The rapid advances that have been made in molecular biology and molecular methods have led, and continue to lead, to the development of sensitive and specific diagnostic tests, which hold the promise of substantially strengthening our ability to diagnose, treat and control many of the major infectious diseases in developing countries. It is imperative that these new diagnostics are rigorously and properly evaluated in the situations in which they will be deployed in disease control before they are released for general use. A poorly performing diagnostic might not only waste resources but might also impede disease control. The basic procedures described in this booklet for designing and conducting diagnostic evaluations provide an outline for ensuring the proper evaluation of new diagnostics in laboratory and field trials.

Malaria is making a dramatic comeback in the world. The disease is the foremost health challenge in Africa south of the Sahara, and people traveling to malarious areas are at increased risk of malaria-related sickness and death. This book examines the prospects for bringing malaria under control, with specific recommendations for U.S. policy, directions for research and program funding, and appropriate roles for federal and international agencies and the medical and public health communities. The volume reports on the current status of malaria research, prevention, and control efforts worldwide. The authors present study results and commentary on the: Nature, clinical manifestations, diagnosis, and epidemiology of malaria. Biology of the malaria parasite and its vector. Prospects for developing malaria vaccines and improved treatments. Economic, social, and behavioral factors in malaria control.

Introduction We know that translating new knowledge from research into change in health care delivery is not a simple process. This thesis examines this process for a new technology applied to primary health care in tropical countries: including RDTs in clinical guidelines for treating fever in children Method The thesis examines the question: -does implementing policy of using RDTs to target treatment instead of presumptive treatment of fever result in better quality patient care under experimental conditions as well as in routine practice?‖ Three methodological approaches are used to delineate translation to change in the field. A Cochrane review of randomised trials examines effects on quality of care in a trial, where delivery conditions are usually optimal. An analysis of a dataset from an effectiveness trial from Uganda examines effects of the policy on quality of care delivered within the context of a trial through routine health services. And third, a survey of current practice assesses implementation of an RDT-based guideline when it is introduced into the health system for routine use in selected districts. Across all three components, the thesis examines implementation of the guideline. In addition, both the systematic review and the effectiveness trial measure effects of the intervention on prescribing of antimalarials and antibiotics, and clinical outcomes (primary outcomes).The effectiveness trial evaluates effects of the policy on incremental cost, and the survey of current practice also assesses adequacy of essential health systems inputs and support services. Results The systematic review showed that HWs prescribed antimalarials to as many as 40% to 80% of cases with negative RDTs under experimental conditions. Use of RDTs was associated with 29% decline in prescribing of antimalarial drugs. Prescribing of antibiotics did not change in one trial but increased by 19% in another. Data from the effectiveness trial show that HWs used RDTs and adhered to RDT results almost all the time. This reduced antimalarials usage by 60.2% (high), 48.9% (medium) and by 22.1% (low). The data show no significant change in usage of antibiotics. Both the review and the pragmatic trial detected no significant difference in clinical outcomes between RDT and clinical diagnosis arms. Data from the effectiveness trial shows that use of RDTs is associated with a cost-saving of US$ 0.50 per case of fever (24.5% decline) in low transmission setting, and a cost-saving of US$ 0.33 per case of fever (17.7% decline) in medium transmission. Use of RDTs did not lead to a significant change in cost in high transmission settings: US$ +0.02 (95% CI: US$ -0.97 to US$+1.06). Cost-savings were accrued exclusively in older children and adults. The survey found inadequate implementation of all components of the guideline in both districts. Essential supplies, equipment and in-service training were inadequate in both districts. Discussion and conclusion Antimalarial use is lower when RDTs are used to guide treatment of fever instead of presumptive treatment. This results in savings from drugs costs in older children and adults with fever in low and medium transmission areas. This research does not confirm whether or not use of RDT-based guidelines has any effects on usage of antibiotics or clinical outcomes. A case study of Uganda shows that when delivered through routine services, none of the components of an RDT-based guideline is implemented to acceptable standards. There is insufficient evidence to suggest that the policy is superior to presumptive treatment of fever in terms of clinical outcomes. However, it can save money for medicines in low and medium transmission settings if its use is restricted to older children and adults.

This is an open access title available under the terms of a CC BY-NC 4.0 International licence. It is free to read at Oxford Scholarship Online and offered as a free PDF download from OUP and selected open access locations. Before new interventions are released into disease control programmes, it is essential that they are carefully evaluated in field trials'. These may be complex and expensive undertakings, requiring the follow-up of hundreds, or thousands, of individuals, often for long periods. Descriptions of the detailed procedures and methods used in the trials that have been conducted have rarely been published. A consequence of this, individuals planning such trials have few guidelines available and little access to knowledge accumulated previously, other than their own. In this manual, practical issues in trial design and conduct are discussed fully and in sufficient detail, that Field Trials of Health Interventions may be used as a toolbox' by field investigators. It has been compiled by an international group of over 30 authors with direct experience in the design, conduct, and analysis of field trials in low and middle income countries and is based on their accumulated knowledge and experience. Available as an open access book via Oxford Medicine Online, this new edition is a comprehensive revision, incorporating the new developments that have taken place in recent years with respect to trials, including seven new chapters on subjects ranging from trial governance, and preliminary studies to pilot testing.