| Criteria |
Parameters |
Rationale |
| Inclusion criteria |
Population
• Age: adults (≥ 18 years or ≥ 16 years if defined by author)
•Sex: any
•Race: any
•Disease: advanced or metastatic malignant melanoma |
•Mean age of diagnosis is 50 years. Approximately 20% of melanoma cases occur in young adults aged 15 to 39 years
•Melanoma can occur in both men and women, although men are at a higher risk
•Clinical trials and other studies usually enroll participants of all races to have a sample population representative of the larger population and to reduce bias. Patients with other types of skin cancers (non-melanoma skin cancers), such as basal cell and squamous-cell cancers, Kaposi sarcoma, and lymphoma of the skin, were not included |
| Intervention
•Dabrafenib (GSK2118436)
•Trametinib (GSK1120212)
•Ipilimumab
•Vemurafenib
•Dacarbazine
•Fotemustine |
•The interventions listed were included as both monotherapy and combination therapy
•These interventions were identified from clinical practices or ongoing clinical trials for the treatment of metastatic malignant melanoma |
| Comparator
•Any treatment from the above mentioned included list of interventions
•Placebo or best supportive care
•Any other chemotherapy
•Any immunotherapy |
•These comparators were selected to potentially enable both direct and indirect treatment comparisons between the interventions of interest |
| Study design
•RCTs with any blinding status
•nRCTs
•Observational studies
•Single-arm studies |
•RCTs are the gold standard of clinical evidence, minimizing the risk of confounding and allowing the comparison of the relative efficacy of interventions. To enhance the level of evidence, studies with double-blind, single-blind, and open-label designs were included
•Apart from providing long-term benefit data, nRCTs will supplement evidence provided by RCTs. Observational studies include wider patient populations and present real-life effectiveness data |
| Language restrictions
•English only |
•The restriction does not limit results substantially due to data availability provided in English |
| Publication time frame
•1960 to October 22, 2012 for literature searches
•2010 to 2012 for conference searching |
•Studies presented at conferences are usually published in journals within three years |
| Exclusion criteria |
•No subgroup analysis for the disease or intervention of interest
•Conference abstracts published before 1990 |
•Studies with no subgroup data for the disease were not included, because these studies could introduce heterogeneity into the review. Studies that enrolled a mixed population of stage I, II, III, and IV melanoma will be included only if there is a subgroup analysis of the stage III or IV patient population
•Studies presented in very old conferences would have been published in journals as full-text articles and would have been retrieved from our searches |
| nRCT: non-Randomized Controlled Trial; RCT:Randomized Controlled Trial |
