Articles - Methodology

The Global Health Trials Methodology Research Agenda: A Priority Setting Exercise

The following invitation to take part in trials methodology research comes from the Network of Hubs for Trials Methodology Research (HTMR) which was established by the UK Medical Research Council (MRC) to improve the quality of clinical trials.

Reporting missing participant data in randomised trials: systematic survey of the methodological literature and a proposed guide

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. 

Q&A with Professor Trudie Lang: Why Global Health Trials?

In celebration of Global Health Trials' fifth birthday (May 11th 2015) Professor Trudie Lang, Principal Investigator of the programme, talks to us about why Global Health Trials was started, why people should share their experience, and what the future holds.

Evaluating Clinical Trial Designs for Investigational Treatments of Ebola Virus Disease

This article published in PLOS Medicine on April 14th, 2015 discusses how best to test Ebola treatment.

Translating research into practice: the introduction of the INTERGROWTH-21st package of clinical standards, tools and guidelines into policies, programmes and services

This paper describes the approach to translating the findings, tools and resources generated by the INTERGROWTH-21^st Project into practice. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12416/abstract

Implementation of the INTERGROWTH-21st Project in the United States

This paper describes the implementation of the INTERGROWTH-21^st Project in Seattle, USA. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12126/abstract

Implementation of the INTERGROWTH-21st Project in the UK

This paper describes the implementation of the INTERGROWTH-21^st Project in Oxford, UK. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12033/abstract

Implementation of the INTERGROWTH-21st Project in Oman

This paper describes the implementation of the INTERGROWTH-21^st Project in Muscat, Oman. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12043/abstract

Implementation of the INTERGROWTH-21st Project in Kenya

This paper describes the implementation of the INTERGROWTH-21^st Project in Nairobi, Kenya. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12045/abstract

Implementation of the INTERGROWTH-21st Project in Italy

This paper describes the implementation of the INTERGROWTH-21^st Project in Turin, Italy. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12124/abstract

Implementation of the INTERGROWTH-21st Project in India

This paper describes the implementation of the INTERGROWTH-21^st Project in Nagpur, India. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12058/abstract

Implementation of the INTERGROWTH-21st Project in China

This paper describes the implementation of the INTERGROWTH-21^st Project in Beijing, China. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12044/abstract

Implementation of the INTERGROWTH-21st Project in Brazil

This paper describes the implementation of the INTERGROWTH-21^st Project in Pelotas, Brazil. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12046/abstract

Ethical issues arising from the INTERGROWTH-21st Fetal Growth Longitudinal Study

The INTERGROWTH-21^st Project presented a complex set of ethical challenges given the involvement of health institutions in geographically and culturally diverse areas of the world, with differing attitudes to pregnancy. This paper addresses how the research team dealt with some of those issues. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12030/abstract

Statistical considerations for the development of prescriptive fetal and newborn growth standards in the INTERGROWTH-21st Project

This paper considers the statistical aspects of the three components of the INTERGROWTH-21^st Project - the Fetal Growth Longitudinal Study, the Preterm Postnatal Follow-up Study, and the Newborn Corss-Sectional Study - as they relate to the construction of the INTERGROWTH-21^st standards, in particular, the sample size. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12031/abstract

Standardisation of neonatal clinical practice

Given the multicentre nature of the INTERGROWTH-21^st Project and the expected number of preterm births, it is vital that all centres follow the same standardised clinical care protocols to assess and manage preterm infants, so as to ensure maximum validity of the resulting standards as indicators of growth and nutrition with minimal confounding. Moreover, it is well known that evidence-based clinical practice guidelines can reduce the delivery of inappropriate care and support the introduction of new knowledge into clinical practice. The INTERGROWTH-21^st Neonatal Group produced an operations manual, which reflects the consensus reached by members of the group regarding standardised definitions of neonatal morbidities and the minimum standards of care to be provided by all centres taking part in the project. This paper describes the process of developing the Basic Neonatal Care Manual, as well as the morbidity definitions and standardised neonatal care protocols applied across all the INTERGROWTH-21^st participating centres. Thoughts about implementation strategies are presented. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12312/abstract

Anthropometric standardisation and quality control protocols for the construction of new, international, fetal and newborn growth standards: the INTERGROWTH-21st Project

The INTERGROWTH-21^st Project involved taking anthropometric measurements, including head circumference, recumbent length and weight of infants, and the stature and weight of parents. In a large, international, multicentre project, it is critical that all study sites follow standardised protocols to ensure maximal validity of the growth and nutrition indicators used. This paper describes, in detal, the anthropometric training, standardisation and quality control procedures used to collect data for these new standards. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12127/abstract

Standardisation and quality control of ultrasound measurements taken in the INTERGROWTH-21st Project

Meticulous standardisation and ongoing monitoring of adherence to measurement protocols during data collection are essential to ensure consistency and to minimise systematic error in multicentre studies. Strict ultrasound fetal biometric measurement protocols are used in the INTERGROWTH-21^st Project so that data of the highest quality from different centres can be compared and potentially pooled. A central Ultrasound Quality Unit (USQU) has been set up to oversee this standardisation, training and quality control process. This paper describes the procedures used, which can form a model for research settings involving ultrasound measurements.

Ultrasound methodology used to construct the fetal growth standards in the INTERGROWTH-21st Project

A unified protocol is essential to ensure that fetal ultrasound measurements taken in multicentre research studies are accurate and reproducible. This paper describes the methodology used to take two-dimensional, ultrasound measurements in the longitudinal, fetal growth component of the INTERGROWTH-21^st Project. These standardised methods should minimise the systematic errors associated with pooling data from different sites. They represent a model for carrying out similar research studies in the future. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12313/abstract

The objectives, design and implementation of the INTERGROWTH-21st Project

This paper outlines the objectives, design and implementation of the INTERGROWTH-21^st Project, a multicentre, multiethnic, population-based project conducted in eight geographical areas (Brazil, China, India, Italy, Kenya, Oman, UK and USA), with technical support from four global specialised units, to study growth, health and nutrition from pregnancy to early infancy. It aims to produce prescriptive growth standards, which conceptually extend the World Health Organization (WHO) Multicentre Growth Reference Study (MGRS) to cover fetal and newborn life. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12047/abstract

Introduction to INTERGROWTH-21st Methodology

Zulfiqar Bhutta, Chair of the INTERGROWTH-21^st Steering Committee, introduces the rationale for the INTERGROWTH-21^st Project. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12032/abstract

Preface to INTERGROWTH-21st Methodology

Professor Sir Sabaratnam Arulkumaran, President of FIGO, introduces the methods of the INTERGROWTH-21^st Project. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12314/abstract