Background:Challenging behaviors among people with dementia are frequently treated with pharmacological interventions, with antipsychotic medications being the treatment of choice. Concerns with the use of these medications include the risk of mortality, their side effects and their effectiveness in managing the challenging behaviors. Various non-pharmacological approaches have been implemented to manage the challenging behaviors; however there has been no review undertaken to investigate the effects of doll therapy in the management of challenging behaviors among people with dementia. Objectives:The overall objective of this study was to undertake a systematic review of the effects of doll therapy on challenging behaviors (including agitation and verbal or physical aggression) in people with dementia. Inclusion criteria Types of participants:This review considered studies that included adults (age >18years) diagnosed with dementia and living in a community setting or residential accommodation. Types of intervention(s)/phenomena of interest The intervention of interest was the use of doll therapy compared to pharmacological and or other non-pharmacological interventions. Types of studies All randomized, quasi-randomized and cluster randomized controlled trials evaluating the effect of doll therapy in managing challenging behaviors in people with dementia were included in the review. In the absence of randomized controlled trials, cohort, case-control and descriptive studies were included. Types of outcomes The outcomes of interest were changes in challenging behaviors including agitation, verbal and physical aggression, as well as interaction with staff, other patients and residents, activity level and quality of life. Search strategy The search aimed to find published and unpublished studies through electronic databases, reference lists, key reports and the World Wide Web. An extensive search was undertaken for the following databases MEDLINE, CINAHL, EMBASE, and the Cochrane Central Register of Controlled Trials. Databases were searched up to February 2014.The search for unpublished studies included: Dissertation Abstracts International, ProQuest Dissertation & Theses and MedNar. Methodological quality Methodological quality was assessed independently by three reviewers using the Joanna Briggs Institute Meta-Analysis of Statistics Assessment and Review Instrument checklists. Disagreements that arose between the reviewers were resolved through discussion. Data collection Quantitative data were extracted from papers included in the review using the standardized data extraction tool from the Joanna Briggs Institute Meta-Analysis of Statistics Assessment and Review Instrument. The data was extracted by one reviewer and checked by a second reviewer. Disagreements that arose between the reviewers were resolved through discussion. All results were subject to double data entry. Data synthesis For this review statistical pooling of the data was not possible due to the heterogeneity of the studies, therefore, the finding...