Who’s your Patient group?
What’s your Intervention / Exposure?
Have you got a Comparator?
What Outcomes are you interested in?
What Study type would best address the question?
Only use these sites:
Cochrane Library – http://www.thecochranelibrary.com
NHS Evidence – http://www.evidence.nhs.uk
PubMed – http://www.pubmed.gov
TRIPdatabase – http://www.tripdatabase.com
Description
A clinical trial needs a carefully structured, written plan in order not only to ensure its smooth running and successful conclusion but also to gain the compulsory agreement of an ethical committee. Such a plan is called a protocol. It consists of several stages. These are:
1 An introduction;
2 A statement of aims, objectives, hypotheses and the calculation of sample size;
3 A detailed account of the methodology, which itself is divided into a number of sections including the methods used in the statistical analysis of the data;
4 A study schedule and costing;
5 Any necessary appendices; and
6 A supporting bibliography.
ABSTRACT
Introduction
Methods and analysis
Ethics and dissemination
INTRODUCTION
METHODS AND ANALYSIS Criteria for considering studies for this review
Type of studies
Type of participants
Types of interventions
Types of outcome measures Primary outcomes
Pain intensity
Secondary outcomes
Search methods for identification of studies
Electronic searches
Searching other resources
Data collection and analysis
Selection of studies
Data extraction and management
Assessment of risk of bias in included studies
Measures of treatment effect
Unit of analysis issues
Dealing with missing data
Assessment of heterogeneity
Assessment of reporting biases
Data synthesis
Subgroup analysis
Sensitivity analysis
DISCUSSION
REFERENCES
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