SUNScholar - Browsing by Author "Mayosi, Bongani M."

Browsing by Author "Mayosi, Bongani M."

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An approach to the patient with suspected pericardial disease
(Health & Medical Publishing Group, 2016) Kyriakakis, Charles G.; Mayosi, Bongani M.; De Vries, Elma; Isaacs, Abdul; Doubell, Anton F.
ENGLISH ABSTRACT: Diseases of the pericardium commonly manifest in one of three ways: acute pericarditis, pericardial effusion and constrictive pericarditis. In the developed world, the most common cause of acute pericarditis is viral or idiopathic disease, while in the developing world tuberculous aetiology, particularly in sub-Saharan Africa, is commonplace owing to the high prevalence of HIV. This article provides an approach to the diagnosis, investigation and management of these patients.
Arrhythmogenic right ventricular cardiomyopathy type 6 (ARVC6) : support for the locus assignment, narrowing of the critical region and mutation screening of three candidate genes
(BioMed Central, 2006-03) Matolweni, Luzuko O.; Bardien, Soraya; Rebello, George; Oppon, Ekow; Munclinger, Miroslav; Ramesar, Rajkumar; Watkins, Hugh; Mayosi, Bongani M.
Background: Arrhythmogenic right ventricular cardiomyopathy (ARVC) is a heritable disorder characterized by progressive degeneration of right ventricular myocardium, arrhythmias and an increased risk of sudden death at a young age. By linkage analysis, ARVC type 6 was previously mapped to a 10.6 cM region on chromosome 10p12-p14 in a large North American kindred. To date, the genetic defect that causes ARVC6 has not been identified. Methods: We identified a South African family of 13 members with ARVC segregating as an autosomal dominant disorder. The diagnosis of ARVC was based on international diagnostic criteria. All available family members were genotyped with microsatellite markers at six known ARVC loci, and positional candidate gene screening was performed. Results: Genetic linkage and haplotype analysis provided lod scores that are highly suggestive of linkage to the ARVC6 locus on chromosome 10p12-p14, and the narrowing of the critical region to ~2.9 Mb. Two positional candidate genes (ITG8 and FRMD4A) were screened in which defects could possibly disrupt cell-cell adhesion. A non-positional candidate gene with apoptosis inducing properties, LAMR1P6 (laminin receptor 1 pseudogene 6) was also screened. Direct sequencing of DNA from affected individuals failed to detect disease-causing mutations in the exonic sequences of the three genes investigated. Conclusion: The narrowing of the ARVC6 critical region may facilitate progress towards the identification of the gene that is involved in ARVC. Identification of the causative genes for ARVC will contribute to the understanding of the pathogenesis and management of this poorly understood condition.
Burden of non-communicable diseases in sub-Saharan Africa, 1990–2017 : results from the Global Burden of Disease Study 2017
(Elsevier, 2019-10) Gouda, Hebe N.; Charlson, Fiona; Sorsdahl, Katherine; Ahmadzada, Sanam; Ferrari, Alize J.; Erskine, Holly; Leung, Janni; Santamauro, Damian; Lund, Crick; Aminde, Leopold Ndemnge; Mayosi, Bongani M.; Kengne, Andre Pascal; Harris, Meredith; Achoki, Tom; Wiysonge, Charles S.; Stein, Dan J.; Whiteford, Harvey
Background: Although the burden of disease in sub-Saharan Africa continues to be dominated by infectious diseases, countries in this region are undergoing a demographic transition leading to increasing prevalence of noncommunicable diseases (NCDs). To inform health system responses to these changing patterns of disease, we aimed to assess changes in the burden of NCDs in sub-Saharan Africa from 1990 to 2017. Methods: We used data from the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2017 to analyse the burden of NCDs in sub-Saharan Africa in terms of disability-adjusted life-years (DALYs)—with crude counts as well as all-age and age-standardised rates per 100000 population—with 95% uncertainty intervals (UIs). We examined changes in burden between 1990 and 2017, and differences across age, sex, and regions. We also compared the observed NCD burden across countries with the expected values based on a country’s Socio-demographic Index. Findings: All-age total DALYs due to NCDs increased by 67·0% between 1990 (90·6 million [95% UI 81·0–101·9]) and 2017 (151·3 million [133·4–171·8]), reflecting an increase in the proportion of total DALYs attributable to NCDs (from 18·6% [95% UI 17·1–20·4] to 29·8% [27·6–32·0] of the total burden). Although most of this increase can be explained by population growth and ageing, the age-standardised DALY rate (per 100000 population) due to NCDs in 2017 (21757·7 DALYs [95% UI 19 377·1–24380·7]) was almost equivalent to that of communicable, maternal, neonatal, and nutritional diseases (26491·6 DALYs [25165·2–28129·8]). Cardiovascular diseases were the second leading cause of NCD burden in 2017, resulting in 22·9 million (21·5–24·3) DALYs (15·1% of the total NCD burden), after the group of disorders categorised as other NCDs (28·8 million [25·1–33·0] DALYs, 19·1%). These categories were followed by neoplasms, mental disorders, and digestive diseases. Although crude DALY rates for all NCDs have decreased slightly across sub-Saharan Africa, age-standardised rates are on the rise in some countries (particularly those in southern sub-Saharan Africa) and for some NCDs (such as diabetes and some cancers, including breast and prostate cancer). Interpretation: NCDs in sub-Saharan Africa are posing an increasing challenge for health systems, which have to date largely focused on tackling infectious diseases and maternal, neonatal, and child deaths. To effectively address these changing needs, countries in sub-Saharan Africa require detailed epidemiological data on NCDs.
