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      Feasibility of a pragmatic randomized adaptive clinical trial to evaluate a brief negotiational interview for harmful and hazardous alcohol use in Moshi, Tanzania

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          Abstract

          Introduction

          Low-resourced settings often lack personnel and infrastructure for alcohol use disorder treatment. We culturally adapted a Brief Negotiational Interview (BNI) for Emergency Department injury patients, the “Punguza Pombe Kwa Afya Yako (PPKAY)” (“Reduce Alcohol For Your Health”) in Tanzania. This study aimed to evaluate the feasibility of a pragmatic randomized adaptive controlled trial of the PPKAY intervention.

          Materials and methods

          This feasibility trial piloted a single-blind, parallel, adaptive, and multi-stage, block-randomized controlled trial, which will subsequently be used to determine the most effective intervention, with or without text message booster, to reduce alcohol use among injury patients. We reported our feasibility pilot study using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework, with recruitment and retention rates being our primary and secondary outcomes. We enrolled adult patients seeking care for an acute injury at the Kilimanjaro Christian Medical Center in Tanzania if they (1) exhibited an Alcohol Use Disorder Identification Test (AUDIT) ≥8, (2) disclosed alcohol use prior to injury, or (3) had a breathalyzer ≥0.0 on arrival. Intervention arms were usual care (UC), PPKAY, PPKAY with standard text booster, or a PPKAY with a personalized text booster.

          Results

          Overall, 181 patients were screened and 75 enrolled with 80% 6-week, 82.7% 3-month and 84% 6-month follow-up rates showing appropriate Reach and retention. Adoption measures showed an overwhelmingly positive patient acceptance with 100% of patients perceiving a positive impact on their behavior. The Implementation and trial processes were performed with high rates of PPKAY fidelity (76%) and SMS delivery (74%). Intervention nurses believed Maintenance and sustainability of this 30-minute, low-cost intervention and adaptive clinical trial were feasible.

          Conclusions

          Our intervention and trial design are feasible and acceptable, have evidence of good fidelity, and did not show problematic deviations in protocol. Results suggest support for undertaking a full trial to evaluate the effectiveness of the PPKAY, a nurse-driven BNI in a low-income country.

          Trial registration

          Trial registration number NCT02828267. https://classic.clinicaltrials.gov/ct2/show/NCT02828267.

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          Most cited references64

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          Alcohol use and burden for 195 countries and territories, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016

          Summary Background Alcohol use is a leading risk factor for death and disability, but its overall association with health remains complex given the possible protective effects of moderate alcohol consumption on some conditions. With our comprehensive approach to health accounting within the Global Burden of Diseases, Injuries, and Risk Factors Study 2016, we generated improved estimates of alcohol use and alcohol-attributable deaths and disability-adjusted life-years (DALYs) for 195 locations from 1990 to 2016, for both sexes and for 5-year age groups between the ages of 15 years and 95 years and older. Methods Using 694 data sources of individual and population-level alcohol consumption, along with 592 prospective and retrospective studies on the risk of alcohol use, we produced estimates of the prevalence of current drinking, abstention, the distribution of alcohol consumption among current drinkers in standard drinks daily (defined as 10 g of pure ethyl alcohol), and alcohol-attributable deaths and DALYs. We made several methodological improvements compared with previous estimates: first, we adjusted alcohol sales estimates to take into account tourist and unrecorded consumption; second, we did a new meta-analysis of relative risks for 23 health outcomes associated with alcohol use; and third, we developed a new method to quantify the level of alcohol consumption that minimises the overall risk to individual health. Findings Globally, alcohol use was the seventh leading risk factor for both deaths and DALYs in 2016, accounting for 2·2% (95% uncertainty interval [UI] 1·5–3·0) of age-standardised female deaths and 6·8% (5·8–8·0) of age-standardised male deaths. Among the population aged 15–49 years, alcohol use was the leading risk factor globally in 2016, with 3·8% (95% UI 3·2–4·3) of female deaths and 12·2% (10·8–13·6) of male deaths attributable to alcohol use. For the population aged 15–49 years, female attributable DALYs were 2·3% (95% UI 2·0–2·6) and male attributable DALYs were 8·9% (7·8–9·9). The three leading causes of attributable deaths in this age group were tuberculosis (1·4% [95% UI 1·0–1·7] of total deaths), road injuries (1·2% [0·7–1·9]), and self-harm (1·1% [0·6–1·5]). For populations aged 50 years and older, cancers accounted for a large proportion of total alcohol-attributable deaths in 2016, constituting 27·1% (95% UI 21·2–33·3) of total alcohol-attributable female deaths and 18·9% (15·3–22·6) of male deaths. The level of alcohol consumption that minimised harm across health outcomes was zero (95% UI 0·0–0·8) standard drinks per week. Interpretation Alcohol use is a leading risk factor for global disease burden and causes substantial health loss. We found that the risk of all-cause mortality, and of cancers specifically, rises with increasing levels of consumption, and the level of consumption that minimises health loss is zero. These results suggest that alcohol control policies might need to be revised worldwide, refocusing on efforts to lower overall population-level consumption. Funding Bill & Melinda Gates Foundation.
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            Global burden of disease and injury and economic cost attributable to alcohol use and alcohol-use disorders.

