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How can health economics be used in the design and analysis of adaptive clinical trials? A qualitative analysis
Introduction
Adaptive designs offer a flexible approach, allowing changes to a trial based on examinations of the data as it progresses. Adaptive clinical trials are becoming a popular choice, as the prudent use of finite research budgets and accurate decision-making are priorities for healthcare providers around the world. The methods of health economics, which aim to maximise the health gained for money spent, could be incorporated into the design and analysis of adaptive clinical trials to make them more efficient. We aimed to understand the perspectives of stakeholders in health technology assessments to inform recommendations for the use of health economics in adaptive clinical trials.
Methods
A qualitative study explored the attitudes of key stakeholdersâincluding researchers, decision-makers and members of the publicâtowards the use of health economics in the design and analysis of adaptive clinical trials. Data were collected using interviews and focus groups (29 participants). A framework analysis was used to identify themes in the transcripts.
Results
It was considered that answering the clinical research question should be the priority in a clinical trial, notwithstanding the importance of cost-effectiveness for decision-making. Concerns raised by participants included handling the volatile nature of cost data at interim analyses; implementing this approach in global trials; resourcing adaptive trials which are designed and adapted based on health economic outcomes; and training stakeholders in these methods so that they can be implemented and appropriately interpreted.
Conclusion
The use of health economics in the design and analysis of adaptive clinical trials has the potential to increase the efficiency of health technology assessments worldwide. Recommendations are made concerning the development of methods allowing the use of health economics in adaptive clinical trials, and suggestions are given to facilitate their implementation in practice
Landscape and technology in the Peak District of Derbyshire : the fifth and fourth millennia B.C.
This thesis is concerned with two closely related themes: the inhabitation of the Peak District over the fifth and fourth millennia BC, and the procedures and principles by which we attempt to interpret the durable material traces thereof. A four stage interpretative framework is outlined. Social life is understood through its materiality. The engagement of the self with others is constrained and enabled by that materiality. Archaeologists can represent that process through a textual model. Analogical reasoning mediates each stage and must be made explicit. The Mesolithic and Neolithic, analytical objects constructed through conceptual metaphors, fail to express time and the materiality of practice as mutually constitutive. An integrated theory of landscape and technology is proposed whereby artefacts are understood in terms of relational metaphors, situating them in practice and capturing both their materiality and temporality. Prior research in the study area is critiqued on the basis that the historically specific material conditions therein cannot support models transposed from other regional contexts. A methodology for collection and analysis is developed which privileges those specific conditions in the interpretation of prehistoric technology. Artefact assemblages, it is argued, offer us no unmediated access to prehistoric settlement. No immediate functional equivalence between aggregations similar in composition should be expected. The analysis of stone tools and waste must be integrated with other categories of evidence and interpreted in terms of the potentials offered by their socio-physical context. Original data are analysed in terms of assemblage density, raw material and technological composition, chronological patterning and landscape situation. Integration into the regional corpus, through an explicitly multi-scalar approach, attends to the constitution of social life through practice and developing tradition. The role ascribed to early `monuments' by other archaeologists is particularly brought into question, with respect to the model of relational practice maintained throughout the dissertation
A career in sport does not eliminate risk of cardiovascular disease; A systematic review and meta-analysis of the cardiovascular health of field-based athletes
