Bladder Managment for Adults with Spinal Cord Injury - 11

CLINICAL PRACTICE GUIDELINE

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Hydronephrosis (improved/no change/worse/present or new). Bladder neck obstruction (improved/no change/worse/present or new). Bladder calculi. Renal calculi. Chronic pyelonephritis. Renal failure. Urethral stricture. Other urologic complications.

Levels of Evidence The concept of levels of evidence grew out of the work of the Canadian Task Force for the Periodic Health Examination, which tied recommendations for preventive health measures to an assessment of the supporting evidence in the published literature. For this review, the assignment of levels of evidence was based on the following criteria from the Steering Committee on Clinical Practice Guidelines for the Care and Treatment of Breast Cancer published by the Canadian Medical Association: I. Evidence based on randomized controlled clinical trials (or meta-analysis of such trials) of adequate size to ensure a low risk of incorporating false-positive or false-negative results.

Complications of the intervention. Number of deaths. Urodynamic Outcomes Bladder capacity (ml). Maximum detrusor pressure (cm H2O). Compliance (mllcm H2O). Post-void residual volume (ml). Other. Economic (Utilization) Outcomes Hospitalization frequency (number of individuals hospitalized per unit time). Emergency room visits (per unit time). Cost of treatment (hospitalizations, emergency room visits, pharmacy, other). Humanistic outcomes: • • Quality of life before and after intervention or therapy. Quality of life instrument name and score or number of individuals with improved/worse/no change. General psychological and social health: mobility, independence, activity, sexual function, satisfaction with treatment.

II. Evidence based on randomized controlled trials that were too small to provide level I evidence. These may have shown either positive trends that were not statistically significant or no trends and were associated with a high risk of false-negative results. III. Evidence based on nonrandomized, controlled or cohort studies, case series, case-controlled studies, or cross-sectional studies. IV Evidence based on the opinion of respected . authorities or that of expert committees as indicated in published consensus conferences or guidelines. V . Evidence that expressed the opinion of those individuals who were writing and reviewing these guidelines, based on their experience, knowledge of the relevant literature, and discussion with peers.

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E V I D E N C E A N A LY S I S

All studies accepted for data extraction were given a grade for Level of Evidence using the criteria described below. In addition, randomized clinical trials were assessed using the Jadad Quality Score Assessment (“Index to Measure the Likelihood of Bias in Pain Research Reports”). Industry sponsorship was also noted.

These five levels of evidence do not directly describe the quality or credibility of evidence. Rather, they indicate the nature of the evidence being used. In general, a randomized, controlled trial has the greatest credibility (level I); however, it may have defects that diminish its value, and these should be noted. Evidence that is based on too few observations to give a statistically significant result is classified as level II. In general, level III studies carry less credibility than level I or II studies, but credibility is increased when consistent results are obtained from several level III studies carried out at different times and in different places. Decisions must often be made in the absence of published evidence. In these situations it is necessary to use the opinion of experts based on their knowledge and clinical experience. All such evi-

Bladder Managment for Adults with Spinal Cord Injury

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