            Alcohol consumption has been identified as an important risk factor for chronic disease and injury. In the first paper in this Series, we quantify the burden of mortality and disease attributable to alcohol, both globally and for ten large countries. We assess alcohol exposure and prevalence of alcohol-use disorders on the basis of reviews of published work. After identification of other major disease categories causally linked to alcohol, we estimate attributable fractions by sex, age, and WHO region. Additionally, we compare social costs of alcohol in selected countries. The net effect of alcohol consumption on health is detrimental, with an estimated 3.8% of all global deaths and 4.6% of global disability-adjusted life-years attributable to alcohol. Disease burden is closely related to average volume of alcohol consumption, and, for every unit of exposure, is strongest in poor people and in those who are marginalised from society. The costs associated with alcohol amount to more than 1% of the gross national product in high-income and middle-income countries, with the costs of social harm constituting a major proportion in addition to health costs. Overall, we conclude that alcohol consumption is one of the major avoidable risk factors, and actions to reduce burden and costs associated with alcohol should be urgently increased.
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              Effectiveness of brief alcohol interventions in primary care populations

              Excessive drinking is a significant cause of mortality, morbidity and social problems in many countries. Brief interventions aim to reduce alcohol consumption and related harm in hazardous and harmful drinkers who are not actively seeking help for alcohol problems. Interventions usually take the form of a conversation with a primary care provider and may include feedback on the person's alcohol use, information about potential harms and benefits of reducing intake, and advice on how to reduce consumption. Discussion informs the development of a personal plan to help reduce consumption. Brief interventions can also include behaviour change or motivationally‐focused counselling. This is an update of a Cochrane Review published in 2007. To assess the effectiveness of screening and brief alcohol intervention to reduce excessive alcohol consumption in hazardous or harmful drinkers in general practice or emergency care settings. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and 12 other bibliographic databases to September 2017. We searched Alcohol and Alcohol Problems Science Database (to December 2003, after which the database was discontinued), trials registries, and websites. We carried out handsearching and checked reference lists of included studies and relevant reviews. We included randomised controlled trials (RCTs) of brief interventions to reduce hazardous or harmful alcohol consumption in people attending general practice, emergency care or other primary care settings for reasons other than alcohol treatment. The comparison group was no or minimal intervention, where a measure of alcohol consumption was reported. 'Brief intervention' was defined as a conversation comprising five or fewer sessions of brief advice or brief lifestyle counselling and a total duration of less than 60 minutes. Any more was considered an extended intervention. Digital interventions were not included in this review. We used standard methodological procedures expected by Cochrane. We carried out subgroup analyses where possible to investigate the impact of factors such as gender, age, setting (general practice versus emergency care), treatment exposure and baseline consumption. We included 69 studies that randomised a total of 33,642 participants. Of these, 42 studies were added for this update (24,057 participants). Most interventions were delivered in general practice (38 studies, 55%) or emergency care (27 studies, 39%) settings. Most studies (61 studies, 88%) compared brief intervention to minimal or no intervention. Extended interventions were compared with brief (4 studies, 6%), minimal or no intervention (7 studies, 10%). Few studies targeted particular age groups: adolescents or young adults (6 studies, 9%) and older adults (4 studies, 6%). Mean baseline alcohol consumption was 244 g/week (30.5 standard UK units) among the studies that reported these data. Main sources of bias were attrition and lack of provider or participant blinding. The primary meta‐analysis included 34 studies (15,197 participants) and provided moderate‐quality evidence that participants who received brief intervention consumed less alcohol than minimal or no intervention participants after one year (mean difference (MD) ‐20 g/week, 95% confidence interval (CI) ‐28 to ‐12). There was substantial heterogeneity among studies (I² = 73%). A subgroup analysis by gender demonstrated that both men and women reduced alcohol consumption after receiving a brief intervention. We found moderate‐quality evidence that brief alcohol interventions have little impact on frequency of binges per week (MD ‐0.08, 95% CI ‐0.14 to ‐0.02; 15 studies, 6946 participants); drinking days per week (MD ‐0.13, 95% CI ‐0.23 to ‐0.04; 11 studies, 5469 participants); or drinking intensity (‐0.2 g/drinking day, 95% CI ‐3.1 to 2.7; 10 studies, 3128 participants). We found moderate‐quality evidence of little difference in quantity of alcohol consumed when extended and no or minimal interventions were compared (‐20 g/week, 95% CI ‐40 to 1; 6 studies, 1296 participants). There was