Guidelines

Muscle-invasive and Metastatic Bladder Cancer

2. METHODS

2.1. Data identification

For the 2021 MIBC Guidelines, new and relevant evidence has been identified, collated and appraised through a structured assessment of the literature. A broad and comprehensive literature search, covering all sections of the MIBC Guideline was performed. The search was limited to English language publications. Databases searched included Medline, EMBASE and the Cochrane Libraries, covering a time frame between May 14th, 2020 and June 11th, 2021. A total of 2,290 unique records were identified, retrieved and screened for relevance resulting in 61 new publications having been included in the 2022 print. A detailed search strategy is available online:
https://uroweb.org/guideline/bladder-cancer-muscle-invasive-and-metastatic/?type=appendices-publications

For each recommendation within the guidelines there is an accompanying online strength rating form, the basis of which is a modified GRADE methodology [5,6] which addresses a number of key elements namely:

  1. the overall quality of the evidence which exists for the recommendation, references used in this text are grade according to a classification system modified from the Oxford Centre for Evidence-Based Medicine Levels of Evidence [7];
  2. the magnitude of the effect (individual or combined effects);
  3. the certainty of the results (precision, consistency, heterogeneity and other statistical or
    study related factors);
  4. the balance between desirable and undesirable outcomes;
  5. the impact of patient values and preferences on the intervention;
  6. the certainty of those patient values and preferences.

These key elements are the basis which panels use to define the strength rating of each recommendation. The strength of each recommendation is represented by the words ‘strong’ or ‘weak’ [6]. The strength of each recommendation is determined by the balance between desirable and undesirable consequences of alternative management strategies, the quality of the evidence (including certainty of estimates), and nature and variability of patient values and preferences.

Additional information can be found in the general Methodology section of this print, and online at the EAU website; http://www.uroweb.org/guideline/. A list of Associations endorsing the EAU Guidelines can also be viewed online at the above address.

The results of a collaborative multi-stakeholder consensus project on the management of advanced and variant BC have been incorporated in the 2020 MIBC Guidelines update [8,9]. Only statements which reached the a priori defined level of agreement - > 70% agreement and < 15% disagreement – across all stakeholders involved in this consensus project are listed. The methodology is presented in detail in the scientific publications. Since the publication of these consensus papers, emerging evidence prompted a re-evaluation of these findings, resulting in the removal of a number of consensus statements.

2.2. Peer-review

The 2021 print of the MIBC Guidelines were peer reviewed prior to publication.

2.2.1. Lay review

Post publication, the 2018 MIBC Guidelines were shared with seven patients treated for MIBC. Their comments were requested, but not limited to:

  • the overall tone of the guidelines content;
  • any missing information;
  • any information considered incorrect;
  • any information which is not presented in a clear fashion;
  • any text which is considered redundant and should be omitted;
  • any text section that should be more detailed.

Common comments across reviewers:

  • In general, the overall tone of the text was considered informational and instructive, but the language used obviously targets medical professionals, which make certain parts of the text difficult to understand for lay persons. The use of many abbreviations is considered an additional hindrance, as are the methodological elements. In case the EAU are considering producing a lay version of this text, the language needs to be adapted and clear instructions are to be provided.
  • It is difficult for lay reviewers to comment on what may be omitted since, in their opinion, they lack the expertise.
  • Some sections, such as ‘Recurrent disease’ and ‘Markers’ denote areas where less evidence is available. Consequently, the available data is less systematically presented which makes these sections more difficult to understand.
  • There is an interest whether screening for BC is a consideration.
  • In particular ‘follow-up’, ‘quality of life’ and ‘survivorship aspects’ should be elaborated on; providing additional information on what may be expected after treatment is considered very helpful for patients and their families. Also lifestyle elements would be of relevance (healthy living, ‘what to do to prevent cancer’). For this section, in particular, involvement of patients in the text development was considered missing. Transparency about the process of patient involvement in guidelines development was considered most relevant.

The MIBC Guidelines Panel is most grateful for the unique insights and guidance provided by the lay reviewers.

2.3. Future goals

Topics considered for inclusion in the 2023 update of the MIBC Guidelines:

  • a systematic review on the role of Positron Emission Tomography (PET) in the diagnosis and staging of patients presenting with suspected MIBC;
  • development of a diagnostic pathway for the assessment of visible and non-visible haematuria;
  • participation in developing strategies to ensure meaningful participation of patients in the development and implementation of the MIBC Guidelines.