Testing Treatments interactive is an online version of the book, Testing Treatments. This is a very valuable resource to learn about the importance of fair tests for new treatments and interventions, and why these are not always done. This is essential reading for anyone planning to get involved in clinical research.
Saved once (save)Bookmarked by The Editorial Team on 16 Jan 2013
Consortium of Universities fo Global Health (CUGH) offers a bi - weekly feature: a case - series from rural Uganda called “Reasoning without Resources”.The target audience is clinicians practicing in low resource settings, medicine and family medicine residents, and senior medical students with an interest in clinical global health.
The series is assumes that medical textboo ks, written for those who can access and afford them, have limited relevance to making a diagnosis in most of the world’s hospitals. This case-series addresses that reality by developing clinical skills as the fundamental "diagnostic test" available to clinicians, and sound clinical reasoning as the clinician’s principle resource. Through its Question and Answer format, the series focuses as much on pedagogical process as on biomedical content. In taking on these broad basic challenges, it hopes to inform medical education and cost-effective medical practice in modern medical settings as well.
Saved 2 times (save)Bookmarked by Liam Boggs on 21 Jun 2013
KIT are offering a 1 week training course, 'Laboratory quality management and the WHO LQSI tool' in collaboration with DATOS. ...
Professional Diploma in Tropical Medicine & Hygiene (East African Partnership) Deadline 15th January 2017!
Scholars: Full scholarships are competitively awarded to postgraduate doctors from low- and middle-income countries. There is an administrative fee. ...
I have just completed the Short Course in Clinical Trials at the London School of Hygiene and Tropical Medicine. I ...
Several of Global Health Trials' Regional Faculties have implemented exceptional, cost-effective blended learning schemes, using a computer room and the Global Health Network's free eLearning courses to create a novel way of building their research teams' skills and knowledge. The Nigerian faculty explain their experiences here, and you can download their "how to" document on the right hand side of the screen, to use at your own site!
This Guide to Efficient Trial Management, published by the Trial Manager's Network (UK) and available freely online, is a must for all trial managers or coordinators. This link is for the 5th Edition (2016)
The TDR Global Competency Framework for Clinical Research: a set of tools to help develop clinical researchersby TDR, The Global Health Network
The TDR Global Competency Framework for Clinical Research is a flexible framework which lists all the competencies that should be demonstrated by a research team to carry out a successful clinical study. It can be used for any research study, regardless of the size of the team and of the study itself. It can help to plan the staffing requirements for a study, to help carry out appraisals of staff, to help individuals plan their career development, and to help to develop educational curricula for research staff.
The Good Participatory Practice (GPP) Guidelines were developed by AVAC and UNAIDS. They provide trial funders, sponsors, and implementers with systematic guidance on how to effectively engage with all stakeholders in the design and conduct of biomedical HIV prevention trials. The guidelines are available in multiple languages. AVAC has also developed an array of supplementary GPP tools tools.
An online Research Communication Guide produced as part of a series of Development Research Uptake in Sub-Saharan Africa (DRUSSA) learning materials.
The original manual to Outcome Mapping produced by the International Development Research Centre (IDRC).
The ‘Rainbow’ framework guides the reader through a series of key questions to systematically look at all the issues involved when planning an evaluation.
Developed for engagement in community regeneration in the UK, Auditing Community Participation looks at ways of assessing levels of community involvement in area regeneration initiatives.
A guide to evaluation of public engagement developed by the Royal Academy of Engineers, UK. Whilst not specific to health and community engagement it is a useful starting point to those looking to evaluate any engagement project.
A guide to evaluating public engagement events, with a focus on events and research dissemination rather than more concerted community engagement.
A comprehensive guide to theory of change which can be used as a valuable tool for evaluating community engagement projects.
A guide to developmental evaluation.
A clear and accessible introduction to evaluation of social media linked to community radio initiatives but with wider application.
A practical guide including clear step by step explanations of how to develop a theory of change for an organisation or project
Identifying the Unique Non-Technical Skills Used by Surgeons Operating in Low and Middle Income Contextsby Global Musculoskeletal
As surgical training and capacity increase in low- and middle-income countries (LMICs), new strategies for improving surgical education and care in resource-poor settings are required. Non-technical skills (NTS) have been identified as critical to high-quality surgical performance in high-income countries (HICs), but little is known about the NTS used by surgeons in LMICs. This study aims to identify the non-technical skills used by surgeons operating in a LMIC context.
