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Introduction to field trials of health interventions

Introduction to field trials of health interventions  

Peter G. Smith, Richard H. Morrow, and David A. Ross

in Field Trials of Health Interventions: A Toolbox (3 ed.)

Print Publication Year: 
Jun 2015
Series: 
Other
Published Online: 
Jun 2015
eISBN: 
9780191797675
DOI: 
10.1093/med/9780198732860.003.0001
Career: 
Allied Health Professional, Doctor, Qualified, early specialism training, Qualified, late specialism training, Qualified, specialist
Specialty: 
Public Health and Epidemiology
Item type: 
chapter
ISBN: 
9780198732860
Most trials of preventive measures, such as immunizations or health education, are ‘ field trials . Important differences in field and clinical trials include inclusion and exclusion criteria that may be less stringent in field trials than criteria often imposed in clinical trials , in which it may be important to have a clearly defined disease condition for treatment. To the extent that there are less stringent inclusion and exclusion criteria, there may be fewer problems with the external validity of trial conclusions than there often are for clinical trials that limit
Field organization and ensuring data of high quality

Field organization and ensuring data of high quality  

Peter G. Smith, Richard H. Morrow, and David A. Ross

in Field Trials of Health Interventions: A Toolbox (3 ed.)

Print Publication Year: 
Jun 2015
Series: 
Other
Published Online: 
Jun 2015
eISBN: 
9780191797675
DOI: 
10.1093/med/9780198732860.003.0016
Career: 
Allied Health Professional, Doctor, Qualified, early specialism training, Qualified, late specialism training, Qualified, specialist
Specialty: 
Public Health and Epidemiology
Item type: 
chapter
ISBN: 
9780198732860
substudy in selected trial participants. A checklist of some of the most important items that it may be necessary to consider when planning a field trial is given in Box Box 16.1 A checklist for planning a field trial 16.1 . Trial investigators should draw up a detailed and specific list tailored to the requirements of their particular trial . Box 16.1 A checklist for planning a field trial 1 Proposed trial • Title • Purpose • Type • Population included: location and numbers involved • Expected duration of trial • Persons in charge:
Trial design

Trial design  

Peter G. Smith, Richard H. Morrow, and David A. Ross

in Field Trials of Health Interventions: A Toolbox (3 ed.)

Print Publication Year: 
Jun 2015
Series: 
Other
Published Online: 
Jun 2015
eISBN: 
9780191797675
DOI: 
10.1093/med/9780198732860.003.0004
Career: 
Allied Health Professional, Doctor, Qualified, early specialism training, Qualified, late specialism training, Qualified, specialist
Specialty: 
Public Health and Epidemiology
Item type: 
chapter
ISBN: 
9780198732860
it is proved to be effective within the field trial . 3.2 Number of interventions compared The choice of the number of different interventions to compare in a field trial is likely to be determined not only by the number of competing alternatives, but also by the implications the choice has on the size of the trial . This, in turn, is dependent on the frequency with which the outcome of interest occurs. ‘Rare’ outcomes require large trials (as discussed in Chapter Chapter 5 Trial size 5 ). For example, in a trial of leprosy vaccines in South India, it was
Ethical considerations

Ethical considerations  

Peter G. Smith, Richard H. Morrow, and David A. Ross

in Field Trials of Health Interventions: A Toolbox (3 ed.)

Print Publication Year: 
Jun 2015
Series: 
Other
Published Online: 
Jun 2015
eISBN: 
9780191797675
DOI: 
10.1093/med/9780198732860.003.0006
Career: 
Allied Health Professional, Doctor, Qualified, early specialism training, Qualified, late specialism training, Qualified, specialist
Specialty: 
Public Health and Epidemiology
Item type: 
chapter
ISBN: 
9780198732860
countries 2.8.6 2.8.6 Consolidated Standards of Reporting Trials (CONSORT) Consolidated Standards of Reporting Trials (CONSORT) 2.8.7 2.8.7 Extending the CONSORT statement to randomized trials of non-pharmacologic treatments Extending the CONSORT statement to randomized trials of non-pharmacologic treatments 2.8.8 2.8.8 Other useful background documents Other useful background documents 3 3 Special issues in field trials in low- and middle-income countries Special issues in field trials in low- and middle-income countries 3.1 3.1 Obtaining communal
Censuses and mapping

Censuses and mapping  

Peter G. Smith, Richard H. Morrow, and David A. Ross

in Field Trials of Health Interventions: A Toolbox (3 ed.)

