Does offering an incentive payment improve recruitment to clinical trials and increase the proportion of socially deprived and elderly participants?

BACKGROUND: Patient recruitment into clinical trials is a major challenge, and the elderly, socially deprived and those with multiple comorbidities are often underrepresented. The idea of paying patients an incentive to participate in research is controversial, and evidence is needed to evaluate this as a recruitment strategy. METHOD: In this study, we sought to assess the impact on clinical trial recruitment of a £100 incentive payment and whether the offer of this payment attracted more elderly and socially deprived patients. A total of 1,015 potential patients for five clinical trials (SCOT, FAST and PATHWAY 1, 2 and 3) were randomised to receive either a standard trial invitation letter or a trial invitation letter containing an incentive offer of £100. To receive payment, patients had to attend a screening visit and consent to be screened (that is, sign a consent form). To maintain equality, eventually all patients who signed a consent form were paid £100. RESULTS: The £100 incentive offer increased positive response to the first invitation letter from 24.7% to 31.6%, an increase of 6.9% (P < 0.05). The incentive offer increased the number of patients signing a consent form by 5.1% (P < 0.05). The mean age of patients who responded positively to the invitation letter was 66.5 ± 8.7 years, whereas those who responded negatively were significantly older, with a mean age of 68.9 ± 9.0 years. The incentive offer did not influence the age of patients responding. The incentive offer did not improve response in the most socially deprived areas, and the response from patients in these areas was significantly lower overall. CONCLUSION: A £100 incentive payment offer led to small but significant improvements in both patient response to a clinical trial invitation letter and in the number of patients who consented to be screened. The incentive payment did not attract elderly or more socially deprived patients. TRIAL REGISTRATIONS: Standard care versus Celecoxib Outcome Trial (SCOT) (ClinicalTrials.gov identifier: NCT00447759). Febuxostat versus Allopurinol Streamlined Trial (FAST) (EudraCT number: 2011-001883-23). Prevention and Treatment of Hypertension with Algorithm Guided Therapy (British Heart Foundation funded trials) (PATHWAY) 1: Monotherapy versus dual therapy for initiating treatment (EudraCT number: 2008-007749-29). PATHWAY 2: Optimal treatment of drug-resistant hypertension (EudraCT number: 2008-007149-30). PATHWAY 3: Comparison of single and combination diuretics in low-renin hypertension (EudraCT number: 2009-010068-41). ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-015-0582-8) contains supplementary material, which is available to authorized users

Cord blood banking – bio-objects on the borderlands between community and immunity

Umbilical cord blood (UCB) has become the focus of intense efforts to collect, screen and bank haematopoietic stem cells (HSCs) in hundreds of repositories around the world. UCB banking has developed through a broad spectrum of overlapping banking practices, sectors and institutional forms. Superficially at least, these sectors have been widely distinguished in bioethical and policy literature between notions of the ‘public’ and the ‘private’, the commons and the market respectively. Our purpose in this paper is to reflect more critically on these distinctions and to articulate the complex practical and hybrid nature of cord blood as a ‘bio-object’ that straddles binary conceptions of the blood economies. The paper draws upon Roberto Esposito’s reflections on biopolitics and his attempt to transcend the dualistic polarisations of immunity and community, or the private and the public. We suggest that his thoughts on immunitary hospitality resonate with many of the actual features and realpolitik of a necessarily internationalised and globally distributed UCB ‘immunitary regime’

A Blessing and a Curse? Political Institutions in the Growth and Decay of Generalized Trust: A Cross-National Panel Analysis, 1980–2009

Despite decades of research on social capital, studies that explore the relationship between political institutions and generalized trust–a key element of social capital–across time are sparse. To address this issue, we use various cross-national public-opinion data sets including the World Values Survey and employ pooled time-series OLS regression and fixed- and random-effects estimation techniques on an unbalanced panel of 74 countries and 248 observations spread over a 29-year time period. With these data and methods, we investigate the impact of five political-institutional factors–legal property rights, market regulations, labor market regulations, universality of socioeconomic provisions, and power-sharing capacity–on generalized trust. We find that generalized trust increases monotonically with the quality of property rights institutions, that labor market regulations increase generalized trust, and that power-sharing capacity of the state decreases generalized trust. While generalized trust increases as the government regulation of credit, business, and economic markets decreases and as the universality of socioeconomic provisions increases, both effects appear to be more sensitive to the countries included and the modeling techniques employed than the other political-institutional factors. In short, we find that political institutions simultaneously promote and undermine generalized trust

Using qualitative research methods in biomedical innovation:the case of cultured red blood cells for transfusion

Background&nbsp; Qualitative research has a key role to play in biomedical innovation projects. This article focuses on the appropriate use of robust social science methodologies (primarily focus group studies) for identifying the public&rsquo;s willingness and preference for emerging medical technologies. Our study was part of the BloodPharma project (now known as the Novosang project) to deliver industrially generated red blood cells for transfusion. Previous work on blood substitutes shows that the public prefers donated human blood. However, no research has been conducted concerning attitudes to stem cell derived red blood cells.&nbsp; Method&nbsp; Qualitative research methods including interviews and focus groups provide the methodological context for this paper.&nbsp; Results&nbsp; Focus groups were used to elicit views from sub-sections of the UK population about the potential use of such cultured red blood cells. We reflect on the appropriateness of that methodology in the context of the BloodPharma project. Findings are in the form of lessons transferable to other interdisciplinary, science-led teams about what a social science dimension can bring; why qualitative research should be included; and how it can be used effectively.&nbsp; Discussion&nbsp; Qualitative data collection offers the strength of exploring ambivalence and investigating the reasons for views, but not necessarily their prevalence in wider society. The inherent value of a qualitative method, such as focus groups, therefore lies in its ability to uncover new information. This contrasts with a quantitative approach to simply &lsquo;measuring&rsquo; public opinion on a topic about which participants may have little prior knowledge. We discuss a number of challenges including: appropriate roles for embedded social scientists and the intricacies of doing upstream engagement as well as some of the design issues and limitations associated with the focus group method

Rural World, Migration, and Agriculture in Mediterranean EU: An Introduction

AbstractThis book investigates the dynamics that are reshaping human and natural landscapes in the European agrarian world, with a specific focus on Mediterranean Europe. We focus here on more marginal rural settings, where the potential for agricultural intensification is structurally limited. These areas in particular have suffered from the geographical and socio-economic polarization of development patterns and have paid a relevant burden to the recent crisis