Evaluation Of Health Care Interventions Research Articles

Practices and Attitudes of Swiss Stakeholders Regarding Investigator-Initiated Clinical Trial Funding Acquisition and Cost Management

Randomized clinical trials (RCTs) are an essential method of evaluating health care interventions and a cornerstone for evidence-based health care. However, RCTs have become increasingly complex and costly, which is particularly challenging for independent investigator-initiated clinical trials (IICTs). IICTs have an essential role in clinical research, and it is important that efforts are made to ensure IICTs are adequately funded and are conducted cost-effectively. To examine the practices and attitudes of Swiss stakeholders regarding IICT funding acquisition and cost management. For this qualitative study, interviews were conducted in Switzerland between February and August 2020. The purposive sample comprised 48 stakeholders from 4 different groups: primary investigators (n = 27), funders and sponsors (n = 9), clinical trial support organizations (n = 6), and ethics committee members (n = 6). Practices and attitudes of stakeholders regarding IICT funding acquisition and cost management were assessed using individual semistructured qualitative interviews. Interviews were analyzed using conventional content analysis. After interviews with 48 IICT stakeholders (75% male presenting), these participants identified a systemic problem of IICTs being underfunded, which can lead to compromises being made regarding the quality and conduct of IICTs. Participants identified 2 overarching and interconnected groups of reasons why IICTs in Switzerland are regularly underfunded. First, it was reported that IICT budget estimations are often inaccurate because of poor planning and preparation, unforeseeable events, investigators intentionally underestimating budgets, and limited budget assessment and oversight. Second, with the exception of a specific IICT funding program by the Swiss National Science Foundation, it was reported that limited funding sources and unrealistic expectation of funders led to underlying challenges in getting IICTs fully funded. A number of measures that could help reduce the underfunding of IICTs were identified, including improving the support of investigators and IICTs, strengthening networking and guidance, harmonizing and simplifying bureaucracy, and increasing public funding of IICTs. This study highlights the inadequate expertise of Swiss stakeholders to correctly, systematically, and reproducibly calculate RCT budgets and the need for transparency on trial costs as well as training in budgeting practices. Limited financial resources for academic clinical research and issues regarding the professional planning and conduct of IICTs are persistent issues that many other countries also face.

Use of health-related quality-of-life measures for Indigenous child and youth populations: a scoping review protocol

IntroductionMeasures of health-related quality-of-life (HRQoL) are increasingly important for evaluating healthcare interventions and treatments, understanding the burden of disease, identifying health inequities, allocating health resources and for use in epidemiological...

Acceptability of a nurse-led, person-centred, anticipatory care planning intervention for older people at risk of functional decline: A qualitative study.

As the population of older adults increases, the complexity of care required to support those who choose to remain in the community amplifies. Anticipatory Care Planning (ACP), through earlier identification of healthcare needs, is evidenced to improve quality of life, decrease aggressive interventions, and prolong life. With patient acceptability of growing importance in the design, implementation, and evaluation of healthcare interventions, this study reports on the acceptability of a primary care based ACP intervention on the island of Ireland. As part of the evaluation of a feasibility cluster randomized controlled trial (cRCT) testing an ACP intervention for older people at risk of functional decline, intervention participants [n = 34] were interviewed in their homes at 10-week follow-up to determine acceptability. The intervention consisted of home visits by specifically trained registered nurses who assessed participants' health, discussed their health goals and plans, and devised an anticipatory care plan in collaboration with participants' GPs and adjunct clinical pharmacist. Thematic analysis was employed to analyze interview data. The feasibility cRCT involved eight general practitioner (GP) practices as cluster sites, stratified by jurisdiction, four in Northern Ireland (NI) (two intervention, two control), and four in the Republic of Ireland (ROI) (two intervention, two control). Participants were assessed for risk of functional decline. A total of 34 patients received the intervention and 31 received usual care. Thematic analysis resulted in five main themes: timing of intervention, understanding of ACP, personality & individual differences, loneliness & social isolation, and views on healthcare provision. These map across the Four Factor Model of Acceptability ('4FMA'), a newly developed conceptual framework comprising four components: intervention factors, personal factors, social support factors, and healthcare provision factors. Acceptability of this primary care based ACP intervention was high, with nurses' home visits, GP anchorage, multidisciplinary working, personalized approach, and active listening regarded as beneficial. Appropriate timing, and patient health education emerged as vital.