Evidence-based medicine for all: what we can learn from a programme providing free access to an online clinical resource to health workers in resource-limited settingsby Global Musculoskeletal
In 2009, the Global Health Delivery Project collaborated with UpToDate to provide free subscriptions to qualifying health workers in resource-limited settings.
Preparing for Genomic Medicine Nurse Training in Africa : A special report by Victoria Nembaware, Nicola Mulder and Raj Ramesar from H3ABioNet and the University of Cape Town Division of Human Genetics on
Preparing for and Executing a Randomised Controlled Trial of Podoconiosis Treatment in Northern Ethiopiaby Henok Negussie, Thomas Addissie, Adamu Addissie, Gail Davey
This study highlights the utility of rapid ethical assessment prior to clinical trials involving complex procedures and concepts.
This framework describes key components of capacity development, indicators for their success and ways to verify capacity development.
Public Health Degrees.org is a comprehensive search engine designed for students who are interested in learning more about Public Health and Health Sciences programs around the United States.
Reporting missing participant data in randomised trials: systematic survey of the methodological literature and a proposed guideby Akl et al 2016
Authors conducted a systematic survey of the methodological literature to identify recommended approaches for how and what randomised clinical trial (RCT) authors should report on missing participant data and, on the basis of these approaches, to propose guidance for RCT authors. Most identified approaches invite trial authors to report the extent of MPD and the underlying reasons. Fewer approaches focus on reporting missingness patterns, methods for handling MPD and implications of MPD on results.
Mental Health Innovation Network (MHIN), a global community of mental health innovators, have released a toolkit which will help researchers communicate their findings to stakeholders. The toolkit is aimed at mental health research but can be applied to other types of research
New articles from the African Society for Laboratory Medicine (ASLM).
New INTERGROWTH-21st International Postnatal Growth Standards for Preterm Infants - Charts availableby INTERGROWTH-21st
New INTERGROWTH-21st Postnatal Growth Standards charts for individual measurements of length, weight, head circumference, as well as a combined standards chart for length, weight and head circumference are now available for download here.
The CONSORT (CONsolidated Standards of Reporting Trials) 2010 guideline is intended to improve the reporting of parallel-group randomized controlled trial (RCT), enabling readers to understand a trial's design, conduct, analysis and interpretation, and to assess the validity of its results. This can only be achieved through complete adherence and transparency by authors. This series explores how an abstract can be improved through use of the CONSORT guidelines.
Postnatal growth standards for preterm infants: the Preterm Postnatal Follow-up Study of the INTERGROWTH-21st Projectby INTERGROWTH-21st
The first international stnadards for monitroing the growth of preterm babies have now been published in the Lancet Global Health (October 2015).
Evidence shows that in many African regions, including Ghana, malaria is massively over-diagnosed. This means that patients who are not diagnosed with malaria by tests that identify malaria parasites in the blood are still considered to have the disease and therefore receive anti-malarial treatment.
Individual Participant Data (IPD) Meta-analyses of Randomised Controlled Trials: Guidance on Their Useby Tierney et al
Systematic reviews involving the central collection and analysis of individual participant data (IPD) usually are larger-scale, international, collaborative projects that can bring about substantial improvements to the quantity and quality of data, give greater scope in the analyses, and provide more detailed and robust results. Following this step-by-step guide will help reviewers and users of IPD meta-analyses to understand them better and recognise those that are well designed and conducted and so help ensure that policy, practice, and research are informed by robust evidence about the effects of interventions.
Trainer and Learner handbooks for workshops aimed at improving health centre management and patient centred services.
The TACT training manuals and patient leaflet were designed to support the use of malaria rapid diagnostic tests (RDTs). Here we provide Trainer/Trainee manuals in English and French, and visual patient information sheets in English, French and Swahili.
Guidance for non-economist audience on the importance of household costs related to seeking health care from the ACT Consortium.
Field trials of interventions against disease in low and middle income countries (LMICs) may be complex and expensive undertakings. This 3rd edition of the Field Trials Toolbox has been compiled by over 30 contributors with extensive direct experience in the design, conduct, and analysis of field trials in LMICs, and it attempts to document their accumulated experience for the guidance of those who might undertake field trials of health interventions. It can be read in its entirety as an introduction to the field and/or can serve as a reference volume during each of the different stages of planning, conducting, and analysing a field trial.
Grant applications differ substantially depending on the individual funding organisation, and each funding organisation has its own organisational aims, which are important to understand when you are considering which grant to apply to. In this article we provide practical tips and information for writing grant applications, which can be applied to grant applications of all sorts, from fellowships to large funding applications.
