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. 2023 May 9;2023(5):CD013350. doi: 10.1002/14651858.CD013350.pub2

Jordans 2019.

Study characteristics
Methods Study design: randomized controlled trial
Country: Nepal
Setting: community‐ and facility‐based primary care
Eligibility criteria: included were adults with alcohol use disorder. Excluded were individuals that were pregnant, needed urgent medical treatment, were diagnosed with psychosis or epilepsy, or were unable to communicate clearly.
Duration of follow‐up: 12‐months
Informed consent: all participants provided informed consent
Ethical approvals: study procedures were approved by the Nepal Health Research Council (NHRC), the University of Cape Town, and the World Health Organization
Participants Sample size: 162 (80 Counseling for Alcohol Problems, 82 mhGAP/treatment as usual)
Description of the target population: adults with alcohol problems in the community
Age: 16‐30: 13.0%; 30‐50: 59.9%, >50: 26.5%
Sex: 16.0% female
Race/Ethnicity: not reported
Marital status: 93.8% married
Harmful alcohol use (baseline): AUDIT median between 26‐27
Co‐occurring disorders: PHQ‐9 median between 7.5‐9
Interventions Type: non‐pharmacologic
Description: counseling for alcohol problems: a motivational interviewing‐based intervention consisting of personal assessment, developing cognitive‐behavioral skills, and relapse prevention/management
Duration and frequency: 4 individual sessions delivered weekly
Delivery and provider: community‐based counselors
Comparison group: treatment as usual (mhGAP), which includes assessment, psychoeducation, pharmacologic management, and referral
Outcomes Primary outcome(s): Hazardous alcohol use
Primary outcome measurement tool(s): AUDIT
Secondary outcome(s): disability, low‐risk drinking
Secondary outcome measurement tool(s): WHODAS, AUDIT
Time points: 3, 12‐months
Notes Study funding and conflicts of interest: UK Department of International Development, National Institutes of Health
Linked study records: ISRCTN Protocol ISRCTN72875710
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "After each participant completed their baseline assessments for the cohort study (without imposing a randomisation constraint), randomisation was done by the research coordinator in Kathmandu (N.P.L.) by using computer‐generated random numbers (in SPSS Version 22 for Windows). A list of numbers (1–400) was randomised so that each number corresponded to either the treatment or control group." Pg. 486
Allocation concealment (selection bias) Low risk Quote:"The ID code of each new eligible participant was sent to the research coordinator, who then matched it to the next number on the list." Pg. 486
"For those allocated to the treatment condition, the ID code was send to the study field coordinator and clinical supervisor so that they could connect these respondents to research assistant and community counsellors, respectively." Pg. 486
Blinding of participants and personnel (performance bias)
All outcomes High risk Quote:"participants could not be blinded" Pg. 487
Blinding of outcome assessment (detection bias)
All outcomes High risk "Research assessors were blinded to participants’ assignment to study arms" Pg. 487
Outcomes reported by participant not blind to intervention
Incomplete outcome data (attrition bias)
All outcomes Low risk Quote:"In the AUD trial, participants retained in and lost to follow‐up from the study differed in terms of religion and education." Pg. 488
"All outcome analyses were on an intention‐to‐treat basis with use of multiple imputation for those with missing outcome data. Continuous variables were imputed using Poisson models, whereas binary variables were imputed using logistic regression. Sensitivity analyses were conducted by running the same analyses among all participants with available data, without imputation." Pg. 488
Selective reporting (reporting bias) Low risk Article reports on primary outcomes from study protocol