Browsing by Author "Thabane, Lehana"

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    A cluster randomised trial of a classroom communication resource program to change peer attitudes towards children who stutter among grade 7 students
    (BioMed Central, 2018-11-29) Mallick, Rizwana; Kathard, Harsha; Borhan, A. S M; Pillay, Mershen; Thabane, Lehana
    Abstract Background Classroom-based stuttering intervention addressing negative peer attitudes, perceptions, teasing and bullying of children who stutter (CWS) is required as part of holistic stuttering management because of its occurrence in primary school. This study was conducted in 2017, in 10 primary schools in the Western Cape, South Africa within lower (second and third) and higher (fourth and fifth) quintiles. Objectives The primary objective of this study was to determine treatment effect at six months after intervention of grade 7 participants (Classroom Communication Resource [CCR] intervention versus no CCR) using global Stuttering Resource Outcomes Measure (SROM) scores in school clusters. The secondary objective was to determine grade 7 participant treatment effect on the SROM subscales including Positive Social Distance (PSD), Social Pressure (SP) and Verbal Interaction (VI). The subgroup objective was to determine any difference in the primary outcome between schools between and across quintile clusters (lower and higher). Methods Once schools were stratified into lower and higher quintile (which are defined according to geographical location, fee per school and resources) subgroup clusters, schools were assigned randomly to control and intervention groups consisting of grade 7 participants who were typically aged ≥ 11 years. Teachers received 1 h of training before administering the single-dose CCR intervention over a 60–90-min session. The CCR intervention included a social story, role-play and discussion. All participants viewed a video of a CWS and stuttering was defined at baseline. The SROM measured peer attitudes at six months after intervention. Randomisation was stratified by quintile group using a 1:1 allocation ratio. Full blinding was not possible; however, the outcome assessor was partially blinded and the analyst was also blinded. Generalised estimating equations (GEE) was used assuming an exchangeable correlation structure to analyse the data adopting an intention-to-treat principle. Multiple imputation was used to handle missing data. Criterion for statistical significance was set at alpha = 0.05. Results Ten schools were randomly allocated to control (k = 5) and intervention groups (k = 5), with n = 223 participants allocated to intervention and n = 231 to control groups. A total of 454 participants completed the SROMs in control (n = 231) and intervention (n = 223) groups and were analysed at baseline and six months after intervention. There was no statistically significant difference on the global SROM score (mean difference − 0.11; 95% confidence interval [CI] − 1.56–1.34; p = 0.88). There were also no significant differences on SROM subscales: PSD (mean difference 1.04; 95% CI − 1.02–311; p = 0.32), SP (mean difference − 0.45; 95% CI − 1.22–0.26; p = 0.21) and VI (mean difference 0.05; 95% CI − 1.01–1.11; p = 0.93). Additionally, there was no significant subgroup effect on the global SROM score (lower versus higher quintile subgroups) (interaction p value = 0.52). No harms were noted or reported. Conclusion No statistically significant differences were noted. It is possible that the time frame was too short to note changes in peer attitudes and that further study is required to confirm the findings of this study. Trial registration Clinicaltrials.gov, NCT03111524 . Registered on 9 March 2017.
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    Advancing global health through cardiovascular research, mentorship, and capacity building: in memoriam, professor Bongani Mayosi (1967–2018)
    (BioMed Central, 2018-10-03) Nachega, Jean B; Ntsekhe, Mpiko; Volmink, Jimmy; Thabane, Lehana
    We are deeply saddened by the passing of Professor Bongani Mayosi. Bongani was one of the inaugural board members of Pilot and Feasibility Studies. He contributed greatly to the design and conduct of pilot and feasibility studies in cardiovascular research. Before his untimely death on Friday, July 27, 2018, he rose rapidly through the ranks to become a top cardiologist and one of the premier medical researchers in South Africa, Africa and the World Born in Mthatha, Eastern Cape Province on January 28, 1967, Bongani Mawethu Mayosi followed in his father’s footsteps to become a doctor. He trained at the now Nelson R. Mandela School of Medicine at University of KwaZulu-Natal, where he received his M.B., Ch.B. (Cum Laude) in 1989 and also met his wife, Professor and Head of Dermatology, Nonhlanhla Khumalo, in their first week of medical school. In 1990, the pair made their way to Port Elizabeth to work at the Livingstone Hospital as interns, before moving to Cape Town to establish long-term careers. After completing his specialist training in internal medicine and cardiology at the University of Cape Town (UCT), Professor Mayosi moved to Oxford University, UK, on a prestigious Nuffield Medical Fellowship where he completed a D.Phil. in cardiovascular genetics at the Wellcome Trust Centre for Human Genetics.
