Evaluation of an alternative informed consent procedure for clinical trials conducted in The Gambia

Background: Comprehension of informed consent poses greater challenges to clinical trial participants in The Gambia because of low literacy and absence of standardised formats for writing the local languages. This thesis reports the development and evaluation of a locally developed informed consent tool that addresses these challenges. Objectives: 1. Develop and validate an audio digitised tool for assessment of comprehension of informed consent. 2. Develop a multimedia consent tool for Gambian research participants. 3. Evaluate acceptability and ease of use of the multimedia tool. 4. Assess the effectiveness of the multimedia tool compared to ‘standard’ consent among participants in a clinical trial. Methods: A 34-item questionnaire was developed and audio-recorded in three major Gambian languages. This was digitised and validated among clinical trial participants in Gambian urban and rural areas. The informed consent document of a malaria drug trial was developed into a multimedia tool which integrated video, animations and audio narrations in three major Gambian languages. Acceptability and ease of use of the tool were assessed using quantitative and qualitative methods. Participants in the drug trial were randomised to either receive consent information through the multimedia tool or ‘standard’ procedure. Participant comprehension was assessed using the digitised questionnaire at baseline and follow-up visits. Results: The questionnaire was deemed to be valid and reliable (Cronbach’s alpha: 0.73- 0.79). Majority of the participants (70%) reported that the multimedia tool was clear and easy to understand. Participants in the intervention arm had significantly higher comprehension scores than those in the control arm at baseline and follow-up visits. Higher comprehension scores were associated with being a male participant (p=0.03), resident in a peri-urban area (p=0.02) and having basic formal education (p=0.005). Male participants (OR = 0.29, 95% CI: 0.12-0.70, p=0.006) and living in a peri-urban area (OR= 0.33, 95% CI: 0.13-0.82, p=0.017) were independent predictors of comprehension. Survival analysis showed that participants in the intervention arm took longer time to drop to 50% of the baseline comprehension scores than those in the control arm (hazard ratio=0.22, 95% CI: 0.16-0.31). Conclusions: A customised multimedia tool was more effective in delivering consent information and sustaining participant comprehension than ‘standard’ consent procedure. Further research is needed to compare the tool with conventional consent method in other sub-Saharan Africa settings

Developing a survey instrument to evaluate tertiary chemistry students' attitudes and learning experiences

New Zealand tertiary institutions, like others worldwide, have experienced a decline in science and chemistry enrolments in recent times as students seek other career paths that they perceive to be more lucrative. In a previous article we described a qualitative study of the learning experiences of students enrolled in a first year chemistry course at a New Zealand tertiary institution. Researchers in education and science education have two choices of methodology, a qualitative or a quantitative approach, and each possesses advantages and disadvantages. Qualitative studies typically use resource intensive data gathering techniques such as interviews. These studies are useful in that they allow researchers to study issues of interest in great depth and, for example, allow investigators to probe for underlying reasons about students' views for abstract scientific concepts. However, because qualitative studies are more labour intensive, they typically involve only small numbers of participants, which in the minds of many researchers and teachers results in a lack of generalisability. In other words, it is not necessarily clear what implications the findings hold in other contexts. In contrast, quantitative studies involve larger numbers of participants. By the judicious use of statistical analysis, researchers can investigate changes and trends, and extrapolate their findings to a large (or target) population. However, whilst the results from quantitative studies are more generalisable, they are often less detailed. Hence researchers are confronted with a trade-off situation in which they must choose between the depth of understanding provided from qualitative studies, versus the generalisability of a quantitative approach: because of this dilemma, increasingly researchers employ a mixed methodology approach. In this paper we describe a quantitative study that complements previous qualitative work. We report on the development of a questionnaire that investigates tertiary level learning experiences of chemistry students, along with their attitude toward chemistry and chemistry self-efficacy

The validity of the Youth Physical Activity Questionnaire in 12-13 year old Scottish adolescents

