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Table 2 Quality assessment of randomized controlled trial included in review

From: Frequency patterns of core constipation symptoms among the Asian adults: a systematic review

Randomized controlled trial study Jayasimhan et al Support for the authors judgment
1. Selective + Quote: “Subjects were randomized using the sealed envelope method to either the treatment or placebo group…The placebo sample was similar in appearance and composition…”
a) Random sequence generation
b) Allocation concealment +
2) Performance + Quote: “Patients and researchers were blinded to the allocated groups and the treatment allocation was revealed at the end of the research, once analysis was done”
Patient returned home and would be reviewed for the outcome in the next appoinment (after 7 days)
a) Blinding of participants and personnel
3) Detection + Unlikely the blinding could have been broken.
Quote: “Follow-up was done at the end of the study period based on a questionnaire which includes symptomatic improvement and a stool diary”
a) Blinding outcome assessment
4) Attrition + Reasons for missing outcome data unlikely to be related to the true outcome.
Quote: “A total of 120 subjects were recruited but 12 did not complete the study and were considered dropouts. Dropouts were due to loss to follow-up, consent withdrawal and non-compliance such as consuming <80% of the test samples, intake of antibiotics, laxatives or other probiotics during the treatment period”
a) Incomplete outcome data
5) Reporting bias + The study protocol is available and all of the study’s pre-specified primary and secondary outcomes that are of interest in the review have been reported in the pre-specified way.
Quote: “The protocol was approved by the Institutional Review Board (IRB) of the University Malaya Medical Centre (Reference no: 866.59)…CONSORT diagram of patient recruitment and analysis”
a) Selective reporting
6) Other bias ? No description of what was defined by ‘normal diet’ which is an important risk of bias especially when this study consists of more than one ethnic and elderly population.
Justification for risk of bias + Low risk of bias for most key domains
  1. + Low risk of bias, − High risk of bias,? Unclear risk of bias