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    Quality of pilot trial abstracts in heart failure is suboptimal: a systematic survey
    (BioMed Central, 2018-05-31) Isiguzo, Godsent C; Zunza, Moleen; Chirehwa, Maxwell; Mayosi, Bongani M; Thabane, Lehana
    Background: Pilot trials are miniature researches carried out with the sole aim of acting as the precursor for larger more definitive studies. Abstracts are used to summarize and introduce the findings to the reading audience. There is substantive empirical evidence showing that abstracts, despite their important roles, are not informative enough, lacking the necessary details. This systematic survey was designed to assess the quality of reporting of heart failure pilot trial abstracts. The quality of reporting was defined as the completeness of reporting based on adherence to the CONSORT extension for reporting of pilot trial abstracts. We also identified factors associated with reporting quality. Methods: We searched MEDLINE (PubMed), Cochrane Controlled Trials Register, Scopus, and African-wide information databases for abstracts from heart failure pilot trials in humans published from 1 January 1990 to 30 November 2016. These were assessed to determine the extent of adherence to CONSORT extension checklist for reporting of abstracts of pilot trials. We screened identified studies for inclusion based on title and abstract. Data were independently extracted by two reviewers using the checklist. We used regression analysis to assess the association between completeness of reporting (measured as the number of items in the CONSORT extension checklist for reporting of abstracts in pilot trials contained in each abstract) and factors influencing the quality of the reports. Results: Two hundred and twenty-eight (228) articles were retrieved, of which 92 met the inclusion criteria. The mean CONSORT extension score was 8.3/16 (standard deviation 1.7); the least reported items were the source of funding (1% [1/92]), trial registration (13% [12/92]), randomization sequence (13% [12/92]), number randomized to each arm (16% [15/92]), and number analyzed in each arm (16% [15/92]). Multivariable regression analysis showed that pharmacological intervention pilot trials [incidence rate ratio (IRR) = 0.88; 95% confidence interval (CI), 0.81–0.97] were significantly associated with better reporting. Other factors such as structured abstract (IRR = 1.10; 95% CI, 0.99–1.23) and CONSORT endorsement (IRR = 1.10; 95% CI, 0.99–1.23) only showed minimal relationship with better reporting quality. Conclusion: The quality of reporting of abstracts of heart failure pilot trials was suboptimal. Pharmacological intervention was significantly associated with better reporting. These findings are consistent with previous research on reporting of trials.