Spotlight commentary: A role for real-world evidence to inform the clinical care of patients with diabetes mellitus.

Spotlight commentary: A role for real-world evidence to inform the clinical care of patients with diabetes mellitus.

Discounting in economic evaluation of healthcare interventions: what about the risk term?

Results from economic evaluations of long-term outcomes are strongly dependent on the chosen discount rate. A recent review of national guidelines for evaluation of healthcare interventions finds that “the level of currently used discount rates seems relatively high in many countries”. However, this conclusion comes from a comparison to rates derived or observed for investments in safe assets, while rate of return requirements are typically considerably higher when investment involves risk. This paper reviews recent literature on how to account for project-specific risk in determination of the social rate of discount and discusses implications for economic evaluation of healthcare interventions. It concludes that the available empirical evidence strongly suggests that the demand for and consumer value of health and healthcare is co-variant with income, which therefore implies that there is a non-diversifiable risk component of health-related investment.

Methods for the Economic Evaluation of Health Care Interventions for Priority Setting in the Health System: An Update From WHO CHOICE.

The World Health Organization’s (WHO’s) Choosing Interventions that are Cost-Effective (CHOICE) programme has been a global leader in the field of economic evaluation, specifically cost-effectiveness analysis for almost 20 years. WHO-CHOICE takes a "generalized" approach to cost-effectiveness analysis that can be seen as a quantitative assessment of current and future efficiency within a health system. This supports priority setting processes, ensuring that health stewards know how to spend resources in order to achieve the highest health gain as one consideration in strategic planning. This approach is unique in the global health landscape. This paper provides an overview of the methodological approach, updates to analytic framework over the past 10 years, and the added value of the WHO-CHOICE approach in supporting decision makers as they aim to use limited health resources to achieve the Sustainable Development Goals (SDGs) by 2030.

Using area-level measures of social determinants of health to deliver improved and effective health care

: There is growing emphasis on social determinants of health (SDoH) and their role in health care outcomes and health care delivery. Despite the importance of SDoH in determining individual health, this information is not routinely or systematically captured during clinical encounters. Providers cite lack of time, hesitation to ask patients for personal information, and lack of confidence in addressing social risk factors as barriers to the routine collection and use of SDoH in clinical practice. SDoH have been operationalized as composite scores of measures spanning several domains such as transport, income, crime, housing, and built environment at the area level. Living in deprived neighborhoods has been associated with adverse health outcomes. Several national and international efforts have focused on using area-level measures of SDoH to describe area-level deprivation information, or its counterpart, opportunity that measures potential for human progress, to communicate implications for individual and population health outcomes. We provide an overview of the current state of the field to orient readers to area-level measures of SDoH. We briefly discuss potential applications and limitations of area-level SDoH, as well as, implications for health care and health policy. Our overview is likely to help with the design and evaluation of health care interventions that aim to use area-level measures of SDoH.

The prevalence and risk of missing outcome data in prenatal vitamin D supplemented gestational diabetes mellitus patients: a systematic review and meta-analysis protocol

The prevalence and risk of missing outcome data in prenatal vitamin D supplemented gestational diabetes mellitus patients: a systematic review and meta-analysis protocol

Analysis of the quality of reporting of randomized controlled trials in anticoagulant versus antiplatelet medication for venous thromboembolism prophylaxis as governed by the CONSORT statement.