Clinical characteristics and initial management of patients with tuberculous pericarditis in the HIV era : the investigation of the management of Pericarditis in Africa (IMPI Africa) registry
(BioMed Central, 2006-01) Mayosi, Bongani M.; Wiysonge, Charles Shey; Ntsekhe, Mpiko; Volmink, Jimmy A.; Gumedze, Freedom; Maartens, Gary; Aje, Akinyemi; Thomas, Baby M.; Thomas, Kandathil M.; Awotedu, Abolade A.; Thembela, Bongani; Mntla, Phindile; Maritz [Late], Frans; Ngu Blackett, Kathleen; Nkouonlack, Duquesne C.; Burch, Vanessa C.; Rebe, Kevin; Parish, Andy; Sliwa, Karen; Vezi, Brian Z.; Alam, Nowshad; Brown, Basil G.; Gould, Trevor; Visser, Tim; Shey, Muki S.; Magula, Nombulelo P.; Commerford, Patrick J.
Background: The incidence of tuberculous pericarditis has increased in Africa as a result of the human immunodeficiency virus (HIV) epidemic. However, the effect of HIV co-infection on clinical features and prognosis in tuberculous pericarditis is not well characterised. We have used baseline data of the Investigation of the Management of Pericarditis in Africa (IMPI Africa) registry to assess the impact of HIV co-infection on clinical presentation, diagnostic evaluation, and treatment of patients with suspected tuberculous pericarditis in sub-Saharan Africa. Methods: Consecutive adult patients in 15 hospitals in three countries in sub-Saharan Africa were recruited on commencement of treatment for tuberculous pericarditis, following informed consent. We recorded demographic, clinical, diagnostic and therapeutic information at baseline, and have used the chi-square test and analysis of variance to assess probabilities of significant differences (in these variables) between groups defined by HIV status. Results: A total of 185 patients were enrolled from 01 March 2004 to 31 October 2004, 147 (79.5%) of whom had effusive, 28 (15.1%) effusive-constrictive, and 10 (5.4%) constrictive or acute dry pericarditis. Seventy-four (40%) had clinical features of HIV infection. Patients with clinical HIV disease were more likely to present with dyspnoea (odds ratio [OR] 3.2, 95% confidence interval [CI] 1.4 to 7.4, P = 0.005) and electrocardiographic features of myopericarditis (OR 2.8, 95% CI 1.1 to 6.9, P = 0.03). In addition to electrocardiographic features of myopericarditis, a positive HIV serological status was associated with greater cardiomegaly (OR 3.89, 95% CI 1.34 to 11.32, P = 0.01) and haemodynamic instability (OR 9.68, 95% CI 2.09 to 44.80, P = 0.0008). However, stage of pericardial disease at diagnosis and use of diagnostic tests were not related to clinical HIV status. Similar results were obtained for serological HIV status. Most patients were treated on clinical grounds, with microbiological evidence of tuberculosis obtained in only 13 (7.0%) patients. Adjunctive corticosteroids were used in 109 (58.9%) patients, with patients having clinical HIV disease less likely to be put on them (OR 0.37, 95% CI 0.20 to 0.68). Seven patients were on antiretroviral drugs. Conclusion Patients with suspected tuberculous pericarditis and HIV infection in Africa have greater evidence of myopericarditis, dyspnoea, and haemodynamic instability. These findings, if confirmed in other studies, may suggest more intensive management of the cardiac disease is warranted in patients with HIV-associated pericardial disease.
