Page 23 - Demo

CUAJ %u2022 APRIL 2025 %u2022 VOLUME 19, ISSUE 4 93Guideline: IC/BPSguideline panel was comprised of six urologists from across Canada who subspecialize in IC/BPS, and two methodologists. Two members of the panel were community urologists. The GRADE methodology provides a systematic and rigorous approach to gathering, compiling, and interpreting evidence for a given clinical question, resulting in the determination of the level of certainty in the evidence (also known as the quality of the evidence). The certainty in the evidence can be rated as high, moderate, low, or very low. For a question regarding the treatment of diseases, this approach considers evidence arising from a body of randomized trials to represent high certainty and evidence from a body of observational studies to represent low certainty. These levels can be further rated down for methodologic limitations (risk of bias, inconsistency, imprecision, indirectness, and publication bias) or rated up in select circumstances (for high magnitude of effect and direction of plausible confounders).34-39Following determination of the certainty in the effect of any given treatment, EtD framework puts forth clear areas of consideration for the panels to deliberate when formulating a recommendation. These areas include desirable effects, undesirable effects, certainty of evidence, values, balance of effects, resources required, cost-effectiveness, equity, acceptability, and feasibility. Recommendations are then framed as either for or against an intervention compared with a standard in a specific population. Recommendations can either be strong or conditional, largely depending on the quality of evidence and the balance between desired and undesired effects. Interpreting recommendationsA strong recommendation implies that the guideline panel believes the vast majority of the patients would opt for the recommended treatment (or the comparator) when sufficiently informed about the benefits and risks of the treatment. More commonly, a conditionalrecommendation is made when the panel believes most of the patients would opt for the recommended course of action; however, a substantial minority of patients would choose the alternative. Therefore, it is crucial for the practitioner to focus on shared decision-making and informing the patient of the available evidence prior to making a decision.40The panel identified five main areas of interest to the guideline. Corresponding clinical questions were formulated within those areas and were updated through the process by iterative panel discussions to arrive at the final questions. In addition, the panel identified the outcomes that were critical to decision-making for the areas of interest.41 Notably, the area of intravesical cocktail could not be addressed systematically, given the variability of interventions and lack of evidence. In turn, the evidence was summarized narratively, and the recommendations were made having the EtD framework in mind. The clinical questions of interest are listed in Table 1.It is important to recognize that the panel did not set out a priori to create a treatment-based guideline. Without guidance or instruction, the panel reached consensus and the questions rated highest in importance all happened to be treatment-related. To synthesize the evidence, the panel identified the most comprehensive and most recent systematic reviews addressing the questions of interest and additional studies not included in the reviews. The original studies included from the reviews were assessed for eligibility and risk of bias. The data was then pooled de novo using direct comparison meta-analysis and certainty in the evidence was determined. The forest plots and summary of findings tables were created using STATA software and GRADEPro online software.40-42 The panel then reviewed the evidence during online meetings and voted on each domain of the EtD framework and achieved final recommendation through consensus.For the narrative section of the guideline, the panel members, who are experts with extensive experience on the subject and familiarity with the evidence, narratively reviewed the literature and summarized the accepted approach to this disease. Systematic evaluation of the evidence, as described above, was not conducted for this section of the guideline.Table 1. Clinical questions of interest1. Is oral pentosan polysulfate (Elmiron) indicated for the treatment of IC/BPS?2. What is the optimal intravesical cocktail for treatment of IC/BPS?3. Is intradetrusor onabotulinumtoxin-A indicated for the treatment of IC/BPS?4. What is the optimal treatment modality for treating Hunner lesion-IC/BPS?5. Is oral cyclosporin A indicated for the treatment of IC/BPS?IC/BPS: interstitial cystitis/bladder pain syndrome.