Randomized controlled trials (RCTs) are the gold standard research in evaluating healthcare interventions. The CONSORT (Consolidated Standards of Reporting Trials) statement improves the quality of RCTs in an evidence-based approach. To evaluate the reporting quality of published RCTs concerning the use of anticoagulants versus antiplatelet agents for venous thromboembolism prophylaxis according to the CONSORT statement.Electronic databases were searched for English-language RCTs involving patients who received either anticoagulant or antiplatelet medication for prophylaxis of deep vein thrombosis and pulmonary embolism published from 2000 to 2019. Trials were considered eligible when the included patients received either anticoagulant or antiplatelet medication for primary and secondary prevention of deep vein thrombosis or pulmonary embolism and were randomly assigned to at least two treatment arms. Quality of reporting was assessed using a 37-item questionnaire based on the CONSORT 2010 checklist. Reporting was assessed in 2 publication periods (2000-2009) and (2010-2019). The effect of CONSORT statement in high- and low-ranked medical journals, according to their impact factor, has also been evaluated. The search identified 13 eligible articles for analysis. Only 12 of the 37 items of the checklist were addressed in 75% or more of the studies. Most items concerning the methodological issues were reported by fewer than 50% of the studies. Improvements over time were seen for items that assessed the methodological quality with no statistically significant difference. RCTs published in high-ranked journals showed better quality of reporting.Quality of reporting in RCTs focusing on the use of anticoagulants versus antiplatelet agents for venous thromboembolism prophylaxis remains unsatisfactory. Further improvement of reporting is necessary to assess the validity of clinical research.

Систематический обзор применения томосинтеза для диагностики травм и заболеваний опорно-двигательной системы

Digital tomosynthesis is a radiological method having an intermediate position between x-ray and computed tomography (CT). Benefits with the imaging technology include improved image quality, post-processing (reconstructed to 1 mm thick slices), minimal tissue overlap in the projection image and a lower X-ray dose as compared to CT. Tomosynthesis is most commonly used in breast, chest (pulmonary tuberculosis), musculoskeletal and intraoral screening examinations. There is disagreement among professionals on feasibility and clinical effectiveness of tomosynthesis in the diagnosis of musculoskeletal injuries and diseases. Our goal was to summarize evidence relating to efficacy and feasibility of tomosynthesis in the diagnosis of musculoskeletal injuries and diseases. Russian and foreign literature was reviewed based on methodological principles of the PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions. The review included 34 articles in English and in Russian (referenced 16 to 49) describing an original study with focus on phantom, diagnostic, clinical studies. We considered articles which investigated use of tomosynthesis in the diagnosis of musculoskeletal injuries and diseases including rheumatoid arthritis affecting the hands and feet, specific and nonspecific spine lesions and injuries, nonspecific lesions and injuries to the joints; subtle fractures and dislocations. With the advantages of tomosynthesis in clinical practice, the imaging modality can be recommended for the diagnosis of the above conditions.

SwCRTdesign: An [formula omitted]Package for Stepped Wedge Trial Design and Analysis

Background and objectiveStepped wedge trials (SWTs) are a type of cluster-randomized trial that are commonly used to evaluate health care interventions. Most SWT-related software packages have restrictive assumptions about the study design and correlation structure of the data. The objective of this paper is to present a package and corresponding web-based graphical user interface (GUI) that provide researchers with another, more flexible option for SWT design and analysis. MethodsWe developed an Rpackage swCRTdesign (‘stepped wedge Cluster Randomized Trial design’), which uses a random effects model to account for correlation in the data induced by a SWT design. Possible sources of correlation include clusters, time within clusters, and treatment within clusters. ResultsswCRTdesign allows a user to calculate power, simulate SWT data to streamline simulation studies (e.g. to estimate power), and create descriptive summaries and plots. Additionally, a GUI, developed using shiny, is available to calculate power and create power curves and design plots. ConclusionsThe swCRTdesign package accommodates a wide variety of SWT designs, and makes it easy to account for some sources of correlation which are not found in other packages. The user-friendly web-based GUI makes some swCRTdesign features accessible to researchers not familiar with R. These two resources will make appropriately complex SWT calculations more accessible to scientists from a wide variety of backgrounds.

