MEDLINE (Ovid) (1966 through October 2004), Medline Daily Update (October 22, 2004), Medline In-Process & Other Non-Indexed Citations (October 22, 2004), HealthStar (1975 through September 2004), CINAHL (1982 through October 2004), EMBASE (Ovid) (1982 through 2004 Week 42), and the Cochrane Library (2004, Issue 4) databases were searched. The search strategy for MEDLINE is shown in Appendix 1 in the original guideline document; searches in other databases were similar. Literature searches were not restricted for publication type or study design.
In addition, conference proceedings of the American Society of Clinical Oncology (1995-2004) and the American Society of Hematology (1996-2004) were searched for abstracts of relevant trials. The Canadian Medical Association Infobase (http://mdm.ca/cpgsnew/cpgs/index.asp), the National Guideline Clearinghouse (http://www.guideline.gov/), and the National Institute for Clinical Excellence (http://www.nice.org.uk/) were also searched for existing evidence-based practice guidelines.
Relevant articles and abstracts were selected and reviewed by two reviewers, and the reference lists from these sources were searched for additional trials. Personal files were also searched.
Study Selection Criteria
Inclusion Criteria
Articles of study designs of any type (including systematic reviews, meta-analyses, and evidence-based practice guidelines) were selected for inclusion in this systematic review of the evidence if they were published full report articles or published meeting abstracts in the English language of:
- Studies including adult patients with myeloma, Waldenstrom's macroglobulinemia, or lymphoma (any histologic subtype, stage, performance status, or disease type)
- Studies evaluating bortezomib as a single agent or in combination with other regimens
- Comparative trials, in which bortezomib could be compared with any agent, any combination of agents, or placebo
- Results reporting one or more of the following outcomes: survival, quality of life, disease control (e.g., time-to-progression [TTP]), response duration, response rate, or adverse effects
Exclusion Criteria
Studies were excluded if they were:
- Letters, comments, books, notes, or editorial publication types
- Studies reporting fewer than 20 patients (all disease types combined)
Article Selection
Citations in the initial search of the literature were reviewed by two independent reviewers for inclusion. Citations were not blinded for the selection process. Each citation was scored as "Yes" (inclusion criteria were met, no exclusion criteria were met), "No" (one or more exclusion criteria were met), or "Maybe" (unclear from the citation if article meets any criteria). All discrepancies were resolved by consensus between the two reviewers and, if necessary, scored by a third reviewer. Interobserver kappa coefficients were calculated using GraphPad QuickCalcs © (GraphPad Software, Inc.) (http://graphpad.com/quickcalcs/kappa1.cfm). Any subsequent exclusions of selected articles were documented.