Background: Gastrointestinal tuberculosis (TB) is diagnostically challenging; therefore, many cases are treated presumptively. We aimed to describe features and outcomes of gastrointestinal TB, determine whether a clinical algorithm could distinguish TB from non-TB diagnoses, and calculate accuracy of diagnostic tests. Methods: We conducted a prospective cohort study of hospitalized patients in Kota Kinabalu, Malaysia, with suspected gastrointestinal TB. We recorded clinical and laboratory characteristics and outcomes. Tissue samples were submitted for histology, microscopy, culture and GeneXpert MTB/RIF®. Patients were followed for up to 2 years. Results: Among 88 patients with suspected gastrointestinal TB, 69 were included in analyses; 52 (75%) had a final diagnosis of gastrointestinal TB; 17 had a non-TB diagnosis. People with TB were younger (42.7 versus 61.5 years, p = 0.01) and more likely to have weight loss (91% versus 64%, p = 0.03). An algorithm using age < 44, weight loss, cough, fever, no vomiting, albumin > 26 g/L, platelets > 340 × 10 9 /L and immunocompromise had good specificity (96.2%) in predicting TB, but very poor sensitivity (16.0%). GeneXpert® performed very well on gastrointestinal biopsies (sensitivity 95.7% versus 35.0% for culture against a gold standard composite case definition of confirmed TB). Most patients (79%) successfully completed treatment and no treatment failure occurred, however adverse events (21%) and mortality (13%) among TB cases were high. We found no evidence that 6 months of treatment was inferior to longer courses. Conclusions: The prospective design provides important insights for clinicians managing gastrointestinal TB. We recommend wider implementation of high-performing diagnostic tests such as GeneXpert® on extra-pulmonary samples.

Gastrointestinal tuberculosis (TB) is diagnostically challenging; therefore, many cases are treated presumptively. We aimed to describe features and outcomes of gastrointestinal TB, determine whether a clinical algorithm could distinguish TB from non-TB diagnoses, and calculate accuracy of diagnostic tests. Methods We conducted a prospective cohort study of hospitalized patients in Kota Kinabalu, Sabah, Malaysia, with suspected gastrointestinal TB. We recorded clinical and laboratory characteristics and outcomes. Tissue samples were submitted for histology, microscopy, culture and GeneXpert MTB/RIF®. Patients were followed for up to two years. Results Among 88 patients with suspected gastrointestinal TB, 69 were included in analyses; 52 (75%) had a final diagnosis of gastrointestinal TB; 17 had a non-TB diagnosis. People with TB were younger (42.7 versus 61.5 years, p=0.01) and more likely to have weight loss (91% versus 64%, p=0.03). An algorithm using age <44, weight loss, cough, fever, no vomiting, albumin >26 g/L, platelets >340 x109/L and immunocompromise had good specificity (96.2%) in predicting TB, but very poor sensitivity (16.0%). GeneXpert® performed very well on gastrointestinal biopsies (sensitivity 95.7% versus culture 35.0% against a gold standard case definition of confirmed TB). Most patients (79%) successfully completed treatment and no treatment failure occurred, however adverse events (21%) and mortality (13%) among TB cases were high. We found no evidence that six months of treatment was inferior to longer courses. Conclusions The prospective design provides important insights for clinicians managing gastrointestinal TB. We recommend wider implementation of high-performing diagnostic tests such as GeneXpert® on extra-pulmonary samples.

Background Gastrointestinal tuberculosis (TB) is diagnostically challenging; therefore, many cases are treated presumptively. We aimed to describe features and outcomes of gastrointestinal TB, determine whether a clinical algorithm could distinguish TB from non-TB diagnoses, and calculate accuracy of diagnostic tests. Methods We conducted a prospective cohort study of hospitalized patients in Kota Kinabalu, Malaysia, with suspected gastrointestinal TB. We recorded clinical and laboratory characteristics and outcomes. Tissue samples were submitted for histology, microscopy, culture and GeneXpert MTB/RIF®. Patients were followed for up to two years. Results Among 88 patients with suspected gastrointestinal TB, 69 were included in analyses; 52 (75%) had a final diagnosis of gastrointestinal TB; 17 had a non-TB diagnosis. People with TB were younger (42.7 versus 61.5 years, p=0.01) and more likely to have weight loss (91% versus 64%, p=0.03). An algorithm using age <44, weight loss, cough, fever, no vomiting, albumin >26 g/L, platelets >340 x10 9 /L and immunocompromise had good specificity (96.2%) in predicting TB, but very poor sensitivity (16.0%).GeneXpert® performed very well on gastrointestinal biopsies (sensitivity 95.7% versus 35.0% for culture against a gold standard composite case definition of confirmed TB). Most patients (79%) successfully completed treatment and no treatment failure occurred, however adverse events (21%) and mortality (13%) among TB cases were high. We found no evidence that six months of treatment was inferior to longer courses. Conclusions The prospective design provides important insights for clinicians managing gastrointestinal TB. We recommend wider implementation of high-performing diagnostic tests such as GeneXpert® on extra-pulmonary samples. Background Gastrointestinal tuberculosis (TB) is a relatively uncommon form of TB which is defined as infection of the peritoneum, abdominal organs or abdominal lymphatic system.(1) TB control programs typically focus on pulmonary TB which is the predominant form of the disease; extra-pulmonary TB, in particular gastro-intestinal TB, is relatively neglected. This is likely due to it being more difficult to diagnose and lacking the transmission potential of smear-positive pulmonary TB. However, extrapulmonary TB, including gastrointestinal TB often represents the worst end of the TB disease severity 4 spectrum, with poorer prognosis and treatment outcomes.(2) Severe and potentially life-threatening complications of gastrointestinal TB include intestinal strictures, obstruction, perforation and bleeding.(3) TB is a disease of major public health importance in Malaysia. Sabah State, located in Malaysian Borneo, has a particularly high burden of disease, accounting for approximately 20 to 30 per cent of Malaysia's TB cases despite having only 10 per cent of Malaysia's population.(4, 5) Gastrointestinal TB is particularly difficult to diagnose, with only a minority of cases able to be microbiologically confirmed. This creates risks of both under a...