little difference in binges per week (‐0.08, 95% CI ‐0.28 to 0.12; 2 studies, 456 participants; moderate‐quality evidence) or difference in days drinking per week (‐0.45, 95% CI ‐0.81 to ‐0.09; 2 studies, 319 participants; moderate‐quality evidence). Extended versus no or minimal intervention provided little impact on drinking intensity (9 g/drinking day, 95% CI ‐26 to 9; 1 study, 158 participants; low‐quality evidence). Extended intervention had no greater impact than brief intervention on alcohol consumption, although findings were imprecise (MD 2 g/week, 95% CI ‐42 to 45; 3 studies, 552 participants; low‐quality evidence). Numbers of binges were not reported for this comparison, but one trial suggested a possible drop in days drinking per week (‐0.5, 95% CI ‐1.2 to 0.2; 147 participants; low‐quality evidence). Results from this trial also suggested very little impact on drinking intensity (‐1.7 g/drinking day, 95% CI ‐18.9 to 15.5; 147 participants; very low‐quality evidence). Only five studies reported adverse effects (very low‐quality evidence). No participants experienced any adverse effects in two studies; one study reported that the intervention increased binge drinking for women and two studies reported adverse events related to driving outcomes but concluded they were equivalent in both study arms. Sources of funding were reported by 67 studies (87%). With two exceptions, studies were funded by government institutes, research bodies or charitable foundations. One study was partly funded by a pharmaceutical company and a brewers association, another by a company developing diagnostic testing equipment. We found moderate‐quality evidence that brief interventions can reduce alcohol consumption in hazardous and harmful drinkers compared to minimal or no intervention. Longer counselling duration probably has little additional effect. Future studies should focus on identifying the components of interventions which are most closely associated with effectiveness. Effectiveness of brief alcohol interventions in primary care populations What is the aim of this review? We aimed to find out whether brief interventions with doctors and nurses in general practices or emergency care can reduce heavy drinking. We assessed the findings from 69 trials that involved a total of 33,642 participants; of these 34 studies (15,197 participants) provided data for the main analysis. Key messages Brief interventions in primary care settings aim to reduce heavy drinking compared to people who received usual care or brief written information. Longer interventions probably make little or no difference to heavy drinking compared to brief intervention. What was studied in the review? One way to reduce heavy drinking may be for doctors and nurses to provide brief advice or brief counselling to targeted people who consult general practitioners or other primary health care providers. People seeking primary healthcare are routinely asked about their drinking behaviour because alcohol use can affect many health conditions. Brief interventions typically include feedback on alcohol use and health‐related harms, identification of high risk situations for heavy drinking, simple advice about how to cut down drinking, strategies that can increase motivation to change drinking behaviour, and the development of a personal plan to reduce drinking. Brief interventions are designed to be delivered in regular consultations, which are often 5 to 15 minutes with doctors and around 20 to 30 minutes with nurses. Although short in duration, brief interventions can be delivered in one to five sessions. We did not include digital interventions in this review. Search date The evidence is current to September 2017. Study funding Funding sources were reported by 60 (87%) studies. Of these, 58 studies were funded by government institutes, research bodies or charitable foundations. One study was partly funded by a pharmaceutical company and a brewers association, another by a company developing diagnostic testing equipment. Nine studies did not report study funding sources. What are the main results of the review? We included 69 controlled trials conducted in many countries. Most studies were conducted in general practice and emergency care. Study participants received brief intervention or usual care or written information about alcohol (control group). The amount of alcohol people drank each week was reported by 34 trials (15,197 participants) at one‐year follow‐up and showed that people who received the brief intervention drank less than control group participants (moderate‐quality evidence). The reduction was around a pint of beer (475 mL) or a third of a bottle of wine (250 mL) less each week. Longer counselling probably provided little additional benefit compared to brief intervention or no intervention. One trial reported that the intervention adversely affected binge drinking for women, and two reported that no adverse effects resulted from receiving brief interventions. Most studies did not mention adverse effects. Quality of the evidence Findings may have been affected because participants and practitioners were often aware that brief interventions focused on alcohol. Furthermore, some participants could not be contacted at one‐year follow‐up to report drinking levels. Overall, evidence was assessed as mostly moderate‐quality. This means the reported effect size and direction is likely to be close to the true effect of these interventions.
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                Author and article information

