PHDH908 Intervention studies

Contents and structure

The course gives the candidates a nuanced insight into different aspects of planning, conducting and applying intervention studies. The theoretical and methodological basis for the various phases of a clinical study, planning and development, evaluation and implementation is elucidated on the basis of the Medical Research Council's (MRC) Framework for Complex Interventions. The course emphasizes experimental methodology, ethical issues, quality assurance and results assessment.

Learning Outcome

A PhD-student who completed course shall achieve the following learning outcomes defined in knowledge, skills and general competence:

Knowledge:
The student ...

• has extensive knowledge of designing complex interventions (modeling and design phase, pilot / feasibility studies, evaluation design and implementation)
• has extensive knowledge of different types of intervention study designs
• has extensive knowledge in assessing choice of endpoint and sample size
• has extensive knowledge about the evaluation of results from intervention studies
• has knowledge of monitoring intervention studies

Skills:
The student ...

• is able to problematize existing theory and practice and identify knowledge gaps in the health service
• can evaluate literature and use systematic reviews and evidence-based recommendations to design intervention studies
• can design issues research based on the best available evidence from research, individual clinical expertise, the patient’s values, needs and circumstances, and the practice context
• can design a protocol for an intervention study
• can problematize randomization, stratification, blinding and bias
• can apply relevant legislation, regulations for registration of clinical studies and can prepare applications to relevant bodies
• can assess the outcome of an intervention study (statistical versus clinical significance)

General competence:
The student ...

• is in the knowledge front when it comes to being able to plan, conduct and evaluate the effect of intervention in clinical trials in line with current regulations
• can identify and analyze relevant research ethical issues in planning, conducting and evaluating intervention studies
• can initiate and facilitate user involvement at all stages of the research process
• can disseminate research and development work to different target groups
• can assess the need for and initiate innovation work

Entry requirements

Master's degree with 120 ECTS credits or equivalent in relevant academic fields.

Number of participants: The course requires a minimum of 5 and a maximum of 20 participants. Furthermore, the number of PhD students participating must be 50% or more of the total number of participants

Teaching methods

The course is conducted as a combination of synchronous and asynchronous lectures and web seminars.

Compulsory learning activities

None

Assessment

Task
Individual written assignment in accordance with the learning outcomes decription of the course. Maximum scope of 3500 words.

Grading
Pass / fail

If failing to pass, a second exam date allows for an improved version of the assignment to be handed- in.