Print Publication Year: 
Jun 2015
Series: 
Other
Published Online: 
Jun 2015
eISBN: 
9780191797675
DOI: 
10.1093/med/9780198732860.003.0010
Career: 
Allied Health Professional, Doctor, Qualified, early specialism training, Qualified, late specialism training, Qualified, specialist
Specialty: 
Public Health and Epidemiology
Item type: 
chapter
ISBN: 
9780198732860
in the field . Names of villages may have changed or they may be known by different names locally, and villages and households may have been abandoned or been newly formed if the maps are not recent. Checks, and alterations as necessary, should be made on the positions of roads and tracks, health facilities, schools, official offices, markets, churches, mosques, bars, shops, hotels, boreholes, and other locally important features. In field trials , the first time that a map is likely to be needed is for planning the baseline survey. In longer-term field trials where
Trial governance

Trial governance  

Peter G. Smith, Richard H. Morrow, and David A. Ross

in Field Trials of Health Interventions: A Toolbox (3 ed.)

Print Publication Year: 
Jun 2015
Series: 
Other
Published Online: 
Jun 2015
eISBN: 
9780191797675
DOI: 
10.1093/med/9780198732860.003.0007
Career: 
Allied Health Professional, Doctor, Qualified, early specialism training, Qualified, late specialism training, Qualified, specialist
Specialty: 
Public Health and Epidemiology
Item type: 
chapter
ISBN: 
9780198732860
conduct, and reporting of trials to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner (< http://www.ich.org >). In this chapter, we highlight aspects of trial design and conduct that have evolved significantly in recent years, particularly with respect to the role of the sponsor, the functioning of steering committees and data safety and monitoring boards (DSMBs) and requirements for trial registration. 2 The trial sponsor Whenever a field or clinical trial is conducted that involves
Preliminary studies and pilot testing

Preliminary studies and pilot testing  

Peter G. Smith, Richard H. Morrow, and David A. Ross

in Field Trials of Health Interventions: A Toolbox (3 ed.)

Print Publication Year: 
Jun 2015
Series: 
Other
Published Online: 
Jun 2015
eISBN: 
9780191797675
DOI: 
10.1093/med/9780198732860.003.0013
Career: 
Allied Health Professional, Doctor, Qualified, early specialism training, Qualified, late specialism training, Qualified, specialist
Specialty: 
Public Health and Epidemiology
Item type: 
chapter
ISBN: 
9780198732860
people who do not come forward for the trial . It also has the technical advantage that the individuals and communities involved in subsequent rounds of the pilot test will have had similar prior exposure to the procedures to those in the main trial population. The pilot study can often be linked to staff training. For example, in a multi-round field trial of vitamin A supplementation in children, staff received a specific training course that covered all the field data collection methods that would be used in the subsequent trial round. This course lasted a total of
Community engagement

Community engagement  

Peter G. Smith, Richard H. Morrow, and David A. Ross

in Field Trials of Health Interventions: A Toolbox (3 ed.)

Print Publication Year: 
Jun 2015
Series: 
Other
Published Online: 
Jun 2015
eISBN: 
9780191797675
DOI: 
10.1093/med/9780198732860.003.0009
Career: 
Allied Health Professional, Doctor, Qualified, early specialism training, Qualified, late specialism training, Qualified, specialist
Specialty: 
Public Health and Epidemiology
Item type: 
chapter
ISBN: 
9780198732860
the understanding and ownership of key trial issues among front-line staff, and hence their ability to communicate these effectively with the trial community. Training and supportive supervision sessions are likely to need to include information on what a trial is and how the rights of participants are protected in trials , benefits to local communities from this trial , and what happens when the trial ends. Role plays and demonstrations, based on local knowledge and experience, can help to develop a range of strategies for field staff to cope with both expected and
Outcome measures and case definition

Outcome measures and case definition  

Peter G. Smith, Richard H. Morrow, and David A. Ross

in Field Trials of Health Interventions: A Toolbox (3 ed.)

