Patient Group

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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