Objectives: To determine the prevalence of cardiovascular disease (CVD) risk factors in current field-based athletes. Design: Meta-analysis. Methods: This review was conducted and reported in accordance with PRISMA and pre-registered with PROSPERO. Articles were retrieved via online database search engines, with no date or language restriction. Studies investigating current field-based athletes (>18years) for CVD risk factors according to the European Society of Cardiology and American Heart Association were screened. Full texts were screened using Covidence and Cochrane criteria. Eligible articles were critically appraised using the AXIS tool. Individual study estimates were assessed by random-effect meta-analyses to examine the overall effect. Results: This study was ascribed a 1b evidence level, according to the Oxford Centre for Evidence-based Medicine. 41 studies were identified, including 5,546 athletes from four sports; American football; soccer; rugby and baseball (mean ages:18-28). Despite participation in sport, increased body mass was associated with increased total cholesterol, low-density lipoprotein, triglycerides, hypertension, systolic blood pressure, and decreased high-density lipoprotein. Linemen had increased prevalence of hypertension compared to non-athletes. Conflicting findings on fasting glucose were prevalent. There were inconsistencies in screening and reporting of CVD risk factors. Sport specific anthropometric demands were associated with elevated prevalence of CVD risk factors, most notably: elevated body mass; dyslipidemia; elevated systolic blood pressure and; glucose Conclusions: There are elevated levels of risk for CVD in some athletes, primarily football players. Lifestyle behaviours associated with elite athleticism, particularly football linemen potentially expose players to greater metabolic and CVD risk, which is not completely offset by sport participation
Examining the Relationship between Brand Emotion and Brand Extension among Supporters of Professional Football Clubs
Purpose: There is debate and controversy about the use of branding in sport. Often, fans show loyalty to their club that many brands could only dream of, and a key argument of previous research is that supporters do not like to think of their club in commercial terms, as a brand (Chadwick and Beech, 2007; Chadwick and Holt, 2006). However, we argue that in todayâs environment fans have a pragmatic attitude towards the necessity of branding and its importance in the future success of their clubs. Thus a model conceptualising the relationship between supportersâ emotional attachment, supportersâ brand perception/strength and their support for brand extension was developed and tested.
Methodology: In-depth interviews with, players, clubsâ officials and supporters, leading to the design of a survey instrument completed by 852 supporters of two professional Norwegian football clubs.
Findings: The model confirms that fans that have a strong emotional attachment to their club have a stronger perception of the club as a brand and support brand extension.
Research limitations: This is a one country study.
Practical implications: Club management needs to be careful when extending its brand. Brand extension must be designed to reflect the heritage and tradition of the club. Also, club management needs to show in brand extension an element of competitiveness which improves brand image, strengthens supportersâ belief in their club and attracts new supporters.
Originality/value: We provide new evidence which contradicts existing theory. The study challenged the widely accepted argument that supporters of football clubs are likely to disapprove of and reject the thought of their favourite football club as a brand
Analisis Faktor-faktor yang Mempengaruhi Keberhasilan Lelang Eksekusi Hak Tanggungan pada Kantor Pelayanan Kekayaan Negara dan Lelang Palu (2015 - September 2016)
ANALISIS FAKTOR-FAKTOR YANG MEMPENGARUHI KEBERHASILAN LELANG EKSEKUSI HAK TANGGUNGAN PADA KANTOR PELAYANAN KEKAYAAN NEGARA DAN LELANG PALU (2015 - SEPTEMBER 2016) Agus Susanto, Tri Oldy Rotinsulu, George M.V. Kawung Fakultas Ekonomi dan Bisnis, Magister Ilmu EkonomiUniversitas Sam Ratulangi, Manado ABSTRAKPenelitian ini bertujuan untuk mengetahui faktor-faktor yang mempengaruhi keberhasilan (laku terjual atau tidak laku terjual) lelang eksekusi hak tanggungan obyek property riil di KPKNL Palu. Penelitian ini penting dilakukan karena keberhasilan lelang eksekusi hak tanggungan di KPKNL Palu relatif rendah dan keberhasilan lelang secara langsung akan meningkatkan debt recovery serta penerimaan negara seperti bea lelang, pajak penghasilan pasal 25, dan BPHTB.Data yang diteliti berupa risalah lelang eksekusi hak tanggungan di KPKNL Palu yang terletak di Kota Palu dari tahun 2015 sampai dengan September 2016 dengan mengambil sampel sebanyak 200 transaksi lelang. Metode analisis yang digunakan adalah analisis berganda binari dengan menggunakan model logit.Hasil penelitian menunjukkan bahwa faktor faktor yang berpengaruh positif dan signifikan terhadap hasil lelang eksekusi hak tanggungan di KPKNL Palu adalah lokasi, aksesibilitas, penyelenggara pra lelang dan cara penawaran lelang. Kata Kunci : Keberhasilan lelang eksekusi Hak Tanggungan, Hasil Lelang, Laku atau Tidak Laku terjual, Properti Riil ABSTRACTThis study aims to determine the factors that influence the success (sold or not sold) mortgage auction of real property objects in KPKNL Palu. This research is important because the success of real property mortgage auction in KPKNL Palu relatively low and the success of the auction will directly will increase debt recovery and also state revenues such as auction fee, income tax and real estate tax.The data used in this research consist of real property mortgage auction in KPKNL Palu located in the city of Palu from 2015 until September 2016 by taking a sample of 200 transactions auction. The binary multiple regression method with logit model used to analysis in this researchThe result of this research show that significant factors influencing mortgage auction outcome in KPKNL Palu are location, accessibility, pre-auctioning houses and way bidding
