CROSS-SECTIONAL ANALYSIS: INTERPRETATION OF NON-STATISTICALLY SIGNIFICANT RESULTS IN RANDOMISED CONTROLLED CLINICAL TRIALS IN REHABILITATION

Abstract

Introduction Despite the CONSORT guidelines, which aim to improve the quality of studies, authors often formulate conclusions based on the dichotomous distinction of the p-value, declaring differences between ′statistically significant′ and ′non-significant′. This approach confuses the identification of the real efficacy of the studied treatment. To solve this problem, CONSORT guidelines recommend using confidence intervals, which offer a more complete view of possible effects. However, authors′ conclusions often remain based on a binary approach, confusing the absence of evidence with the evidence of absence. This error can influence clinical practice and future research, leading to the identification of ′negative′ treatments based on ′statistical insignificance′, which reflects a lack of evidence of absence, not the absence of evidence. Objectives To assess the prevalence of misinterpretation of non-statistically significant results, both in the abstract and in the article, in a sample of all randomised controlled trials (RCTs) with non-statistically significant primary outcomes published in 5 rehabilitation journals with the highest impact factor (IF) published between 2019 and 2023 and to assess whether the primary outcome result is reported according to CONSORT guidelines. Methods We will conduct a cross-sectional analysis of all Rcts with non-statistically significant primary outcomes in 5 general rehabilitation journals with the highest IF published between 2019 and 2023. We will determine the prevalence of trials in which non-significance is interpreted as absence of evidence, evidence of absence, or advice to use the intervention in clinical practice in the abstract and article conclusions, and the prevalence of trials that adhered to CONSORT guidelines for reporting the primary outcome.

Competing Interest Statement

The authors have declared no competing interest.

Funding Statement

This study did not receive any funding

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

All data produced in the present work are contained in the manuscript

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