The impact of the National HIV Health Care Worker Hotline on patient care in South Africa

<p>Abstract</p> <p>Background</p> <p>South Africa has a huge burden of illness due to HIV infection. Many health care workers managing HIV infected patients, particularly those in rural areas and primary care health facilities, have minimal access to information resources and to advice and support from experienced clinicians. The Medicines Information Centre, based in the Division of Clinical Pharmacology at the University of Cape Town, has been running the National HIV Health Care Worker (HCW) Hotline since 2008, providing free information for HIV treatment-related queries via telephone, fax and e-mail.</p> <p>Results</p> <p>A questionnaire-based study showed that 224 (44%) of the 511 calls that were received by the hotline during the 2-month study period were patient-specific. Ninety-four completed questionnaires were included in the analysis. Of these, 72 (77%) were from doctors, 13 (14%) from pharmacists and 9 (10%) from nurses. 96% of the callers surveyed took an action based on the advice received from the National HIV HCW Hotline. The majority of actions concerned the start, dose adaption, change, or discontinuation of medicines. Less frequent actions taken were adherence and lifestyle counselling, further investigations, referring or admission of patients.</p> <p>Conclusions</p> <p>The information provided by the National HIV HCW Hotline on patient-specific requests has a direct impact on the management of patients.</p

Health economic evidence in clinical guidelines in South Africa: a mixedmethods study

Evidence-informed clinical practice guidelines (CPGs) are useful tools to inform transparent healthcare decision-making. Consideration of health economic evidence (HEE) during CPG development in a structured manner remains a challenge globally and locally. This study explored the views, current practice, training needs and challenges faced by CPG developers in the production and use of HEE for CPGs in South Africa.This mixed-methods study comprised an online survey and a focus group discussion. The survey was piloted and subsequently sent to CPG role players - evidence reviewers, CPG panellists, academics involved with training in relevant disciplines like health economics and public health, implementers and funders. The focus group participants hold strategic roles in CPG development and health economic activities nationally. The survey evaluated mean values, measures of variability, and percentages for Likert scales, while narrative components were thematically analysed. Focus group data were manually coded, thematically analysed and verified

Tuberculosis treatment intervention trials in Africa: A cross-sectional bibliographic study and spatial analysis

Background Mycobacterium Tuberculosis (TB) poses a substantial burden in sub-Saharan Africa and is the leading cause of death amongst infectious diseases. Randomised controlled trials (RCTs) are regarded as the gold standard for evaluating the effectiveness of interventions. We aimed to describe published TB treatment trials conducted in Africa. Methods This is a cross-sectional study of published TB trials conducted in at least one African country. In November 2019, we searched three databases using the validated Africa search filter and Cochrane’s sensitive trial string. Published RCTs conducted in at least one African country were included for analysis. Records were screened for eligibility. Co-reviewers assisted with duplicate data extraction. Extracted data included: the country where studies were conducted, publication dates, ethics statement, trial registration number, participant’s age range. We used Cochrane’s Risk of Bias criteria to assess methodological quality. Results We identified 10,495 records; 175 trials were eligible for inclusion. RCTs were published between 1952 and 2019. The median sample size was 206 participants (interquartile range: 73–657). Most trials were conducted in South Africa (n = 83) and were drug therapy trials (n = 130). First authors were from 30 countries globally. South Africa had the most first authors (n = 55); followed by the United States of America (USA) (n = 28) and Great Britain (n = 14) with fewer other African countries contributing to the first author tally. Children under 13 years of age eligible to participate in the trials made up 17/175 trials (9.71%). International governments (n = 29) were the most prevalent funders. Ninety-four trials provided CONSORT flow diagrams. Methodological quality such as allocation concealment and blinding were poorly reported or unclear in most trials. Conclusions By mapping African TB trials, we were able to identify potential research gaps. Many of the global north’s researchers were found to be the lead authors in these African trials. Few trials tested behavioural interventions compared to drugs, and far fewer tested interventions on children compared to adults to improve TB outcomes. Lastly, funders and researchers should ensure better methodological quality reporting of trials

Mixed method evaluation of the CEBHA+ integrated knowledge translation approach : a protocol