Fetal Growth Standards for ultrasound measurements of head circumference (HC), bi-parietal diameter (BPD), occipito-frontal diameter (OFD), femur length (FL) and abdominal circumference (AC) are now available for download. For information about how to perform these measurements, or for other information on standards in ultrasound imaging, please see the ultrasound training toolkit.
Job interviews can be intimidating, but simply preparing well can make the difference between succeeding or failing, regardless of how nervous you are. In this article we pull together advice on how to prepare for job interviews and how to know what questions you’ll be asked.
Notes on How to Survive a GCP Audit forum discussion based on the GCP Inspection Course (Global Health Network eLearning course)by A. Nair, C. Ovenstone, B. Wright, E. Allen, C. Reddy
Documents for seeking ISARIC endorsement for research studies.
Pioneering New Diagnostics: Addressing Challenges and Implications for Point-of-Care Testing in African Settingsby Laurel Oldach
Links to the SPIRIT guidelines for protocol development and information about these guidelines - all free and open access.
On the 19th September 2014, Global Health Trials Southern Africa held its Annual Faculty Meeting, themed Clinical Trial Site Project Management. You can download the presentations from the talk and leave feedback here.
This protocol outlines the technique for taking a pregnant woman's blood pressure. http://www.medscinet.net/Intergrowth/patientinfodocs/BP%20protocol.pdf
The aim of this manual is to ensure all trained ultrasonographers are familiar with the standardized way crown-rump length measurements should be taken for the purposes of using the INTERGROWTH-21st fetal growth standards. http://www.medscinet.net/Intergrowth/patientinfodocs/CRLstandardisation_Website.pdf
This manual details the technique for assessing sleep-wake cycles in children. http://www.medscinet.net/Intergrowth/patientinfodocs/Sleep-wake%20cycle%20assessment%20manual%20July%202014.pdf
We share a brief on the MCL shared at at the Women Deliver Conference 2013.
Despite published guidance on writing the abstract in the PRISMA Statement guiding the reporting of systematic reviews in general and elsewhere, evaluations show that reporting of systematic reviews in journal and conference abstracts is poor. Teh authors developed consensus-based reporting guidelines as an extension to the PRISMA Statement on good reporting of systematic reviews and meta-analyses in abstracts.
Research misconduct is a global problem as research is a global activity. Wherever there is human activity there is misconduct, but we lack reliable data on the extent and distribution of research misconduct. This PLoS paper seeks to illustrate some examples of researsch misconduct in LMICs.
In this article, the authors illustrate five basic statistical concepts that can significantly impact the interpretation of the medical literature and its application to the care of patients, drawing examples from the vaccine literature: (i) consider clinical and statistical significance separately, (ii) evaluate absolute risks rather than relative risks, (iii) examine confidence intervals rather than p values, (iv) use caution when considering isolated significant p values in the setting of multiple testing, and (v) keep in mind that statistically nonsignificant results may not exclude clinically important benefits or harms.
Transnational Working Group on Data management of the ECRIN, the European Clinical Research Infrastructures Network, present recommendations for quality and harmonisation for data management. In addition good data management practices in general are identified.
Clinical Data Management: Current status, challenges and future directions from industry perspectives.by Harry van Loen
Collecting biospecimens for research from your community is a long-term commitment. It requires earning and keeping their trust by being as transparent as possible. It requires following the highest ethical, regulatory and legal standards.And it should include a mechanism for providing feedback to the community on the research that has been done using their samples. In some cases, there may be risks to ethnic and social groups or communities due to the release of aggregate research findings even when no individually identifiable information has been revealed. In addition, some populations or groups have specific beliefs about the disposition and use of their specimens, which should be respected. We provide the following templates:
- informed consent to collect biospecimens during pregnancy
- participant information sheet
In determining the feasibility of establishing a biorepository at your facility, there are several key factors to consider. But first, there are a few that must be in place before commencing. They are:
- The commitment of your institutional
- The trust of the community within which you work
- Informed consents that allow specimens to be used for multiple research studies
- Vision/commitment for the distribution and sharing of biospecimens and data with the wider scientific community
We share the WHO 2009 guideline that provides a framework for integrating nutrition support into the routine care of HIV-infected children (6 months-14 years). HIV-infected children deserve special attention because of their additional needs to ensure growth and development and their dependency on adults for adequate care including nutrition care and support for treatment. Vertical implementation of HIV programmes, such as PMTCT and ART, have resulted in missed opportunities to gain synergy with other existing services.
This guidance article aims to provide a fully comprehensive, pragmatic guide for researchers of all roles, but especially ethics reviewers, to explain the details of each type of ethics review. The article is available in English, Spanish, Portuguese and Chinese, and has been kindly provided by www.ctmagnifier.org.