Queensland Cardiovascular Data Linkage (QCard): A population-based cohort study

Queensland is Australia's hotspot for cardiovascular disease (CVD). Critically, beyond modifiable lifestyle risk factors; socio-demographic differences and environmental factors account for significant variations in healthcare use and outcomes among cardiac patients across the country. To better understand the impacts of these factors on the health of cardiac patients, there is a need for a comprehensive and robust longitudinal cohort study that can unpack the underlying dynamics. This paper describes the protocol for the Queensland Cardiovascular Linkage (QCard) Study. The QCard is a longitudinal linkage cohort study of cardiac patients who were first hospitalised with any cardiac condition in 2010, with follow up hospitalisations until December 2015. The primary aim of the QCard is to identify and characterise the nature and impact of socio-demographic inequality among those presenting for the first time with the most common form of CVD in Australia (heart disease) in Queensland from 2010 with minimum 5-years follow-up of subsequent healthcare utilisation and outcomes. A secondary aim is to undertake an exploration of the impact of environmental and specific health service factors on healthcare use and survival time in the same QCard cohort. Administrative public and private hospital inpatient, outpatient and emergency department data for all of Queensland will be linked with individual primary care data and pharmaceutical data. These data will also be linked to regional socio-demographic data and environmental data, as well as data that describes the features of each hospital in the region. The findings from the study will provide critical information for cardiac patients, clinicians and health policymakers. Such information ranges from identifying most vulnerable cardiac patients who may require targeted needs to providing estimates for cost-effective ways of evaluating healthcare interventions that seek to improve the health of cardiac patients.

Optimizing the design of invasive placebo interventions in randomized controlled trials.

BackgroundPlacebo‐controlled trials play an important role in the evaluation of healthcare interventions. However, they can be challenging to design and deliver for invasive interventions, including surgery. In‐depth understanding of the component parts of the treatment intervention is needed to ascertain what should, and should not, be delivered as part of the placebo. Assessment of risk to patients and strategies to ensure that the placebo effectively mimics the treatment are also required. To date, no guidance exists for the design of invasive placebo interventions. This study aimed to develop a framework to optimize the design and delivery of invasive placebo interventions in RCTs.MethodsA preliminary framework was developed using published literature to: expand the scope of an existing typology, which facilitates the deconstruction of invasive interventions; and identify placebo optimization strategies. The framework was refined after consultation with key stakeholders in surgical trials, consensus methodology and medical ethics.ResultsThe resulting DITTO framework consists of five stages: deconstruct treatment intervention into constituent components and co‐interventions; identify critical surgical element(s); take out the critical element(s); think risk, feasibility and role of placebo in the trial when considering remaining components; and optimize placebo to ensure effective blinding of patients and trial personnel.ConclusionDITTO considers invasive placebo composition systematically, accounting for risk, feasibility and placebo optimization. Use of the framework can support the design of high‐quality RCTs, which are needed to underpin delivery of healthcare interventions.

Secondary prevention of UV-induced skin cancer: development and pilot testing of an educational patient counseling approach for individual sun protection as standard procedure of patient care

ObjectiveTo outline the development and pilot testing of a patient counseling approach for individual sun protection for patients in outdoor professions diagnosed with squamous cell carcinoma or multiple actinic keratosis due to solar UV radiation. This is a secondary prevention measure as part of the standard procedure of patient care by the respective statutory accident insurance.MethodsResults of guideline-based qualitative interviews with seven outdoor workers and a search of literature formed the basis for the counseling approach, which was compiled in a manual. Interdisciplinary experts (dermatologists and educators) reviewed and consented the final manual. The pilot testing was conducted in consecutive steps (N1 = 36 patients and N1 = 2 counselors; N4 = 12 patients and N4 = 6 counselors). The first two stages of the revised guideline ‘Criteria for Reporting the Development and Evaluation of Complex Interventions in healthcare (CReDECI 2)’ serve as background and structure for presenting the results.ResultsThe ‘counseling approach for individual sun protection (ILB: Individuelle Lichtschutz-Beratung)’ consists of seven general and eight add-on modules. These can be combined and tailored according to the patient’s individual needs. Interactive, educational components (e.g. haptic experiments) are crucial elements of the counseling approach.ConclusionsThe special requirements of outdoor workers are hardly taken into consideration in Germany, even though the interest for an improved sun protection behavior of some occupational groups is high. The advantage of the presented approach is that the heterogeneous needs of patients can be specifically addressed with its various modules.

