75196 - Nursing and Midwifery Research

Learning outcomes

At the end of the course students should investigate the nursing and midwifery organizational, educational and care processes related to the evolution of the health problems of the population, the functioning of health and social systems and specific paths of professionalization.

Course contents

General introduction:
Health research: Objectives and areas of basic, clinical, health services, qualitative research
Biomedical information: Primary research: observational and experimental studies

Clinical research architecture
Study design, objectives and main biases:
o Observational: descriptive (case reports, case series) and analytical (case-control, cohort, cross-sectional)
o Experimental: uncontrolled trials, non-randomized controlled trials, randomized controlled trials

From the research question to the study design
• Define the study's objective: etiology, prognosis, diagnosis, prevention / therapy
• Structuring the research question: the PICO model
• Carry out a systematic review of published studies and ongoing studies
• Primary databases: MEDLINE, EMBASE, CINHAL
• Systematic review databases: Cochrane Database of Systematic Reviews (CDSR), Database of Abstracts of Reviews of Effects (DARE)
• trials Registers (ClinicalTrials.gov) and systematic reviews (PROSPERO)
• Verify the relevance of the research question in relation to the available evidence
• Refine the research question
• Choose the most appropriate study design

Research designs: trials Classification
Uncontrolled trials, non-randomized controlled trials, randomized controlled trials (RCTs)

clinical trials variats
1. Explanatory trial (efficacy) vs pragmatic trials (effectiveness)
2. Trial of equivalence and non-inferiority
3. Phase I, II, III, IV trials
4. Trial with parallel, crossover, factorial design
5. Trials that randomize body parts, individuals, groups of individuals (cluster RCTs)
6. Trial with fixed vs variable sample
7. Trial in open and blinded (blinded)
8. Trials that consider the preferences of the participants

Bias in clinical trials

Quality of clinical trials
1. Internal validity, clinical relevance, applicability
2. Ethics, integrity and social value

Planning and management
Scientific and rational background, Hypotheses and objectives: definition of the research question Participants: inclusion and exclusion criteria, setting and timing of enrollment, Experimental intervention and control, Primary outcome and secondary outcomes; Statistical aspects: sample size estimation, definition of stopping rules, planning of ad-interim analyzes. Randomization and blinding methods and techniques. Follow-up

Analysis and interpretation of the results
flow chart of the participants: enrollment, randomization, allocation, follow-up, analysis.
Protocol violations and related reasons; Baseline data of the participants, Choice of statistical tests, Analysis of the primary outcome: intention-to-treat vs per-protocol analysis. Secondary analyzes: subgroup and adjusted analyzes. Calculation of efficacy measures (RR, RRR, OR, ARR, NNT) and confidence limits.

Observational Studies
Classification of observational studies
cohort studies, case-control studies, cross-sectional studies Ethical aspects of observational research Hypotrophy and limited methodological quality of diagnostic, etiological and prognostic research

Diagnostic Research
Objective: to evaluate the accuracy of a diagnostic test
The cross-sectional study
Design and main biases. Planning and management methodologies

Etiological Research
• Objective: to identify the etiological responsibility of a disease risk factor

Architecture of etiological research Descriptive studies: case reports, case series Analytical studies: cohort studies with parallel cohort, traditional and nested case-control studies Cohort studies and case control studies : design and main biases, advantages and disadvantages, planning and management methodologies, data analysis association measures (relative risk, odds-ratio) Quality criteria of the etiological studies

The Prognostic Research
• Objective: to evaluate the natural history of the disease and the power of prognostic factors.

Architecture of prognostic research: prospective and retrospective cohort studies. Phases of prognostic research: development of the prognostic model, validation studies, impact studies, cohort studies: design and main biases, planning and management methodologies, data analysis. Quality criteria of prognostic studies. Observational reporting: the STROBE Statement

Ethical Aspects of Research and Publication Protecting Participants: The Helsinki Declaration Privacy and Confidentiality

Editorial aspects of the publication Obligation to register clinical trials and publish negative studies Copyright and the PARC addendum

Drafting of the manuscript
• Reporting guidelines: CONSORT, STARD, STROBE, PRISMA, etc.
• Title
• Notification of conflicts of interest
• Abstract and keywords
• The IMRaD structure
• Bibliography: styles, formats, reference management software
• Tables and figures
• Units of measurement, abbreviations and symbols

 

From submission to publication
• Choose the right Journal
• Follow the instructions for the authors
• Prepare the cover letter
• Wait for the outcome of the editorial process
• Respond to reviewers and "deal" with the publisher

Organizational research:

Features. Evolution and criticality with respect to clinical research
The research path: objectives, questions / hypotheses and research variables.
Organizational research designs: peculiarities and weaknesses.
The indications of the Cochrane Collaboration

Readings/Bibliography

Fondamenti di Ricerca Infermieristica 2/ed
Denise F. Polit, Cheryl Tatano Beck.

Teaching methods

Series of reports on a pre-arranged theme
Work in small groups on problems and clinical cases with production of a final report to be discussed with an expert
Direct execution by all students of practical or technical activities

Assessment methods

production of its own research protocol

Teaching tools

Computer

power point slides

check list and format to produce a scientific protocol

Office hours

See the website of Cristiana Forni