Background: The development of accurate methods to measure health-behaviours forms an integral component in behavioural epidemiology. Population surveillance of physical activity often relies on self/proxy reported questionnaires due to cost and relative ease of administration. The aim of this study was to examine the criterion validity and measurement agreement between the Youth Physical Activity Questionnaire (YPAQ) and accelerometry before being included in a Scotland-wide study. Methods: Forty four participants (12–13 years old; 61% girls) completed the YPAQ following 7 days wearing the Actigraph GT3X+. Mean moderate-to-vigorous physical activity (MVPA) per day was derived from YPAQ and accelerometer and validity was assessed using Spearman's correlation; Bland-Altman plots examined absolute agreement between methods. Results: Pearson's and Spearman’s correlations between YPAQ and accelerometer were r = 0.47 and rs = 0.39 (p<0.01) respectively. The YPAQ over reported mean MVPA by 25.6 ± 50.2 minutes (95% CI 10.4-40.9 minutes; p <0.001), with 95% limits of agreement of −72.69 minutes and + 123.99 minutes. Evidence of underreporting at lower levels of activity and over reporting at higher levels of activity was evident (Pearson's r=0.81), in addition to heteroscedasticity, where variances increased as MVPA increased. Conclusions: Although a moderate correlation between the two methods was apparent, the YPAQ should not be used interchangeably with accelerometry. The YPAQ does demonstrate a reasonable ability to rank MVPA, although it tends to under-report lower levels and over-report higher levels. This, and other administering factors, should be taken into consideration if being used for group or individual level analyses

A pragmatic randomized trial comparing tablet computer informed consent to traditional paper-based methods for an osteoporosis study

AbstractObjectiveMethods to improve informed consent efficiency and effectiveness are needed for pragmatic clinical trials. We compared informed consent using a tablet computer to a paper approach to assess comprehension and satisfaction of patients and clinic staff for a future osteoporosis clinical trial.MethodsNine community-based practices identified and recruited patients to compare the informed consent processes (tablet vs. paper) in a mock osteoporosis clinical trial. The tablet informed consent included an animation summarizing the trial, complete informed consent document, and questions to assess and reinforce comprehension of the study. Participants were women age ≥55 years with ≥1 year of alendronate use. We surveyed participants to assess comprehension and satisfaction and office staff for satisfaction and perceived time demands.ResultsThe nine practices enrolled 33 participants. There was not a significant difference in comprehension between the tablet vs. paper informed consent [mean (SD) tablet: 12.2 (1.0) vs. paper: 11.4 (1.7)]. Office staff preferred the tablet to the paper informed consent for identifying potential study participants (two-sided t-test p = 0.02) despite an increased perceived time spent to complete the tablet process [tablet: 28.3 min (SD 16.3) vs. paper: 19.0 min (SD 6.9); p = 0.08].ConclusionsAlthough, there were no significant differences in participant satisfaction and comprehension with the tablet informed consent compared to a paper informed consent, patients and office staff trended towards greater satisfaction with the tablet informed consent. Larger studies are needed to further evaluate the utility of electronic informed consent in pragmatic clinical trials

Permission form synopses to improve parents' understanding of research: a randomized trial.

ObjectiveWe hypothesized that, among parents of potential neonatal research subjects, an accompanying cover sheet added to the permission form (intervention) would increase understanding of the research, when compared to a standard form (control).Study designThis pilot study enrolled parents approached for one of two index studies: one randomized trial and one observational study. A one-page cover sheet described critical study information. Families were randomized 1:1 to receive the cover sheet or not. Objective and subjective understanding and satisfaction were measured.ResultsThirty-two parents completed all measures (17 control, 15 intervention). There were no differences in comprehension score (16.8±5.7 vs 16.3±3.5), subjective understanding (median 6 vs 6.5), or overall satisfaction with consent (median 7 vs 6.5) between control and intervention groups (all P>0.50).ConclusionA simplified permission form cover sheet had no effect on parents' understanding of studies for which their newborns were being recruited

