Randomized study of the impact of a therapeutic education program on patients suffering from chronic low-back pain who are treated with transcutaneous electrical nerve stimulation

Thomas Garaud, MDa , Christine Gervais, CRNAb , Barbara Szekely, MDa,b, Mireille Michel-Cherqui, MDa,b, Jean-Franois Dreyfus, MDc , Marc Fischler, MDa,

Critical Appraisal Practice Part II Assignment

Purpose: Practice appraising the trustworthiness of quantitative research.

Appraising evidence in published literature is a multi-step process. This second part of the appraisal process provides a systematic approach to reading, understanding, and appraising the methods, results, discussion, and conclusion sections of a research study.

continue practicing this process with the quantitative research study introduced in Week 2 and used in Week 4 of this course.

To prepare

• Read 5 in the textbook
• Review Chapter 4 as needed
• View all videos/topics in Week 5 Lesson folder
• Check your knowledge with the Week 5 Quiz
• Review Tables 5-2, 5-4, 5-5
• Access the sample research study for this assignment.

Instructions:

1. Read the sample research study.
2. Complete the table below based on information you gather from the sample study.
   1. Provide the article reference at the top of the table.
   2. In the "Rationale" sections, provide specific information/details from the study that addresses each question listed above it. Do not alter or delete any of the existing text in the table.
   3. Indicate your overall appraisal of the section of the study in the far right column based on your rationale.

Source Reference: Garaud, T., Gervais, C., Szekely, B., Michel-Cherqui., Dreyfus, Jean-Francois, D., & Fischler, M. (2018). Medicine. Randomized study of the impact of a therapeutic education program on patients suffering from chronic low-back pain who are treated with transcutaneous electrical nerve stimulation: https://doi.org/10.1097/MD.0000000000013782

Study Section	Content	Questions to Ask	Appraisal (Check one)
Methods	Research Design	Does the research design align with the purpose of the study? Are the outcomes of interest relevant to the research question? Are the researchers blinded to the assignment of participants? Are the participants blinded to their group assignment? Does the research design include measures to limit the effects of extraneous variables? Are there potential sources of bias in the study design, and is the risk for bias low, moderate, or high?	___Strength ___Limitation ___Not Evident ___Not Applicable
Rationale:
Methods	Sample	Did the authors clearly describe both the general population of interestand the sample population? Are sampling methods adequately described? Are they likely to minimize bias? Does the study sample represent the population of interest? Were inclusion and exclusion criteria clearly described? Were inclusion criteria appropriate for the intended studypurpose? Was a sample-size calculation discussed and was the study sample size appropriate?	___ Strength ___Limitation ___Not Evident ___Not Applicable
Rationale:
Methods	Research Protocol	Wasthe study protocolclearly and adequately described? Was the protocol appropriate for the study purpose? Was the protocol realistic for a clinical or real-world setting? Was the protocol consistently administered toall participants in each group (other than thedifferences in interventions)? Did the researchers take steps to control for extraneous variables? Was the protocol ethical and approved by a Review Board?	___ Strength ___Limitation ___Not Evident ___Not Applicable
Rationale:
Methods	Data Collection	Were data collectionprocedures described and appropriate for thestudy purpose? Were data collection procedures consistently applied toall participants? Was the validity and reliability of data collection instruments ortools sufficiently established? Wasthereliability of researchers who measured or collected data established at a high enough level?	___Strength ___Limitation ___Not Evident ___Not Applicable
Rationale:
Results	Sample	Were groups similar in demographics, characteristics, and baseline outcome measurements at the beginning of the study? How are all participants who entered the study accounted for throughout the study? Was theattrition (dropout) rate compared between the treatment and control/comparison group?	___Strength ___Limitation ___Not Evident ___Not Applicable
Rationale:
/Methods/Results	Data Analysis	Was a statistical power analysis conducted and what did it indicate? Were data analyzed using an on-protocol or intention-to-treat analysis or both? If intention-to-treat analysis was used, what method was used toaccount for missing data? Were both descriptive and inferential statistics applied to the results? Were the statistical analyses appropriate for the level of data collected (nominal, ordinal, interval or ratio)? Were the statistical analyses appropriate to test the hypotheses and answer the research questions?	___Strength ___Limitation ___Not Evident ___Not Applicable
Rationale:
Results	Findings	Are findings presented relative to each hypothesis and research question? Are findings reported as statistically significant or not statistically significant? Are confidence intervals reported and does the test statistic fall within the confidence interval range? Do the findings have clinical significance or relevance?	___Strength ___Limitation ___Not Evident ___Not Applicable
Rationale:
Discussion		Did the researchers thoroughly explain their interpretation of the findings? Were the explanations logical? Did the researchers compare their findings tothose of similar previous studies? Did researchers provide a rationale on why they might differ? Are study limitations clearly identified and discussed? Do the researchers address implications for practice? What specific future research recommendations are made?	___Strength ___Limitation ___Not Evident ___Not Applicable
Rationale:
Conclusions		Is a clear conclusion providedthat aligns with the intended purpose of the study? Do the conclusions logically follow from the authors' interpretations of the findings?	___Strength ___Limitation ___Not Evident ___Not Applicable
Rationale: