predefinition process of outcome measures. Additionally, the institutions were contacted by email. Relevant information was extracted. All process steps were performed independently by two reviewers.Results: Twenty-four manuals and ten responses from the email request were included in the analysis. Overall, 88.5 percent of the institutions describe the type of outcomes that should be considered in detail and 84.6 percent agree that the main focus should be on patient relevant outcomes. Specifically related to MD, information could be obtained in 26 percent of the included manuals and email responses. Eleven percent of the institutions report a particular consideration of MD related outcomes.Conclusions: This detailed analysis on common procedures of HTA institutions in the context of defining relevant outcome measures for the assessment of MD shows that standardized procedures for MD from the perspective of HTA institutions are not widespread. This leads to the question if a homogenous approach should be implemented in the field of HTA on MD.


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