Can we achieve better recruitment by providing better information? : Meta-analysis of 'studies within a trial' (SWATs) of optimised participant information sheets

BACKGROUND: The information given to people considering taking part in a trial needs to be easy to understand if those people are to become, and then remain, trial participants. However, there is a tension between providing comprehensive information and providing information that is comprehensible. User-testing is one method of developing better participant information, and there is evidence that user-tested information is better at informing participants about key issues relating to trials. However, it is not clear if user-testing also leads to changes in the rates of recruitment in trials, compared to standard trial information. As part of a programme of research, we embedded 'studies within a trial' (SWATs) across multiple ongoing trials to see if user-tested materials led to better rates of recruitment. METHODS: Seven 'host' trials included a SWAT evaluation and randomised their participants to receive routine information sheets generated by the research teams, or information sheets optimised through user-testing. We collected data on trial recruitment and analysed the results across these trials using random effects meta-analysis, with the primary outcome defined as the proportion of participants randomised in a host trial following an invitation to take part. RESULTS: Six SWATs (n=27,805) provided data on recruitment. Optimised participant information sheets likely result in little or no difference in recruitment rates (7.2% versus 6.8%, pooled odds ratio = 1.03, 95% CI 0.90 to 1.19, p-value = 0.63, I2 = 0%). CONCLUSIONS: Participant information sheets developed through user testing did not improve recruitment rates. The programme of work showed that co-ordinated testing of recruitment strategies using SWATs is feasible and can provide both definitive and timely evidence on the effectiveness of recruitment strategies. TRIAL REGISTRATION: Healthlines Depression (ISRCTN14172341) Healthlines CVD (ISRCTN27508731) CASPER (ISRCTN02202951) ISDR (ISRCTN87561257) ECLS (NCT01925625) REFORM (ISRCTN68240461) HeLP Diabetes (ISRCTN02123133)

Impact of COVID-19 on cardiovascular testing in the United States versus the rest of the world

Objectives: This study sought to quantify and compare the decline in volumes of cardiovascular procedures between the United States and non-US institutions during the early phase of the coronavirus disease-2019 (COVID-19) pandemic. Background: The COVID-19 pandemic has disrupted the care of many non-COVID-19 illnesses. Reductions in diagnostic cardiovascular testing around the world have led to concerns over the implications of reduced testing for cardiovascular disease (CVD) morbidity and mortality. Methods: Data were submitted to the INCAPS-COVID (International Atomic Energy Agency Non-Invasive Cardiology Protocols Study of COVID-19), a multinational registry comprising 909 institutions in 108 countries (including 155 facilities in 40 U.S. states), assessing the impact of the COVID-19 pandemic on volumes of diagnostic cardiovascular procedures. Data were obtained for April 2020 and compared with volumes of baseline procedures from March 2019. We compared laboratory characteristics, practices, and procedure volumes between U.S. and non-U.S. facilities and between U.S. geographic regions and identified factors associated with volume reduction in the United States. Results: Reductions in the volumes of procedures in the United States were similar to those in non-U.S. facilities (68% vs. 63%, respectively; p = 0.237), although U.S. facilities reported greater reductions in invasive coronary angiography (69% vs. 53%, respectively; p < 0.001). Significantly more U.S. facilities reported increased use of telehealth and patient screening measures than non-U.S. facilities, such as temperature checks, symptom screenings, and COVID-19 testing. Reductions in volumes of procedures differed between U.S. regions, with larger declines observed in the Northeast (76%) and Midwest (74%) than in the South (62%) and West (44%). Prevalence of COVID-19, staff redeployments, outpatient centers, and urban centers were associated with greater reductions in volume in U.S. facilities in a multivariable analysis. Conclusions: We observed marked reductions in U.S. cardiovascular testing in the early phase of the pandemic and significant variability between U.S. regions. The association between reductions of volumes and COVID-19 prevalence in the United States highlighted the need for proactive efforts to maintain access to cardiovascular testing in areas most affected by outbreaks of COVID-19 infection

FOOD CONSUMPTION AND NUTRITION DIVISION April 2005 FCND Discussion Paper 191 Program Participation under Means-Testing and Self-Selection Targeting Methods

www.ifpri.org IFPRI Division Discussion Papers contain preliminary material and research results. They have not been subject to formal external reviews by IFPRI’s Publications Review Committee, but have been reviewed by at least one internal or external researcher. They are circulated in order to stimulate discussion and critical comment

Expanding the Boundaries of Boundary Dispute Settlement: International Law and Critical Geography at the Crossroads

This Article identifies a new trend in the adjudication of international boundary disputes and examines it from a historical and normative perspective. For many years, the resolution of international land boundary disputes was governed exclusively by the principle of the stability and continuity of boundaries. Under this paradigm, the main role of international adjudicators was to determine the exact location of historical boundary lines that had been set forth in colonial-era treaties or decrees. Once these lines were ascertained, they were strictly enforced, and any attempt to challenge them was dismissed. In recent years, however, international adjudicators have been increasingly inclined to deviate from historical boundaries in order to promote human-oriented goals such as the protection of borderland populations or the bolstering of peace efforts. After demonstrating this development in several cases, the Article evaluates its normative implications. For that purpose, the Article turns to Critical Border Studies (CBS), an emerging field within political geography that critically explores the sources, functions, and effects of borders. CBS sheds light on the power asymmetries that underlie the traditional paradigm and points to the need to adopt a more dynamic and equitable approach to boundary delineation. Drawing on CBS insights, as well as on recent boundary jurisprudence, the Article maps out several types of human-oriented considerations that international adjudicators should take into account when deciding boundary disputes and examines ways to balance them with the principle of the stability of boundaries. Beyond its contribution to the study and development of international boundary law, this Article demonstrates the broader potential of marrying international law with critical geography, which has, so far, mostly been overlooked