Factors associated with development of gastrointestinal problems in patients with scleroderma: a protocol for a systematic review

BACKGROUND Scleroderma affects the gastrointestinal (GI) tract in 90% of all cases. Malnutrition, diarrhea, and constipation are some GI complications that can stem from scleroderma, and they contribute considerably to impairment in quality of life. Reports of haphazard clusters of high prevalence suggest that environmental exposure is a risk factor for scleroderma. However, it is largely uncertain whether the GI involvement secondary to scleroderma is influenced by these environmental factors. This study will review the association between GI involvement (unintentional weight loss, choking, early satiety, etc.) and environmental exposure in patients with scleroderma. METHODS/DESIGN Any available observational studies that report GI problems in patients with scleroderma along with the associated risk factors will be selected. We will search CINAHL, EMBASE, LILACS, MEDLINE, and Web of Science for relevant articles written in English from June 1884 to May 2014. Identified articles will be screened in duplicate, and full text for selected articles will be retrieved. Data extraction will be done in duplicate on sociodemographic characteristics of participants, diagnosis of scleroderma, diagnosis of risk of GI problem, risk factors reported, etc. Discrepancies will be resolved by consensus or by consulting a third author. We will assess the participants, methods, and intervention effects of included studies for heterogeneity. Any identified clinical or statistical heterogeneity will be explored visually or using the chi-square test. Data will be pooled statistically using the DerSimmonian and Laird random effects method if we have a measure of relative risk and its precision. Our findings will be reported according to the Meta-Analyses and Systematic Review of Observational Studies (MOOSE) guideline. DISCUSSION Our findings may help patients with scleroderma and health care professionals in preventing GI morbidity. Knowing that the cost of care for patients with scleroderma increases with more organ involvement, study findings can inform policy developers to identify ways to curb health care costs. SYSTEMATIC REVIEW REGISTRATION PROSPERO CRD42014010707.