Developing the African national health research systems barometer
(BioMed Central, 2016-07-22) Kirigia, Joses Muthuri; Ota, Martin Okechukwu; Senkubuge, Flavia; Wiysonge, Charles Shey; Mayosi, Bongani M.
ENGLISH SUMMARY : Background: A functional national health research system (NHRS) is crucial in strengthening a country’s health system to promote, restore and maintain the health status of its population. Progress towards the goal of universal health coverage in the post-2015 sustainable development agenda will be difficult for African countries without strengthening of their NHRS to yield the required evidence for decision-making. This study aims to develop a barometer to facilitate monitoring of the development and performance of NHRSs in the African Region of WHO. Methods: The African national health research systems barometer algorithm was developed in response to a recommendation of the African Advisory Committee for Health Research and Development of WHO. Survey data collected from all the 47 Member States in the WHO African Region using a questionnaire were entered into an Excel spreadsheet and analysed. The barometer scores for each country were calculated and the performance interpreted according to a set of values ranging from 0% to 100%. Results: The overall NHRS barometer score for the African Region was 42%, which is below the average of 50%. Among the 47 countries, the average NHRS performance was less than 20% in 10 countries, 20–40% in 11 countries, 41–60% in 16 countries, 61–80% in nine countries, and over 80% in one country. The performance of NHRSs in 30 (64%) countries was below 50%. Conclusion: An African NHRS barometer with four functions and 17 sub-functions was developed to identify the gaps in and facilitate monitoring of NHRS development and performance. The NHRS scores for the individual sub-functions can guide policymakers to locate sources of poor performance and to design interventions to address them.
The efficacy and safety of complete pericardial drainage by means of intrapericardial fibrinolysis for the prevention of complications of pericardial effusion : a systematic review protocol
(BMJ Publishing Group, 2016) Kakia, Aloysious; Wiysonge, Charles S.; Ochodo, Eleanor A.; Awotedu, Abolade A.; Ristic, Arsen D.; Mayosi, Bongani M.
ENGLISH SUMMARY : Introduction: Intrapericardial fibrinolysis has been proposed as a means of preventing complications of pericardial effusion such as cardiac tamponade, persistent and recurrent pericardial effusion, and pericardial constriction. There is a need to understand the efficacy and safety of this procedure because it shows promise. Methods and analysis: We aim to assess the effects of intrapericardial fibrinolysis in the treatment of pericardial effusion. We will search PubMed, the Cochrane Library, African Journals online, Cumulative Index to Nursing and Allied Health Literature, Trip database, Clinical trials.gov and the WHO International Clinical Trials Registry Platform for studies that evaluate the efficacy and/or safety of complete pericardial fluid drainage by intrapericardial fibrinolysis irrespective of study design, geographical location, language, age of participants, aetiology of pericarditis or types of fibrinolytics. Two authors will do the search independently, screen the search outputs for potentially eligible studies and assess whether the studies meet the inclusion criteria. Discrepancies between the two authors will be resolved through discussion and arbitration by a third author. Data from the selected studies shall be extracted using a standardised data collection form which will be piloted before use. The methodological quality of studies will be assessed using the Cochrane Collaboration’s tools for assessing risk of bias for experimental studies and non-randomised studies, respectively. The primary meta- analysis will use random effects models due to expected interstudy heterogeneity. Dichotomous data will be analysed using relative risk and continuous with data mean differences, both with 95% CIs.