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    The Classroom Communication Resource (CCR) intervention to change grade 7 peers' attitudes towards children who stutter (CWS) in the Western Cape: a randomised controlled trial
    (2018) Mallick, Rizwana; Kathard, Harsha; Thabane, Lehana
    Background: There is an established need to manage teasing and bullying of children who stutter (CWS) through changing the attitudes of their peers. The intervention, the Classroom Communication Resource (CCR), was implemented by teachers in classrooms. The primary objective of the main study was to determine the effectiveness of the CCR through a cluster Randomised Controlled Trial (RCT). The secondary objective of this study was to determine the treatment effect of the Stuttering Resource Outcomes Measure (SROM) within the subscales of Positive Social Distance (PSD), Social Pressure (SP) and Verbal Interaction (VI). The subgroup objective was to determine the primary objective between and across lower and higher school quintile clusters. Method: A cluster RCT was conducted. Participants in grade 7, aged 11 years and older, were randomly assigned to control and intervention groups using school and subgroup (quintile) clusters classifications. Following randomisation, stratification took place using a 1:1 allocation ratio. Participants viewed a video of a child who stuttered at baseline. Teachers administered the CCR (social story, role-play, discussion) in intervention groups only over a 60-90 minute session after they received an hour of training. Peer attitudes were measured at baseline and at 6 months post-intervention using the SROM in intervention and control groups. Results: A total of 10 schools were included whereby they were randomly allocated to control (k=5) and intervention groups (k=5). Within the schools, 454 participants were included with n =223 participants in the intervention and n= 231 in the control group. The study showed no statistically significant difference on the global SROM score (mean difference: -0.11 [95% confidence interval: -1.56, 1.34]; p = 0.88). Similarly, no significant differences were noted on SROM subscales: PSD (1.04 [-1.02,311]; p =0.32), SP (-0.45 [-1.22, 0.26]; p=0.21) and VI (0.05 [-1.01, 1.11]; 0.93), the secondary objective of this study. No significant subgroup effect on the global SROM score (lower vs higher quintile subgroups) [interaction p-value = 0.52] was observed during subgroup analysis. Results were however consistent with the hypothesis and quintile subgroups behaved similarly. Results were found clinically important when considering confidence intervals as well as the magnitude and direction of treatment effect. Conclusion: While the treatment effect showed no statistically significant differences on the global SROM and within the constructs of PSD, SP and VI, a clinically important result was noted when evaluating the meaningfulness of this study as well as its implications. Subgroup analysis showed that the quintiles behaved similarly, showing that the CCR was appropriate for schools within the lower and higher quintiles.
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    The Classroom Communication Resource (CCR) intervention to change peer’s attitudes towards children who stutter (CWS): study protocol for a randomised controlled trial
    (BioMed Central, 2018-01-17) Mallick, Rizwana; Kathard, Harsha; Thabane, Lehana; Pillay, Mershen
    Background: Children who stutter (CWS) are at a high-risk of being teased and bullied in primary school because of negative peer attitudes and perceptions towards stuttering. There is little evidence to determine if classroom-based interventions are effective in changing peer attitudes towards stuttering. The primary objective is to determine the effect of the Classroom Communication Resource (CCR) intervention versus usual practice, measured using the Stuttering Resource Outcomes Measure (SROM) 6-months post-intervention among grade 7 students. The secondary objective is to investigate attitude changes towards stuttering among grade participants on the SROM subscales. Methods: A cluster randomised controlled trial (RCT) will be conducted with schools as the unit of randomization. Schools will be stratified into quintile groups, and then randomized to receive the CCR intervention or usual practice. Quintile stratification will be conducted in accordance to the Western Cape Department of Education classification of schools according to geographical location, fee per school and allocation of resources and funding. Participants will include primary schools in the lower (second and third) and higher (fourth and fifth) quintiles and children aged 11 years or older in grade 7 will be included. The study will consist of the CCR intervention program or usual practice as a no-CCR control. The CCR is a classroom-based, teacher led intervention tool including a story, role-play and discussion. The grade 7 teachers allocated to the CCR intervention, will be trained and will administer the intervention. The analysis will follow intention-to-treat (ITT) principle and generalized estimating equations (GEE) to compare groups on the global SROM and its subscales to account for possible clustering within schools. The subgroup hypothesis will be tested by adding an interaction term of quintile group x intervention. Discussion: This study is designed to assess whether the CCR intervention versus usual practice in schools will lead to positive shift in attitudes about stuttering at 6-months post-intervention among grade 7 participants. Trial registration: The trial number is NCT03111524. It was registered with clinical trials.gov Protocol registration and results system (PRS) retrospectively on 9 March 2017.
