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Enrollment of research subjects through telemedicine networks in a multicenter acute intracerebral hemorrhage clinical trial: design and methods.

ABSTRACT: BACKGROUND:Enrollment of subjects in acute stroke trials is often hindered by narrow timeframes, because a large proportion of patients arrive via transfers from outside facilities rather than primary arrival at the enrolling hospital. RATIONALE:Telemedicine networks have been increasingly used for provision of care for acute stroke patients at facilities outside of major academic centers. Treatment decisions made through telemedicine networks in patients with acute ischemic stroke have been shown to be safe, reliable, and effective. With the expanding use of this technology and the impediments to enrolling subjects into clinical trials, this approach can be applied successfully to the field of clinical research. METHODS AND CONCLUSIONS:The Antihypertensive Treatment of Acute Cerebral Hemorrhage II trial is a phase III randomized multicenter trial that has developed a protocol in collaboration with participating sites to implement the use of telemedicine networks for the enrollment of research subjects. The protocol describes the operating procedures and legal and Institutional Review Board perspectives for its implementation.

SUBMITTER: Alfredo Caceres J

PROVIDER: S-EPMC4188255 | biostudies-literature | 2014 Sep

REPOSITORIES: biostudies-literature

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Enrollment of research subjects through telemedicine networks in a multicenter acute intracerebral hemorrhage clinical trial: design and methods.

Alfredo Caceres J J Greer David M DM Goldstein Joshua N JN Viswanathan Anand A Suarez Jose I JI Brau Logan L Zacko Joseph Christopher JC Lowenkopf Theodore J TJ Miller Chad M CM Shah Qaisar A QA Chang Ira I Sen Souvik S Messe Steven R SR Chou Sherry H SH Qureshi Adnan I AI

Journal of vascular and interventional neurology 20140901 3

<h4>Background</h4>Enrollment of subjects in acute stroke trials is often hindered by narrow timeframes, because a large proportion of patients arrive via transfers from outside facilities rather than primary arrival at the enrolling hospital.<h4>Rationale</h4>Telemedicine networks have been increasingly used for provision of care for acute stroke patients at facilities outside of major academic centers. Treatment decisions made through telemedicine networks in patients with acute ischemic strok ...[more]

PMID: 25298858

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Project description:ObjectiveTelemedicine networks are beginning to provide an avenue for conducting emergency medicine research, but using telemedicine to recruit participants for clinical trials has not been validated. The goal of this consent study was to determine whether patient comprehension of telemedicine-enabled research informed consent is noninferior to standard face-to-face (F2F) research informed consent.MethodsA prospective, open-label randomized controlled trial was performed in a 60,000-visit Midwestern academic emergency department (ED) to test whether telemedicine-enabled research informed consent provided noninferior comprehension compared with standard consent. This study was conducted as part of a parent clinical trial evaluating the effectiveness of 0.12% oral chlorhexidine gluconate in preventing hospital-acquired pneumonia among adult ED patients with expected hospital admission. Prior to being recruited into the study, potential participants were randomized in a 1:1 allocation ratio to consent by telemedicine versus standard F2F consent. Telemedicine connectivity was provided using a commercially available interface (REACH platform, Vidyo Inc.) to an emergency physician located in another part of the ED. Comprehension of research consent (primary outcome) was measured using the modified quality of informed consent (QuIC) instrument, a validated tool for measuring research informed consent comprehension. Parent trial accrual rate and qualitative survey data were secondary outcomes.ResultsA total of 131 patients were randomized (n = 64, telemedicine), and 101 QuIC surveys were completed. Comprehension of research informed consent using telemedicine was not inferior to F2F consent (QuIC scores 74.4 ± 8.1 vs. 74.4 ± 6.9 on a 100-point scale, p = 0.999). Subjective understanding of consent (p = 0.194) and parent trial study accrual rates (56% vs. 69%, p = 0.142) were similar.ConclusionTelemedicine is noninferior to F2F consent for delivering research informed consent, with no detected differences in comprehension and patient-reported understanding. This consent study will inform design of future telemedicine-enabled clinical trials.