Health trends, inequalities and opportunities in South Africa’s provinces, 1990–2019 : findings from the Global Burden of Disease 2019 Study
(BMJ, 2022-01-19) Achoki, Tom; Sartorius, Benn; Watkins, David; Glenn, Scott D.; Kengne, Andre Pascal; Oni, Tolu; Wiysonge, Charles Shey; Walker, Alexandra; Adetokunboh, Olatunji O.; Babalola, Tesleem Kayode; Bolarinwa, Obasanjo Afolabi; Claassens, Mareli M.; Cowden, Richard G.; Day, Candy T.; Ezekannagha, Oluchi; Ginindza, Themba G.; Iwu, Chidozie C. D.; Iwu, Chinwe Juliana; Karangwa, Innocent; Katoto, Patrick D. M. C.; Kugbey, Nuworza; Kuupiel, Desmond; Mahasha, Phetole Walter; Mashamba-Thompson, Tivani Phosa; Mensah, George A.; Ndwandwe, Duduzule Edith; Nnaji, Chukwudi A.; Ntsekhe, Mpiko; Nyirenda, Thomas Elliot; Odhiambo, Julius Nyerere; Asante, Kwaku Oppong; Parry, Charles D. H.; Pillay, Julian David; Schutte, Aletta Elisabeth; Seedat, Soraya; Stein, Dan J.; Tanser, Frank C.; Useh, Ushotanefe; Zar, Heather J.; Zuhlke, Liesl J.; Mayosi, Bongani M.; Hay, Simon I.; Murray, Christopher J. L.; Naghavi, Moshen
Background: Over the last 30 years, South Africa has experienced four ‘colliding epidemics’ of HIV and tuberculosis, chronic illness and mental health, injury and violence, and maternal, neonatal, and child mortality, which have had substantial effects on health and well-being. Using data from the 2019 Global Burden of Diseases, Injuries and Risk Factors Study (GBD 2019), we evaluated national and provincial health trends and progress towards important Sustainable Development Goal targets from 1990 to 2019. Methods: We analysed GBD 2019 estimates of mortality, non-fatal health loss, summary health measures and risk factor burden, comparing trends over 1990–2007 and 2007–2019. Additionally, we decomposed changes in life expectancy by cause of death and assessed healthcare system performance. Results: Across the nine provinces, inequalities in mortality and life expectancy increased over 1990–2007, largely due to differences in HIV/AIDS, then decreased over 2007–2019. Demographic change and increases in non-communicable diseases nearly doubled the number of years lived with disability between 1990 and 2019. From 1990 to 2019, risk factor burdens generally shifted from communicable and nutritional disease risks to non-communicable disease and injury risks; unsafe sex remained the top risk factor. Despite widespread improvements in healthcare system performance, the greatest gains were generally in economically advantaged provinces. Conclusions: Reductions in HIV/AIDS and related conditions have led to improved health since 2007, though most provinces still lag in key areas. To achieve health targets, provincial governments should enhance health investments and exchange of knowledge, resources and best practices alongside populations that have been left behind, especially following the COVID-19 pandemic.
History of medicine : the Hamilton Naki Clinical Scholarship, 2007-2011
(Health and Medical Publishing Group (HMPG), 2012-01) Madiba, Thandinkosi E.; Awotedu, Abolade A.; Du Plessis, Dion; Nchabeleng, Maphoshane; Sathekge, Mike M.; Velaphi, Sithembiso C.; Volmink, Jimmy A.; Walubo, Andrew; Mayosi, Bongani M.
The Hamilton Naki Scholarship was introduced because of the shortage of qualified academic leaders in South African medical schools, especially for academic clinicians from previously disadvantaged backgrounds. There were only a handful of African academic doctors with a significant published record of scholarship in South Africa. If academic physicians from the whole population were not recruited and trained, South Africa would lose its ability to train high-quality health practitioners. To address these deficiencies, the Netcare Physician Partnerships Trust established a scholarship to produce world-class academics in all medical specialties to teach and conduct research comparable to other parts of the world.
HIV infection is associated with a lower incidence of constriction in presumed tuberculous pericarditis : a prospective observational study
(Public Library of Science (PLOS), 2008-04) Ntsekhe, Mpiko; Wiysonge, Charles S.; Gumedze, Freedom; Maartens, Gary; Commerford, Patrick J.; Volmink, Jimmy A.; Mayosi, Bongani M.
Background: Pericardial constriction is a serious complication of tuberculous pericardial effusion that occurs in up to a quarter of patients despite anti-tuberculosis chemotheraphy. The impact of human immunodeficiency virus (HIV) infection on the incidence of constrictive pericarditis following tuberculous pericardial effusion is unknown. Methods and Results: We conducted a prospective observational study to determine the association between HIV infection and the incidence of constrictive pericarditis among 185 patients (median age 33 years) with suspected tuberculous pericardial effusion. These patients were recruited consecutively between March and October 2004 on commencement of anti-tuberculosis treatment, from 15 hospitals in Cameroon, Nigeria and South Africa. Surviving patients (N = 119) were assessed for clinical evidence of constrictive pericarditis at 3 and 6 months of follow-up. Clinical features of HIV infection were present in 42 (35.2%) of the 119 patients at enrolment into the study.66 of the 119 (56.9%) patients consented to HIV testing at enrolment. During the 6 months of follow-up, a clinical diagnosis of constrictive pericarditis was made in 13 of the 119 patients (10.9%, 95% confidence interval [CI] 5.9-18%). Patients with clinical features of HIV infection appear less likely to develop constriction than those without (4.8% versus 14.3%; P = 0.08). None of the 33 HIV seropositive patients developed constriction, but 8 (24.2%, 95%CI 11.1-42.3%)of the 33 HIV seronegative patients did (P = 0.005). In a multivariate logistic regression model adjusting simultaneously for several baseline characteristics, only clinical signs of HIV infection were significantly associated with a lower risk of constriction (odd ratio 0.14, 95% CI 0.02-0.87, P = 0.035). Conclusions: These data suggest that HIV infection is associated with a lower incidence of pericardial constriction in patients with presumed tuberculous pericarditis. © 2008 Ntsekhe et al.
