Publications by authors named "Anthony Manyara"
In this call for transparency, we aim to disseminate knowledge about recent CONSORT-Surrogate and SPIRIT-Surrogate checklists. SPIRIT-Surrogate is an extension of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist, developed as a consensus document and designed as a reporting guideline for randomized controlled trial (RCT) protocols using surrogate end points as the primary end points. CONSORT-Surrogate is an extension of the Consolidated Standards of Reporting Trials (CONSORT) checklist, a consensus-driven reporting guideline for RCTs using surrogate end points as the primary end points.
View Article and Find Full Text PDFObjectives: To review current methodological guidance for handling and reporting of multiple outcomes (MOCs) in randomized controlled trials (RCTs).
Study Design And Setting: A scoping review with bibliographic database searches including Embase, PubMed, and Web of Science up to January 16, 2025 was conducted. Inclusion criteria were articles that: (1) provide advice on the design, analysis, or reporting of RCTs using MOCs; and/or (2) discuss statistical approaches for handling MOCs in RCTs.
Introduction: Africa's older population is increasing and this, necessitates the development of interventions to promote healthy ageing. Nutrition is a key determinant of healthy ageing and local contextual evidence is needed to inform nutritional intervention development in Africa. There are already reviews on nutritional status and food insecurity in older adults in Africa.
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- The study explored the links between HIV, frailty, and health-related quality of life in adults aged 40 and older in Zimbabwe, using various assessments to define and measure frailty.
- Of the 1,034 participants, 21.6% were living with HIV, with most knowing their status and receiving antiretroviral therapy, yet HIV status itself was not directly linked to increased frailty.
- However, longer duration of living with HIV increased the odds of frailty, while longer use of ART reduced those odds, suggesting that early initiation of ART may help decrease future frailty risk.
Background: The prevalence of diabetes is on the rise globally, with likely disproportionate increase in Sub-Saharan Africa. In Kenya, diabetes has been acknowledged as one of the top non-communicable diseases needing prevention and control. Research can contribute to diabetes prevention and control: however, the landscape of diabetes research in Kenya remains understudied.
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- This study focused on the appropriate sample size needed for multistakeholder Delphi surveys, particularly looking at how sample size impacts the replicability of results and examining variations based on participant characteristics such as gender, age, and profession.
- Data from three significant Delphi surveys were analyzed to develop better guidelines for reporting healthcare intervention trials, revealing that an average sample size of 60 yielded a replicability rate of 81%.
- Results indicated that increasing the sample size from 80 to 160 participants improved replicability by 3% while lowering variability, with different subgroup analyses highlighting that a sample size of 20 to 30 provided moderate replicability.
Article Synopsis
- Randomised controlled trials often use surrogate endpoints instead of direct outcomes to enhance efficiency and reduce costs, but this can lead to increased uncertainty regarding treatment effects and intervention harms.
- A new guideline, known as CONSORT-Surrogate, provides a checklist for reporting trials that utilize surrogate endpoints, ensuring better clarity and transparency in the results.
- The recommended checklist, tailored for all stakeholders involved in clinical trials, aims to improve the reporting quality of these studies and ultimately reduce wasted research efforts.
Article Synopsis
- Randomised controlled trials often use surrogate endpoints instead of direct outcomes to save time, cost, and ethical concerns, but this can create uncertainty about the actual treatment effects and potential harms.
- The SPIRIT-Surrogate is a new guideline to enhance the reporting standards for trial protocols that use surrogate endpoints, building on the existing SPIRIT checklist.
- This guideline includes nine modified items, encouraging all stakeholders to adopt it, which aims to improve trial design, transparency, and ultimately reduce wasted research efforts.
Objective: To synthesise current evidence on knowledge, perceptions and practices towards type 2 diabetes risk in sub-Saharan Africa.
Design: Mixed-methods scoping review, which included 101 studies (seventy-three quantitative, twenty qualitative and eight mixed methods) from seven electronic databases.
Setting: Sub-Saharan Africa, 2000-2023.
Background: Type 2 diabetes is increasing in Kenya, especially in urban settings, and prevention interventions based on local evidence and context are urgently needed. Therefore, this study aimed to explore diabetes risk and co-create a diabetes prevention theory of change in two socioeconomically distinct communities to inform future diabetes prevention interventions.
Methods: In-depth interviews were conducted with middle-aged residents in two communities in Nairobi (one low-income (n = 15), one middle-income (n = 14)), and thematically analysed.
Surrogate endpoints are biomarkers or intermediate outcomes that are used as substitutes for clinical outcomes of interest, often to expedite research or decision-making. In contrast, patient-important (or patient-centered) outcomes are health outcomes that are of direct relevance and importance to patients themselves; clinical trials may have measured the impact of the intervention on other endpoints related to, but different from, those of primary importance to patients. This article aims to elaborate on the use and understanding of surrogate endpoints.
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- The paper discusses the increasing use of surrogate endpoints in interventional trials and introduces a framework for better defining and reporting them.
- A series of studies, including reviews and surveys involving various stakeholders, revealed inconsistencies in how surrogate endpoints are currently defined and understood.
- It was found that while traditional surrogate endpoints focus on biomarkers, broader interpretations including intermediate outcomes like function or symptoms also require clearer consensus among stakeholders, particularly between patients and health technology experts.
Article Synopsis
- - The objective of this study was to review existing literature on surrogate endpoints in clinical trials, focusing on their definitions, acceptability, limitations, and providing guidance for design and reporting.
- - A systematic search led to the inclusion of 90 documents, which revealed that the majority addressed definitions (79%), acceptability (77%), and limitations (72%), resulting in 17 identified trial reporting items for better clarity and guidance.
- - The findings aim to enhance the understanding of surrogate endpoints in research and will contribute to developing standardized reporting recommendations for their use in interventional trials.
Using a surrogate endpoint as a substitute for a patient-relevant final outcome enables randomised controlled trials (RCTs) to be conducted more efficiently. However, the use of surrogates remains controversial and there is currently no guideline for the reporting of RCTs using surrogate endpoints; therefore, we seek to develop SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and CONSORT (Consolidated Standards of Reporting Trials) extensions to improve the reporting of these trials. We would like to invite interested individuals (trial methodologists, journal editors, healthcare industry, regulators and payers, and patient/public representative groups), particularly those with experience in the use of surrogate endpoints in trials.
View Article and Find Full Text PDFIntroduction: Using a surrogate endpoint as a substitute for a primary patient-relevant outcome enables randomised controlled trials (RCTs) to be conducted more efficiently, that is, with shorter time, smaller sample size and lower cost. However, there is currently no consensus-driven guideline for the reporting of RCTs using a surrogate endpoint as a primary outcome; therefore, we seek to develop SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and CONSORT (Consolidated Standards of Reporting Trials) extensions to improve the design and reporting of these trials. As an initial step, scoping and targeted reviews will identify potential items for inclusion in the extensions and participants to contribute to a Delphi consensus process.
View Article and Find Full Text PDFIntroduction: Randomised controlled trials (RCTs) may use surrogate endpoints as substitutes and predictors of patient-relevant/participant-relevant final outcomes (eg, survival, health-related quality of life). Translation of effects measured on a surrogate endpoint into health benefits for patients/participants is dependent on the validity of the surrogate; hence, more accurate and transparent reporting on surrogate endpoints is needed to limit misleading interpretation of trial findings. However, there is currently no explicit guidance for the reporting of such trials.
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