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The project summary (sometimes called the abstract) should give the reader a clear description of the central question that the research intends to answer and why the question is important.  In addition, the summary should briefly describe the methods and procedures to be used in the trial.  The clinical, health services delivery, or health policy significance of the expected results should also be mentioned in the summary.

If you are writing a protocol for a particular funding body then the length of the summary may well be limited to 250-1000 words.  Even if there is no fixed word limit, it is best to keep the summary short and succinct.  It is worth noting that the only review panel members to read the entire proposal document are often those specifically responsible for a particular application.  Most members read ONLY the summary.  This makes it crucial that it is written both clearly and comprehensively.

Things to consider when writing a protocol

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Illustrative examples - WHO pre-eclampsia trial

‘Hypertensive disorders of pregnancy (HDP) affect approximately 10% of all pregnancies. The aetiology and pathophysiology of HDP are still largely unknown and an ideal prevention and treatment strategy does not exist. Although there has been progress in perinatal survival, largely due to developments in care of small babies, HDP continue to be major contributors to maternal and perinatal morbidity and mortality, especially in developing countries. The systematic review of randomized controlled trials of calcium supplementation provides promising evidence that calcium supplementation may be effective in preventing HDP in women with low calcium intake. It is important to obtain a reliable, definitive answer to this question for both clinical and programmatic reasons.

The World Health Organization and its collaborating institutions in developing countries propose a double-blind randomized controlled trial (RCT) to evaluate the impact of calcium supplementation (1.5 g/d) started before the twentieth week of pregnancy to nulliparous women with low calcium intake, on the incidence of pre-eclampsia. The proposed trial will enrol approximately 8500 women in seven countries over a period of 18 months. The primary outcomes are the incidence of pre-eclampsia (hypertension and proteinuria) for women and preterm birth for newborns. The sample size calculation is based on a reduction in the rate of pre-eclampsia from 4% in the placebo group to 2.8% in the calcium-supplemented group (30% reduction).

The UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP) of the Department of Reproductive Health and Research (RHR) at WHO will coordinate the study in collaboration with local institutions. If the effectiveness of routine calcium supplementation in preventing pre-eclampsia is confirmed, WHO will develop and circulate recommendations for incorporation of this practice into routine antenatal care.

Nutritional strategies to reach the recommended calcium intake from food sources will also be prepared and disseminated. It is expected that if the research confirms effectiveness, implementation of this low-cost intervention will contribute to the reduction of maternal and perinatal severe morbidity and mortality due to HDP in developing countries. (WHO Multicentre Randomized Trial of Calcium Supplementation for the Prevention of Pre-eclampsia - go to protocol)

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Illustrative examples - Perinatal care trial

Many obstetrical interventions used in Latin America, as in other parts of the world, have been shown to be ineffective or harmful, while effective interventions remain underutilized. The goal of this project is to develop and evaluate an intervention intended to implement evidence-based practices among birth attendants in Latin America.

The aim of this project is to perform a cluster randomized controlled trial of a behavioral intervention in Argentina and Uruguay that will increase the use of two evidence-based birth practices, the selective use of episiotomies and active management of the third stage of labor. The intervention will be based on the stages of change and organizational change theories and tailored by formative research that will include baseline questionnaires and focus groups.

Twenty-four hospitals in three urban districts of Argentina and Uruguay will be randomized. Opinion leaders in the 12 intervention hospitals will be identified and trained to develop evidence-based guidelines. They will then diffuse the guidelines by using a multifaceted approach including seminars, academic detailing, reminders, and feedback on utilization rates.  The 12 hospitals in the nonintervention group will continue with their standard in-service training activities. The main outcomes to be assessed are the use of episiotomies and of oxytocin during the third stage of labor. Secondary outcomes will be perineal sutures, potspartum hemorrhages, and birth attendants’ opinions.

The Latin American Center for Perinatology (CLAP) will be the coordinating center for the trial.  In this way, the project endeavors to facilitate capacity building of CLAP and its network of hospitals to perform studies integrating behavioral and clinical research methods. It is also anticipated that the project will contribute to the Global Network by increasing access to a large number of Latin American hospitals that have the capacity to participate in multicentric randomized controlled trials and other clinical studies’ (CLAP Trial - go to protocol)

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Illustrative examples - CRASH trial

CRASH is a large simple, placebo controlled trial of the effects of a 48-hour infusion of corticosteroids on death and on neurological disability, among adults with head injury and some impairment of consciousness.  Head injured patients with impaired consciousness who are judged to be 16 years or older are eligible if the responsible doctor is for any reason substantially uncertain whether or not to use corticosteroids.  Numbered drug or placebo packs will be available in each participating emergency department.  Randomisation involves calling a 24-hour freephone service. The call should last only a minute or two, and at the end of it the service will specify to the caller which numbered treatment pack to use.  The drug or placebo in the pack is made up in saline and, following a one-hour loading dose, is infused over 48 hours (or as close to 48 hours as possible).  No extra tests are required, but a short form is to be completed two weeks later (or after prior death or discharge).  Long term recovery will be assessed at six months either by a simple questionnaire, sent directly to each trial participant from the CRASH Co-ordinating Centre, or by telephone interview.  This does not involve any additional work for collaborating hospitals. ( CRASH Trial - go to protocol)

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This page was last updated 19th May 2003.