Project description:BACKGROUND:In most emergency situations or severe illness, patients are unable to consent for clinical trial enrollment. In such circumstances, the decision about whether to participate in a scientific study or not is made by a legally designated representative. OBJECTIVE:To address the willingness of patients admitted to the intensive care unit (ICU) to be enrolled in a scientific study as volunteers, and to assess the agreement between patients' and their legal representatives' opinion concerning enrollment in a scientific study. METHODS:This survey was conducted in two hospitals in São Paulo, Brazil. Patients (≥18 years) with preserved cognitive functions accompanied by a surrogate admitted to the ICU were eligible for this study. A survey containing 28 questions for patients and 8 questions for surrogates was applied within the first 48h from ICU admission. The survey for patients comprised three sections: demographic characteristics, opinion about participation in clinical research and knowledge about the importance of research. The survey for legal representatives contained two sections: demographic characteristics and assessment of legal representatives' opinion in authorizing patients to be enrolled in research. RESULTS:Between January 2017 and May 2018, 208 pairs of ICU patients and their respective legal representatives answered the survey. Out of 208 ICU patients answering the survey, 73.6% (153/208) were willing to be enrolled in the study as volunteers. Of those patients, 65.1% (97/149) would continue participating in a research even if their legal representative did not support their enrollment. Agreement between patients' and surrogates' opinion concerning participation was poor [Kappa = 0.11 (IC95% -0.02 to 0.25)]. If a consent for study participation had been obtained, 69.1% (103/149) of patients would continue participating in the study until its conclusion, and 23.5% (35/149) would allow researchers to use data collected to date, but would withdraw from the study on that occasion. CONCLUSION:The majority of patients admitted to the ICU were willing to be enrolled in a scientific study as volunteers, also after a deferred informed consent procedure has been used. Nevertheless, contradictory opinions between patients and their and their legal representatives' concerning enrollment in a scientific study were often observed.

Project description:Objectives: Hemorrhage expansion (HE) is a common and serious condition in patients with intracerebral hemorrhage (ICH). In contrast to the volume changes, little is known about the morphological changes that occur during HE. We developed a novel method to explore the patterns of morphological change and investigate the clinical significance of this change in ICH patients. Methods: The morphological changes in the hematomas of ICH patients with available paired non-contrast CT data were described in quantitative terms, including the diameters of each hematoma in three dimensions, the longitudinal axis type, the surface regularity (SR) index, the length and direction changes of the diameters, and the distance and direction of movement of the center of the hematoma. The patterns were explored by descriptive analysis and difference analysis in subgroups. We also established a prognostic nomogram model for poor outcomes in ICH patients using both morphological changes and clinical parameters. Results: A total of 1,094 eligible patients from four medical centers met the inclusion criteria. In 266 (24.3%) cases, the hematomas enlarged; the median absolute increase in volume was 14.0 [interquartile range (IQR), 17.9] mL. The initial hematomas tended to have a more irregular shape, reflected by a larger surface regularity index, than the developed hematomas. In subtentorial and deep supratentorial hematomas, the center moved in the direction of gravity. The distance of center movement and the length changes of the diameters were small, with median values of less than 4 mm. The most common longitudinal axis type was anterior-posterior (64.7%), and the axis type did not change between initial and repeat imaging in most patients (95.2%). A prognostic nomogram model including lateral expansion, a parameter of morphological change, showed good performance in predicting poor clinical outcomes in ICH patients. Conclusions: The present study provides a morphological perspective on HE using a novel automatic approach. We identified certain patterns of morphological change in HE, and we believe that some morphological change parameters could help physicians predict the prognosis of ICH patients.

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Enrollment of research subjects through telemedicine networks in a multicenter acute intracerebral hemorrhage clinical trial: design and methods.

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Enrollment of research subjects through telemedicine networks in a multicenter acute intracerebral hemorrhage clinical trial: design and methods.

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