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    The role and essence of pilot trials and subgroup analysis in cardiovascular research: the IMPI trial experience
    (2019) Isiguzo, Godsent Chichebem; Ntsekhe, Mpiko; Thabane, Lehana; Sliwa, Karen; Gumedze, Freedom
    Background Randomised control trials (RCTs) are capital-intensive projects and demand substantial human and capital resources. Therefore, proper planning, precise research questions and adequate thoughts are required in areas such as acceptability of the intervention, participant recruitment, and selection of measurable outcomes. Ensuring all these are possible before delving into the main work can be forecasted through pilot trials. They help in determining the feasibility of the intended critical endpoints and ensure the applicability of the result findings. However, no matter how noble and vital the results are, improper reporting can make them unusable. The thesis brings to the fore the importance of pilot trials in low- and medium-income countries and how they can help make a case for more extensive definitive trials. It then focuses on how subgroup analysis can be used as an essential statistical tool for fully understanding clinical trial results and can be used to unearth non-apparent results in RCT. In the thesis, we highlight the need for accurate, systematic and complete reporting of pilot trials, by critically appraising the literature on abstract reporting in heart failure. The thesis discusses several aspects of pilot trial processes to understand better its unique role in helping refine the components of RCT, to make the running smooth and findings affirmative. Leveraging on the experience of working as a clinical research fellow in the second Investigation for Management of Pericarditis in Africa (IMPI-2) trial, the lessons learnt in planning, designing, implementation, recruitment and reporting of the IMPI-2 pilot forms the nucleus of this thesis. The experience acquired in the process and how they can help in planning future definitive studies are discussed in different sections of the thesis. Methodology The thesis uses the experience gained in critical appraisal of the literature, participation in preliminary planning and active participation in a multicentre randomised control trial to understand the importance of some issues during an RCT. These areas include the need for specific objective setting, identification of research participants and collaborators, the acceptability of research intervention, proper identification of possible outcome measures, retention of participants and quality reporting of research findings. It begins with an overview of pilot trials, subgroup analysis and tuberculous pericarditis which is the primary disease focus of the IMPI project. Each subsequent chapter of the thesis is presented either as a published manuscript or prepared for submission as a manuscript. The quality of reporting of pilot trials is then examined by systematically surveying the reporting of abstracts of pilot trials in heart failure using the checklist of the Consolidated standard for reporting of trials (CONSORT) extension for pilot trials. A subgroup analysis of IMPI-1 trial planned a priori on the modification of the effect of prednisolone by baseline pericardiocentesis status of trial participants is used to highlight the role subgroup analysis can play in unmasking the group effect in the randomised control trial. The thesis then goes on to present the preliminary report of the IMPI-2 pilot study, highlighting the lessons learned and aspirations in need of refining. Retention of study participants is essential to achieve success in clinical trials, one way of ensuring this is by letting the study participants understand the objectives and processes of the research and gaining their confidence. Thus, in chapter six, we piloted the use of the University of California San Diego Brief Assessment of Capacity to Consent (UBACC), a screening tool for evaluation of informed consent (IC) comprehension as a training tool for iterative learning and evaluation of consent comprehension among IMPI-2 pilot trial participants. Results and Conclusion Enormous resources expended in clinical research can yield good returns before the main work commences, a well-planned micro trial run in the form of a pilot study is undertaken. Our systematic survey of abstracts of pilot trials in heart failure showed that reporting of abstracts of pilot trials is currently suboptimal. Deciding ahead of time on what to report by systematically identifying the different sections needed to inform the audience can improve the quality adequately. Planning subgroup analysis during the design of main studies can help reveal unsuspected findings. The subgroup analysis result showed that pericardiocentesis, despite its essential use among patients with pericardial effusion, did not significantly influence the effect of prednisolone on the primary critical outcomes among IMPI-1 participants. The preliminary report of IMPI-2 trial was designed as a two-phase study; phase 1 results showed that at 50mg, intrapericardial alteplase was safe in facilitating complete pericardiocentesis, while phase two showed that it was feasible to recruit, randomised and follow up patients in line with the study protocol. However, we identified participant retention as a considerable challenge. The result of the pilot revealed that more effort should be expended on participants’ education on the clinical condition, the reason for the trial and the need for follow-up adherence. There is also a need to make adequate provision for the use of field workers for contact tracing to reduce the dropout rate. In the main trial protocol, there may also be a need to reconsider the patient's selection and use of fibrinolysis in malignant effusion, judging from the high rate of 3 months mortality in this group of patients. The results of the informed consent study showed that an improved level of comprehension followed the use of iterative learning, a higher level of education and non-use of interpreters during informed consent delivery. These finding led us to conclude that every effort should be made to ensure that research participants entirely buy into the research they are asked to be part of through thorough information delivery. Doing so can help improve participants adherence to the trial follow-up.