                Contributors
                Role: ConceptualizationRole: Funding acquisitionRole: Project administrationRole: SupervisionRole: Writing – original draftRole: Writing – review & editing
                Role: Writing – original draftRole: Writing – review & editing
                Role: Data curationRole: Formal analysisRole: Project administrationRole: Writing – original draft
                Role: Data curationRole: Formal analysisRole: Writing – original draft
                Role: SupervisionRole: Writing – review & editing
                Role: Data curationRole: InvestigationRole: ResourcesRole: SoftwareRole: Writing – review & editing
                Role: ConceptualizationRole: Writing – review & editing
                Role: ConceptualizationRole: Writing – review & editing
                Role: ConceptualizationRole: Writing – review & editing
                Role: ConceptualizationRole: SupervisionRole: Writing – review & editing
                Role: ConceptualizationRole: Formal analysisRole: MethodologyRole: SoftwareRole: Writing – review & editing
                Role: Editor
                Journal
                PLoS One
                PLoS One
                plos
                PLOS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                3 August 2023
                2023
                : 18
                : 8
                : e0288458
                Affiliations
                [1 ] Division of Emergency Medicine, Duke University School of Medicine, Durham, NC, United States of America
                [2 ] Duke Global Health Institute, Duke University, Durham, NC, United States of America
                [3 ] Kilimanjaro Christian Medical Centre, Moshi, Tanzania
                [4 ] Kilimanjaro Clinical Research Institute, Moshi, Tanzania
                [5 ] Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittbsurgh, PA, United States of America
                [6 ] Department of Emergency Medicine, University of Maryland School of Medicine, Baltimore MD, United States of America
                [7 ] Department of Epidemiology, Georgia State University School of Public Health, Atlanta, GA, United States of America
                [8 ] Kilimanjaro Christian Medical University College, Moshi, Tanzania
                PLOS: Public Library of Science, UNITED KINGDOM
                Author notes

                Competing Interests: The authors have declared that no competing interests exist.

                Author information
                https://orcid.org/0000-0002-6468-2894
                https://orcid.org/0000-0002-5247-529X
                Article
                PONE-D-21-39881
                10.1371/journal.pone.0288458
                10399826
                37535693
                2555edd0-6990-4774-913b-18397ece7d5d
                © 2023 Staton et al

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 25 January 2022
                : 26 June 2023
                Page count
                Figures: 1, Tables: 4, Pages: 19
                Funding
                Funded by: funder-id http://dx.doi.org/10.13039/100000061, Fogarty International Center;
                Award ID: K01-TW010000-01A1
                Award Recipient :
                Funded by: funder-id http://dx.doi.org/10.13039/100000061, Fogarty International Center;
                Award ID: 1R01AA027512-01A1
                Award Recipient :
                This project was conducted with funding from the National Institutes of Health Fogarty International Center K01- TW010000-01A1 (PI Staton). Subsequently, the PI received further funding (1R01AA027512-01A1) from the Fogarty International Center to evaluate this intervention. The sponsor had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
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                Data cannot be shared publicly because of confidentiality and privacy concerns surrounding the human participant data. Data are only available upon request as data transfer requires a written agreement approved by the National Institute for Medical Research (Tanzania). Data inquiries can be sent to Gwamaka W. Nselela at gwamakawilliam14@ 123456gmail.com .

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