Study Design and Procedures Clause Samples
Study Design and Procedures. In a period of 4 months, three senior Industrial Engineering & Management students performed a total of 500 hours of observations, in 62 8-hours shifts in both ICUs. Prior to data collection, the observers met several times with the medical staff of the ICUs to develop rapport and consistency in the observation and coding process. Meetings with staff members from both ICUs helped observers understand and recognize when an AAE occurred. To ensure consistency among the three observers, the initial observations were conducted in pairs. The senior engineering students were selected to conduct observation as bias-free as possible. The observers received permission to perform the observations from the local research ethics committee, the hospital management, and the medical staff members. The observers did not interfere with the daily work and did not speak with the staff members while observing their work; they documented every activity they saw in the units. The observations only focused on the medical staff members while they were performing their tasks, and not on the patients in the units; therefore permission from parents was unnecessary. For the purpose of the study, an AAE was defined as an error that did not result in clinically significant adverse outcome [2]. The severity of each AAE observed in the NICU and the PICU was rated independently and anonymously by five medical staff members at each ICU, including three senior physicians and two senior nurses chosen by the ICU managers. The severity was rated on a three-point severity scale, where 1 represents an event that has no severe clinical implications or an event that could only cause a minor inconvenience to the patient, 2 represents an event that could potentially prolong the hospitalization or cause a severe illness, and 3 represents an event that could potentially result in the loss of a body organ, or a significant deterioration in patient’s status that can lead to death. The severity scale was based on expert opinion and developed by medical professionals and human factors researchers for the specific purpose of the research and was not statistically validated against actual outcomes. Each medical staff member received the AAEs descriptions prepared by the observers, and rated the severity based on personal opinion and experience. As soon as the task was completed, the files were returned to the researchers.
Study Design and Procedures. The Bay Area Heart Health Study recruited 95 African American men between the ages of 30 and 50 from the San Francisco Bay Area between February of 2010 and May of 2010. In order to be eligible, participants had to report being between 30 and 50 years of age, self identify as African American, report US nativity and parental US nativity, be free of any serious illness, and be able to read, write, and understand English. Participants were recruited from socioeconomically diverse neighborhoods through self-referral, posted advertisements, and word-of-mouth. A trained lay research staff performed data collection in a university or church room. Interviewers administered a questionnaire to assess basic demographic characteristics. Participants then completed a self-administered computer-assisted questionnaire that included psychological, socioeconomic, and behavioral measures. A minimally invasive physical was performed during which anthropometric and biological data were collected. Study participants were compensated with a $70 gift card. The University of California, San Francisco Committee on Human Research approved all study protocols. Telomere length was measured in dried blood spot (DBS) samples collected from study participants. To collect these samples, each participant’s finger was pricked with a micro-lancet, and the first drop of blood was wiped away. The four subsequent drops of about 50 µL were applied to filter paper, allowed to dry, and stored at -80 C (▇▇▇▇▇▇ et al., 2007). Genomic DNA was purified from the DBS samples, and telomere length was measured twice on each DBS sample with an average CV of 6.3% between the two runs for the entire sample of 95 specimens. The original published telomere length assay was adapted for this study (▇▇▇▇▇▇▇ ▇.▇., 2002; Lin et al., 2010). Because preliminary analyses suggested an absence of a linear relationship between predictor variables and LTL, Telomere lengths were divided into tertiles and categorized as ‘short,’ ‘medium,’ or ‘long.’ Several recent studies have analyzed quantiles of telomere length (e.g., ▇▇▇▇▇ et al., 2011; Weischer et al., 2013)
Study Design and Procedures. This is a multi-center post-market, single-arm, prospective follow-up study Assessment and Roll-in Phase Subjects will be recruited by the treating physicians, screened for eligibility, invited to participate in the study and provide informed consent. The subject’s demographics, medical history, co-morbidities and wound characteristics will be documented and the subject will complete a SF-36 quality of life questionnaire. Subject will be instructed on proper nutrition. Wound will undergo sharp debridement, be traced, photographed, and dressed per standard of care. Two tissue sections of at least 2mm will be retained for histological analysis. Subject will be fitted with and instructed on an offloading device. Subjects will return for MIRODERM treatment in two weeks. Treatment Phase On treatment day, wound will undergo sharp debridement, be traced, photographed and MIRODERM Biologic Wound Matrix will be applied. After treatment, subjects will be considered enrolled into the trial. Details of treatment will be documented. Subject will present weekly for the next twelve weeks. The dressing will be changed and may undergo further MIRODERM treatment if indicated. The wound will be traced and photographed. Physician will document their assessment on whether the wound is 100% closed. Subjects whose wound is completely closed at or prior to 12-weeks post- treatment, will be instructed to return 1-week following for a confirmation visit. Subjects whose wound is not assessed as closed by 12-weeks post-treatment, will have two tissue sections of at least 2mm collected, complete a quality of life assessment, and will then be discontinued per protocol. Confirmation Phase Subject will complete a quality of life assessment and have their wound area photographed. Physician will confirm the wound is still closed and the subject will be discontinued per protocol. If wound has reopened subject will return to the treatment phase. Subject Participation Subjects can be expected to reasonably participate in the study for a minimum of 9 weeks and a maximum of 15 weeks depending treatment course. Inclusion Criteria To be included in this study, subjects must: Be 18 years old or older at time of initial visit Have Type I or Type II diabetes Be willing and able to sign an informed consent Have a neuropathic diabetic foot ulcer with the following characteristics: • Is greater than 1 cm2 and less than or equal to 12 cm2 • Has failed to close following at least 2 treatments with a biol...
Study Design and Procedures