Challenges for Economic Evaluation of Health Care Strategies to Contain Antimicrobial Resistance.

The threat of antimicrobial resistance has global health and economic consequences. Medical strategies to reduce unnecessary antibiotic prescribing, to conserve the effectiveness of current antimicrobials in the long term, inevitably result in short-term costs to health care providers. Economic evaluations of health care interventions therefore need to consider the short-term costs of interventions, to gain future benefits. This represents a challenge for health economists, not only in terms of the most appropriate methods for evaluation, but also in attributing the potential budget impact over time and considering health impacts on future populations. This commentary discusses the challenge of accurately capturing the cost-effectiveness of health care interventions aimed at tackling antimicrobial resistance. We reflect on methods to capture and incorporate the costs and health outcomes associated with antimicrobial resistance, the appropriateness of the quality-adjusted-life year (QALY), individual time preferences, and perspectives in economic evaluation.

Measuring, valuing and including forgone childhood education and leisure time costs in economic evaluation: Methods, challenges and the way forward

Economic evaluations carried out to inform the allocation of finite public funds ought to take into account all relevant costs and benefits. When such evaluations adopt a societal perspective, it is important that they include ‘time-related’ costs arising from productivity and leisure time losses due to receipt of care, ill health or both. For programmes that relate to children, similar costs arise from forgone time, though there is a distinct lack of insights into how such costs should be identified, measured and valued. We set out to explore how forgone time—including absence from formal education and childhood leisure time—can be estimated and incorporated into economic evaluations. To do so, we look at theories and approaches to time valuation proposed in different disciplines and we discuss their suitability for use in health economics research. We find that, while there is a sizeable literature on time valuation methods in education, labour and transportation economics, much of this is not directly applicable to economic evaluation of health care interventions for children. We identify gaps in existing methods and practice, we outline challenges in moving forwards and we provide a list of considerations aiming to assist researchers in deciding whether, and how, to include foregone time-related costs in economic evaluation.

Antibiotic treatment for ocular toxoplasmosis: a systematic review and meta-analysis: study protocol

BackgroundOcular toxoplasmosis (OT) is the most common cause of posterior uveitis, leading to visual impairment in a high proportion of patients. Antibiotics and corticosteroids lower the risk of permanent visual impairment by reducing the size of the retinochoroidal scar, the risk of recurrence, and the severity and duration of acute symptoms. Although OT is a very common cause of infectious posterior uveitis, its treatment remains controversial. Through our systematic review and meta-analysis, we aim to provide the best possible evidence-based information on the safety and effectiveness of the different antibiotic regimes for OT.MethodsThis systematic review protocol has been developed based on PRISMA-P guidelines for reporting systematic reviews evaluating health care interventions. We will include all published and unpublished randomized controlled trials (RCTs) comparing different antibiotics used for the treatment of OT. We will consider changes in visual acuity, number of recurrences, improvement or worsening of ocular inflammation, size of lesion, and adverse effects as our outcomes. Screening, data extraction, and quality assessment will be undertaken by two reviewers with disagreements resolved through discussion. Studies that compared antibiotics with placebo will be excluded. The reviews will be assessed for quality and relevance. We will assess the risk of bias in five domains according to Cochrane group’s tool. The type of data will dictate measures of treatment effect. We will use a random-effects model to calculate our meta-analysis, as eligible studies represent clinically varied populations of participants.DiscussionThe strength of our study will lie in the exhaustive and systematic nature of the literature search, as well as in its methods for assessing quality and analyzing RCT data. Considering the controversial efficacy of the treatment for OT, our study will contribute to improving the existing evidence on the effectiveness of different antibiotics. Future studies may be conducted to increase physicians’ awareness of antibiotic therapies, improving the health of patients with OT.Systematic review registrationPROSPERO CRD42018085468.