Previously we have shared the guidelines pertaining to the early initiation and continuation of breast feeding and complementary feeding for newborns and infants. However there are concerns regarding breast feeding for women living with HIV. In particular, evidence has been reported that antiretroviral (ARV) interventions to either the HIV-infected mother or HIV-exposed infant can significantly reduce the risk of postnatal transmission of HIV through breastfeeding. This evidence has major implications for how women living with HIV might feed their infants, and how health workers should counsel these mothers. In light of this, the World Health Organization (WHO) commenced a guideline development process, culminating in a Guideline Development Group meeting in Geneva on 22–23 October 2009. We share here the revised guidelines by WHO for principles and recommendations for infant feeding inthe context of HIV.
A sample plan for sample collection with regards to a potential novel coronavirus outbreak, developed by Kenneth Baillie and ISARIC's Working Group 3.
A Skills Sharing Workshop took place in Blantyre on 2nd October 2012. Presentations given on the day are shown here.
Essential Interventions, Commodities and Guidelines for Reproductive, Maternal, Newborn and Child Healthby Jai K Das
Point of Care Testing for Infectious Diseases: Diversity, Complexity and Barriers in Low- and Middle Income Countriesby Nitika Pant Pai, MD MPH PhD, Caroline Vadnais, Claudia Denkinger, Nora Engel, Madhu Pai
The process of obtaining informed consent continues to be a contentious issue in clinical and public health research carried out in resource-limited settings. We sought to evaluate this process among human research participants in randomly selected active research studies approved by the School of Medicine Research and Ethics Committee at the College of Health Sciences, Makerere University.
A range of downloadable templates and tools for Clinical Research, including monitoring checklists, budget spreadsheets, informed consent forms, SOPs and so on.
This article is an introduction to cluster randomised trials.
“Piggy-Backing” on Diagnostic Platforms Brings Hope to Neglected Diseases: The Case of Sleeping Sicknessby Joseph M Ndung'u , Sylvain Bieler, Giorgio Roscigno
This article explains the process of data management operations within clinical trials from start to finish.
Five seed documents are provided here for use in clinical research, which can be adapted and altered for each study. Here we provide a template concept protocol, a study protocol, a CRF, an informed consent form, and a generic SOP.
Strengthening the Informed Consent Process in International Health Research through Community Engagement: The KEMRI-Wellcome Trust Research Programme Experienceby Mwanamvua Boga, Alun Davies, Dorcas Kamuya, Samson M. Kinyanjui, Ester Kivaya, Francis Kombe, Trudie Lang, Bibi Mbete, Albert Mlamba, Sassy Molyneux, Stephen Mulupi, Salim Mwalukore
These guidelines were developed following a Working Group on Disaster Research and Ethics (WGDRE) meeting in 2007 with the aim of developing ethical guidelines which would be applicable to post-disaster research, partiuclarly that performed in the developing world. We welcome any feedback from members.
It is a recommendation of some IRB/ECs that back translation is included as a necessary step for the translation of some clinical trial documentation, including informed consent documents. This article explains the reasons for back translation, and takes you through how to effectively perform this step, including explaining how to find a suitable translator for the task.
During the setting up of our trial in Cameroon we met several operational issues that we needed to overcome. For some of these issues we developed some tools and we have made them available here so that other research groups can use them in their clinical trials.
This articles explores some of the ethical issues arising in the context of collaborative global health research networks involving partners in developing and developed countries.
This article aims to give guidance and support to new clinical trial project managers and is written as a hypothetical case study. A situation is set out and then the process is described in terms of how a project manager might conduct their role.
Health research: the challenges related to ethical review and informed consent in developing countriesby Raffaella Ravinetto
An article about a workshop that assessed ethical review and informed consent in vulnerable populations. This article aims to prompt a debate leading to better guiding principles on health research in constrained settings
The WHO invite comments on these new guidelines: Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants
A set of 4 consent templates for clinical trials, interview studies, observation studies and sampling only studies.
An overview on trial registration. Here you can find out why trials need to be registered and what the difference is between all the registries - and how to register your study.
This article was written by a researcher from Sri Lanka and presents a very helpful overview on Biomedical Ethics. This article will be helpful to all levels of research staff and others who might want an accessible overview
Reciprocal or in-house monitoring schemes could be an alternative to expensive out-sourcing. Read on to find out more.
The site initiation process is important as it ensures that all the logistics are organised and the site is ready to begin recruiting subjects.