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Table 3 Examples of study text that were categorized in each analytic theme

From: Recommendations and evidence for reporting items in pediatric clinical trial protocols and reports: two systematic reviews

Analytic theme

Example of study text that was categorized within the analytic theme

Transparency

“It is our hope that more transparent reporting on consenting procedures, sample composition, and demographic characteristics would enable future studies on the association between consenting procedures and these variables, which may ultimately increase our knowledge about the impact of the unspoken rule requiring the collection of parental consent.” [45]

Reproducibility

“Other investigators should be able to replicate a vaccine trial in different settings and populations. Outcomes across trials can then be compared using: for example, the same serological cutoff points at the same intervals.” [14]

Interpretability

“Experienced practitioners and researchers also need to appreciate how setting and child characteristics affect the validity and interpretation of measures.” [158]

Usefulness

“When designing an RCT, investigators must also specify the size of the treatment effect that can be detected reliably with the proposed sample size. This minimum detectable treatment difference and the actual choice of the primary outcome strongly affect the clinical utility of the study results.” [159]

Internal validity

“Hence, it is the authors’ responsibility to demonstrate the measurement properties (validity, reliability, responsiveness) of the outcome measures used in their studies.” [160]

External validity

“As stated previously, investigators should justify such exclusions. Overly restrictive criteria concerning exclusion of patients with concurrent diagnoses seriously limit the generalizability of study results.” [161]

Reporting bias

“Selective reporting of clinical trials can also hamper the ability of conducting systematic reviews of the pediatric literature.” [89]

Publication bias

“Registration also provides a mechanism for addressing publication bias.” [162]

Accountability

“Why register trials? To satisfy public demand for unbiased evidence on the effectiveness of treatments, and to promote the public accountability of medical research in general.” [163]

Scientific soundness

“Environmental research with children should be scientifically justified, with sound research questions and valid study protocols of sufficient statistical power …” [164]

Research ethics

“In our opinion, it is very important for ethical reasons to state at least if informed consent was obtained and if the study was approved by the responsible REC.” [165]

  1. RCT randomized controlled trial