CHRONIC LACK OF SLEEP IS ASSOCIATED WITH INCREASED SPORTS INJURY IN ADOLESCENTS: A SYSTEMATIC REVIEW AND META-ANALYSIS

Background:Although sleep has been identified as an important modifiable risk factor for sports injury, the effect of decreased sleep on sports injuries in adolescents is poorly studied.Purpose:To ...

OP122 Resource Use Measurement Issues: A Scoping Review

IntroductionResource use measurement is known to be a challenging and time-consuming, but essential step in economic evaluations of health care interventions. Measuring true quantities of resources utilized is of major importance for generating valid costing estimates. As consequence of the absence of a gold standard and of acknowledged guidelines, the choice of a measurement method is often based on practicality instead of methodological evidence. An overview of resource use measurement issues is currently lacking. Such overview could enhance clearance in the quality of resource use measurement methods in economic evaluations and may facilitate to opt for evidence based measurement methods in the future. This study aims to provide an overview of methodological evidence regarding resource use measurement issues in economic evaluations.MethodsLiterature was searched by three different methods. First, a search strategy was used in six different databases. Second, the Database of Instruments for Resource Use Measurement (DIRUM) was hand-searched. Third, experts from six different European Union countries within the field of health economics were asked to provide relevant studies. Data was analyzed according to the Resource Use Measurement Issues (RUMI-) framework, which was developed for this study.ResultsOf the 3,478 articles provided in the initial search, 77 were fully analyzed. An overview with evidence is provided for every resource use measurement issue. Most research focused around the issue ‘how to measure’, in particular the effect of self-reported data versus administrative data. In contrast, little to no research has been done on issues ‘what to measure’ and ‘for which purpose to measure’.ConclusionsResults of this study provide insight in the effect of a chosen measurement method. The results stress the importance of measuring the true quantities of resources utilized for generating valid costing estimates. Furthermore, this article highlights the lack of evidence in appropriate resource use measurement methods.

3Z: STEPWISE: Tackling Urban Air Pollution in a Low Resource Setting: A Qualitative Study

INTRODUCTION: Air pollution is a global rising problem and its ill effects on human health are well established. For the first time air pollution can be found among 10 greatest risks for premature death globally. 92% of the worlds population is living in an area where the air quality does not meet the pollutant levels recommended by the “WHO air quality guidelines”. Croatia, especially the city of Zagreb is facing a rising traffic problem without a defined strategy on dealing with it and reducing its effects on human health. Stochastic action as a result of specialised scientific staff and knowledge base deficit has provided suboptimal performance.AIM: To create a framework for appropriate air pollution reduction intervention in urban environment using a combined qualitative approach.METHODS: A modified nominal group of epidemiology residents in Croatia will be used to pinpoint the main issues underlying the low efficacy of existing traffic air pollution reduction strategies. Using the results of nominal group, a ranking list of the main issues will be made, identifying the potential targets for air pollution reduction intervention. Systematic review of literature (SRL) will be conducted, using the PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions, to identify existing traffic air pollution reduction interventions in urban environments. RAND-UCLA appropriateness method, using inputs from the nominal group and SRL will be used to select the most appropriate intervention for the local setting. Policy recommendation will be made to facilitate implementation of selected intervention.CONCLUSION: This project will emphasise air pollution as a greatest environmental risk for its citizens with concluding policy recommendation for air pollution reduction and individual action plan.