CITATION: Pfadenhauer, L. M., et al. 2021. Mixed method evaluation of the CEBHA+ integrated knowledge translation approach : a protocol. Health Research Policy and Systems, 19:7, doi:10.1186/s12961-020-00675-w.The original publication is available at https://health-policy-systems.biomedcentral.comBackground: The Collaboration for Evidence-based Healthcare and Public Health in Africa (CEBHA+) is a research consortium concerned with the prevention, diagnosis and treatment of non-communicable diseases. CEBHA+ seeks to engage policymakers and practitioners throughout the research process in order to build lasting relationships, enhance evidence uptake, and create long-term capacity among partner institutions in Ethiopia, Malawi, Rwanda, South Africa and Uganda in collaboration with two German universities. This integrated knowledge translation (IKT) approach includes the formal development, implementation and evaluation of country specific IKT strategies. Methods: We have conceptualised the CEBHA+ IKT approach as a complex intervention in a complex system. We will employ a comparative case study (CCS) design and mixed methods to facilitate an in-depth evaluation. We will use quantitative surveys, qualitative interviews, quarterly updates, and a policy document analysis to capture the process and outcomes of IKT across the African CEBHA+ partner sites. We will conduct an early stage (early 2020) and a late-stage evaluation (early 2022), triangulate the data collected with various methods at each site and subsequently compare our findings across the five sites. Discussion: Evaluating a complex intervention such as the CEBHA+ IKT approach is complicated, even more so when undertaken across five diverse countries. Despite conceptual, methodological and practical challenges, our comparative case study addresses important evidence gaps: While involving decision-makers in the research process is gaining traction worldwide, we still know very little regarding (i) whether this approach really makes a difference to evidence uptake, (ii) the mechanisms that make IKT successful, and (iii) relevant differences across socio-cultural contexts. The evaluation described here is intended to provide relevant insights on all of these aspects, notably in countries in Sub-Saharan Africa, and is expected to contribute to the science of IKT overall.https://health-policy-systems.biomedcentral.com/articles/10.1186/s12961-020-00675-wPublisher's versio

Grading of recommendations, assessment, development and evaluations concept 7: issues and insights linking guideline recommendations to trustworthy essential medicine lists

Objectives: Guidelines and essential medicine lists (EMLs) bear similarities and differences in the process that lead to decisions. Access to essential medicines is central to achieve universal health coverage. The World Health Organization (WHO) EML has guided prioritization of essential medicines globally for nearly 50 years, and national EMLs (NEMLs) exist in over 130 countries. Guideline and EML decisions, at WHO or national levels, are not always coordinated and aligned. We sought to explore challenges, and potential solutions, for decision-making to support trustworthy medicine selection for EMLs from a Grading of Recommendations, Assessment, Development and Evaluations (GRADE) Working Group perspective. We primarily focus on the WHO EML; however, our findings may be applicable to NEML decisions as well. Study Design and Setting: We identified key challenges in connecting the EML to health guidelines by involving a broad group of stakeholders and assessing case studies including real applications to the WHO EML, South Africa NEML, and a multiple sclerosis guideline connected to a WHO EML application for multiple sclerosis treatments. To address challenges, we utilized the results of a survey and feedback from the stakeholders, and iteratively met as a project group. We drafted a conceptual framework of challenges and potential solutions. We presented a summary of the results for feedback to all attendees of the GRADE Working Group meetings in November 2022 (approximately 120 people) and in May 2023 (approximately 100 people) before finalizing the framework. Results: We prioritized issues and insights/solutions that addressed the connections between the EML and health guidelines. Our suggested solutions include early planning alignment of guideline groups and EMLs, considering shared participation to strengthen linkage, further clarity on price/cost considerations, and using explicit shared criteria to make guideline and EML decisions. We also provide recommendations to strengthen the connection between WHO EML and NEMLs including through contextualization methods. Conclusion: This GRADE concept article, jointly developed by key stakeholders from the guidelines and EMLs field, identified key conceptual issues and potential solutions to support the continued advancement of trustworthy EMLs. Adopting structured decision criteria that can be linked to guideline recommendations bears the potential to advance health equity and gaps in availability of essential medicines within and between countries

Classification of early tuberculosis states to guide research for improved care and prevention: an international Delphi consensus exercise

The current active–latent paradigm of tuberculosis largely neglects the documented spectrum of disease. Inconsistency with regard to definitions, terminology, and diagnostic criteria for different tuberculosis states has limited the progress in research and product development that are needed to achieve tuberculosis elimination. We aimed to develop a new framework of classification for tuberculosis that accommodates key disease states but is sufficiently simple to support pragmatic research and implementation. Through an international Delphi exercise that involved 71 participants representing a wide range of disciplines, sectors, income settings, and geographies, consensus was reached on a set of conceptual states, related terminology, and research gaps. The International Consensus for Early TB (ICE-TB) framework distinguishes disease from infection by the presence of macroscopic pathology and defines two subclinical and two clinical tuberculosis states on the basis of reported symptoms or signs of tuberculosis, further differentiated by likely infectiousness. The presence of viable Mycobacterium tuberculosis and an associated host response are prerequisites for all states of infection and disease. Our framework provides a clear direction for tuberculosis research, which will, in time, improve tuberculosis clinical care and elimination policies

