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Factors associated with recruitment success in the phase 2a study of aztreonam-avibactam development programme: a descriptive qualitative analysis among sites in Spain

Por: Jimenez-Rodriguez · R. M. · Martin-Gutierrez · G. · Jimenez-Jorge · S. · Rosso-Fernandez · C. M. · Tallon-Aguilar · L. · Roca-Oporto · C. · Padillo · J. · Luckey · A. · Cano · A. · Lopez-Ruiz · J. · Gomez-Zorrilla · S. · Bonnin-Pascual · J. · Boix-Palop · L. · Montejo · J. M. · Tor
Objective

Successful clinical trials are subject to recruitment. Recently, the REJUVENATE trial, a prospective phase 2a open-label, single-arm interventional clinical trial conducted within the Innovative Medicines Initiative-supported Combatting Bacterial Resistance in Europe-Carbapenem Resistance project, was published, with 85% of the recruitment performed in Spain. We analysed the recruitment success in this trial by establishing a model of recruitment practice.

Methods

A descriptive qualitative study was performed from May 2016 to October 2017 at 10 participating Spanish centres. Data were extracted from: (1) feasibility questionnaires to assess the centre’s potential for patient enrolment; (2) delegation of responsibility records; (3) pre-screening records including an anonymised list of potentially eligible and (4) screening and enrolment records. A descriptive analysis of the features was performed by the participating centre. Pearson’s and Spearman’s correlation coefficients were calculated to determine factors of recruitment success.

Results

The highest recruitment rate was observed in Hospitals 3 and 6 (58.8 and 47.0 patients per month, respectively). All the study teams were multidisciplinary with a median of 15 members (range: 7–22). Only Hospitals 3, 5 and 6 had dedicated nursing staff appointed exclusively to this study. Moreover, in those three hospitals and in Hospital 9, the study coordinator performed exclusive functions as a research planner, and did not assume these functions for the other hospitals. The univariate analysis showed a significant association between recruitment success and months of recruitment (p=0.024), number of staff (p

Conclusions

The existence of broad multidisciplinary teams with staff dedicated exclusively to the study as well as the implementation of a well-designed local patient assessment strategy were the essential optimisation factors for recruitment success in Spain.

Trial registration number

NCT02655419; EudraCT 2015-002726-39; analysis of pre-screened patients.

Association between informal employment and mortality rate by welfare regime in Latin America and the Caribbean: an ecological study

Objective

We aimed to estimate the association between informal employment and mortality in Latin America and the Caribbean (LAC) by comparing welfare state regimes.

Design

Ecological study using time-series cross-sectional analysis of countries. Informality was estimated from household surveys by the Center for Distributive, Labor and Social Studies in collaboration with the World Bank, and the adult mortality rates for 2000–2016 were obtained from the WHO databases. Countries were grouped by welfare state regimes: state productivist, state protectionist and familialist. We calculated the compound annual growth rate for each country and performed linear regression between the informality and the adult mortality rates stratified by sex and welfare state regime.

Setting

Seventeen countries from LAC with available data on informality and adult mortality rates for 2000–2016.

Primary outcome measure

The association between informality and mortality by welfare state regime.

Results

Between 2000 and 2016, mortality rates decreased an average 1.3% per year and informal employment rates 0.5% per year. We found a significant positive association between informality and mortality rates (women: R2=0.48; men: R2=0.36). The association was stronger among the state regime countries (women: R2=0.58; men: R2=0.77), with no significant association among the familialist countries.

Conclusion

Informal employment negatively impacts population health, which is modified by welfare state regimes. Addressing informal employment could be an effective way to improve population health in LAC. However, linkage with public health and labour market agendas will be necessary.

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