Interventions for treating tuberculous pericarditis
(John Wiley & Sons, Ltd. on behalf of The Cochrane Collaboration, 2017) Wiysonge, Charles S.; Ntsekhe, Mpiko; Thabane, Lehana; Volmink, Jimmy; Majombozi, Dumisani; Gumedze, Freedom; Pandie, Shaheen; Mayosi, Bongani M.
Background: Tuberculous pericarditis – tuberculosis infection of the pericardial membrane (pericardium) covering the heart – is becoming more common. The infection can result in fluid around the heart or fibrosis of the pericardium, which can be fatal. Objectives: In people with tuberculous pericarditis, to evaluate the effects on death, life‐threatening conditions, and persistent disability of: 1. 6‐month antituberculous drug regimens compared with regimens of 9 months or more; 2. corticosteroids; 3. pericardial drainage; and 4. pericardiectomy. Search methods: We searched the Cochrane Infectious Diseases Group trials register (January 2005); the Cochrane Controlled Trials Register (Issue 4, 2004); MEDLINE (1966 to January 2005); EMBASE (1980 to January 2005); and checked the reference lists of existing reviews. We also contacted organizations and individuals working in the field. Selection criteria: Randomized and quasi‐randomized controlled trials of treatments for tuberculous pericarditis. Data collection and analysis: Two reviewers independently assessed trial quality and extracted data. Meta‐analysis using fixed effects models calculated summary statistics, provided there was no statistically significant heterogeneity, and expressed results as risk ratio. Study authors were contacted for additional information. Main results: Four trials met the inclusion criteria, with a total of 469 participants. Treatments tested were adjuvant steroids and surgical drainage. Two trials with a total of 383 participants tested adjuvant steroids in participants with suspected tuberculous pericarditis in the pre‐HIV era. Fewer participants died in the intervention group, but numbers were small (risk ratio [RR] 0.65; 95% confidence interval [CI] 0.36 to 1.16, n = 350). One small trial tested steroids in HIV positive participants with effusion showed a similar pattern (RR 0.50; 95% CI 0.19 to 1.28, n = 58). One trial examined open surgical drainage compared with conservative management, and showed surgery relieved cardiac tamponade. Authors' conclusions: Steroids could have important clinical benefits, but the trials published to date are too small to demonstrate an effect. This requires large placebo controlled trials. Subgroup analysis could explore whether effusion or fibrosis modify the effects. Therapeutic pericardiocentesis under local anaesthesia and pericardiectomy also require further evaluation.
Molecular genetics of cardiomyopathy: changing times, shifting paradigms
(Clinics Cardiv Publishing, 2003-06) Moolman-Smook, Johanna C.; Mayosi, Bongani M.; Brink, Paul A.; Corfield, Valerie A.
Congestive heart failure is a major problem in developed and developing countries alike. Primary dysfunction of the heart muscle accounts for a significant proportion of patients with a non-ischaemic cause of heart failure. Application of genetic techniques has facilitated identification of some molecular causes of the inherited form of these diseases, dramatically increasing our understanding of the pathogenesis of these primary, previously termed ‘idiopathic’, cardiomyopathies over the last few decades. Knowledge of the different causes is beginning to coalesce into aetiological principles underlying the clinically distinguished cardiomyopathies. Hypertrophic cardiomyopathy (HCM) now appears to be a disease caused by a dysfunctional sarcomere, dilated cardiomyopathy (DCM), a disease of myocytic structural instability, and arrhythmogenic right ventricular cardiomyopathy, a disease of accelerated myocyte death. The aetiology of both HCM and DCM probably also involves cardiac energy imbalances, while additional factors modify the clinical expression in all cardiomyopathies. Even though our knowledge of the genetic aetiology of the cardiomyopathies is still incomplete, it already has relevant clinical significance. Elucidation of the full genetic contribution to the development and progression of the cardiomyopathies represents a new challenge in the study of these diseases, and will undoubtedly lead to new therapeutic approaches in the not-too-distant future.
