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De Silvestri Annalisa1, Scotti Valeria1, Capittini Cristina1, Curti Moreno1, Scudeller Luigia2, Klersy Catherine1


1. Fondazione IRCCS Policlinico San Matteo Pavia, Italy

2. Fondazione IRCCS Ca’ Granda Ospedale Maggiore, Italy



In conducting systematic reviews the role of librarian is essential in implementing a good search strategy. But other role are possible. For example, librarians could greatly contribute to develop quality assessment tools to evaluate papers potentially eligible for meta-analysis. 

Our aim was to develop and propose a checklist for quality assessment of genetic studies, to be used by different stakeholders involved in SRs in genetics. No specific formal tool to assess quality of this kind of studies is available to date, although the HuGENet™ HuGE Review Handbook, a guideline for conducting systematic reviews (SR) in genetic association studies; includes a chapter on assessing and addressing potential biases [1].


A multidisciplinary panel (statistician, clinical epidemiologist, geneticists, clinicians, meta-analysts, librarians) adopted formal consensus methods with the following steps:

  • preliminary conceptual decisions (focus group);
  • item generation, taking into account existing guidelines in similar field (e.g. QUADAS) and guidelines for reporting genetic studies (STREGA) (review of the relevant methodological literature) [2-3] retrieved in a systematic search performed by the librarians in the team;
  •  assessment of face validity (Delphi rounds);
  • pilot trial (application to an ongoing systematic review);
  •  field trials to assess consistency and construct validity;
  •  the generation of the refined instrument (planned).

’Quality' was defined to include both the internal and external validity of a study.


We adopted the following principles for checklist development: quality assessment to be used in systematic reviews of genetic association studies, assessing the methodological quality of a study in generic terms (relevant to all studies), allow consistent and reliable assessment of quality by raters with different backgrounds, be relatively short and simple to complete. From an initial 63 potential items (choosen with the aid of the articles retrieved by librarians), we selected 39 items, in three domains (geneticist n=11, clinicians n=14, statistician n=14). This was used in 3 meta-analyses on association between autoimmune diseases and HLA-class II alleles [4-6]. Reliability (Cohen kappa of agreement ranging from 0.79 to 0.97) and feasibility (median time needed to complete <20’ )


Our work will assess item consistency, construct validity, and feasibility (including time needed to complete), also in other genetic systems (not only HLA genes). Our tool will help in standardizing procedures in SRs in this field. Also for developing a methodological bibliographic research., librarians has an important and strategical role to play.


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