Precision of the Integrated Cognitive Assessment for the assessment of neurocognitive performance in athletes at risk of concussion
Choice reaction time tests are commonly used for the assessment of cognitive function, and may be useful to assess the effect of mild traumatic injuries or concussions. This study investigated the precision of the Integrated Cognitive Assessment (ICA; Cognetivity Neurosciences Ltd., Vancouver, Canada) test for the assessment of cognitive function in athletes. Thirty-one participants volunteered to take part in this study, from both contact (n = 22) and non-contact sports (n = 9). Participants performed the ICA test consecutively both before and after normal training session to simulate resting and post-sport conditions. Precision errors were calculated for three variables, ICA Index (overall information processing ability), ICA Speed (information processing speed) and ICA Accuracy (information processing accuracy). ICA precision errors [root mean squared-standard deviation, RMS-SD (coefficient of variation, %CV)] pre-sport were ICA Index: 5.18 (7.14%), ICA Speed: 3.98 (4.64%), and ICA Accuracy: 3.64 (5.00%); and post-sport were ICA Index: 3.96 (4.94%), ICA Speed: 2.14 (2.32%), and ICA Accuracy 3.40 (4.25%). The ICA test demonstrates high in-vivo precision with all variables, with all variables except ICA Index (7.14%) demonstrating an acceptable precision error of â€5% %CV. The ICA test is suitable for the assessment of cognitive function pre- and post-sport
Playful mapping in the digital age:The Playful Mapping Collective
From Mah-Jong, to the introduction of Prussian war-games, through to the emergence of location-based play: maps and play share a long and diverse history. This monograph shows how mapping and playing unfold in the digital age, when the relations between these apparently separate tropes are increasingly woven together. Fluid networks of interaction have encouraged a proliferation of hybrid forms of mapping and playing and a rich plethora of contemporary case-studies, ranging from fieldwork, golf, activism and automotive navigation, to pervasive and desktop-based games evidences this trend. Examining these cases shows how mapping and playing can form productive synergies, but also encourages new ways of being, knowing and shaping our everyday lives. The chapters in this book explore how play can be more than just an object or practice, and instead focus on its potential as a method for understanding maps and spatiality. They show how playing and mapping can be liberating, dangerous, subversive and performative
Graphene OxideâDoped Gellan GumâPEGDA Bilayered Hydrogel Mimicking the Mechanical and Lubrication Properties of Articular Cartilage
Articular cartilage (AC) is a specialized connective tissue able to provide a low-friction gliding surface supporting shock-absorption, reducing stresses, and guaranteeing wear-resistance thanks to its structure and mechanical and lubrication properties. Being an avascular tissue, AC has a limited ability to heal defects. Nowadays, conventional strategies show several limitations, which results in ineffective restoration of chondral defects. Several tissue engineering approaches have been proposed to restore the AC's native properties without reproducing its mechanical and lubrication properties yet. This work reports the fabrication of a bilayered structure made of gellan gum (GG) and poly (ethylene glycol) diacrylate (PEGDA), able to mimic the mechanical and lubrication features of both AC superficial and deep zones. Through appropriate combinations of GG and PEGDA, cartilage Young's modulus is effectively mimicked for both zones. Graphene oxide is used as a dopant agent for the superficial hydrogel layer, demonstrating a lower friction than the nondoped counterpart. The bilayered hydrogel's antiwear properties are confirmed by using a knee simulator, following ISO 14243. Finally, in vitro tests with human chondrocytes confirm the absence of cytotoxicity effects. The results shown in this paper open the way to a multilayered synthetic injectable or surgically implantable filler for restoring AC defects
A randomised controlled trial and cost-effectiveness evaluation of 'booster' interventions to sustain increases in physical activity in middle-aged adults in deprived urban neighbourhoods
Background: More evidence is needed on the potential role of 'booster' interventions in the maintenance of increases in physical activity levels after a brief intervention in relatively sedentary populations.
