Study participation rate of patients with acute spinal cord injury early during rehabilitation

Abstract

Study design: Retrospective observational study. Objectives: To investigate the study participation rate of patients with acute spinal cord injury (SCI) early during rehabilitation after conveying preliminary study information. Setting: Single SCI rehabilitation center in Switzerland. Methods: Newly admitted acute SCI patients receive a flyer to inform them concerning the purpose of clinical research, patient rights and active studies. Upon patient request, detailed study information is given. The rate of patients asking for detailed information (study interest) and the rate of study participation was evaluated from May 2013 to October 2014. Furthermore, the number of patients not withdrawing consent to the utilization of coded health-related data was determined. Results: The flyer was given to 144 of the 183 patients admitted during the observation period. A total of 96 patients (67%) were interested in receiving detailed information, and 71 patients (49%) finally participated in at least one study. The vast majority of patients (that is, 91%) did not withdraw consent for retrospective data analysis. An age over 60 years had a significantly (P ⩽ 0.023) negative effect on study interest and participation, and the consent rate to retrospective data analysis was significantly (Po0.04) lower in patients older than 75 years. Study interest and participation were reduced more than 5 and 14-fold, respectively, in patients older than 60 years. Conclusions: The relatively low (approximately 50%) study participation rates of acute SCI patients should be considered when planning clinical trials. The recruitment of patients older than 60 years may be reduced substantially.

Process evaluation of a tailored work-related support intervention for patients diagnosed with gastrointestinal cancer

“…N = 1 no form-no information available **** From the total N = 10 N = 1 only a third meeting-no comparison of timing with first meeting percentage. Low or high inclusion rates have not be defined in the literature; however, similar 'low' rates were reported in other studies, all of them under 55% [23,[29][30][31]. A study by Tamminga et al [23], regarding a hospital-based intervention that was targeted at patients diagnosed with cancer, reported an inclusion rate similar to that in our study.…”

Spinal cord regeneration: A brief overview of the present scenario and a sneak peek into the future

“…[ 200–202 ] It is depressive to accept that most patients still prefer a wheelchair to elaborative treatment awaiting their active participation in medical institutes. [ 203 ] The advancement of technology from in‐vivo live cell imaging to Clustered regularly interspaced short palindromic repeats (CRISPR‐Cas) enabling genomic editing has now made it possible to observe dynamic changes induced by injury to repair mechanism following therapeutics. This review attempts to understand the multifaceted problem with three distinct approaches aimed towards restoring the native tissue property and attaining enhanced functional outcome via different routes.…”

Immunomodulation for primary prevention of urinary tract infections in patients with spinal cord injury during primary rehabilitation: protocol for a randomized placebo-controlled pilot trial (UROVAXOM-pilot)

“…We have therefore minimized the burden of trial assessments. In the present trial, potential participants are approached within the first 56 days after SCI, when many still feel overwhelmed by the new life-changing condition and thus may rather decline participation than consent [ 24 ]. Nevertheless, we have chosen this population to investigate, whether immunomodulation has an effect during the phase of immuno-depression shortly after SCI [ 25 ] and whether it prevents bladder colonization with pathogenic bacteria, which is very common in this population.…”