Health professionals need to make decisions based on the best available evidence.
Need to determine the quality of evidence to ensure it has a clinically significant impact.
The quality of a research study is related to how the research was conducted.
Findings should be a true and accurate representation, not due to biased methodology.
Peer Review
Check if a research study has been peer-reviewed.
Articles are reviewed by qualified researchers familiar with the topic before publication.
Many journals require several peer reviews before accepting an article.
Check the peer review process on the journal's homepage under author submission guidelines.
Peer review does not guarantee good quality research as the level of scrutiny varies.
Key Terms
Validity: Relates to research using a quantitative methodology.
Rigor: Relates to research using a qualitative methodology.
Applicability of Research
Consider whether the findings can be generalized to other settings.
In quantitative research, generalizability is referred to as external validity.
Control of bias is referred to as internal validity.
Researchers may prioritize internal validity (control of bias) at the expense of external validity (generalizability).
Ideally, research should be both good quality and able to be generalized.
Undertaking Critical Appraisal
Do not just read the abstract and discussion.
Critique each part of the reported research.
Read the entire article at a superficial level first, then read in detail and make notes.
Consider skipping the abstract initially and compare your understanding after detailed reading.
Non-Inferiority Trials
Designed to show that a treatment is equivalent to another treatment.
Relevant when a new treatment offers advantages like improved safety, convenience, compliance, or cost.
Example: Comparing telehealth delivery with in-clinic delivery.
Telehealth offers reduced costs and increased convenience but must demonstrate equivalent efficacy.
N-of-1 Trials
Also referred to as a single case study, it involves a single participant.
Random allocation can be used to determine the order of experimental and control interventions.
Used for people with rare health conditions; increasingly recognized for common conditions.
Critical Appraisal Tools
Guide you through questions evaluating research.
What was the clinical question?
Which study design was used and was it appropriate?
What were the characteristics of the sample and recruitment procedure?
What data were collected and how?
What was the independent variable, and how was it administered (for quantitative research)?
What other potential sources of bias may have affected the study?
What are the results, and are they applicable to practice?
Developing Appraisal Skills
With experience, you may not need a tool.
Recognize common quality pitfalls in specific areas of practice.
Critical appraisal tools ensure a thorough EBP (Evidence-Based Practice) process.
Validity
Concerns the integrity of the findings from a study.
Health practitioners must be aware of the main types of validity.
Internal Validity
Addresses causality: Can we draw a causal relationship between two variables?
Dependent variable (y): The variable researchers need to understand or explain why it varies.
Independent variable (x): The variable believed to produce variation in the dependent variable.
Need to be confident that x causes y and not an extraneous variable.
Example: Birth control classes and increased knowledge of birth control options.
Eliminate other plausible explanations to ensure the independent variable is responsible.
Post Hoc Fallacy:
The logical fallacy that because Y followed X, Y was caused by X.
In Latin: Post hoc ergo propter hoc or post hoc for short.
Other confounding factors might be responsible for changes detected.
External Validity
The degree to which findings can be generalized beyond the study participants.
Research is intended to guide practice, so generalizability is important.
Asks whether causal relationships can be generalized to different measures, persons, settings, and times.
Criticism: Highly controlled studies may only show treatment effectiveness in ideal circumstances.
Ecological Validity
Do the findings of a research study reflect real-life settings?
Researchers often focus on maximizing internal validity, potentially sacrificing external validity.
Academic journals and funding organizations often require high internal validity.
Efficacy Studies
Focus on demonstrating internal validity through highly controlled methodology.
Effectiveness Studies
Follow efficacy studies and are carried out in less controlled, real-life situations.
Establishing External Validity
Consider how well the research, using a sample, can be generalized to the population.
How many participants were involved, and was this a sufficient number to generalize to the population?
Was the sample size justified?
Is a clear description of the key characteristics of the sample provided? For example, the age and gender, and the time of onset of the health condition of interest.
If there were multiple groups in the study, were they comparable in terms of size and participant characteristics?
Were appropriate inclusion and exclusion criteria described?
Identifying Common Types of Bias
Bias can affect the internal and external validity of research.
Internal validity: Identifying a causal relationship between independent and dependent variables.
External validity: Factors like sample size and comparability of different groups.
Bias affects study results in a particular direction, favoring either the treatment or control group.
Categories of Bias
Sample or selection bias
Measurement or detection bias
Intervention or performance bias
Sample or Selection Bias
Volunteer or referral bias
Attention bias
Measurement or Detection Bias
Number of outcome measures used
Lack of ‘masked’ or ‘independent’ evaluation
Recall or memory bias
Intervention or Performance Bias
Contamination
Co-intervention
Timing of intervention
Site of intervention
Different administrators of the intervention
Measurement Errors
Categorized as random or systematic.
Random error: Unpredictable and cannot be controlled.
Systematic error: Predictable and can be identified and eliminated (e.g., imperfect calibration).
Types of Bias
Sample or Selection Bias
Volunteer or Referral Bias
Description: Participants volunteer for the study, potentially being more motivated.
Potential solution: Randomly select participants where possible; invite from waiting lists rather than advertising.
Attention Bias
Description: Awareness of the study's intention might cause participants to perform differently (placebo effect).
Potential solution: Include a control group and, if possible, a placebo treatment.
Intervention or Performance Bias
Contamination
Description: The control group inadvertently receives treatment.
Potential solution: Strict protocols for treatment delivery and control group management.
Co-intervention
Description: A participant receives another intervention simultaneously, influencing results.
Potential solution: Obtain information about medications or other interventions participants are undergoing.
Timing of Intervention
Description: Short duration may not allow noticeable change; long duration may lead to maturation.
Potential solution: Follow treatment protocols; use a control group to address maturation.
Site of Intervention
Description: The intervention site may affect the result.
Potential solution: Ensure consistency across all treatment sites.
Different administrators of the intervention
Description: Different therapists deliver the treatment, leading to variability.
Potential solution: Address therapist variability to ensure more consistent results
Other Limitations in Quantitative Research
Sample characteristics
Dropouts
Method and frequency of measurement
Sample
Questions to ask:
How many participants were involved, and was this a sufficient number to be able to generalize the results of population?
Was the sample size justified? Preliminary studies may involve small sample sizes, but if the researchers aim to demonstrate efficacy, then a larger sample is needed.
Was a clear description of the key characteristics of the same provided (e.g. the age and gender of participants, and the onset of the health condition of interest)?
If there were multiple groups in the study, were they comparable in terms of size and participant characteristics?
Were appropriate inclusion and exclusion criteria described?
Dropouts
Also known as experimental mortality or attrition.
Questions to ask:
Were the number of drops outs reported?
Were the reasons for the dropouts documented?
How did the researchers manage the analysis of the data to deal with any missing data caused by participants dropping out?
Measurement
Questions to ask:
How frequently were the outcomes measured; for example, were they measured before and after treatment, or were short-term and long-term follow-up data also collected?
Did the researchers report whether the outcomes measures used are well- established as being reliable and valid?