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Related Concept Videos

Observational Studies01:11

Observational Studies

10.5K
Observational studies are a type of analytical study where researchers observe events without any interventions. In other words, the researcher does not influence the response variable or the experiment's outcome.
There are three types of observational studies – Prospective, retrospective, and cross-sectional.
Prospective Study
Prospective studies, also known as longitudinal or cohort studies, are carried out by collecting future data from groups sharing similar characteristics. One...
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Study Designs in Epidemiology01:20

Study Designs in Epidemiology

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Epidemiological study designs are fundamental tools for investigating the distribution, determinants, and control of health conditions in populations. They help researchers understand the relationships between exposures and outcomes, and they broadly fall into two categories: "observational" and "experimental" studies.
Observational studies are those where the researcher does not intervene but rather observes natural variations. They include cross-sectional, cohort, and...
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Blind Procedures02:07

Blind Procedures

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Ideally, the people who observe and record the children’s behavior are unaware of who was assigned to the experimental or control group, in order to control for experimenter bias. Experimenter bias refers to the possibility that a researcher’s expectations might skew the results of the study. Remember, conducting an experiment requires a lot of planning, and the people involved in the research project have a vested interest in supporting their hypotheses. If the observers knew which...
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Naturalistic Observations02:30

Naturalistic Observations

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If you want to understand how behavior occurs, one of the best ways to gain information is to simply observe the behavior in its natural context. However, people might change their behavior in unexpected ways if they know they are being observed. How do researchers obtain accurate information when people tend to hide their natural behavior? As an example, imagine that your professor asks everyone in your class to raise their hand if they always wash their hands after using the restroom. Chances...
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Blinding01:11

Blinding

3.7K
Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.
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Study Design in Statistics01:15

Study Design in Statistics

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A study design is a set of techniques that allow a researcher to collect and analyze data from different variables defined for a specific research problem. Statistics is commonly for effective study design and more robust experiments,
Does aspirin reduce the risk of heart attacks? Is one brand of fertilizer more effective at growing roses than another? Is fatigue as dangerous to a driver as the influence of alcohol? Questions like these are answered using randomized experiments with proper...
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Observational Study Protocol for Repeated Clinical Examination and Critical Care Ultrasonography Within the Simple Intensive Care Studies
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Standardized Protocol Items Recommendations for Observational Studies (SPIROS) for Observational Study Protocol

Raman Mahajan1,2, Sakib Burza2, Lex M Bouter3,4

  • 1Care and Public Health Research Institute, Maastricht University, Maastricht, Netherlands.

JMIR Research Protocols
|October 21, 2020
PubMed
Summary
This summary is machine-generated.

Developing Standardized Protocol Items Recommendations for Observational Studies (SPIROS) guidelines is crucial for improving the quality and transparency of observational research. These expert-based recommendations will enhance protocol completeness and reproducibility in epidemiology.

Keywords:
DelphiSPIROSguidelinesobservational studiesprotocol

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Area of Science:

  • Epidemiology
  • Biostatistics
  • Medical Research Methodology

Background:

  • Observational studies constitute approximately 90% of published research.
  • Lack of standardized protocols hinders assessment of bias and protocol deviations.
  • No current comprehensive guidance exists for observational study protocols.

Purpose of the Study:

  • To formulate the Standardized Protocol Items Recommendations for Observational Studies (SPIROS) reporting guidelines.
  • Focus on three core analytical epidemiology designs: cohort, case-control, and cross-sectional studies.
  • Enhance the quality, transparency, and reproducibility of observational research.

Main Methods:

  • Scoping review of published observational study protocols to identify candidate items.
  • Extended item list with Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) checklist.
  • Two-round Delphi survey with experts to achieve consensus on essential protocol items.
  • Expert-driven consensus workshop to finalize SPIROS reporting guidelines.

Main Results:

  • A scoping review identified 59 candidate items for the SPIROS guidelines.
  • The Delphi survey was launched in early 2020 to gather expert consensus.
  • The process involves expert rating on a 5-point Likert scale for item relevance.

Conclusions:

  • SPIROS aims to improve the timeliness, completeness, and clarity of observational study protocols.
  • Expert-based recommendations will facilitate the preparation and registration of high-quality protocols.
  • Implementation of SPIROS guidelines will enhance the transparency and reproducibility of observational studies.