Mortality in patients treated for tuberculous pericarditis in Sub-Saharan Africa
(Health and Medical Publishing Group (HMPG), 2008-01) Mayosi, Bongani M.; Wiysonge, Charles Shey; Ntsekhe, Mpiko; Gumedze, Freedom; Volmink, Jimmy A.; Maartens, Gary; Aje, Akinyemi; Thomas, Baby M.; Thomas, Kandathil M.; Awotedu, Abolade A.; Thembela, Bongani; Mntla, Phindile; Maritz, Frans; Blackett, Kathleen Ngu; Nkouonlack, Duquesne C.; Burch, Vanessa C.; Rebe, Kevin; Parrish, Andy; Sliwa, Karen; Vezi, Brian Z.; Alam, Nowshad; Brown, Basil G.; Gould, Trevor; Visser, Tim; Magula, Nombulelo P.; Commerford, Patrick J.
Objective. To determine the mortality rate and its predictors in patients with a presumptive diagnosis of tuberculous pericarditis in sub-Saharan Africa. Design. Between 1 March 2004 and 31 October 2004, we enrolled 185 consecutive patients with presumed tuberculous pericarditis from 15 referral hospitals in Cameroon, Nigeria and South Africa, and observed them during the 6-month course of antituberculosis treatment for the major outcome of mortality. This was an observational study, with the diagnosis and management of each patient left at the discretion of the attending physician. Using Cox regression, we have assessed the effect of clinical and therapeutic characteristics (recorded at baseline) on mortality during follow-up. Results. We obtained the vital status of 174 (94%) patients (median age 33; range 14-87 years). The overall mortality rate was 26%. Mortality was higher in patients who had clinical features of HIV infection than in those who did not (40% v. 17%, p=0.001). Independent predictors of death during follow-up were: (i) a proven non-tuberculosis final diagnosis (hazard ratio (HR) 5.35, 95% confidence interval (CI) 1.76-16.25), (ii) the presence of clinical signs of HIV infection (HR 2.28, CI 1.14-4.56), (iii) coexistent pulmonary tuberculosis (HR 2.33, CI 1.20-4.54), and (iv) older age (HR 1.02, CI 1.01-1.05). There was also a trend towards an increase in death rate in patients with haemodynamic instability (HR 1.80, CI 0.90-3.58) and a decrease in those who underwent pericardiocentesis (HR 0.34, CI 0.10-1.19). Conclusion. A presumptive diagnosis of tuberculous pericarditis is associated with a high mortality in sub-Saharan Africa. Attention to rapid aetiological diagnosis of pericardial effusion and treatment of concomitant HIV infection may reduce the high mortality associated with the disease.
Quality of abstracts of pilot trials in heart failure : a protocol for a systematic survey
(Elsevier, 2017) Isiguzo, Godsent; Zunza, Moleen; Chirehwa, Maxwell; Mayosi, Bongani M.; Thabane, Lehana
Introduction: Pilot trials are initial small-scale studies done to inform the design of larger trials. Their findings like other studies are usually disseminated as peer-reviewed journal articles. Abstracts are used to introduce the contents to readers, and give a general idea about the full reports and sometimes are the only source of information available to readers. Despite their importance, the contents of abstracts of trial reports are usually not informative enough and lack the essential details. Methods and analysis: This is a protocol for a planned systematic survey with a primary aim of analyzing the reporting quality measured as the completeness of the reporting of pilot trial abstracts in heart failure. The secondary aim will be to explore factors associated with better reporting quality. Abstracts of heart failure pilot trials in humans (journal and conference abstracts) published in the English language from 1 January 1990 to 30 November 2016 will be assessed to determine the reporting quality, based on the CONSORT 2010 statement extension to randomized pilot and feasibility trials. All non-pilot/feasibility trials and non-human pilot trials will be excluded. We will search Medline (PUBMED), Cochrane controlled trials register, Scopus and African wide information databases for pilot trials in heart failure. Title and abstracts of identified studies will be screened for inclusion and data extracted independently by two reviewers in duplicate without using the full text. Reported and unreported items on the abstracts will be presented as frequencies and percentages, a descriptive analysis will be used to interpret the reporting quality and regression analysis used for characteristics associated with greater statistical reporting at 95% confidence interval.
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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