Enrollers’ perceptions of communication during informed consent at a South African tuberculosis research site

The informed consent process (ICP) in clinical trials is an interaction of communication: one in which important information should be adequately conveyed by the enroller and sufficiently understood by the potential participant. However, barriers to effective communication are often encountered during the process and result in participants’ comprehension of information being compromised. This study aimed to use qualitative methods to explore the reported experiences of thirteen enrollers involved in the ICP pre- and post- the implementation of a communication training programme in a Human Immunodeficiency Virus (HIV) and tuberculosis (TB) research study in Rustenburg, South Africa. The communication training programme aimed to improve communication processes during the ICP and enhance participant comprehension of information. This study used journaling and FGDs as data collection methods. Inductive thematic analysis was used to explore the reported experiences of enrollers during the ICP, and to identify perceived barriers and facilitators to communication during these interactions. Findings revealed language-, procedure- and participant-related facilitators and barriers. Furthermore, communication and language strategies employed by enrollers to overcome reported barriers were discussed. Several strategies paralleled the communication and language skills taught during the communication skills training. Many of these strategies were found to facilitate communication processes within the enroller-participant interaction, improve understandings of the informed consent form (ICF) and obtain proper informed consent. These findings confirm that enrolment is a complex process impacted by many variables. Keywords: informed consent, communication, enrollers, clinical researchGR201

Lost in Translation: Assessing Effectiveness of Focus Group Questioning Techniques to Develop Improved Translation of Terminology Used in HIV Prevention Clinical Trials

Achieving participant comprehension has proven to be one of the most difficult, practical, and ethical challenges of HIV prevention clinical trials. It becomes even more challenging when local languages do not have equivalent scientific and technical vocabularies, rendering communication of scientific concepts in translated documents extremely difficult. Even when bilingual lexicons are developed, there is no guarantee that participants understand the terminology as translated

Comprehension of the Matrix Clause in Embedded Sentences in Agrammatic Aphasia: A Test of the Trace-Deletion Hypothesis

Prior research has demonstrated that persons with agrammatic aphasia present with characteristic deficits in the comprehension of semantically-reversible noncanonical sentences. The aim of this study is to replicate the work of Hickok and colleagues (1993) who evaluated Grodzinsky’s Trace Deletion Hypothesis (TDH). Participants included two persons with agrammatic aphasia and one control subject. Results suggest that the comprehension of the matrix clause was impaired for one participant with aphasia while the second participant with aphasia did not demonstrate any comprehension deficits for any sentence construction tested. Implications for treatment with individuals with agrammatic aphasia and linguistic theory are discussed

Participant comprehension and perspectives regarding the convenience, security, and satisfaction with teleconsent compared to in-person consent:A parallel-group pilot study among Danish citizens

BACKGROUND: Teleconsent via video conferencing enables decentralized trials with remote consent and has the additional benefit of allowing a real-time reaction to potential misunderstandings. However, participant acceptance of and satisfaction with teleconsent versus in-person consent processes are unknown. METHODS: We conducted a parallel-group pilot study to evaluate participant comprehension and perspectives regarding the convenience, security, and satisfaction with teleconsent compared to in-person consent among Danish citizens for a hypothetical research study. RESULTS: There were no statistically significant differences in perceptions of security or satisfaction between teleconsent and in-person consent arms. However, participants viewed teleconsent as more convenient than in-person consent, as no transportation was needed and the process was less time-consuming. Recruitment was also faster in the teleconsent arm, and more people dropped out of the in-person arm, citing difficulties with transportation and time. CONCLUSION: Decentralized clinical trials have been demonstrated to increase recruitment and enrollment rates, improve trial efficiency, and decrease dropout rates and trial delays. We add to this literature by suggesting that patients perceive teleconsent as similar to in-person consent, suggesting this is a feasible and acceptable substitution for in-person consent in multisite, decentralized trials. Future work should include patient perspectives from a larger, more diverse group of participants