Table 3Strengths and Limitations of Clinical Studies Using the Downs and Black Checklist7

Strengths Limitations
Feinstein et al. (2018)9
  • The objective of the study, the main outcomes to be measured, the characteristics of the patients included in the study, the interventions of interest, and the main findings were clearly described.
  • Safety and tolerability of the interventions were reported.
  • The study had 2 patients lost to follow-up, but ITT analysis was applied for the main outcomes.
  • Actual probability and standard deviation values were reported for the main outcomes.
  • All patients not lost to follow-up were followed up for the same length of time (i.e., 90 minutes).
  • Statistical tests were used appropriately, and the main outcome measures were accurate and reliable.
  • Patients in different intervention groups appeared to be recruited from the same population and over the same period of time.
  • As the study population was relatively small (N = 31), it was unclear if the study participants represented the entire population from which they were recruited.
  • As the study was conducted at a university research setting, it was unclear if staff, places, and facilities where the patients were treated were representative of the treatment the majority of patients receive.
  • This was a non-blinded crossover RCT, in which investigators and patients were aware of the treatment. This may have resulted in high risk of bias.
  • The authors of the study did not report whether a sample size calculation was performed.
Jonsson and Kjellgren (2016)10
  • The objective of the study, the main outcomes to be measured, the characteristics of the patients included in the study, the interventions of interest, and the main findings were clearly described.
  • Actual probability and standard deviation values were reported for the main outcomes.
  • All patients not lost to follow-up were followed up for the same length of time (i.e., 12 treatment sessions over 7 weeks and 6 months of follow-up after treatment).
  • Statistical tests were used appropriately, and the main outcome measures were accurate and reliable.
  • Patients in different intervention groups appeared to be recruited from the same population and over the same period of time.
  • Sample size calculation was performed in the study.
  • The study did not report on safety or tolerability of the interventions.
  • This study had 4 patients lost to follow-up, and ITT analysis was not applied for the main outcomes.
  • As the study population was relatively small (N = 50), it was unclear if the study participants represented the entire population from which they were recruited.
  • As the study was conducted at a university research setting, it was unclear if staff, places, and facilities where the patients were treated were representative of the treatment the majority of patients receive.
  • This was a non-blinded parallel-group RCT, in which investigators and patients were aware of the treatment. This may have resulted in high risk of bias.

ITT = intention-to-treat; RCT = randomized controlled trial.

From: Floatation Therapy for Mental Health Conditions

Cover of Floatation Therapy for Mental Health Conditions
Floatation Therapy for Mental Health Conditions: CADTH Health Technology Review [Internet].
Tran K, Loshak H; Authors.
Copyright © 2021 Canadian Agency for Drugs and Technologies in Health.

Except where otherwise noted, this work is distributed under the terms of a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International licence (CC BY-NC-ND), a copy of which is available at http://creativecommons.org/licenses/by-nc-nd/4.0/

NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.