Print Publication Year: 
Jun 2015
Series: 
Other
Published Online: 
Jun 2015
eISBN: 
9780191797675
DOI: 
10.1093/med/9780198732860.003.0012
Career: 
Allied Health Professional, Doctor, Qualified, early specialism training, Qualified, late specialism training, Qualified, specialist
Specialty: 
Public Health and Epidemiology
Item type: 
chapter
ISBN: 
9780198732860
smears for malaria. All these options have important consequences on the trial logistics and cost, so careful consideration needs to be given to them when designing the trial and selecting its study outcomes. Issues concerning laboratory tests of relevance to diagnosis in field trials are outlined in Chapter Chapter 17 Field laboratory methods 17 . 2.2.3 Lay worker-based case definitions Some trials use lay workers (fieldworkers) to measure a study outcome. Examples of such trials are diarrhoeal diseases where prevalent diarrhoea might be defined as three
Field Stimulation

Field Stimulation  

Ehren R. Nelson, Andrew Vaclavik, and Milan P. Stojanovic

in Surgical Pain Management: A Complete Guide to Implantable and Interventional Pain Therapies

Print Publication Year: 
Feb 2016
Series: 
Other
Published Online: 
Apr 2016
eISBN: 
9780199377398
DOI: 
10.1093/med/9780199377374.003.0010
Career: 
Doctor, Qualified, specialist, Qualified, late specialism training, Qualified, early specialism training
Specialty: 
Clinical Medicine, Pain Medicine, Anaesthetics, Surgery
Item type: 
chapter
ISBN: 
9780199377374
Chapter 10 Field Stimulation Ehren R. Nelson , Andrew Vaclavik , and Milan P. Stojanovic Introduction Introduction Preoperative Considerations Preoperative Considerations Non-Surgical and Medical Management Non-Surgical and Medical Management Goals Goals Advantages Advantages Patient Screening and Trial of Therapies Patient Screening and Trial of Therapies Field Stimulation Overview Field Stimulation Overview Alternative Therapies Alternative Therapies Trial Trial Preparing the Patient for Surgery
Types of intervention and their development

Types of intervention and their development  

Peter G. Smith, Richard H. Morrow, and David A. Ross

in Field Trials of Health Interventions: A Toolbox (3 ed.)

Print Publication Year: 
Jun 2015
Series: 
Other
Published Online: 
Jun 2015
eISBN: 
9780191797675
DOI: 
10.1093/med/9780198732860.003.0002
Career: 
Allied Health Professional, Doctor, Qualified, early specialism training, Qualified, late specialism training, Qualified, specialist
Specialty: 
Public Health and Epidemiology
Item type: 
chapter
ISBN: 
9780198732860
2.2.2 Surgical and radiation treatment RCTs of surgical and radiation treatments are usually done as clinical trials ; field trials of these interventions are relatively uncommon. However, procedures, such as cataract extraction or simple inguinal hernia repair, are examples of where field trials have been usefully undertaken. In general, the only distinctive feature that may set these apart, in terms of study design, from other field trials is the issue of ‘blinding’ (see Chapter Chapter 11 Randomization, blinding, and coding 11 , Section 4 Blinding 4
Trial size

Trial size  

Peter G. Smith, Richard H. Morrow, and David A. Ross

in Field Trials of Health Interventions: A Toolbox (3 ed.)

Print Publication Year: 
Jun 2015
Series: 
Other
Published Online: 
Jun 2015
eISBN: 
9780191797675
DOI: 
10.1093/med/9780198732860.003.0005
Career: 
Allied Health Professional, Doctor, Qualified, early specialism training, Qualified, late specialism training, Qualified, specialist
Specialty: 
Public Health and Epidemiology
Item type: 
chapter
ISBN: 
9780198732860
5.2 Comparison of more than two groups Field trials comparing two groups (for example, intervention and control, or treatment A and treatment B) are by far the commonest. However, in some trials , three or more groups may be compared. For example, in a trial of a new vaccine, there may be four trial groups receiving different doses of the vaccine. It is unusual for field trials to have more than four groups, because of logistical constraints or trial size limitations. It is suggested that, in designing a trial with three or more groups, the investigator should
Preparing grant applications

Preparing grant applications  

Peter G. Smith, Richard H. Morrow, and David A. Ross

in Field Trials of Health Interventions: A Toolbox (3 ed.)

Print Publication Year: 
Jun 2015
Series: 
Other
Published Online: 
Jun 2015
eISBN: 
9780191797675
DOI: 
10.1093/med/9780198732860.003.0008
Career: 
Allied Health Professional, Doctor, Qualified, early specialism training, Qualified, late specialism training, Qualified, specialist
Specialty: 
Public Health and Epidemiology
Item type: 
chapter
ISBN: 
9780198732860
to cost the trial carefully, and justify all the costs requested. 5.9 How will the project be supervised and administered? The grant application should demonstrate, for the conduct and analysis of the trial , that the trial team either has all the necessary skills and experience or will have access to the appropriate expertise. This may include aspects of trial governance and monitoring of GCP and Good Clinical Laboratory Practice (GCLP) (see Chapters Chapter 16 Field organization and ensuring data of high quality 16 and Chapter 17 Field laboratory methods
Reporting and using trial results

Reporting and using trial results  

Peter G. Smith, Richard H. Morrow, and David A. Ross

in Field Trials of Health Interventions: A Toolbox (3 ed.)

Print Publication Year: 
Jun 2015
Series: 
Other
Published Online: 
Jun 2015
eISBN: 
9780191797675
DOI: 
10.1093/med/9780198732860.003.0023
Career: 
Allied Health Professional, Doctor, Qualified, early specialism training, Qualified, late specialism training, Qualified, specialist
Specialty: 
Public Health and Epidemiology
Item type: 
chapter
ISBN: 
9780198732860
progress. From an early stage in a trial , it is often useful to involve or to consult a person with past experience in communicating with policy makers and the general public about the conduct of a trial , ideally someone familiar with research in the context of the trial . At a minimum, in a large field trial , it is advisable to involve such an expert during the planning of the overall trial communication action plan and during the planning of the final dissemination of the findings of the trial . A useful starting point is for the trial team to construct a list of all
How Diagnostic Manuals Are Made

How Diagnostic Manuals Are Made  

Joel Paris

in The Intelligent Clinician's Guide to the DSM-5® (2 ed.)

Print Publication Year: 
Feb 2015
Series: 
Other
Published Online: 
Apr 2015
eISBN: 
9780190243982
DOI: 
10.1093/med/9780199395095.003.0003
Career: 
Doctor, Undergraduate Doctor, Qualified, early specialism training, Allied Health Professional, Qualified AHP, Nurse, Qualified Nurse
Specialty: 
Psychiatry
Item type: 
chapter
ISBN: 
9780199395095
over time as new data come in. Field Trials To determine whether new diagnostic methods are feasible and valid, one needs to conduct field trials . These procedures involve testing new procedures on suitable patient populations, determining reliability and clinical utility. Field trials were carried out in several clinical settings in 2011 and 2012. On the positive side, samples were generally large and fairly representative of practice, and clinicians—not researchers—made the ratings. However, these trials began too late in the process, leaving little
Field laboratory methods

Field laboratory methods  

Peter G. Smith, Richard H. Morrow, and David A. Ross

in Field Trials of Health Interventions: A Toolbox (3 ed.)

Print Publication Year: 
Jun 2015
Series: 
Other
Published Online: 
Jun 2015
eISBN: 
9780191797675
DOI: 
10.1093/med/9780198732860.003.0017
Career: 
Allied Health Professional, Doctor, Qualified, early specialism training, Qualified, late specialism training, Qualified, specialist
Specialty: 
Public Health and Epidemiology
Item type: 
chapter
ISBN: 
9780198732860
quality assurance (QA) arrangements ( World Health Organization, 2009 ). The organization and operation of a field laboratory for the support of a field trial are different from those of a routine medical laboratory and have become more demanding in recent years. Laboratory accreditation (see Section 6 Accreditation and links between laboratories 6 ) may be necessary when laboratory data are required for the process of product licensure. In field trials , the emphasis is often on the collection and processing of large numbers of samples, on which only a few specific
Social and behavioural research

Social and behavioural research  

Peter G. Smith, Richard H. Morrow, and David A. Ross

in Field Trials of Health Interventions: A Toolbox (3 ed.)

