Study design and settings: Forty-three patients have been enrolled in a multi-institutional prospective open enrollment study using the "Repose" bone screw system.
Prospective, observational, multicenter and voluntary enrollment study (Spanish registry ENVIN-HELICS) [1].
Because NVSA© diary completion started at enrollment (study week 0), week 1 NVSA© data (enrollment to week 1) were used for this analysis while KDQOL-36™ reflects enrollment (week 0) cPresence: FLIE Total < 108; Absence: FLIE Total ≥ 108.
Because NVSA© diary completion started at enrollment (study week 0), week 1 NVSA© data (enrollment to week 1) were used for this analysis while FLIE reflects enrollment (week 0).
At enrollment study subjects had a physical examination and medical history taken by the study nurse.
CM contributed to study enrollment, study logistics, quality control, and methods.
Methods, including enrollment, study design, and procedures, have been previously published [ 20].
This was an open enrollment study protocol in which the majority of the patients had prior treatment with chemotherapy, including gemcitabine, before being enrolled in the study.
During enrollment, study participants are also provided with instructions (including a log-in name and password) for accessing the study website to complete surveys or report adverse events.
Differing geographic areas included in our enrollment study list and different patient demographics may have greater or less incidence of AKI risk.
There were no differences between groups in patients enrolled in any randomized trial (209 (11.2%) versus 239 (12.8%), P = 0.14), or the proportion in each group enrolled in any of the five most common co-enrollment studies (197 (10.5%) versus 223 (11.9%), P = 0.20).