Clinical practice guidelines within the Southern African development community: a descriptive study of the quality of guideline development and concordance with best evidence for five priority diseases

<p>Abstract</p> <p>Background</p> <p>Reducing the burden of disease relies on availability of evidence-based clinical practice guidelines (CPGs). There is limited data on availability, quality and content of guidelines within the Southern African Development Community (SADC). This evaluation aims to address this gap in knowledge and provide recommendations for regional guideline development.</p> <p>Methods</p> <p>We prioritised five diseases: HIV in adults, malaria in children and adults, pre-eclampsia, diarrhoea in children and hypertension in primary care. A comprehensive electronic search to locate guidelines was conducted between June and October 2010 and augmented with email contact with SADC Ministries of Health. Independent reviewers used the AGREE II tool to score six quality domains reporting the guideline development process. Alignment of the evidence-base of the guidelines was evaluated by comparing their content with key recommendations from accepted reference guidelines, identified with a content expert, and percentage scores were calculated.</p> <p>Findings</p> <p>We identified 30 guidelines from 13 countries, publication dates ranging from 2003-2010. Overall the '<it>scope and purpose' </it>and '<it>clarity and presentation' </it>domains of the AGREE II instrument scored highest, median 58%(range 19-92) and 83%(range 17-100) respectively. '<it>Stakeholder involvement' </it>followed with median 39%(range 6-75). '<it>Applicability'</it>, '<it>rigour of development' </it>and '<it>editorial independence' </it>scored poorly, all below 25%. Alignment with evidence was variable across member states, the lowest scores occurring in older guidelines or where the guideline being evaluated was part of broader primary healthcare CPG rather than a disease-specific guideline.</p> <p>Conclusion</p> <p>This review identified quality gaps and variable alignment with best evidence in available guidelines within SADC for five priority diseases. Future guideline development processes within SADC should better adhere to global reporting norms requiring broader consultation of stakeholders and transparency of process. A regional guideline support committee could harness local capacity to support context appropriate guideline development.</p

Treatment and outcomes in children with multidrug-resistant tuberculosis: a systematic review and individual patient data meta-analysis.

CAPRISA, 2018.Abstract available in pdf

Tuberculosis screening among ambulatory people living with HIV: a systematic review and individual participant data meta-analysis.

