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. 2021 Dec 21;2021(12):CD002008. doi: 10.1002/14651858.CD002008.pub5

Paton 2004.

Study characteristics
Methods RCT.
Parallel design with 2 treatment arms.
Duration: 24 weeks (intervention for 6 or 12 weeks and follow‐up to 24 weeks).
Location: single centre (Hospital‐based TB Control Unit, Singapore).
Participants Inclusion criteria: males and females aged 18 ‐ 69 years old, evidence of active tuberculosis (symptoms of fever or cough + sputum smear ‐ acid‐fast bacilli or chest x‐ray), evidence of wasting (BMI < 20 kg/m2), started on combination antituberculous chemotherapy within the previous 2 weeks.
Exclusion criteria: diabetes mellitus, severe underlying disease, concomitant corticosteroid or immunosuppressive therapy, positive HIV test or considered at risk of HIV infection, past history of noncompliance to tuberculosis therapy, unable to tolerate conventional treatment, required inpatient treatment for their disease.
Number randomised: 36 participants (intervention group, n = 15; control group, n = 13). Attrition: 10 participants lost to follow‐up (4 in intervention group and 6 in control group).
Gender split: intervention group 8 (47%) males and 11 (53%) females; control group 8 (42%) males and 9 (58%) females.
Age: mean (SD), intervention group 39.5 (14.3) years; control group 38.4 (19.3) years.
Nutritional status: mean(SD) BMI, intervention 16.7 (1.5) kg/m2; control 17.9 (1.9) kg/m2.
Interventions Intervention: participants received dietary advice and ONS in the form of advice to increase intake, aim 35 kcal/kg body weight/day; high energy oral nutritional supplements (2 ‐ 3 packets/day), contacted by telephone to assess progress, target of 35 kcal/kg and explained why important to meet, also phoned at 2 ‐ 3 weeks, 6 weeks and 12 weeks.
Control: participants received no dietary advice and no ONS in the form of general advice to address any major dietary imbalance identified, instructed to increase intake as they could but no specific instructions.
Outcomes Weight*, BMI, body composition (DEXA)*, energy intake*, grip strength*, QoL, physical function (sit‐to‐stand test).
Publication details Language: English.
Funding: none detailed.
Publication status: peer‐reviewed journal.
Notes Additional data requested from author.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: sequence generated by a member of staff not otherwise involved in the study.
Allocation concealment (selection bias) Low risk Described as shuffling of sealed opaque envelopes.
Blinding (performance bias and detection bias)
Clinical outcomes Low risk Not stated but assessment of mortality unlikely to be affected by lack of blinding.
Blinding (performance bias and detection bias)
Functional outcomes Unclear risk Not stated but assessment of functional outcomes may have been affected by lack of blinding.
Blinding (performance bias and detection bias)
Nutritional outcomes Unclear risk Not stated but assessment of nutritional outcomes may have been affected by lack of blinding.
Blinding of participants and personnel (performance bias)
All outcomes High risk Not described and likely that researchers and participants were aware of group allocation as this was a nutritional intervention. It is possible that assessment of some outcomes was influenced by lack of blinding.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Not stated and assessment of some outcomes may have been affected by lack of blinding.
Incomplete outcome data (attrition bias)
All outcomes Low risk Attrition fully reported and reasons balanced between groups. 10/36 (28%) participants lost to follow‐up at participants' request, 4/19 (21 %) in dietary advice and supplement group and 6/17 (35 %) in dietary advice group.
Selective reporting (reporting bias) Unclear risk No protocol identified. All specified outcomes reported but some in unusable format. Data on change in energy intake was presented in the text and not suitable for entry into meta‐analysis therefore obtained from author. Other data were extracted from the paper although 'n' for weight and grip strength were clarified with the authors.
Other bias Low risk Baseline variables given, groups similar at baseline.