Articles

Basic Neonatal Care Manual

The INTERGROWTH-21^st Project used this manual to standardize definitions, treatment and management recommendations of neonatal morbidities.  http://www.medscinet.net/Intergrowth/patientinfodocs/Neonatal%20Manual%20Final.pdf

Anthropometry Handbook

This handbook describes the methods used to perform accurate, precise and standardized anthropometric measurements for all components of the INTERGROWTH-21^st study, including:

• height and weight of pregnant mothers
• birth weight, length and head circumference of newborns
• weight, length and head circumference of preterm babies

Measurement of Symphysis Fundus Height Protocol

This protocol outlines the technique for measuring symphysis fundus height. http://www.medscinet.net/Intergrowth/patientinfodocs/Measurement%20of%20Symphysis%20Fundus%20Height.pdf

Blood Pressure Measurement Protocol

This protocol outlines the technique for taking a pregnant woman's blood pressure. http://www.medscinet.net/Intergrowth/patientinfodocs/BP%20protocol.pdf

Ultrasound Operations Manual

The aims of this manual are to ensure all trained ultrasonographers are familiar with the standardized way measurements should be taken for the purposes of using the INTERGROWTH-21^st growth standards, including standardization of the way the equipment should be used, ultrasound findings are recorded, data is entered and transfered, and how to train, asesses and certify these standardized techniques.  http://www.medscinet.net/Intergrowth/patientinfodocs/US%20Manual%20FINAL.pdf

Correct Measurement of Fetal Crown Rump Length and Standardization of Ultrasonographers

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-21^st fetal growth standards. http://www.medscinet.net/Intergrowth/patientinfodocs/CRLstandardisation_Website.pdf

Sleep-Wake Cycle Assessment Manual

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

The basic requirements for new sites wanting to take part in clinical research - What sites need to know!

Climate change and the emergence of vector-borne diseases in Europe: case study of dengue fever

Article looks at the risk of dengue fever outbreaks in southern Europe as temperatures increase. Abstract Background Dengue fever is the most prevalent mosquito-borne viral disease worldwide. Dengue transmission is critically dependent on climatic factors and there is much concern as to whether climate change would spread the disease to areas currently unaffected. The occurrence of autochthonous infections in Croatia and France in 2010 has raised concerns about a potential re-emergence of dengue in Europe. The objective of this study is to estimate dengue risk in Europe under climate change scenarios. Methods We used a Generalized Additive Model (GAM) to estimate dengue fever risk as a function of climatic variables (maximum temperature, minimum temperature, precipitation, humidity) and socioeconomic factors (population density, urbanisation, GDP per capita and population size), under contemporary conditions (1985–2007) in Mexico. We then used our model estimates to project dengue incidence under baseline conditions (1961–1990) and three climate change scenarios: short-term 2011–2040, medium-term 2041–2070 and long-term 2071–2100 across Europe. The model was used to calculate average number of yearly dengue cases at a spatial resolution of 10 × 10 km grid covering all land surface of the currently 27 EU member states. To our knowledge, this is the first attempt to model dengue fever risk in Europe in terms of disease occurrence rather than mosquito presence. Results The results were presented using Geographical Information System (GIS) and allowed identification of areas at high risk. Dengue fever hot spots were clustered around the coastal areas of the Mediterranean and Adriatic seas and the Po Valley in northern Italy. Conclusions This risk assessment study is likely to be a valuable tool assisting effective and targeted adaptation responses to reduce the likely increased burden of dengue fever in a warmer world.

Five keys to improving research costing in low- and middle-income countries

ESSENCE on Health Research have created a good practice document on research costing. It includes a review of the funding practices related to the definition and funding of direct and indirect costs. 

A template for writing a research protocol

Technology issues for research in remote areas/developing regions

Researchers can often be tripped up by issues they encounter in developing regions and remote areas. Although no definitive answers are provided (there are just too many options and unknowns), the following issues should be considered when planning such a trial.  

PRISMA for Abstracts: Reporting Systematic Reviews in Journal and Conference Abstracts

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.

Good Clinical Practice in Resource-Limited Settings: Translating Theory into Practice

Research Misconduct in Low- and Middle-Income Countries.

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.

5 ways statistics can fool you—Tips for practicing clinicians

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.

GCP-compliant data management in multinational clinical trials.

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.

Templates for Informed Consent and Participant Information Sheet

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

Reviewing Clinical Trials: A Guide For The Ethics Committee

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.