BackgroundThe WHO-recommended tuberculosis screening and diagnostic algorithm in ambulatory people living with HIV is a four-symptom screen (known as the WHO-recommended four symptom screen [W4SS]) followed by a WHO-recommended molecular rapid diagnostic test (eg Xpert MTB/RIF [hereafter referred to as Xpert]) if W4SS is positive. To inform updated WHO guidelines, we aimed to assess the diagnostic accuracy of alternative screening tests and strategies for tuberculosis in this population.MethodsIn this systematic review and individual participant data meta-analysis, we updated a search of PubMed (MEDLINE), Embase, the Cochrane Library, and conference abstracts for publications from Jan 1, 2011, to March 12, 2018, done in a previous systematic review to include the period up to Aug 2, 2019. We screened the reference lists of identified pieces and contacted experts in the field. We included prospective cross-sectional, observational studies and randomised trials among adult and adolescent (age ≥10 years) ambulatory people living with HIV, irrespective of signs and symptoms of tuberculosis. We extracted study-level data using a standardised data extraction form, and we requested individual participant data from study authors. We aimed to compare the W4SS with alternative screening tests and strategies and the WHO-recommended algorithm (ie, W4SS followed by Xpert) with Xpert for all in terms of diagnostic accuracy (sensitivity and specificity), overall and in key subgroups (eg, by antiretroviral therapy [ART] status). The reference standard was culture. This study is registered with PROSPERO, CRD42020155895.FindingsWe identified 25 studies, and obtained data from 22 studies (including 15 666 participants; 4347 [27·7%] of 15 663 participants with data were on ART). W4SS sensitivity was 82% (95% CI 72-89) and specificity was 42% (29-57). C-reactive protein (≥10 mg/L) had similar sensitivity to (77% [61-88]), but higher specificity (74% [61-83]; n=3571) than, W4SS. Cough (lasting ≥2 weeks), haemoglobin (2), and lymphadenopathy had high specificities (80-90%) but low sensitivities (29-43%). The WHO-recommended algorithm had a sensitivity of 58% (50-66) and a specificity of 99% (98-100); Xpert for all had a sensitivity of 68% (57-76) and a specificity of 99% (98-99). In the one study that assessed both, the sensitivity of sputum Xpert Ultra was higher than sputum Xpert (73% [62-81] vs 57% [47-67]) and specificities were similar (98% [96-98] vs 99% [98-100]). Among outpatients on ART (4309 [99·1%] of 4347 people on ART), W4SS sensitivity was 53% (35-71) and specificity was 71% (51-85). In this population, a parallel strategy (two tests done at the same time) of W4SS with any chest x-ray abnormality had higher sensitivity (89% [70-97]) and lower specificity (33% [17-54]; n=2670) than W4SS alone; at a tuberculosis prevalence of 5%, this strategy would require 379 more rapid diagnostic tests per 1000 people living with HIV than W4SS but detect 18 more tuberculosis cases. Among outpatients not on ART (11 160 [71·8%] of 15 541 outpatients), W4SS sensitivity was 85% (76-91) and specificity was 37% (25-51). C-reactive protein (≥10 mg/L) alone had a similar sensitivity to (83% [79-86]), but higher specificity (67% [60-73]; n=3187) than, W4SS and a sequential strategy (both test positive) of W4SS then C-reactive protein (≥5 mg/L) had a similar sensitivity to (84% [75-90]), but higher specificity than (64% [57-71]; n=3187), W4SS alone; at 10% tuberculosis prevalence, these strategies would require 272 and 244 fewer rapid diagnostic tests per 1000 people living with HIV than W4SS but miss two and one more tuberculosis cases, respectively.InterpretationC-reactive protein reduces the need for further rapid diagnostic tests without compromising sensitivity and has been included in the updated WHO tuberculosis screening guidelines. However, C-reactive protein data were scarce for outpatients on ART, necessitating future research regarding the utility of C-reactive protein in this group. Chest x-ray can be useful in outpatients on ART when combined with W4SS. The WHO-recommended algorithm has suboptimal sensitivity; Xpert for all offers slight sensitivity gains and would have major resource implications.FundingWorld Health Organization

Assessing the completeness and comparability of outcomes in systematic reviews addressing food security : protocol for a methodological study

CITATION: Durao, S., et al. 2020. Assessing the completeness and comparability of outcomes in systematic reviews addressing food security : protocol for a methodological study. Systematic Reviews, 9:9, doi:10.1186/s13643-019-1268-1.The original publication is available at https://systematicreviewsjournal.biomedcentral.comBackground: Systematic reviews should specify all outcomes at the protocol stage. Pre-specification helps prevent outcome choice from being influenced by knowledge of included study results. Completely specified outcomes comprise five elements: (1) domain (title), (2) specific measurement (technique/instrument), (3) specific metric (data format for analysis), (4) method of aggregation (how group data are summarised), and (5) time points. This study aims to assess the completeness of outcome pre-specification in systematic reviews of interventions to improve food security, specifically food availability, in low- and middle-income countries, as well as to assess the comparability of outcome elements across reviews reporting the same outcome domains. Methods: We will examine systematic reviews from an ongoing overview of systematic reviews, which assessed the effects of interventions addressing food insecurity through improving food production, access, or utilisation compared with no intervention or a different intervention, on nutrition outcomes. We will examine the original protocols; if unavailable, we will examine the “Methods” section of the systematic reviews’ most recent version. One investigator will identify and group all outcome domains that the authors of the included protocols intended to measure in the systematic review and a second investigator will verify the domains. For outcome domains reported in at least 25% of protocols, one author will extract data using a pre-specified form and a second author will verify the data. We will use descriptive statistics to report the number, types, and degree of specification of outcomes in included protocols. We will assess the extent of completeness of outcome pre-specification based on the number of outcome elements (out of five). We will assess comparability of outcome domains through examining how individual elements are described across SRs reporting the same outcome domains. Discussion: Our findings will contribute to understanding about the best approach to pre-specify outcomes for systematic reviews and primary research in the field of food security.https://systematicreviewsjournal.biomedcentral.com/articles/10.1186/s13643-019-1268-1Publisher's versio