Objectives: To determine whether objectively measured physical activity, 6 months after a brief intervention, is increased in those receiving physical activity 'booster' consultations delivered in a motivational interviewing (MI) style, either face to face or by telephone.
Design: Three-arm, parallel-group, pragmatic, superiority randomised controlled trial with nested qualitative research fidelity and geographical information systems and health economic substudies. Treatment allocation was carried out using a web-based simple randomisation procedure with equal allocation probabilities. Principal investigators and study statisticians were blinded to treatment allocation until after the final analysis only.
Setting: Deprived areas of Sheffield, UK.
Participants: Previously sedentary people, aged 40-64 years, living in deprived areas of Sheffield, UK, who had increased their physical activity levels after receiving a brief intervention.
Interventions: Participants were randomised to the control group (no further intervention) or to two sessions of MI, either face to face ('full booster') or by telephone ('mini booster'). Sessions were delivered 1 and 2 months post-randomisation.
Main outcome measures: The primary outcome was total energy expenditure (TEE) per day in kcal from 7-day accelerometry, measured using an Actiheart device (CamNtech Ltd, Cambridge, UK). Independent evaluation of practitioner competence was carried out using the Motivational Interviewing Treatment Integrity assessment. An estimate of the per-participant intervention costs, resource use data collected by questionnaire and health-related quality of life data were analysed to produce a range of economic models from a short-term NHS perspective. An additional series of models were developed that used TEE values to estimate the long-term cost-effectiveness.
Results: In total, 282 people were randomised (control = 96; mini booster = 92, full booster = 94) of whom 160 had a minimum of 4 out of 7 days' accelerometry data at 3 months (control = 61, mini booster = 47, full booster = 52). The mean difference in TEE per day between baseline and 3 months favoured the control arm over the combined booster arm but this was not statistically significant (-39 kcal, 95% confidence interval -173 to 95, p = 0.57). The autonomy-enabled MI communication style was generally acceptable, although some participants wanted a more paternalistic approach and most expressed enthusiasm for monitoring and feedback components of the intervention and research. Full boosters were more popular than mini boosters. Practitioners achieved and maintained a consistent level of MI competence. Walking distance to the nearest municipal green space or leisure facilities was not associated with physical activity levels. Two alternative modelling approaches both suggested that neither intervention was likely to be cost-effective.
Conclusions: Although some individuals do find a community-based, brief MI 'booster' intervention supportive, the low levels of recruitment and retention and the lack of impact on objectively measured physical activity levels in those with adequate outcome data suggest that it is unlikely to represent a clinically effective or cost-effective intervention for the maintenance of recently acquired physical activity increases in deprived middle-aged urban populations. Future research with middle-aged and relatively deprived populations should explore interventions to promote physical activity that require less proactive engagement from individuals, including environmental interventions
Role of habit in treatment adherence among adults with cystic fibrosis
Among adults with cystic fibrosis (CF), medication adherence is low and reasons for low adherence are poorly understood. Our previous exploratory study showed that stronger 'habit' (ie, automatically experiencing an urge to use a nebuliser) was associated with higher nebuliser adherence. We performed a secondary analysis of pilot trial data (n=61) to replicate the earlier study and determine whether habit-adherence association exists in other cohorts of adults with CF. In this study, high adherers also reported stronger habit compared with low adherers. Habit may be a promising target for self-management interventions. ACtiF pilot, ISRCTN13076797. [Abstract copyright: © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
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