DEUDAS A LARGO PLAZO POR PRÉSTAMOS RECIBIDOS Y OTROS CONCEPTOS.

Noknoy 2010 RCT Thailand (Continued)

stage, the main technique was feedback, using reflection and questioning skills to elicit self motivational statements. If change was contemplated, the study nurse would work with the patient’s ambivalence using a pros and cons technique. At the same time, an empathic counselling style and encouragement of the patient’s self efficacy were used to support change in drinking behaviour. Subsequently, each participant’s readiness to change drinking behaviour was assessed. If in the determination stage, options on how to reduce drinking behaviour were provided

CONTROL:Patients without MET intervention, who were told that the trial focused on health behaviours, which included questions on smoking, exercise, eating behaviour, weight and alcohol use (to minimise intervention effect on health behaviour)

CO-INTERVENTIONS:None

Outcomes Patient:AUDIT tool (for screening); outcome measures: health survey questionnaire

that included amount of alcohol consumption in the previous week*, measured in 4 ways (mean drinking/per drinking day/previous week, hazardous drinking/drinking day/ previous week, mean drinking/per week, hazardous drinking/per week) and number of episodes of binge drinking in 7 days, frequency of accidents and traffic accidents and frequency of being drunk in the last month. GGT: blood test for evaluation of current drinking severity§, and honesty/accuracy of patient information through collateral in- formant interviews§

Carer:None

Process/health worker outcomes:None Economic outcomes:None

(*: primary outcomes of the study; §: outcomes that we have not reported in this review) Time points:Baseline, 6 weeks (post-intervention), 3 months, 6 months

Notes Source of funding:Thai Health Promotion Foundation

Notes on validation of instruments:AUDIT is validated but not the health survey Additional information:Provided by authors for characteristics of NSHWs and inter- vention

Handling the data:As per footnotes in data and analysis Prospective trial registration number:No protocol Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection bias)

Low risk Quote: “The unit of randomisation was

the individual patient. Randomization of subjects to the intervention and control groups was carried out from the Coordi- nating Centre in Phramong-Kutklao Hos- pital in Bangkok using a standard randomi- sation table. Each PCU had both control and intervention groups. In order to keep both groups of similar size, random alloca- tion was done in blocks. On average, the trial was to have 6-8 participants in each study condition in each PCU”

Noknoy 2010 RCT Thailand (Continued)

Allocation concealment (selection bias) Low risk Quote: “Randomization codes were dis-

tributed to each PCU in sealed envelopes. Eligible study participants were enrolled by health personnel when subjects”

Blinding of participants and personnel (performance bias)

All outcomes

Low risk Quote: “In order to minimize the in-

tervention effect of the research proce- dures, the subjects randomised into the control condition were told that the trial focused on health behaviours, which in- cluded questions on smoking, exercise, eat- ing behaviour, weight and alcohol use. The study interviewers at follow-up visits were not aware of the assignment allocation of the study participants”

Blinding of outcome assessment (detection bias)

objective outcomes

Low risk Comment:Less than 20% of those were

meant to have GGT test dropped out

Blinding of outcome assessment (detection bias)

subjective outcomes

High risk Comment:The tools were not validated

Baseline outcome measurements similar Low risk Comment:All similar

Baseline characteristics similar? Low risk Comment:All similar

Incomplete outcome data (attrition bias) Efficacy data

High risk Comment:There is < 20% dropout rate in

intervention between baseline and last fol- low-up; however, there is more than 20% dropout rate in the control group. May af- fect the outcomes. No mention about anal- ysis of the control dropouts, therefore clas- sify as high risk

Incomplete outcome data (attrition bias) Safety data (e.g. adverse events)

High risk Information from author: “We didn’t

look for the adverse event. However, I have found that there was problems there were some cases of participants that need to be excluded as it was not originally detected” Comment:they have not searched for ad- verse events of the intervention

Protection against contamination Low risk Quote: “In order to minimize the in-

tervention effect of the research proce- dures, the subjects randomised into the control condition were told that the trial focused on health behaviours, which in- 151 Non-specialist health worker interventions for the care of mental, neurological and substance-abuse disorders in low- and middle-

Noknoy 2010 RCT Thailand (Continued)

cluded questions on smoking, exercise, eat- ing behaviour, weight and alcohol use” Comment: Also unlikely contamination between groups as dispersed communities (clinics) and not aware the intervention was regarding alcohol necessarily

Reliable primary outcome measures High risk Comment:Many subjective outcomes but

GGT objective - but not always specific to alcohol disease

Selective reporting (reporting bias) Low risk Comment:All outcomes reported

Other bias High risk Comment:The trial showed an increase in

GGT at 6 months in both groups possibly because baseline data was collected just af- ter ’Kao Pansaa’ a 3-month Buddhist retreat where it is customary for people to avoid wrongdoing including reducing drinking

Papas 2011 RCT Kenya

Methods Study design:Randomised, gender-stratified, parallel group, open-label, controlled clin- ical trial

Duration of study:February to December 2009

Participants Country:Kenya

Income classification:Low income

Geographical scope:Urban, HIV clinic affiliated with Moi Teaching and Referral Hos- pital, Eldoret, Kenya

Healthcare setting:Outpatient clinic

Mental health condition:Hazardous use of alcohol or binge drinking Population:Patients

• Age:≥18 years

• Gender:Both

• Socioeconomic background:Not specified

• Inclusion criteria:≥18 years, enrolment as an AMPATH HIV outpatient attending the Eldoret clinic affiliated with Moi Teaching and Referral Hospital, hazardous or binge drinking criteria (score≥3 on the AUDIT-C, or more than 6 drinks per occasion at least monthly), any alcohol use in the past 30 days, being antiretroviral eligible or antiretroviral initiated in the past 12 months, spoken knowledge of Kiswahili, living within 1 hour’s travelling distance from the clinic, no plans to move further away during the study period and being available during the weekly group time

• Exclusion criteria:Active psychosis or suicidal, attendance in the past year at an existing AMPATH alcohol peer support group or participation in the study’s group CBT pre-pilot development

Papas 2011 RCT Kenya (Continued)

Interventions Stated purpose:To use CBT due to empirical evidence of success in reducing risky

behaviours in African HIV-infected people, and its structured format that makes it feasible to train paraprofessionals

INTERVENTION 1: