Bladder Managment for Adults with Spinal Cord Injury - 9

CLINICAL PRACTICE GUIDELINE

searches. Abstracts from the electronic search were downloaded and evaluated using the literature review process described below. The last step was to search Medline back to 1980 using the same search strategy in order to find relevant reviews and expert opinion papers on bladder management in individuals with SCI.
STUDY SELECTION

articles were then eligible for data extraction. Any study that was rejected at this level was reviewed by two researchers and listed in a reject log. This process resulted in 71 papers being accepted for data extraction. An additional 11 papers were linked publications (additional publications for a given cohort of individuals).
D ATA E X T R A C T I O N A N D D ATA B A S E DEVELOPMENT

To be eligible for inclusion in this review, studies had to meet the following criteria. Exclusion Criteria Studies were excluded if they contained the following elements: Abstracts, letters, comments, editorials. Animal and in vitro studies. Pharmacokinetic and pharmacodynamic studies. Language other than English. Publication prior to 1993. Inclusion Criteria Studies were included if they met the following criteria and did not meet any exclusion criteria: Any of the following study designs: interventional or observational. Any geographic location. Condition of interest: traumatic spinal cord injury in individuals age 13 or older. Study focus: bladder management. Case reports were set aside and given to the guideline development panel, but they were not extracted for inclusion in the database. Review articles published since 1980 were set aside for possible use in framing the discussion of findings in the systematic review. A complete list of these papers along with abstracts was provided to the guideline development panel for supplemental use in developing the guidelines.
SEARCH YIELD

Data extraction involves the capturing of various data elements from each study. This task was performed by one investigator using data extraction forms (DEFs) designed specifically for this project. A second investigator established a consensus for all extracted data, and a third investigator arbitrated any disagreements. The consensus versions of the DEFs were entered into MetaHub™, MetaWorks’ relational database of clinical trials information. After 100 percent of the entered data were validated against the consensus DEFs and full consistency and logic checks were performed on the database, the data were locked. After the data passed these quality control measures, they were used to generate evidence tables, which were delivered to the guideline development panel for review. The following data elements were extracted, when possible, from each accepted study. Study Characteristics Author and/or study name. Publication year. Geographic location (North America, Europe, Other). Study design: interventional (RCT, nRCT, UCS) or observational (prospective or retrospective cohort). Level of evidence (I–III). Study quality score (for RCTs only). Industry sponsorship (company name or not reported). Study duration and/or follow-up. Study sample (number of individuals enrolled). Voiding method (intermittent catheter, indwelling catheter, reflex voiding, Credé/Valsalva). Procedure/treatment to facilitate bladder management (e.g., surgery, pharmacology, acupuncture).

The searches yielded 1,421 abstracts. When all the abstracts were downloaded, a level 1 screening was performed in which the abstracts were reviewed against the exclusion criteria. The full article was obtained for all accepted abstracts and for those abstracts for which a clear determination could not be made. The full articles of 214 accepted studies underwent a level 2 screening in which both the inclusion and exclusion criteria were applied. After the level 2 screening was completed, all accepted

Bladder Managment for Adults with Spinal Cord Injury

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