Print Publication Year: 
Jun 2015
Series: 
Other
Published Online: 
Jun 2015
eISBN: 
9780191797675
DOI: 
10.1093/med/9780198732860.003.0015
Career: 
Allied Health Professional, Doctor, Qualified, early specialism training, Qualified, late specialism training, Qualified, specialist
Specialty: 
Public Health and Epidemiology
Item type: 
chapter
ISBN: 
9780198732860
in social research 3 , we outline qualitative methods that are commonly incorporated in the design and conduct of intervention trials . Rather than detailing all possible methods, examples are given of how different methods can be used in the context of such trials . 1.1 Formative research to define the intervention package All of the component parts of an intervention (the ‘intervention package’) to be tested in the field trial and the method of delivering the intervention should be clearly defined. To maximize the potential for the intervention package
Basic understanding and tools

Basic understanding and tools  

Andrew Moore and Henry McQuay

in Bandolier's Little Book of Making Sense of the Medical Evidence

Print Publication Year: 
Jul 2006
Series: 
Other
Published Online: 
Jul 2013
eISBN: 
9780191769672
DOI: 
10.1093/med/9780198566045.003.0001
Career: 
Doctor, Undergraduate Doctor, Qualified, early specialism training, Qualified, late specialism training, Qualified, specialist
Specialty: 
Professional Development in Medicine, Clinical Medicine
Item type: 
chapter
ISBN: 
9780198566045
of large trials with small trials with different quality criteria Common comparator Comparison Ratio of odds ratios (95% CI) Large trials Small trials with inadequate generation of allocation sequence 0.46 (0.25 to 0.83) Large trials Small trials with adequate generation of allocation sequence 0.90 (0.47 to 1.76) Large trials Small trials with inadequate allocation concealment 0.49 (0.27 to 0.86) Large trials Small trials with adequate allocation concealment 1.01 (0.48 to 2.11) Large trials Small
Randomization, blinding, and coding

Randomization, blinding, and coding  

Peter G. Smith, Richard H. Morrow, and David A. Ross

in Field Trials of Health Interventions: A Toolbox (3 ed.)

Print Publication Year: 
Jun 2015
Series: 
Other
Published Online: 
Jun 2015
eISBN: 
9780191797675
DOI: 
10.1093/med/9780198732860.003.0011
Career: 
Allied Health Professional, Doctor, Qualified, early specialism training, Qualified, late specialism training, Qualified, specialist
Specialty: 
Public Health and Epidemiology
Item type: 
chapter
ISBN: 
9780198732860
was used in a trial of ivermectin against onchocerciasis in Sierra Leone was to allocate 20 codes for ivermectin or placebo treatments (A, B, C, D, and so on) ( Whitworth et al., 1991 ). The drugs were taken to the field in 20 tins, with the code letters on them (ten of which contained ivermectin, and ten contained placebo tablets), and participants were allocated to one of the 20 codes at random. If a participant was allocated, say to code E, then each time they were treated, the dose was taken from tin E. About 1000 patients were included in the trial , so that breaking
Squamous cell carcinoma of the anus

Squamous cell carcinoma of the anus  

Rob Glynne-Jones and Mark Harrison

in External Beam Therapy (3 edn)

Print Publication Year: 
May 2019
Series: 
Radiotherapy in Practice
Published Online: 
Jun 2019
eISBN: 
9780191828881
DOI: 
10.1093/med/9780198786757.003.0009
Career: 
Doctor, Qualified, late specialism training
Specialty: 
Radiology, Clinical Oncology
Item type: 
chapter
ISBN: 
9780198786757
randomized phase III study has published the site(s) of local failure (within, marginal to, or outside of the radiotherapy field ). Therefore it remains uncertain whether the majority of loco-regional failure is due to inadequate clinical target volumes (CTVs), insufficient radiation dose, or intrinsic radio-resistance, but preliminary data from the ACT II trial suggest the majority of loco-regional failure is in- field ( 8 ) . The ACT II trial mandated a total dose of 50.4 Gy, which probably delivered in the region of 53 Gy. Many centres in Europe and other parts of

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